Mr. USFDA: It’s Time to Revise Homework!

Remember the Generic 23/6 Battle with Teva and Ranbaxy fighting to obtain 180-day marketing exclusivity under Hatch-Waxman provision for their respective strengths of generic Simvastatin tablets after USFDA refused their citizen petitions to re-list Merck’s two de-listed patents and not to approve subsequent ANDAs till the period of 180-day exclusivity period get expired. On April 30, 2006 Judge Richard W. Roberts of the U.S. District Court for the District of Columbia supported Ranbaxy and Ivax motion for summary judgment seeking to vacate the FDA decision, and asked FDA for review its decision. However, FDA appealed and filed a motion with US Court of Appeals for the District Court of Columbia Court seeking expedited review concerning Ivax and Ranbaxy’s 180-day exclusivity issue but did not request a stay. Meanwhile, after receiving final marketing approval from the FDA, Ranbaxy and Teva became the sole generic players to enter US Simvastatin market following Simvastatin patent expiry on June 23, 2006. On November 14, 2006 Court of Appeals affirmed the district court decision finding that the FDA wrongly delisted two Merck patents on Zocor. The Court of Appeals upheld the district court’s finding that FDA’s interpretation of the statue was contrary to the clear intent of Congress. The Court of Appeals in its opinion analyzed that “whether the FDA may delist a patent upon the request of the NDA holder after a generic manufacture 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.” Relying on two-step analysis in Chevron, U.S.A. Inc. v. NRDC, 467 U.S. 837 (1984), the Court of Appeals knock-down FDA’s policy, concluding that “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.” Further added that “the FDA’s policy allows an NDA holder, by delisting its patent, to deprive the generic applicant of 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.” The Court of Appeals concluded that “the FDA improperly denied Ranbaxy and Teva a period of marketing exclusivity by delisting Merck’s patents” and that “the FDA’s policy conditioning a generic applicant’s period of marketing exclusivity upon the generic applicant being sued for patent infringement by the NDA holder is inconsistent with the text and structure of the Act”. This means now Ranbaxy and Teva will continue to be sole generic players till end of December 2006 before other generic players make way to generic Simvastatin market and as far as FDA is concerned – It’s time for Mr. FDA to revise their homework! Ranbaxy Laboratories Ltd. et al v. Michael O. Leavitt, No. 05cv01838