Mylan Ruling Will 'Drastically' Alter Hatch-Waxman Litigation
Appeals Court Ruling In Limits Venue For Paragraph IV Filings
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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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.
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.
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.