Actavis Group and Actavis (Judgment of the Court) [2013] EUECJ C-443/12 (12 December 2013)

Actavis Group and Actavis (Judgment of the Court) [2013] EUECJ C-443/12 (12 December 2013)

Article 3(c) of Regulation (EC) No 469/2009 precludes a patent holder from obtaining more than one SPC for the same active ingredient based on the same patent, even if the subsequent medicinal product contains that active ingredient in combination with another not protected as such by the patent.

Source-derived case information.

Citation
[2013] EUECJ C-443/12
Parties
Claimant: Actavis Group PTC EHF; Claimant: Actavis UK Ltd; Respondent: Sanofi; Respondent: Sanofi Pharma Bristol-Myers Squibb SNC
Jurisdiction
European Union
Judgment Date
12 December 2013
Procedural Posture
Preliminary Ruling / Reference From National Court
Outcome
Second SPC for irbesartan-hydrochlorothiazide combination may not be granted; Article 3(c) precludes it.
Legal Topics
Supplementary Protection Certificate, Patent Law, Medicinal Products, Regulation (ec) No 469/2009
Intellectual Property Pharmaceutical Law European Union Law Supplementary Protection Certificate Patent Law Medicinal Products Regulation (ec) No 469/2009

Source-derived case record

Summary, issues, holding and outcome

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Parties

Actavis Group PTC EHF

Claimant

Actavis UK Ltd

Claimant

Sanofi

Respondent

Sanofi Pharma Bristol-Myers Squibb SNC

Respondent

Procedural Posture

Preliminary Ruling / Reference From National Court

Legal Issues

  1. 1 Whether Article 3(c) of Regulation (EC) No 469/2009 precludes the grant of more than one supplementary protection certificate (SPC) for the same active ingredient based on the same patent
  2. 2 Criteria for determining if a product is protected by a basic patent under Article 3(a) of Regulation (EC) No 469/2009

Ratio Decidendi

Article 3(c) of Regulation (EC) No 469/2009 precludes a patent holder from obtaining more than one SPC for the same active ingredient based on the same patent, even if the subsequent medicinal product contains that active ingredient in combination with another not protected as such by the patent.

Court Disposition

Second SPC for irbesartan-hydrochlorothiazide combination may not be granted; Article 3(c) precludes it.

Orders

  • No need to answer Question 1.
  • Costs are a matter for the national court.