By Kurt R. Karst –
The Medicines Company is reportedly continuing its multi-year and multi-million dollar lobbying effort to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), an anticoagulant drug product FDA first approved on December 15, 2000 for use in conjunction with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. The ‘404 patent expires on March 23, 2010, but is subject to a 6-month period of pediatric exclusivity that FDA granted in June 2009 after the Medicines Company conducted pediatric studies identified by FDA in a Written Request. We understand that thus far The Medicines Company has been unsuccessful in its search for a legislative vehicle for its legislative fix, which has been dubbed the “Dog Ate My Homework Act.”
The Medicines Company submitted a PTE application to the PTO 62 days after FDA approved the company’s ANGIOMAX New Drug Application (“NDA”). The patent term extension law at 35 U.S.C. § 156(d)(1) 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” (i.e., within 60-days of the date of NDA approval). In April 2007, the U.S. Patent and Trademark Office (“PTO”) denied the PTE 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.”
As we previously reported (here and here), legislation has been introduced and debated over the past several years that would amend 35 U.S.C. § 156 to permit the PTO to accept the late filing of a PTE application, and in particular, The Medicines Company’s PTE application for the ‘404 patent. In June 2008, Representative William Delahunt (D-MA) introduced, and the U.S. House of Representatives quickly passed by voice vote, H.R. 6344, which included a provision to amend 35 U.S.C. § 156 to add new subsection stating 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 law.) However, there is a cost for unintentional delay. The bill states that “[i]n 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 . . . .” The fee for The Medicines Company is $65 million. For other patent owners, the fee is determined based on a complex calculation. Specifically, with respect to ANGIOMAX, H.R. 6344 states that a patent holder shall pay a fee equal to “(i) $65,000,000 with respect to any original application for a [PTE], filed with the [PTO] before the date of the enactment of this Act, for a drug intended for use in humans that is in the anticoagulant class of drugs.” (H.R. 6344 failed to obtain Senate passage and died in the 110th Congress.)
The latest version of the “Dog Ate My Homework Act” reportedly being floated on Capitol Hill and obtained by FDA Law Blog, is substantially similar to the language in H.R. 6344. It maintains the $65 million fee targeted to a PTE for a patent covering ANGIOMAX. To build support for the legislative fix, The Medicines Company enlisted the help of PricewaterhouseCoopers (“PwC”) and is reportedly circulating with the proposed legislative language an 11-page PwC report titled “Impact of a Proposed Patent Restoration Under Hatch-Waxman on Federal Budget and Hospital Costs.” According to the report:
[PwC], based on assumptions incorporated by CBO in its estimate of the patent restoration legislation, estimates that hospitals would have net savings of roughly $1 billion over the next 20 years if the patent for Angiomax was restored. PwC further estimates, based on more recent data, that hospitals would have savings of $700 million in the first 10 years and $7.0 billion over the 20-year period FY2009-FY2028 if the Angiomax patent is restored.
The impact of patent restoration would be neutral to the federal budget during in the FY2009-FY2018 period, under the CBO assumptions, given the $65 million fee. Net savings in hospital costs accruing in the FY2019-FY2028 period would result in net federal budget savings over the 20-year period, FY2009-FY2028, even under the CBO assumptions. Further, using the assumptions about savings from the 2009 Premier data, patent restoration would result in $83 million in net savings to the federal government in the first 10 years as well.
The Medicines Company reportedly has not yet secured a legislative vehicle for its proposed legislation. We understand that the company’s attempts to get the provision added to the Fiscal Year 2010 Departments of Commerce and Justice, and Science, and Related Agencies appropriations bill (H.R. 2847) have not yet panned out.
Earlier this year, the PTO issued two new patents that The Medicines Company promptly asked FDA to list in the Orange Book as covering ANGIOMAX – U.S. Patent Nos. 7,582,727 and 7,598,343. Several companies with pending Abbreviated NDAs (“ANDAs”) amended their applications to include a Paragraph IV Certification to the ‘727 patent (and presumably to the ‘343 patent as well), and the Medicines Company has initiated patent infringement litigation. Because the ‘727 and ‘343 patents are later-listed patents, no 30-month stay of approval will apply to companies with pending ANDAs, as FDA has explained.