Senator Nelson Takes Another Crack at the Drug Price Competition Act

By Kurt R. Karst –   

With all of the FDA-related amendments being introduced for consideration to the Tax Extenders Act (H.R. 4213), including the Preserve Access to Affordable Generics Act to address patent settlement agreements and an amendment to legislatively extend a patent covering The Medicines Company’s ANGIOMAX (bivalirudin), it was a fait accompli that Sen. Bill Nelson (D-FL) would reintroduce his Drug Price Competition Act by proposing it as an amendment to the bill.  That happened on June 15th, with the submission of SA4361.

SA4361, which is viewed by some as a complement to the Preserve Access to Affordable Generics Act, appears to be identical to Sen. Nelson’s S. 1315, which was introduced last June.  Rep. Alcee Hastings (D-FL) introduced a companion bill (H.R. 3777) in the House of Representatives.  Rep. Hastings also initially proposed his bill as an amendment to the House Health Care Reform Bill last November, but then withdrew it from consideration.  In January 2010, before the election of Scott Brown (R-MA) to the Senate, the American Antitrust Institute, among several other organizations, penned a letter to Senate Majority Leader Harry Reid (D-NV) and House Speaker Nancy Pelosi (D-CA) encouraging inclusion of the Drug Price Competition Act in the final Health Care Bill, along with a per se ban on patent settlement agreement payments. 

As we previously reported (here and here), Sen. Nelson’s legislation would amend the definition of “first applicant” at FDC Act § 505(j)(5)(B)(iv)(II)(bb) with respect to 180-day exclusivity eligibility so that certain subsequent ANDA applicants could trigger and also be eligible for such exclusivity.  Specifically, under SA4361, a subsequent applicant subject to a first applicant’s 180-day exclusivity eligibility could qualify as a “first applicant,” and could obtain approval and trigger 180-day exclusivity for all first applicants if there is no timely filed patent infringement lawsuit arising from its Paragraph IV certification, or if there is a timely filed lawsuit and there is a court decision (including a district court decision) of patent invalidity or non-infringement or a “substantive determination that there is no cause of action for patent infringement or invalidity.”  Curiously, SA4361 also provides that any subsequent ANDA applicant that submits a “section viii” statement to an Orange Book-listed patent would be considered a “first applicant” eligible for 180-day exclusivity.

SA4361 and its predecessors appear to be rooted in a paper Apotex issued early last year.  In that paper, Apotex recommends that Congress work for legislation “that gives shared (if not sole) exclusivity to a generic challenger who, although not first to file a paragraph iv certification, is first to succeed in addressing the listed patents.”