Amendment to Rules for Extension of Patent Term

The Patent and Trademark Office (Office) is revising the rules directed to the extension of patent term to implement the provisions of Pub. L. 103-179, section 5; 107 Stat. 2040 codified at 35 U.S.C. 156(d)(5) and to clarify the requirements for eligibility. The amended rules establish procedures for the Commissioner to issue an interim extension of the term of a patent where the original term would expire before a product covered by the patent has received regulatory approval for commercial marketing or use. The amended rules also clarify that an application for patent term extension must be based on regulatory activities performed by the patent owner or its agent.