Short Summary
Merck has filed a post‑grant review petition challenging Halozyme’s U.S. Pat. 11,952,600, arguing that the claims lack written description, are not enabled, and are obvious over prior art.
Detailed Summary
In a petition for post‑grant review (PGR2025‑00003), Merck Sharp & Dohme LLC challenges Halozyme’s patent covering engineered human PH20 hyaluronidase proteins. Merck asserts that claims 1‑21 are unpatentable because the specification fails to provide a sufficient written description or enablement for the enormous genus of multiply‑mutated PH20 variants, relying only on single‑mutation examples and a prophetic research plan. Additionally, Merck contends that the D320K mutant claimed in the independent claims would have been obvious to a skilled artisan in 2011 based on Halozyme’s own ’429 patent and the Chao 2007 article, rendering those claims unpatentable under § 103. The petition seeks institution of the PGR and cancellation of all 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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