Case Name: G.D. Searle LLC  v. Lupin Pharms, Inc., Civ. No. 13-cv-121 (E.D. Va. Mar. 12, 2014) (Wright Allen, J.)

Drug Product and Patent(s)-in-Suit: Celebrex^® (celecoxib); U.S. Reissue Patent No. 44,048 (“the ’048 patent”)

Nature of the Case and Issue(s) Presented: The ’048 patent claims the treatment of acute pain and symptoms of arthritis, osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis or spondyloarthropathy, and primary dysmenorrhea or menstrual cramps. The ’048 patent is a reissue of U.S. Patent No. 5,760,068 (“the ’068 patent”). The Federal Circuit held that the ’068 patent was invalid under the doctrine of obviousness-type double patenting. The Federal Circuit held that since the ’068 patent was a continuation-in-part of the parent patent, as opposed to a divisional application, the ’068 patent was not protected by the safe-harbor provisions of 35 U.S.C. § 121, and thus invalid. Following the ruling, Pfizer asked the U.S. Patent and Trademark Office (“USPTO”) to reissue the ’068 patent as a divisional to correct the deficiencies identified by the Federal Circuit. The USPTO initially rejected the claim because of the patentee’s failure to timely file a divisional application prior to issuance of the original patent. Pfizer then asserted that reissue was proper because the ’068 patent contained indefinite claim terms. Based on Pfizer’s assertion, the USPTO issued the ’048 patent. That same day, plaintiffs filed suit against defendants alleging infringement of the ’048 patent stemming from the submission of defendants’ ANDAs with the FDA.

Defendants brought motions for summary judgment of invalidity for failure to meet the reissue requirements and for obviousness-type double patenting. Defendants asserted four arguments as to why the reissue was invalid: (i) new matter was added; (ii) a claim was broadened more than two years after the patent issued; (iii) failure to file a divisional is not correctable via reissue; and (iv) intentional acts are not correctable via reissue. The court found the reissued patent invalid. While the claims did not add new matter and were not broadened, the court determined that the patentee failed to file a divisional and that act was intentional. Since the court determined that the patent was a divisional, it was not protected by the safe harbor provision and thus, invalid under the doctrine of obviousness-type double patenting.

Why Defendants Prevailed:  Defendants prevailed because the court determined that the question was not whether reissue is permitted on another basis, but rather whether the reissue ’048 patent could have been filed as a divisional. Thus, Pfizer’s other asserted errors requiring correction was insufficient to avoid invalidity. The designation of the reissue application as a divisional, instead of a continuation-in-part, is not a correctable error under 35 U.S.C. § 251 and could not be classified as a narrowing change to the patent claims. The court found that the patentee made an intentional decision to file a continuation-in-part and gain the benefit of an extended period of exclusivity as to celecoxib. This decision resulted in no protection under 35 U.S.C. § 121 for obviousness-type double patenting. Therefore, the court determined that the ’048 patent was invalid for obviousness-type double patenting under the same rationale that the Federal Circuit applied to the original ’068 patent.