NAPP Pharmaceutical Holdings Ltd v Dr Reddy's Laboratories (UK) Ltd & Anor

NAPP Pharmaceutical Holdings Ltd v Dr Reddy's Laboratories (UK) Ltd & Anor

The claim percentages in the Patent refer to the composition of the finished product (outputs), not the input ingredients. The numerical limits are expressed to the nearest whole number, with 'about 10%' interpreted as a small permitted imprecision (≥9.0 to <11.0 %-wt). On the evidence and statistical analysis, neither Sandoz’s nor Dr Reddy’s product falls within the claim, and any possible infringement would be de minimis. Therefore, there is no actionable threat of infringement and no relief is warranted.

Parties
Claimant: Napp Pharmaceutical Holdings Limited; First Defendant: Dr Reddy’s Laboratories (UK) Limited; Second Defendant: Sandoz Limited
Jurisdiction
England and Wales
Judgment Date
28 June 2016
Procedural Posture
Patent Infringement and Quia Timet Claim / Judgment After Expedited Trial
Outcome
Claim dismissed; no infringement found; no injunction or other relief granted.
Legal Topics
Patent Infringement, Quia Timet Injunctions, Statistical Evidence in Patent Cases, Interpretation of Numerical Ranges in Claims, De Minimis Principle, Remedies for Patent Infringement
Intellectual Property Law Patent Law Patent Infringement Quia Timet Injunctions Statistical Evidence in Patent Cases Interpretation of Numerical Ranges in Claims De Minimis Principle Remedies for Patent Infringement

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Parties

Napp Pharmaceutical Holdings Limited

Claimant

Dr Reddy’s Laboratories (UK) Limited

First Defendant

Sandoz Limited

Second Defendant

Procedural Posture

Patent Infringement and Quia Timet Claim / Judgment After Expedited Trial

Legal Issues

  1. 1 Whether Sandoz and Dr Reddy’s proposed buprenorphine transdermal patches infringe European Patent (UK) No. 2 305 194 ('the Patent')
  2. 2 Proper construction of the claim, specifically whether composition percentages refer to inputs or outputs
  3. 3 Interpretation of numerical limits and the term 'about' in the claim

Ratio Decidendi

The claim percentages in the Patent refer to the composition of the finished product (outputs), not the input ingredients. The numerical limits are expressed to the nearest whole number, with 'about 10%' interpreted as a small permitted imprecision (≥9.0 to <11.0 %-wt). On the evidence and statistical analysis, neither Sandoz’s nor Dr Reddy’s product falls within the claim, and any possible infringement would be de minimis. Therefore, there is no actionable threat of infringement and no relief is warranted.

Court Disposition

Claim dismissed; no infringement found; no injunction or other relief granted.

Orders

  • No injunction granted against Sandoz or Dr Reddy’s.
  • No declaration of non-infringement necessary as products do not fall within the claim.