Legal & IP
The IGBA has introduced its first global intellectual property and competition report, addressing the urgent need to reform current regulations. But, in a bid to increase access to medicines across the world, did it stop short at just IP and patents?
A month after Vanda failed to win a trade secrets case against the US FDA corresponding to generic approvals for its brands Hetlioz and Fanapt, the originator has again fallen, this time to the agency and Teva in the alleged unlawful approval of the Israeli firm’s generic Hetlioz product.
Teva will have to wait until the end of the next decade to launch its proposed generic version of Axsome Therapeutics’ Auvelity treatment for MDD.
While the UK Court of Appeal’s decision in Merck Serono v Comptroller-General will be unwelcome by innovators, it provides much-needed certainty for companies seeking – or seeking to invalidate – supplementary protection certificates based on marketing authorizations for new uses of known active ingredients.
Reporting global Entresto sales of more than $7.8bn in 2024, Novartis spoke to investors on the latest legal dynamics for its best-selling product as the threat of US generic competition from MSN Laboratories continues to loom.
Lannett will recognize the validity and enforceability of pair of US patents shielding the tablet formulation of J&J’s Uptravi (selexipag) blockbuster until 2030, under a consent judgment and order of permanent injunction signed by a judge in a federal district court in Delaware.
Celltrion has shaken hands with Amgen on a settlement agreement for its proposed US rivals to Prolia/Xgeva, as it continues to await approval from the US FDA for its biosimilar denosumab candidates.
The Teva v. Amneal battle over inhaler patents in the FDA’s Orange Book has become a noteworthy case that will impact both branded and generic drug companies. Yet, the clarity over patent listings might be overshadowed by possible future litigations, discussed law firm Polsinelli’s chair Chad Landmon with Generics Bulletin.
“While Vanda developed the brand-name drugs, the trade secret and confidential and proprietary information claimed to have been taken by the government was, in fact, proposed and recommended to Vanda by the FDA,” a US federal court found as it granted summary judgment to the US government.
Teva has filed a complaint in Washington D.C. challenging certain aspects of the drug-pricing provisions of the Inflation Reduction Act as well as Centers for Medicare & Medicaid Services guidance, claiming that the statute will disrupt the balance of innovation and affordability.
Sandoz has reached a confidential settlement agreement after being sued over half-a-dozen US patents shielding Pfizer’s Mektovi.
Sandoz is facing a lengthy wait for its proposed generic version of the touted mega blockbuster Caplyta (lumateperone), while the market waits with anticipation to see if the product’s robust IP can hold up to challenges from an additional six ANDA filers.
A lot can happen in 24 hours, as Novartis can attest. The Swiss originator has managed to win a court order temporarily putting the brakes on MSN’s Entresto ANDA product – just hours after a lower court refused a similar request.
Boehringer Ingelheim “made it more difficult” for doctors to prescribe generic versions of its Spiriva (tiotropium) inhalers, Romania’s Competition Council has found, as it levied a fine of more than $25m on the German originator.
Novartis has been spooked by the potential for MSN Laboratories to launch its generic version of the originator’s $3bn Entresto (sacubitril/valsartan) heart failure brand, filing an emergency motion in an appeals court in Washington DC just days ahead of the proposed expiry of one of Entresto’s US patents.
Catalyst saw its share price jump by around 14% after striking what the market termed a favorable patent-litigation settlement agreement with ANDA sponsor Teva over its rare disease drug Firdapse.
The fight between Teva and Amneal over the ProAir HFA inhaler has reached another milestone, with the appellate court affirming the previous ruling to delist five patents from the FDA’s Orange Book. However, Teva might not be backing down.
Generics Bulletin looks back at a selection of the most significant legal stories from 2024, including a surprising outcome in biosimilars, a major small-molecule generic opportunity, and a flurry of activity over GLP-1s.
Only weeks before arguments were due to be heard in Sun Pharma’s appeal against an unfavorable lower court ruling over patents shielding Orexo’s Zubsolv, the two parties have shaken hands on a settlement agreement.
Fresenius Kabi was unable to persuade a US court that its proposed generic version of Heron Therapeutics’ Cinvanti (aprepitant) injectable emulsion for chemotherapy-induced nausea and vomiting would not infringe a pair of patents stretching into the next decade.