FDA ‘Monster’ Patent Reg: Brands, Generics Each Want More Options To Pick Fights
Executive Summary
PhRMA is concerned about the agency giving deference to generic sponsors in patent use code disputes, while GPhA wants a mechanism to challenge refuse-to-receive letters.
You may also be interested in...
Patent Regulation Drops Deference To ANDA, 505(b)(2) Sponsors
FDA's final rule implementing provisions of Medicare Modernization Act ‘will fuel litigation,’ attorney predicts.
Patent Use Codes For Brands Can Be Challenged By Generics, Supreme Court Rules
The high court says the Hatch-Waxman Act did not intend for one patented use of a drug to prevent the marketing of a generic for unpatented uses; Justice Sotomayor criticizes FDA for not providing clearer direction to brand manufacturers about what to include in their use codes.
Updated: ImprimisRx's Approval And Superiority Claims For Compounded Drug Draw FDA Warning
The company known for compounding versions of Martin Shkreli’s Daraprim and Allergan’s Restasis is hit with a warning letter for promotions in professional periodicals about its compounded eye drop.