The Coda in the ANGIOMAX Symphony; Approaching Fine (the End)

February 9, 2012

By Kurt R. Karst –      

In music, “coda” is a term used primarily to designate a passage that brings a piece (or a movement, which may be part of a symphony – an extended musical composition) to an end – the “fine.”  A coda can be as simple as a few measures, or as complex as an entire section.  These musical terms serve as a nice metaphor for The Medicines Company’s (“MDCO’s”) decade-long battle (multi-movement symphony) to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin). 

As most folks know by now, FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000 under NDA No. 020873, and MDCO submitted its PTE application to the U.S. Patent and Trademark Office (“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.”  (For additional background, see our previous post here.) 

In August 2010, 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 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.  The government decided not to appeal the decision, and the PTO proceeded to request that FDA determine the regulatory review period with respect to MDCO’s PTE application for the ‘404 patent.  FDA issued a notice in December 2010 with its determination. 

ANDA sponsor APP Pharmaceuticals, LLC (“APP”) attempted to intervene in the PTE litigation before Judge Hilton; however, APP’s Motion to Intervene was denied.  APP appealed the decision to the Federal Circuit challenging not only the district court’s intervention decision, but also the underlying merits decision.  

In the meantime, Congress passed the Leahy-Smith America Invents Act (“AIA”) (Pub. Law No. 112-029).  Section 37 of the AIA, titled “Calculation of 60-Day Period for Application of Patent Term Extension” and referred to by some as “The Dog Ate My Homework Act” or the “Medco fix,” amended the PTE statute at 35 U.S.C. § 156(d), and was intended to legislatively resolve MDCO’s PTE battle.  (There were several failed attempts in Congress to pass “The Dog Ate My Homework Act” going back to 2006.)  There was a post-AIA attempt in Congress to effectively nullify Section 37, but that effort failed – see here.

Shortly after the enactment of the AIA, MDCO sent a letter to the Federal Circuit notifying the Court of the enactment of Section 37 and asserting that it resolves the merits of the ongoing ‘404 patent PTE litigation with APP.  APP vigorously disagreed that Section 37 resolved the case, however, and argued that Section 37 cannot constitutionally be applied and that Section 37 does not take effect for one year after the AIA‘s enactment (i.e., September 16, 2012).  The parties brief the issues and oral argument was held on November 15, 2011 – see our previous post here

Before the Federal Circuit could issue its decision on AIA Section 37, MDCO and APP entered into a settlement agreement that includes APP’s agreement to dismiss its appeal of Judge Hilton’s August 2010 decision, as well as another Hatch-Waxman patent infringement lawsuit brought in the U.S. District Court for the District of Delaware over  two other Orange Book-listed patents for ANGIOMAX – see our previous post here.  The Federal Circuit dismissed the case on January 24, 2012.

Exiting the last movement of the ANGIOMAX Symphony and moving on to the coda, the PTO issued a Notice of Final Determination on January 31, 2012 saying that the ‘404 patent is entitled to a PTE of 1,728 days that expires on December 15, 2014 – 14 years to the clendar day that FDA approved NDA No. 020873, but three days earlier than the December 18, 2000 next business day date MDCO was determined to have received notification of the approval.  Although not necessary, MDCO promptly notified the PTO on February 3, 2012 of its acceptance of the 1,728-day PTE.  While the ‘404 PTE battle has taken numerous twists and turns throughout the years and has touched all three brances of government, we expect the coda here to be short.  All that seems to be left now is for the PTO to issue a Certificate of Extension (which will look something like this) and publish the information on the Official Gazette – fine!  Adieu ANGIOMAX PTE battle.