Intellectual Property

The US PTO faces criticism after withdrawing a proposed rule intended to address double-patenting by changing terminal disclaimers.

The US PTO is facing criticism after withdrawing a proposed rule that sought to address double-patenting with changes to terminal disclaimers.

Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs.

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.

Biogen has struck another blow against European generic competitors to Tecfidera, after the European Patent Office upheld a dosage patent for the brand that runs until February 2028. Meanwhile, the firm reported flat biosimilars sales in the third quarter of 2024.

Sandoz has indicated that Amgen’s recently-announced at-risk US launch of a rival to Eylea doesn’t change its thinking around launch timing for its own FDA-approved aflibercept biosimilar.

The latest twist in MSN’s legal fight with Novartis over Entresto has seen a US court rule that the FDA was correct to approve MSN’s skinny-label generic, which carves out certain protected Entresto indications. However, an appeal has already been filed and an imminent generic launch looks unlikely.

In the space of a few days, all four generics manufacturers that had successfully petitioned for a re-examination of a key patent shielding Novo Nordisk’s mega blockbuster Ozempic have reached settlement agreements terminating their challenges.

Fresenius Kabi is facing up to a patent-litigation suit over its proposed biosimilars to Amgen’s Prolia/Xgeva brands – although a prior lawsuit involving biosimilar sponsor Sandoz concluded with a settlement agreement.

The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.