Legal alert: “safe harbor” provisions of Hatch-Waxman offer protection for certain post-approval activities *

USA - August 10 2012
After finding that the Hatch-Waxman Act’s “safe harbor” provision protects “post-approval studies that are ‘reasonably related to the development and submission of information under a Federal law,’” a split panel of the U.S. Court of Appeals for the Federal Circuit vacated a preliminary injunction blocking the sale of a generic version of LOVENOX® (enoxaparin injection) by Amphastar Pharmaceuticals, Inc. and Watson Pharmaceuticals, Inc., because the generic drug makers’ protected post-FDA approval activities did not infringe a Momenta Pharmaceuticals, Inc. patent (Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., No. 2012-1062 (Fed. Cir. Aug. 3, 2012)).

Co-authors: William L. Warren.

Legal alert: Federal Circuit tightens inequitable conduct standards: what does this mean for patent practice in the future? *

USA - May 27 2011
On May 25, 2011, the en banc Federal Circuit raised the bar for establishing inequitable conduct in patent infringement cases.

Co-authors: William L. Warren, Christopher J. Chan.

Tafas v. Doll *

USA - March 27 2009
The Federal Circuit recently weighed in on the ability of the U.S. Patent and Trademark Office (USPTO) to effect proposed controversial changes to the rules under which patent applications can be prosecuted.

Co-authors: William L. Warren, Peter G. Pappas.