Patent Subject Matter Eligibility in the Biotechnology Industry
On patent subject matter eligibility, 35 U.S.C. § 101 provides that: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.”[1] This definition has remained essentially unchanged since 1793 and today has proven to be difficult to apply with regards to certain biotechnological inventions implicating genetic material.[2]
In 2014, the Supreme Court laid down the analytical framework used in determining patent eligibility:
Determine whether the invention is based on an abstract idea, natural law, or natural phenomenon and if so, determine whether there were additional requirements of the claim so that it does not preempt all uses of the abstract idea, natural law, or natural phenomenon, but involves an inventive use of it.[3]
In the realm of biotechnology, the breakthrough of patenting “life” is illustrated in the Supreme Court’s decision in Diamond v. Chakrabarty.[4] There, the court held that modified mutant bacteria can be patentable because the organisms were not naturally occurring and instead a product of manmade invention.[5] Thus, the Supreme Court implied that the fact that the product was a natural, living thing did not preclude its patentability.
Subsequent patent applications used this ruling to attempt to patent things of nature, but quickly ran into problems upon realizing that there needed to be a balance between the broad patent eligibility granted by Diamond v. Chakrabarty and the rule banning patents for what occurs in nature.[6] In fact, the Court ran into this problem in Mayo v. Prometheus, where a pharmaceutical company attempted to patent a diagnostic test that assessed whether a particular drug dosage was too high or too low.[7] The Court found that the effect that a drug has in a patient’s bloodstream exists in principle apart from any human action and thus is ineligible patent subject matter.[8] Further, the Court noted that adding a conventional step to the invention that applies the natural phenomenon of drug metabolism (such as using a physician to administer the test) does not suddenly make the invention patent eligible.[9]
While the Court noted that their decision does not prevent patenting of new pharmaceuticals or processes that use existing pharmaceuticals, the Court showed concern with the danger of precluding research by allowing a monopoly on what is essentially a broad natural law.[10] After all, one of the main reasons for patent protection is to promote innovation by fostering competition.[11] By allowing patents on broad claims to natural laws that have some conventional steps attached to them, the tools to future creation would be tied up and this would be an easy way around patent laws.
While it seems obvious that naturally occurring substances or processes are not within the reach of patents, before Mayo and Alice, that was the reality.[12] In fact, by 2005, approximately 20 percent of the human genome was subject to patent protection.[13]However, patents on genetic material ended with the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, where the Court unanimously ruled against patenting isolated DNA since this was not something “markedly different” from anything found in nature.[14]
Recently, however, there have been challenges by the biotechnology industry to overturn Myriad because it limits patentability of certain biomedical innovations.[15] They claim that unless the reach of patents is broadened, biomedical creation will be stifled and research will not be adequately funded.[16] In 2019, Senators Chris Coons (D-Del) and Thom Tillis (R-NC) drafted a bill that would have overridden decisions limiting the patentability of natural laws rightfully within the public domain.[17]
However, in January of 2020 when SARS-CoV-2 was identified, researchers were able to develop vaccines and treatments to combat the virus rapidly because of the absence of patents.[18] Needless to say, the Coons-Tillis legislation did not advance due to opposition by many advocacy groups and private companies.[19] However, because of the debate surrounding the issue of broadening patent subject matter eligibility within the biotechnology industry, the Patent Office issued a request for public input in 2021 on how the current jurisprudence has impacted investment and innovation, especially in areas like diagnostic methods and pharmaceutical treatments.[20]
Patent advocates worry about losing to foreign competition and declining investment in research, but these fears are unfounded.[21]Patent law jurisprudence never allowed pharmaceutical companies to monopolize natural phenomena or abstract laws to further investment, promote innovation, or keep up with foreign competition.[22] Allowing patents on natural phenomena in the biotechnology industry would only serve to endanger public health and human life with higher costs on medical treatments and drugs. Instead of broadening patent subject matter eligibility, patent law jurisprudence should focus on further nurturing and clarifying the balance between prohibiting patents on natural phenomena and promoting innovation.
Footnotes
