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:
- Brief by Petitioner Merck KGaA
- Brief for the United States Government
- Brief of Amici Curiae Eli Lilly, Wyeth, and Pfizer
- EON Labs Brief
- AARP Brief
- Amicus Brief for the Consumer Project and the Electronic Frontier Foundation (EFF)
- PhRMA Amicus Brief
- Amicus Brief for Sepracor
- NY Intellectual Property Law Association’s Brief
- Brief of Genentech and Biogen Idec
In Support of Integra:
- Brief by Respondent Integra
- Benitec Amicus Brief
- Vaccinex Amicus Brief
- Applera and Isis Amicus Brief
- Invitrogen Amicus Brief
- WARF Amicus Brief
In Support of Neither Party: