Virginia enacts the first state law regulating interchangeable biosimilar products *

USA - March 28 2013
On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist's substitution of an interchangeable biologic drug…

Co-authors: Siegfried J.W. Ruppert, Ph.D, Alan Klein, Louis Norwood ("Woody") Jameson , Vicki G. Norton, Ph.D..

Addressing breach of method-of-use patents by generics *

USA - May 2 2012
The U.S. Court of Appeals for the Federal Circuit on April 16, 2012, in Bayer Schering Pharma AG v. Sandoz Inc., Nos. 2011-1143, -1228 (Yasmin), affirmed a district court's holding that as a matter of law, generic drug makers could not infringe patent claims reciting a method of use of a U.S. Food and Drug Administration (FDA)-approved drug where the FDA had not approved the drug for the claimed uses, and where the FDA-approved labeling did not indicate instructions or intent to encourage the claimed use.

Co-authors: Michele A. Kliem, Ph.D. , Kristina A. Caggiano, Matthew C. Mousley .

Federal Circuit addresses infringement of method-of-use patents by generics in YASMIN® case *

USA - April 18 2012
The U.S. Court of Appeals for the Federal Circuit on April 16, 2012, in Bayer Schering Pharma AG v. Sandoz, Inc., Nos. 2011-1143, -1228 (YASMIN®), affirmed a district court's holding that as a matter of law, generic drug makers could not infringe patent claims reciting a method of use of an FDA-approved drug where the U.S. Food and Drug Administration had not approved the drug for the claimed uses, and where the FDA-approved labeling did not indicate instructions or intent to encourage the claimed use.

Co-authors: Michele A. Kliem, Ph.D. , Kristina A. Caggiano, Matthew C. Mousley .