Legal

A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.

EPO Appeal Board overturns earlier ruling and invalidates Biogen’s 480mg Tecfidera patent, clearing the way for broader dimethyl fumarate competition in Europe.

UK ruling clears the way for Alvotech to stockpile its aflibercept biosimilar ahead of Eylea’s SPC expiry later this month, positioning the firm for a day-one launch across Europe and the UK.

Teva has agreed to pay $35m and delist six patents tied to its QVAR asthma inhalers to resolve claims it illegally blocked cheaper generics.

Experts from UCB, Alnylam, Lantheus and Medtronic deliberated at a recent summit best uses of agentic AI in the MLR review process, its human replaceability quotient and ways to balance creativity with compliance, a significant discussion amid DTC advertising and US FDA scrutiny.

Experts from UCB, Alnylam, Lantheus and Medtronic deliberate on the best use of agentic AI in the MLR review process, its human replaceability quotient and ways to balance creativity with compliance, a significant discussion amid DTC advertising and US FDA scrutiny

Sawai’s settlement brings an end to a years-long legal battle over the manufacturing method for the firm’s generic teriparatide injection, following a court ruling that upheld Asahi Kasei’s process patent for its osteoporosis brand Teribone.

The EU’s top court has rejected Teva and Cephalon’s final appeal, ruling that their 2005 settlement to delay a generic version of modafinil was inherently anticompetitive and upheld a €60.5m fine.

The Supreme Court of India has allowed Natco Pharma to continue selling its generic version of Roche’s spinal muscular atrophy drug Evrysdi (risdiplam), declining to interfere with a Delhi High Court order that denied Roche an injunction while the patent infringement case proceeds.

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.

Natco Pharma has begun selling a generic version of Roche’s spinal muscular atrophy drug Evrysdi in India after the Delhi High Court dismissed Roche’s appeal, clearing the company to launch at a price roughly 97% lower than the branded product.

Generics manufacturers have succeeded in overturning a decision awarding Biogen an extra year of market exclusivity for its multiple sclerosis brand Tecfidera.