Legislation that would permit the U.S. Patent and Trademark Office (“PTO”) to exercise discretion to accept untimely filed Patent Term Extension (“PTE”) applications has reportedly been added to the “Patent Reform Act of 2007” (S. 1145) by Senator Edward Kennedy (D-MA). Representative William Delahunt (D-MA), who introduced a stand-alone bill earlier this year in the House, H.R. 1778, is trying to get the legislation added to the House version of the “Patent Reform Act of 2007” (H.R. 1908).
The legislation, dubbed the “Dog Ate My Homework Act,” has been an agenda item for Massachusetts lawmakers for several years now, and is intended to help Massachusetts-based The Medicines Company, which submitted its PTE application for U.S. Patent #5,196,404 (“the ‘404 patent”) for ANGIOMAX (bivalirudin) 62 days after FDA approved its New Drug Application (“NDA”) . The patent term extension law, 35 U.S.C. § 156, requires the submission of such an application “within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use” (i.e., within 60-days of the date of NDA approval).
FDA Approved ANGIOMAX on December 15, 2000. On February 14, 2001, The Medicines Company submitted a PTE application to the PTO for the ‘404 patent, which is currently scheduled to expire in 2010. After confirming the NDA approval date with FDA, the PTO dismissed the application in March 2002. The Medicines Company subsequently requested reconsideration on the basis that the date of approval of the ANGIOMAX NDA was in fact first effective as of December 18, 2000, and in January 2007 requested a stay of action on its PTE application. In April 2007, after permitting the company to amend and supplement its application, the PTO denied the extension request. Among other things, the PTO cited Unimed, Inc. v. Quigg, 888 F2d 826; 12 USPQ2d 1644 (Fed. Cir. 1989), in which the Federal Circuit addressed the timeliness of a PTE application submission and observed that “section 156(d)(1) admits of no other meaning than that the sixty-day period begins on the FDA approval date.” A copy of the file history of the ‘404 patent, including the April 2007 PTO decision, can be found on the PTO’s Patent Application Retrieval Database by searching by patent number.
While the PTO was considering The Medicine Company’s PTE application and request for reconsideration, the company was, according to Securities and Exchange Commission filings made as early as March 2003, “exploring an alternative to extend the term of the patent.” (The company’s most recent annual report reiterates this.) This alternative took the form of lobbying Massachusetts lawmakers to push for legislation that would provide the PTO with discretion to consider PTE applications filed late unintentionally. Until recently, the closest such legislation came to becoming law was on December 6, 2006, when the House passed the Senate version of the “Vessel Hull Design Protection Amendments of 2006’’ (S. 1785), which included language similar to H.R. 5120, a bill that had been introduced in April 2006 and that was vetted during a September 2006 House Judiciary Committee hearing. The Senate adjourned on December 9, 2006 without further considering S. 1785.
The issue did not remain dormant long. In March 2007, Representative Delahunt introduced H.R. 1778, and in April, both the Senate and House began debating patent reform legislation, which offered one vehicle to which to attach such legislation. Although the House Judiciary Committee passed H.R. 1908 (“Patent Reform Act of 2007”) on July 18, 2007 without the Delahunt PTE provision, Representative Delahunt will reportedly try to get it added when the full House considers the legislation. In the Senate, Senator Kennedy reportedly was successful in his attempt to add language similar to the Delahunt House bill when the Senate Judiciary Committee considered S. 1145 (“Patent Reform Act of 2007”) during a mark-up session held on July 18, 2007. The Senate Judiciary Committee is still considering the legislation.
- A copy of Sen. Kennedy's amendment agreed to at the Senate Judiciary Committee Executive Business Meetingis available here.