Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Blow For Industry As GSK-Teva ‘Skinny Label’ Decision Upheld

Executive Summary

A controversial ruling involving labeling carve-outs that saw Teva hit with $235m in damages over its generic rival to GSK’s Coreg has been upheld after being reheard by the US Court of Appeals for the Federal Circuit. However, the court sought to counter the suggestion that its decision upends Hatch-Waxman labeling carve-out provisions.

You may also be interested in...



Generic Manufacturers Face Uphill Climb After Federal Circuit’s ‘Skinny Label’ Decision

Split appeals court denies en banc review of GSK v. Teva ruling, but suggests the district court could consider GSK’s patent declarations in determining whether Teva’s label is evidence of inducement to infringe. Teva plans to file petition for Supreme Court review.

‘Skinny Label’ Case Gives Brands A ‘Blueprint’ To Alter Use Codes In Patent Litigation

Federal Circuit ruling in GSK v. Teva shows brands can broaden a use code to include other patented indications years into litigation, AAM attorney says. The case is ‘scarier’ for biosimilar makers since they must market their products, Teva lawyer notes.

‘Skinny Label’ Case Gives Brands A ‘Blueprint’ To Alter Use Codes In Patent Litigation

Federal Circuit ruling in GSK v. Teva shows brands can broaden a use code to include other patented indications years into litigation, AAM attorney says. The case is ‘scarier’ for biosimilar makers since they must market their products, Teva lawyer notes.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS144765

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel