The Court of Appeals for the D.C. Circuit today affirmed a district court decision finding that the FDA wrongly delisted two Merck patents on Zocor (simvastatin), which in turn unlawfully denied Teva and Ranbaxy from 180 days of marketing exclusivity on generic simvastatin. FDA appealed the district court decision but did not request a stay. FDA then granted final approval of Teva and Ranbaxy's ANDAs in June, after which the two companies launched their generic simvastatin products.
In today's D.C. Circuit opinion, written by Judge Ginsburg for a unanimous panel, the court upheld the district court's finding that FDA's interpretation of the statue was contrary to the clear intent of Congress. FDA's policy was to allow delisting when a generic drug maker had filed an ANDA containing a paragraph IV certification and the NDA holder had not filed a lawsuit to contest the certification, as occured in the Zocor case.
The appeals court framed the question at issue as "whether the FDA may delist a patent upon the request of the NDA holder after a generic manufaturer has filed an ANDA containing a paragraph IV certification so that the effect of delisting is to deprive the applicant of a period of marketing exclusivity." In striking down FDA's policy, the court reasoned:
Not only does the statute not require litigation to preserve a generic applicant's eligibility for exclusivity . . . such a requirement is inconsistent with the structure of the statute because, if the patent is delisted before a pending ANDA is approved, then the generic manufacturer may not initiate a period of marketing exclusivity.
By thus reducing the certainty of receiving a period of marketing exclusivity, the FDA's delisting policy diminishes the incentive for a manufacturer of generic drugs to challenge a patent listed in the Orange Book in the hope of bringing to market a generic competitor for an approved drug without waiting for the patent to expire. The FDA may not, however, change the incentive structure adopted by the Congress.
This case appears to require FDA to set a new policy, whereby it should refuse to delist a patent if a generic manufacturer has filed an ANDA containing a paragraph IV certification with respect to the patent.