Legal Issues

A lot can happen in 24 hours, as Novartis can attest. The Swiss originator has managed to win a court order temporarily putting the brakes on MSN’s Entresto ANDA product – just hours after a lower court refused a similar request.

Novartis has been spooked by the potential for MSN Laboratories to launch its generic version of the originator’s $3bn Entresto (sacubitril/valsartan) heart failure brand, filing an emergency motion in an appeals court in Washington DC just days ahead of the proposed expiry of one of Entresto’s US patents.

Alexion has been refused in its bid for injunctions to block the sale of Samsung Bioepis and Amgen’s European Soliris biosimilars, following a decision by the Court of Appeal of Europe’s Unified Patent Court.

Sandoz announced a $275m settlement to resolve class action antitrust litigation over price-fixing allegations and disclosed that the company made a further provision of $265m linked to the case.

Sandoz has announced a $275m settlement to resolve with end payers class action antitrust litigation in the US over historical price-fixing allegations, as well as disclosing that it has made a further provision of $265m linked to the case.

Will Novartis’ monopoly on Entresto, one of the biggest-selling small molecule drugs in the US, last until its proffered mid-2025 date? An unfavorable decision by the US Court of Appeals for the Federal Circuit that has handed victory to ANDA sponsor MSN Labs could upend the originator’s projection.

MSN Laboratories has struck a patent-litigation settlement deal with BeiGene that will allow it to launch its zanubrutinib generic rival to Brukinsa in the US from 2037.

Removing the patent-protected indication from the label of Norwich Pharmaceuticals's proposed generic for Xifaxan did not convince the US Supreme Court to hear its petition to review a case from Bausch Health that blocked approval until 2029.

The US Supreme Court has failed to come to the aid of Norwich Pharmaceuticals in its legal battle over a generic version of Xifaxan (rifaximin) that has a patented indication carved out of its label. An earlier decision over the generic thus bars approval and launch until 2029.

The new court ruling could enhance the appeal of the Unified Patent Court for enforcing European patents.