The Fat Lady Goes Back to Her Dressing Room; Federal Circuit Denies MDCO Motions in ANGIOMAX PTE Litigation

February 6, 2011

By Kurt R. Karst –      

The drama in the decade-old fight over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) has taken yet another turn.  The U.S. Court of Appeals for the Federal Circuit has denied MDCO’s Motion to Dismiss or, in the Alternative, to Bifurcate and Stay in Part APP Pharmaceuticals, LLC’s (“APP’s”) appeal related to Judge Claude M. Hilton’s August 3, 2010 decision

Briefly, FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000 under New Drug Application (“NDA”) No. 20-873, and MDCO submitted its PTE application to the PTO on February 14, 2001 – 62 days after NDA approval, including the December 15, 2000 date of approval.  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.”  In his August 3rd decision, Judge Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) granted MDCO’s Motion for Summary Judgment and ordered the U.S. Patent and Trademark Office (“PTO”) to consider timely filed MDCO’s PTE application for the ‘404 patent under a next business day interpretation of the PTE statute, making December 18, 2000 the operative date for beginning the 60-day period instead of December 15, 2000.  (See our previous post for additional background on the case.)  The PTO proceeded to request that FDA determine the regulatory review period with respect to MDCO’s PTE application for the ‘404 patent, and FDA issued a notice in December 2010 with its determination.  The ‘404 patent is currently listed in FDA’s Orange Book with an August 13, 2011 expiration date, and is subject to a period of pediatric exclusivity that expires on February 13, 2012.
On September 1, 2010, APP, which had submitted an amicus brief in the Virginia district court, and is pursuing approval of an Abbreviated NDA, filed an anticipatory Notice of Appeal to the Federal Circuit once the government bowed out of the litigation and decided not to appeal Judge Hilton’s decision to the Federal Circuit.  APP had filed a Motion to Intervene in the district court case in August.  Judge Hilton denied APP’s Motion to Intervene on September 13, 2010 without addressing standing on the basis that APP should have sought intervention earlier, and that allowing intervention at that point would unfairly prejudice MDCO.  So on to the Federal Circuit, where APP proceeded to file an amended Notice of Appeal challenging not only the district court’s September 13th intervention decision, but also the underlying merits decision.

MDCO argued in its motions that the Federal Circuit should either straight out deny APP’s appeal for lack of either prudential standing or Article III standing, or, in the alternative, “bifurcate (1) APP’s appeal of the district court’s September 13, 2010 order, which denied its motion to intervene (the ‘intervention appeal’), and (2) APP’s appeal of the district court’s August 3, 2010 order, which addressed the merits of MDCO’s underlying claims and found in MDCO’s favor (the ‘merits appeal’).”  APP responded that the company does have standing and that MDCO’s request to bifurcate the appeal would be a waste of judicial resources.  MDCO reasserts in its brief reply that APP does not have standing, noting, for example that “APP is not in a position to enter the market even in the absence of the ‘404 patent because it has not even received tentative FDA approval, which is a necessary precondition to lawfully marketing its drug.”

In a 2-page February 2nd Order, the Federal Circuit denied MDCO’s motions, stating that “[t]he court deems it the better course for the parties to put their arguments concerning standing and any other issues in their briefs without directing that briefing be bifurcated.”  We assume that the “any other issues” language in the Order means placing the underlying merits decision on the table.  So here we go again folks with a new chapter in the ANGIOMAX PTE saga.  Stay tuned.

Categories: Hatch-Waxman