Last Month at the Federal Circuit - December 2010

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In this issue: Federal Circuit Affirms Preliminary Injunction Barring Defendant from Launching FDA Approved Generic Drug; Federal Circuit Declines to Rehear Double Patenting Case in a Split Decision; Period Between Entry of Judgment and Entry of Permanent Injunction Should Be Considered When Calculating Damages; En Banc Court Refuses to Limit New Evidence in § 145 Actions Apart from the Federal Rules of Evidence and Civil Procedure; Federal Circuit Law Governs Patent Assignment Interpretation and Nunc Pro Tunc Assignments Cannot Retroactively Confer Standing; Court Clarifies the Prejudice Requirement for Prosecution Laches and the Intent Requirement for Inequitable Conduct; Patent Owner Is a Necessary and Indispensable Party Where Exclusive Licensee Acquired Less Than All Substantial Rights; Substitute Service of Process Ordered for Defendant from Russian Federation.

Excerpt from 'Federal Circuit Affirms Preliminary Injunction Barring Defendant from Launching FDA-Approved Generic Drug':

In AstraZeneca LP v. Apotex, Inc., Nos. 09-1381, -1424 (Fed. Cir. Nov. 1, 2010), the Federal Circuit upheld the district court’s finding of no anticipation of AstraZeneca LP and AstraZeneca AB’s (collectively “AstraZeneca”) method claims and affirmed the district court’s grant of a preliminary injunction against Apotex, Inc. and Apotex Corp. (collectively “Apotex”). The Court also affirmed the district court’s invalidity finding of AstraZeneca’s “kit” claims.

AstraZeneca markets its FDA-approved budesonide inhalation suspension under the name PULMICORT RESPULES®. The Orange Book entry for this budesonide product includes U.S. Patent Nos. 6,598,603 (“the ’603 patent”) and 6,899,099 (“the ’099 patent”). Both patents have nearly identical specifications. Both patents include method claims directed to administering a budesonide composition once daily and product claims directed to a kit containing either a budesonide composition or suspension and a label indicating once-daily administration by nebulization. The label repeatedly warns patients to “titrate down” to the lowest effective dose of the medication. The FDA requires all manufacturers of inhaled corticosteroids, such as budesonide, to include this downward titration language in their labels.

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