Novelty and Obviousness In An Empirical Research Field – The Decision of the UK Court of Appeal in Dr Reddy’s Laboratories v Eli Lilly

From Paul Cole

The Lilly patent for olanzapine has been litigated in many jurisdictions including the US, Canada, the Czech Republic, Finland,

Romania, Slovakia, Slovenia, Spain, China and Hungary. In US Court of Appeals for the Federal Circuit in Eli Lilly v Zenith Goldline (26 December 2006) Judge Rader held that allegations of lack of novelty and of obviousness did not succeed, whereas in the Canadian decision in Eli Lilly Canada v Novopharm (5 October 2009) O’Reilly J. held that the patent did not meet the requirements for a selection patent and was invalid. Key issues before the UK Court of Appeal were how novelty and obviousness of a secondary patent in the pharmaceutical field should be evaluated, the extent to which decisions of courts within the UK prior to the introduction of a “new law of patents” in 1977 remained relevant, and in particular whether the reasoning in the Canadian decision should be followed. The members of the court included Lord Neuberger in his capacity as Master of the Rolls and Sir Robin Jacob, both very experienced in handling pharmaceutical patent disputes.

Their decision confirms the extent to which, at least in this field, the law in the UK has departed from relatively restrictive pre-1977 standards and has become aligned with more open decisions of the EPO Appeal Boards. It also shows that in future there will be scope for differences between decisions of the UK courts following the “new” post-1977 law and those in e.g. Canada, India, Australia and New Zealand where the link to the older common law remains unbroken.

The Court of Appeal refused to hold that disclosure of a class was disclosure of all members of that class, relying on a quotation from G. K Chesterton’s Father Brown story “The Sign of the Broken Sword: “Where does a wise man hide a leaf? In a forest?” Accordingly the invention as claimed was novel. And even though prior art disclosures included ethyl olanzepine which differed from the claimed compound in only a single carbon atom, the court refused to hold that an objection of lack of inventive step had been established.

The decision includes scathing comments on a prior art reference with a Markush claim allegedly covering some 10-to-the-19th compounds. The court observed that all the skilled reader would get from that reference was a vague promise of neuroleptic, sedative or relaxant effect for all the 10-to-the-19th compounds with an equally vague promise of high therapeutic index coupled with no evidence to support these promises. Given that the whole field was unpredictable, the woolly teaching of the reference (described by Lord Neuberger as “mere speculation”), if not totally useless, was no guide to any particular compound. It could not be said that any compound out of a vast class was obvious if there was no real idea how any individual member of that class might behave.

Yet further confirmation has been given to the realistic approach of UK courts to inventions in empirical research fields, and to the supportive judicial attitude towards the research-based pharmaceutical industry as also demonstrated by Sir Robin’s speech on 29 November 2008 to the EU Directorate-General of Competition at the time of their preliminary report on their Phrma-sector enquiry, see Patents and Pharmaceuticals

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