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England and Wales Court of Appeal (Civil Division) Decisions
You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Napp Pharmaceutical Holdings Limited v Dr Reddy's Laboratories (UK) Ltd & Anor  EWCA Civ 1053 (01 November 2016)
Cite as:  EWCA Civ 1053
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ON APPEAL FROM THE HIGH COURT OF JUSTICE
Mr Justice Arnold
Strand, London, WC2A 2LL
B e f o r e :
LADY JUSTICE GLOSTER
LORD JUSTICE FLOYD
| NAPP PHARMACEUTICAL HOLDINGS LIMITED
|- and -
|(1)DR REDDY'S LABORATORIES (UK) LIMITED
Michael Silverleaf QC and Benet Brandreth (instructed by Bird & Bird LLP) for Dr Reddy's Laboratories (UK) Limited
Justin Turner QC and Anna Edwards-Stuart (instructed by Olswang LLP) for Sandoz Limited
Hearing date: 2 August 2016
Crown Copyright ©
Lord Justice Floyd:
The patent and "Hille"
"Despite these advances in the art, there remains a need for methods of treating patients with buprenorphine that provide effective analgesic levels of buprenorphine for prolonged periods of time while eliminating or minimizing dependence, tolerance, and side effects, thus providing a safe and effective method of pain management. Further, there remains a need for a transdermal formulation of an opioid analgesic, preferably, buprenorphine, that provides effective analgesic levels of buprenorphine for periods of time beyond that contemplated or practical in the prior art, while eliminating or minimizing dependence, tolerance, and side effects, thus providing a safe and effective method of pain management."
"a method and pharmaceutical formulation … which allows for reduced plasma concentrations of buprenorphine over a prolonged time period than possible according to prior art methods, while still providing effective pain management."
"In a preferred embodiment, the transdermal delivery device is prepared in accordance with Example 1 appended hereto. In this example, the transdermal delivery device was prepared in accordance with the disclosure of [Hille]. In this device, the buprenorphine transdermal delivery device contains resorption-promoting auxiliary substances. The resorption-promoting auxiliary substance forms an undercooled mass. The delivery device contains 10% buprenorphine base, 10-15% acid (such as levulinic acid), about 10% softener (such as oleyloleate); 55-70% polyacrylate; and 0-10% polyvinylpyrollidone (PVP)."
" A seven day pharmacokinetic/pharmacodynamic study was conducted on 24 healthy human patients. … In this study, the buprenorphine was administered via a transdermal patch which is described in [Hille].
 The transdermal patch is prepared in accordance with the disclosure of [Hille] for Example 1 therein as follows:"
"The formulation utilized for Example 1 is substantially the same as that described in Example 3 of [Hille] which is prepared in accordance with Example 1 and is stated therein to include 10% buprenorphine, 10% levulinic acid, 10% polyvinylpyrollidone, 10% oleyloleate, and 60% polyacrylate. "
"1.139 [kg] of a 47.83 w/% polyacrylate solution of a self-crossing acrylate copolymer of 2-ethylhexylacrylate, vinyl acetate, acrylic acid (solvent: ethyl acetate:heptane:iso-propanol:toluene:acetylacetonate in the ratio of 37:26:26:4:1), 100 g levulinic acid, 150 g oleyl oleate, 100 g polyvinylpyrrolidone, 150 g ethanol, 200 g ethyl acetate and 100 g buprenorphine base are homogenised. The mixture is stirred for about 2 hours and checked visually to see if all the solids are dissolved. The evaporation loss is controlled by weighing, and, if necessary, replenishing the loss of solvent with ethyl acetate.
The mixture is then spread onto a 420 mm wide transparent polyester film, so that the surface weight of the dried adhesive layer is 80 g per m². The polyester film, which can be removed again with a silicon treatment, serves as a protective layer.
The solvent is removed by drying with heated air which is passed over the damp track. The heat treatment does not only cause the solvents to evaporate, but also melts the levulinic acid. The adhesive film is subsequently covered with a 15 µ polyester film. A 16 cm2 area is punched out with appropriate cutting tools, and the edges remaining between the individual systems are removed."
"A buprenorphine transdermal delivery device comprising a polymer matrix layer containing buprenorphine or a pharmaceutically acceptable salt thereof, for use in treating pain in humans for a dosing interval of at least 7 days, wherein the transdermal delivery device comprises 10%-wt buprenorphine base, 10 to 15%-wt levulinic acid, about 10 %-wt oleyloleate, 55 to 70%-wt polyacrylate, and 0 to 10%-wt polyvinylpyrrolidone."
The dispute about the interpretation of the patent specification
Issues of construction of claim 1
The grounds of appeal
i) The judge was wrong to say that it was feasible for the skilled person to determine the composition of the patch of claim 1 with respect to all of its components;
ii) The judge should have found that it was routine and conventional to refer to products by reference to their ingredients even where losses during manufacture were to be expected;
iii) The judge failed to give effect to the undisputed evidence (e.g. of Professor Williams) that the skilled reader of the patent would understand that the final composition of the patch of Example 1 of the patent could not be predicted or described with any precision given the information in the patent.
I will refer to these points as the first, second and third evidential points respectively.
What is Example 1 of the patent?
Input or output?
The numerical ranges
"As I have said, the approach to be adopted to the interpretation of claims containing a numerical range is no different from that to be adopted in relation to any other claim. But certain points of particular relevance to claims of this kind do emerge from the authorities to which I have referred and which are worth emphasising. First, the scope of any such claim must be exactly the same whether one is considering infringement or validity. Secondly, there can be no justification for using rounding or any other kind of approximation to change the disclosure of the prior art or to modify the alleged infringement. Thirdly, the meaning and scope of a numerical range in a patent claim must be ascertained in light of the common general knowledge and in the context of the specification as a whole. Fourthly, it may be the case that, in light of the common general knowledge and the teaching of the specification, the skilled person would understand that the patentee has chosen to express the numerals in the claim to a particular but limited degree of precision and so intends the claim to include all values which fall within the claimed range when stated with the same degree of precision. Fifthly, whether that is so or not will depend upon all the circumstances including the number of decimal places or significant figures to which the numerals in the claim appear to have been expressed."
Lady Justice Gloster:
Lord Justice Patten: