Trade secrets protection reduces microbial innovation necessary for environmental remediation, including for plastics pollution

Although the U.S. is considered a leader on the global stage, it is noteworthy that other countries have not followed the U.S. very far down this road of patent ineligibility. Isolated and purified forms of naturally-occurring products remain eligible for patenting everywhere else in the world, although some countries have specific exceptions for isolated genes.15 For example, the European Patent Office permits patenting of isolated genes and gene fragments as long as the patent’s description “indicate[s] the way in which the invention is capable of exploitation in industry.”16 Likewise, Australia, China, Japan, and Korea (for example) continue to grant patents on isolated natural products. Most countries permit patenting of diagnostic methods unless they are excepted on public policy grounds. For example, the European Patent Office permits patenting of diagnostic methods as long as they are not “practised on the human or animal body,”17 and so permits patenting of diagnostic methods conducted using saliva or blood samples (for example). Australia permits patenting of diagnostic methods without restriction (similar to the U.S. prior to Mayo), and methods of detecting specific markers of a disease or condition in a biological sample may be patented in China, Japan, and Korea (although methods of “diagnosing” a patient are excepted on public policy grounds).

This means that, since the changes in U.S. patent eligibility law flowing from Mayo, Myriad, and Alice,18 there are inventions that cannot be patented in the U.S. that can be patented in other countries. For example, as outlined above, isolated natural products that may be useful as medications, diagnostic agents, vaccines, antibiotics, or in industrial applications, can be patented around the world, except in the U.S. This leads to an imbalance in intellectual property rights that can be obtained in the U.S. versus elsewhere.

Regardless of where you seek to obtain a patent, you have to describe your invention in your patent application in a level of detail sufficient for others to practice the invention. This means that inventors who pursue patent protection have to disclose their inventions to the whole world, but cannot protect them to the same extent in the U.S. if they are caught in the § 101 snares of Mayo, Myriad, and Alice. This imbalance may cause innovators to think twice before pursuing a patent. If they do not expect to be able to adequately protect their investments, they may decide to maintain the technology as a trade secret, or shelve it altogether.

The imbalance in the “quid pro quo” of disclosure in return for patent rights19 is particularly acute for technologies related to isolated microorganisms, such as bacteria determined to have specific properties that make them particularly useful in commercial and industrial processes. (A few examples include bacteria used in brewing, baking, cheese- and yogurt-making, oil- and plastic-degrading bacteria used for environmental remediation, and carbon-fixing microbes used to address CO2 emissions.) In order to satisfy the 35 U.S.C. § 112 “written description” requirement for obtaining a patent relating to a newly discovered microorganism that is not readily available to the public, the patent applicant must “deposit” a sample of the bacteria with a qualified depository—such as the American Type Culture Collection (ATCC) in Gaithersburg, Maryland.20 The patent applicant also must assure that “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.”21

Prior to Myriad, isolated bacteria were included in patent-eligible subject matter. Thus, even though members of the public could obtain a sample of the bacteria once a patent granted, the public’s freedom to use the bacteria often was limited by patent rights that covered any and all uses of the isolated bacteria. Under Myriad, however, it is no longer possible to obtain a patent on isolated bacteria per se. That means that a U.S. patent granted today might only cover a specific method of using the bacteria. Nevertheless, the patent owner still must irrevocably remove “all restrictions ... on the availability to the public of the deposited material” once the patent grants.22 This is another imbalance that has arisen in the wake of Mayo, Myriad, and Alice that may cause innovators to hesitate before pursuing a U.S. patent or developing technology for the U.S. market.