Federal Circuit Denies Pfizer's Petition for Rehearing in Norvasc Case
Pfizer v. Apotex, No. 2006-1261 (Fed. Cir. 2007)
This afternoon, the Federal Circuit denied Pfizer's petition for rehearing and rehearing en banc of Pfizer v. 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.
Three of the twelve judges ruling on Pfizer's petition dissented from the decision not to rehear the case en banc: Newman, Lourie, and Rader. Each of the three filed dissenting opinions.
Judge Newman voiced strong disagreement with the three-judge panel opinion, writing that "the panel's application of the obvious-to-try standard is in direct conflict with precedent" and "the panel decision changes the criteria as well as the analysis of patentability." Judge Lourie expressed his view that "the panel erred in its legal determinations, and those errors will confuse the law relating to the rebuttal of a prima facie case of obviousness of a chemical compound." Both Newman and Lourie are chemists by training. Judge Rader stated that the panel gave insufficient deference to numerous factual findings of the district court, and substituted its own judgment on those issues. He concluded: "this decision calls into question countless pharmaceutical patents, which in turn could have a profoundly negative effect on investments into the design and development of new life-saving pharmaceuticals."
The most immediate beneficiary of today's decision may be Apotex. The FDA announced last month that it would grant final approval to Apotex's ANDA for generic Norvasc when the Federal Circuit issues a mandate in Pfizer v. Apotex. In addition to denying Pfizer's petition to rehear the case today, the Federal Circuit also granted Apotex's motion for expedited issuance of the mandate and issued the mandate. Thus, Apotex's final approval appears imminent.
As we previously reported, Mylan, who currently has the only approved ANDA for generic Norvasc, filed suit to enjoin FDA from approving any other generics. Mylan lost that case and appealed to the D.C. Circuit. Mylan might now file an emergency motion with the D.C. Circuit, aiming to prevent FDA from approving Apotex's ANDA until the appeal is decided.
REHEARING BRIEFS:
- Pfizer's Petition for Rehearing
- Amicus Brief of SmithKline Beecham and Eli Lilly
- Amicus Brief of BIO
- Amicus Brief of PhRMA
- Amicus Brief of Mylan Labs
- Apotex's Answer to Pfizer's Petition
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