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
Source-derived case record
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
Legal Issues
- 1 Whether the defendants' proposed 7-day buprenorphine transdermal patches infringe the claimant's patent
- 2 Proper construction of the numerical ranges and terms in claim 1 of the patent
- 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.
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