In an April 1 decision, U.S. Court of Appeals for the Federal Circuit upholds Caraco Pharmaceuticals' ability seek declaratory judgment against Forest Labs in a dispute involving a patent for Forest's Lexapro (escitalopram). The suit is aimed at forging a path to market for generic versions of the antidepressant, which holds patent protection until 2012. The ruling overturns a lower court decision dismissing Caraco's action on the basis that there is no threat of a lawsuit from Forest over Caraco's ANDA for a generic version of the drug. The appeals court ruling is consistent with a March 2007 decision by the same court in Teva v. Novartis that expanded the parameters under which generic firms can seek declaratory judgments for patent non-infringement (1"The Pink Sheet," April 9, 2007, p. 22). Ivax was the first to obtain approval for generic Lexapro. However, Forest has obtained a court judgment against Ivax upholding the validity of the patent covering the drug's active ingredient (2"The Pink Sheet," Sept. 10, 2007, In Brief)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
