tag:blogger.com,1999:blog-27740421258836582024-03-19T05:02:35.295-05:00Holman's Biotech IP BlogChris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.comBlogger193125tag:blogger.com,1999:blog-2774042125883658.post-14080338866796009792016-05-09T14:20:00.001-05:002016-05-09T14:20:42.708-05:00DNA Copyright and Sequence Searching (Part 1)<br />
<span style="font-size: large;">A couple of months ago I wrote a </span><a href="http://holmansbiotechipblog.blogspot.com/2016/03/copyright-for-engineered-dna-part-3.html"><span style="font-size: large;">three-part series of blog posts</span></a><span style="font-size: large;"> for GQ Life Sciences on the topic of copyright for engineered genetic sequences. Given GQ Life Sciences' status as a leading provider of patent sequence search services, I thought it would be interesting to write a couple posts that consider the potential role of sequence searching under a legal regime that recognizes copyright protection for engineered DNA. The first installment of this two-part series, which focuses on the use of sequence searching by the Copyright Office in conjunction with its copyright registration function, is available </span><a href="https://www.gqlifesciences.com/unlocking-dna-copyright-protection-with-sequence-searches-part-1/"><span style="font-size: large;">here</span></a><span style="font-size: large;">.</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com194tag:blogger.com,1999:blog-2774042125883658.post-39676771606031171192016-03-21T16:38:00.003-05:002016-03-21T16:38:50.222-05:00Sequenom Petitions Supreme Court for Review of Ariosa Decision<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">Sequenom today filed a Petition for Writ of Certiorari
asking the Supreme Court to review <em>Ariosa Diagnostics v. Sequenom</em>, an
important patent eligibility case described in previous posts (see for
<a href="http://holmansbiotechipblog.blogspot.com/2015/08/here-are-all-amicus-briefs-that-have.html">example</a>).<span style="mso-spacerun: yes;"> </span>If the Court grants
certiorari, it will be the sixth grant of certiorari on the issue of patent
eligibility in the last decade (the first was <i style="mso-bidi-font-style: normal;">LabCorp v. Metabolite</i>, a case that was fully briefed and argued but
ultimately dismissed because certiorari had been “improvidently granted”).<span style="mso-spacerun: yes;"> </span>Significantly, it would be the fourth case in
which the patent relates to diagnostic testing (<i style="mso-bidi-font-style: normal;">LabCorp,</i> <i style="mso-bidi-font-style: normal;">Mayo</i>, and <i style="mso-bidi-font-style: normal;">Myriad </i>where the other three).<span style="mso-spacerun: yes;"> </span>The petition for certiorari is available
</span><a href="https://drive.google.com/file/d/0B9_llJGo9WK0N1ota19PdGNOTmc/view?usp=sharing"><span style="font-family: Times, "Times New Roman", serif; font-size: large;">here</span></a><span style="font-family: Times, "Times New Roman", serif; font-size: large;">.</span><br />
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;"><span style="font-family: Times, "Times New Roman", serif;"><o:p> </o:p>As framed by Sequenom, the question presented
is:</span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<blockquote class="tr_bq">
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">Whether a novel method is patent-eligible where: (1) a
researcher is the first to discover a natural phenomenon; (2) that unique
knowledge motivates him to apply a new combination of known techniques to that
discovery; and (3) he thereby achieves a previously impossible result without
preempting other uses of the discovery?</span></blockquote>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;"><span style="font-family: Times, "Times New Roman", serif;">Sequenom argues that the Federal Circuit’s interpretation of<i style="mso-bidi-font-style: normal;"> Mayo</i> will have catastrophic effects on
biomedical innovation, likely precluding effective patent protection for
important inventions such as vaccines, methods of pharmaceutical treatment, and
most particularly methods of diagnostics.<span style="mso-spacerun: yes;">
</span>Pointing to three opinion penned by Federal Circuit judges in the denial
of en banc rehearing, Sequenom argues that the Federal Circuit believes that
its hands have been tied by the broad language of<i style="mso-bidi-font-style: normal;"> Mayo</i>, and that only the Supreme Court can address the situation.</span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;"><span style="font-family: Times, "Times New Roman", serif;">Sequenom argues that the Federal Circuit’s decision below has
exacerbated the confusion created by<i style="mso-bidi-font-style: normal;"> Mayo</i>
“by jettisoning the one reliable compass this Court has identified for Section
101 cases-the patent’s ‘preemptive’ scope.”<span style="mso-spacerun: yes;">
</span>Their brief posits that under the Federal Circuit’s interpretation of<i style="mso-bidi-font-style: normal;"> Mayo</i>, a number of historic inventions
would have failed the test for patent eligibility, including the method at issue in<i style="mso-bidi-font-style: normal;"> Diehr</i> (which the Supreme Court found to
be patent eligible in 1981), the invention claimed in the very first patent
issued in the U.S. (which was signed by George Washington after being reviewed by Thomas Jefferson),
and PCR.<o:p></o:p></span></span></div>
<span style="font-size: large;"><span style="font-family: Times, "Times New Roman", serif;">
The petition argues that this case is an ideal
vehicle for clarifying <i style="mso-bidi-font-style: normal;">Mayo</i>, pointing
out that “this is an extremely well-ventilated patent, with a far-more-developed
record than is usual for Section 101 cases.”<span style="mso-spacerun: yes;">
</span>For example, the claims have been construed and the patent has already
undergone inter partes review.<span style="mso-spacerun: yes;"> </span>In
addition, the patent includes not only relatively broad independent claims, but
also narrower dependent claims that “refine down to the level of individual
tests.”<o:p></o:p></span></span><br />
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;"><span style="font-family: Times, "Times New Roman", serif;">According to Sequenom, supporting amicus briefs will need to
be filed no later than April 20.<span style="mso-spacerun: yes;"> </span>I would
expect to see a number of those.<span style="mso-spacerun: yes;"> </span>Quite a
few were filed with the Federal Circuit in support of en banc rehearing - many of
them can be found in previous posts on my blog.<o:p></o:p></span></span></div>
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span></div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com28tag:blogger.com,1999:blog-2774042125883658.post-32081931719679781702016-03-18T17:59:00.001-05:002016-03-18T17:59:55.339-05:00PTAB Denies Institution of IPR for Amgen’s ENBREL Patent<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<span style="font-size: large;"><span style="font-family: Times, "Times New Roman", serif;">
On March 11, 2016, the Patent Trial and Appeal Board (PTAB) <a href="https://drive.google.com/file/d/0B9_llJGo9WK0Y3E4bTZ3UC1YSHc/view?usp=sharing">denied</a> </span><span style="font-family: Times, "Times New Roman", serif;">institution of Inter Partes Review (IPR) for U.S. Patent Number
8,163,522.<span style="mso-spacerun: yes;"> </span>This is an important
biotechnology patent, directed towards polynucleotides encoding a fusion
protein comprising the extracellular region of an insoluble human TNF receptor
and “all of the domains of the constant region of human IgG1 immunoglobulin
heavy chain other than the first domain of said constant region.”<span style="mso-spacerun: yes;"> </span>The ‘522 patent is owned by Hoffman-La Roche
and exclusively licensed to Amgen - according to Amgen, the patent would be
infringed by the marketing ofa biosimilar version of Amgen’s Enbrel.<o:p></o:p></span></span><br />
<span style="font-family: Times, "Times New Roman", serif; font-size: large;"></span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;"><span style="font-family: Times, "Times New Roman", serif;">The petition for IPR was brought by a group including Hayman
Capital, Kyle Bass, and the Coalition for Affordable Medicine (hereinafter I
will refer to the group as simply the “Coalition”).<span style="mso-spacerun: yes;"> </span>The Coalition has made a name for itself filing
IPR challenges on pharmaceutical patents and then essentially betting against
the targeted companies (as discussed in a previous post).<span style="mso-spacerun: yes;"> </span>In its petition challenging the ‘522 patent,
the Coalition cited several prior art patents that disclose DNA sequences
encoding the TNF receptor and immunoglobulin fusion proteins, and argued that
it would have been obvious to combine the references to arrive at the claimed
invention.<o:p></o:p></span></span></div>
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;"><span style="font-family: Times, "Times New Roman", serif;">In denying institution of IPR, the Board found that the
Coalition had “failed to show an articulated reason with a rational
underpinning why one of skill in the art would have combined the teachings of [the
cited prior art] to arrive at the claimed invention.”<span style="mso-spacerun: yes;"> </span>All of the prior art cited by the Coalition was
before the patent examiner during prosecution of the patent, and this appeared
to weigh against its case.<span style="mso-spacerun: yes;"> </span>Furthermore,
the Board pointed out that the Coalition had not adequately addressed the
objective indicia of nonobviousness presented to the Office during the
prosecution of the patent.<span style="mso-spacerun: yes;"> </span>This included
“expert testimony concerning the unexpected results of improved TNF binding
affinity, potency, kinetic stability, and reduced antibody effector function
and aggregation ability.”<o:p></o:p></span></span></div>
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">A decision to institute IPR would have been good news for
Sandoz.<span style="mso-spacerun: yes;"> </span>In a lawsuit filed February 26,
2016, Amgen charges Sandoz with infringing the ‘522 patent, based on FDA’s
acceptance of Sandoz’s abbreviated Biologics License Application (“aBLA”)
seeking approval to market a biosimilar version of Enbrel.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">See</i>
<i style="mso-bidi-font-style: normal;">Immunex Corp. v. Sandoz Inc.</i>, Case
No. 2:16-cv-01888 (D.N.J.) (</span><a href="https://drive.google.com/file/d/0B9_llJGo9WK0aGVjY0hGZnRjMzg/view?usp=sharing"><span style="font-family: Times, "Times New Roman", serif; font-size: large;">complaint</span></a><span style="font-family: Times, "Times New Roman", serif; font-size: large;">).</span></div>
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;"><span style="font-family: Times, "Times New Roman", serif;">In 2013, Sandoz had filed a declaratory judgment action
seeking a determination that the ‘522 patent is invalid or would not be infringed
by its biosimilar version of Enbrel.<span style="mso-spacerun: yes;"> </span>In
that case, however, the Federal Circuit upheld the district court’s decision to
dismiss the case for lack of standing, given that at the time Sandoz had not
filed an application for FDA approval to market a biosimilar version of Enbrel.<span style="mso-spacerun: yes;"> </span><i style="mso-bidi-font-style: normal;">See Sandoz
Inc. v. Amgen Inc</i>., 773 F.3d 1274, 1275 (Fed. Cir. 2014).<i style="mso-bidi-font-style: normal;"><o:p></o:p></i></span></span></div>
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Times, "Times New Roman", serif; font-size: large;"> </span></o:p></div>
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Times, "Times New Roman", serif; font-size: large;"> </span></o:p></div>
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Times, "Times New Roman", serif; font-size: large;"> </span></o:p></div>
<span style="font-family: Times, "Times New Roman", serif; font-size: large;">
</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com44tag:blogger.com,1999:blog-2774042125883658.post-53943695207235882852016-03-10T11:15:00.001-06:002016-03-10T11:15:37.299-06:00Copyright for Engineered DNA (Part 3)<span style="font-size: large;"></span><br />
<span style="font-size: large;">The third installment of my series of blog posts on copyright for engineered DNA is now available on the </span><a href="https://www.gqlifesciences.com/copyright-for-engineered-dna-part-3/"><span style="font-size: large;">GQ Life Sciences Blog</span></a><span style="font-size: large;"> for anyone who might be interested.</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com10tag:blogger.com,1999:blog-2774042125883658.post-60433289602824506322016-03-02T10:46:00.000-06:002016-03-02T10:46:10.682-06:00Copyright for Engineered DNA (Part 2)<span style="font-size: large;"></span><br />
<span style="font-size: large;"><span style="font-family: inherit;">Part 2 of my series of posts on the topic of Copyright for Engineered DNA on the <span>GQ Life Sciences Blog is now available <a href="https://www.gqlifesciences.com/copyright-for-dna-part-2/">here</a>.</span></span></span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com9tag:blogger.com,1999:blog-2774042125883658.post-51224017445152142762016-02-25T10:19:00.000-06:002016-02-25T10:23:33.093-06:00Cleveland Clinic Foundation v. True Health Diagnostics: District Court Finds Diagnostic Claims Patent-Ineligible<span style="font-family: inherit; font-size: large;">
</span><br />
<span style="font-family: inherit; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-family: inherit; font-size: large;">On February 23, 2016, a judge in the Northern District of Ohio
found three patents invalid for ineligible subject matter on a Rule 12(b)(6)
motion to dismiss (see </span><a href="https://drive.google.com/file/d/0B9_llJGo9WK0X2xCQjVhbDFoc1U/view?usp=sharing"><span style="font-family: inherit; font-size: large;">opinion and order</span></a><span style="font-size: large;"><span style="font-family: inherit;">).<span style="mso-spacerun: yes;"> </span>The patents, U.S. Patents
Numbers 7,223,552, 7,459,286, and 8,349,581, are generally directed towards
Myeloperoxidase (“MPO”) testing, which analyzes inflammation of the blood
vessels to assess a patient’s risk for cardiovascular disease.<span style="mso-spacerun: yes;"> </span>MPO is an enzyme released by white blood
cells when inflammation occurs in the body, and thus MPO is an early symptom of
many types of cardiovascular disease.<o:p></o:p></span></span></span></div>
<span style="font-family: inherit; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><span style="font-family: inherit;">The claims recite limitations such as “<em>comparing</em> levels of [MPO]
in a bodily sample from the test subject with levels of [MPO] in comparable
bodily samples from control subjects diagnoses not having the disease” and “<em>determining</em>
levels of [MPO] activity… in a bodily sample of the test subject.”<span style="mso-spacerun: yes;"> </span>They also contain “<em>wherein</em>” clauses, e.g., “wherein
elevated levels of [MPO] in the bodily sample from the test subject relative to
the levels of [MPO] in the comparable bodily sample from control subjects is
indicated of the extent of the test subject’s risk of having atherosclerotic
cardiovascular disease.”<o:p></o:p></span></span></span></div>
<span style="font-family: inherit; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><span style="font-family: inherit;">For those familiar with patent eligibility case law, it
should come as no surprise that the District Court found these claims to be patent
ineligible under the <em>Mayo</em>/<em>Alice</em> test for patent eligibility (named after the <i style="mso-bidi-font-style: normal;">Alice</i> and <i style="mso-bidi-font-style: normal;">Mayo</i> Supreme Court decisions].<span style="mso-spacerun: yes;">
</span>The court found that the relationship between MPO levels in the
bloodstream and the risk of having or developing cardiovascular disease is a
natural phenomenon (first prong of the <i style="mso-bidi-font-style: normal;">Alice
</i>test) and that the “determining” and “comparing” steps are insufficiently
inventive (second prong of the<i style="mso-bidi-font-style: normal;"> Alice</i>
test).<span style="mso-spacerun: yes;"> </span>The court found that at the time
of invention a “myriad of methods well-known in the arts existed” for “determining”
MPO levels, and that a “comparing” step involves a mental process, “which does
not add an inventive step.”<o:p></o:p></span></span></span></div>
<span style="font-family: inherit; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><span style="font-family: inherit;">The patent owner might have been able to help itself by
arguing for a narrower interpretation of claim terms such as “comparing levels”
and “determining levels.”<span style="mso-spacerun: yes;"> </span>Unfortunately,
in connection with its motion for temporary restraining order and preliminary
injunction, plaintiff argued to the Court that “[e]xcept for “MPO Activity and “MPO
Mass,” all of the claim terms should simply be afforded their plain and ordinary
meaning.”<span style="mso-spacerun: yes;"> </span>Later, in its brief opposing the Rule 12(b)(6) motion to dismiss, the plaintiff indicated “that it is now
apparent that additional terms new construction,” including “immunological
technique,” “comparing levels,” and “determining levels,” and argued that the Court could not address the
issue of patent eligibility prior to claim construction.
<span style="mso-spacerun: yes;"> </span>The judge rejected this argument,
noting that the defendant had stipulated to plaintiff’s proposed claim
construction, and that the plaintiff had failed to offer its own proposed
construction for these terms.<o:p></o:p></span></span></span></div>
<span style="font-family: inherit; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: inherit; font-size: large;">The court stated that “Plaintiff’s failure [offer its
proposed construction of the claim terms] will not serve to block the Court
from considering defendant’s motion.<span style="mso-spacerun: yes;">
</span>Otherwise, a plaintiff could prevent dismissal before claim construction
simply by noting without explanation that claim construction is ‘necessary.’<span style="mso-spacerun: yes;"> </span>The Court rejects any such rule.”</span></div>
<span style="font-family: inherit; font-size: large;">
</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com34tag:blogger.com,1999:blog-2774042125883658.post-56927536671657391662016-02-23T17:43:00.002-06:002016-02-25T10:20:05.262-06:00Copyright for Engineered DNA (Part 1)<br />
<span style="font-size: large;">I have observed increasing interest in the idea of extending copyright to engineered DNA, not only among academics, but also some attorneys at IP firms working in the biotechnology space, as well as some biotechnology companies. A few years ago I wrote a law review article on the topic, and it remains an area of interest for me.</span><br />
<span style="font-size: large;"></span><br />
<span style="font-size: large;">GQ Life Sciences, Inc., a global life science information and search company (formerly known as GenomeQuest) has invited me to write a series of blog posts on the topic. The first installment is available </span><a href="https://www.gqlifesciences.com/copyright-for-engineered-dna/"><span style="font-size: large;">here</span></a><span style="font-size: large;">.</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com133tag:blogger.com,1999:blog-2774042125883658.post-53915625410151941072015-12-02T18:07:00.001-06:002015-12-02T18:07:33.929-06:00Federal Circuit Denies En Banc Rehearing of Ariosa v. Sequenom, But Some Judges Urge Supreme Court to Fix Flawed Patent Eligibility Precedent<span style="font-size: large;"></span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Today the Federal Circuit issued an order (available </span><a href="http://www.cafc.uscourts.gov/opinions-orders"><span style="font-size: large;">here</span></a><span style="font-size: large;">) denying
en banc rehearing of<i style="mso-bidi-font-style: normal;"> Ariosa v. Sequenom</i>,
an important patent eligibility decisions discussed in earlier </span><a href="http://holmansbiotechipblog.blogspot.com/2015/06/federal-circuit-decides-ariosa-and-its.html"><span style="font-size: large;">posts</span></a><span style="font-size: large;">.<span style="mso-spacerun: yes;"> </span>I filed a </span><a href="http://holmansbiotechipblog.blogspot.com/2015/08/bio-and-phrma-file-amici-brief-urging.html"><span style="font-size: large;">brief</span></a><span style="font-size: large;"> on behalf of the
Biotechnology Industry Organization (BIO) and Pharmaceutical Research and
Manufacturers of America (PhRMA) arguing in favor of en banc rehearing, and
discussing the negative implications of the decision for patenting in
biotechnology, particularly as related to diagnostics and personalized medicine.
<span style="mso-spacerun: yes;"> </span>The decision to deny rehearing was
accompanied by two concurring and one dissenting opinions filed by a total of
four judges (Lourie and Moore, Dyk, and Newman), which provide some very
interesting insight into their views on the current state of patent eligibility
jurisprudence, particularly as it relates to the life sciences.</span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">There was some substantial overlap in the opinions of all
four judges.<span style="mso-spacerun: yes;"> </span>For example, they all
appeared to agree that the decision invalidating Sequenom’s method was both
ill-advised as a matter of policy and not compelled by the language of the
patent statute.<span style="mso-spacerun: yes;"> </span>All of the judges seemed
to recognize that <i style="mso-bidi-font-style: normal;">Ariosa</i>’s interpretation
and application of the <i style="mso-bidi-font-style: normal;">Mayo</i> framework
threatened the availability of effective patent protection for a broad swath of
biotechnological innovation, particularly in the area of diagnostics.<span style="mso-spacerun: yes;"> </span>Lourie and Moore, for example, found “some
truth” in concerns raised by Sequenom and their amici “that a crisis of patent
law and medical innovation may be upon us,” and that a broad range of claims
appear to be in serious jeopardy, particularly diagnostic claims. <o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The judges recognized that the claims might raises concerns
regarding overbreadth and/or indefiniteness, but suggested more measured
approaches to address these concerns rather than the blunt instrument of the
Supreme Court’s new patent eligibility jurisprudence.<span style="mso-spacerun: yes;"> </span>Lourie and Moore suggested that “the finer
filter of Section 112 [i.e., the enablement and definiteness requirement] might
be better suited to treating these [concerns] as questions of patentability,
rather than reviewing them under the less-defined eligibility rules.” In
contrast, Judge Dyk opined that these other statutory requirements of
patentability might not be entirely up to the task, but instead proposed a novel
alternative approach to patent eligibility analysis that would have likely
salvage some patent protection for a company like Sequenom, albeit at the cost
of substantially narrower claim scope.<span style="mso-spacerun: yes;">
</span>His suggested approach is discussed in more detail below.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The concurrence by Lourie and Moore found that while the
blood fractionation and DNA analysis steps recited in the claims are
individually well known, “the innovative aspect of the claims appears to be the
improvement in the method of determining fetal genetic characteristics []
consisting of use of the non-cellular fraction of fetal DNA obtained from
maternal blood sample.”<span style="mso-spacerun: yes;"> </span>The result is a
novel, innovative and practical method of diagnosis that constitute a
substantial improvement over the highly intrusive means use prior to the
invention.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Lourie and Moore went on to find that the claims would not
preempt the asserted natural phenomenon, since there exist “other uses for
cffDNA and other methods of prenatal diagnostic testing using cffDNA that do not
involve the steps recited in the various claims,” and that this “fact should
sufficiently address the concern of improperly tying up future use of natural
phenomena and laws.”<span style="mso-spacerun: yes;"> </span>In other words, these
judges appear to support the notion that a claim only raises patent ineligibility
concerns if it preempts all applications of a natural phenomenon.<span style="mso-spacerun: yes;"> </span>This is in stark contrast to the approach of
the panel that decided <i style="mso-bidi-font-style: normal;">Ariosa</i> - they treated
the question of preemption as essentially irrelevant to the determination of
patent eligibility.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Dyk’s concurring opinion largely tracked Lourie and Moore,
agreeing that the language of <i style="mso-bidi-font-style: normal;">Mayo</i>,
while unfortunate, compelled the panel decision in <i style="mso-bidi-font-style: normal;">Ariosa</i>.<span style="mso-spacerun: yes;"> </span>But Dyk goes on to
suggest that in assessing patent eligibility courts should distinguish between
a patent eligible concept that is well known and long-standing at the time of
invention as opposed to one that is newly discovered.<span style="mso-spacerun: yes;"> </span>In his view:</span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"></span><blockquote class="tr_bq">
<span style="font-family: Calibri;"><span style="font-size: large;"><em>Mayo </em>did not fully
take into account the fact that an inventive concept can come not just from
creative, unconventional application of a natural law, but also from the
creativity and novelty of the discovery of law itself.<span style="mso-spacerun: yes;"> </span>This is especially true in the life sciences,
or development of useful new diagnostic and therapeutic methods is driven by
investigation of complex biological systems.<span style="mso-spacerun: yes;">
</span>I worry that method claims that apply newly discovered natural laws and
phenomena in some conventional ways are screened out by the <em>Mayo</em> test.<span style="mso-spacerun: yes;"> </span>In this regard I
think that <em>Mayo</em> may not be entirely
consistent with the Supreme Court’s decision in <em>Myriad</em>.</span></span></blockquote>
<span style="font-family: Calibri;"><o:p></o:p></span><br />
<span style="font-size: large;">
</span><span style="font-family: Calibri;"><span style="font-size: large;">I think Judge Dyk raises a very interesting and insightful
point regarding <i style="mso-bidi-font-style: normal;">Myriad</i>.<span style="mso-spacerun: yes;"> </span>In that case, the Supreme Court found that
the genetic sequence of the BRCA genes was a natural phenomenon, but that the
corresponding cDNA sequences were nonetheless patent eligible, in spite of the
fact that nothing could be more routine and conventional than to synthesize
cDNA based on the discovery of a naturally occurring gene. <span style="mso-spacerun: yes;"> </span>Judge Dyk inferred that<i style="mso-bidi-font-style: normal;"> Myriad</i> “recognize[d] that an inventive concept can sometimes come
from discovery of an unknown natural phenomenon, not just from unconventional
application of the phenomenon.”<span style="mso-spacerun: yes;"> </span>He went
on to propose a refinement of the Supreme Court’s test for patent eligibility,
whereby “the novelty of the discovery [of a natural phenomenon] should be
enough to supply the necessary inventive concept.” <o:p></o:p></span></span><br />
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Significantly, under Dyk’s proposed approach, an inventor
would only be able to claim applications of a newly discovered natural phenomenon
that had been “actually reduced practice, not merely ‘constructively” reduced
to practice by filing of a patent application replete with prophetic examples.”<span style="mso-spacerun: yes;"> </span>According to Dyk, the resulting claims would
be narrow in scope and “would allow the inventor to enjoy an exclusive right to
what he himself has invented and put into practice, but not to prevent new
applications of the natural law by others.”<span style="mso-spacerun: yes;">
</span>In other words, the narrow scope of the claims would obviate the
preemption concerns underlying the patent eligibility doctrine.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Dyk’s concurrence concludes by suggesting that:</span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"></span><blockquote class="tr_bq">
<span style="font-family: Calibri;"><span style="font-size: large;">A future case is likely to present a patent claim where the
inventive concept resides the newly discovered law of nature or natural
phenomenon, but the claims narrowly drawn and actually reduced practice.<span style="mso-spacerun: yes;"> </span>That case will, I hope, provide the Supreme
Court with an opportunity to revisit the<i style="mso-bidi-font-style: normal;">
Mayo/Alice</i> framework in this one limited aspect.</span></span></blockquote>
<span style="font-size: large;"></span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The third opinion was a dissent by Judge Newman.<span style="mso-spacerun: yes;"> </span>Not surprisingly, she agreed with the other
judges that the decision below was wrongly decided, but she did not “share
their view that this incorrect decision is required by Supreme Court precedent.”<span style="mso-spacerun: yes;"> </span>She found that the facts of <i style="mso-bidi-font-style: normal;">Ariosa</i> diverge significantly from those
in<i style="mso-bidi-font-style: normal;"> Mayo</i> and<i style="mso-bidi-font-style: normal;"> Myriad</i>, and that the patent eligibility of Sequenom’s claims could
be upheld without contravening Supreme Court precedent.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Calibri; font-size: large;"> </span></o:p></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Calibri; font-size: large;"> </span></o:p></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Calibri; font-size: large;"> </span></o:p></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Calibri; font-size: large;"> </span></o:p></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Calibri; font-size: large;"> </span></o:p></div>
<span style="font-size: large;">
</span></div>
</div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com12tag:blogger.com,1999:blog-2774042125883658.post-81138868263865595042015-11-24T10:15:00.001-06:002015-11-24T10:15:26.175-06:00The Cleveland Clinic Foundation v. True Health Diagnostics: Judge Denies Preliminary Injunction Based on Likelihood That Diagnostic Testing Method Is Patent Ineligible
<span style="font-family: "Times New Roman",serif; font-size: 14pt; line-height: 107%;"></span><br />
<span style="font-family: "Times New Roman",serif; font-size: 14pt; line-height: 107%;">On December 18, 2015, in <i style="mso-bidi-font-style: normal;">The Cleveland Clinic Foundation v. True Health Diagnostics</i>,<i style="mso-bidi-font-style: normal;"> LLC</i>, a district court judge in Ohio issued an <a href="https://drive.google.com/file/d/0B9_llJGo9WK0YW1taWJXRVlkTXc/view?usp=sharing">order</a> denying
the Cleveland Clinic Foundation’s (“CCF’s”) Motion for Temporary Restraining
Order and Preliminary Injunction after concluding that CCF had failed to
establish a likelihood of success on the merits.<span style="mso-spacerun: yes;"> </span>In particular, the court found that CCF had “fail[ed]
to make a clear showing that the patents-in-suit” are directed towards patent
eligible subject matter.<span style="mso-spacerun: yes;"> </span>This is yet
another example of the challenges facing the developers of diagnostic tests in
the wake of <i style="mso-bidi-font-style: normal;">Mayo v. Prometheus</i>.<o:p></o:p></span><br />
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: "Times New Roman",serif; font-size: 14pt; line-height: 107%;">The patents at issue in the case, U.S. Patent No.
