Life Sciences Cases to Watch in 2013

​Michael Shuster, co-chair of Fenwick’s Life Sciences Group, is quoted in a Law360 article titled “Life Science Cases to Watch in 2013.”

The article discusses the major life sciences cases coming up this year, according to attorneys in the sector. In The Association of Molecular Pathology et al. v. Myriad Genetics Inc., the Supreme Court will decide whether human genes are patentable, which Shuster says is a misleading question.

“Hopefully [the justices] realize the question relates to the sequences of human genes.”

He said that funding will decrease if isolated-gene patents aren’t available. The decision is “going to turn on the willingness of the court to roll up its sleeves and understand the nuanced history in patent law and the critical role that venture capital plays in sustaining and maintaining the biotech industry,” Shuster said.

Another case attorneys have indicated they are watching closely involves a potential Supreme Court ruling on the issue of pay-for delay deals in the pharmaceutical industry.

In these “pay-for-delay” agreements, manufacturers of brand-name drugs compensate generic makers in order to drop patent challenges and keep competing products off the market. The Court will rule on the validity of these agreements in the matter Federal Trade Commission v. Watson Pharmaceuticals.

Shuster suggested the high court’s conservative wing is most likely to be sympathetic to a freedom-of-contract argument but that there is a strong case to be made that the agreements are subverting U.S. law.

“I do think that pay-for-delay frustrated the intent behind the Hatch-Waxman Act, which is of course to assure that generics could get to market,” he said.