30
Jul2013

by Maeve Luthin, JD, Professional Development Manager

In June’s Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) decision, the Supreme Court determined that human genes fall within the “laws of nature” exception to patentable material. This decision invalidated Myriad’s exclusive claim to BRCA 1 and BRCA 2 tests that can be used in determining a woman’s risk in contracting breast and ovarian cancer. However, Myriad wasn’t asserting a patent on the tests; its theory was that since it patented the genes, no one else had the right to use the genes in their research.

Contesting patent claims is a lengthy, expensive process that is usually avoided unless multiple deep-pocketed competitors are claiming the same patent, because if they prevail, they expect their profits to cover the cost of litigation (e.g., the Apple/Samsung trial last spring). Myriad was proactive and aggressive in asserting its patent claims and sending cease and desist orders to researchers, universities, and other entities engaged in the business of assessing the genetic risk for cancers associated with the BRCA 1 and BRCA 2 genes. It wasn’t until a group of physicians, patients, and others—frustrated by their inability to conduct testing through non-Myriad labs—banded together that the case was made its way to court.

Many people in the biomedical research community are predicting that this decision will help lower the cost of personalized medicine, making tests like the ones Myriad offers more financially accessible and easier for patients to obtain. However, if companies believe there is little incentive to enter into the research arena because of the loss of exclusivity in selling a product, prices cannot fall due to a lack of competition in the marketplace. The court tried to circumvent this problem by narrowing its ruling to only include human genes, thereby allowing applicants to seek method patents and patents that incorporate the knowledge gained by gene and mutation discovery.

This ruling reinforces the importance both public domain and private discovery have in human subjects research. In declaring that human genes cannot be monopolized by any one entity, the court guarantees researchers open access to genetic source material, thereby assuring a scenario in which multiple investigators can conduct research simultaneously, challenging one another to improve upon previous discoveries. Ideally, this would lead to discovering more mutations, more effective therapies, and better answers to critical clinical care questions faster than if a single corporation were to monopolize all research associated with a single gene.

By clearly stating that patents on novel methods, manipulated DNA, and new applications of knowledge gained by gene research constitutes patentable subject matter, the court recognized the importance of incentivizing scientific discovery. Investors are more likely to back expensive research when the possibility of profit exists; this is especially critical right now, with federal government spending on research at an all-time low. Additionally, the patent process balances the monopoly rights (generally twenty year periods) awarded to successful applicants with transparency. All patent applications are published in their entirety, including the section in which applicants describe how to create the patentable object. Though competitors are liable if they reverse engineer the patentable subject matter, that knowledge can still propel research forward.

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