Friday, August 28, 2015
Here Are All the Amicus Briefs That Have Been Filed Seeking En Banc Rehearing of Ariosa v. Sequenom
Thursday, August 27, 2015
BIO and PhRMA File Amici Brief Urging En Banc Reconsideration of Ariosa v. Sequenom
The Biotechnology Industry Organization (BIO) and the Pharmaceutical
Research and Manufacturers of America (PhRMA) have jointly filed an amici brief curiae brief urging the
Federal Circuit to grant en banc rehearing of Ariosa v. Sequenom. The
brief is available here. I am the
counsel of record.
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. 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. 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. 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.
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. For example, Appendix 3
of the recent PTO “July 2015 Update: Subject Matter Eligibility,” identifies 24
post-Mayo subject matter eligibility cases decided by the
Federal Circuit, of which 22 held all
of the challenged claims to be patent ineligible.
The brief urges the court to clarify the
contours of both Step I and Step II of the
Mayo two-step test for patent eligibility.
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 any analytical
or detection method would ever not satisfy
Step I, so long as that method is designed to detect something that occurs
naturally. 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. As an example, the brief discusses the
practical challenges facing the inventor of a new diagnostic test under the new
patent eligibility jurisprudence.
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 en banc
reconsideration would allow the Federal Circuit to address the nature of these
limiting principles suggested in Mayo. 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. Ariosa v. Sequenom would be an appropriate vehicle for alerting the Supreme Court to the
urgent need for this clarification.
Law Professors File Amicus Brief Supporting En Banc Rehearing of Ariosa v. Sequenom
A group of 23 law professors, myself included, have filed an amicus brief in support of en banc rehearing of Ariosa v. Sequenom.
The brief is available here.
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.
Eli Lilly v. Teva: District Court Applies the Federal Circuit's Recent Akamai Decision to Drug Method-of-Treatment Claim
In 2014 I published an article entitled “Caught between a
Rock and a Hard Place: How Limelight Compounds the Challenges Facing
Biotechnology Innovators after Mayo and Myriad” (available here), which
explained how Supreme Court’s decision in Limelight
Networks v. Akamai Technologies 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. In that article, I noted that in Limelight the Court had explicitly pointed out that
its decision did not necessarily preclude the Federal Circuit from revisiting
that court's decision in Muniauction, 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. 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.
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. Akamai Technologies, Inc. v. Limelight
Networks, Inc., 2015 WL 4760450 (Fed. Cir.). Akamai 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.
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 Akamai, 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 attributable to the
other 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, Akamai 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.”
In Limelight, 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).’’
On August 25, 2015, Eli Lilly’s concerns were presumably at
least partially abated by the district court's decision in Eli Lilly v. Teva (available
here). The Eli Lilly court applied the new Akamai
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.
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. 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.
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 Akamai 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.” 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.” 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:
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 required to do so to receive the full benefit of the treatment.
Wednesday, August 26, 2015
WARF Files Amicus Brief in Support of En Banc Rehearing of Ariosa v. Sequenom
The Federal Circuit’s discouraging opinion in Ariosa v.
Sequenom has been discussed in previous posts.
Sequenom has petitioned for en banc rehearing, its brief is available
here, Amicus briefs are due tomorrow, Aug 27, but WARF got its in a bit early,
and it is available here.
Here is a summary
of WARF’s argument, i.e., their argument as set forth in the Table of Contents:
- 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
- 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
- The panel’s analysis of Mayo/Alice Step Two was mistaken because isolation, amplification, and analysis of cffDNA in maternal fluids were not conventional
More briefs will be posted shortly, including one I am helping to prepare for Biotechnology Industry Organization
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