English Patents Court Rules Patent Not Infringed Four Months After Claim Filed

The English High Court (Patents Court) is a world-leading forum for efficient, high quality resolution of patent disputes. Demonstrating again the benefits of the court's flexible and adaptable procedure, Mr Justice Arnold has delivered a full first instance judgment in a patent infringement case regarding therapeutic patches less than four and a half months after the claim was filed. This is less time than is needed to obtain preliminary relief in many jurisdictions.

Irrespective of 'Brexit', it is business as usual at the English Courts, which means the continuation of the UK as the European forum of choice for the resolution of patent disputes - both those of greater complexity and value (the Patents Court) and those of a simpler nature with less at stake in financial terms (the Intellectual Property Enterprise Court).

Summary

Napp commenced proceedings for patent infringement in February 2016 and applied for an interim injunction (i.e. to restrain infringement pending determination of the main claim for infringement). Instead of setting a timetable for hearing of Napp's interim application, Mr Justice Arnold ordered an expedited trial of the claim for infringement, for early June 2016, and the defendants undertook not to launch their products pending determination of the claim.

The judge returned his reasoned decision, finding no infringement or threat of infringement of the patent and hence disposing of the claim, on 28 June 2016: Napp v Dr Reddy's & Sandoz [2016] EWHC 1517 (Pat).

Background

Napp has (through a subsidiary) marketed a seven-day buprenorphine transdermal patch under the brand name BuTrans since 2005. Both Sandoz and Dr Reddy's sought marketing authorisation for buprenorphine transdermal patches, based on bioequivalence with Napp's BuTrans.

Sandoz's marketing authorisation was given on 10 February 2016. Napp commenced infringement proceedings against Sandoz on 19 February 2016, and against Dr Reddy's on 22 February 2016. By the hearing of the trial, on 7-9 June 2016, Dr Reddy's marketing authorisation was still yet to grant.

The issues between the parties

In theory, the issues between the parties were relatively confined for a patent case:

Except for a technical challenge regarding the clarity of the claim language, the validity of the patent was not in dispute. The court was, however, required to rule on the meaning of several numerical limits in the language of the patent claim, and also on whether the claim language...