Intellectual Property

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.

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.

Paul Hudson has acknowledged the firm’s R&D setbacks but says they are par for the course when tackling science ‘that has never been done before.’

Conclusion of India-EU talks sets ground for a free trade agreement to cut pharma tariffs, in turn lowering the cost for novel drugs like Novo’s obesity treatment Wegovy, though an investment protection agreement – likely influencing data exclusivity – will be concluded later.

An India-EU trade deal sets ground for a free trade agreement to lower tariffs on pharma, though an investment protection agreement – likely influencing data exclusivity – will be concluded later. Will the US now reconsider its India tariffs?

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.

After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.

After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.

Dr Reddy's had not ruled out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

Dr. Reddy's doesn’t fully rule out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

Beximco said it will manufacture a generic rival to Vertex’s Trikafta, offering cystic fibrosis patients a much-needed cheaper alternative. However, people will be subject to domestic personal use importation laws to access the drug.

Roche, which faced a high stakes patent setback for Evrysdi in India, appears to have appealed against a lower court’s ruling, which went decisively Natco’s way but also included distinct 'reservations' by the judges.