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Protecting the Rights of The People v. the Rights of The Researchers: Does the Current U.S. Approach to Patentability of Gene Therapy Treatments Attain This?

Protecting the Rights of The People v. the Rights of The Researchers: Does the Current U.S. Approach to Patentability of Gene Therapy Treatments Attain This?

Kara Grooms

Science is progressing at an unprecedented rate.[1] The scientific field is introducing revolutionary new concepts, methodologies, and products that are unlike previously patented innovations. In particular, the legal community is scrambling to play catch-up and grapple with the patentability of biotechnology.[2]

This is in light of recent Supreme Court decisions in cases regarding biotechnology and the express prohibition by Congress in the America Invents Act (AIA)[3] of patents “directed to or encompassing [of] human organisms.”[4] Where many concepts were once patentable, people are beginning to question the ethics surrounding the ability to “own” parts of a human. In 2013, the United States Supreme Court sent shockwaves throughout the patent field with their decision in Association for Molecular Pathology v. Myriad Genetics, Inc.[5] The Court’s decision radically changed the approach to what was patent-eligible subject matter. Leaving the scientific and legal communities scrambling to resolve and understand this uncertainty. Importantly, the Court also noted in a separate section that their decision specifically did not apply to method patent claims, patents involving “new applications of knowledge,” and patentability of altered DNA.[6]

This Note will analyze whether it is time to change the approach, availability, access, and expense of biotechnology patents. This analysis is important because due to the often fundamental nature of biotechnology discoveries and their unknown future applications or implications, researchers, scholars, and medical personnel’s ability to access this knowledge has untold benefits – and it is potentially devastating and detrimental to withhold such access. Without adequate access to biotechnology, the scientific community faces years of delayed development.

First, this Note will discuss patent claims and patent eligible subject matter. Next, this Note will define and discuss genetic concepts and gene therapies. Then, this Note will review the relevant case law to show the evolution of patent eligibility. With this information in mind, the next section will parse through the ethical debate surrounding patentability. First, focusing on the viewpoints of researchers and biotechnology companies. Second, broaching the subject from the standpoint of society as a whole. Finally, the Note will conclude by discussing possible ways in which this dichotomy could best be resolved.

Questions and inquiries regarding this Note may be forwarded to the author at LawReview@vermontlaw.edu.


[1] See, e.g., Lawrence M. Rausch, Int’l Patenting Trends in Biotechnology: Genetic Engineering, Div. of Sci. Res. Stud. Issue Brief (Nat’l Sci. Found., Arlington, Va.), NSF 99-351, June 18, 1999 (showing that the U.S. was the priority country for 63% of the sets of international patents filed in the first half of the 1990s, and for 59% of the most highly cited biotechnology inventions).

[2] See Sardiaa Leney, Much Ado About Genes: Untangling the Evolving Law of Subject Matter Eligibility, 16 J. High Tech. L. 522 (2016) (analyzing the responses by the USPTO in the wake of Myriad).

[3] See Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) (clarifying the application of Mayo and  discussing the ineligibility of “abstract ideas”); Myriad Genetics, Inc., 133 S. Ct. at 2107 (holding that genes and the information they encode are not patent eligible simply because they have been isolated from the surrounding genetic material; whereas cDNA, which removed codes for anything other than amino acids, is not a product of nature, thus is patentable, since something was unquestionably created by removing the unwanted codes); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (deciding unanimously to revoke patents protecting a method of determining the proper drug dosage in conjunction with metabolic rates because all arguments were based on previously known laws of nature and knowledge, and provided no inventive concept in their application). Leahy-Smith America Invents Act, Pub. L. No 112–29, 125 Stat. 284, 340 (2011) (codified as amended in § 33(a) of Title 35 of the U.S. Code).

[4] Leahy-Smith America Invents Act, Pub. L. No 112–29, 125 Stat. 284, 340 (2011) (codified as amended in § 33(a) of Title 35 of the U.S. Code).

[5] Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117–19 (2013).

[6] Myriad Genetics, Inc., 133 S. Ct. at 2120.

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