Posts Tagged: "Mayo v. Prometheus"

Post-Myriad Legal and Policy Considerations for Patenting Genetic Inventions

The U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. Myriad Genetics changed the landscape of what is considered patentable material in the context of genetic inventions. In the five years since Myriad, companies have pushed the boundaries of patenting certain types of genetic materials. Despite Myriad’s express statement that it was not considering “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” the courts have not yet established the contours of how much nucleotide sequences need to be altered in order to “create something new” in order to be patentable. However, as we discuss in the next section, we expect the Court to address these questions as biotechnology companies increasingly invest resources into emerging, expensive technologies involving genes and seek to protect their investments through patents.

Why the Federal Circuit is to Blame for the 101 Crisis

When the Supreme Court believes that the Federal Circuit has made an error, they will reverse and remand with broad guidance, but often are not able to determine what the proper test should be. The Supreme Court wants, and expects, the Federal Circuit to determine the proper test because, after all, it is the Federal Circuit that is charged with being America’s chief patent court. But the Federal Circuit has become myopic. It is getting tiring to read in case after case— where real innovation is involved—the Federal Circuit saying that they are constrained, even forced by either Alice or Mayo, to find the very real innovation to be declared patent ineligible. This madness has to stop! It is time for the judges of the Federal Circuit to stand up and fulfill their Constitutional Oaths. They must interpret Supreme Court precedent—all of it—consistent with the statute and the Constitution.

Federal Circuit Affirms Athena’s Diagnostic Method Claims Are Patent Ineligible as Directed to a Law of Nature

The Federal Circuit recently issued an opinion affirming the decision of the United States District Court for the District of Massachusetts, which held that Athena’s medical diagnostic methods were directed toward laws of nature and patent ineligible under 35 U.S.C. § 101. Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 17-2508, 2019 U.S. App. LEXIS 3645 (Fed Cir. Feb. 6, 2019) (Before Newman, Lourie, and Stoll, Circuit Judges) (Opinion for the Court, Lourie, Circuit Judge) (Dissenting Opinion, Newman, Circuit Judge).
The inventors of U.S. Patent 7,267,820 (the 820 Patent) discovered that about 20% of patients with the neurological disorder myasthenia gravis (MG) generate autoantibodies to a membrane protein called MuSK. Until their discovery, no disease had ever been associated with the protein. The ‘820 patent disclosed and claimed methods for diagnosing neurological disorders by detecting antibodies that bind to MuSK. Athena Diagnostics (Athena), the ‘820 Patent’s exclusive licensee, sued Mayo Collaborative Services (Mayo) for infringement. Mayo moved to dismiss, and the district court granted Mayo’s motion, concluding that the patent claimed ineligible subject matter and was invalid under 35 U.S.C. § 101. Athena appealed, and the Federal Circuit affirmed.

The Federal Circuit is Shirking Its Constitutional Duty to Provide Certainty for Critical Innovation

Here we go again! Another patent whose claims have been invalidated at the Federal Circuit—predictably, another medical diagnostic patent. Athena Diagnostics v. Mayo Collaborative (Fed. Cir. Feb. 6, 2019). This is getting old, tired and fundamentally ridiculous. The statute, which is all of one-sentence long, specifically lists discoveries as patent eligible. So why are discoveries being declared patent ineligible? To the extent these decisions are mandated by the Supreme Court, they directly contradict the easy to understand and very direct language of the statute. The Federal Circuit is wrong, period. Perhaps they are so close to these cases and trying so hard to do what they think is right that they have lost perspective, but these rulings are fundamentally saying that discoveries are not patent eligible. We are told repeatedly that they are mandated by Supreme Court precedent. Obviously, that cannot be correct. The statute says: “Whoever invents or discovers… may obtain a patent…” Clearly, Congress wants discoveries to be patented, and in our system of governance, Congress has supremacy over the Supreme Court with respect to setting the law unless the law is unconstitutional. 35 U.S.C. 101 has never been declared unconstitutional, so discoveries must be patent eligible, period. It is time to face the facts—the Supreme Court has considered only bad cases, with bad facts, where there was really no innovation presented in the claims, or even in the patent application as a whole. These decisions have absolutely no meaning or proper application with respect to any inventions, let alone inventions of monumental complexity such as true artificial intelligence, autonomous vehicles, or new medical diagnostics that allow risk-free testing of common ailments, where previously existing tests required potentially catastrophic risk.

In CAFC Holding Finding Dice Games Abstract, Judge Mayer Delivers Concerning Concurrence

On December 28, 2018, the U.S. Court of Appeals for the Federal Circuit issued an opinion in In re Marco Guldenaar Holding B.V. (2017-2465) in which the claims of a patent application directed to a dice game were held to be patent-ineligible for being directed to an abstract idea, with “the only arguable inventive concept relat[ing] to dice markings, which constitute printed matter.” The holding in the case is unsurprising post-Alice, but Judge Mayer’s concurrence reveals some concerning views on patent eligibility. The concurrence concludes by alleging that “Alice, for all intents and purposes, articulated a ‘technological arts’ test for patent eligibility.” The statute certainly does not hint at the sort of “technological arts” test that Judge Mayer would prefer and that Alice itself never required, despite Judge Mayer purportedly being concerned with precedent.