Celltrion said on Friday that it won the first trial of two patents (Patent No. US 9254338, US 9669069) against Regeneron, a leading biotechnology company in the United States.
The lawsuit regards a U.S. patent on the treatment of angiogenic ophthalmic diseases of Eylea (ingredient: aflibercept), an original drug for the CT-P42 biosimilar which Celltrion is developing.
Accordingly, Celltrion has been jointly participating in the Inter Partes Review (IPR) filed by Mylan against the original drug developer, Regeneron, in May 2021 through a December 2021 litigation. Approximately 11 months later, the U.S. Patent Tribunal ruled in favor of Celltrion in the first trial.
The expiration dates of the two patents are January and May 2032, respectively. If Celltrion and other joint litigants win the other U.S. patent invalidation lawsuit, CT-P42 will be able to enter the U.S. market swiftly after the development is completed, said a Celltrion representative.
Previously, Celltrion filed a lawsuit for invalidation of another Regeneron patent (Patent No. US 10,857,231) related to Eylea’s formulation in September 2021, leading to the victory of the invalidation suit in March earlier this year.
Meanwhile, Celltrion completed recruiting global phase 3 clinical patients for CT-P42 in April and is conducting comparative studies on the efficacy and safety of original drugs, pharmacokinetics, and immunogenicity for diabetic macular edema (DME) patients in 13 countries, including Germany and Spain.
Eylea’s substance patents are scheduled to expire in June 2023 and May 2025 in the U.S. and Europe respectively. However, the expiration date of market exclusivity in the U.S. has been extended to May 2024, with the recent approval of pediatric exclusivity. In this regard, Celltrion plans to commercialize CT-P42 quickly in time for the expiration of the original drug's substance patent and monopoly rights.
"Based on this victory in the first trial of the U.S. patent invalidation, we expect CT-P42 to enter the U.S. market smoothly," a Celltrion official said. "We will focus on product development so that high-quality biopharmaceuticals can be provided to patients with eye diseases in the U.S."