Monday, March 21, 2016

Sequenom Petitions Supreme Court for Review of Ariosa Decision

Sequenom today filed a Petition for Writ of Certiorari asking the Supreme Court to review Ariosa Diagnostics v. Sequenom, an important patent eligibility case described in previous posts (see for example).  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 LabCorp v. Metabolite, a case that was fully briefed and argued but ultimately dismissed because certiorari had been “improvidently granted”).  Significantly, it would be the fourth case in which the patent relates to diagnostic testing (LabCorp, Mayo, and Myriad where the other three).  The petition for certiorari is available here.

 As framed by Sequenom, the question presented is:
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?

Sequenom argues that the Federal Circuit’s interpretation of Mayo 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.  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 Mayo, and that only the Supreme Court can address the situation.
Sequenom argues that the Federal Circuit’s decision below has exacerbated the confusion created by Mayo “by jettisoning the one reliable compass this Court has identified for Section 101 cases-the patent’s ‘preemptive’ scope.”  Their brief posits that under the Federal Circuit’s interpretation of Mayo, a number of historic inventions would have failed the test for patent eligibility, including the method at issue in Diehr (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.
The petition argues that this case is an ideal vehicle for clarifying Mayo, pointing out that “this is an extremely well-ventilated patent, with a far-more-developed record than is usual for Section 101 cases.”  For example, the claims have been construed and the patent has already undergone inter partes review.  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.”

According to Sequenom, supporting amicus briefs will need to be filed no later than April 20.  I would expect to see a number of those.  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.

Friday, March 18, 2016

PTAB Denies Institution of IPR for Amgen’s ENBREL Patent

On March 11, 2016, the Patent Trial and Appeal Board (PTAB) denied institution of Inter Partes Review (IPR) for U.S. Patent Number 8,163,522.  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.”  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.

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”).  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).  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.

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.”  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.  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.  This included “expert testimony concerning the unexpected results of improved TNF binding affinity, potency, kinetic stability, and reduced antibody effector function and aggregation ability.”

A decision to institute IPR would have been good news for Sandoz.  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.  See Immunex Corp. v. Sandoz Inc., Case No. 2:16-cv-01888 (D.N.J.) (complaint).

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.  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.  See Sandoz Inc. v. Amgen Inc., 773 F.3d 1274, 1275 (Fed. Cir. 2014).




Thursday, March 10, 2016

Copyright for Engineered DNA (Part 3)

The third installment of my series of blog posts on copyright for engineered DNA is now available on the GQ Life Sciences Blog for anyone who might be interested.

Wednesday, March 2, 2016

Copyright for Engineered DNA (Part 2)

Part 2 of my series of posts on the topic of Copyright for Engineered DNA on the GQ Life Sciences Blog is now available here.

Thursday, February 25, 2016

Cleveland Clinic Foundation v. True Health Diagnostics: District Court Finds Diagnostic Claims Patent-Ineligible

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 opinion and order).  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.  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.

The claims recite limitations such as “comparing 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 “determining levels of [MPO] activity… in a bodily sample of the test subject.”  They also contain “wherein” 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.”

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 Mayo/Alice test for patent eligibility (named after the Alice and Mayo Supreme Court decisions].  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 Alice test) and that the “determining” and “comparing” steps are insufficiently inventive (second prong of the Alice test).  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.”

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.”  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.”  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.  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.

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.  Otherwise, a plaintiff could prevent dismissal before claim construction simply by noting without explanation that claim construction is ‘necessary.’  The Court rejects any such rule.”

Tuesday, February 23, 2016

Copyright for Engineered DNA (Part 1)

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.

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 here.

Wednesday, December 2, 2015

Federal Circuit Denies En Banc Rehearing of Ariosa v. Sequenom, But Some Judges Urge Supreme Court to Fix Flawed Patent Eligibility Precedent

Today the Federal Circuit issued an order (available here) denying en banc rehearing of Ariosa v. Sequenom, an important patent eligibility decisions discussed in earlier posts.  I filed a brief 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.  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.

There was some substantial overlap in the opinions of all four judges.  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.  All of the judges seemed to recognize that Ariosa’s interpretation and application of the Mayo framework threatened the availability of effective patent protection for a broad swath of biotechnological innovation, particularly in the area of diagnostics.  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.

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.  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.  His suggested approach is discussed in more detail below.

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.”  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.

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.”  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.  This is in stark contrast to the approach of the panel that decided Ariosa - they treated the question of preemption as essentially irrelevant to the determination of patent eligibility.

Dyk’s concurring opinion largely tracked Lourie and Moore, agreeing that the language of Mayo, while unfortunate, compelled the panel decision in Ariosa.  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.  In his view:
Mayo 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.  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.  I worry that method claims that apply newly discovered natural laws and phenomena in some conventional ways are screened out by the Mayo test.  In this regard I think that Mayo may not be entirely consistent with the Supreme Court’s decision in Myriad.

I think Judge Dyk raises a very interesting and insightful point regarding Myriad.  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.  Judge Dyk inferred that Myriad “recognize[d] that an inventive concept can sometimes come from discovery of an unknown natural phenomenon, not just from unconventional application of the phenomenon.”  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.”

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.”  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.”  In other words, the narrow scope of the claims would obviate the preemption concerns underlying the patent eligibility doctrine.

Dyk’s concurrence concludes by suggesting that:
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.  That case will, I hope, provide the Supreme Court with an opportunity to revisit the Mayo/Alice framework in this one limited aspect.

The third opinion was a dissent by Judge Newman.  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.”  She found that the facts of Ariosa diverge significantly from those in Mayo and Myriad, and that the patent eligibility of Sequenom’s claims could be upheld without contravening Supreme Court precedent.