After a patent term extension (PTE) application for its anti-coagulant Angiomax patent was denied yet again by the U.S. Patent and Trademark Office (USPTO), The Medicines Company (MDCO) has, for the second time, challenged the USPTO’s decision by filing an Administrative Procedure Act (APA) lawsuit against the USPTO in the U.S. District Court for the Eastern District of Virginia. Medicines Co. v. Kappos, Case No. 1:10-cv-00286 (E.D. Va., Mar. 16, 2010) (Hilton, J.).

At issue is whether The Medicines Company’s (MDCO’s) PTE application was timely filed. Under 35 U.S.C. § 156(d)(1), a PTE application must be submitted to the USPTO “within the sixty-day period beginning on the date the product received permission … for commercial marketing or use.” At 6:17 p.m. on Friday, December 15, 2000, MDCO received a facsimile from the Food and Drug Administration (FDA) indicating that Angiomax had been approved. MDCO then filed its PTE application on February 14, 2001 (i.e., 62 days after December 15, 2000). MDCO has argued, in part, that its application was timely filed because the term “date” in § 156(d)(1) should be interpreted to mean “business day,” not “calendar day.” Under a “calendar day” interpretation, the Friday evening transmission did not trigger the 60-day clock from starting until Monday, December 18, 2000. MDCO has also argued that denying its PTE application runs counter to the remedial purposes of the Hatch-Waxman Act. MDCO has maintained that the USPTO is not bound by the FDA’s “calendar day” interpretation of the term “date” in the analogous statute regarding how the extension regulatory review period is calculated (35 U.S.C. § 156(g)(1)(B(ii)).

On March 16, 2010, the U.S. District Court for the Eastern District of Virginia adopted these arguments of MDCO, deciding in favor of MDCO in its first APA suit by vacating the USPTO’s prior decision that the Angiomax PTE application was late. Medicines Co. v. Kappos, E.D. Va., No. 1:10-cv-00081. Just three days later, on March 19, the USPTO again denied MDCO’s PTE application. This most recent USPTO decision highlights that the USPTO is doggedly adhering to its “calendar day” interpretation of the statute and in doing so, it believes it is acting consistently with both the FDA interpretation of § 156(g)(1)(B(ii) and with congressional intent to provide a “non-extendable period, … by which all players would know their future rights.” The USPTO also points out that MDCO repeatedly acknowledged to various governmental bodies, including in its first unamended PTE application, and to the public, via its Annual Report, that FDA approval was on December 15.

With the Angiomax patent set to expire on May 23, 2010, MDCO has filed this most recent APA suit, arguing, in part, that the USPTO’s disregard of the district court’s opinion and failure to allow MDCO to address its decision is “arbitrary and capricious, an abuse of discretion, and contrary to law.”

Practice Note: Although it has yet to be determined whether MDCO will ultimately prevail in its suit again the USPTO and obtain the PTE it seeks, one thing is clear: the USPTO will not consider a PTE application it deems late. Therefore, PTE applications should be filed well before the 60-day deadline. In fact, the USPTO aptly points out in one of its decisions against MDCO that a PTE application is a short document, which, except for listing the approval date, can be prepared in its entirety prior to FDA approval.