Celebrex Reissue Patent Reawakens Generic Litigation
Pfizer sues five generic firms alleging their celecoxib ANDAs infringe a reissued method-of-use patent, which protects the blockbuster COX-2 inhibitor until December 2015, 18 months longer than had been expected.
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Ongoing battle over 180-day exclusivity shows just how complex life under the 1984 amendments to the FD&C Act can get.
Pfizer had hoped to gain an extra 18 months of patent protection with a reissue patent granted last year but a district court ruled the method of use patent is invalid.
Last patent covering Pfizer’s pain drug is a reissue of an earlier patent on which 180-day exclusivity has already been triggered; FDA has previously declined to award exclusivity to such patents.