The discovery and isolation of a naturally-occurring gene is not eligible for patent protection. Such was the holding issued by the U.S. Supreme Court in a unanimous opinion in Association for Molecular Pathology v. Myriad Genetics, Inc. While the Court’s decision has drawn both praise and ire from different pockets of the biotech community, the Myriad Genetics decision is not as much of a game-changer as the popular press would have you believe. While the Court did hold that isolated genes were not patentable, synthetic DNA and screening tests that identify whether a subject carries a particular DNA sequence are patent eligible.
The Supreme Court has used the 2012-13 term to more clearly define the boundaries of its patent jurisprudence. In Bowman v. Monsanto Co., the court analyzed whether patent rights extended to subsequent generations of self-replicating seeds. (OFW Law participated in this case.) In Bowman, the Court held that patent rights extended to subsequent generations of patented soybean seeds; however, it limited the scope of the decision to the context of agricultural seeds. With the Myriad decision, the Court has established another bright-line rule – isolated, but naturally-occurring DNA is a “product of nature” and not patentable.
In Myriad, the plaintiffs challenged three of Myriad’s patents related to BRCA-testing. The BRCA test, recently made famous by Angelina Jolie, allows a patient to determine whether she carries a gene for an increased risk of breast cancer. Myriad held a patent on the isolated DNA sequence for the BRCA1 and BRCA2 gene. Myriad also held a patent on complimentary DNA, known as cDNA, for these genes, which was synthetically-replicated based on the isolated DNA sequence in question.
35 U.S.C. § 101 delineates patent eligibility in rather simple, albeit legal, terms. It reads: “[w]hoever 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 therefor, subject to the conditions and requirements of this title.” Simple enough, right? Not really. Disputes over these 36 words keep thousands of patent lawyers across the country very busy.
The difficult question Myriad posed to the Court was whether the act of discovering and isolating a naturally-occurring gene, an expensive and time-consuming breakthrough that could save millions of lives, was patentable. Patent protection would give Myriad the right to determine how the gene was used and could allow it to recoup the cost it invested in discovering the gene. However, one problem that was ultimately fatal to Myriad’s case is that “products of nature” cannot be patented. The Court invalidated Myriad’s patents in the isolated DNA because it was a naturally-occurring product of nature that Myriad had discovered, but not made. At the same time, the Court held that cDNA was patentable subject matter because its existence came about by human intervention, not nature.
Biotechnology has made waves in the patent world ever since the Supreme Court affirmed that living things are eligible for patent protection in Diamond v. Chakrabarty. Myriad is certainly a landmark case that places some boundaries on Chakrabarty. However, in practice, its effect will be limited and I would not expect a significant impact on the biotech industry for two reasons. First, Myriad does not place limits on developing synthetic DNA, patenting methods to identify naturally-occurring genes, or transgenic modification (genetic engineering). Myriad simply stands for the proposition that one must take a step beyond isolating DNA to qualify for patent protection. Second, most biotechnology players that hold (now-invalid) patents on isolated DNA also hold patents for subsequent processes or technology that utilize the naturally-occurring DNA; the patents for these processes and technologies are still valid. For instance, Myriad’s now-famous test to identify the BRCA genes remains patented.
