Patent Reform: What Does It Mean For A Pharmaceutical Enterprise?

By Jeffrey A. Wolfson, Partner, Haynes and Boone, LLP

The America Invents Act (AIA), enacted in September 2011, has already modified various aspects of U.S. patent law and includes various provisions that phase in this September and March 2013, such as a completely new guiding statute addressing prior art and patentability — 35 U.S.C. § 102. In many ways, however, patenting will continue as usual, particularly for international companies who already prepare patent applications for international use.

The AIA provides changes to a variety of provisions affecting U.S. patent law, including:

• permitting only marketplace competitors to sue for competitive injury caused by patent mismarking (e.g., because they are expired);
• permitting virtual marking of patent rights using a free website;
• implementing a prior user defense;
• creating supplemental examination proceedings to permit patent holders to seek to eliminate the taint of a patent obtained without submitting all the known prior art, starting Sept. 16, 2012;
• creating post-grant review (PGR) proceedings that provide an avenue to challenge the validity of a patent before the Patent Office without requiring court litigation, starting Sept. 16, 2012;
• replacing the first-to-invent system by awarding patent rights to the first-inventor-tofile an enabled patent application (even if preceded by a publication of the invention less than a year before filing), starting March 16, 2013; and
• providing derivation proceedings to challenge patent applications filed by anyone alleged to have misappropriated an invention.