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Supreme Court To Reconsider “Rules Of the Road” In Generic Preemption

This article was originally published in The Pink Sheet Daily

Executive Summary

Design defect claims made against generic companies are focus of a case involving Mutual Pharmaceutical’s generic sulindac; ruling may eliminate lower court carve-outs to its Mensing decision.

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FDA May Drop Generic Liability Shield, Allow ANDA Manufacturers To Change Labels

Solicitor General notes that FDA is considering changing its regulations in an amicus brief in Mutual Pharmaceutical v. Bartlett; government says design defect claims against generic manufacturers are preempted by federal law in the case at hand but may be brought in other situations.

Supreme Court Won’t Inoculate GSK In Hatch-Waxman Safe Harbor Case; Momenta May Have Better Shot

The high court also denied petitions seeking review of Otsuka’s Abilify patent and patents covering Cephalon’s Amrix; Supreme Court to hear oral arguments in generic preemption and “pay-for-delay” cases in March.

Hatch-Waxman Safe Harbor Ruling Wrong In GSK Case, Solicitor General Says, But Should Not Be Reviewed

Supreme Court should not take up GlaxoSmithKline v. Classen given the Federal Circuit’s subsequent decision in Momenta v. Amphastar, the Solicitor General argues; Momenta plans to seek review of its case.

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