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Mylan Ruling Will 'Drastically' Alter Hatch-Waxman Litigation

Appeals Court Ruling In Limits Venue For Paragraph IV Filings

Executive Summary

An appeals court ruling in the US stands to “drastically change” the venue options for brand companies to sue ANDA filers.

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US Federal Circuit Refuses To Rehear Arguments In Hatch-Waxman Venue Litigation

Mylan disputed Valeant's complaint in New Jersey federal court for improper venue, on the basis that Valeant firm had no relevant ties to New Jersey and the only alleged act of infringement – submission of the ANDA – did not occur there.

US Court Refuses To Rehear Hatch-Waxman Venue Case

A ruling that could play a key role in limiting venue for Hatch-Waxman litigation in the US will not be reviewed by the full US Court of Appeals for the Federal Circuit after it refused a rehearing petition by Valeant.

FDA Seeks Feedback On Continuous Manufacturing

A draft ICH guidance on continuous manufacturing has been opened up for comment by the FDA, as continuous manufacturing becomes an increasingly prominent topic for the generics industry.

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