Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more
On March 25, 2013, the U.S. Supreme Court heard oral argument in FTC v. Actavis, Inc.,1 which is on appeal from the U.S. Court of Appeals for the Eleventh Circuit. This case addresses a type of patent litigation settlement...more
The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more
The U.S. Supreme Court today heard arguments over whether big pharmaceutical companies can pay generic drug manufacturers to delay their entry into the marketplace....more
[Ed. The Supreme Court heard oral argument today in Federal Trade Commission v. Watson Pharmaceuticals. While Patent Docs will provide analysis regarding the oral argument in a subsequent post, we provide the following...more
On March 21, 2013, Virginia governor Bob McDonnell signed into law the nation’s first state law concerning substitution of biosimilars. The law’s requirements that pharmacists keep records of substitutions, give notice of...more
Today, the Supreme Court of the United States held oral argument in Mutual Pharmaceutical Co. v. Bartlett, a follow-up to its landmark ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed federal...more
Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more
The U.S. Supreme Court on Jan. 14, 2013, denied GlaxoSmithKline’s petition for certiorari seeking review of the Federal Circuit’s interpretation of the Hatch-Waxman safe-harbor provision at 35 USC 271(e)(1) in Classen...more
The Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., to address whether and when “reverse payment” agreements made to settle ANDA litigation violate antitrust laws....more
The U.S. Supreme Court will hear arguments next year on whether lawsuits against defective generic drugs can proceed in state court if they are not in violation of federal law. In Mutual Pharmaceutical Co v. Bartlett,...more
When the Supreme Court decided Mensing, we imagine generic drug manufacturers felt like Stephen Sondheim’s “Everything’s Coming Up Roses” was written just for them. But, to borrow from another Broadway hit, they may now be...more
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