Sessions/Coburn Amendment to FDA Approps Bill Seeks To Effectively Nullify AIA Section 37 ANGIOMAX PTE Provision

By Kurt R. Karst –    

Like any good thriller movie that coaxes you into a feeling of finality – right before the surprise twist makes you jump out of your seat – the saga 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 been a legal thriller for the ages with many surprise twists.  Now there’s a new one . . . . 

As FDA Law Blog readers know, MDCO’s PTE battle has touched all three branches of government throughout the years.  Most recently, Section 37 of the Leahy-Smith America Invents Act (“AIA”) (Pub. Law No. 112-029), 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. 

The inclusion of Section 37 in the AIA was contentious to say the least.  During the Senate’s consideration of the AIA, U.S. Senators Jeff Sessions (R-AL), Tom Coburn (R-OK) and Joe Manchin (D-WV) proposed an amendment to strike Section 37 from the AIA, and sent out a “Dear Colleague” letter urging support for their amendment.  But the amendment failed by a narrow 51-47 vote and Section 37 became law. 

Shortly after the enactment of the AIA, MDCO sent a letter to the U.S. Court of Appeals for 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 Pharmaceuticals, LLC (“APP”) (see our previous posts here, here, and here).  APP vigorously disagreed, however, that Section 37 resolved the case, and has argued that Section 37 cannot constitutionally be applied and that Section 37 does not take effect for one year after AIA enactment.  The Federal Circuit ordered MDCO and APP to simultaneously file supplemental briefs addressing the effect of Section 37 of the AIA on the disposition of the case.  Those briefs were filed earlier this week.  Oral argument is scheduled for November 15, 2011.

Now Sens. Sessions and Coburn have reignited their opposition to Section 37.  Earlier this week, they proposed an amendment – SA 812 – to the 2012 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (H.R. 2112), intended to effectively nullify Section 37.  SA 812 would add Section 114 to the appropriations bill and states:

Sec. 114. No funds appropriated, or otherwise made available, under this Act may be used by the Director of the United States Patent and Trademark Office to carry out section 37 of the Leahy-Smith America Invents Act (35 U.S.C. 156 note), including the flush sentence added to section 156(d)(1) of title 35, United States Code, by such section 37.

The Sessions/Coburn amendment has received support from the Generic Pharmaceutical Association and Citizens Against Government Waste (“CAGW”).  CAGW sent out a letter to the Senate on October 19th urging support for SA 812.  Other groups may be waiting in the wings to voice their support for the amendment. 

As noted above, the previous amendment failed by a narrow 51-47 vote; however, many of the "nay" votes last time may have been cast to prevent a disruption in the AIA's enactment.  Now separated from patent reform, the vote could change.

We know you’re on the edge of your seats.  Stay tuned for more thrills.