Intellectual Property

The Medicines Patent Pool has entered into a partnership with three companies for glecaprevir/pibrentasvir, a WHO-recommended treatment for people living with hepatitis C. The companies join previous generic licensee Mylan and originator AbbVie.

The generics firm essentially paid the brand to keep its product off the market, FTC alleges in case about Opana ER litigation. Endo considered bringing back its original formulation of oxymorphone but instead reached agreement with Impax to share profits of its generic, antitrust suit claims.

Amgen has asserted 34 patents for alleged infringement against Samsung Bioepis, which is the highest number out of the three lawsuits filed by the originator against a denosumab biosimilar maker.

This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.

With concern over the mpox health emergency continuing to build, the Medicines Patent Pool has offered its services to play a part in the global response.

MSN Laboratories will be unable to move forward – for now – with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US after the originator won a stay on the firm’s ANDA pending appeal from the US Court of Appeals For the District of Columbia Circuit.

MSN Laboratories will be unable to move forward – for now – with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US after the originator won a stay on the firm’s ANDA pending appeal from the US Court of Appeals for the District of Columbia Circuit.

Letter to US FDA by a bipartisan group of House members cites clinical trials sponsored by Eli Lilly and Pfizer as examples of a widespread industry practice. But any legislation to curtail such practices is not expected to be part of the BIOSECURE Act.

Spooked by the prospect of earlier-than-expected US generic competition to its powerhouse MS brand Tecfidera, Biogen entered into illicit agreements with PBMs to stifle generic competition while it “scrambled” to switch the market to its follow-on brand, a US class action lawsuit alleges.

Amgen has asserted 34 patents for alleged infringement against Samsung Bioepis, which is the highest number out of the three lawsuits filed by the originator against a denosumab biosimilar maker.

A US district court in Delaware was at times withering in its appraisals of Novartis’ defenses as it refused to grant an order that would block ANDA sponsor MSN Labs from selling a generic version of the multi-billion-dollar blockbuster Entreso.

Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

Sandoz has celebrated a US FDA approval for its Enzeevu biosimilar rival to Eylea. However, ongoing court proceedings make launch timing uncertain.

Citizen petitions, Hatch-Waxman, and now a lawsuit against the FDA itself: Novartis continues to fight tooth and nail to protect its core $3bn Entresto brand in the US, following the latest agency approval of a generic version. Generics Bulletin dives into the originator’s complaint against the FDA.

Sun’s chief Dilip Shanghvi talks about partnering intent for the firm’s GLP-1 candidate, which he hopes can complete studies in an accelerated timeframe, while legal action in the US has a cast a shadow on launch timelines of the Indian drug maker's alopecia areata treatment.

The shake up in the US presidential campaign line up could have implications for future drug pricing policies. VP Kamala Harris has been an advocate for “march in” rights and could push that policy harder than incumbent President Joe Biden.

A Hatch-Waxman case in Delaware stemming from AMTA Labs’ proposed generic version of Upsher-Smith’s Qudexy XR (topiramate) extended-release capsules has closed with a swift settlement.

A New York district court ordered the asset freeze after finding that the owners of H&H Wholesale Services had concealed or gambled away money owed to Abbott. The company was ordered to pay Abbott $33m in 2023 for distributing test strips authorized for sale only outside the US.

US Customs and Border Protection ruled that Apple’s ECG technology doesn’t infringe on AliveCor’s patent and doesn’t have to comply with a previous import ban.

“The principles of fairness in procedural conduct, especially in commercial disputes, is crucial,” Delhi’s High Court told Zydus Lifesciences as it agreed to temporarily block the sale of the firm’s recently launched biosimilar to Roche’s Perjeta.