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This 3-part series will provide a brief overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada.  Part 1 will examine the patentability of diagnostic inventions in the U.S.

United States

As many readers are aware, beginning in 2012, the U.S. Supreme Court issued the first of a series of three decisions over three consecutive years that had a tremendous impact on the patenting of inventions in the life science industry.  These decisions were Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 575 U.S. 208 (2014).  For diagnostic companies, the Mayo decision was particularly problematic.  The patents in Mayo, namely, U.S. Patent Nos. 6,355,623 (the ‘623 patent) and 6,680,302, were directed to methods for optimizing drug dosages for the treatment of autoimmune diseases in humans.  Specifically, the inventions involved the discovery of the relationship between the concentration of a metabolite in the blood following administration of a drug and the likelihood that the dosage administered would be ineffective or cause harmful side effects.  Claim 1 of the ‘623 patent was considered representative and recited:

  1.  A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject, and

wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Court in Mayo held that the claims of the ‘623 patent were invalid as directed to a law of nature and thus encompassing patent ineligible subject matter pursuant to 35 U.S.C. § 101 (§ 101).  Additionally, the Court introduced a two-step test or framework for distinguishing patent ineligible concepts from patent-eligible applications of those concepts.  The first step involves determining whether the claims are directed to a judicially recognized exception to patentability, such as a law of nature, natural phenomena or abstract idea. If the answer to the first question is “yes”, the claim is considered to be directed to a judicially recognized exception and the analysis moves to the second question.  The second question involves determining whether the claims “do significantly more than simply describe those natural relations,” when considered separately and in an ordered combination.  If the answer to this question is “no”, then the claims are considered to be directed to ineligible subject matter, and not patentable.

The patents involved in the Myriad decision related to isolated human genes, namely, the BRCA1 and BRCA2 genes and mutations thereof, that were associated with a predisposition to breast and ovarian cancer.  In its decision, the Supreme Court unanimously held that genes (e.g., DNA) and the information they encode (e.g., proteins) were not patent eligible simply because they had been isolated from surrounding genetic material since such DNA and proteins did not exhibit any “markedly different characteristics” than those products found in nature.

The final decision in Alice, which was issued about one year after Myriad, involved a series of patents directed to a computer-implemented scheme for mitigating “settlement risk” (e.g., the risk that only one party to a financial transaction will pay what it owes) by using a third-party intermediary.  In Alice, the Court reaffirmed the Mayo two-step test, applying it to claims directed to a computer-implemented process, a computer system, and computer-readable medium for mitigating the settlement risk.  With respect to the second step of the Mayo test, the Court referred to this step as a “search for an inventive concept – i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounted to significantly more than a patent upon the ineligible concept itself”. 

Since these three decisions, the Mayo/Alice 2-step framework has been used by the U.S. Patent and Trademark Office (USPTO) and courts in determining the patent eligibility of claimed subject matter under § 101. Unfortunately, since the Court’s decisions in Mayo, Myriad, and Alice, the United States Court of Appeals for the Federal Circuit (Federal Circuit) has found all eight cases involving patents claiming diagnostic methods to be invalid as being directed to patent ineligible subject matter. 

Despite the challenges of the Mayo decision as well as the subsequent decisions at the Federal Circuit, it is still possible to obtain claims to diagnostic inventions in the U.S.  While the types of claims currently being granted by the USPTO tend not to be as broad as the claims granted before the Mayo decision, patent protection is still possible.  The ability to obtain patent protection for diagnostic inventions is important, particularly during times of significant public health crisis, such as that currently being experienced with COVID-19, in order to provide an incentive for diagnostic manufacturers to invest the time and resources to pursue the research and commercialization of new diagnostic tests. 

To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions.  You can register for the webinar at the following link:  Link to webinar.

This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.

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