Actavis Group PTC EHF & Anor v Sanofi Pharma Bristol-Myers Squibb SNC

Actavis Group PTC EHF & Anor v Sanofi Pharma Bristol-Myers Squibb SNC

The judge held that the correct interpretation of Article 3(a) of the Regulation is unclear and requires further guidance from the CJEU. He provisionally concluded that a combination product is only 'protected by' a basic patent if the combination, as distinct from one ingredient, embodies the inventive advance of the patent. Since the inventive advance of the patent lies in the disclosure of irbesartan, not its combination with HCT, the combination SPC may not be valid. The judge also found the interpretation of Article 3(c) unclear and referred both questions to the CJEU.

Parties
Claimant: Actavis Group PTC EHF; Claimant: Actavis UK Limited; Defendant: Sanofi; Claimant by Counterclaim: Sanofi Pharma Bristol-Myers Squibb SNC
Jurisdiction
England and Wales
Judgment Date
20 September 2012
Procedural Posture
Patent/intellectual Property / First Instance Judgment With Reference to CJEU for Preliminary Ruling
Outcome
Reference to the Court of Justice of the European Union for preliminary ruling; no final determination on validity of the Combination SPC pending CJEU answers.
Legal Topics
Supplementary Protection Certificates (spcs), Patent Construction, Combination Therapies, Interpretation of Regulation (ec) No 469/2009, Validity of Spcs, Article 3(a), 3(c), 3(d) of Regulation, Medicinal Product Authorisations
Intellectual Property Law Pharmaceutical Law European Union Law Supplementary Protection Certificates (spcs) Patent Construction Combination Therapies Interpretation of Regulation (ec) No 469/2009 Validity of Spcs +2 more

Case Brief

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Parties

Actavis Group PTC EHF

Claimant

Actavis UK Limited

Claimant

Sanofi

Defendant

Sanofi Pharma Bristol-Myers Squibb SNC

Claimant by Counterclaim

Procedural Posture

Patent/intellectual Property / First Instance Judgment With Reference to CJEU for Preliminary Ruling

Legal Issues

  1. 1 Whether the combination of irbesartan and hydrochlorothiazide (HCT) is 'protected by' the basic patent within Article 3(a) of Regulation (EC) No 469/2009
  2. 2 Whether the grant of a second SPC for a combination product is precluded by Article 3(c) and/or 3(d) of the Regulation when an SPC for irbesartan alone has already been granted

Ratio Decidendi

The judge held that the correct interpretation of Article 3(a) of the Regulation is unclear and requires further guidance from the CJEU. He provisionally concluded that a combination product is only 'protected by' a basic patent if the combination, as distinct from one ingredient, embodies the inventive advance of the patent. Since the inventive advance of the patent lies in the disclosure of irbesartan, not its combination with HCT, the combination SPC may not be valid. The judge also found the interpretation of Article 3(c) unclear and referred both questions to the CJEU.

Court Disposition

Reference to the Court of Justice of the European Union for preliminary ruling; no final determination on validity of the Combination SPC pending CJEU answers.

Orders

  • Two questions of interpretation of Regulation (EC) No 469/2009 referred to the CJEU for preliminary ruling.