Handling the Mayo Powder Keg: Emphasizing Preemption in § 101 Biotechnology Inquiries

By Zachary M. Robole. Full Text. 

To incite a jury’s emotions, attorneys have stated that the “clear and convincing” evidentiary standard required to invalidate a patent is the same standard of proof required to justify taking a child away from a parent. Although such statements are likely an evidentiary rule violation, the point is illustrative of how inventors may feel about their inventions. Some put their entire life’s work into securing a patent. However, even decades of research and discovery may still not prove adequate to merit the issuance of a patent. The claimed invention must fall within a category of subject matter that is eligible for patenting under 35 U.S.C. § 101. Further, the Supreme Court has staunchly held that even some of the most profound discoveries and exciting scientific advancements may not be eligible for patenting if they are simply an attempt to monopolize a law of nature, natural phenomenon, or abstract idea (“patent-ineligible concepts”). Nonetheless, the incredible time and energy put into the scientific research process needs to be respected for a patent system to have any value. There is no better way to respect inventors and their work than to provide them clear and defined rules for what claims describing their inventions will and will not be eligible for patenting.

Unfortunately, it is nearly impossible to find a patent attorney who will agree that the federal courts’ current application of § 101 is crystal clear. The modern state of patentable subject matter law derives from the four Supreme Court holdings of Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories, Inc., Ass’n for Molecular Pathology v. Myriad Genetics Inc., and Alice Corp. v. CLS Bank International (Mayo and Alice being the more prevalent of the four). The test that comes out of these cases has two steps. At step one, a court asks “whether the claims at issue are directed to one of those patentineligible concepts.” If they are not, the claims are patent eligible. If they are, a court must consider the claims individually and together “to determine whether additional elements ‘transform the nature of the claim’ into a patent-eligible application.” What exactly it means to be “directed to” a patent-ineligible concept and what it means to “transform the nature of the claim” have been left up to the district courts and the Federal Circuit to determine.

After Alice, the Court denied petitions having to do with patentable subject matter eligibility. In 2021, there was a new hope that the Court was going to grant a writ of certiorari for what would have likely been another landmark case on the issue. It requested the Solicitor General’s opinion on the case and, after a year of waiting, the opinion recommended the Court take the case. But, in June 2022, the Court ultimately declined to hear the matter. The Court’s rejection inspired Senator Thom Tillis to introduce a significant amendment to § 101 in August 2022. Senator Tillis’s proposed bill included specific categories of discovery that cannot be patented and provided criteria for the courts to weigh when considering patent eligibility. The bill was applauded by intellectual property attorneys and judges as a much needed solution to the uncertainty in patent eligibility. At present, however, the future of the bill is unclear.

One of the greatest difficulties in creating a uniform system on patent eligibility is that each field of innovation flirts with ineligibility in its own way. This means that drafting one-size fits all legislation can be hard to do. It is thus important for legislators to consider each field separately and how the proposed legislation will affect that field. The purpose of this Essay is to analyze how the Mayo/Alice framework is being applied in the field of biotechnology at the Federal Circuit level and to highlight the Federal Circuit’s inconsistencies when applying the framework within that discipline. Through this analysis the goals of the Essay are twofold: first, to show why a bill like Senator Tillis’s is needed and second, to provide a recommendation for how a proposed bill could best serve the biotechnology field.

This Essay ultimately asserts that the Federal Circuit’s incorporation of the Mayo/Alice “two-step” test proves it to be a confusing test for inventors to follow and blurs the line of becoming a §§ 102 and 103 inquiry into novelty and obviousness. At step one, the Federal Circuit has created a confusing standard for what it means for a claim to be “directed to” patent eligible subject matter. At step two, the consideration of “what the claims add” has created a near impossible bar for biotechnology patents to overcome. The Essay further endorses Senator Tillis’s proposed amendment as it pertains to doing away with this quasi-§§ 102, 103 standard. Although this Essay agrees the Mayo/Alice framework has caused disarray, the Mayo Court was correct in its recognition of the importance of “preemption” in the § 101 inquiry. Unfortunately, it was not emphasized enough for the Federal Circuit to give the concept the proper weight in its analyses. Therefore, this Essay further recommends that—to create more clarity—the proposed legislation should incorporate an emphasis on the importance of preemption in the § 101 inquiry.

Part I provides a more detailed background of how the Mayo/Alice framework developed. Part II evaluates the “biotechnology-patentable subject matter” cases heard by the Federal Circuit since Alice. It explains how—in practice—the Mayo/Alice framework has created both unwanted confusion at step one and unwanted consistency of result at step two. Part III explains how preemption emphasis reconciles the Federal Circuit cases, points out which cases were flawed, and creates a more consistent standard going forward. Such emphasis could help better amend Senator Tillis’s proposed bill should it move forward in the legislative process.

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