Legal & IP
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.
“Section viii cannot function as Congress intended,” if a Federal Circuit ruling stands, the US solicitor general has argued as he urged the Supreme Court to review and reverse the closely-watched Hikma skinny-label Vascepa case.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
Delaware district court refuses to shorten 30-month stay, leaving Hopewell unable to launch its generic Mavenclad product.
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.