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Napp Pharmaceutical Holdings Limited v Dr Reddy’s Laboratories (UK) Limited and Sandoz Limited, England & Wales Court of Appeal, London, UK, 1 November 2016, Neutral Citation Number [2016] EWCA Civ 1053

This was an appeal from a decision of Arnold J holding that there was no infringement of European Patent (UK) 2 305 194 (‘the Patent”) concerning transdermal patches for treating patients with buprenorphine.

At first instance the judge had interpreted the phrases “10%-wt buprenorphine base” and “10 to 15%-wt levulinic acid” appearing in the claims of the Patent to express limits to the nearest whole number, and hence cover products containing 9.5 to 10.5%-wt buprenorphine base and 9.5 to 15.5%-wt levulinic acid. The judge had also interpreted the phrase “about 10%-wt oleyloleate” appearing in the claims of the Patent to allow a margin of 1% around the figure of 10%-wt on the grounds that the word “about” would be understood to give a small degree of imprecision over and above that permitted by normal rounding.

In the appeal Napp Pharmaceuticals presented arguments that the %-wt figures in the claims referred to input components of the matrix layer of the device (excluding solvents removed during drying) and that the limits appearing in the claims should have been given a broader interpretation with “about 10%-wt oleyloleate”  being understood to include 15%-wt oleyloleate; “10 to 15%-wt levulinic acid” being understood to refer to a range of %-wt levulinic acid to the nearest 5% (the range 7.5 to 17.5%-wt); and “10%-wt buprenorphine” being understood to refer to the amount of buprenorphine to the nearest 5%-wt.

The Court rejected these arguments finding that there had been no error in the way that the judge had approached the interpretation of the claims at first instance and dismissed the appeal.

The judgement notes that the claim to enforce the Patent the subject of the appeal had been commenced on 19 February 2016 with an expedited trial of the claim subsequently being fixed for 7 and 8 June 2016. The appeal of the decision at first instance was then heard on 2 August 2016 following an order for expedition of the appeal being made on 5 July 2016. A dismissal of the appeal was issued at the appeal hearing with written reasons to follow. Thus due to the expedition of the case both at first instance and on appeal, a final decision on appeal was delivered less than six months from the issue of proceedings.
A copy of the judgment (in English) can be found here.

Head note: Nicholas Fox Simmons & Simmons LLP