Abstract

When Congress enacted the United States Patent Act in 1952, it specified that patentable subject matter included anything “under the sun that is made by man.” Three decades ago the United States Patent and Trademark Office (USPTO) issued the first gene patent and ushered in a brave new gold rush. Some genes are associated with specific diseases, so being able to identify these sequences is an essential first step for developing genomic diagnostic tests and therapies. The problem with gene patents is that they allow modern-day prospectors to cordon off access to naturally occurring DNA sequences and exclude others from conducting research or developing useful applications based on these sequences. In 2009, a broad coalition of plaintiffs challenged Myriad Genetics over its breast cancer gene patents. In July 2011, the U.S. Court of Appeals for the Federal Circuit ruled 2-1 in favor of upholding Myriad’s gene patents, overturning a lower court decision.

On March 20, 2012, Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Prometheus) potentially restored sanity on the issue of whether gene sequences can be patented. While not addressing gene patents specifically, a unanimous Supreme Court correctly reaffirmed that one cannot patent “the underlying laws of nature themselves.” However, the Court explicitly linked its decision to the viability of gene patents when less than a week later it vacated the Myriad decision and remanded it back to the Federal Circuit to reconsider in light of its ruling in Prometheus.

While it is not definitively clear that gene patents are dead in light of Prometheus, this essay argues that properly understanding the Supreme Court’s logic should lead to no other result. Predicting whether the “patent-friendly” Federal Circuit reaches the same conclusion is not the focus of this essay. Instead, this essay serves to rebut claims that gene patents are consonant with patent law and needed to stimulate genomics research and development.

Through the lens of the Myriad case, we will recount why there was such a strong public interest movement against recognizing such patents. Specifically, we will show how this particular patent stifles research, impedes access to affordable testing, and detrimentally effects future developments in the cancer world. Furthermore, we will briefly examine the Supreme Court’s legal reasoning in Prometheus and why it should be read as invalidating gene patents.

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