A Federal Circuit panel of Judges Newman, Rader, and Prost heard oral arguments Monday in Integra LifeSciences v. Merck KGaA, No. 02-1052. An mp3 audio file of the 45-minute session is available here (be patient when downloading this; it's a 40 mB file).
The case involves the scope of the "FDA exemption" under 35 U.S.C. 271(e)(1), which exempts activities "reasonably related to the development and submission of information" to the FDA from charges of patent infringement. Last year, the Supreme Court reversed the Federal Circuit's earlier decision in the case, and remanded it to the Federal Circuit for further proceedings. The Supreme Court held that the FDA exemption "extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA," including all clinical and preclinical studies of patented compounds appropriate for submission to the FDA.
At this stage of the proceedings, Merck stated the issue as follows:
The Supreme Court has now clarified that the FDA exemption immunizes an experiment from patent infringement claims where (1) it is reasonable for a scientist to believe that a drug candidate "may work through a particular biological process, to produce a particular physiological effect"; and (2) the experiment "uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA." There is no dispute that, by the time Scripps scientists conducted the accused experiments at issue here, Merck and Scripps had discovered that the accused compounds shrank tumors in animals, and that every accused experiment was reasonably designed to yield data on topics that the Supreme Court has confirmed are relevant to the FDA. Should judgment be entered as a matter of law?
The oral arguments grew heated early, with intense questioning by Judge Rader focusing on whether "research tools" are protected by the FDA exemption under the Supreme Court's decision. Judge Rader called this the "central issue we're going to be dealing with here." Merck's attorney tried to refocus the court on whether Merck's specific experiments with Integra's patented compounds are entitled to the FDA exemption (arguing they are), saying, "I've only got 10 more minutes." But Judge Rader would have none of it, replying, "You're going to spend them on this issue, so you might as well get used to it."
The question whether research tools fall under the FDA exemption is especially important to small biotechnology companies. The Supreme Court decision left this question unanswered.
- Dennis Crouch's Patently-O post on the Supreme Court decision
- Brief of Merck KGaA
- Brief of Integra LifeSciences
- Reply brief of Merck KGaA
- Amicus brief of Bavarian Nordic A/S
- Amicus brief of Consumer Project on Technology, Electronic Frontier Foundation, and Public Knowledge
- Amicus brief of D.C. Bar Association