Short Summary
Merck has filed a post‑grant review petition challenging Halozyme’s U.S. Patent 12,077,791 covering modified PH20 hyaluronidase proteins. The petition asserts that the claims are overly broad and lack both written description and enablement under 35 U.S.C. §112(a). Merck seeks institution of the proceeding and cancellation of all claims.
Detailed Summary
In a petition for post‑grant review of U.S. Patent No. 12,077,791, Merck Sharp & Dohme LLC challenges Halozyme’s claims to modified human PH20 hyaluronidase polypeptides. The claims define a genus of proteins that may contain a substitution at position 309 and up to twenty additional substitutions, encompassing between 10^49 and 10^60 distinct variants. Merck argues that the patent’s specification provides no representative examples, structural “blaze marks,” or a workable method for producing the full scope, rendering the claims invalid for lack of written description and enablement under 35 U.S.C. §112(a). The petition requests that the PTAB institute the trial and invalidate all ten challenged claims.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before local courts. Understanding the court's reasoning in Merck Sharp & Dohme LLC vs Halozyme, Inc. et al. is valuable context for structuring arguments or assessing risk in similar proceedings.
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