In a win for Regeneron, Novartis' syringe for AMD drug declared 'unpatentable'

2023-01-26

专利侵权临床结果

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea. The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea. In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021. The patent in question is dubbed ‘631, which relates to a syringe for into-the-eye injections, had multiple “purported foreign priority applications” and specifications related to the syringe and the delivery of the therapeutic. The patent case had a total of 26 claims attached, with Regeneron challenging each claim. The case looked at several factors, including the “ordinary skill in the art” threshold, commercial success and prior failures. The Patent Trial and Appeal Board ended up ruling that all claims for the ‘631 patent are “unpatentable.” This clears a hurdle for one of Regeneron’s major sellers. Eylea, according to Regeneron’s Q3 results, earned more than $1.6 billion in sales and was granted an additional six months of “pediatric exclusivity” by the FDA. Regeneron and Novartis have been duking it out in the AMD field for a while now, but more competitors have been tossing their hats into the ring with the approval of Roche/Genentech’s Susvimo . Novartis is no stranger to patent cases. In 2020 the Big Pharma picked up a win in a long-running patent fight against generic versions of its multiple sclerosis drug. It announced that the validity of its dosing regimen for Gilenya was upheld by the US District Court of Delaware.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构