7,223,552 (“the ’552 patent”); U.S. Patent No. 7,459,286 (“the ’286 patent”);
and U.S. Patent No. 8,349,581 (“the ’581 patent”), relate to methods of
analyzing Myeloperoxidase (“MPO”) biomarkers in a patient’s blood sample to predict
a patient’s potential for heart disease, by comparing the level of MPO found in
the patient’s blood sample with levels of MPO in control subjects to see if the
patient has elevated levels of MPO. <span style="mso-spacerun: yes;"> </span>MPO
is an enzyme released by white blood cells when an artery wall is damaged or becomes
inflamed, and its presence is thus an early symptom of many types of cardiovascular
disease (“CVD”).<o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: "Times New Roman",serif; font-size: 14pt; line-height: 107%;">Applying the <i style="mso-bidi-font-style: normal;">Mayo/Alice</i>
two-step test for patent eligibility, the court concluded that “it appears that
the correlation between MPO levels and cardiovascular disease is more akin to a
law of nature,” and that, “[m]easuring a sample of blood or blood product1
appears to be a “’well-understood, routine and conventional activity’ known in
the scientific community.”<span style="mso-spacerun: yes;"> </span>As a
consequence, at least “at this point in the litigation,” the court was “not
convinced that plaintiff has demonstrated that the patents-in-suit contain ‘an
element or combination of elements’ sufficient to satisfy step two of the <i style="mso-bidi-font-style: normal;">Mayo/Alice</i> test.” The court rejected CCF’s
argument that its patents require “measurement of a closed set of specific bodily
samples” and, therefore, that its patents apply a “phenomenon in a combination
of steps that has never been done before.” <o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: "Times New Roman",serif; font-size: 14pt; line-height: 107%;">Interestingly, the judge’s Order denying preliminary
relief expounds in great detail on the important role the patents played in
allowing CCF to translate the patented discovery into a successful commercial
product.<span style="mso-spacerun: yes;"> </span>It describes how in 2009, CCF
launched HeartLab as the exclusive licensee of the patents to commercialize MPO
testing.<span style="mso-spacerun: yes;"> </span>CCF and HeartLab reportedly invested
millions of dollars in their effort to build the MPO testing market, which has involved
conducting ongoing medical and scientific studies, application for FDA
approvals, and establishment of Medicare reimbursement status for MPO testing. <span style="mso-spacerun: yes;"> </span>In addition, they “have focused considerable
effort on developing stringent manufacturing and quality standards and also invested
in educational programs about MPO testing.”<o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: "Times New Roman",serif; font-size: 14pt; line-height: 107%;">To illustrate the success of CCF’s and HeartLab’s
efforts to develop and commercialize MPO testing, the Order notes that at its “inception,
HeartLab had eight employees who performed only a few hundred MPO tests. It now
has 140 employees who will perform hundreds of thousands of MPO tests in 2015.”<o:p></o:p></span></div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com5tag:blogger.com,1999:blog-2774042125883658.post-17069870417782227942015-11-19T09:45:00.001-06:002015-11-19T09:46:28.913-06:00Endo v. Actavis: Court Adopts Magistrate's Recommendation Finding Drug Method of Use Claims Facially Invalid Under 35 USC 101<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-family: "calibri";"><span style="font-size: large;">In a September 28, 2015 </span><a href="http://holmansbiotechipblog.blogspot.com/search?q=Endo"><span style="font-size: large;">post</span></a><span style="font-size: large;"> I reported on <i style="mso-bidi-font-style: normal;">Endo v. Actavis</i>, wherein a magistrate judge’s Report and
Recommendation from a magistrate judge in the District of Delaware recommending
invalidation of a drug method of treatment patent for patent ineligibility on a
motion to dismiss under Rule 12(b)(6). <span style="mso-spacerun: yes;"> </span>The
magistrate judge essentially found the claim to be highly analogous to method
of treatment claims found to be patent ineligible by the Supreme Court in <i style="mso-bidi-font-style: normal;">Mayo v. Prometheus, </i>and in my post I explained
why the decision was consistent with my long-standing concern that an expansive
interpretation of the literal language of <i style="mso-bidi-font-style: normal;">Mayo</i>
threatened the validity of drug method of use claims in general.</span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-family: "calibri";"><span style="font-size: large;">In a November 17, 2015, </span><a href="https://drive.google.com/file/d/0B9_llJGo9WK0Q0s2QzVFMTJvbUU/view?usp=sharing"><span style="font-size: large;">Order Adopting Report and Recommendation</span></a><span style="font-size: large;">, the
district court judge hearing the case adopted the magistrate judge’s
recommendation in its entirety and dismissed Endo’s Counts relating to
infringement of U.S. Patent No. 8,808,737 (the '"737 patent"), finding
the patent to be “facially invalid.”</span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-size: large;"><o:p><span style="font-family: "calibri";"> </span></o:p><span style="font-family: "calibri";">The district court judge rejected several arguments made by Endo in
support of patent eligibility of the claims. <o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-family: "calibri";"><span style="font-size: large;">Of particular significance to the patentability of method of use claims in general, Endo argued “that
the Magistrate Judge's reliance on the similarities between the '737 patent's
representative claim and the claim involved in <em>Mayo Collaborative Servs. v.
Prometheus Labs., Inc</em>., 132 S. Ct. 1289 (2012), was in error because the claim
at issue in Mayo did not require that anyone act upon or apply the method in a
tangible way, while claim 1 of the '737 patent actually requires that the lower
dose be administered.”<span style="mso-spacerun: yes;"> </span>As I mentioned in
my previous post, many of
us have held out hope that even post-<i style="mso-bidi-font-style: normal;">Mayo</i> a method of treatment claim that explicitly recites
administration of the drug to a patient would remain patent eligible.<span style="mso-spacerun: yes;"> </span>The district court judge, however, agreed
with the magistrate judge’s conclusion that “limitations at issue in <i style="mso-bidi-font-style: normal;">Mayo </i>do in fact mirror the analogous
limitations of Claim 1 of the '737patent.”<span style="mso-spacerun: yes;">
</span><o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-family: "calibri";"><span style="font-size: large;">The court considered the following side-by-side comparison of the language of the <i style="mso-bidi-font-style: normal;">Mayo</i> and Endo claims: "indicates a need
to [increase/decrease] the amount of said drug subsequently administered to
said subject"(<i style="mso-bidi-font-style: normal;">Mayo</i>) vs. "orally
administering to said patient, in dependence on which creatinine clearance rate
is found, a lower dosage of the dosage form to provide pain relief"(Endo), and concluded that the “slight
difference in phrasing is immaterial, because neither formulation provides any
sort of 'inventive concept.'"<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-size: large;"><span style="font-family: "calibri";">The court further found Endo’s argument that the '737 patent does not
claim a law of a nature, but rather"a new and useful process," to
be “thoroughly unconvincing.” </span><span style="font-family: "calibri";">The district court found that Endo had essentially admitted in
their briefing that the '737 patent claims a natural law as its invention based
on the following statement by Endo: “[I]t is true that the claimed inventions
relate to the unexpected discovery that the bioavailability of oxymorphone is
increased in patients with renal impairment.”</span></span></div>
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-family: "calibri"; font-size: large;"></span> </div>
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-family: "calibri";"><span style="font-size: large;">This is troubling, because while the patent statute explicitly states
that a “discovery” can be patented, this court apparently construes a patent
owner’s use of the term “discovery” as an admission that the “discovery” is a
natural phenomenon.<span style="mso-spacerun: yes;"> </span>If anything that can
be discovered is a natural phenomenon, the availability of patent protection
for innovation in the life sciences would appear to be extremely limited post<em>-Mayo.<o:p></o:p></em></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-family: "calibri";"><span style="font-size: large;">Endo made the policy argument “that the reasoning employed
by the Magistrate Judge's Report and Recommendation would in effect invalidate
all pharmaceutical method-of treatment patents using an existing, well-known
compound.”<span style="mso-spacerun: yes;"> </span>The district court
responded that “this case is hardly the poster child for [such] a policy
argument,” and speculated that patent protection would still be available for
method of use claims are directed towards an invention embodying “creative
steps or inventive leaps aside from the discovery of a natural law.”<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt;">
<span style="font-family: "calibri";"><span style="font-size: large;">But if the discovery that a chemical compound has therapeutic effect on
a patient is to be considered a “natural law,” which appears to be the case
under the rationale of this decision, how successful will a pharmaceutical
company be in arguing that use of that chemical compound for its therapeutic
effect constitutes a sufficient “inventive leap” to satisfy the new post-<i style="mso-bidi-font-style: normal;">Mayo</i> patent eligibility standard?<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com3tag:blogger.com,1999:blog-2774042125883658.post-75004558214018689002015-11-17T18:06:00.001-06:002015-11-17T18:06:59.302-06:00The Medicines Company v. Hospira: Federal Circuit Will Reconsider "Suppliers Exception" to 102(b) On-Sale Bar<span style="font-family: inherit; font-size: large;"></span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 8pt; mso-layout-grid-align: none;">
<span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";"><span style="font-size: large;"><span style="font-family: Arial, Helvetica, sans-serif;">In a previous </span><a href="http://holmansbiotechipblog.blogspot.com/search?q=medicines+company"><span style="font-family: Arial, Helvetica, sans-serif;">post</span></a><span style="font-family: Arial, Helvetica, sans-serif;"> I reported on the Federal
Circuit’s July 2, 2015, decision in the <em>The
Medicines Company v. Hospira</em>, wherein</span></span></span><span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";"><span style="font-size: large;"><span style="font-family: Arial, Helvetica, sans-serif;"> a panel of the Federal Circuit held that a patent
owner’s use of a contract manufacturer to prepare three “validation batches” of
a drug formulation embodying the claimed invention created an invalidating
on-sale bar, even though the contract was for manufacturing service, not for
the sale of product, and title to the drug always resided with the patent
owner, and even though the batches were produced for the purpose of
demonstrating to FDA that the invention resulted in a formulation that satisfied
FDA specifications.<span style="mso-spacerun: yes;"> </span>In the post I
pointed out that the decision illustrates the risk of using a contract
manufacturer prior to filing a patent application, particularly now that the
AIA has called into question the availability of the one year grace period
previously available under pre-AIA 102(b).<o:p></o:p></span></span></span></div>
<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 8pt; mso-layout-grid-align: none;">
<span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";"><span style="font-size: large;"><span style="font-family: Arial, Helvetica, sans-serif;">On November 13, 2015, the Federal Circuit
granted The Medicine Company’s petition for rehearing en banc and vacated the panel’s
decision.<span style="mso-spacerun: yes;"> </span>The court requested that the
parties file new briefs addressing the following issues:<o:p></o:p></span></span></span></div>
<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoListParagraphCxSpFirst" style="line-height: normal; margin: 0in 0in 0pt 0.5in; mso-layout-grid-align: none; mso-list: l0 level1 lfo1; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";"><span style="mso-list: Ignore;">(a)<span style="font-family: "Times New Roman"; font-size-adjust: none; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";">Do the circumstances presented here constitute a
commercial sale under the on-sale bar of 35 USC 102(b)?<o:p></o:p></span></span></span></div>
<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoListParagraphCxSpMiddle" style="line-height: normal; margin: 0in 0in 0pt 1.5in; mso-add-space: auto; mso-layout-grid-align: none; mso-list: l1 level1 lfo2; text-indent: -0.5in;">
<!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";"><span style="mso-list: Ignore;">(i)<span style="font-family: "Times New Roman"; font-size-adjust: none; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";">Was the resale for the
purpose of 102(b) despite the absence of a transfer of title?<o:p></o:p></span></span></span></div>
<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoListParagraphCxSpMiddle" style="line-height: normal; margin: 0in 0in 0pt 1.5in; mso-add-space: auto; mso-layout-grid-align: none; mso-list: l1 level1 lfo2; text-indent: -0.5in;">
<!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";"><span style="mso-list: Ignore;">(ii)<span style="font-family: "Times New Roman"; font-size-adjust: none; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";">Was the sale commercial
in nature for the purpose of 102(b) or an experiment to use?<o:p></o:p></span></span></span></div>
<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoListParagraphCxSpLast" style="line-height: normal; margin: 0in 0in 8pt 0.5in; mso-layout-grid-align: none; mso-list: l0 level1 lfo1; text-indent: -0.25in;">
<!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";"><span style="mso-list: Ignore;">(b)<span style="font-family: "Times New Roman"; font-size-adjust: none; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span style="color: black; font-family: "Times New Roman",serif; mso-fareast-font-family: "Times New Roman";">Should this court overrule or revise the
principle in <i style="mso-bidi-font-style: normal;">Special Devices, Inc. v.
