GENERICS (UK) LTD (T/A MYLAN) v YEDA RESEARCH AND DEVELOPMENT CO. LTD

[2018] R.P.C. 2 101 GENERICS (UK) LTD (T/A MYLAN) v YEDA RESEARCH AND DEVELOPMENT CO. LTD PATENTS COURT Arnold J.: 10-12, 17 and 26 October 2017 [2017] EWHC 2629 (Pat); [2018] R.P.C. 2 H1 Patents – European Patents – Revocation – Validity – Pharmaceuticals – Dosage regimen – Claim construction – Purposive construction – Skilled person – Novelty – Assessment – Prior art equivalents – Obviousness – Obvious to try – Fair expectation of success – Insufficiency – Duplicative expert evidence – Arrow declarations – Exercise of discretion H2 This was an action by the claimants (“Mylan” and “Synthon”) for the revocation of European patent (UK) No. 2,949,353 entitled “low frequency glatiramer acetate therapy” (“the Patent”) and for an Arrow declaration, i.e. a declaration that a product which they intended to place on the market would have lacked novelty and/or been obvious as at the priority date of the Patent in so far as a particular dosage regimen was concerned. The precise terms of the declaration sought are set out at [205] of the judgment reported here. The proprietor of the Patent (“Yeda”) counterclaimed for threatened infringement. The exclusive licensee under the Patent (“Teva”) had been joined as a third party to the proceedings. Both Yeda and Teva are referred to together as “the Defendants” in the judgment. The Patent was directed to a dosage regimen for the administration of glatiramer acetate (“GA”) therapy for the treatment of relapsing forms of muscular sclerosis (“MS”). GA was marketed by Teva under the trade mark COPAXONE. Worldwide sales of COPAXONE in the year ending 31 December 2016 were in the region of $4.2 billion. GA was one of a number of disease modifying therapies (“DMTs”) approved for use in the UK and available for treating MS patients. Subcutaneously injected DMTs had well known side effects, particularly, injection site reactions (“ISRs”) and immediate post-injection reactions (“IPIRs”). Claims 1 and 3 of the Patent were asserted to be independently valid. Claim 1 was in the following terms: H3 H4 “Glatiramer acetate for use in a regimen of three subcutaneous injections of a 40mg dose of glatiramer acetate every seven days with at least one day between each subcutaneous injection for use in treating a patient who is suffering from a relapsing form of multiple sclerosis or who has experienced a first clinical episode and is at high risk of developing clinically definite multiple sclerosis and wherein the pharmaceutical composition further comprises mannitol.” Claim 3 addressed the use of GA in accordance with claim 1 wherein the “tolerability” of GA treatment was “increased by reducing the frequency of immediate post injection reaction or an injection site reaction”. It would appear to have been common ground [2018] R.P.C., Issue 2 ß Crown copyright 2018. This article contains public sector information licensed under the Open Government Licence v3.0 (http://www. nationalarchives.gov.uk/doc/open-government-licence/version/3/) 102 H5 H6 H7 H8 H9 GENERICS (UK) LTD (T/A MYLAN) V YEDA that previously GA had been approved for administration in a regimen consisting of daily subcutaneous injections of 20 mg (“20mg QD”). There was no challenge to the claimed priority date of the Patent, namely 20 August 2009. Nor was it in dispute that, if the Patent was valid, the claimants’ intended acts would infringe. The main area of dispute was as to the validity of claims 1 and 3 of the Patent. The claimants contended that the Patent was invalid on grounds of lack of novelty, lack of inventive step and insufficiency. Particular reliance was placed upon common general knowledge and three specific pieces of prior art, namely, patent applications filed by Teva and by Yeda respectively and referred to in the judgment as “Pinchasi” and “Flechter” and also on an abstract of a paper referred to as “Caon”. Secondary evidence was also relied upon by the claimants in the form of (i) a number of internal Teva documents which had come to light on discovery in parallel US proceedings, and (ii) a proposal for a phase III trial which Teva had filed with the Federal Drugs Agency (“FDA”) on 17 December 2009. One of the issues raised in these proceedings was the effect of the decision of the Supreme Court in Actavis v Eli Lilly1 on (i) the interpretation of claims, and (ii) the law on novelty. In particular, before coming to the question of equivalents, did it remain the law that patent claims should be given a purposive construction? The defendants argued that the law had changed and that a patent claim should now be interpreted in the same manner as a clause in a commercial contract and without regard to the patentee’s purpose. The defendants also argued it was no longer the law that a claim lacked novelty if the prior publication relied upon disclosed subject-matter which, if performed, would necessarily infringe the claim. It was not enough that the subject-matter in question would infringe the claim applying the doctrine of equivalents. A claim would only lack novelty if the prior publication disclosed subject-matter which fell within the claim on its proper interpretation. The claimants contended that purposive construction continued to be the correct approach when interpreting claims and that the law of novelty remained unchanged. Even if the subject-matter would not fall within the claim on its proper interpretation, it was sufficient that it would infringe the claim applying the doctrine of equivalents. Otherwise a claim could be infringed by a person doing exactly what the prior publication taught and yet the claim would be novel over that prior publication. That would be a radical departure from English patent law as previously understood. There was also a dispute as to whether the skilled person or team to whom the Patent was addressed would have had expertise in the field of neuroimmunology (including the pathology of MS and the analysis of medical resonance images (“MRI”) of MS sufferers) and would have known about clinical trial design and medical statistics. As to construction more specifically, there was an issue as to the meaning of the words “for use in treating a patient who is suffering from a relapsing form of multiple sclerosis” in claim 1. The claimants contended that this merely required that the regimen be suitable for treating such a patient i.e. that it have some degree of efficacy. The defendants argued that it required the patented regimen to reduce the annualised relapse rate to essentially the equivalent in efficacy of the 20mg QD regimen. There would appear to have been little, if any, dispute as to the construction of claim 3. As to the relevant prior art, it would appear to have been accepted that the only difference between Pinchasi and claim 1 of the Patent was that Pinchasi disclosed a 1 Actavis UK Ltd v Eli Lilly & Co [2017] UKSC 48, [2017] R.P.C. 21, SC. Published by Oxford University Press for the Intellectual Property Of (...truncated)