Amendment to the America Invents Act Would Give MDCO Some Legislative Security in Battle Over ANGIOMAX PTE

By Kurt R. Karst –      

A recent amendment to the America Invents Act (H.R. 1249) introduced by Representative John Conyers (D-MI) and passed by voice vote during a markup of the bill last week by the
House Committee on the Judiciary would give The Medicines Company (“MDCO”) some legislative assurance of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering the company’s ANGIOMAX (bivalirudin) as the the drama in the decade-old fight over a PTE continues to unfold in court. 

As we reported earlier this year, in February the U.S. Court of Appeals for the Federal Circuit 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 in which he 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.  (As folks might 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 the PTE statute at 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.”)  The Federal Circuit’s February decision was precipitated by Judge Hilton’s September 13, 2010 decision denying APP’s Motion to Intervene in the litigation without addressing standing (on the basis that APP should have sought intervention earlier, and that allowing intervention at that point would unfairly prejudice MDCO).  APP appealed the decision to the Federal Circuit challenging not only the district court’s September 13th intervention decision, but also the underlying merits decision.  ANDA sponsor PLIVA recently filed an amicus brief in the Federal Circuit case in support of APP. 

Now back to the legislative front . . . .

Rep. Conyers’s amendment to H.R. 1249 would amend 35 U.S.C. § 156(d)(1) to add at the end of that section the following flush sentence:

For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to receive permission on the next business dy.  For purposes of the preceding sentence, the term "business day" means any Monday, Tuesday, Wednesday, Thursday or Friday, excluding any legal holiday under section 6103 of title 5.

The “applicability” section of the amendment states that language above “shall apply to any application for extension of a patent term under section 156 of title 35, United States Code, that is pending on, that is filed after, or as to which a decision regarding the application is subject to judicial review on, the date of enactment of this Act.”  The language seems to match up pretty well with the current situation surrounding a PTE for the ‘404 patent.

Rep. Conyers’s amendment to H.R. 1249 – language that is not in the Senate-passed version of the bill, S. 23 – is not the first attempt to amend the PTE statute to accommodate the ‘404 patent; nor is it the first time that Rep. Conyers has been involved in what has come to be known as “The Dog Ate My Homework Act.”  In Securities and Exchange Commission filings made as early as March 2003, MDCO said that the company was “exploring an alternative to extend the term of the patent.”  Legislation was introduced in Congress in 2006, 2007, 2008, 2009, and 2010 (see our previous posts here, here, here, and here) reflecting the changing circumstances of the ‘404 patent PTE saga.  In June 2008, Rep. Conyers urged the House to pass the Responsive Government Act of 2008, which would have amended 35 U.S.C. § 156 to permit the PTO to accept late PTE submissions . . . for a fee ($65,000,000 for MDCO).

Although some industry support for H.R. 1249 seems to be fading – the Biotechnology Industry Organization issued a statement last week opposing House floor consideration of the bill due to a non-PTE issue – a legislative fix to MDCO’s ‘404 patent issue still appears to be alive and could ultimately be included in a final, enacted version of the America Invents Act. We’ll keep you posted.