The claimant company (M) brought proceedings under the Patents Act 1977 s.60(1)(c) for infringement of its European patents by the first defendant pharmaceutical company (N). N counterclaimed for revocation of the patents. M was the joint proprietor with the second defendant Medical Research Council of two European patents in respect of method claims relating to antibody phage display, a biotechnological technique. M claimed that the patents had priority derived from a priority document (PD3) filed in November 1990 and alleged that N had infringed the patents by sales of a pharmaceutical product, ranibizumab, marketed as "Lucentis", developed for treating wet age-related macular degeneration. M claimed that ranibizumab was a direct product of the patented processes. N disputed that ranibizumab was produced by a process which fell within the scope of the claims and/or that it was a product "obtained directly by means of" any of the claimed processes. N argued that the claimed inventions were not disclosed by PD3 and were invalid as they were not therefore entitled to priority. N further argued that the patents were invalid for: obviousness in the light of a talk given by Professor George Smith at "the Banbury conference" in the United States in April 1990; insufficiency, as the claims exceeded the technical contribution to the art made by the invention; and added matter.
Judgment accordingly.
(1) For an invention claim to be entitled to priority from an earlier application, it had to be supported by matter disclosed in that earlier application, Intervet UK Ltd v Merial [2010] EWHC 294 (Pat) applied. PD3 did not clearly and unambiguously disclose the inventions claimed and it followed that the claims were not entitled to priority from PD3 and were invalid (see paras 303-344 of judgment). (2) Taking the different factors and evidence into account, the conclusion was that the claimed inventions were obvious. Professor Smith had explicitly proposed antibody phage display during his talk at the Banbury conference and the skilled team would have had a reasonable expectation that that would succeed in a reasonable period of time (paras 456-457). (3) The method claims were of fairly broad scope and not claims to a single product, and M was correct to characterise the invention disclosed in the patents as a principle of general application. At its core, it was a technique for selecting a binding molecule of interest from among a potentially large population of other binding molecules and did not depend on the precise identity of the binding molecule. On the contrary, part of the usefulness of the technique was that it could be applied to a diverse range of binding molecules, fragments and derivatives. Nor did the technique depend on the precise application which the user had in mind and the implementation of the technique for the purpose of a new application did not involve undue burden on the part of the skilled team. Neither claim was invalid on the ground of insufficiency, Biogen Inc v Medeva Plc [1997] R.P.C. 1 and Kirin-Amgen Inc v Transkaryotic Therapies Inc (No.2) [2004] UKHL 46, [2005] 1 All E.R. 667 followed, BAYER SCHERING PHARMA AKTIENGESELLSCHAFT/Reach-through claim (T1063/06) [2010] E.P.O.R. 17 considered (paras 485-492). (4) There was clear disclosure in the earlier application of the "added matter" relied on by N. The claims of the patents in issue did not disclose any new matter (paras 493-502). (5) Ranibizumab was not produced by a process which fell within M's method claims and N would not have infringed either of the patents even if they had been valid. If it had been produced by such a process, then it would be a product obtained directly by means of those claims within s.60(1)(c) of the 1977 Act and, on that hypothesis, N would have infringed both patents if they had been valid, Pioneer Electronics Capital Inc v Warner Music Manufacturing Europe GmbH [1997] R.P.C. 757 applied. That conclusion was not affected by Directive 98/44 art.8(2) (paras 520-577). (6) The CPR r.35.3, CPR PD 35 and the Protocol for the Instruction of Experts to Give Evidence in Civil Claims emphasised the responsibilities of expert witnesses and the lawyers instructing them. It was the lawyer's responsibility to ensure that the expert was properly instructed and in a position to express an independent and impartial opinion. The degree of appropriate consultation between lawyer and expert would depend on the nature of the claim, the expertise of the witness and other relevant circumstances of the case. The law reports were littered with cases, including patent cases, in which judges had criticised expert witnesses for failing to be objective. It was regrettable and unacceptable that from time to time expert witnesses succumbed to the temptation of giving partisan evidence. Instructing lawyers bore a heavy responsibility for ensuring that an expert witness was not put in a position where he could be made to appear to have failed in his duty to the court even though he conscientiously believed that he had complied with that duty. It was also important that courts should be cautious about criticising an expert witness purely on the basis of omissions from his report, unless it was clear that the fault lay with the expert rather than those instructing him (paras 99-114).