OEA, Inc.,</i> 270 F.3d 1353 (Fed. Cir. 2001), that there is no “supplier
exception” to the on-sale bar of 35 USC 102(b)?<o:p></o:p></span></span></span></div>
<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 8pt; mso-layout-grid-align: none;">
<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;"><span>In <em>Special
Devices </em>the court rejected the patent
owner’s policy-based argument urging the Federal Circuit to create a “supplier
exception” to the 102(b) on-sale bar, concluding that the text of section 102(b) itself
“makes no room for” such an exception.</span></span></div>
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 8pt; mso-layout-grid-align: none;">
<span style="font-family: Arial, Helvetica, sans-serif; font-size: large;"><span>Of course, for that matter the experimental use exception likewise finds no support in the language of the
statute, and there is nothing to prevent the court from creating another judge-made exception to the 102(b) on-sale bar.<span style="mso-spacerun: yes;"> </span>Such an
exception would seem to be justified on policy grounds, given that without a
"supplier exception" an inventor, faces a loss of
patent rights based solely on a decision to contract out manufacturing rather
than manufacture in-house. This could be particularly problematic for a small or underfunded inventor lacking the resources to manufacture its invention itself.</span></span></div>
<span style="font-family: inherit; font-size: large;">
</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com1tag:blogger.com,1999:blog-2774042125883658.post-1103087323538618522015-11-11T18:59:00.000-06:002015-11-11T18:59:21.230-06:00Court Dismisses “Disaffected” Professor’s Attempt to Change Inventorship on Johns Hopkins Patent<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Peter Pedersen, a professor in the Department of Biological
Chemistry at The Johns Hopkins University School of Medicine is one of three
named inventors on US Patent Nos. 7,547,673 and 8,119,116.<span style="mso-spacerun: yes;"> </span>The patents are directed towards
chemotherapeutic uses of certain adenosine triphosphate (“ATP”) inhibitors,
particularly 3-bromopyruvate.<span style="mso-spacerun: yes;"> </span>The patents
have been exclusively licensed to a company called PreScience Labs. <span style="mso-spacerun: yes;"> </span>According to the company’s webpage, “PreScience
Labs has successfully completed preclinical mechanistic, in–vitro and animal
testing using the intro–arterial delivery of its proprietary drug
3–bromopyruvate ( “3–BrPA” or “PSL-001” ), and FDA has authorized Phase I
testing.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">One of the other named inventors on the patent is Young Hee
Ko.<span style="mso-spacerun: yes;"> </span>According to court documents, Ko and
Pedersen “have a lengthy professional history:<span style="mso-spacerun: yes;">
</span>Ko joined Plaintiff’s laboratory in 1991 and the two worked together
until Ko’s resignation from JHU in 2006.<span style="mso-spacerun: yes;">
</span>The two also appear to have had some sort of domestic arrangement: Ko
acknowledged in a 2006 deposition that she sometimes stayed overnight at Plaintiff’s
house and that she co-owned a vehicle with plaintiff.”<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The third named inventor on the patents is Jean-Francois
Geschwind, a former member of The Johns Hopkins University School of Medicine
Department of Radiology.<span style="mso-spacerun: yes;"> </span>He is currently
identified on the PreScience Labs website as Founder and CEO.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">On June 11, 2015, Pedersen filed a lawsuit in the District
of Maryland seeking a (1) declaration under 35 USC 256 that Ko is the sole
inventor of both patents and (2) an order directing the United States Patent and
Trademark Office (USPTO) to issue a Certificate of Correction accordingly.</span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
</div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Even though Pedersen initiated the patenting
process in 2001 by executing an invention disclosure with the Johns Hopkins
Office of Technology Licensing identifying all three of them as inventors of
the subject matter, he claims that at the time did not
understand the distinction between inventorship and authorship.<span style="mso-spacerun: yes;"> </span>He now claims that Geschwind’s sole
contribution during the experimentation phase of the invention was to “guide
the catheter into the hepatic arteries” of laboratory animals and “push the
plunger,” and that Geschwind “did not even know what 3-BrPA was before Ko
educated him.”<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">On October 27, 2015, the court issued an </span><a href="https://drive.google.com/file/d/0B9_llJGo9WK0MjhHREMwWHV0dUE/view?usp=sharing"><span style="font-size: large;">order</span></a><span style="font-size: large;"> granting Defendants’
(Johns Hopkins and Geschwind) motion to dismiss.<span style="mso-spacerun: yes;"> </span>The court found that Pedersen lacked standing
under Article III of the Constitution because he had failed to identify a “cognizable
injury redressable by the section 256 relief that he seeks.”<span style="mso-spacerun: yes;"> </span></span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><span style="mso-spacerun: yes;"></span></span></span> </div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><span style="mso-spacerun: yes;"></span>In particular, the court rejected his
argument that his status as “named inventor” was enough to allow him to sue the
University for change inventorship.<span style="mso-spacerun: yes;">
</span>According to the court, “Plaintiff cannot seriously contend that he has
standing to sue in federal court simply because he is unhappy with the manner
in which a bona fide assignee of a patent chooses to deploy or license its
interest.<span style="mso-spacerun: yes;"> </span>Such a theory would confer
near-limitless standing on disaffected scientists, well beyond the bounds of
the particularized injury that Article III mandates.”<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The court also rejected Pedersen’s argument that he had
financial interest in the matter sufficient to establish standing, pointing out
that Pedersen currently enjoyed a financial interest equal to one-third of the 35% “inventors’
personal share” provided by the Johns Hopkins IP Policy, which he would lose if
he succeeded in removing himself as an inventor on the patents.</span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri; font-size: large;"></span> </div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Pedersen also argued for standing based purely on “reputational
interest,” asserting that his status as a “fair and honest academician is and
will be adversely affected by the inclusion of himself and Geschwind as
co-inventors.”<span style="mso-spacerun: yes;"> </span>The court acknowledged
the fact that a recent Federal Circuit decision held that “concrete and
particularized reputational injury can give rise to Article III standing” (citing
<i style="mso-bidi-font-style: normal;">Shukh v. Seagate Technologies</i>
(decided October 2, 2015)).<span style="mso-spacerun: yes;"> </span>However, <i style="mso-bidi-font-style: normal;">Shukh </i>involved a plaintiff who argued he
has been wrongfully omitted as an inventor.<span style="mso-spacerun: yes;">
</span>In contrast, the District Court characterized as “conclusory and
speculative” Pedersen’s allegation that his reputation has been harmed by being
wrongly included as a named inventor on the patents.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<span style="font-size: large;">
</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com7tag:blogger.com,1999:blog-2774042125883658.post-14749256070022463582015-10-27T16:54:00.000-05:002015-10-27T16:54:01.317-05:00PTAB Upholds Validity of Herceptin Patent<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Today the Patent Trial and Appeal Board issued a unanimous
</span><a href="https://drive.google.com/file/d/0B9_llJGo9WK0bWFHTzh1SEZWcUU/view?usp=sharing"><span style="font-size: large;">decision</span></a><span style="font-size: large;"> in <em>Phigenix, Inc. v. ImmunoGen, Inc.,</em> upholding the validity of Immunogen’s US Patent Number 8,337,856.<span style="mso-spacerun: yes;"> </span>The petition for inter partes review (IPR)
was filed by </span><a href="http://phigenix.com/"><span style="font-size: large;">Phigenix, Inc</span></a><span style="font-size: large;">.</span></span><span style="font-family: Calibri;"><span style="font-size: large;">.<span style="mso-spacerun: yes;"> </span>Genentech is a real party-in-interest in the
proceedings.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;"><o:p><span style="font-family: Calibri;"> </span></o:p><span style="font-family: Calibri;">The ’856 patent claims “[a]n immunoconjugate comprising an
anti-ErbB2 antibody conjugated to a maytansinoid, wherein the antibody is [HERCEPTIN].”<span style="mso-spacerun: yes;"> </span>Herceptin is a biologic developed by
Genentech for the treatment of some forms of breast cancer and gastric cancer.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Phigenix cited several prior art references which
allegedly rendered the claims obvious and thus invalid under 35 USC 103.<span style="mso-spacerun: yes;"> </span>One of the primary references, Chari 1992, describes
immunoconjugates comprising an anti-ErbB2 mouse monoclonal antibody chemically
coupled to a maytansinoid toxin (DMI).<span style="mso-spacerun: yes;">
</span>The other primary reference was the HERCEPTIN label itself.<span style="mso-spacerun: yes;"> </span>A Phigenix expert (Rosenblum) submitted a
declaration which, according to Phigenix, established that it
would have been obvious to substitute HERCEPTIN for the mouse antibody
described in Chari 1192 “based on the teachings of Chari 1992 and HERCEPTIN
label, as well as the general knowledge in the art at the time.”<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The PTAB rejected petitioner’s argument, however, finding
that the patent owner had provided persuasive evidence that at the time the
patent was filed “prior art indicated that HERCEPTIN®-maytansinoid
immunoconjugates would have been expected to exhibit unacceptable levels of
antigen-dependent toxicity in normal human liver tissue in patients.”<span style="mso-spacerun: yes;"> </span>The PTAB went on to find persuasive evidence in
support of patent owner’s argument that ordinary artisans would not have had a
reasonable expectation that any immunoconjugate, much less the claimed
Herceptin®-maytansinoid immunoconjugate in particular, would be useful to treat
solid tumors in humans,” given that “[r]esearchers had targeted tumors with
immunoconjugates for about 40 years before the ’856 patent” without success and
in view of evidence “indicating that preparing any antibody-toxin
immunoconjugate for use in the treatment of human tumors was difficult and
unpredictable.”<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Previously, the PTAB declined to Institute review in a
separate case involving a related patent, US Patent Number 7,575,748.<span style="mso-spacerun: yes;"> </span><em>Phigenix, Inc. v. Genentech, Inc. and
ImmunoGen, Inc.,</em> Case IPR2014-00842 (PTAB Dec. 9, 2014) (Paper 10).<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Calibri; font-size: large;"></span></o:p> </div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com3tag:blogger.com,1999:blog-2774042125883658.post-44539966429215215702015-10-05T17:33:00.002-05:002015-10-05T17:33:47.276-05:00Apotex Dances the BPCIA Patent Dance with Amgen, But Claims It Does Not Need to Provide 180-Day Notice of Commercial Marketing <span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The Federal Circuit held in <em>Amgen v. Sandoz</em> that the
so-called “patent dance” is optional for applicants <span style="mso-spacerun: yes;"> </span>seeking approval of a biosimilar product under
the abbreviated BPCIA pathway, as discussed <a href="http://www.patentdocs.org/2015/07/amgen-v-sandoz-fed-cir-2015.html">here</a>. <span style="mso-spacerun: yes;"> </span>Indeed, biosimilar applicants have in a number of cases chosen not to participate in the “patent dance.”<span style="mso-spacerun: yes;"> </span>This occurred, for example, in a recent lawsuit
filed by Amgen against Hospira in connection with Hospira’s plan to bring a
biosimilar version of Epogen to market, as described in an earlier <a href="http://holmansbiotechipblog.blogspot.com/2015/09/amgen-sues-hospira-claims-that.html">post</a>.<span style="mso-spacerun: yes;"> In fact, u</span>ntil today I was personally unaware of any case
in which a biosimilar applicant actually did participate in the patent dance
with a reference sponsor, but that has changed with Amgen’s filing of a lawsuit
against Apotex on October 2, 2015.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><em>Amgen v. Apotex</em> was filed in the Southern District of Florida,
and alleges that Apotex has infringed, or will infringe, US Patent Numbers
8,952,138 and 6,162,427 by seeking approval under the abbreviated BPCIA pathway
for a biosimilar version of filgrastim (which is sold by Amgen under the trade
name Neupogen).<span style="mso-spacerun: yes;"> </span>The complaint is
available <a href="https://drive.google.com/file/d/0B9_llJGo9WK0R2t4RXN6QkRzNE0/view?usp=sharing">here</a>.</span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">According to the complaint, Apotex participated in the
exchange of information set forth in the BPCIA, i.e., the patent dance,
which included providing Amgen with a copy of its abbreviated Biologic License
Application (aBLA), and as a result of these exchanges the parties agreed to
the inclusion of these two US patents in the lawsuit.<span style="mso-spacerun: yes;"> </span>The ‘138 patent “covers improved redox
chemistry-based methodologies for efficiently refolding cysteine -containing
proteins expressed in non-mammalian cells at high protein frustrations.” <span style="mso-spacerun: yes;"> </span>Presumably Amgen believes the patent will be
infringed by the processes Apotex will use to manufacture the biosimilar
filgrastim. <span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The ‘427 patent is directed towards a method that “employs a
combination of G-CSF and a chemotherapeutic agent to mobilize stem cells more
efficiently from the bone marrow to peripheral blood in a patient in need of a
peripheral stem cell transplant.”<span style="mso-spacerun: yes;"> </span>Amgen
alleges that if FDA approves the Apotex product for the same indications as
Amgen’s Neupogen product (which is what FDA did with respect to Zarxio, Sandoz’s biosimilar
version of Neupogen), or if FDA requires Apotex’s label to contain the same
information as Amgen’s Neupogen, then this will induce infringement of the ‘427
patent.<span style="mso-spacerun: yes;"> </span>According to Amgen, “absent a
legally cognizable and enforceable commitment by Apotex preventing Apotex from
marketing its filgrastim product with a label that includes the same
information regarding clinical trials, dosage and standard of care as Neupogen
label… an actual controversy exists between the parties.”<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The BPCIA also requires that biosimilar applicants “shall
provide notice to the reference product sponsor not later than 180 days before
the date of the first commercial marketing of the” biosimilar product.<span style="mso-spacerun: yes;"> </span>In <em>Amgen v. Sandoz</em>, the Federal Circuit
interpreted this language as requiring that a biosimilar applicant “only give
effective notice of commercial marketing after FDA has licensed its product.”<span style="mso-spacerun: yes;"> </span>According to the complaint, Apotex sent Amgen
a letter purporting to be Apotex’s Notice of Commercial Marketing on April 17,
2015.<span style="mso-spacerun: yes;"> </span>Amgen seeks a declaratory judgment
that the notice provided by Apotex on April 17, 2015 is invalid because at that
time Apotex’s product had not been approved for licensure by FDA.</span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">For its part, Apotex has reportedly taken the
position, in a letter to Amgen dated August 24, 2015, that “because Apotex
followed the pathway and provided Amgen with its application and manufacturing
information, providing a notice of commercial marketing is not mandatory.”<span style="mso-spacerun: yes;"> </span>Significantly, the Federal Circuit decided <em>Amgen
v. Sandoz</em> on July 21, 2015, i.e., prior to Apotex’s letter, and held that
notice of commercial marketing after licensure is mandatory.<span style="mso-spacerun: yes;"> </span>I do not understand the basis for Apotex’s
argument that notice of commercial marketing is not mandatory if the biosimilar
applicant has participated in the patent dance, but it will likely be interesting to
see how this plays out in the courts.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Calibri; font-size: large;"> </span></o:p></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p></o:p> </div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<o:p><span style="font-family: Calibri; font-size: large;"> </span></o:p></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><o:p></o:p></span></span> </div>
<span style="font-size: large;">
</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com2tag:blogger.com,1999:blog-2774042125883658.post-73135749138317910372015-09-28T09:36:00.001-05:002015-09-28T09:36:35.146-05:00Magistrate Judge Finds Drug Method of Treatment Claim Patent Ineligible in Endo Pharmaceuticals v. Actavis<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">In 2009, I filed an amici brief on behalf of myself and
several other law professors in<i style="mso-bidi-font-style: normal;">
Prometheus v.<span style="mso-spacerun: yes;"> </span>Mayo</i>, which was the
first time the Federal Circuit heard the case.<span style="mso-spacerun: yes;">
</span>In the decision below, the district court held that the interaction of a
synthetic, non-naturally occurring pharmaceutical compound with the human body
is a “natural phenomenon.”<span style="mso-spacerun: yes;"> </span>In our brief,
we basically argued that the interaction of a synthetic compound with the human
body is not a natural phenomenon, but that if the definition of “natural
phenomena” is interpreted so broadly as to encompass the interaction of human-made
drugs with the human body, then by implication drug method of treatment claims
seemed vulnerable to invalidation under 101 for encompassing patent ineligible
subject matter.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Nonetheless, the Federal Circuit and the Supreme Court
invalidated the Prometheus claims based on an assumption that the interaction
of the pharmaceutical agent (the metabolic breakdown product of a drug) with
the human body is a natural phenomenon.<span style="mso-spacerun: yes;"> </span>In
the Supreme Court’s decision, <i style="mso-bidi-font-style: normal;">Mayo v.
