Actavis Group PTC EHF & Anor v Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat) (20 September 2012)

Actavis Group PTC EHF & Anor v Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat) (20 September 2012)

The court held that the criteria for determining whether a combination product is 'protected by a basic patent' under Article 3(a) of Regulation (EC) No 469/2009 are unclear and require a further reference to the CJEU. The inventive advance of the patent lies in the disclosure of irbesartan, not in its combination with a diuretic such as HCT. Therefore, a combination of irbesartan and HCT does not embody the inventive advance of the patent and is not 'protected by' the patent within the meaning of Article 3(a).

Citation
[2012] EWHC 2545 (Pat)
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 After Expedited Trial
Outcome
Reference to the Court of Justice of the European Union (CJEU) for a preliminary ruling on the interpretation of Article 3(a) of Regulation (EC) No 469/2009; no final determination on validity of the Combination SPC.
Legal Topics
Supplementary Protection Certificates (spc), Patent Construction, Validity of Spcs, Interpretation of Regulation (ec) No 469/2009, Combination Pharmaceutical Products
Intellectual Property Law Pharmaceutical Law European Union Law Supplementary Protection Certificates (spc) Patent Construction Validity of Spcs Interpretation of Regulation (ec) No 469/2009 Combination Pharmaceutical Products

Case Brief

Summary, issues, holding and outcome

More case intelligence is available

Unlock the full research layer for this judgment.

Full judgment text Downloadable case file Legal principles 3 Authorities cited 15 Party arguments 2 Amounts and remedies 10
Sign in to unlock

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 After Expedited Trial

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 supplementary protection certificate (SPC) for the combination product is precluded by Articles 3(c) and 3(d) of the Regulation

Ratio Decidendi

The court held that the criteria for determining whether a combination product is 'protected by a basic patent' under Article 3(a) of Regulation (EC) No 469/2009 are unclear and require a further reference to the CJEU. The inventive advance of the patent lies in the disclosure of irbesartan, not in its combination with a diuretic such as HCT. Therefore, a combination of irbesartan and HCT does not embody the inventive advance of the patent and is not 'protected by' the patent within the meaning of Article 3(a).

Court Disposition

Reference to the Court of Justice of the European Union (CJEU) for a preliminary ruling on the interpretation of Article 3(a) of Regulation (EC) No 469/2009; no final determination on validity of the Combination SPC.

Orders

  • A question is referred to the CJEU as to the criteria for deciding whether a product is 'protected by a basic patent in force' under Article 3(a) of Regulation (EC) No 469/2009.