Generic Line

Merck and Upsher-Smith Laboratories agreed to pay $60.2 million to settle a 17-year-long class action suit over plans to delay a generic potassium deficiency treatment — a case that survived three rounds of mediation, over four years of discovery, and a trip to the Supreme Court. Source: Generic Line

Celltrion has filed two petitions against a Genentech patent with the PTO, requesting an inter partes review of a method for making antibodies related to Herceptin. Source: Generic Line

The FDA published 21 new and 16 revised product-specific draft guidances, outlining methods for establishing bioequivalence for generics. Source: Generic Line

Amgen is suing Coherus Biosciences over its processes for manufacturing a biosimilar of Neulasta, saying it infringes patented methods for purifying proteins. Source: Generic Line

In yet another pressure point on generic drug prices, a class action suit filed in a Pennsylvania federal court claims Actavis, Teva, Sandoz, Fougera and Taro conspired to fix the prices of fluocinonide creams and gels. Source: Generic Line

The PTO’s Patent Trial and Appeal Board upheld Shire’s patent claims — following a challenge from Green Cross — over methods for the manufacture of Elaprase (idursulfase), an enzyme replacement therapy for Hunter syndrome. Source: Generic Line

Apotex has called on the FDA to require testing on the intended patient population before approving biosimilars. Source: Generic Line

Four major patents for Acorda Therapeutics’ successful MS treatment Ampyra were invalidated by a federal judge nearly a decade before they were set to expire — not a month after they were upheld by the PTO. Source: Generic Line

For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro performance tests — as long as the generic is qualitatively the same as the reference product. Source: Generic Line

In a lawsuit filed Monday, Sanofi says Mylan’s anticompetitive business practices blocked its EpiPen competitor, the Auvi-Q, from gaining a foothold in the epinephrine auto-injector market, resulting in hundreds of millions in lost sales. Source: Generic Line