APP Moves Forward With Appeal Notice in ANGIOMAX PTE Litigation in Light of PTO/FDA Indecision

September 2, 2010

By Kurt R. Karst –      

The long-running dispute 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) may be far from over.  On September 1st, APP Pharmaceuticals, LLC, which previously submitted an amicus brief in the case (as did Teva Pharmaceuticals – here), filed a Notice of Appeal to the U.S. Court of Appeals for the Federal Circuit.  The notice follows APP’s Motion to Intervene in the case. 

As we previously reported, on  August 3, 2010, Judge Claude Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) granted MDCO’s Motion for Summary Judgment and remanded the case to the U.S. Patent and Trademark Office (“PTO”) to consider MDCO’s PTE application for the ‘404 patent “timely filed and to adopt an interpretation of § 156(d)(l) that includes a next business day construction for filing of a [PTE]  application.”  As FDA Law Blog readers will recall, FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000, 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.”  MDCO had argued that the PTO should employ a “rule of construction” under which the Office would consider the 60-day PTE application submission period 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.  Judge Hilton agreed with MDCO, ruling that “the proper interpretation of § 156(d)(1) is a business day construction of the phrase ‘beginning on the date.’  Of the parties’ competing interpretations the business day construction is consistent with the statute’s text, structure, and purpose.” 

Since Judge Hilton issued his decision almost a month ago, folks have wondered whether the PTO/FDA will appeal the decision to the Federal Circuit.  APP, which has an ANDA pending at FDA but has not yet been granted tentative approval, does not want to wait any longer and is attempting to take matters into its own hands.  According to APP’s Motion to Intervene:

On August 11, 2010 . . . , counsel for APP received a letter from counsel for Defendants indicating that Defendants have not decided whether they will appeal the Court’s August 3, 2010, Order and judgment for Plaintiff in this action.  APP no longer can reasonably expect that APP’s interests will be adequately represented (or represented at all) by Defendants.

APP’s anticipatory Notice of Appeal is intended “to become effective upon the granting of APP’s pending Motion for Leave to Intervene . . . .”  And what if Judge Hilton denies APP’s motion?  According to APP, “[i]n the event that the Court denies or conditionally grants APP’s pending Motion for Leave to Intervene, notice is hereby given that APP shall appeal to the United States Court of Appeals for the Federal Circuit from that Order and related rulings as well.”

Although MDCO has not made any submissions to the court since Judge Hilton issued his opinion, the company continues to lobby for its position.  According to FDA’s public calendar, MDCO representatives recently met with officials from FDA’s Office of Chief Counsel to discuss “The Medicines Company v. David Kappos, et al.”  Former Solicitor General of the United States Seth P. Waxman is among those MDCO representatives who attended the meeting – perhaps signaling MDCO’s intentions to go all the way to the U.S. Supreme Court if necessary.

Categories: Hatch-Waxman