Legal & IP

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.

Sandoz has heralded the onset of biosimilar competition to Eylea in Europe with the launch of its Afqlir version. Meanwhile, the firm has also struck up a further ranibizumab alliance with Formycon in Germany.

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.

A federal judge in Hawaii ruled the FDA failed to consider statutory factors relevant to the REMS and provide a “reasoned explanation” for its restrictive treatment of the drug, but remand could result in an agency determination that more extensive restrictions are needed.

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

The AAM has asked for a federal injunction to block a Connecticut state law on drug pricing that it says represents “an unconstitutional overreach that threatens patient access to affordable medicines.”

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.

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.

Thanks to settlements with three generic challengers – Cipla, Laurus Labs and Lupin – Gilead says it has now kept competition to its $13bn Biktarvy brand off the US market until April 2036.

MSN Laboratories has won another legal case against Novartis that will allow it to keep hold of its US Food and Drug Administration approval for its generic version of Entresto.

Another biosimilar sponsor has put pen to paper on a settlement agreement allowing for launch of a US Eylea (aflibercept) rival in the second half of 2026.

Samsung Bioepis will not be able to add an ulcerative colitis indication to its ustekinumab biosimilar in the Netherlands for now, after failing to have a key patent revoked.

With the potentially catastrophic impact of the EU’s Urban Wastewater Treatment Directive continuing to loom large for the off-patent sector, industry representatives have welcomed an intervention by French and German leaders calling on policymakers to simplify the legislation’s requirements.

Sandoz has been given the go-ahead to introduce the first biosimilar to Eylea in Australia following a favorable court ruling denying a temporary injunction.

Generics manufacturers are facing a decade-long wait to launch rivals to AbbVie’s blockbuster Rinvoq (upadacitinib) after settling patent-infringement litigation.

In a newly published report, the US Association for Accessible Medicines highlights the urgent need for legislative reform to deter originators from continuously asserting and litigating patents.