All Eyes are on APP’s Intervention Motion as the Government Bows Out of ANGIOMAX PTE Litigation

September 9, 2010

By Kurt R. Karst –   

Earlier today (September 9th), in a notice filed with the U.S. District Court for the Eastern District of Virginia (Alexandria Division), the government informed the court that “the Solicitor General has, at this time, elected against appeal” of Judge Claude M. Hilton’s August 3rd decision in which he granted The Medicines Company’s (“MDCO’s”) Motion for Summary Judgment and ordered the U.S. Patent and Trademark Office (“PTO”) to consider timely filed MDCO’s Patent Term Extension (“PTE”) application for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering MDCO’s ANGIOMAX (bivalirudin) under a next business day interpretation of the PTE statute (35 U.S.C. § 156).

But MDCO is not popping any champagne corks yet.  As we previously reported, on August 19, APP Pharmaceuticals, LLC (“APP”) filed a Motion to Intervene in the case.  A hearing on APP’s motion is schedule for September 10th at10:00 AM before Judge Hilton, who could very well rule from the bench.

The government decided not to take an official position on APP’s motion, and instead provided a “brief explanation of some of  the thorny legal issues raised through APP’s motion, including the analytical framework and pertinent decisional authority that play a role – at least in part – in this Court’s adjudication of the motion.”  Not surprisingly, MDCO vigorously opposes APP’s intervention, and stated in its opposition brief (before it was clear that the government would not intervene) that:

APP seeks to intervene because it believes the government may choose not to appeal this Court’s decision. But it is hornbook law that a party may not intervene to pursue an appeal in the absence of the principal party on its side unless it can establish both prudential and Article III standing.  And APP’s motion fails even to mention these requirements, much less to show that they are satisfied here.  In fact, APP has neither prudential nor constitutional standing.

APP, which has already put the court on notice that “[i]n the event that the Court denies or conditionally grants APP’s pending Motion for Leave to Intervene, . . . APP shall appeal to the United States Court of Appeals for the Federal Circuit from that Order and related rulings as well,” argues in its rebuttal brief that:

Both the Plaintiff and the Government fundamentally misunderstand, or misrepresent, the grounds for APP’s motion to intervene.  APP is not seeking to challenge the PTO’s action on Plaintiff’s application for extension of the ’404 patent’s term.  APP is not seeking to insert itself into the patent term extension process.  APP does not claim to be harmed by, and does not wish to appeal, the underlying agency decision.  Instead, APP seeks to appeal the decision of this Court changing the timeliness requirements for patent term extension applications retroactively, a decision that harms APP, in substantial ways. . . .

We’ll keep you posted as things progress in this case and will issue an update to this post if Judge Hilton decides on APP’s motion tomorrow.


  • On September 10th, Judge Hilton denied APP’s motion to intervene.  APPs’ appeal has already been docketed in the Federal Circuit – Case No. 10-1534. 
Categories: Hatch-Waxman