By Kurt R. Karst –
As we predicted, Massachusetts-based The Medicines Company (“TMC”) has sued the U.S. Patent and Trademark Office (“PTO”) and FDA in connection with the company’s efforts to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin). FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000 under New Drug Application (“NDA”) 20-873, and TMC submitted its PTE application to the PTO on February 14, 2001 – 62 days after NDA approval (including the December 15, 2000 date of approval).
The Complaintand Motion for Summary Judgment, filed last week in the U.S. District Court for the Eastern District of Virginia (Alexandria Division), follows the PTO’s January 8, 2010 denial of TMC’s December 2009 Request for Reconsideration (see our previous post here) asking 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). The lawsuit also follows TMC’s failed attempts (see our previous post here) to get legislation enacted that would permit the PTO to accept late-filed PTE applications. The ‘404 patent expires on March 23, 2010, but is subject to a 6-month period of pediatric exclusivity that will expire on September 23, 2010. TMC claims that if a PTE were applicable to the ‘404 patent, it would extend the patent expiration date until December 2014.
TMC’s Complaint alleges that the PTO’s denial of the company’s PTE application for the ‘404 patent and FDA’s decision regarding PTE application timeliness violated the Administrative Procedure Act (5 U.S.C. § 706(2)(A)). Specifically, TMC alleges that:
The PTO’s denial of [TMC’s] application for a patent term extension, the PTO’s refusal to reconsider that determination, and the PTO’s and the FDA’s determinations that MDCO’s application for an extension of the term of [the ‘404 patent] was not timely filed under 35 U.S.C. § 156(d)(1) misinterpreted § 156, failed to provide adequate explanations for their conclusions, failed to respond to significant arguments raised by [TMC], reflected a misapprehension of agency authority under § 156, and misinterpreted agency regulations and, relevant case law.
Among other things, TMC argues that there is a discrepancy in how FDA (and the PTO) treats the dates of NDA receipt and approval:
[U]nder the government’s approach to [the PTE] statute, an application for approval of a new drug received by the FDA after business hours is deemed to be filed on the following business day. By contrast, when a [NDA] is approved after business hours, the government deems the approval to have occurred on the same business day and takes the position that this day starts the 60-day period for filing a patent term extension application. Despite this inconsistency, the PTO somehow concluded that its interpretation was mandated by statute and regulation.
As a result, TMC alleges that “[t]he PTO’s decision is not merely arbitrary and capricious; it is profoundly unfair and undermines the remedial design of the patent term restoration system.”
TMC requests the court to vacate and set aside various PTO and FDA deicisions made in connection with the ‘404 patent PTE application, to declare that ANGIOMAX “received permission . . . for commercial marketing or use” within the meaning of 35 U.S.C. § 156(d)(1) no earlier than December 18, 2000 and that the company’s PTE application was timely filed, and to order the PTO to extend the ‘404 patent until December 2014. TMC also requests the court to grant expedited consideration of the case and to “grant any preliminary injunctive relief necessary to maintain the status quo pending resolution of this case.”