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...
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.
Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod
Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.
EU’s Health Emergency Response Plans Must Address Existing Flaws
The EU’s creation of a Health Emergency Response Authority to deal with future health threats has been welcomed by off-patent industry association Medicines for Europe. However, the organization pointed out current policy and regulatory weaknesses that must be addressed if HERA is to be successful.