Legal & IP
Among other schemes, Cigna alleges that Celgene and parent Bristol Myers Squibb “paid” generic challengers – via lucrative Revlimid profit-sharing agreements – to delay generic market entry for Pomalyst until 2026, unlawfully extending their monopoly and overcharging purchasers.
The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.
Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.
The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.
In a further setback for generics manufacturers, the District Court of The Hague has upheld the validity of a key Xtandi (enzalutamide) patent and its Dutch supplementary protection certificate, rejecting Sandoz and Accord’s challenge based on lack of inventive step.
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.
Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.
The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.
A class action suit alleging AstraZeneca delayed generic competition for Seroquel XR by making illegal agreements that stifled market entry for generic quetiapine competitors has been dismissed after the originator agreed to settle for tens of millions of dollars.
In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.
Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.
Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.
After being refused an injunction as part of ongoing litigation over a private-label ustekinumab biosimilar being marketed in the US by Sandoz and Samsung Bioepis, Stelara originator Johnson & Johnson is continuing to pursue an appeal. However, newly-unsealed court documents suggest the brand company had demonstrated a likelihood of success - and reveal further details about the case, including the identity of the PBM involved and why the injunction request was denied.
Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.
Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.
Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”
Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.
Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.