Written By: Elyse Gottschalk
If you Google the top 10 life-improving inventions of the 2000s, unsurprisingly, the top of the list is “mobile broadband”, the technology that brought live streaming to “cat video” lovers across the globe. [1] While Apple and Samsung were in a race for the best smart phone, science was partaking in its own endeavor – the task of sequencing the human genome, known as the Human Genome Project. After nearly 13 years, three billion DNA base pairs and every gene in the human genome were identified, qualifying it as the second ranked life-improving invention of the 2000s. [2]
But, the Human Genome Project was not the end. It was the beginning of the “genomic revolution”, with the race for development of gene-based therapies at the forefront. [3]
Gene therapy, the replacement of mutated, dysfunctional genes with functional ones as a cure for lifelong (typically fatal) diseases caught the interest of scientists, recognizing the expansive and potentially lucrative opportunity. However, development and testing of these kinds of treatments involves huge amounts of money, and scientists are beginning seek patents to protect their discoveries. [4]
Gene patents are one of the most controversial categories of patents in the United States and abroad. Patent proponents focus on incentivizing invention and promoting commercialization through the economic efficiency provided by a patent monopoly. [5] They argue that, without the protection of patents, because of the unusually high failure rate of biology-based research, the economic burden would limit development to large biopharma companies that could absorb the loss. In addition, in the absence of patent protection, collaborative efficiencies would be stagnated, with companies relying on trade secrets as a means of protection, slowing the development of treatments. [6]
Those opposing patent protection to genetic material argue that it is not consistent with the intent of 35 U.S.C. § 101, which does not historically extend patent protection to phenomena of nature. [7] Their concerns were addressed in Association for Molecular Pathology v. Myriad Genetics, where the Supreme Court held that a gene sequence in its natural form was not patentable, as distinguished from cDNA, a stripped version of DNA sequence isolated in a lab. [8] This means that a specific version of the DNA once isolated or with a specific mutation is patentable, while the sequence itself is broadly available for use.
While the court refused to address the public policy implications, this was a win for those concerned that gene patenting had negative implications for patient care. In fact, as part of the Appellate courts review, the AMA submitted an amicus curiae brief stated that gene patents interfere with diagnosis and treatment, quality assurance, and patient access to health care because it limited the options available for the treatments, leaving patients at the mercy of those holding the monopoly. [9]
Gene therapy, though in its infancy, is becoming a hot topic for scientists and patent lawyers alike. While the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics has provided some guidance into the patentability of genetic material and treatments, like gene therapy itself, the potential developments remain largely untapped. Patent attorneys, the scientists of patent law, will find themselves tasked with navigating the world of opportunities (and associated challenges) presented by the “genomic revolution”, by walking the line between protecting the inventor and benefiting society. The public policy implications that are the underpinnings of patent law are no exception here.
[1] Will McClennan, Great Life-Improving Inventions of the 2000s, The Richest (Nov. 23, 2013), https://www.therichest.com/business/technology/the-top-10-life-improving-inventions-of-the-2000s/.
[2] Id.
[3] Simon Trip and Martin Gruber, Economic Impact of the Human Genome Project (2011).
[4] Id.
[5] Laurie L. Hilla, The Race to Patent the Genome: Free Riders, Hold Ups, and The Future of Medical Breakthroughs, 11 Tex. Intell. Prop. L.J. 221, 237-42 (2003).
[6] Id.
[7] Id.
[8] Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
[9] Id.
