Merck Sharp & Dohme Ltd v Ono Pharmaceutical Co Ltd & Anor [2015] EWHC 2973 (Pat) (22 October 2015)

Merck Sharp & Dohme Ltd v Ono Pharmaceutical Co Ltd & Anor [2015] EWHC 2973 (Pat) (22 October 2015)

The claims as granted were found invalid for lack of inventive step (obviousness) over the prior art and common general knowledge. The judge held that, at the priority date, the skilled team would have found it obvious to try anti-PD-1 antibodies for cancer treatment, given the analogy with CTLA-4 and the state of knowledge regarding the PD-1 pathway. The conditional amendment to limit the claims to melanoma treatment was allowed, and in that amended form, the claims were found to be novel, sufficiently enabled, and entitled to the first priority date, but still obvious and therefore invalid.

Citation
[2015] EWHC 2973 (Pat)
Parties
Claimant: Merck Sharp & Dohme Limited; Defendant: Ono Pharmaceutical Co. Limited; Defendant: Tasuku Honjo; Claimant: Bristol Myers Squibb Company; Claimant: Ono Pharmaceutical Co. Limited; Claimant: Tasuku Honjo; Defendant: Merck & Co. Inc.; Defendant: Merck Sharp & Dohme Limited
Jurisdiction
England and Wales
Judgment Date
22 October 2015
Procedural Posture
Patent Infringement and Validity Proceedings / First Instance Judgment
Outcome
Patent claims as granted and as conditionally amended found invalid for obviousness; amendment to limit claims to melanoma treatment allowed; no injunction granted; parties to agree appropriate royalty if necessary.
Legal Topics
Patent Validity, Patent Infringement, Obviousness, Novelty, Priority Entitlement, Insufficiency, Added Matter, Cancer Immunotherapy, Antibody Therapy
Intellectual Property Patents Biotechnology Patent Validity Patent Infringement Obviousness Novelty Priority Entitlement +4 more

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Parties

Merck Sharp & Dohme Limited

Claimant

Ono Pharmaceutical Co. Limited

Defendant

Tasuku Honjo

Defendant

Bristol Myers Squibb Company

Claimant

Ono Pharmaceutical Co. Limited

Claimant

Tasuku Honjo

Claimant

Merck & Co. Inc.

Defendant

Merck Sharp & Dohme Limited

Defendant

Procedural Posture

Patent Infringement and Validity Proceedings / First Instance Judgment

Legal Issues

  1. 1 Whether claims 1 and 3 of EP (UK) 1 537 878 are novel over cited prior art
  2. 2 Whether the claims are obvious in light of prior art and common general knowledge
  3. 3 Whether the claims are entitled to the first priority date

Ratio Decidendi

The claims as granted were found invalid for lack of inventive step (obviousness) over the prior art and common general knowledge. The judge held that, at the priority date, the skilled team would have found it obvious to try anti-PD-1 antibodies for cancer treatment, given the analogy with CTLA-4 and the state of knowledge regarding the PD-1 pathway. The conditional amendment to limit the claims to melanoma treatment was allowed, and in that amended form, the claims were found to be novel, sufficiently enabled, and entitled to the first priority date, but still obvious and therefore invalid.

Court Disposition

Patent claims as granted and as conditionally amended found invalid for obviousness; amendment to limit claims to melanoma treatment allowed; no injunction granted; parties to agree appropriate royalty if necessary.

Orders

  • Claims as granted held invalid for obviousness
  • Conditional amendment to limit claims to melanoma treatment allowed