Prometheus, </i>Justice Breyer seemed cognizant of this concern, and
affirmatively stated that drug method of treatment claims should not be
threatened by the holding in<i style="mso-bidi-font-style: normal;"> Mayo</i>.<span style="mso-spacerun: yes;"> </span>Still, I have continued to wonder how
secure drug method of use claims are post-<i style="mso-bidi-font-style: normal;">Mayo</i>,
particularly given the expansive interpretation of the<i style="mso-bidi-font-style: normal;"> Mayo/Alice</i> by the district court’s and the Federal Circuit in
decisions such as <i style="mso-bidi-font-style: normal;">Ariosa</i> (discussed
in a previous post).<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">Thus, it came as no surprise when I saw a September
23, 2015 Report and Recommendation from a magistrate judge in the District of
Delaware recommending invalidation of a drug method of treatment patent for patent
ineligibility on a motion to dismiss under Rule 12(b)(6).<span style="mso-spacerun: yes;"> </span>The case, <i style="mso-bidi-font-style: normal;">Endo
Pharmaceuticals v.<span style="mso-spacerun: yes;"> </span>Actavis, </i>is an
ANDA litigation brought by Endo Pharmaceuticals against Actavis in connection
with a Generic Oxymorphone ER Tablets.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> The Report and Recommendation is available <a href="https://drive.google.com/file/d/0B9_llJGo9WK0ejM2VnZWQ09CZFU/view?usp=sharing">here</a>.</span></span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="mso-spacerun: yes;"></span><span style="font-size: large;">The patent is US Patent Number 8,871,779, and
representatives of claim one recites:<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><em>1. A method of treating pain in a renally impaired patient,
comprising the steps of: <o:p></o:p></em></span></span></div>
<span style="font-size: large;"><em>
</em></span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><em>a. providing a solid oral controlled release dosage form,
comprising: i. about 5 mg to about 80 mg of oxymorphone or a pharmaceutically
acceptable salt thereof as the sole active ingredient; and ii. a controlled
release matrix; <o:p></o:p></em></span></span></div>
<span style="font-size: large;"><em>
</em></span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><em>b. measuring a creatinine clearance rate of the patient and
determining it to be (a) less than about 30 ml/min, (b) about 30 mL/min to
about 50 mL/min, (c) about 51 mL/min to about 80 mL/min, or (d) above about 80
mL/min; and <o:p></o:p></em></span></span></div>
<span style="font-size: large;"><em>
</em></span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><em>c. orally administering to said patient, in dependence on
which creatinine clearance rate is found, a lower dosage of the dosage form to
provide pain relief; <o:p></o:p></em></span></span></div>
<span style="font-size: large;"><em>
</em></span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><em>wherein after said administration to said patient, the
average AUC of oxymorphone over a 12-hour period is less than about 21 nghr/mL.
</em>
<!--[if !supportLineBreakNewLine]--></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The magistrate judge applied the<i style="mso-bidi-font-style: normal;"> Mayo/Alice</i> two-part test for patent eligibility.<span style="mso-spacerun: yes;"> </span>The first step is to determine whether the
claims at issue are “directed to a patent-eligible concept,” in this case a
natural law.<span style="mso-spacerun: yes;"> </span>The magistrate judge notes
that the “<i style="mso-bidi-font-style: normal;">Mayo</i> court provided a broad
definition for a law of nature: ‘[a] patent that… describes a relationship that
is the consequence of entirely natural processes sets forth a natural law.’”<span style="mso-spacerun: yes;"> </span>The judge went on to conclude that “the
connection between the severity of renal impairment and the bioavailability of
oxymorphone” was the relevant natural law to which the claims are directed.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The second step is to determine whether the claims “add
enough” to the “natural law” to render the claim patent eligible.<span style="mso-spacerun: yes;"> </span>The magistrate judge essentially determined
that the “providing,” “measuring,” and “administering” steps were analogous to
the steps in the claims held to be patent ineligible in<i style="mso-bidi-font-style: normal;"> Mayo</i>, and thus did not provide “enough” extra.<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">The claims at issue in <i style="mso-bidi-font-style: normal;">Mayo</i>
essentially recited a method of performing a diagnostic test and determining
the optimal dosage of drug for a patient.<span style="mso-spacerun: yes;">
</span>The claim did not recite a step of actually administering the optimized
dosage to a patient, and many have held out the hope that in the future a claim
that included this additional step of actually applying the information derived
from the diagnostic test would be found patent eligible.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">But note that Endo’s claim does expressly recite
administering a lower dosage of drug to a patient based on the results of the
diagnostic test, i.e., the claim does include the extra step that many thought
would have rendered the claims in <i style="mso-bidi-font-style: normal;">Mayo </i>patent
ineligible. <span style="mso-spacerun: yes;"> </span>But, at least in the view of
this magistrate judge, the inclusion of this extra step was not sufficient to
render the claim patent eligible.<span style="mso-spacerun: yes;"> </span>And
given the sweeping language of <i style="mso-bidi-font-style: normal;">Mayo</i>, particularly
as interpreted by the Federal Circuit in <i style="mso-bidi-font-style: normal;">Ariosa</i>,
it is not hard to see how the magistrate judge came to this conclusion.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">It is important to note that the Endo claim is not a
straightforward method of treatment claim, i.e., “a method of treating disease X
by administering drug Y,” and does not necessarily indicate that the magistrate
judge would have ruled such a claim patent ineligible.<span style="mso-spacerun: yes;"> </span>The decision does explicitly note that “oxymorphone
is ‘widely used’ for acute and chronic pain relief, the showing that the
utilization of oxymorphone is not the invention.”<span style="mso-spacerun: yes;"> </span>Thus, the magistrate judge seemed to imply
that in a case where the “invention” is the discovery of a new pharmaceutical
agent for the treatment of some medical condition a method of treatment claim could
still be patent eligible under <i style="mso-bidi-font-style: normal;">Mayo</i>.<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">It seems inevitable that before long we will be seeing a
decision involving an allegation that a more conventional method of treatment
claim is patent ineligible.<span style="mso-spacerun: yes;"> </span>It will be
interesting to see how the courts handle that case, and also how the district
court judge in <i style="mso-bidi-font-style: normal;">Endo v. Actavis</i> (and
perhaps the Federal Circuit eventually) responds to the magistrate judge’s
recommendation.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<span style="font-size: large;">
</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com3tag:blogger.com,1999:blog-2774042125883658.post-48517392518329435302015-09-22T14:16:00.000-05:002015-09-22T14:18:47.744-05:00Amgen Sues Hospira, Claims That Biosimilar Version of Epogen Infringes<br />
<span style="font-family: Calibri; font-size: large;">In <em>Amgen v. Sandoz</em>, a fractured panel of the Federal Circuit
held that an applicant seeking approval of a biosimilar under the abbreviated
BPCIA pathway is not required to participate in the so-called “patent dance,”
and that if a biosimilar applicant fails to provide the reference product
sponsor with its application and the other patent dance information, then the
reference product sponsor’s only recourse is to bring a declaratory judgment
action for patent infringement.</span><br />
<span style="font-family: Calibri; font-size: large;">
</span><div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">On September 18, Amgen did just that, filing a lawsuit
against Hospira alleging that Hospira’s planned marketing of a biosimilar
version of Amgen’s biologic Epogen (epoiten alfa) infringes Amgen patents.<span style="mso-spacerun: yes;"> </span>The complaint is available </span><a href="https://drive.google.com/file/d/0B9_llJGo9WK0UExDRzA4cVJHNVE/view?usp=sharing"><span style="font-size: large;">here</span></a><span style="font-size: large;">.<span style="mso-spacerun: yes;"> </span></span></span><br />
<span style="font-size: large;"></span><br />
<span style="font-family: Calibri; font-size: large;">Amgen states that this “is one of the first
actions for patent infringement under 35 USC 271(e)(2)(C), which was enacted in
2010 as part of the” BPCIA.</span></div>
<span style="font-family: Calibri;"><span style="font-size: large;">
</span><div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;">According to the complaint, Hospira submitted its Biologic
License Application (BLA) under the expedited subsection (k) pathway, relying
on Amgen’s demonstration of the safety and efficacy of Epogen, but has failed
to comply with the patent provisions of the BPCIA.<span style="mso-spacerun: yes;"> </span>For example, Hospira has not provided Amgen
with manufacturing information that “would have given Amgen the opportunity to
evaluate the manufacturing processes used by Hospira to determine whether those
processes would infringe any patents held by Amgen.”<span style="mso-spacerun: yes;"> </span>This is essentially the same complaint Amgen
had with respect to Sandoz's application for expedited approval of a
biosimilar filigrastim based on Amgen’s Neupogen product.</span></div>
<span style="font-size: large;">
</span><div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: large;">Amgen is also seeking a declaratory judgment that Hospira is
required to provide Amgen with legally effective notice of commercial marketing
of its biosimilar product, and information describing the processes or products
used to manufacture the biosimilar product.<span style="mso-spacerun: yes;">
</span>In <em>Amgen v. Sandoz</em>, the Federal Circuit held that a biosimilar applicant
must provide notice to the reference sponsor on or after the date that the FDA
approves its biosimilar application, but according to the complaint Hospira has
refused to do so.<o:p></o:p></span></div>
<span style="font-size: large;">
</span><div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Times New Roman; font-size: large;">
</span></div>
<span style="font-size: large;">
</span></span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
</div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com3tag:blogger.com,1999:blog-2774042125883658.post-90831685626647652472015-09-01T15:18:00.000-05:002015-09-01T15:18:16.360-05:00Rapid Litigation Management (Celsis) v. Cellzdirect: BIO Files Amicus Brief in Another Patent Eligibility Case before the Federal Circuit
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: inherit; font-size: large;">On August 28, 2015, the Biotechnology Industry Organization
(BIO) filed an </span><a href="https://drive.google.com/open?id=0B9_llJGo9WK0bHhEa0Jpc2hnZEU"><span style="font-family: inherit; font-size: large;">amicus brief</span></a><span style="font-family: inherit;"><span style="font-size: large;"> in another important patent eligibility case
currently before the Federal Circuit, <i style="mso-bidi-font-style: normal;">Rapid
Litigation Management (formerly Celsis In Vitro) v. Cellzdirect.</i><span style="mso-spacerun: yes;"> </span>The claims at issue are directed towards a
"method for freezing hepatocytes multiple times without further significant loss
of cell health and viability."<span style="mso-spacerun: yes;"> </span>The method
has three steps: (1) previously frozen cells are thawed, (2) nonviable cells
are separated from viable ones using a “density gradient fractionation,” and
then (3) viable cells are cryopreserved for later use.<span style="mso-spacerun: yes;"> </span>In the decision below, the District Court
invalidated the claims, finding them to be directed towards patent ineligible
subject matter.<o:p></o:p></span></span></div>
<span style="font-family: inherit;"><span style="font-size: large;">
In applying the first step of the<i style="mso-bidi-font-style: normal;"> Mayo</i> two-step test for patent eligibility, the District Court
found that the “patent is directed to an ineligible law of nature: the
discovery that hepatocytes are capable of surviving multiple freeze-thaw
cycles.”<span style="mso-spacerun: yes;"> </span>In the second step, the court
found the claimed method to lack sufficient “inventive concept,” because
claimed elements such as freezing cells and the use of density gradient
fractionation were found to be “well understood.”<o:p></o:p></span></span><br />
<span style="font-family: inherit; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: inherit;"><span style="font-size: large;">In its brief, BIO urges the Federal Circuit to clarify the
boundaries regarding the scope of the term “law of nature,” and argues that
hepatocytes are not subject to repeated freezing in nature under the conditions
of the claimed methods, and thus that the claim does not implicate a law of
nature.<span style="mso-spacerun: yes;"> </span>The brief also argues that the
district court’s approach, which essentially “requires an undefined ‘something
else,’ that cannot be satisfied by the application of known techniques and
reagents to a newly recognized natural phenomenon, threatens the availability
of patent protection for a host of important innovations spanning the length
and breadth of biotechnology.”<o:p></o:p></span></span></div>
<span style="font-family: inherit; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: inherit;"><span style="font-size: large;">BIO also argues that “[b]ecause of its well-developed record
on the non-obviousness of the claimed invention, this case may present a good
opportunity for this court to clarify the interplay between Section 103 and
Step II of the<i style="mso-bidi-font-style: normal;"> Mayo/Alice</i> framework."<o:p></o:p></span></span></div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com2tag:blogger.com,1999:blog-2774042125883658.post-55480283211915935062015-08-28T11:17:00.000-05:002015-08-28T11:24:54.801-05:00Here Are All the Amicus Briefs That Have Been Filed Seeking En Banc Rehearing of Ariosa v. Sequenom<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<span style="font-family: "Times New Roman",serif;"><o:p><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">Yesterday I posted the amici brief I filed on behalf of BIO and PhRMA seeking en banc rehearing of <em>Ariosa v. Sequenom</em>. Here are links to all twelve amicus briefs that were filed, in one place for your convenience. Enjoy. I have not read most of them, but I am glad to see people have taken notice and agree that there is a need for action.</span></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<span style="font-family: "Times New Roman",serif;"><o:p><span style="font-family: Arial, Helvetica, sans-serif; font-size: large;"></span></o:p></span> </div>
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<span style="font-family: "Times New Roman",serif;"><o:p></o:p></span><span style="font-family: "Times New Roman",serif;"><a href="https://drive.google.com/file/d/0B9_llJGo9WK0YW14dzdhN1JTR0k/view?usp=sharing"><span style="color: black;"><span style="font-family: Arial, Helvetica, sans-serif;"><span style="font-size: large;"><strong>BIO AND PhRMA</strong><o:p></o:p></span></span></span></a></span></div>
