High Court Axes Edwards’ Bid to Limit Drug-Patent Safe Harbor

The US Supreme Court rejected a case asking the justices to interpret a patent-infringement safe-harbor provision in a federal statute “solely for uses reasonably related” to the process winning government approval of a drug or medical device.

That language from Section 271(e)(1) of the Hatch-Waxman Act, a 1984 law governing the US system for regulating and shepherding to market generic drugs, was the focus of the petition filed by medical device maker Edwards Lifesciences Corp. that was denied by the high court on Monday.

California-based Edwards had been unable to convince the US Court of Appeals for the Federal Circuit ...