Myriad and Patenting of the Human Gene

The June 2013 Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013) which considered whether portions of human genes may be patented, fueled an extraordinary amount of heated discussion for an intellectual property case.

The patents at issue in Myriad concern mutated genes associated with increased risk of breast and ovarian cancer. Health care advocates worried that a ruling in favor of patentability would make it difficult for the general public to afford genetic testing. On the contrary, the biotechnology industry argued that robust patent protection would incentivize the market to invest in developing and marketing diagnostic and therapeutic products containing genetic material.

In its 9-0 decision striking down Myriad’s patent on isolating human genes from the bloodstream, the Supreme Court took the middle ground and held that naturally occurring human genes are not patentable, but the synthetic human genes manipulated by scientists may be patented. The Court reasoned that for the patent on genomic DNA that has been merely “isolated” from the body, the word “isolated” in claim language means, simply, removed and separated from its natural environment in the cell, and therefore, does not meet the threshold test of patentable subject matter under Sec. 101 of Title 35.

However, despite the Court’s decision, Myriad filed patent infringement suits against Ambry Generics Corporation and Gene By Gene, LTD., on July 9, 2013 and July 10, 2013, respectively. Both Ambry and Gene by Gene announced they will provide BRCA 1 and 2 tests almost immediately after the Supreme Court’s decision. Myriad has not sued on the naturally occurring DNA claims that the Court threw out, nor on the method claims that were invalidated by the Federal Circuit but not reviewed by the Supreme Court. Instead, Myriad alleges that the defendants’ tests infringe a number of other claims in ten different patents that cover various features, including the synthetic cDNA.

Myriad’s lawsuits are motivated by its desire to warn the competitors that Myriad is not ready to concede its patent-based monopoly on BRCA testing despite the Supreme Court decision. However, by asserting the infringement claims, Myriad must now survive the more stringent novelty and non-obviousness standards to overcome the danger of invalidating its patents. It is difficult to predict how these infringement suits will play out, though it will be interesting to see what strategies Myriad will employ in its use-them-or-lose-them battle against competitors following the Supreme Court decision.