Posts Tagged: "diagnostics"

The 2012 Supreme Court decision in Mayo Collaborative Servs. v. Prometheus Labs changed the landscape for patenting diagnostic inventions in the United States. Patent eligibility/ineligibility in the United States stems from two sources: (1) 35 U.S.C. § 101, and (2) judicially-created exclusions, including laws of nature, natural phenomena, abstract ideas, and mental processes. In Mayo, the Supreme Court struck down method of treatment claims for being directed to a law of nature. While Mayo did not create this exclusion, it significantly expanded its applicability to diagnostic-based inventions. This paper explores Federal Circuit case law on patent eligibility of diagnostic-based inventions since the Mayo decision, as well as provides practical guidance on drafting diagnostic patent claims in light of these decisions.

A strategy for the COVID-19 pandemic is testing for antibodies to determine possible immunity. Such diagnostic tests may suffer from a high false positive rate. Improving accuracy is therefore desirable. However, the U.S. Patent and Trademark Office (USPTO) is generally not receptive to diagnostic claims that improve accuracy. The recent case of CardioNet v. Infobionic, makes patenting more accurate diagnostics easier. CardioNet considered whether a more accurate cardiac monitoring device was eligible. Claim 1 recites a device that detects abnormal heart rhythms (atrial fibrillation or atrial flutter) in a patient. The district court held that the claims were directed to an abstract idea of identifying atrial fibrillation or atrial flutter “by looking at the variability in time between heartbeats and taking into account ventricular beats.” The Federal Circuit reversed and held an improved cardiac monitoring device was not an abstract idea.

In our last article exploring patent trends across 12 industries, we addressed the industrial design industry. Today’s article pertains to the therapeutic and diagnostic molecules industry. Few other industries have the potential to so dramatically affect individuals’ lives as does this industry. While on a day-to-day basis it can be easy to forget the intensive bench work and clinical trials that are being undertaken in attempts to better treat or cure disease, it is this steady pulse of investment and effort that has led to the cure of many ailments and diseases. Rather recently, biologics advancements have expanded the field to no longer merely rely on small-molecule compositions but to draw upon a large pool of sophisticated large-molecule options. However, research and development in the pharmaceutical space remains heavily regulated and extraordinarily expensive. Thus, investments must be chosen and protected wisely.

April 22 was the deadline for filing amicus briefs with the Court of Appeals for the Federal Circuit in Athena Diagnostics’ petition for an en banc rehearing by the court. The petition comes after a 2-1 panel decision in early February affirmed a district court’s ruling that patent claims covering methods of diagnosing myasthenia gravis (MG), an autoimmune disorder that causes weakness in skeletal muscles, were directed toward laws of nature and were thus unpatentable subject matter under 35 U.S.C. § 101. In an invitation to file briefs with the Federal Circuit in this case, Knowles IP Strategies Founder Sherry Knowles and AddyHart Partner Meredith Addy discussed the need for amici to hold the Federal Circuit accountable regarding its duty to apply a strict statutory construction of the literal language of Section 101 to ensure that patent eligibility cases are decided in a way that is consistent with Constitutional statutes. Knowles and Addy filed a brief on behalf of Freenome Holdings and Achillon Pharmaceuticals (discussed below). Theirs and other briefs that have now been filed raise concerns about the inability to patent life-saving diagnostic methods that are found ineligible under Section 101 using the Alice/Mayo framework simply because the invention or discovery involves monitoring natural processes.

Athena Diagnostics filed a petition for en banc rehearing of the United States Court of Appeals for the Federal Circuit’s decision in Athena Diagnostics v. Mayo on April 8, 2019. Amicus briefs are due April 22, 2019. The Athena decision continues to apply U.S. Supreme Court-created common law to the analysis of 35 U.S.C. §101. In its brief requesting rehearing, Athena argues that the decision is “precisely the evisceration of patent law against which the U.S. Supreme Court has long warned” and that the claims at issue were patent eligible, as they are “novel, man-made substances”, “do not preempt natural laws” and “serve a new and useful purpose of diagnosing serious diseases”. Knowles IP Strategies LLC (Sherry M. Knowles) and AddyHart (Meredith Addy) intend to file an amicus brief in support of neither party requesting that the Federal Circuit carry out its constitutional duty to apply strict statutory construction of the literal words of 35 U.S.C. §101 to decide the case (See, Unconstitutional Application of 35 U.S.C. § 101 by the U.S. Supreme Court; 18 J. Marshall Rev. Intell. Prop. L. 144 (2018)).

Scott Elmer is Director, Office of Technology Licensing, at St. Jude Children’s Research Hospital, one of the leading pediatric cancer hospitals in the country. The institution is focused on treatment of and research on children’s catastrophic diseases, particularly leukemia and other cancers. The hospital costs about $2.8 million a day to run and is 100% free to patients. St. Jude and more than 46 of its staff have been the recipients of prestigious awards and achievements, including the 1996 Nobel Prize in Physiology or Medicine, which went to St. Jude faculty member, Peter C. Doherty. Recently, Elmer read Sherry Knowles’ John Marshall Intellectual Property Law Review article, Unconstitutional Application of 35 U.S.C. §101 by the U.S. Supreme Court and was inspired to write her in support of her argument that the Supreme Court’s misreading of the patent statute is causing real harm to inventors and industry on the ground. “I reached out to Sherry because I thought her article was well written and took a different approach to something that’s been a concern for a long time,” Elmer told IPWatchdog. “Sherry made the point that the Supreme Court’s more recent patent eligibility decisions have failed to recognize the patent statute’s reference to the term ‘discovery’ as a basis for the generation of patent-eligible subject matter, which particularly impacts diagnostics.”

On Monday, April 1, the Court of Appeals for the Federal Circuit issued a decision in Cleveland Clinic Foundation v. True Health Diagnostics affirming the invalidity of patents covering medical diagnostic tests for determining a patient’s risk for cardiovascular disease. The decision, which is nonprecedential and was decided along similar lines to another 2017 decision between the two parties, is yet another depressing sign that U.S. patent law is woefully inadequate when it comes to supporting important innovations in the biotech fields. Of particular note is the Federal Circuit’s finding against Cleveland Clinic’s argument that the district court didn’t give appropriate deference to subject matter eligibility guidance published by the U.S. Patent and Trademark Office (USPTO) as required by the U.S. Supreme Court’s 1944 decision in Skidmore v. Swift & Co. Although this argument related to USPTO guidelines published in 2016, it would seem to call into question the USPTO’s more recent revised subject matter eligibility guidance issued earlier this year by USPTO Director Andrei Iancu. This gives voice to fears that the “Iancu Effect” on subject matter eligibility won’t matter much if the Federal Circuit and other courts don’t adhere to the USPTO’s views on patent eligibility under Section 101.