Supreme Court Hearing Set on Experimental Use Safe Harbor Statute

"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."

For summaries and PDF copies of the various briefs filed in the case, please see this post from Patently-O from which the foregoing quote was taken.