Medicines Company (MDCO) v. Kappos (Fed. Cir. 2011)
The FDA approved the new drug application (NDA) for MDCO's blockbuster drug Angiomax (bivalirudin) on December 15, 2000. As it turns out, it is important that the approval came at 5:18 pm on a Friday. After the approval, MDCO filed for a patent term extension (PTE) based upon the delay in the regulatory approval process. Unfortunately, the company waited until February 14, 2001 to file the PTE application — just past the sixty-day period allowed under the statute. The PTO refused to consider the application because it was late.
MDCO has been fighting its loss of term extension on three fronts: (1) privately with its prosecution firm; (2) in court against the PTO and (3) in the halls of Congress. It appears that the company is likely be successful in the end.
First, in February 2011, WilmerHale (and its malpractice insurers) agreed to pay MDCO $18 million for past expenses and made available an additional $214 million in case generic bivalirudin goes on the market in the US prior to June 2015 as a result of PTE not being granted or being held valid. The $18 million reportedly covers the expenses associated with litigation against the PTO and lobbying congress.
In court, the district court applied an “after-business-hours” exception to the statute and therefore agreed with MDCO that the PTE application was timely filed. The PTO chose not to appeal that decision. However, a German generic manufacturer – APP Pharma — is attempting to intervene and appeal on behalf of the USPTO. APP has a strong argument on the merits, but a weak argument on its own standing. The appellate court earlier rejected a motion to bifurcate the appeal between the standing issue and the merits issue and will instead hear them jointly.
Finally, the recent patent reform bill passed in the House of Representatives (H.R. 1249) includes a provision particularly crafted to aide MDCO. The provision says simply that, for the purposes of calculating the PTE application due date, any regulatory after 4:30 pm will be considered to have occurred on the next business day. (Amending 35 U.S.C. 156(d)(1)). That provision, however, is not in the Senate's version.
Although not written as such, the legislative measure is essentially a private relief bill directed to help MDCO (no other pharmaceutical company has or will make the same mistake). There is some precedent for straightforward term extensions, including ones for patents covering aspartame (6 years), isoflurane (5 years), Impro (15 years), glyburide (6 years), gemfibrozil (3 1/2 years), olestra (3 years), oxaprozin (2 years).
Notes: Kurt Karst has been following the case in detail at his FDA Law Blog.