Supreme Court Declines Appeal of EDVA Patent Case

On January 11, the Supreme Court declined certiorari in the case of Astellas Pharma, Inc. v. Lupin, et al., Case No. 09-335, upholding a June, 2007 decision by Judge Payne in the Eastern District of Virginia. Our earlier post on the Federal Circuit's Decision can be found here.

The Astellas case involves a generic version of the drug Omnicef (cefdinir), which is an antibiotic used to treat a number of common infections. The generic manufacturer, Lupin, alleged that Astellas’ patent on crystalline cefdinir only covered the Crystal A form of the drug, and Lupin alleged that its generic version of Omnicef only contained the Crystal B form.

In his claim construction opinion, Judge Payne ruled that Astellas’ patent was limited to the Crystal A form, effectively deciding the case in favor of Lupin. In short, the claims at issue were “product by process” claims, and Judge Payne ruled that each of the process steps in the claim were limitations on the invention. In an en banc decision, the Federal Circuit agreed, settling a long-standing split of authority on product by process claims.

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