Generics [UK] Limited (trading as Mylan) v Yeda Research and Development Co. Ltd & Anor  EWHC 1848 (Pat), 11 July 2012, Patents Court, Arnold J.
In this action the Claimant (“Mylan”) sought revocation of European Patent (UK) No. 0 762 888 (“the Patent”) and a declaration of non-infringement. The First Defendant (“Yeda”) and the Second Defendant (“Teva”) were respectively the proprietor of, and the exclusive licensee under, the Patent. The Patent relates to a material known as copolymer-1, a polymer composed of amino acids alanine, glutamic acid, lysine and tyrosine in a particular ratio. The claims protect Copolymer 1 in a specified molecular weight range, and use of this for the treatment of multiple sclerosis (“MS”). Teva sells a product which it claims is protected by the Patent under the trade mark Copaxone (non-proprietary name glatiramer acetate) for the treatment of relapsing-remitting MS.
The action raised a large number of issues: whether the claims are entitled to the first claimed priority date; whether the Patent is invalid for obviousness over the prior art; whether the Patent is invalid for obviousness as making no technical contribution, but rather being an arbitrary selection from known copolymer-1 material; whether the Patent is invalid for insufficiency because the claims are ambiguous; whether the Patent is invalid for insufficiency on classical grounds; whether the Patent is invalid for insufficiency because it makes no technical contribution; whether the Patent is invalid for added matter; and whether the sale of Mylan’s glatiramer acetate product would infringe any of the claims of the Patent.
In respect of these issues it was held: none of claims 2-3 and 5-12 is entitled to priority from the Priority Document; none of the claimed inventions is obvious in the light of the prior art, Teitelbaum 1971, Bornstein 1987 or Johnson 1994; the product claims are not obvious as being an arbitrary selection; the Patent is not insufficient in any of the ways alleged; none of the claims is invalid for added matter; and; the proposed glatiramer acetate product would infringe the Patent.