Intellectual Property

“The principles of fairness in procedural conduct, especially in commercial disputes, is crucial,” Delhi’s High Court told Zydus Lifesciences as it agreed to temporarily block the sale of the firm’s recently launched biosimilar to Roche’s Perjeta.

In a joint proposal with its partners, the Medicines Patent Pool explores challenges in monoclonal antibody equity in low- and middle-income countries and provides actionable solutions to increase development and manufacturing.

Despite the first and only US FDA approval, Jiangsu Hengrui’s US eVenus has been tipped to stay out of the generic Exparel market until at least the end of the 2030s. Generics Bulletin investigates.

US Federal Trade Commission says the policy would enhance its ability to detect reverse payment settlements between pharmaceutical companies that raise antitrust concerns.

In long-running litigation over perindopril ‘pay for delay’ settlements, appeals have been refused and certain earlier findings by Europe’s general court have been set aside in a fresh ruling by the Court of Justice of the EU.

Following reports of the FTC escalating its investigations into Teva over inhaler patents listed in the FDA’s Orange Book, the firm is standing by its intellectual property.

A third US biosimilar to Regeneron’s Eylea has won approval. However, enthusiasm is muted at this stage as biosimilar sponsors, including latest recipient Formycon, continue to battle against court-issued blockades.

Reading Hikma’s press releases and other public documents made it “at least plausible” that a physician would look to prescribe Hikma’s generic Vascepa product for any of its indications, including the highly-valued, patent-protected cardiovascular indication, the US Federal Circuit has decided, reopening a lawsuit against the generics firm.

Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.

In the ongoing fight for fair market competition and improved medication access, the US Congressional Budget Office calculated $3bn in savings from a bill that would prevent originators from product hopping.

Regeneron’s lynchpin US formulation patent for its Eylea 2mg appears to remain a thorn in the side for biosimilar sponsors, as Samsung Bioepis joins Biocon in being blocked from launching its US FDA-approved biosimilar to the near $6bn eye-disease biologic.

Unichem has bowed to Axsome Therapeutics’ IP portfolio and strategy, signing a settlement agreement that will keep the Indian firm’s US generic version of Sunosi from the market until the beginning of the 2040s.

While the European SPC manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

The inhaler patent saga goes on. A US District Court orders Teva to either de-list or correct patents for its inhaler ProAir HFA, but the originator disagrees and gets ready to appeal.

At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Generics Bulletin’s editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA’s Orange Book.