Dr Reddy's Laboratories (UK) Ltd & Anor v Warner-Lambert Company LLC [2012] EWHC 3715 (Pat) (20 December 2012)

Dr Reddy's Laboratories (UK) Ltd & Anor v Warner-Lambert Company LLC [2012] EWHC 3715 (Pat) (20 December 2012)

The extension to the SPC for atorvastatin was validly granted because the PIP was lawfully approved and complied with, Article 45(3) did not apply as all studies in the PIP were initiated after the Regulation came into force, and even if there was a technical breach, the court would exercise its discretion not to revoke the extension.

Citation
[2012] EWHC 3715 (Pat)
Parties
Claimant: Dr Reddy's Laboratories (UK) Ltd; Claimant: Dr Reddy's Laboratories Ltd; Defendant: Warner-Lambert Company LLC
Jurisdiction
England and Wales
Judgment Date
20 December 2012
Procedural Posture
Patent/regulatory Challenge / Judgment After Trial
Outcome
Claim dismissed
Legal Topics
Supplementary Protection Certificate (spc), Paediatric Regulation (ec) 1901/2006, Marketing Authorisation, Judicial Review of Regulatory Decisions
Intellectual Property Law Pharmaceutical Regulation European Union Law Supplementary Protection Certificate (spc) Paediatric Regulation (ec) 1901/2006 Marketing Authorisation Judicial Review of Regulatory Decisions

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Parties

Dr Reddy's Laboratories (UK) Ltd

Claimant

Dr Reddy's Laboratories Ltd

Claimant

Warner-Lambert Company LLC

Defendant

Procedural Posture

Patent/regulatory Challenge / Judgment After Trial

Legal Issues

  1. 1 Whether the extension to the SPC for atorvastatin was validly granted under Article 36 of the Paediatric Regulation
  2. 2 Whether the Paediatric Investigation Plan (PIP) was lawfully approved and complied with
  3. 3 Whether Article 45(3) of the Paediatric Regulation applies to the grant of the paediatric extension

Ratio Decidendi

The extension to the SPC for atorvastatin was validly granted because the PIP was lawfully approved and complied with, Article 45(3) did not apply as all studies in the PIP were initiated after the Regulation came into force, and even if there was a technical breach, the court would exercise its discretion not to revoke the extension.

Court Disposition

Claim dismissed

Orders

  • The challenge to the validity of the paediatric extension is dismissed.
  • No order for revocation of the paediatric extension.