Regeneron Pharmaceuticals just won its patent case against Novartis AG, with the U.S. court ruling for protection of its Eylea (aflibercept) drug delivery system, used for the treatment of retinal diseases such as age-related macular degeneration (AMD), wet AMD, macular edema, and diabetic retinopathy (DR).
I need some background.
Novartis filed a complaint in 2020 to the U.S. International Trade Commission that some of Regeneron’s pre-filled intravitreal injectable syringes— and Eylea delivery system—were in violation of its patent for Lucentis (ranibizumab). Regeneron then submitted a request for reconsideration of Novartis’s claims in 2021.
What’s the difference between Eylea and Lucentis?
While the two eye drugs have similar safety and efficacy profiles for treating wet AMD, Eylea is administered into the eye by injection between 6 to 8 times per year; Lucentis, in contrast, is administered into the eye on a monthly basis. (via)
Talk about this patent.
According to the Patent Trial and Appeal Board, the patent (dubbed “the ‘631 patent”), “relates to a syringe, particularly to a small volume syringe such as a syringe suitable for ophthalmic injections” had multiple “purported foreign priority applications” and specifications related to the syringe and delivery of the therapeutic. (via)
Regeneron challenged each of the 26 claims attached to the patent.
So what happened in the case?
Several factors were considered, including the “ordinary skill in the art” threshold, commercial success of the drug, and prior failures. The court determined that, due to the preponderance of evidence Regeneron provided, all 26 claims were “unpatentable.” (via)
Significance?
Regeneron just scored a major win; generating over $1.6 billion in revenue (according to the company’s Q3 financial report), Eylea is one of the company’s biggest revenue-earning products on the market.
And with its patent firmly in place, Eylea can continue to be marketed without any generic version competition in the U.S. until approximately 2028. (via)