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Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.

Citations: 518 F.3d 1353; 86 U.S.P.Q. 2d (BNA) 1001; 2008 U.S. App. LEXIS 4969; 2008 WL 613118Docket: 2007-1271

Court: Court of Appeals for the Federal Circuit; March 6, 2008; Federal Appellate Court

Original Court Document: View Document

Narrative Opinion Summary

This case concerns an appeal by Teva Pharmaceuticals USA, Inc. from a judgment by the United States District Court for the District of New Jersey, which favored Pfizer, Inc. in a patent infringement suit. Pfizer claimed that Teva's Abbreviated New Drug Application (ANDA) for a generic version of Celebrex infringed upon its patents. The district court found Teva infringed on three Pfizer patents and rejected Teva's defenses of invalidity based on best mode and inequitable conduct. However, on appeal, the court invalidated claims of the ’068 patent due to obviousness-type double patenting in relation to the ’165 patent, while upholding the validity of claims in the ’823 and ’165 patents. The court ruled that the safe harbor provision of 35 U.S.C. § 121 did not apply to the ’068 patent, as it was a continuation-in-part rather than a divisional application. The decision partly affirmed and partly reversed the district court's judgment, maintaining some patent claims' validity while invalidating others, resulting in a mixed outcome for the parties involved.

Legal Issues Addressed

Best Mode Requirement under 35 U.S.C. § 112

Application: The district court held that Pfizer's preference for COX-2 selectivity did not violate the best mode requirement, as it did not materially affect the claimed invention.

Reasoning: The court determined that Pfizer's preference for COX-2 selectivity did not meet the disclosure requirements of best mode.

Inequitable Conduct

Application: The court ruled that Teva failed to establish inequitable conduct by Pfizer, as there was no intent to deceive the PTO.

Reasoning: Teva argued that Pfizer failed to disclose two Merck publications during the patent prosecution process. However, the district court found that neither the ’501 application nor the ’995 patent was material to the patents in question.

Obviousness-Type Double Patenting

Application: The appellate court found the claims of the ’068 patent were invalid due to obviousness-type double patenting in relation to the ’165 patent.

Reasoning: The appellate court found that claims of the ’068 patent were invalid based on double patenting, while affirming the validity of claim 9 of the ’823 patent and claim 17 of the ’165 patent concerning best mode.

Patent Infringement under 35 U.S.C. § 271(e)

Application: Teva's filing of an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification was ruled as constituting patent infringement.

Reasoning: Pfizer initiated litigation in February 2004, claiming Teva's ANDA filing constituted patent infringement under 35 U.S.C. § 271(e).

Safe Harbor Provision of 35 U.S.C. § 121

Application: The court determined that the safe harbor provision did not apply to the ’068 patent, as it was not a divisional application.

Reasoning: The court concludes that Pfizer cannot invoke section 121 for the ’068 patent, leading to its invalidation due to obviousness-type double patenting.