The US Supreme Court has invited the solicitor general to file a brief in a case that raises issues about safe harbour from patent infringement liability for generic drugs
Should the justices agree to hear GlaxoSmithKline v Classen Immunotherapies, the court will decide whether to affirm or reject the Federal Circuit’s decision to restrict safe harbour to pre-marketing approval of generic drugs.
The question before the court is: “Whether the Federal Circuit’s interpretation of § 271(e)(1), which arbitrarily restricts the safe harbor to preapproval activities, is faithful to statutory text that contains no such limitation, and decisions of this Court rejecting similar efforts to impose extra-textual limitations on the statute”.