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.  Here, we review the brief submitted by the Intellectual Property Owners Association (IPO).

The IPO begins by expressing its support for the petition for rehearing en banc filed by Sequenom, Inc. and Sequenom Center For Molecular Medicine, LLC so that the en banc Court can "clarify the analysis for determining the patent-eligibility of a claimed invention in view of the evolving Supreme Court jurisprudence on patent-eligible subject matter."  According to the IPO, the appeal presents the following question of exceptional importance:

[H]ow to determine, in view of the extensive recent Supreme Court jurisprudence on the subject, whether a claimed invention includes sufficiently more than patent-ineligible subject matter and thus is eligible for patenting under 35 U.S.C. § 101, including whether evidence that a claim at issue does not unduly preempt ineligible subject matter is relevant to such an analysis?

The IPO then urges the Court, sitting en banc, "to hold that a claimed method must be considered as a whole for purposes of determining patent eligibility, and may not be dissected into its individual steps when considering whether it claims more than routine, conventional, and well-understood activity," and further, "to clarify that evidence that a claim does not unduly preempt use of ineligible subject matter strongly supports a finding that it recites a patent-eligible invention."

With regard to the first issue, the brief notes that "[t]he Supreme Court has long held that claimed inventions must be analyzed as a whole in order to determine their patent eligibility," citing Diamond v. Diehr, 450 U.S. 175, 188 (1981), for the proposition that "a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made."  The brief also points out that in Mayo Collaborative Servs. v. Prometheus Labs, Inc., the Supreme Court reiterated the importance of considering claims as a whole as part of the eligibility analysis, and declares that "the Mayo Court did not establish some new, heightened requirement that individual elements of an invention must themselves be 'inventive.'"  The IPO, however, argues that "since Mayo, courts and the PTO faced with questions of patent-eligibility have not consistently considered claimed inventions in their totality, improperly denying patent protection to deserving inventions," and states that in the instant case "the panel acknowledged the requirement to consider claim elements both individually and as an ordered combination but then failed to do so."

According to the IPO, the claimed methods in Mayo and those in the instant appeal are distinguishable "because even as an ordered combination as a whole, [the claims at issue in Mayo] amounted to nothing more than enunciating a natural law in the context of a process that was already routine practice."  The brief also argues that the instant claims and those in Ass'n for Molecular Pathology v. Myriad Genetics, Inc. are also distinguishable, stating that:

[I]n Myriad, the Court held that isolated genes were laws of nature, such that claims merely reciting them and nothing more were drawn to patent-ineligible subject matter.  In contrast, the claims here recite a use of cffDNA in pregnant women's blood, not merely its existence [citation omitted; emphasis in brief].

The IPO contends that "the panel overlooked the real question here: whether the groundbreaking application of a natural phenomenon, as described in a claimed method as a whole, is patent eligible" (emphasis in brief).  With respect to this first issue, the IPO concludes:

The panel's misapplication of the Supreme Court's jurisprudence on this issue is representative of the difficulties courts and the PTO are often having in properly evaluating patent eligibility since Mayo.  As a result, many inventions are improperly being denied protection and there is significant uncertainty among patentees and patent applicants as to the breadth of the judicially created exclusions from patent eligibility.  To assist courts and the PTO in the proper analysis of patent eligibility, IPO urges this Court to emphasize how claimed methods must be evaluated as a whole when determining patent eligibility.  Preventing the continuing trend of judicial and PTO decisions holding claimed methods to be ineligible for patenting beyond what the Supreme Court envisioned, let alone required, is an issue of exceptional importance to the patent-owning community, and this case presents an ideal opportunity for this Court to curb that unfortunate trend.

On the second issue, the IPO notes that "[t]he Supreme Court has consistently couched its patent-eligibility jurisprudence as designed to prevent the undue preemption of laws of nature, natural phenomena, and abstract ideas."  Although the Ariosa panel acknowledged that the principle of preemption is the basis for the judicial exceptions to patentability, the panel "[p]aradoxically . . . called preemption concerns in this case 'moot.'"  The IPO argues that:

Taken to its logical conclusion, the panel decision in this case would mean that under the test for patent eligibility described by the Supreme Court in Mayo, an invention may be found patent ineligible no matter how much evidence there is that it does not unduly preempt a law of nature, natural phenomenon, or abstract idea.  This is not a result compelled by Mayo or the other the recent § 101 decisions by the Supreme Court.  Indeed, it undermines the entire stated purpose of the Supreme Court's patent-eligibility jurisprudence: to prevent undue preemption.  The approach taken by the panel is not what the Supreme Court said and cannot be what it intended in view of its focus on preventing preemption.

Asserting that "Sequenom presented substantial evidence that its claims do not unduly preempt the use of cffDNA found in pregnant women's blood," the brief observes that "[y]et the panel improperly disregarded all of this evidence as 'moot.'"  The IPO concludes the brief by urging the en banc Court to rehear the case in order "to clarify that evidence of a lack of preemption is never 'moot' under the Supreme Court's two-step test for patent eligibility."

For additional information regarding this topic, please see:

• "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