Regeneron Celebrates Legal Win: Court Upholds Eylea Medication Patent

Wednesday, a court ruling that found Viatris Inc's VTRS replica of Regeneron Pharmaceuticals Inc's REGN eye drug, Eylea (aflibercept), violated patent rights.

The decision from the U.S. District Court for the Northern District of West Virginia notes that Viatris (formerly Mylan) has not shown clear and convincing evidence supporting the anticipation or obviousness, under prior art, of claims 4, 7, 9, 11, 14, 15, 16, and 17 of the ’865 Patent, nor their invalidity under 35 U.S.C. § 112 due to lack of written description, enablement, or indefiniteness. 

Regarding claim 6 of the ’572 Patent, Mylan has demonstrated clear and convincing evidence of its invalidity. 

Additionally, for claim 25 of the ’572 Patent, Mylan has not provided clear and convincing evidence supporting its anticipation but has demonstrated clear and convincing evidence of its invalidity.

Moreover, Mylan has not substantiated, with clear and convincing evidence, the anticipation of Claim 11 of the ‘601 Patent, whereas it has successfully demonstrated its invalidity. 

Similarly, Mylan has proven, by clear and convincing evidence, the obviousness leading to the invalidity of Claim 19 of the ‘601 Patent.

The legal tussle was initiated in August 2022 when Regeneron filed a lawsuit against Viatris’ Mylan unit, alleging the infringement of 24 patents associated with the retinal disease treatment through its proposed biosimilar version of Eylea. 

Eventually, the lawsuit was narrowed down to contesting three patents, Bloomberg noted.

Citing BMO Capital Markets analyst Bloomberg highlighted the potential for a settlement that could pave the way for Regeneron to introduce a full high-dosage variant of Eylea, termed Eylea HD. 

Expressing contentment with the court’s ruling, Regeneron emphasized its extensive investment in the design and development of Eylea over numerous years. 

Price Action: REGN shares are down 2.84% at $849.53 premarket on the last check Thursday. VTRS shares are down 0.19% at $10.75.