The Medicines Company Initiates an 11th Hour Push for ANGIOMAX Patent Term Extension; Petitions PTO to Adopt a Rule of Construction for Determining NDA Approval Date

By Kurt R. Karst –      

Tick tock!  Tick tock!  Like sand through the hourglass so too are the days that The Medicines Company (“TMC”) has to convince Congress or the U.S. Patent and Trademark Office (“PTO”) to allow a Patent Term Extension for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), an anticoagulant drug product FDA first approved late on Friday, December 15, 2000 (9 years ago today) under New Drug Application (“NDA”) 20-873.  The ‘404 patent expires on March 23, 2010, but is subject to a 6-month period of pediatric exclusivity.

We recently reported that TMC has been lobbying Congress to pass legislation that would amend the PTE statute at 35 U.S.C. § 156 to permit the PTO to accept the late filing of a PTE application, and in particular, TMC’s PTE application for the ‘404 patent – but for a $65 million fee.  Thus far, TMC’s lobbying efforts have not been fruitful. 

As background, TMC submitted a PTE application to the PTO 62 days after FDA approved the company’s ANGIOMAX NDA.  Under 35 U.S.C. § 156(d)(1), the submission of a PTE application must occur “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 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 U.S. Court of Appeals for 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.”  (For additional information, see our previous blog posts here and here.)

Apparently not having any success on the Hill, TMC has once again turned to the PTO.  Earlier this month, TMC submitted a Petition and a Request for Reconsideration of its PTE application to the PTO. 

The Petition requests that the PTO suspend its regulations at 37 C.F.R. § 1.750 “to the extent they limit requests for reconsideration of patent term extension applications to a single submission within the times specified in the rule.”  TMC had already requested reconsideration of the PTO’s denial of a PTE for the ‘404 patent on the basis that the date of approval of the ANGIOMAX NDA was in fact first effective as of Monday, December 18, 2000, the next business day after the December 15, 2000 NDA approval.

The Request for Reconsideration asks the PTO to employ a “rule of construction” under which the Office would consider the 60-day PTE application submission period at 35 U.S.C. § 156(d)(1) to commence on the first business day after the day the FDA transmits notice of NDA approval of the drug product if that transmittal occurs after normal business hours.  In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that would mean the 60-day period would have begun on December 18, 2000 and the PTE application would have been timely filed within 35 U.S.C. § 156(d)(1).  TMC explains in its Petition for Reconsideration that:

PTO can and should interpret the language of § 156(d)(1) to conclude that the present application was timely filed.  The PTO can do this by concluding that this application was filed within 60 days of the first business day on which the product had “received permission . . . for commercial marketing.”  Recognizing that the notice of approval of Angiomax was sent after the close of the FDA’s normal business hours, it is reasonable for the PTO to conclude that the first day of the period specified in § 156(d)(1) was the first business day after Friday, December 15, 2000 – namely, Monday, December 18, 2000.

As justification for its proposed “rule of construction,” TMC argues that the determination the PTO makes under 35 U.S.C. § 156(d)(1) is distinct from the question of when an NDA  is “approved” under the Food, Drug, and Cosmetic Act (“FDCA”), as well as from FDA’s determination of the end of the “regulatory review period” under 35 U.S.C. § 156(g)(1)(B)(ii) for PTE calculation purposes.  “Those distinct dates are phrased in different statutory language, have distinct purposes, and are properly determined by the FDA,” states TMC in its Request for Reconsideration.  “Specifically, provisions in the FDCA refer to the ‘effective’ date of ’approval’ of [an NDA] and generally concern the legal effect of approval of [an NDA] and FDA obligations regarding review of those applications.  Section 156(g)(1)(B)(ii) similarly refers to the date [an NDA] was ‘approved’ and serves to define the end of the regulatory review period of that application.”

Moreover, TMC argues that its Request for Reconsideration is “particularly appropriate in this case” given the PTO’s “newly announced approach to counting days under § 156(d)(1).”  As we previously reported (here and here), the PTO, after being challenged as to the date on which the 60-day period at 35 U.S.C. § 156(d)(1) begins, ruled in the context of another PTE application (for PRILOSEC OTC) that although the PTO had in some instances started counting the 60-day period on the date after NDA approval, “[b]y not counting the date of FDA approval as one of the sixty days included in the time period for filing a PTE application, the USPTO was failing to comply with section 156 and case law.”  TMC comments in its Request for Reconsideration that “[a]bsent adoption of the proposed next business day rule, application of this new interpretation in cases where the FDA transmits notice of approval of the drug product after normal business hours would impermissibly shorten the period for filing a § 156 application to less than the 60 days the statute requires.”

Presumably, TMC’s Petition and Request for Reconsideration are being fast-tracked at the PTO given the March 23, 2010 expiration date of the ‘404 patent.  We will continue to update our loyal readers on any developments – both at the PTO and on the Hill – that we become aware of.