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Generic Firms Use Pediatric Exclusivity As Weapon In Toprol XL Fight

Executive Summary

Sandoz and KV Pharmaceutical are locked in a regulatory struggle to keep each other's generic versions of AstraZeneca's Toprol XL (metoprolol extended release) off the market

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Toprol-XL patents found invalid

The U.S. Court of Appeals for the Federal Circuit upheld a district court ruling that AstraZeneca's Toprol-XL (metoprolol succinate) patents are invalid and unenforceable based on double patenting. However, the court vacated the lower court's finding of inequitable conduct by AstraZeneca. The court concluded that there are questions of fact involving AstraZeneca's failure to disclose a dispute over inventorship to the U.S. Patent and Trademark Office and sent the issue back to the U.S. District Court for the Eastern District of Missouri for review. AstraZeneca filed suit against KV Pharmaceutical, Andrx and Eon Labs after they filed ANDAs to market generic versions of the hypertension treatment. Sandoz and KV subsequently filed citizen petitions to block each other from marketing formulations of the drug (1"The Pink Sheet" July 9, 2007, p. 26)...

Toprol-XL patents found invalid

The U.S. Court of Appeals for the Federal Circuit upheld a district court ruling that AstraZeneca's Toprol-XL (metoprolol succinate) patents are invalid and unenforceable based on double patenting. However, the court vacated the lower court's finding of inequitable conduct by AstraZeneca. The court concluded that there are questions of fact involving AstraZeneca's failure to disclose a dispute over inventorship to the U.S. Patent and Trademark Office and sent the issue back to the U.S. District Court for the Eastern District of Missouri for review. AstraZeneca filed suit against KV Pharmaceutical, Andrx and Eon Labs after they filed ANDAs to market generic versions of the hypertension treatment. Sandoz and KV subsequently filed citizen petitions to block each other from marketing formulations of the drug (1"The Pink Sheet" July 9, 2007, p. 26)...

Apotex Is Appealing Plavix Patent Ruling, Links Case to Norvasc

Apotex contends that Plavix is an obvious invention in the same way Norvasc is, but a district court judge made a sharp distinction between the two drugs in ruling that Apotex had failed to prove the patent covering Plavix is invalid or unenforceable

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