Merck has agreed to pay Bristol Myers Squibb and Ono Pharmaceutical $625 million, plus royalties on global Keytruda sales, to resolve patent-infringement allegations involving an antibody designed to treat cancer…

The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing…

The Supreme Court has agreed to hear a case centered on whether a 180-day notification is mandatory or optional — when the appropriate disclosures are made — before a biosimilar…

The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones…

Juno has filed a lawsuit against Kite Pharma for the alleged infringement of eight patent claims covering a cancer immunotherapy that uses a chimeric T cell receptor. Source: Generic Line

The U.S. Supreme Court has declined to hear a case on whether all biosimilar makers must give a six-month notice before bringing an FDA-approved product to market, even when disclosures…

Teva alleges six generics makers infringed a patent covering its multiple sclerosis therapy Copaxone when seeking approvals for copycat versions of the drug. Source: Generic Line

Generic approvals and rejections were little changed from November, remaining stable as ANDAs slightly fell in the second month of fiscal 2017. Source: Generic Line

A majority of patent settlements reached last year in the European Union restricted the market entry of generics, according to a European Commission report. Source: Generic Line

The U.S. solicitor general has urged the Supreme Court to review a Federal Circuit decision that requires some biosimilar makers wait six months after receiving FDA approval to launch a…