Sandoz Ltd & Anor v G.D. Searle LLC & Anor [2017] EWHC 987 (Pat) (03 May 2017)

Sandoz Ltd & Anor v G.D. Searle LLC & Anor [2017] EWHC 987 (Pat) (03 May 2017)

Darunavir is 'protected' by the Patent within the meaning of Article 3(a) of the SPC Regulation because it falls within the claims of the Patent, which specify the product by means of a Markush formula covering it. The inventive advance of the claim lies in the identification of compounds as HIV protease inhibitors, which darunavir embodies. There is no tenable interpretation of Article 3(a) that would exclude darunavir from protection. Objections as to the breadth of the claim are objections to the validity of the Patent, not to the validity of the SPC, and the Patent's validity was not put in issue.

Citation
[2017] EWHC 987 (Pat)
Parties
Claimant: Sandoz Limited; Claimant: Hexal AG; Defendant: G. D. Searle LLC; Defendant: Janssen Sciences Ireland UC
Jurisdiction
England and Wales
Judgment Date
03 May 2017
Procedural Posture
Patent Revocation and Counterclaim for Injunction / Judgment After Trial
Outcome
Claim dismissed
Legal Topics
Supplementary Protection Certificates (spc), Patent Claims Interpretation, Markush Claims, Article 3(a) SPC Regulation, Validity of Spcs
Intellectual Property Pharmaceutical Law European Union Law Supplementary Protection Certificates (spc) Patent Claims Interpretation Markush Claims Article 3(a) SPC Regulation Validity of Spcs

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Parties

Sandoz Limited

Claimant

Hexal AG

Claimant

G. D. Searle LLC

Defendant

Janssen Sciences Ireland UC

Defendant

Procedural Posture

Patent Revocation and Counterclaim for Injunction / Judgment After Trial

Legal Issues

  1. 1 Whether darunavir is 'protected' by the basic patent within the meaning of Article 3(a) of the SPC Regulation
  2. 2 Whether a Markush claim can specify or identify a product for SPC purposes
  3. 3 Whether the SPC for darunavir is valid

Ratio Decidendi

Darunavir is 'protected' by the Patent within the meaning of Article 3(a) of the SPC Regulation because it falls within the claims of the Patent, which specify the product by means of a Markush formula covering it. The inventive advance of the claim lies in the identification of compounds as HIV protease inhibitors, which darunavir embodies. There is no tenable interpretation of Article 3(a) that would exclude darunavir from protection. Objections as to the breadth of the claim are objections to the validity of the Patent, not to the validity of the SPC, and the Patent's validity was not put in issue.

Court Disposition

Claim dismissed

Orders

  • Claimants' claim for revocation of the SPC is dismissed
  • Further argument to be heard on relief for Defendants' counterclaim for injunction