NAPP Pharmaceutical Holdings Ltd v Dr Reddy's Laboratories (UK) Ltd & Anor [2016] EWHC 1517 (Pat) (28 June 2016)

NAPP Pharmaceutical Holdings Ltd v Dr Reddy's Laboratories (UK) Ltd & Anor [2016] EWHC 1517 (Pat) (28 June 2016)

The court held that the proper construction of claim 1, including the numerical ranges, encompassed the inherent manufacturing variability of the defendants' products. The evidence showed that the products as manufactured would fall within the claimed composition, and the de minimis principle did not apply as the...

Source-derived case information.

Citation
[2016] EWHC 1517 (Pat)
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 / First Instance Judgment
Outcome
Claim allowed in part; quia timet injunction granted against Sandoz; declaration of non-infringement refused to Dr Reddy's; costs reserved.
Legal Topics
Patent Infringement, Quia Timet Injunctions, Construction of Patent Claims, Numerical Ranges in Claims, Transdermal Drug Delivery Systems
Intellectual Property Patents Patent Infringement Quia Timet Injunctions Construction of Patent Claims Numerical Ranges in Claims Transdermal Drug Delivery Systems

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Summary, issues, holding and outcome

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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 / First Instance Judgment

  1. 1 Whether the defendants' proposed 7-day buprenorphine transdermal patches infringe the claimant's patent
  2. 2 Proper construction of the numerical ranges and terms in claim 1 of the patent
  3. 3 Whether the products fall within the claimed composition given inherent manufacturing variability

Ratio Decidendi

The court held that the proper construction of claim 1, including the numerical ranges, encompassed the inherent manufacturing variability of the defendants' products. The evidence showed that the products as manufactured would fall within the claimed composition, and the de minimis principle did not apply as the overlap was not trivial. Quia timet relief was appropriate given the real threat of imminent infringement before patent expiry.

Court Disposition

Claim allowed in part; quia timet injunction granted against Sandoz; declaration of non-infringement refused to Dr Reddy's; costs reserved.

Orders

  • Sandoz restrained from launching its 7-day buprenorphine transdermal patch in the UK until expiry of the patent or further order.
  • Dr Reddy's not entitled to a declaration of non-infringement.