Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

How Can Firms Avoid Falling Into GSK-Teva ‘Skinny Label’ Trap?

Industry Must Tread Carefully, Suggests Troy Groetken Of McAndrews, Held & Malloy

Executive Summary

In the wake of a controversial US decision on carving out patented indications from generics labels, Troy Groetken of law firm McAndrews, Held & Malloy tells Generics Bulletin about the key issues that firms with ‘skinny label’ generics should be aware of given the potential for induced-infringement attacks.

You may also be interested in...



Generics Bulletin Editor’s Picks For Q3 2021

Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.

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

A controversial ruling revolving around labelling 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 the Hatch-Waxman framework’s labelling carve-out provisions.

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.

Topics

UsernamePublicRestriction

Register

GB151218

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