Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine

By Donald Zuhn --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013, and that the panel's decision poses a threat to patent protection in multiple fields of invention.  On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc.  Over the next few weeks, Patent Docs will examine these amicus briefs.  Today, we review the brief submitted by the Coalition for 21st Century Medicine.

In its brief, the Coalition describes itself as an organization "represent[ing] more than two dozen of the world's most renowned molecular diagnostic companies, clinical laboratories, and patient advocacy groups, as well as researchers, physicians, and venture capitalists involved in the industry, all of whom agree that continuous diagnostic innovation is essential to help patients and healthcare professionals make better, more informed treatment decisions and continue to improve patient outcomes."  A list of the Coalition's members can be found here.

The Coalition's brief begins by declaring that "[r]ecent panel decisions issued by this Court have improperly expanded the scope of the Supreme Court's narrow holdings in the life sciences to exclude entire categories of invention from patent eligibility, injected an element of arbitrariness into patent examination, and made it nearly impossible for stakeholders to enforce thousands of issued claims."  The brief then presents three arguments for the Federal Circuit to grant Sequenom's petition for rehearing en banc.

The Coalition first argues that the Federal Circuit should grant en banc review of the Ariosa panel decision "to prevent expansion of the Supreme Court's narrow holdings under 35 U.S.C. §101 in Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and Mayo Collaborative Servs. v. Prometheus Labs, 132 S. Ct. 1289 (2012)," stating that recent panel decisions by the Court "have improperly extended Mayo and Myriad to exclude entire categories of invention from patent eligibility."  Noting that the U.S. Patent and Trademark Office has taken its cue from the Federal Circuit and "has in turn interpreted those panel decisions expansively in its guidance for the examining corps," and that the Office's guidance has been "again over-extended by individual examiners to arbitrarily reject claims to subject matter that would have been patent eligible under the original narrow Supreme Court holdings," the Coalition contends that "[t]he en banc Federal Circuit holds the pivotal position in this spiral of ineligibility."

With regard to its second argument for granting Sequenom's petition, the Coalition states that recent Supreme Court case law excludes relatively little subject matter from eligibility under § 101.  The brief argues that the Federal Circuit's approach to subject matter eligibility "should be guided -- as it once was -- by the simple principle that a patent claim is presumptively eligible for patenting under §101 unless the plain language of the statute or binding precedent clearly excludes it," stating that "[a] careful reading of the Supreme Court's recent decisions on patent eligibility in the life sciences shows that the scope of subject matter excluded by each is quite modest."  The Coalition then briefly examines what it contends were the Supreme Court's narrow holdings of Mayo and Myriad, arguing that "a faithful reading of Mayo leads to the conclusion that a process comprises patent eligible subject matter provided it differs in at least one material element from what was routine, conventional and well-understood in the art," and explaining that the Myriad Court "went out of its way to emphasize the limited extent of the subject matter it excluded from patent eligibility in the final sentence of the opinion" (which states "[w]e merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material").

The Coalition closes the brief by arguing that the Ariosa panel decision exemplifies the improper expansion of the Supreme Court's narrow holding in Mayo.  With regard to this argument, the brief first asserts that the Ariosa panel failed to correctly define the subject matter of the claims at issue in that case, stating that:

Sequenom neither invented nor sought to claim cffDNA.  Nor did Sequenom seek to preempt all methods of testing cffDNA, or even all methods of testing cffDNA in maternal blood.

The brief next asserts that the Ariosa panel wrongly suggested that diagnostic claims are prima facie patent ineligible, arguing that:

This troubling expansion of Mayo sets a dangerous precedent for the precision medicine industry in particular because a typical diagnostic test begins by "detecting a natural phenomenon."  If allowed to stand, this newly-minted expansion of Mayo would potentially render all diagnostic inventions prima facie patent ineligible and subject them to the vagaries of the subjective "significantly more" inquiry that the PTO has struggled to apply consistently.

The Coalition suggests that "[t]he opinion's failure to mention Diamond v. Diehr, 450 U.S. 175 (1981), further shows a willingness to expand Myriad and Mayo to exclude ever more inventions."  The brief finally asserts that the Ariosa panel improperly conflated the patent eligibility test of Mayo with a traditional obviousness analysis.  The Coalition concludes the final section of its brief by "urg[ing] the full Court to unequivocally reject this aspect of the majority's opinion and clarify that Mayo sets forth at most a §102-like eligibility analysis limited to what was routine, conventional and well-understood at the time of filing" (emphasis in original).

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015

Comments

[Nick Landau]

In this practitioner's humble opinion, the panel decision misused the "routine, well-understood, and conventional" test from Mayo in a way that renders it meaningless. In Mayo, all of the claimed steps, except the abstract ones, were known in the art in exactly the combination found in the claims. In Ariosa, although the combination of claimed steps minus the abstract ones was unknown, each individual step was routine,well-understood, and conventional. Nobody had ever amplified paternal DNA from non-cellular DNA in material plasma. That is an obviousness rejection, minus the need for a motivation or reason to modify the prior art. Virtually no invention would survive such a test. The Court in Mayo never set forth such a test.

[Skeptical]

Nick,

That's just one problem with legislating from the bench - the bigger problem of course is that the Court has written a law that is (and should be found to be) void for vagueness.