Legal Issues
Speaking to Generics Bulletin on the sidelines of the AAM’s Access! 2026 conference, IGBA chair for 2026 Jim Keon – also president of the CGPA and Biosimilars Canada – discussed IP abuses, supply challenges, biosimilar streamlining and the importance of giving the off-patent industry a global voice.
Cipla has agreed to delay US launch of its sodium thiosulfate generic until 2033 – albeit six years before patent expiry – resolving multi-patent litigation with Fennec while leaving key commercial terms undisclosed.
Ascent had hoped to join a growing field of US mirabegron competitors, but a Delaware court found its ANDA product would infringe valid Astellas patents covering the sustained-release formulation.
After losing US patent litigation against Amgen over Enbrel and failing to gain traction with a separate antitrust lawsuit, Sandoz isn’t giving up just yet. The firm has just filed an appeal in response to the latest district court dismissal.
Genentech has asked the US International Trade Commission to investigate Biocon and related entities over alleged infringement tied to pertuzumab biosimilars, seeking remedies that could block imports into the US.
A proposed settlement would resolve claims that Actelion used REMS restrictions to block generic rivals from accessing Tracleer samples, allegedly delaying competition and inflating prices for insurers and other payors.
Moderna will pay $950m upfront under the settlement, which lifts a significant weight off its shoulders, as investors had feared it could be on the hook for $5bn.
As the US Supreme Court prepares to review litigation over skinny-label generics with carved-out indications, Hikma has once again won the backing of the US solicitor general for its position.
During a candid and revealing discussion, lobbying experts shared trade secrets with the AAM’s Access! 2026 conference on how to get the generics and biosimilars industry’s message heard by lawmakers, as well as looking ahead to the importance of upcoming US midterms.
Legal procedures brought by Poland and Ireland could still force a rethink of controversial measures in the updated Urban Wastewater Treatment Directive, despite a recent legal setback for the pharmaceutical industry.
Sandoz has told Generics Bulletin that it is mulling further options, including an appeal, after a US court dismissed its antitrust complaint against Amgen over Enbrel. Currently, Sandoz’s Erelzi etanercept biosimilar – approved almost a decade ago – is blocked from launch for a further three years.
Long-running litigation between Teva and GSK over a skinny-label generic carvedilol version of Coreg has ended not with a bang but with a whimper, after the two firms settled on undisclosed terms.