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Litigation

‘Cannot Have It Both Ways’: AAM Fights MSN’s Corner In Entresto Patent Revival Appeal

The US Association for Accessible Medicines says it is looking to “protect the public’s interests in ensuring that patents do not let inventors control more than they invented,” as it moved to file in support of MSN Laboratories’ legal tussle with Novartis over a key patent shielding the originator’s $7.8bn Entresto blockbuster.

J&J Slaps Samsung Bioepis With Stelara Lawsuit In US

The same day as Samsung Bioepis and Sandoz launched their partnered Pyzchiva biosimilar rival to Stelara in the US, originator J&J hit the Korean developer with a lawsuit claiming that a private-label commercialization deal with a US pharmacy benefit manager violates the ustekinumab settlement that allowed the firms to launch.

In Exit Message, FTC Consumer Protection Chief Urges Return Of 13(b) Monetary Relief Authority

“We have made significant strides in finding new ways to return money to consumers, but a fix to our 13(b) authority is badly needed,” says Sam Levine.

MSN Hit With Temporary Pause On Entresto Generic As US Patent Runs Its Course

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.

FTC Proposed Rule Change Targeting Direct Sellers Gets Direct Challenge From Incoming GOP Majority

FTC seeks comment on three proposals to “strengthen the agency’s tools to curb deceptive earnings claims in industries where they are pervasive: multi-level marketing programs and money-making opportunities.” However, Republican members say they’ll reconsider the proposals as a majority after Trump takes office.

Teva Leapfrogs One ANDA Sponsor But Faces Decade Wait On US Firdapse Opportunity

Catalyst saw its share price jump by around 14% after striking what the market termed a favorable patent-litigation settlement agreement with ANDA sponsor Teva over its rare disease drug Firdapse.

European UPC Ruling Refuses Block On Soliris Biosimilars

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 Pays Another $275m Over Price-Fixing

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 Forks Out Another $275m Over Price-Fixing

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.

BeiGene Blocks US Rival To Brukinsa Blockbuster Until 2037

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.