product-by-process claims : CAFC Alert

The Federal Circuit indirectly imports limitations from the specification into the claims through claim construction

John M. Wang | April 24, 2017

The Medicines Company v. Mylan Inc. Etc.

April 6, 2017

Before Dyk Wallach, and Hughes.  Opinion by Dyk.

Summary

Mylan submitted two Abbreviated New Drug Applications (“ANDA”) to seek approval of Food and Drug Administration (“FDA”) for selling generic bivalirudin drug products before the expiration of patents-in-suit: the ‘727 patent and the ‘343 patent. In its ANDA, Mylan stated that it would limit the Asp9 level of its generic product to less than 2.0 percent. Medicines sued Mylan for infringement of the ‘727 and ‘343 patents. Mylan filed counter-claims seeking declaratory judgments of invalidity. The district court held that Mylan infringed the ‘727 patent, but not the ‘343 patent. The Federal Circuit reverses in part, and held that Mylan does not infringe both patents.


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