EPLAW Patent Blog

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.

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.