On April 20, 2005, the Supreme Court will hear Merck KGaA v. Integra to determine boundaries of the statutory safe harbor created by 35 USC 271(e)(1). The safe harbor immunizes would-be infringing activity when the activity is done while preparing an FDA application for drug approval. Attorneys for both Merck and Integra as well as for the U.S. Government are expected to present oral arguments.
Merck KGaA has now filed its reply brief that focuses on picking-apart Integra’s answer. In particular, Merck begins its argument with the statement that “everyone agrees” that “preclinical experiments reasonably related to an IND application are immune from patent infringement claims as clinical trials.”
Importantly, Merck challenged Integra’s procedural argument that the is “no present controversy.” This issue is one that could allow the High Court to completely avoid deciding the important statutory issues.
The SCOTUS Blog provides an excellent preview of the case here.
Briefs on the Merits:
- In Support of Merck:
- Brief by Petitioner Merck KGaA
- Reply Brief by Petitioner Merck KGaA
- NY Intellectual Property Law Association’s Brief
- EON Labs Brief
- AARP Brief
- Amicus Brief for the Consumer Project and the Electronic Frontier Foundation (EFF)
- PhRMA Amicus Brief
- Amicus Brief for Sepracor
- Brief of Genentech and Biogen Idec
- Brief for the United States Government
- Brief of Amici Curiae Eli Lilly, Wyeth, and Pfizer
- Professors’ Amicus Brief
- AIPLA Amicus Brief
- Bar Association of the District of Columbia (BADC) Brief
- San Diego Intellectual Property Law Association (SDIPLA) Brief
- Biotechnology Industry Organization (BIO) Brief
- Brief by Respondent Integra
- Benitec Amicus Brief
- Vaccinex Amicus Brief
- Applera and Isis Amicus Brief
- Invitrogen Amicus Brief
- WARF Amicus Brief