In re Omeprazole Patent Litigation, No. 04-1562 (Fed. Cir. 2007)
In a 2-1 decision released today, the Federal Circuit affirmed a 2004 district court decision finding AstraZeneca's U.S. Patent No. 6,013,281 invalid as inherently anticipated. The '281 patent covers a process for making Prilosec, Astra's blockbuster anti-ulcer medication.
The case arose from the efforts of several generic drug companies, including Andrx, Genpharma, and Kudco, to market generic versions of Prilosec. In the same litigation, the Federal Circuit previously found that Andrx's generic Prilosec infringed two Astra patents on Prilosec formulations: U.S. Patent Nos. 4,786,505 and 4,853,230.
In today's decision, Judge Rader (writing for himself and Judge Bryson) concluded that a Korean patent application to Chong Kun Dan Corp. ("CKD") inherently anticipated claim 1 of the '281 patent, which recites a process for making a pharmaceutical formulation by "forming in situ a separating layer" between an active ingredient core and an enteric coating. In support, J. Rader cited numerous statements--apparently admissions--that Astra made in Korean litigation and Korean patent office proceedings, as well as the district court's finding that Andrx's expert was more credible than Astra's.
J. Rader's opinion further stated:
Inherency is not necessarily coterminous with knowledge of those of ordinary skill in the art. Artisans of ordinary skill may not recognize the inherent characteristics of functioning of the prior art. Though [Astra's scientists] may not have recognized that a characteristic of CKD's Method A ingredients, disclosed in the CKD Patent Application, resulted in an in situ formation of a separating layer, the in situ formation was inherent.
Judge Newman, dissenting, wrote that the majority opinion applied a "novel theory" and a "flawed analysis" of inherent anticipation. She stressed that the majority failed to appreciate that claim 1 of the '281 patent is directed to a process--not a composition of matter. Moreover, she noted, "[i]t is not disputed that a sublayer does not form under the conditions in the CKD patent application." J. Newman explained:
While some properties and uses of known compositions may indeed be 'inherently anticipated' in that their existence would have been known to persons in the field of the invention, even if unpublished, that is not this situation. No prior art describes the Astra process, and there is no evidence that a person of ordinary skill would have known of its existence. What is unknown cannot 'anticipate.'
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