On Friday afternoon, a group of amici led by Eli Lilly filed an amici curiae brief in the United States Supreme Court in the matter of Sequenom, Inc. v. Ariosa Diagnostics, Inc. The Eli Lilly brief, which names patent attorney and former Eli Lilly General Counsel Robert Armitage as counsel of record, was filed in support of the petitioner, Sequenom. Eli Lilly is joined in this brief by Eisai Inc., Upsher-Smith Laboratories, Inc., Pfizer Inc., and Etiometry, Inc.
On March, 21, 2016, Sequenom (who is represented by Thomas Goldstein, the founder of the widely popular SCOTUS Blog) filed a Petition for Writ of Certiorari in the Supreme Court, challenging the decision of the United States Court of Appeals for the Federal Circuit in Ariosa Diagnostics, Inc. v. Sequenom, Inc. If the Supreme Court takes this case, which they should, they will be required to reconsider the unfortunate breadth of their prior ruling in Mayo Collaborative Servs. v. Prometheus Labs. See SCOTUS Blog Founder asks Supreme Court to Reconsider Mayo.
In the amici brief filed by Eli Lilly et al, an alternative question presented is offered. After explaining that the in addition to the patentability requirements set forth in the Patent Act, the Supreme Court has also started to impose “a non-statutory implicit exception to patentability” as a part of a de facto threshold test for patentability. The brief explains that this implicit exception “bars patents directed or relating to natural produce and entirely mental processes.” The preamble of the question presented ends with the question itself, which reads:
Given the current explicit statutory limitations on patenting in the Patent Act—and the proper interpretation of those limitations—should the Court’s judicially imposed implicit exception to subject matter considered to be eligible for patenting be abrogated, such that patentability and patent validity are to be determined solely under such explicit statutory provisions?
In essence, the Supreme Court in Mayo v. Prometheus conflated the various sections of the Patent Act, forcing a multiplicity of inquiries into the single patent eligibility inquiry. This is something that previous Supreme Court panels had always chided other courts for doing, saying that it is critical to allow the different sections of the statute to do the work for which they were each designed. This is particularly problematic given that the patent eligibility inquiry, which arises under 35 U.S.C. 101, has always intentionally been a very, very low threshold so as to not unnecessarily weed out technologies and innovations without even considering whether they are useful, new, non-obvious and appropriately described. But when the Supreme Court concerns itself under the patent eligibility inquiry with conventional steps, for example, the Court inappropriately interweaved novelty (35 U.S.C 102) and obviousness (35 U.S.C. 103) into the patent eligibility determination, which is legally inappropriate.
Rather than use the word “conflate” to describe the mongrel mixture of patentability requirements the Supreme Court undertook in Mayo, the Eli Lilly brief characterizes the analysis employed by the Supreme Court as including a separate, implicit “threshold test” for patentability that is applied even before consideration of the statutory patentability requirements. Eli Lilly hypothesizes that this “implicit exception was imposed to assure that patents cannot validly protect—or preempt access to—laws of nature, natural phenomena, or abstract ideas.”
The Eli Lilly brief goes on to explain that this implicit exception is unnecessary and should be abrogated:
Today, explicit statutory provisions of the con- temporary Patent Act found in 35 U.S.C. §§ 101, 102, 103, 112(a), 112(b), and 112(f) serve to preclude se- curing a valid patent on the same subject matter that the policy justification for the implicit exception sought to bar from patenting. Therefore, the Court should now consider abrogating the implicit exception in deference to the explicit patentability requirements that Congress imposed.
The brief goes on page after page to show exactly how the sections of the Patent Act, individually and in combination, can and do work together to prevent laws of nature, natural phenomena and abstract ideas from being patented.
Hopefully the Supreme Court will take this case and at a minimum refine the Mayo test so that important scientific breakthroughs will once again become patent eligible.