Teva UK Ltd & Ors v Gilead Sciences Inc

Teva UK Ltd & Ors v Gilead Sciences Inc

It is not sufficient for a product to merely fall within the scope of a claim of the basic patent; more is required. The product must embody the inventive advance (technical contribution) of the basic patent. In this case, the inventive advance is Tenofovir disoproxil (TD), not the combination with Emtricitabine. Therefore, the SPC for the combination does not comply with Article 3(a) of the SPC Regulation. The law remains unclear and a reference to the CJEU is necessary for clarification.

Parties
Claimant: TEVA UK LIMITED; Claimant: ACCORD HEALTHCARE LIMITED; Claimant: LUPIN LIMITED and LUPIN EUROPE LIMITED; Claimant: GENERICS (UK) LIMITED trading as MYLAN; Defendant: GILEAD SCIENCES INC
Jurisdiction
England and Wales
Judgment Date
13 January 2017
Procedural Posture
Patent/intellectual Property / Judgment on Validity of SPC and Reference to CJEU
Outcome
Reference to the Court of Justice of the European Union (CJEU) for a preliminary ruling on the interpretation of Article 3(a) of the SPC Regulation.
Legal Topics
Supplementary Protection Certificate (spc), Patent Interpretation, Combination Products, Article 3(a) SPC Regulation, Inventive Advance
Intellectual Property Law Pharmaceutical Law European Union Law Supplementary Protection Certificate (spc) Patent Interpretation Combination Products Article 3(a) SPC Regulation Inventive Advance

Case Brief

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Parties

TEVA UK LIMITED

Claimant

ACCORD HEALTHCARE LIMITED

Claimant

LUPIN LIMITED and LUPIN EUROPE LIMITED

Claimant

GENERICS (UK) LIMITED trading as MYLAN

Claimant

GILEAD SCIENCES INC

Defendant

Procedural Posture

Patent/intellectual Property / Judgment on Validity of SPC and Reference to CJEU

Legal Issues

  1. 1 Whether Gilead's SPC for the combination of Tenofovir disoproxil and Emtricitabine complies with Article 3(a) of Regulation 469/2009/EC (SPC Regulation)
  2. 2 What is required for a product to be 'protected by a basic patent in force' under Article 3(a)
  3. 3 Whether the combination product embodies the inventive advance of the basic patent

Ratio Decidendi

It is not sufficient for a product to merely fall within the scope of a claim of the basic patent; more is required. The product must embody the inventive advance (technical contribution) of the basic patent. In this case, the inventive advance is Tenofovir disoproxil (TD), not the combination with Emtricitabine. Therefore, the SPC for the combination does not comply with Article 3(a) of the SPC Regulation. The law remains unclear and a reference to the CJEU is necessary for clarification.

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 the SPC Regulation.

Orders

  • The question of the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation is referred to the CJEU.