<span style="font-family: "Times New Roman",serif;"></span><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"> </span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<a href="https://drive.google.com/open?id=0B9_llJGo9WK0SHRVWkFRSmVMczA"><span style="color: black;"><span style="font-family: Arial, Helvetica, sans-serif;"><span style="font-size: large;"><b><span style="font-family: "Times New Roman",serif;">COALITION FOR 21</span></b><b><span style="font-family: "Times New Roman",serif;">ST </span></b><b><span style="font-family: "Times New Roman",serif;">CENTURY </span></b><b><span style="font-family: "Times New Roman",serif; line-height: 107%;">MEDICINE<o:p></o:p></span></b></span></span></span></a></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<b><span style="line-height: 107%;"><a href="https://drive.google.com/file/d/0B9_llJGo9WK0SDV0OWN1dWNPNjA/view?usp=sharing"><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">AMARANTUS BIOSCIENCE HOLDINGS, INC., PERSONALIS, INC., AND POPULATION DIAGNOSTICS, INC.</span></a></span></b></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<a href="https://drive.google.com/file/d/0B9_llJGo9WK0YjUteV81V2s2NDg/view?usp=sharing"><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"><strong>NEW YORK INTELLECTUAL PROPERTY LAW ASSOCIATION</strong></span></a></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<b><span style="font-family: "Times New Roman",serif; line-height: 107%;"><a href="https://drive.google.com/file/d/0B9_llJGo9WK0M1BDV21QVl9fVkE/view?usp=sharing"><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">NOVARTIS</span></a></span></b></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
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<b><span style="font-family: "Garamond-Bold",serif; line-height: 107%; mso-bidi-font-family: Garamond-Bold;"><a href="https://drive.google.com/file/d/0B9_llJGo9WK0WVVVOVZ3WERqYmc/view?usp=sharing"><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">BIOINDUSTRY ASSOCIATION</span></a></span></b></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<b><span style="font-family: "TimesNewRomanPS-BoldMT",serif; line-height: 107%; mso-bidi-font-family: TimesNewRomanPS-BoldMT;"><a href="https://drive.google.com/open?id=0B9_llJGo9WK0RUFmeGp1U2dNbGc"><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">TWENTY-THREE LAW PROFESSORS</span></a></span></b></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
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<span style="font-family: "Century",serif; line-height: 107%; mso-bidi-font-family: Century;"><a href="https://drive.google.com/file/d/0B9_llJGo9WK0NUdKU0E2MW81QU0/view?usp=sharing"><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"><strong>JYANT TECHNOLOGIES INC.</strong></span></a></span></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
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<a href="https://drive.google.com/file/d/0B9_llJGo9WK0UGFJUTM3WnJENVU/view?usp=sharing"><span style="color: black;"><span style="font-family: Arial, Helvetica, sans-serif;"><span style="font-size: large;"><b><span style="font-family: "TimesNewRoman,Bold"; line-height: 107%;">W</span></b><b><span style="font-family: "TimesNewRoman,Bold"; line-height: 107%;">ISCONSIN </span></b><b><span style="font-family: "TimesNewRoman,Bold"; line-height: 107%;">A</span></b><b><span style="font-family: "TimesNewRoman,Bold"; line-height: 107%;">LUMNI </span></b><b><span style="font-family: "TimesNewRoman,Bold"; line-height: 107%;">R</span></b><b><span style="font-family: "TimesNewRoman,Bold"; line-height: 107%;">ESEARCH </span></b><b><span style="font-family: "TimesNewRoman,Bold"; line-height: 107%;">F</span></b><b><span style="font-family: "TimesNewRoman,Bold"; line-height: 107%;">OUNDATION</span></b></span></span></span></a></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: "TimesNewRomanPS-BoldMT",serif; line-height: 107%; mso-bidi-font-family: TimesNewRomanPS-BoldMT;"><a href="https://drive.google.com/file/d/0B9_llJGo9WK0YXNfaGxhLTFXT2c/view?usp=sharing"><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"><strong>PAUL GILBERT COLE</strong></span></a></span></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"><strong>
</strong></span><br />
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<span style="font-family: "TimesNewRomanPS-BoldMT",serif; line-height: 107%; mso-bidi-font-family: TimesNewRomanPS-BoldMT;"><a href="https://drive.google.com/file/d/0B9_llJGo9WK0RzVhUFh2SFJpUG8/view?usp=sharing"><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"><strong>PROFESSORS JEFFREY A. LEFSTIN AND PETER S. MENELL</strong></span></a></span></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"><strong>
</strong></span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<a href="https://drive.google.com/file/d/0B9_llJGo9WK0bFM0eGJhY0E5WXc/view?usp=sharing"><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"><strong> INTELLECTUAL PROPERTY OWNERS ASSOCIATION</strong></span></a></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<b><span style="font-family: "Times New Roman",serif;"></span></b><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"> </span></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<b><span style="font-family: "Times New Roman",serif;"><o:p><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"> </span></o:p></span></b></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span><br />
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<b><span style="font-family: "Times New Roman",serif;"><o:p></o:p></span></b><span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;"> </span></div>
<span style="color: black; font-family: Arial, Helvetica, sans-serif; font-size: large;">
</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com2tag:blogger.com,1999:blog-2774042125883658.post-76469910173024897912015-08-27T15:13:00.002-05:002015-08-27T15:13:50.506-05:00BIO and PhRMA File Amici Brief Urging En Banc Reconsideration of Ariosa v. Sequenom
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: 14pt; line-height: 107%; mso-bidi-font-family: "Times New Roman";">The Biotechnology Industry Organization (BIO) and the</span><span class="BodyTextFirstHalfIndent2Char"><span lang="X-NONE" style="font-size: 14pt; line-height: 107%; mso-bidi-font-family: "Times New Roman";"> Pharmaceutical
Research and Manufacturers of America (PhRMA) have jointly filed an <i style="mso-bidi-font-style: normal;">amici brief</i> curiae brief urging the
Federal Circuit to grant en banc rehearing of <i style="mso-bidi-font-style: normal;">Ariosa v. Sequenom</i>.<span style="mso-spacerun: yes;"> </span>The
brief is available <a href="https://drive.google.com/open?id=0B9_llJGo9WK0V2k5OFFwam5wSUU">here</a>.<span style="mso-spacerun: yes;"> </span>I am the
counsel of record.<o:p></o:p></span></span></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: 14pt; line-height: 107%; mso-bidi-font-family: "Times New Roman";"><span style="font-family: Calibri;">BIO and PhRMA are concerned that the
development and commercialization of a range of biotechnology and
pharmaceutical innovations will be impeded if the Federal Circuit does not
address the mounting uncertainty currently afflicting patentable subject matter
jurisprudence.<span style="mso-spacerun: yes;"> </span>The brief points out the
critical importance of effective patent protection for biotechnology and
pharmaceutical innovators, and the current unprecedented level of uncertainty with
respect to the scope of patent eligible subject matter.<span style="mso-spacerun: yes;"> </span>This uncertainty is affecting both the patent
user community and the PTO, which has responded with an ongoing stream of
revised and re-revised non-final and interim guidance documents.<span style="mso-spacerun: yes;"> </span>With each new PTO Guidance, BIO members have
observed an increasing rate of claim rejections, affecting a diverse range of
biotechnology, including novel antibiotic molecules, industrial enzymes,
diagnostic processes, and crop production products.<o:p></o:p></span></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: 14pt; line-height: 107%; mso-bidi-font-family: "Times New Roman";"><span style="font-family: Calibri;">The unsettled state of the law has also created doubt as to
whether issued patents will be able to withstand challenge. The brief points out that the
vast majority of judicial decisions addressing patent eligibility under the
recently articulated standards have resulted in a determination of
ineligibility. <span style="mso-spacerun: yes;"> </span>For example, Appendix 3
of the recent PTO “July 2015 Update: Subject Matter Eligibility,” identifies 24
post-<i style="mso-bidi-font-style: normal;">Mayo</i> <span style="mso-spacerun: yes;"> </span>subject matter eligibility cases decided by the
Federal Circuit, of which 22 held <i style="mso-bidi-font-style: normal;">all</i>
of the challenged claims to be patent ineligible.<o:p></o:p></span></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: 14pt; line-height: 107%; mso-bidi-font-family: "Times New Roman";"><span style="font-family: Calibri;">The brief urges the court to clarify the
contours of both Step I and Step II of the<i style="mso-bidi-font-style: normal;">
Mayo</i> two-step test for patent eligibility.<span style="mso-spacerun: yes;">
</span>It posits that the Supreme Court would not have articulated a
two-step test if it did not intend the first step to serve some meaningful
gatekeeping function, but that under the standard applied by the panel it is
difficult to see how <i style="mso-bidi-font-style: normal;">any</i> analytical
or detection method would ever <i style="mso-bidi-font-style: normal;">not</i> satisfy
Step I, so long as that method is designed to detect something that occurs
naturally.<span style="mso-spacerun: yes;"> </span>With regard to Step II, the
brief asks for clarification with regard to the proper application of the “inventive
concept” and “preemption” standards of patent eligibility.<span style="mso-spacerun: yes;"> </span>As an example, the brief discusses the
practical challenges facing the inventor of a new diagnostic test under the new
patent eligibility jurisprudence.<o:p></o:p></span></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: 14pt; line-height: 107%; mso-bidi-font-family: "Times New Roman";"><span style="font-family: Calibri;">In its recent decisions the Supreme Court apparently assumed
the existence of limiting principles that would maintain patent eligibility for
truly meritorious inventions (this was Judge Linn’s characterization of Sequenom’s
claimed invention in his concurring opinion), even if that invention can be
deconstructed into a combination of natural phenomena and conventional
technology. The brief argues that <i style="mso-bidi-font-style: normal;">en banc</i>
reconsideration would allow the Federal Circuit to address the nature of these
limiting principles suggested in <i style="mso-bidi-font-style: normal;">Mayo</i>.<span style="mso-spacerun: yes;"> </span>Alternatively, if the court finds that
Supreme Court precedent does not provide for limiting principles that provide a
meaningful opportunity for patenting important biotechnology innovations, that would
suggest a need for the Supreme Court to readdress the contours of patent
eligibility in the context of biotechnology. <em>Ariosa v. Sequenom </em>would be an appropriate vehicle for alerting the Supreme Court to the
urgent need for this clarification.</span></span></div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com1tag:blogger.com,1999:blog-2774042125883658.post-20515376142815841542015-08-27T10:31:00.002-05:002015-08-27T10:31:57.387-05:00Law Professors File Amicus Brief Supporting En Banc Rehearing of Ariosa v. Sequenom<br />
A group of 23 law professors, myself included, have filed an amicus brief in support of en banc rehearing of <em>Ariosa v. Sequenom</em>. <br />
<br />
The brief is available <a href="https://drive.google.com/open?id=0B9_llJGo9WK0RldmdmlrQ1AwTm8">here</a>.<br />
<br />
Adam Mossoff, a professor at George Mason University School of Law and a Director at the Center for the Protection of Intellectual Property (CPIP), and Kevin Noonan, a partner at MBHB, took the lead in drafting the brief.Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com4tag:blogger.com,1999:blog-2774042125883658.post-57130475862594201532015-08-27T09:13:00.002-05:002015-08-27T09:13:28.374-05:00Eli Lilly v. Teva: District Court Applies the Federal Circuit's Recent Akamai Decision to Drug Method-of-Treatment Claim
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">In 2014 I published an article entitled “Caught between a
Rock and a Hard Place: How Limelight Compounds the Challenges Facing
Biotechnology Innovators after <em>Mayo</em> and <em>Myriad</em>” (available </span><a href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2566945"><span style="font-size: large;">here</span></a><span style="font-size: large;">), which
explained how Supreme Court’s decision in <i style="mso-bidi-font-style: normal;">Limelight
Networks v. Akamai Technologies</i> limiting the ability of patentees to
establish liability in cases of divided infringement had undermined the value
of method claims, particularly with respect to diagnostics and drugs.<span style="mso-spacerun: yes;"> </span>In that article, I noted that in <em>Limelight </em>the Court<em> </em>had explicitly pointed out that
its decision did not necessarily preclude the Federal Circuit from revisiting
that court's decision in <i style="mso-bidi-font-style: normal;">Muniauction,</i> and to
reinterpret 271(a) in a manner that would allow a patent owner to hold at least
certain parties liable for active participation in a concerted act of divided
infringement.<span style="mso-spacerun: yes;"> </span>I also predicted that that
the Federal Circuit would likely revisit the issue and expand 271(a) in a
manner that would hold at least some divided infringer’s liable.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">On Aug. 13, 2015, the Federal Circuit did just that when it issued
an en banc opinion unanimously setting forth the law of divided
infringement under 35 U.S.C. § 271(a) and vacating the earlier panel decision. <i style="mso-bidi-font-style: normal;">Akamai Technologies, Inc. v. Limelight
Networks, Inc</i>., 2015 WL 4760450 (Fed. Cir.).<span style="mso-spacerun: yes;"> </span><em>Akamai</em> explicitly overruled prior case law
regarding divided infringement, “[t]o the extent [those] prior cases formed the
predicate for the vacated panel decision,” and no longer limited § 271(a) to
principal-agent relationships, contractual arrangements, and joint enterprises.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;"><span style="line-height: 107%;">Under 35
U.S.C. § 271(a), direct patent infringement occurs where all steps of a claimed
method are performed by or attributable to a single entity. In <i>Akamai</i>, the
court held that “[w]here more than one actor is involved in practicing the
steps, a court must determine whether the acts of one are <em>attributable</em> to the
other </span>such that a single entity is responsible for the infringement.” On
a claim for direct infringement of a method patent, the court will hold an
entity responsible for anothers’ performance of method steps under two
circumstances: (1) where that entity directs or controls others’ performance,
and (2) where the actors form a joint enterprise. With respect to the former
requirement, <em>Akamai</em> concluded that
“liability under § 271(a) can also be found when an alleged infringer
conditions participation in an activity or receipt of a benefit upon
performance of a step or steps of a patented method and establishes the manner
or timing of that performance.” In those instances, the third party’s actions
are attributed to the alleged infringer “such that the alleged infringer
becomes the single actor chargeable with direct infringement.”<o:p></o:p></span></span></div>
<span style="font-size: large;">
In<span style="font-family: Calibri;"> <i style="mso-bidi-font-style: normal;">Limelight, </i>Eli
Lilly filed an amicus brief with the Supreme Court explaining the critical role of method-of-treatment
claims in pharmaceutical innovation, and noting that such claims ‘‘routinely
and sometimes necessarily present divided infringement issues.’’ According to
