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Mylan Ruling Will 'Drastically' Alter Hatch-Waxman Litigation

Appeals Court Ruling In US 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.

Blow For Prestige As Trastuzumab Biosimilar Rejected By EMA

Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.

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