On June 13, 2013, the United States Supreme Court unanimously agreed to end the three-decade-old practice of awarding patents based on human genes. In Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013), the Court held, “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but modified DNA may be patentable.” In short, the Court has changed the landscape of biotech companies – DNA found in nature is not patentable.
Mixed reviews surfaced once the Court issued its decision on Myriad’s patents. Those in favor of the ruling agreed that patients will now have greater access to genetic testing and scientists will be able to engage in research without fear of being sued. On the flip side, those opposed remain skeptical and concerned as to the effects the ruling will have on the biotech industry.
To complement those concerns, Andrew Hirshfeld, the Deputy Commissioner for Patent Examination Policy of the U.S. Trademark and Patent Office, issued a memo following the decision advising Examiners to now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101. The memo concludes by adamantly noting that the U.S. Patent and Trademark Office is closely reviewing the Myriad decision, and as a result will issue more comprehensive guidelines on the patent subject matter eligibility determinations. This may be problematic because the Myriad standard is ambiguous in the eyes of many professionals. The U.S. Patent and Trademark Office’s reaction may have opened the door to endless issues related to patentable subject matter. The ultimate question remains: Where do you draw the line?
Strict interpretation of Myriad, as advocated by Deputy Commissioner Hirshfeld, could force companies to devise a plurality of alternative approaches when claiming their inventions. The Myriad decision eliminates the patentability of a once patentable subject matter and precludes inventors from claiming such subject matter in the future. As a result, companies may no longer invest in these technologies since they cannot be afforded the protection that a patent provides. As an alternative means, companies may seek to protect their inventions by classifying them as trade secrets.
Furthermore, the strict interpretation of Myriad may hinder the patent process. For example, more § 101 rejections are expected to be issued by the U.S. Patent and Trademark Office to applicants for failure to claim patentable subject matter. Moreover, it is possible that applicants will encounter inconsistent reviews from Examiners throughout the patent process. Between the inconsistent reviews by Examiners and the preclusion of a once patentable subject matter stemming from the application of the Myriad standard, the U.S. Patent and Trademark Office may see a reduction in the number of biotech patents filed, which could then have an adverse financial effect on the U.S. Patent and Trademark Office.
Myriad is a molecular diagnostic company that held two gene patents on two newly discovered cancer-associated genes. Myriad did not synthesize or modify the genetic structure of the DNA but merely discovered the location and genetic sequence of the two cancer-associated genes. The Court concluded that although Myriad found the location of the genes, discovery, by itself, does not render the BRCA genes new and useful compositions of matter, 35 U.S.C. § 101, that constitute patent-eligible subject matter. Similarly, Justice Clarence Thomas explained, “Myriad found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
Wilson Elser’s Intellectual Property practice will continue to monitor the development and implementation of the Myriad decision. There are many technical details that will impact the patent prosecution process as well as patent infringement litigation, and businesses should be aware of these before bringing products to market.