Lilly & Company v Human Genome Sciences Inc

Lilly & Company v Human Genome Sciences Inc

The court has jurisdiction to grant declaratory relief and allow the action to proceed. The SPC Regulation permits patent holders to rely on MAs granted to unconnected third parties. The Specification issue is unclear and requires a reference to the ECJ, but such reference should only be made on established facts after trial. The action is not to be struck out but is stayed pending the outcome of the Main Action on patent validity.

Parties
Claimant: Eli Lilly and Company; Defendant: Human Genome Sciences Inc.
Jurisdiction
England and Wales
Judgment Date
03 August 2012
Procedural Posture
Civil / Ruling on Applications for Strike Out and Immediate Reference to ECJ
Outcome
Action not struck out; stay granted; immediate reference to ECJ refused.
Legal Topics
Supplementary Protection Certificates, Patent Specification, Declaratory Relief, Jurisdiction, Reference to ECJ
Intellectual Property Pharmaceutical Law European Union Law Supplementary Protection Certificates Patent Specification Declaratory Relief Jurisdiction Reference to ECJ

Case Brief

Summary, issues, holding and outcome

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Parties

Eli Lilly and Company

Claimant

Human Genome Sciences Inc.

Defendant

Procedural Posture

Civil / Ruling on Applications for Strike Out and Immediate Reference to ECJ

Legal Issues

  1. 1 Whether a patent holder can obtain an SPC based on a marketing authorisation granted to an unconnected third party
  2. 2 Whether the patent sufficiently specifies the Lilly antibody to support an SPC
  3. 3 Whether the action for declaratory relief should be struck out as premature or hypothetical

Ratio Decidendi

The court has jurisdiction to grant declaratory relief and allow the action to proceed. The SPC Regulation permits patent holders to rely on MAs granted to unconnected third parties. The Specification issue is unclear and requires a reference to the ECJ, but such reference should only be made on established facts after trial. The action is not to be struck out but is stayed pending the outcome of the Main Action on patent validity.

Court Disposition

Action not struck out; stay granted; immediate reference to ECJ refused.

Orders

  • Action for declaratory relief allowed to proceed.
  • Action stayed pending Court of Appeal decision on patent validity.