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by Aaron F. Barkoff
Orange Book Blog



Eisai v. Dr. Reddy's and Teva, Nos. 03-9053 and 03-9223 (S.D.N.Y. 2007)

Eisai owns U.S. Patent No. 5,045,552, which claims the chemical compound rabeprazole sodium, the active ingredient in Eisai's blockbuster proton-pump inhibitor Aciphex. Dr. Reddy's (RDY), Teva (TEVA) and Mylan (MYL) filed ANDAs for generic Aciphex with paragraph IV certifications to the '552 patent. Aciphex has annual U.S. sales of over $1 billion and accounts for a large percentage of Eisai's U.S. revenue, so naturally Eisai filed suit against the generic applicants.

Last October (as we previously reported), Judge Gerard E. Lynch of the Southern District of New York granted Eisai's motion for summary judgment of patent validity and partially granted Eisai's motion for summary judgment of no inequitable conduct. Dr. Reddy's and Teva had already stipulated to infringement. Judge Lynch held a two-week bench trial on the remaining inequitable conduct issues in March, and last Friday he issued a 62-page opinion in favor of Eisai.

At trial, Dr. Reddy's and Teva offered three allegations of inequitable conduct:

Eisai failed to disclose a later-filed, later-issuing co-pending patent application directed to the ethyl homolog of rabeprazole;

Eisai failed to disclose an international patent publication; and

Eisai omitted certain data from a Rule 132 declaration filed in the prosecution of the '552 patent, and therefore the declaration was misleading.

Judge Lynch found that Dr. Reddy's and Teva failed to prove that the co-pending application and certain rejections made during its prosecution were of such a highly material nature as to support an inference of an intent to deceive. Moreover, he concluded that the defendants utterly failed to prove any degree of an intent to deceive--finding the Eisai witnesses to be highly credible. Judge Lynch further found that Dr. Reddy's and Teva failed to prove either materiality of the international patent publication or an intent to deceive the patent office by failing to disclose it. Finally, Judge Lynch found that the Rule 132 declaration was not in fact misleading, and that Eisai had no intent to deceive the PTO by omitting certain data from it.

Though Friday's ruling came in the litigations involving Dr. Reddy's and Teva, Mylan had previously agreed to be bound by the outcome in the two cases. The ruling is an especially bitter defeat for Dr. Reddy's--since it was the first ANDA filer and the 180-day exclusivity holder. Dr. Reddy's (and perhaps Teva too) is expected to appeal the decision to the Federal Circuit.


Source: OrangeBookBlog.com




RELATED READING:
- Associated Press Article
- Apotex Loses Emergency Appeal, Dr. Reddy's Launches Generic Zofran
- Generic Drug Companies Suing Each Other!

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