Dr Reddy's Laboratories (UK) Ltd & Ors v Warner-Lambert Company LLC [2022] EWHC 189 (Pat) (03 February 2022)

Dr Reddy's Laboratories (UK) Ltd & Ors v Warner-Lambert Company LLC [2022] EWHC 189 (Pat) (03 February 2022)

Pfizer is precluded from amending its defence to raise new defences under section 70(2A) of the Patents Act 1977 to the unjustifiable threats claim, as the issue was finally determined by Birss J's order of 16 March 2020. Amendments to exclude damages for off-label use for IPCs are refused as having no realistic prospect of success and being contrary to the established counterfactual approach. Amendments based on the construction of the NHS Guidance Order are refused as drafted but may be permitted if limited to factual foreseeability. Amendments to exclude damages for supply of pregabalin used for IPCs on grounds of illegality or equity are refused as an abuse of process and on case...

Citation
[2022] EWHC 189 (Pat)
Parties
Inquiry Claimant: Dr Reddy's Laboratories (UK) Limited; Inquiry Claimant: Secretary of State for Health and Social Care; Inquiry Claimant: The NHS Commissioning Board (NHS England); Inquiry Claimant: The Welsh Ministers; Inquiry Claimant: The Department of Health in Northern Ireland; Inquiry Claimant: The Regional Health and Social Care Board (Health and Social Care Board); Inquiry Claimant: The Scottish Ministers; Inquiry Claimant: Scottish Health Boards (8-21); Inquiry Defendant: Warner-Lambert Company LLC
Jurisdiction
England and Wales
Judgment Date
03 February 2022
Procedural Posture
Patent Damages Inquiry and Unjustifiable Threats Claim / Application to Amend Pleadings and Related Procedural Applications
Outcome
Pfizer's applications to amend its pleadings are largely refused; some amendments permitted in principle subject to further particulars; Dr Reddy's application to strike out is refused at this stage.
Legal Topics
Cross Undertaking in Damages, Unjustifiable Threats, Patent Infringement, Illegality Doctrine, Case Management, Amendment of Pleadings
Intellectual Property Patents Civil Procedure Cross Undertaking in Damages Unjustifiable Threats Patent Infringement Illegality Doctrine Case Management +1 more

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Parties

Dr Reddy's Laboratories (UK) Limited

Inquiry Claimant

Secretary of State for Health and Social Care

Inquiry Claimant

The NHS Commissioning Board (NHS England)

Inquiry Claimant

The Welsh Ministers

Inquiry Claimant

The Department of Health in Northern Ireland

Inquiry Claimant

The Regional Health and Social Care Board (Health and Social Care Board)

Inquiry Claimant

The Scottish Ministers

Inquiry Claimant

Scottish Health Boards (8-21)

Inquiry Claimant

Warner-Lambert Company LLC

Inquiry Defendant

Procedural Posture

Patent Damages Inquiry and Unjustifiable Threats Claim / Application to Amend Pleadings and Related Procedural Applications

Legal Issues

  1. 1 Whether Pfizer can amend its defence to raise new defences to the unjustifiable threats claim under section 70(2A) of the Patents Act 1977
  2. 2 Whether damages for off-label use of pregabalin for inflammatory pain (IPCs) should be excluded from quantum calculations
  3. 3 Whether amendments based on the construction of the NHS Guidance Order should be permitted

Ratio Decidendi

Pfizer is precluded from amending its defence to raise new defences under section 70(2A) of the Patents Act 1977 to the unjustifiable threats claim, as the issue was finally determined by Birss J's order of 16 March 2020. Amendments to exclude damages for off-label use for IPCs are refused as having no realistic prospect of success and being contrary to the established counterfactual approach. Amendments based on the construction of the NHS Guidance Order are refused as drafted but may be permitted if limited to factual foreseeability. Amendments to exclude damages for supply of pregabalin used for IPCs on grounds of illegality or equity are refused as an abuse of process and on case...

Court Disposition

Pfizer's applications to amend its pleadings are largely refused; some amendments permitted in principle subject to further particulars; Dr Reddy's application to strike out is refused at this stage.

Orders

  • Pfizer refused permission to amend its defence to raise new defences under section 70(2A) to the unjustifiable threats claim.
  • Pfizer refused permission to amend to exclude damages for off-label use for IPCs.