$65,000,000 for a PTE Application? That’s Living the High Life.

On June 23, 2008, Representative William Delahunt (D-MA) introduced, and the U.S. House of Representatives passed by voice vote, H.R. 6344. The 12-page bill includes several provisions, including legislation that gives the USPTO discretion accept late-filed Patent Term Extension (“PTE”) applications.  A similar provision was included with the Patent Reform Act of 2007 (S.1145) by Senator Edward Kennedy (D-MA) in August 2007, but efforts to pass S.1145 have stalled.

The motivation behind H.R. 6344 is the PTO’s denial of an application submitted by Massachusetts-based “The Medicines Company” for a PTE for U.S. Patent No. 5,196,404 (“the ‘404 patent”) for ANGIOMAX (bivalirudin). ANGIOMAX is an anticoagulant drug product FDA (first approved on December 15, 2000) for use with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.  The Medicines Company submitted a PTE application to the PTO 62 days after FDA approved the company’s ANGIOMAX New Drug Application (“NDA”).

35 U.S.C. § 156(d)(1), the patent term extension law, requires the submission of a PTE 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”. That is, within 60 days of the date of NDA approval.

Section 4 of H.R. 6344 would amend 35 U.S.C. § 156 to add new subsection (i), which states that the PTO Director “may accept an application under this section that is filed not later than three business days after the expiration of the 60-day period provided in subsection (d)(1) if the applicant files a petition, not later than five business days after the expiration of that 60-day period, showing, to the satisfaction of the Director, that the delay in filing the application was unintentional.”  (The 5-day petition period for a PTE application pending before the PTO would begin on the date of enactment of the Responsive Government Act.) 

However, there is a cost for unintentional delay.  “In order to effect a [PTE] under section 156(i) of title 35, United States Code, the patent holder shall pay a fee to the United States Treasury… .”  “What is the fee?”, you ask: $65,000,000.  For other patent owners, the fee is determined based on a complex calculation.  Specifically, the bill states that a patent holder shall pay a fee equal to:
                 (i) $65,000,000 with respect to any original application for a [PTE] . . . for a drug intended for use in humans that is in the anticoagulant class of drugs (e.g., ANGIOMAX), or
                 (ii) the amount estimated under subparagraph (B) with respect to any other original application for a [PTE].

Under proposed subparagraph (B), the PTO and the Under Secretary of Commerce for Intellectual Property must consider ahost of factors to calculate a late-filing fee, including “any net increase in direct spending arising from the extension of the patent term,” “any net decrease in revenues arising from such [PTE],” and “any indirect reduction in revenues associated with payment of the fee under this subsection.” 

If enacted, proposed § 156(i) would apply to any application:
                 (A) that is made on or after the date of the enactment of this Act; or
                 (B) that, on such date of enactment, is pending before the Director or as to which a decision of the Director is eligible for judicial review.

In discussing the PTE provisions in H.R. 6344, co-sponsor Rep. Donna Christensen (D-VI) stated that the provisions “will make a minor but important amendment to the landmark Hatch-Waxman Act patent act of 1984.  The act of 1984 has done much to make medicine available and more affordable for countless people in this country. Inadvertently though, in patent term restoration, there is an inflexible deadline provision which has the potential to limit the good that the act can do.” 

A copy of the floor discussion of H.R. 6344 is available via the FDALawBlog here.

After passage in the House, H.R. 6344 was referred to the Senate Judiciary Committee for consideration. 

We are pleased that the House is looking out for us and our well-being for the bargain basement price of $65,000,000.

Hat tip to the FDALawBlog for breaking this story.