Lilly, ‘‘[i]t has been increasingly common for patent challengers to argue that
the relationship between these various actors does not meet the current
standard articulated by the Federal Circuit necessary to find liability for direct
infringement under 35 USC 271(a).’’<o:p></o:p></span></span><br />
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">On August 25, 2015, Eli Lilly’s concerns were presumably at
least partially abated by the district court's decision in <em>Eli Lilly v. Teva</em> (available
</span><a href="https://drive.google.com/open?id=0B9_llJGo9WK0NHFET2haNnFkOVk"><span style="font-size: large;">here</span></a><span style="font-size: large;">). The <em>Eli Lilly </em>court applied the new<i style="mso-bidi-font-style: normal;"> Akamai</i>
standard and held that doctors directly infringed an Eli Lilly
method-of-treatment claim, even though the claim explicitly recites the step of
administering folic acid to a patient prior to administration of the drug, and
it is the patient that takes the folic acid, i.e., the doctor does not
administer the folic acid to the patient.<span style="mso-spacerun: yes;">
</span>As a consequence, a generic company would be liable for inducing the
doctor’s infringement based on drug labeling that instructs doctors to have
their patients take folic acid prior to the doctor administering the
drug to the patient.<span style="mso-spacerun: yes;"> </span>It is significant that the
generic drug company is required by law to use essentially the same label as
the branded drug, and is thus required to “induce” doctors to instruct patients to take their folic acid.<o:p></o:p></span></span></div>
<span style="font-size: large;">
</span><br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;"><span style="font-size: large;">In particular, the district court found that “the instant
case involves the administration of a medical treatment, the factual
circumstances are sufficiently analogous to those in <em>Akamai</em> to support a
finding of direct infringement by physicians under § 271(a), and thus
inducement of infringement by Defendants under § 271(b), under the legal
standard recently set forth by the Federal Circuit.”<span style="mso-spacerun: yes;"> </span>The generic company defendants argued unsuccessfully
that the "actions of the patient in taking folic acid prior to [administration
of the drug] cannot be attributed to the physician because the physician does
not physically place the folic acid into the patients’ mouth, and because
patients are instructed to obtain folic acid, either by prescription or over
the counter, and take it on their own.”<span style="mso-spacerun: yes;"> </span>But
the district court found this argument to be premised on “now overruled case
law on divided infringement,” and found the following language of the label to be
unambiguous on this point:</span></span></div>
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<blockquote class="tr_bq">
<span style="font-size: large;"><em>The prescribing information requires physicians to
“[i]nstruct patients to initiate folic acid 400 mcg to 1000 mcg orally once
daily beginning 7 days before the first dose of ALITMA®.” Additionally, the
patient information states “[i]t is very important to take folic acid . . .
during your treatment with ALITMA to lower your chances of harmful side
effects. You must start taking 400-1000 micrograms of folic acid every day for
at least 5 days out of the 7 days before your first dose of ALITMA.” TX. 3017
at 2 (emphasis in original). It is clear from the patent, the prescribing
information, and the patient information that taking folic acid in the manner
specified is a condition of the patient’s participation in pemetrexed treatment
as described by the patent, and is necessary in order to receive the benefit of
such treatment. If the patient fails to carry out this step, he or she would
not receive the benefit of the patented method, i.e. a reduction of potentially
life-threatening toxicities caused by pemetrexed. The physician, based upon the
patented method, directs the manner and timing of the patient’s ingestion of
folic acid—400 to 1000 μg of folic acid for at least five days out of the seven
days prior to and during pemetrexed administration—and the patient is <span style="line-height: 107%;">required to do so to receive the full
benefit of the treatment.</span></em></span></blockquote>
</div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com2tag:blogger.com,1999:blog-2774042125883658.post-34085425417794232112015-08-26T06:52:00.001-05:002015-08-26T06:52:21.958-05:00WARF Files Amicus Brief in Support of En Banc Rehearing of Ariosa v. Sequenom<br />
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The Federal Circuit’s discouraging opinion in <i>Ariosa v.
Sequenom</i> has been discussed in previous <a href="http://holmansbiotechipblog.blogspot.com/2015/06/federal-circuit-decides-ariosa-and-its.html">posts</a>.
Sequenom has petitioned for en banc rehearing, its brief is available
<a href="https://drive.google.com/open?id=0B9_llJGo9WK0a010QXFLekl4VUU">here</a>, Amicus briefs are due tomorrow, Aug 27, but WARF got its in a bit early,
and it is available <a href="https://drive.google.com/open?id=0B9_llJGo9WK0anoyTk9UZHhuQkE">here</a>.</div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Here is a summary
of WARF’s argument, i.e., their argument as set forth in the Table of Contents:</div>
<div class="MsoNormal">
<span style="text-indent: -0.25in;"><br /></span></div>
<div class="MsoNormal">
</div>
<ul>
<li><span style="text-indent: -0.25in;">The goal of the two-step Mayo/Alice framework is
to ensure that patentees cannot effectively monopolize natural phenomena, laws
of nature, and abstract ideas—no more and no less</span></li>
<li><span style="font-size: 7pt; font-stretch: normal; text-indent: -0.25in;"> </span><span style="text-indent: -0.25in;">Where an inventor claims only an application
that makes practical use of a natural phenomenon, the claims do not monopolize
the natural phenomenon itself and are patent-eligible under Section 101</span></li>
<li><span style="text-indent: -0.25in;">The panel’s analysis of Mayo/Alice Step Two was
mistaken because isolation, amplification, and analysis of cffDNA in maternal
fluids were not conventional</span></li>
</ul>
<div style="text-indent: -24px;">
<br /></div>
<div style="text-indent: -24px;">
<br /></div>
<div style="text-indent: -24px;">
More briefs will be posted shortly, including one I am helping to prepare for Biotechnology Industry Organization</div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com0tag:blogger.com,1999:blog-2774042125883658.post-1906741946863908932015-07-21T09:18:00.000-05:002015-07-21T09:18:25.934-05:00Former Grad Student Fails in Bid for “Constructive Trust” in Professor’s Patent
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;">On July 16, 2015, in <i style="mso-bidi-font-style: normal;"><a href="http://www.cafc.uscourts.gov/images/stories/opinions-orders/15-1059.Rule_36_Judgment.7-14-2015.1.PDF">Genspera v. Mahka</a></i>, the Federal Circuit affirmed without discussion (i.e., under Rule
36) a district court decision denying a former doctoral student’s claim to a
constructive trust in a patent issued to her former thesis advisor, a professor
at Johns Hopkins University. The affirmed district court decision also denied
her conversion claim against the professor.<o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;">The professor, along with another professor at Johns Hopkins,
are named inventors on patents claiming a cancer prodrug. The graduate
student, Mahka, claims that she came up with the idea for the only specific
chemical compound claimed in the patents, a compound that is currently
undergoing clinical testing. Genspera is a company started by the professors to
develop and commercialize the prodrug.<o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-family: Calibri;">Mahka initially sought to be added as an inventor to the
patents, but the district court granted Genspera summary judgment because<span style="font-size: 11.5pt; line-height: 107%;"> “a finding that Mhaka added an
invention to the Application after the disclosure was filed would invalidate
the Patents, and a district court cannot apply § 256 to require the Patent
Office to add an inventor to an issued patent when doing so would invalidate
the patent.”<span style="mso-spacerun: yes;"> </span>The problem was that the prodrug
allegedly invented by Mahka was not created until after the filing date of the
patents.<o:p></o:p></span></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: 11.5pt; line-height: 107%;"><span style="font-family: Calibri;">Mahka then
turned to state law causes of action. She claimed conversion of her invention
by the professors, but the district court rejected this claim. The court found
that under Maryland law the tort of conversion does not extend to completely intangible
rights, and that Mahka’s asserted rights in the “invention” claimed in the patents
was completely intangible.<o:p></o:p></span></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: 11.5pt; line-height: 107%;"><span style="font-family: Calibri;">Mahka also
sought a constructive trust, a form of equitable relief which would have
required the professors to share some of the benefits they derived from the patents,
specifically stock in Genspera.<span style="mso-spacerun: yes;"> </span>A
constructive trust remedy is applied when “property has been acquired by fraud,
misrepresentation, or other improper method, or where the circumstances render
it inequitable for the party holding the title to retain it.” Its purpose is
“to prevent the unjust enrichment of the holder of the property.”<o:p></o:p></span></span></div>
<br />
<div class="MsoNormal" style="margin: 0in 0in 8pt;">
<span style="font-size: 11.5pt; line-height: 107%;"><span style="font-family: Calibri;">The district
court denied this claim, finding that it was barred by laches, i.e., Mahka waited
too long to file her lawsuit.<span style="mso-spacerun: yes;"> </span>The
district court held that she needed to file her claim within three years of
learning of the alleged failure to name her on the patent, and that she had
waited more than four years.<span style="mso-spacerun: yes;"> </span>After
leaving Johns Hopkins, Mahka worked at a venture capital firm doing
intellectual property research, which is where she allegedly learned of the
patents.<span style="mso-spacerun: yes;"> </span>She learned about them, and her omission as an inventor, in 2008,
and contacted John Hopkins at that time, who advised her to hire her own
lawyer. She waited until 2012 to file a lawsuit, at which point her cause of
action was time-barred.<o:p></o:p></span></span></div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com5tag:blogger.com,1999:blog-2774042125883658.post-25581724350896676792015-07-20T14:04:00.002-05:002015-07-20T14:04:44.697-05:00Federal Circuit Affirms IPR Invalidation of Columbia University Next-Generation Sequencing Patents<br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<span style="font-family: "Times New Roman",serif; font-size: 12pt;">On July 17, 2015, in <span id="goog_12509132"></span><i style="mso-bidi-font-style: normal;"><a href="https://www.blogger.com/">Trustees of Columbia University in the City
of New York v. Illumina<span id="goog_12509133"></span></a> </i>, the Federal Circuit affirmed inter partes review
(IPR) decisions invalidating all challenged claims in three Columbia University
patents related to Next-Generation DNA sequencing. In particular, the three
patents (U.S. Patent Nos. 7,713,698 (the “’698 patent”) (Appeal No. 2014-1547),
8,088,575 (the “’575 patent”) (Appeal No. 2014-1548), and 7,790,869 (the “’869
patent”) (Appeal No. 2014-1550) are directed towards synthetic nucleotide
analogs that comprise the following features: (1) a deaza substitution in the base
component of the nucleotide; (2) <span style="mso-spacerun: yes;"> </span>a label
attached to the base component (as opposed to the sugar component); and (3) a removable
cap at the 3’OH position of the sugar component of the nucleotide. The
nucleotide analogs are useful in automated sequencing-by-synthesis methods.</span></div>
<br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<span style="font-family: "Times New Roman",serif; font-size: 12pt;"><o:p> </o:p></span><span style="font-family: "Times New Roman",serif; font-size: 12pt;">In a nonprecedential opinion, the
Federal Circuit found that that the Patent Trial and Appeal Board (PTAB) had
not erred in finding all of the challenged claims either anticipated or obvious
in view of seven prior art references. Most of the references are listed on the
face of at least one of the patents, and thus (at least as a formal matter)
were considered by the patent examiner during prosecution of the patents. In
particular, the primary reference relied upon by the PTAB (Roger Tsien et al.,
WO 91/06678 (May 16, 1991) (“Tsien”)) was before the patent examiner. In a
nutshell, the Federal Circuit agreed with the PTAB that the references
disclosed all of the elements of the claimed inventions and provided a
motivation to combine the elements, with a reasonable expectation of success.<o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<span style="font-family: "Times New Roman",serif; font-size: 12pt;"><o:p> </o:p></span><span style="font-family: "Times New Roman",serif; font-size: 12pt;">One of the issues on appeal was
whether the PTAB had erred by not explicitly determining the level of skill in
the art. The Federal Circuit held that under certain circumstances a failure to
determine the level of skill, or an incorrect determination of the level of
skill, can be a reversible error, but not always, particularly</span><span style="font-family: Calibri;"> </span><span style="font-family: "Times New Roman",serif; font-size: 12pt;">“where the prior art
itself reflects an appropriate level and a need for testimony is not shown.” In
this case, the Federal Circuit found that it was not necessary for the PTAB to
explicitly define the relevant level of skill in the art.<o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<span style="font-family: "Times New Roman",serif; font-size: 12pt;"><o:p> </o:p></span><span style="font-family: "Times New Roman",serif; font-size: 12pt;">Interestingly, in making its arguments
regarding level of skill in the art, Columbia actually argued against its own
interests, as explicitly pointed out by the Federal Circuit. In particular,
Illumina’s expert testified that one of skill in the relevant art would be
knowledgeable with respect to molecular biology, while Columbia argued that one
of skill in the art of DNA sequencing technology would be skilled in both
molecular biology <em>and</em> chemistry. As pointed out by the Federal Circuit, the
higher the level of skill in the art, the more likely it is that the invention
would have been obvious to the skilled artisan. Thus, by arguing that the PHOSITA
is skilled in both molecular biology and chemistry, Columbia was actually arguing
that the PHOSITA has a higher level of skill, which would tend to make the
invention more obvious. The Federal Circuit concluded that PTAB had not erred
in finding that the invention would have been obvious to one skilled in
molecular biology, and that it would have been even more obvious to one having
skill in both molecular biology and chemistry.<o:p></o:p></span></div>
<span style="font-family: "Times New Roman",serif; font-size: 12pt;"><o:p></o:p></span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<span style="font-family: "Times New Roman",serif; font-size: 12pt;">The Federal Circuit also identified
another instance in which Columbia made arguments that went against its own
interest. Columbia argued
that other companies had copied its invention from a grant application filed by
the inventors, and that this “copying by others” was an objective indication
that the invention was nonobvious. But Columbia also argued that these other
companies had thought that they would be able to patent invention, which the
Federal Circuit found was inconsistent with them having copied the invention.
