Earlier this week, the United States Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. The case involves challenges to the practice of gene patenting and specifically Myriad Genetics’ seven patents on isolated gene sequences. The American Medical Association (AMA), “concerned about the effect that the decision will have on the practice of medicine and on medical research,” contributed an amicus brief to the court.
Myriad’s patents are particularly susceptible to challenges by organizations like the AMA because of their healthcare implications. The genes in question are the BRCA1 and BRCA2 genes, which account for most inherited forms of breast and ovarian cancer. As holder of the patent, Myriad has complete control over the use of the BRCA1 and BRCA2 gene sequences. Without other competing forces in the market, Myriad is able to charge $3,500 for BRCA diagnostics tests. But the consequences of Myriad’s exclusive use of the gene sequences extend beyond mere cost. Due to Myriad’s monopoly, “no woman can get an independent second opinion about her condition before deciding to have her healthy breasts or ovaries removed in order to avoid cancer.” Without a second opinion, women who receive a false positive test may unnecessarily elect to have their breasts or ovaries removed, a result that could have been avoided had the women had access to an independent second test. Further, since only Myriad can perform these tests, it can keep any data it gleans from the test results. This is especially problematic where the test reveals geographic and demographic patterns or new genetic variants that would be valuable to researchers seeking to understand the dynamics of breast and ovarian cancer genetics.
The AMA brief also discussed the Court’s analysis of similar issues in prior cases. In Diamond v. Chakrabarty, the Court held that products of nature are not patentable. In American Wood-Paper Co v. Fibre, the Court went further, clarifying that isolated or purified products of nature, while requiring human intervention to isolate or purify, were still not patentable. Further expanding on these holdings, the Court in Cochrane v. Badische Anilin & Soda Fabrik held that even synthetic products are not patentable if the product is not markedly different from what is found in nature.
Applying the precedent to the facts present in Myriad’s case, the AMA noted that “Myriad’s isolated genetic sequence claims … are not ‘markedly different’ from the genetic sequence as it occurs in nature.” Moreover, “[t]he term ‘isolated’ adds nothing of significance to the genetic sequence claims because isolation of genetic sequences is a well-understood conventional activity engaged in by geneticists.” Myriad, then, faces an uphill battle in arguing that the isolated sequence is worthy of patent protection, because the beneficial use to which it can be put—diagnostic testing—depends on its natural occurrence in the human body.
The Court heard arguments in the case just this past week, so it will be a while before the Court issues its decision. However, if the Court holds that isolated gene sequences are not patentable, it would be a game-changing ruling. While the AMA and other opponents of gene patenting may initially be pleased with such a ruling, it is unclear whether the AMA has really considered the healthcare implications of that decision. Here, Myriad was able to attract investors only after developing a business model to exclusively offer diagnostic testing services for the BRCA genes and charge a premium price for that exclusivity during the life of the patents. The majority of biotechnology companies will similarly be less likely to engage in gene sequencing efforts without the exclusivity and profitability awarded by patent. That effect could potentially impede future research and therefore impact the availability of new healthcare options.