Stage Set For Hearing on Experimental Use Safe Harbor Statute at Supreme Court

Party and amicus briefs have been filed and the stage is now set for the April 20 hearing of Merck KGaA v. Integra LifeSciences at the Supreme Court. 

Merck v. Integra is slated to determine the scope of 35 U.S.C. §271(e)(1), the safe harbor statute that permits a drug manufacturer to perform potentially infringing experiments needed to obtain FDA approval without incurring liability for patent infringement.  A major question will be how attenuated an experiment may be and still fall within the protection from infringement liability offered by the statute.

I have summarized the various party and amicus briefs here.  The following links provide PDF copies of the briefs.

In Support of Merck:

In Support of Integra:

In Support of Neither Party: