Litigation
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.
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.
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.
FTC’s sending checks totaling more than $40,700 to 578 consumers who purchased deceptively marketed treatment plans from Golden Sunrise between July 2017 and July 2020. Company owner and chief medical officer both pleaded guilty to criminal charges.
US Court of International Trade expects by March 12 to receive from Customs and Border Protection a “short report describing the progress” it “has made toward the development of a process to issue refunds of IEEPA duties paid with interest.”
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.
Corcept said it would “vigorously defend our rights” and is “currently considering the best way to pursue judicial review of this decision.”
“The president is certainly hamstrung in many ways by this ruling. For businesses, there's still just sort of a lot of general uncertainty in regard to what else is the president going to try to do, what other authorities might he try to pull,” says Tax Foundation analyst Alex Durante.
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.
Warning letter, submitted three months after FDA rejected supplement industry groups’ arguments for leeway around how INDs affect dietary ingredient’s availability for use in supplements, stated Prodrome Sciences’ clinical trials with omega-3 supplements should have been registered as IND.