As Section 101 and the Progeny of Mayo and Myriad Continue to Wreak Havoc on Portfolios, How Is The Life Sciences Industry Fighting Back?

Due in part to court and Patent Office guidance in the decades leading up to Myriad, many companies spent billions of dollars identifying genetic markers for use in diagnostic or other medical purposes.

Myriad Genetics

Myriad flipped this approach on its head. In Myriad, Myriad Genetics discovered the specific location and sequence of two human genes, BRAC1 and BRCA2, and that mutations in these genes substantially increase the likelihood of an individual developing breast and ovarian cancer. Myriad obtained a series of patents on this discovery that included claims to the isolated genetic sequences. 569 U.S. at 585. This effectively gave Myriad the right to exclude others from making diagnostic tests for BRCA1 and BRCA2 mutations.

The Supreme Court held that claiming a short sequence found in nature for use in diagnostics was comparable to claiming a newly discovered plant or a newly discovered rock because applicants are not allowed to claim patents on things in nature — even if it is a "[g]roundbreaking, innovative, or [] brilliant discovery". Id. at 591. (The Supreme Court, however, distinguished patent claims for the synthetic creation of genetic materials identical to BRCA1 and BRCA 2. Claims regarding the creation of synthetic BRCA1 and BRCA2 were valid, the Court reasoned, because a "lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived." Id.) In reaching this conclusion, the Court expressly rejected the PTO's longstanding position on the issue. Id. at 594. Myriad therefore foreclosed patent claims regarding some of the essential components of diagnostic kits.

Mayo Collaborative Services

In Mayo, Prometheus improved methods of optimizing the treatment of gastrointestinal disorders with thiopurine drugs by re-evaluating the safe levels of a mildly toxic by product of these drugs, which lead to new cut-offs for when a patient should have their dose of a thiopurine drug increased or decreased for optimal efficacy while limiting side effects. Prometheus obtained a two U.S. patents on this discovery that included claims to methods of optimizing therapeutic efficacy of treating immune-mediated gastrointestinal disorders with thiopurine drugs. 566 U.S. at 74. This effectively gave Prometheus the right to exclude others from optimizing treatment with thiopurine drugs using these new cut-offs.

The Supreme Court held that claiming the "laws of nature recited by Prometheus' patent claims" were not patentable unless they had "additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations." Id. at 66. Mayo therefore effectively foreclosed patent claims to methods of diagnosing, absent more.

It is difficult to understate the effect of these decisions on the biologics and diagnostics industries. The Supreme Court retroactively invalidated entire classes of patents that the life sciences industry had built up and relied on over several decades as a means of protecting their innovations.

Aftermath of Myriad and Mayo

While Myriad and Mayo dealt a blow to the industry, it did not foreclose obtaining patents on diagnostic tests because the holdings were limited to natural correlations and naturally occurring sequences, respectively. In Myriad, the Court found that slightly altered sequences could be patent eligible, and specifically noted that the holding did not reach method claims and applications of knowledge about the genes. 569 U.S. at 595.

But subsequent cases have expanded the impact of Mayo and Myriad. For example, in Arisosa v. Sequenom, the Federal Circuit invalidated Sequenom's patent claims to a method of detecting fetal DNA in a mother's bloodstream as a means of non-invasive pre-natal screening for potential birth defects. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1286 (Fed. Cir. 2015), cert. denied 788 F.3d 1371 (2016). Similarly, the claims at issue in Roche Molecular Systs., Inc. v. Cepheid, 905 F.3d 1363 (Fed. Cir. 2018) were directed to a method of detecting antibiotic-resistant strains of tuberculosis and were held patent ineligible because they relied on naturally occurring sequences and did "not contain an inventive concept that transforms the identified nucleotides into patent-eligible subject-matter." Id. at 1372.

The holdings in Roche and Ariosa limit one of the strategies used to patent diagnostic innovations after Mayo and Myriad: patenting the methods used in genetic testing, instead of patenting the specific genetic sequence identified. What Roche and Ariosa made clear was that innovators needed to claim an inventive concept above and beyond a method of using a novel genetic marker.

Despite the bleak landscape these cases created for the diagnostics industry, a handful of recent opinions and recent USPTO guidelines may provide a glimmer of hope by circumscribing the potential boundaries of Mayo and Myriad's impact.

The Federal Circuit has found certain claims patent eligible when they were not routine or conventional because the claims resulted in a new combination of known steps. For example, the Federal Circuit recently held that method claims for treatment of patients with a particular genotype with iloperdione were valid because the claims were directed to a method of treatment. Vanda Pharms. Inc. v. West-Ward Pharms., 887 F.3d 1117, 1135 (Fed. Cir. 2018). In doing so, the court distinguished other cases with arguably similar claims (including Mayo) because the claims at issue in the prior cases were directed to the natural phenomenon rather than a method of treatment. See also, Rapid Litigation Mgmt. v. CellzDirect, 827 F.3d 1042, 1048 (Fed. Cir. 2016) (holding that a claim involving a method of producing improved hepatocyte cells was valid because the claims were not "simply an observation or detection" but were "directed at a new and useful method of preserving hepatocyte[]").This suggests that the Federal Circuit is still willing to enforce method patents relying on natural phenomenon in certain situations.

The Patent Office also published revised guidelines in January 2019 to bring its examination process in line with recent Federal Circuit decisions by focusing on the circumstances under which an "additional element" beyond a naturally occurring phenomenon will render a patent valid. See, Fed. R. Vol. 84 No. 4, at 50, 53-54 (Jan. 7, 2019). Interestingly, the new guidelines cite the above-mentioned cases in which the claims were found eligible, but do not cite either Roche or Ariosa. Does this indicate an attempt to scale back the effects of Mayo and Myriad? Only time will tell.

Finally, this problem has not escaped the attention of lawmakers. Senators Thom Tillis (R-NC) and Chris Coons (D-DE) organized roundtable meetings with industry groups regarding plans to overhaul Section 101 of the Patent Act. So far, participants have expressed a desire to upend the judicially created exceptions to patentability in favor of new, clearly-defined statutory exceptions. This advice was taken to heart. On April 18, 2019, Senators Tillis and Coons, together with Representatives Doug Collins (R-GA-9), Hank Johnson (D-GA-4), and Steve Stivers (R-OH-15) released a legislative framework for these reforms. The framework proposes eliminating judicially-created patent eligibility requirements and creating a "practical application" test to ensure that that genuine innovations are not improperly treated as unpatentable subject-matter. Whether or not this framework leads to a legislative proposal remains to be seen, but one thing is clear: reforming the criteria for patent subject-matter eligibility under 35 U.S.C. §101, to bring clarity and certainty to the law, has caught the attention of industry groups and lawmakers alike.

Analysis

In the meantime, what is a company to do when seeking to protect discoveries of something useful in the natural world? There are two general strategies. First, hedge against uncertainty by filing multiple patent applications with claims of different scope and modelling the claims after USPTO examples to the extent possible. Second, try to draft claims in reference to recent case law trends by, for example, claiming methods instead of compositions and methods of treatment instead of methods of diagnosis. Do these strategies guarantee the validity of a diagnostic patent? Of course not. But at least for the time being, the industry must — as it has for the seven years since Mayo and Myriad — make do.

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Wesley Overson ([email protected]) is a Litigation Partner in the San Francisco office of Morrison & Foerster LLP, whose clients include pharmaceutical and biotechnology organizations. Otis Littlefield ([email protected]) is a Patent Partner in the San Francisco office, whose practice focuses on life science clients. Mat Swiderski ([email protected]) and Stephanie Blij ([email protected]) are Associates whose practices focus on IP litigation.