Sandoz Ltd & Anor v G.D. Searle LLC & Anor

Sandoz Ltd & Anor v G.D. Searle LLC & Anor

The Court of Appeal held that, on current CJEU jurisprudence, a product is protected by a basic patent for SPC purposes if it is specified in the claims, including by a Markush formula, and the claims relate implicitly but necessarily and specifically to the product. However, there is uncertainty as to whether, for a Markush claim, it is sufficient that the product falls within the claim or whether the specific substituents must be derivable from the patent and common general knowledge. The court therefore stayed the appeal and referred a question to the CJEU for clarification.

Parties
Appellant: Sandoz Limited; Appellant: Hexal AG; Respondent: G. D. Searle LLC; Respondent: Janssen Sciences Ireland UC
Jurisdiction
England and Wales
Judgment Date
25 January 2018
Procedural Posture
Civil Appeal / Court of Appeal Judgment on Appeal From High Court (patents Court)
Outcome
Appeal stayed; question referred to the CJEU for a preliminary ruling.
Legal Topics
Supplementary Protection Certificates (spcs), Patent Law, Interpretation of Article 3(a) of Regulation (ec) No 469/2009, Markush Claims, Scope of Patent Protection
Intellectual Property Law Pharmaceutical Law European Union Law Supplementary Protection Certificates (spcs) Patent Law Interpretation of Article 3(a) of Regulation (ec) No 469/2009 Markush Claims Scope of Patent Protection

Case Brief

Summary, issues, holding and outcome

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Parties

Sandoz Limited

Appellant

Hexal AG

Appellant

G. D. Searle LLC

Respondent

Janssen Sciences Ireland UC

Respondent

Procedural Posture

Civil Appeal / Court of Appeal Judgment on Appeal From High Court (patents Court)

Legal Issues

  1. 1 What is the correct test for determining whether a product is 'protected by a basic patent in force' under Article 3(a) of the SPC Regulation?
  2. 2 Does a Markush claim in a patent suffice to protect a specific product for SPC purposes, even if the product is not individually disclosed or commonly known at the priority date?
  3. 3 Is it necessary for the specific substituents of a product to be derivable from the patent and common general knowledge for SPC protection?

Ratio Decidendi

The Court of Appeal held that, on current CJEU jurisprudence, a product is protected by a basic patent for SPC purposes if it is specified in the claims, including by a Markush formula, and the claims relate implicitly but necessarily and specifically to the product. However, there is uncertainty as to whether, for a Markush claim, it is sufficient that the product falls within the claim or whether the specific substituents must be derivable from the patent and common general knowledge. The court therefore stayed the appeal and referred a question to the CJEU for clarification.

Court Disposition

Appeal stayed; question referred to the CJEU for a preliminary ruling.

Orders

  • Proceedings stayed pending CJEU reference.
  • Parties to agree draft order for reference or make submissions in writing if not agreed.