(Washington, DC)—On April 20, 2016, Partners Matthew Dowd and Ping Wang, Counsel Robert Gutkin and Associate Sushila Chanana filed an amicus brief on behalf of JYANT Technologies, Inc., an early-stage biotechnology/pharmaceutical development company, in regards to the Sequenom, Inc. v. Ariosa Diagnostics, Inc., Natera, Inc. and DNA Diagnostics Center, Inc. The amicus brief supports the petitioner, Sequenom, Inc., by clarifying what can constitute patent-eligible inventions under the Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) precedent and 35 U.S.C. § 101. A copy of the brief can be found here.

The amicus brief focuses on two main objectives: first, the confusion of the court surrounding patent-eligibility in biotechnology and diagnostic inventions; and second, the repercussions for patent-eligible biotechnology and diagnostic inventions when Section 101 is incorrectly applied.

“We see this case as a prime opportunity for the Supreme Court to explain what types of inventions based on genetic technology are eligible for patent protection," said Matthew Dowd, Partner, Andrews Kurth.

JYANT Technologies, Inc.’s (“JYANT”) primary argument is that the Federal Circuit’s underlying decision is an errant attempt to navigate the murky jurisprudence of subject matter patent eligibility under 35 U.S.C. § 101, especially as related to biotechnology and diagnostic inventions. The purpose of the patent laws is to “[t]o promote the [p]rogress of . . . [the] useful Arts.” U.S. Const. art. I, § 8, cl. 8. This encourages the dissemination of ideas and enables others to invent improved or alternative diagnostic methods. For these reasons, JYANT argues that the novelty and nonobviousness requirements of 35 U.S.C. §§ 102 and 103—and not the eligibility requirement of § 101—is the proper test for assessing the patentability of new diagnostic methods.

Further, JYANT argues that the Federal Circuit’s underlying reasoning threatens to abolish wide swaths of existing and future intellectual property. Almost every diagnostic test, whether medical, chemical, or agricultural, relies on some natural phenomenon. Those tests frequently apply known tools, such as reagents or procedures, to solve a specific problem. For example, PCR—the basis of the 1993 Nobel Prize—used known reagents and protocols in a novel combination to produce a revolutionary result. PCR exploited the natural phenomenon of how DNA replicates to create a revolutionary process, yet no one could reasonably contend that PCR is not eligible for patent protection. However, under the Federal Circuit’s reasoning, one can make a strong argument that the invention of PCR itself would not be eligible for patent protection, even though it revolutionized biotechnology.

If the current appeals court’s reasoning were to stand, many diagnostic methods—no matter how novel and nonobvious—would be ineligible for patent protection without any consideration of the merits of the invention under §§ 102 and 103. Diagnostic tests are ubiquitous, and they provide guidance for the detection and treatment of medical conditions and diseases, such as infectious diseases, HIV infection, cancers, inflammatory disorders, stroke, Alzheimer’s, and many others. All of these tests, at their base, are specific applications relying on some natural phenomenon. Absent patent protection, companies will be less inclined to invest in research for new diagnostic tests. Thus, JYANT urges the Supreme Court to grant the petition for certiorari so that companies and individuals may have clear guidance for distinguishing between a patent-ineligible “law of nature, natural phenomenon, and abstract idea” and an eligible “new and useful process, machine, manufacture, or composition of matter.”

 

As released by the former Andrews Kurth Kenyon LLP