Legal & IP
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Latest From Legal Issues
As state attorneys general and Department of Justice move against generic manufacturers, plaintiffs’ firms have filed more than 90 antitrust suits on behalf of third party payers.
Can a company explain the situation surrounding a newly approved drug, including the effect of the indication on access, without violating off-label communication regulations?
Supreme Court nominee's opposition to deference for administrative agencies could help biopharma industry in its battle over off-label communications if the issue ever goes before the court; he also supports securities litigation reform.
Genentech seeks court order requiring Amgen to provide biosimilar manufacturing info so it can evaluate potential infringement; Supreme Court to hear Zarxio case on April 26.
Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.
Sanofi attorneys describe three possible outcomes of fight over injunction and validity of Repatha patents, and contrast litigation to other patent disputes where innovators did not seek removal of innovator product from market.
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