Federal Circuit Blocks Generics-Makers, Finds Eisai's Aciphex Drug Patent Valid and Enforceable

Holding:

The U.S. Court of Appeals for the Federal Circuit in this appeal ruled that plaintiff-appellee Eisai's patent relating to its blockbuster anti-gastric acid drug Aciphex was valid and enforceable. Defendant-appellant Dr. Reddy's and Teva earlier attempted to manufacture a generics version of this billion-dollar earning drug under the Hatch-Waxman Act, 21 U.S.C. Section 355 and 35 U.S.C. Section 271 (e), and in the process challenged the validity of patent-at-issue. Unfortunately for them, the U.S. District Court for the Southern District of New York ruled in favor of patentee Eisai. On appeal, the Federal Circuit found that the district court properly concluded that the record did not support a case of obviousness of the patent as a matter of law. With regard to defendants-appellants' charge of inequitable conduct, the district court likewise correctly determined that Eisai' alleged acts during prosecution did not rise to the level of inequitable conduct, absent any proof of deceptive intent. For these reasons, the Federal Circuit affirmed the district court's finding that defendants-appellants failed to prove that the patent was invalid for obviousness or unenforceable for inequitable conduct.

Detailed Summary:

On summary judgment, the district court found in favor of plaintiffs Eisai Co., Ltd. and Eisai, Inc. (collectively “Eisai”) with respect to the validity and enforceability of 552 patent.  Opinion, pp. 1-2, citing Eisai Co. v. Teva Pharms. USA, Inc., No. 03 Civ. 9223 (S.D.N.Y. Oct. 5, 2006); Eisai Co. v. Dr. Reddy’s Labs., Ltd., No. 03 Civ. 9053 (S.D.N.Y. Oct. 5, 2006).

After a bench trial, the district court found that Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively “Dr. Reddy’s”) and Teva Pharmaceuticals USA, Inc. (“Teva”) had failed to prove the remaining allegations of inequitable conduct, and…

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