Ernest Schaal <[email protected]> wrote in message news:<BB204C01.3D4A%[email protected]>...
Integra LifeSciences I Ltd. v. Merck KGaA The panel majority holds that the 35 U.S.C. 271(e)(1) "safe harbor" does not apply to federal registration of pioneering new drugs like the Scripps/Merck products, but only to registration of generic copies of drugs for which the patent is about to expire. Circuit Judge Newman dissented in part, stating that the statute has been interpreted in the past as of broader scope. He
NEWMAN, Pauline, J. is not a "he".
also accused the court of essentially eliminating the common law research exemption.
This is an interesting an important case because 271(e)(1) has
generally been interpreted very broadly, so this is a bit of a
departure that a lot of companies with broad research method patents
have been awaiting with bated breath.