Intellectual Property

On the heels of a decade-long partnership with ViiV Healthcare that has helped 24 million people with HIV, the Medicines Patent Pool introduces a new version of its patent database for essential medicines and COVID-19 vaccines.

More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case.

Generics Bulletin previews the most noteworthy and anticipated events for May 2024.

Vanda looks likely to have to face up to unimpeded US generic competition to its core Hetlioz brand, after a further denial in its litigation against ANDA sponsors Teva and Apotex.

Lupin and Zydus are targeting a market worth at least $1bn a year – and more than $2.4bn all told – after both in quick succession announcing the launch of generic versions of Astellas Pharma’s Myrbetriq treatment for overactive bladder.

The timing of the request, with Xtandi’s loss of exclusivity on the horizon, could be explained by the concern that a change in the US presidential administration in 2025 may limit the prospects for near-term relief.

Norwich Pharmaceuticals looks set for a five-year wait to launch its generic version of Bausch Health’s core Xifaxan, after the Federal Circuit shot down its appeal to a bar on US FDA approval. The generics manufacturer has previously sought to supercharge its approval by carving a patent-protected indication from the label.

Endo’s Par subsidiary insists that long-existing statute for US patent infringement cases should hold off final approval for a supplemental rival to its Adrenalin treatment for anaphylaxis for several years – in contrast to the FDA granting a recent approval to BPI Labs.

Lupin has shown its confidence in its legal position after introducing the first US generic version of Galderma’s rosacea treatment, Oracea, while the originator battles for injunctive relief.

Tipped to bring in sales of $500m or more by 2030, Arcutis Biotherapeutics’ Zoryve 0.3% cream has become the target of an ANDA filed by Padagis, a partner of Sol-Gel Technologies. The originator responded with an immediate suit to shut down any potential generic launch in the near term.

Teva and Viatris hold firm ambitions in the long-acting schizophrenia space, and have just secured a win in their endeavors by convincing the US Court of Appeals for the Federal Circuit that a lower court erred in its analysis of whether a key Invega Sustenna patent was obvious.

Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.

After sending warning letters over more than 100 improper patent listings last year, the FTC has backed Amneal in its attempt to fight ProAir originator Teva over asthma inhalers.

Even though the cost of Tivicay is 25 times higher in Trinidad and Tobago compared to other countries in the region, GSK says that its pricing is based on several factors such as country income classification.

Reacting to the latest position on the EU pharma legislation overhaul adopted by a European Parliament committee – including changes to previous proposals on regulatory data protection – Medicines for Europe said that the “imperfect” compromise nevertheless offers improvements.

The draft regulation, which includes a ban on exports of drugs manufactured under an EU compulsory license, will be discussed with the EU member states after the June parliamentary elections.