Alvotech Challenges Regeneron's High-Dose Aflibercept Patent in Post-Grant Review
核心洞察
Alvotech filed a petition for post-grant review challenging Regeneron's U.S. Patent No. 12,168,036 covering high-dose aflibercept formulations for treating angiogenic eye disorders (搜索).
The patent covers methods using intravitreal administration of VEGF (搜索) receptor fusion proteins at concentrations of at least 100 mg/ml with specific viscosity requirements.
Alvotech argues the patent is invalid for obviousness and lack of written description, claiming Regeneron previously disclosed similar high-concentration formulations.
Alvotech USA Inc. and Alvotech hf. have filed a petition for post-grant review challenging a key Regeneron Pharmaceuticals patent covering high-dose aflibercept formulations used to treat angiogenic eye disorders (搜索). The September 17, 2025 filing targets U.S. Patent No. 12,168,036, which protects methods underlying Regeneron's EYLEA HD (搜索) therapy.
Patent Details and Claims
The challenged patent, entitled "Methods for treating angiogenic eye disorders (搜索) with high doses of VEGF (搜索) receptor fusion proteins," issued on December 17, 2024. The patent covers methods of treating angiogenic eye disorders using intravitreal administration of high concentration VEGF receptor fusion protein (搜索) formulations with viscosity of about 5-15 centiPoise at 20°C.
Independent claim 1 specifies treatment methods using a volume of "about 100 microliters or less" containing "at least about 8 mg" of a VEGF receptor fusion protein (搜索) at a concentration of "at least 100 mg/ml." Independent claim 35 focuses specifically on aflibercept, covering treatment using "about 70 microliters" of aflibercept at concentrations of "about 103-126 mg/ml."
Alvotech's Challenge Arguments
In petition PGR2025-00085, Alvotech raises four grounds for unpatentability based on obviousness over multiple combinations of prior art, including existing Regeneron patents and publications. The company argues that "Regeneron has repeatedly disclosed high-concentration formulations of aflibercept, including 100 mg/ml and higher, along with the high doses, including up to 10 mg."
Alvotech contends the patent was only granted because Regeneron "convinc[ed] the Examiner" that "the higher-concentration formulations had problems with viscosity, and that Regeneron solved that problem." However, Alvotech maintains that "there was no viscosity problem to be solved" and that the patent "doesn't claim a viscosity-problem solution."
Written Description Challenge
Beyond obviousness arguments, Alvotech challenges the patent's validity for lack of written description. The company argues that "the specification does not show that the inventors possessed formulations reflecting the full scope of the claims that would achieve the required viscosity levels."
According to Alvotech, the patent claims do not "specify any components of the formulation other than the VEGF (搜索) fusion protein itself," and therefore "recite a broad genus of pharmaceutical formulations with functional requirements." The company notes that the "specification discloses only a small number of species that achieve the required viscosity, and all those species contain a buffer."
Commercial Context
The patent challenge directly impacts Regeneron's EYLEA HD (搜索), an 8 mg injection of aflibercept at 114.3 mg/ml concentration that received FDA approval in August 2023. Alvotech is currently developing AVT29, a biosimilar candidate targeting EYLEA HD, positioning this patent challenge as part of the company's broader strategy to enter the high-dose aflibercept market.
The post-grant review represents a significant intellectual property dispute in the ophthalmology space, where high-concentration VEGF (搜索) inhibitor formulations offer potential advantages in treatment frequency and patient convenience for angiogenic eye disorders (搜索).