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Gilead will have to pay Merck $2.5 billion for infringing a patent that covers the active ingredient of its blockbuster hepatitis C drugs, Salvadi and Harvoni, in the country’s largest ever judgment for an infringement. Read More
The FDA rejected Vanda Pharmaceuticals petition to delay the approval of ANDAs referencing its schizophrenia therapy Fanapt until its three-year market exclusivity for a new indication expires. Read More
A federal judge awarded the Federal Trade Commission its request to dismiss a pay-for-delay suit that alleges generics drugmaker Watson Laboratories entered an illegal deal with Endo to block the market entry of Opana ER and Lidoderm generics. Read More
The U.S. Supreme Court has paved the way for non-cash patent settlements, which are often reached by branded and generics drugmakers, to trigger antitrust scrutiny after it refused to hear a case involving GlaxoSmithKline’s epilepsy therapy Lamictal. Read More
A federal judge ruled that a generic version of Merck’s Nasonex developed by Teva Pharmaceuticals does not infringe patent claims covering the allergy treatment’s active ingredient. Read More
The FDA will not approve generics referring to the original and discontinued formulation of Protonix IV, after a review of scientific data confirmed that therapy for gastroesophageal reflux disease was pulled off the market for safety reasons. Read More
The PTO’s Patient Trial and Appeal Board said it was not persuaded by Coherus Biosciences’ challenge over the patentability of methods for manufacturing Humira, and ruled in favor of AbbVie in a trial proceeding. Read More
The antitrust division of the Justice Department has issued subpoenas to a Mylan executive and certain employees over the pricing of four generic drugs. Read More
Generics sponsors hoping to submit the ICH’s alternative postmarket report, known as the the periodic benefit-risk evaluation report (PBRER), at a different frequency than required should plan to file a waiver request, the FDA said. Read More
The FDA has made several amendments to the requirements for filing citizen petitions and petitions for stay of action when used to delay ANDA applications. Read More