Regeneron Pharmaceuticals, Inc. has secured a victory against Viatris, Inc. after a West Virginia judge ruled Viatris’ proposed biosimilar violated the patent for Eylea (aflibercept) injection.
Let’s start with Eylea.
Developed by Regeneron and Bayer AG, Eylea is a vascular endothelial growth factor (VEGF) inhibitor administered as an intravitreal injection.
The formulation can be administered as an intravitreal injection 6-8 times a year. For infants with retinopathy of prematurity (ROP), treatment might require extended periods of monitoring.
Note: Eylea was most recently approved by the FDA in February 2023 with a new indication for ROP treatment in preterm infants.
Prior to that, it was approved for the following retinal diseases:
- Wet age-related macular degeneration (AMD)
- Macular edema following retinal vein occlusion (RVO)
- Diabetic macular edema (DME)
- Diabetic retinopathy (DR)
Now this lawsuit … I need some background.
Back in 2021, Mylan Pharmaceuticals, Inc. (a subsidiary of Viatris), submitted an application to formulate an Eylea biosimilar.
Then, in August 2022, Regeneron filed a lawsuit in August 2022 against Mylan, accusing the company of infringement on the U.S. Patent No 11,084,865 B2 as well as an initial 24 patents that were later cut down to three—for Eylea.
A two-week trial was scheduled for June 2023.
That’s a pretty quick turnaround.
Indeed. That’s because Regeneron sought an expedited trial in order to potentially gain the benefit of a “statutory permanent injunction” that would prohibit any future infringement of the patent before its expiration (pending the court’s final decision in the case).
Talk about this ’865 patent.
Filed in January 2020 and granted in August 2021, Regeneron’s US 11,084,865 B2 (‘865) patent pertains to “ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist” deemed to be “suitable for intravitreal administration to the eye” and “include a stable liquid formulation and a lyophilizable formulation.”
See here for the full description.
Now this court decision.
Decided in the U.S. District Court or the Northern District of West Virginia, the judge ruled that Regeneron demonstrated enough evidence to support its “infringement claims” against Mylan for eight claims (4, 7, 9, 11, 14, 15, 16, and 17) relating to the ’865 patent.
The court also determined that the company demonstrated enough evidence that Mylan would “induce infringement” on two claims each for the company’s two other patents, which are directed to dosing regimens for Eylea.
- 11,253,572 (‘572) patent for claims 6 and 25
- 10,888,601 (’601) patent for claims 11 and 19
What does this mean for validity?
The court ruled that Mylan proved claims 6 and 25 (’572 patent) and claims 11 and 19 (’601 patent) were “invalid as obvious.”
Interesting… so what’s the expiration date on each of these patents?
- ’865 patent
- Expiration: June 2027
- ’601 patent
- Expiraton: January 2032
- ’572 patent
- Expiration: January 2032
Gotcha. This lawsuit sounds familiar…
Not surprising. Regeneron is also involved in a few other lawsuits involving proposed Eylea biosimilars (such as Formycon AG’s and Samsung Bioepis)—both filed in November 2023.
See here for our coverage on the company’s lawsuit against Celltrion Inc (also filed in November 2023), filed for the latter’s proposed production and marketing of yet another biosimilar version of Eylea.
And earlier last year (May 2023)—with a potential biosimilar of their own in mind—Amgen Inc. sought to unseal documents from the Regeneron-Viatris lawsuit, arguing the public should have access to the fillings with “potentially dispositive allegations” of the patents being unenforceable.
*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.