The U.S. Court of Appeals for the Federal Circuit recently ruled that a Pfizer patent covering Celebrex® was invalid for double patenting while affirming a lower court's decision that two other patents covering the blockbuster anti-inflammatory are valid, enforceable and infringed by the generic manufacturer's product. Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 07-1271 (Fed. Cir., March 3, 2008) (Dyk, J.).
The decision arose out of Teva's appeal from a final judgment of a district court, entered after a bench trial, in favor of Pfizer. The district court held that Teva infringed three patents owned by Pfizer: the '823 patent, the '165 patent—covering the active ingredient and a pharmaceutical composition of Celebrex®—and the '068 patent, covering the use in the treatment of inflammation.
The third sentence of 35 U.S.C. § 121 provides a safe harbor from double patenting rejections for patents that issue on divisional applications filed as a result of a restriction requirement issued in the parent application by the U.S. Patent and Trademark Office (USPTO). The district court held that the safe-harbor provision of § 121 prevented the '165 patent from serving as prior art with respect to the '068 patent because both derived from applications filed in response to the restriction requirement made in the common parent application. Because the district court found that the '165 patent was not prior art, it held that the '068 patent was not invalid on grounds of double patenting.
On appeal, Teva argued that § 121 applies exclusively to divisional applications and that, because the '068 patent issued on a continuation-in-part (CIP) rather than on a divisional application, it does not fall within the terms of the statute. Pfizer contended that the term "divisional application" as it is used in § 121 refers broadly to any type of continuing application filed as a result of a restriction, regardless of whether it is labeled by the USPTO as a divisional, a continuation or a CIP.
Pointing to the express language of § 121 as well as the statute's legislative history, the Court concluded that there was no suggestion that the safe-harbor provision of § 121 was, or needed to be, directed at anything but divisional applications. The panel further noted that the commentary and materials published since § 121's enactment similarly contain no suggestion that § 121 was meant to cover any applications other than divisionals. The Court concluded that the protection afforded by § 121 to applications or patents issued therefrom filed as a result of a restriction requirement is limited to divisional applications. Turning to the question of whether the claims of the '068 application are patentably distinct over those of the '165 patent, the panel agreed with the district court that the earlier patent merely claims a particular use that was described in connection with the later claimed compositions. The Court concluded that the asserted claims of the '068 patent are therefore not patentably distinct over the claims of the '165 patent and, without the shield afforded by § 121, the '068 patent is invalid for obviousness-type double patenting. With regard to the other two patents in suit, the Court found no evidence that Pfizer concealed a preferred method of getting to the right dosage such that at least some claims in the '823 and '165 patents did not violate the best mode requirement.
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