Patents

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.

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.

The US Association for Accessible Medicines is looking to preserve competition by fighting MSN Laboratories’ corner in its ongoing legal battle over Entresto.

The US International Trade Commission has banned smart rings from Ultrahuman and RingConn after Oura Health's patent infringement case. Ultrahuman countersued, claiming Oura infringes its intellectual property. Sales and marketing of the affected rings will cease on October 22.

Cipla has reached a settlement with Theravance Biopharma and Viatris regarding its proposed generic version of Yupelri (revefenacin) once-daily nebulized inhalation solution. Under the agreement, Cipla will not introduce its product into the US market prior to April 2039.

In the Delhi High Court, Natco Pharma has initiated proceedings against Novo Nordisk, requesting a ruling of non-infringement regarding a patent tied to semaglutide, the ingredient in the Danish originator’s Ozempic and Wegovy brands.

Roche and its Genentech subsidiary have sued Shanghai Henlius Biotech and commercialization partner Organon in the US, alleging infringement of 24 patents covering Perjeta (pertuzumab). The litigation follows Roche’s recent disclosure that biosimilars to Perjeta could launch as soon as 2026.

The UPC Court of Appeal has signaled that in pharma disputes, being ready to launch can be as risky as actually launching. In a major setback for Zentiva, the court ruled that completing certain steps well before patent expiry amounted to “setting the stage” for infringement.

Germany’s Federal Patent Court has invalidated Bayer’s key patent covering once-daily use of Xarelto (rivaroxaban), paving the way for Sandoz to launch a generic version. Bayer is considering an appeal.

Dr Reddy’s CEO discusses the growth opportunity for semaglutide, including production capacity and ‘crazy’ demand indications, and a potential 20-plus product GLP-1 portfolio. All eyes are also on an upcoming hearing in India pertaining to Novo Nordisk’s semaglutide patent in the country.