Case Study: Association for Molecular Pathology v. Myriad Genetics, Inc.

Association for Molecular Pathology v. Myriad Genetics, Inc. (Docket No. 12-398, Opinion entered June 13, 2013), the U.S. Supreme Court held that the mere act of identifying a particular DNA gene sequence is not sufficient to form the basis of granting the person who identified it a comprehensive and exclusive patent regarding said sequence.

Myriad Genetics, Inc. is a genomic research firm whose mission, among other things, is to learn what various sequences of DNA in the human genome actually do. In the course of their research, and in collaboration with other scientists from other groups, Myriad’s scientists made an extraordinarily useful discovery in 1994 — two genes now known as BRCA1 and BRCA2. The influence of these genes can elevate the risk of a woman developing cancer at some point in her life.

As a result, soon thereafter, the company began offering screening tests to members of the public able to afford them, and filed for patents related to the discovery and associated assets. (You may have heard about these tests in the news after the actress Angelina Jolie was tested, found to have an elevated risk of cancer, and underwent a voluntary double mastectomy.) Certain patents were granted, and Myriad claimed exclusivity over various tests and other items related to the genes in question.

Myriad’s claimed exclusivity was controversial and problematic for many reasons. If valid and comprehensive, the patents essentially would have meant that Myriad “owned” the genes, for most practical purposes and applications. This ownership could have been used to thwart scientific progress and health care efforts that include, but were not limited to preventing:

A coalition of petitioners from such groups eventually filed suit seeking to have Myriad’s patents invalidated so that research, tests and treatments related to the BRCA1 and 2 genes could be pursued in an unrestrained manner.

The Supreme Court agreed with the petitioners, to a limited extent. The mere isolation and identification of a gene sequence is not enough for a patent regarding that sequence, as nothing was “created” (which patent law requires). Methods related to the sequence, and copies and derivatives of the sequence, however, were left open to further review. Undoubtedly, there will be continued litigation related to DNA research as the genomics industry, the Patent and Trademark Office and the courts attempt to fashion a reasonable set of rules to govern it.

The Court unanimously affirmed in part and reversed in part the decision of the court below.

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