FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes” -

October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including abbreviated new drug applications (ANDAs) and 505(b)(2) applications. That’s right – the MMA was passed in 2003, and the FDA issued these implementing regulations 13 years later. Are they game-changing? In at least one respect, yes. While many of the provisions reflect FDA policies that have already been in effect but were never formalized, in one crucial area the FDA changed the game of how the NDA holder (that is, the brand) must identify and defend the method patents that cover the indications approved for its prescription drugs.

Our goal here is not to summarize every aspect of the 80 Federal Register pages of rules and commentary,1 but instead to highlight one change to a highly litigated area involving method patents and their related FDA “use codes.”2 The new regulations become effective on December 5, 2016.