The House patent reform bill (HR 1249) that was passed last week includes a provision that impacts the deadline for filing an application for patent term extension under 35 USC § 156 after receiving FDA approval for a patented product. Although the House provision addresses the issue before the district court in The Medicines Co. v. Kappos, it does not provide the fix we need.
In a decision that sent The Medicines Company’s stock prices soaring, the District Court for the Eastern District of Virginia determined that the USPTO’s rejection of The Medicines Company’s application for Patent Term Extension was based on an incorrect—and unreasonable and unfair —interpretation of the governing statute. The patent at issue relates to Angiomax®, an anticoagulant that is generating revenue of about $100M per quarter. Unless the USPTO appeals, The Medicines Company patent will be extended to December 2014. (Without the extension, the patent will be expired as of March 23, 2010.) In addition to representing a significant victory for The Medicines Company, the decision strikes a blow against the USPTO’s policy of strictly and rigorously applying the statute, sometimes to the detriment of patent holders who miscalculated the filing deadline and suffered potential losses of millions of dollars.