Legal & IP

Serial patent litigations have become a loophole in the Hatch-Waxman Act, disbalancing the scale of innovation and competition, said Jon Potter, executive director of the newly established Coalition Against Pharma Patent Abuse, in an exclusive Generics Bulletin interview.

After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.

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.

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.

Corcept said it would “vigorously defend our rights” and is “currently considering the best way to pursue judicial review of this decision.”

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.

Do Zydus and Lupin’s settlements of Myrbetriq (mirabegron) US patent litigation with Astellas constitute a win or a loss?

Following a $90m settlement with Astellas over Myrbetriq (mirabegron) in the US, Lupin can continue selling its generic product even as Zydus says the Delaware district court has directed mediation but the trial is proceeding. How have the generics fared and what does this mean now?

Organon and Henlius have agreed to settle US litigation with Roche and Genentech over their Poherdy pertuzumab biosimilar rival to Perjeta. But when will they launch?

States allege Novartis and its former generics arm Sandoz colluded with rivals to keep generic drug prices high, then restructured the Sandoz business to limit antitrust liability.

With another settlement secured, US states are gearing up for the first trial of the price-fixing case later this year.

The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, according to Chad Landmon, chair of law firm Polsinelli’s Hatch-Waxman & biologics practice.

A US class action suit alleges that a settlement between Teva and Novo Nordisk illegally delayed generic Victoza for 16 months, kept prices high and transferred an estimated $903m in value to Teva.