Federal Circuit Denies Pfizer's Petition for Rehearing in Norvasc Case

by Aaron F. Barkoff
Orange Book Blog



Reuters reported this afternoon that the Federal Circuit has denied Pfizer's petition for rehearing and rehearing en banc of Pfizer vs. Apotex, in which the court invalidated claims 1-3 of Pfizer's U.S. Patent No. 4,879,303. The '303 patent covers amlodipine besylate, the active ingredient in Norvasc.

According to the Reuters article, three Federal Circuit judges (out of twelve) dissented from the decision not to rehear the case. The court has not yet listed the decision on its disposition sheet, nor has it published any opinions on the decision.

The most immediate beneficiary of today's decision may be Apotex. The FDA previously announced that it would grant final approval to Apotex's ANDA for generic Norvasc when the Federal Circuit's mandate issues. Now that the Federal Circuit has denied Pfizer's petition for rehearing, it is expected to issue the mandate within seven calendar days.

As we've previously reported, Mylan filed suit against the FDA to stop FDA from approving any other generic versions of Norvasc. Mylan will likely file a motion with the D.C. Circuit to prevent FDA from approving Apotex's ANDA, pending its appeal.


Source: OrangeBookBlog.com




RELATED READING:
- District Court Denies All Challenges to FDA Decision on Norvasc Exclusivity
- Mylan Launches Generic Norvasc; Pfizer Counters with Own Generic
- Pfizer Wins Another Round in Norvasc Case as Synthon's Patents Are Found Unenforceable

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