Generics Bulletin 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

AAM Warns Of Dangerous Precedent In Vascepa 'Skinny Label' Case

Files Amicus Brief In Support Of Hikma Over Amarin Induced Infringement Claims

Executive Summary

By allowing Amarin’s allegation of induced infringement against Hikma over its generic version of Vascepa to proceed, a US court is jeopardizing the ‘skinny label’ system that allows generics to carve out patented indications from their labels under the Hatch-Waxman framework, according to the AAM.

You may also be interested in...



Industry Impact Weighed As US Supreme Court Refuses Skinny-Label Review

Teva has been denied in its attempt to convince the US Supreme Court to re-examine long-running litigation with GSK over skinny-label carve-outs of generic indications. However, the generics firm has vowed to fight on as the case is returned to the district court level, while the wider off-patent industry weighs the impact of the latest decision.

Does Hikma’s Vascepa Litigation Dismissal Suggest Safety For Skinny Labels?

An induced-infringement attack on Hikma’s skinny-label generic version of Vascepa had been cited as evidence of the potential harm that would be caused by controversial rulings in separate litigation involving GSK and Teva. However, these fears may now appear overstated after the claim against Hikma was dismissed.

Induced Infringement And Price Fixing Among Legal Headlines In 2021

In 2021, courts across the US and beyond continued to weigh key patent litigation fights, alongside the thorny issue of induced infringement via label carve outs and controversial charges for generic price fixing.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

GB151251

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