Intellectual Property

Rounding up another important year in the fight against HIV, the MPP’s executive director Charles Gore speaks to Generics Bulletin about the organization’s biggest milestones in the past 12 months.

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.

The fight between Teva and Amneal over the ProAir HFA inhaler has reached another milestone, with the appellate court affirming the previous ruling to delist five patents from the FDA’s Orange Book. However, Teva might not be backing down.

Teva vows to make two of its inhalers more accessible in the US through charity Direct Relief, despite still being tangled up in a lawsuit with Amneal over ProAir HFA. Also, another inhaler maker GSK is scrutinized over its pricey authorized generic alternative.

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.