After all, how could they have thought that they could patent the invention if
they had knowingly copied it from someone else’s grant application?<o:p></o:p></span></div>
<span style="font-family: "Times New Roman",serif; font-size: 12pt;"><o:p></o:p></span><br />
<div class="MsoNormal" style="line-height: normal; margin: 0in 0in 0pt; mso-layout-grid-align: none;">
<span style="font-family: "Times New Roman",serif; font-size: 12pt;">The Federal Circuit found that the
near-simultaneous invention by others was a secondary consideration weighing “modestly
in favor of obviousness.” In particular, two other entities were found to have
independently come up with the invention prior to publication of the Columbia
patent applications, i.e., prior to public disclosure of the invention.
Columbia argued that this independent inventive activity did not constitute “prior
art,” but the Federal Circuit </span><span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">criticized
Columbia’s argument as reflecting “confusion over the difference between
simultaneous invention on the one hand and anticipation and obviousness on the
other.” <o:p></o:p></span></div>
<span style="font-family: "Times New Roman",serif; font-size: 12pt;"><o:p></o:p></span><br />
<span style="font-family: "Times New Roman",serif; font-size: 12pt; line-height: 107%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin;">These IPRs arose out of
an ongoing patent infringement litigation between Intelligent Bio-Systems Inc. (IBS, Columbia’s exclusive licensee)
and Illumina, in which both sides have
asserted that the other infringes patents relating to Next-Generation DNA
Sequencing technologies.<span style="mso-spacerun: yes;"> </span>Both sides have
successfully invalidated some of their opponent’s patents using the IPR
process. In <i style="mso-bidi-font-style: normal;">Trustees of Columbia
University in the City of New York v. Illumina </i>the Federal Circuit has
affirmed the PTAB's invalidation of the IBS/Columbia patents.<span style="mso-spacerun: yes;"> </span>We are still waiting to hear the outcome of
Illumina’s appeal of the PTAB’s decisions invalidating a number of patent
claims it has asserted against IBS (the parties’ briefs have already been filed in that case).</span>Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com0tag:blogger.com,1999:blog-2774042125883658.post-4229697463909426052015-07-06T10:25:00.000-05:002015-07-06T10:25:18.029-05:00The Medicines Company v. Hospira: Use of Contract Manufacturer Creates On-Sale Bar
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<span style="font-family: "Times New Roman",serif; font-size: 12pt; mso-fareast-font-family: "Times New Roman";">In
<i style="mso-bidi-font-style: normal;">The Medicines Company v. Hospira</i>,
decided July 2, 2015, the Federal Circuit held that a patent owner’s use of a
contract manufacturer to prepare three “validation batches” of a drug
formulation embodying the claimed invention created an invalidating on-sale
bar, even though the contract was for manufacturing service, not for the sale
of product, and title to the drug always resided with the patent owner, and
even though the batches were produced for the purpose of demonstrating to FDA
that the invention resulted in a formulation that safisfied FDA specifications.
<span style="mso-spacerun: yes;"> </span>The decision illustrates the risk of
using a contract manufacturer prior to filing a patent application,
particularly now that the AIA has called into question the availability of the one
year grace period previously available under pre-AIA 102(b).<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><o:p></o:p></span></div>
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<span style="font-family: "Times New Roman",serif; font-size: 12pt; mso-fareast-font-family: "Times New Roman";">The
Medicines Company (TMC) owns U.S. Patent No. 7,582,727 and U.S. Patent No.
7,598,343, which claim formulations of the drug bivalirudin. TMC sells bivalirudin
under the Angiomax® brand. </span><span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">From 1997 to October
2006, TMC used Ben Venue Laboratories (BVL) as a contract manufacturer of
Angiomax</span><span style="font-family: "CenturySchoolbook",serif; font-size: 8pt; mso-bidi-font-family: CenturySchoolbook;">®</span><span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">.
In 2005, BVL ran into some production problems and began producing batches of
Angiomax that contained an impurity (Asp</span><span style="font-family: "CenturySchoolbook",serif; font-size: 8pt; mso-bidi-font-family: CenturySchoolbook;">9</span><span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">-bivalirudin) at levels exceeding FDA’s approved maximum of
1.5%.<o:p></o:p></span></div>
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<span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">TMC
hired a consultant to investigate and resolve the issue, and the consultant
discovered a method of formulating Angiomax that reduced the level of impurity
to below 0.6%.<span style="mso-spacerun: yes;"> </span>In July 2008, TMC filed
patent applications based on this discovery, resulting the ‘727 and ‘343 patents.<span style="mso-spacerun: yes;"> </span>Prior to the critical date, i.e., more than
one year before the filing date, TMC hired BVL to prepare three “validation batches”
of bivalirudin falling within the scope of the claims for the purpose of
proving to FDA that the product met the already-approved specifications for
finished bivalirudin product.<span style="mso-spacerun: yes;">
</span>Subsequently, post-critical date, TMC sold some of the drug produced by
BVL.<o:p></o:p></span></div>
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<span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">In
the </span><i style="mso-bidi-font-style: normal;"><span style="font-family: "Times New Roman",serif; font-size: 12pt; mso-fareast-font-family: "Times New Roman";">The
Medicines Company v. Hospira</span></i><span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">,
an ANDA litigation, the district court upheld the validity of the patents,
finding that the contract manufacture of the three validation batches by BVL
did not create a 102(b) on-sale bar. The district court based its decision on
its determination that TMC did not purchase the validation batches from BVL,
but rather that the transaction was better characterized as “</span><span style="font-family: "Times New Roman",serif; font-size: 12pt; mso-fareast-font-family: "Times New Roman";">a contract manufacturer relationship in which Ben Venue was
paid to manufacture Angiomax for The Medicines Company, [and] wherein title to
the Angiomax always resided with The Medicines Company. [As] the invoices
clearly stated, “Charge to manufacture Bivalirudin lot.”<o:p></o:p></span></div>
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<span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">The district court acknowledged that in
</span><i><span style="font-family: "Times New Roman",serif; font-size: 12pt; mso-fareast-font-family: "Times New Roman";">Plumtree Software, Inc. v. Datamize,
LLC,</span></i><span style="font-family: "Times New Roman",serif; font-size: 12pt; mso-fareast-font-family: "Times New Roman";"> 473 F.3d 1152, 1163 (Fed.Cir.
2006), the Federal Circuit stated that “performing the patented method for
commercial purposes before the critical date constitutes a sale under §
102(b).” However, the district court found that the “reasoning behind this
statement is that the purpose of § 102(b) ‘is to preclude attempts by the
inventor or his assignee to profit from commercial use of an invention for more
than a year before an application for patent is filed.’” <span style="mso-bidi-font-style: italic;">In contrast, TMC had the</span> batches manufactured
for validation purposes, and “at the time of the supposed sale, the batches
were not for commercial purposes, but experimental batches made in order to
verify that the invention worked for its intended purpose. [TMC] ‘purchased’
the validation batches for its own secret use, [and the] fact that the batches
were subsequently sold does not change the underlying transaction from
experimental to commercial. At the time of the transaction, the intent was
experimental.”<o:p></o:p></span></div>
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<span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">On appeal, the Federal Circuit
reversed, finding that under Federal Circuit precedent there is no “supplier”
exception, so it did not matter that the patent owner was the purchaser, and
that paying another entity to manufacture patented product constitutes an
invalidating “sale” even though title never changed hands and the patent owner
contracted for services, not for sale of a product.<o:p></o:p></span></div>
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<span style="font-family: "CenturySchoolbook",serif; font-size: 12pt; mso-bidi-font-family: CenturySchoolbook;">The Federal Circuit acknowledged that
under some circumstances use of a contract manufacturer in the development of
an invention does not create an on sale bar. For example, in <i style="mso-bidi-font-style: normal;">Trading Technologies Int'l, Inc. v. eSpeed,
Inc., </i>595 F.3d 1340 (Fed. Cir. 2010) the inventor of an automated trading system paid
a contractor on an hourly basis to produce software embodying the invention,
because the inventor lacked the technical expertise to do so himself. The court
in <i style="mso-bidi-font-style: normal;">Trading Technologies</i> </span><span style="font-family: "Times New Roman",serif; font-size: 12pt; mso-fareast-font-family: "Times New Roman";">stated that “[inventors] can request another entity's
services in developing products embodying the invention without triggering the
on-sale bar[, and thus the inventor’s request to the contractor] to make
software for his own secret, personal use could not constitute a sale under 35
U.S.C. § 102(b)."<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman",serif; font-size: 12pt;">In <i style="mso-bidi-font-style: normal;">The Medicines Company</i> the Federal
Circuit distinguished<i style="mso-bidi-font-style: normal;"> Trading
Technologies</i>, finding that TMC used the validation batches for commercial
purposes, as opposed to the “secret, personal use” in<i style="mso-bidi-font-style: normal;"> Trading Technologies</i>. The courted seem to find it significant that
the verification batches</span><span style="font-family: Calibri;"> were </span><span style="font-family: "Times New Roman",serif; font-size: 12pt;">marked with commercial product codes and customer lot
numbers and sent to TMC for “commercial and clinical packaging, consistent with
the commercial sale of pharmaceutical drugs," and that each batch had a
commercial value of over $10 million, i.e., a “not insignificant” amount.<span style="mso-spacerun: yes;"> </span>Furthermore, even though the verification
batches were produced for the purpose of demonstrating to FDA that the drug met
FDA specifications, and none of the drug was sold prior to the critical date,
it appears that after the critical date TMC did sell drug produced in the
verification batches.<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman",serif; font-size: 12pt; mso-fareast-font-family: "Times New Roman";">The Federal Circuit also found that the district court had clearly
erred in finding that the experimental use doctrine bars the application of the
on-sale bar to the verification batches. The Federal Circuit’s explanation for
this is a bit confusing. The court begins by stating that “experimental use
cannot occur after a reduction to practice,’” but later in the same paragraph
asserts that “the experimental use defense may be available even if the
invention had been reduced to practice if the inventor was unaware that the
invention had been reduced to practice (i.e., worked for its intended purpose)
and continued to experiment.” </span></div>
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<span style="font-family: "Times New Roman",serif; font-size: 12pt; mso-fareast-font-family: "Times New Roman";">TMC argued that it had not reduced the invention to practice
when the batches were made because at that time it did not appreciate the
maximum impurity level limitation of the claimed invention. The Federal Circuit
rejected this argument, however, finding that this “is not a situation in which
the inventor was unaware that the invention had been reduced to practice, and
was experimenting to determine whether that was the case. The batches sold
satisfied the claim limitations, and the inventor was well aware that the
batches had levels of Asp <sup>9</sup>-bivalirudin well below the claimed
levels of 0.6%."</span></div>
Chris Holmanhttp://www.blogger.com/profile/13743481878076443159noreply@blogger.com3