EPLAW Patent Blog

UK - Mylan v. Yeda

Generics [UK] Limited (trading as Mylan) v Yeda Research and Development Co. Ltd & Anor [2012] 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.

NL - Ratiopharm v. Eli Lilly / Olanzapine patent invalid

Ratiopharm GmbH, Ratiopharm Nederland B.V., Ratiopharm B.V. v. Eli Lilly and Co Ltd., District Court The Hague, The Netherlands, 24 March 2010, Case No. 2008/2126, including the English translation, with thanks to Chantal Morel & Moïra Truijens, Klos Morel Vos & Schaap

Now including the English translation and a summary/comments in English

The Dutch part of Eli Lilly's patent and SPC re olanzapine was found to be invalid since the  substance olanzapine was  already directly and unambiguously disclosed in the earlier Schauzu publication. The error in Schauzu will, according to the court in The Hague, immediately be recognized by the man skilled in the art. The way this error can be corrected can also directly be derived from Schauzu. There is no trigger for the man skilled in the art to consult an other document.

The court further states that it realizes that its decision deviates from earlier decisions in the United States, China, The Czech Republic, Slovakia, Romania, Ukraine, Russia, Germany, United Kingdom, Austria and Spain. The patent was also invalidated in Canada, but based on a different argument (not a valid selection patent).

Read the decision (in Dutch) here.
Read the decsion (in English) here.

Read a summary in English and comments (provided by András Kupecz and Peter Meyer) here.

NL - Aventis v Apothecon and Ratiopharm / fexofenadine: selection for group of patients

Aventis Inc v. Apothecon B.V., Ratiopharm B.V. and Ratiopharm Nederland B.V., Appeal, Court of Appeal The Hague, The Netherlands, 16 March 2010, Case No. 105.007.817/01, with thanks to Mark van Gardingen and Peter Burgers, Brinkhof

Aventis asked for a preliminary injunction based on alleged infringement by the generic companies Apothecon and Ratiopharm -by marketing fexofenadine products as anti-histaminics- of its European patent for the 'Use of terfenadine derivates as antihistaminics in a hepatically impaired patient'.

Like the judge in first instance preliminary injunction proceedings, the Court of Appeal holds that Aventis is not entitled to a preliminary injunction because there is a serious chance of nullification of the patent in a case on the merits. The Court of Appeal finds the patent is not new (the anti-histaminic effect of fexofenadine was already known, and the group of patients to which the claims are directed does not qualify as a valid selection), and that the patent lacks inventive step.

Read the decision (in Dutch) here.

UK - Dr Reddy’s Laboratories v. Eli Lilly and Company Limited / Olanzapine

Dr Reddy’s Laboratories (UK) Limited v. Eli Lilly and Company Limited, Court of Appeal (Civil Division), UK, 18 December 2009, Docket No: Case No.A3/2008/2966, with thanks to Robert Fitt, Bristows

The Court of Appeal upheld the decision of Mr Justice Floyd and confirmed that Lilly’s (selection) patent concerning the drug olanzapine is valid.

Olanzapine is one of the 10¹⁹ compounds and one of the 86,000 preferred compounds mentioned in the '235 patent. It is not mentioned specifically. Dr Reddy's Research Laboratories (DRL) contention that the specific compound lacks novelty, was rejected (i) as a matter of a priori reasoning (a generalised prior description does not disclose a specific matter within it) and (ii) because it is inconsistent with EPO Board of Appeal Case Law (Hoechst Enantiomers T 0296/87).

The pre-EPC rules, as formulated in I.G. Farbenindustrie's Patents should be regarded as part of legal history, not as part of the living law. The better approach is to see what the EPO Boards do (AgrEvo (T 0939/92) and Wyeth (T133/01). "The EPO jurisprudence is founded firmly around a fundamental question: has the patentee made a novel, non-obvious technical advance and provided sufficient justification for it to be credible?" An 'arbitrary selection' provides no technical contribution.