Litigation

The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, according to Chad Landmon, chair of law firm Polsinelli’s Hatch-Waxman & biologics practice.

Hawaii proposes age-restricted sales but, unlike similar bills also filed in Alaska, Massachusetts, Michigan and Washington legislatures, would require behind-the-counter storage to limit consumer access in stores.

Just a few days after Alvotech announced global settlements for its Eylea rival, Samsung Bioepis has followed up with its own agreements with the originators.

A US class action suit alleges that a settlement between Teva and Novo Nordisk illegally delayed generic Victoza for 16 months, kept prices high and transferred an estimated $903m in value to Teva.

Alvotech has ticked off all of the remaining patent-related matters for its aflibercept biosimilar, with multiple market entries expected in 2026.

Lawsuit filed in District of Columba federal court alleges FDA violated the authoritative statement provisions of FD&C Act, Constitutional Avoidance Doctrine and First Amendment by rejecting ANH-USA’s petition to allow 114 science-based health claims sourced directly from federal agencies.

BMS will continue to seek legal recourse even as Zydus Lifesciences launches the world’s first cut-price nivolumab biosimilar in India following a Delhi High Court division bench ruling in favor of the Indian company.

Amarin has hit back over the US Supreme Court’s decision to review skinny-label induced infringement litigation with Hikma over Vascepa (icosapent ethyl).

Marking the latest step in the long-running saga of Hikma and Amarin’s induced infringement dispute over Vascepa (icosapent ethyl), the US Supreme Court has agreed to review the litigation, which cuts to the heart of key issues around skinny-label generics and carved-out indications.

What is the strategic intent behind Aurobindo’s moves to settle a Galafold patent dispute with Amicus Therapeutics, acquire the non-oncology business of compatriot Khandelwal Labs and get full control of a Chinese JV with Shandong Luoxin?

FDA rejects petition asking for approval to use, as health claims for supplements, nutrient–disease statements drawn directly from government publications and public-facing materials produced by NIH, CDC and other federal health agencies.

Unified Patent Court ruling removes legal overhang on cabazitaxel generics already on the European market.