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Zyprexa: "selection patent" doctrine briefly back in the limelight

By Johanna Gibson, David Pearce, Jeremy Phillips and Ilanah Simon.

Hot off the press comes the ruling today of Mr Justice Floyd (Patents Court, England and Wales) in Dr Reddy's Laboratories (UK) Ltd v Eli Lilly and Company Ltd [2008] EWHC 2345 (Pat). This was a revocation action brought by Dr Reddy's against Eli Lilly's patent for the drug olanzapine -- a widely-prescribed anti-psychotic agent used for the treatment of schizophrenia. The case raises the issue of the validity of patents for individual compounds selected from a prior class (what used to be called "selection patents"). The individual compound in this instance was olanzapine, which Lilly launched commercially under the name ZYPREXA in 1996.

Dismissing the revocation claim, Floyd J held the patent valid. So far as novelty was concerned, the judge must have brought waves of nostalgia upon older readers of his judgment by reviewing the old case law on "selection patents" under the Patents Act 1949, in particular the guidance laid down by Maugham J in I.G. Farbenindustrie's Patent (1930) 47 RPC 289 before summarising the post-1978 situation both in the UK and the European Patent Office before concluding:

"(i) In relation to lack of novelty, it is doubtful in the light of the EPO jurisprudence whether a newly discovered effect complying with Maugham J's principles could overcome a finding that a compound was specifically disclosed in a prior document.

(ii) Whether or not that is so, provided there is novelty on conventional grounds, obviousness is to be decided according to ordinary principles.

(iii) The existence of an advantage possessed by the selected compound will be relevant to the overall assessment of obviousness, but is not an essential pre-requisite.

(iv) Compliance with Maugham J's principles in IG Farbenindustrie's Patent is equally not an essential requirement for inventive step to be found".

The judge also took the opportunity to discourage optimistic arguments relating to non-obviousness based on commercial success:

"113 Commercial success can be a relevant secondary indicator of non-obviousness. Like all secondary indications it needs to be kept in its place. Why is it relevant at all? It is said that, when coupled with a long felt want which skilled researchers were attempting to meet, it is evidence that the claimed solution cannot have been obvious. In other words, commercial incentives would have driven those skilled in the art to the claimed solution but for one thing: it was not obvious.

114 Any influence an argument of commercial success might have on the issue of obviousness can be negated by a number of factors. In some cases the prior art over which the invention is said to be obvious was published only shortly before the priority date. So the commercial success just proves that the prior art made a good commercial idea obvious. In other cases there may have been some practical or commercial impediment to embarking on the line of enquiry in question, such as the existence of a prior patent. In yet further cases such commercial success as occurred can be demonstrated to be due to factors other than the invention: such as a newly created need or to marketing or other factors".

Since the judgment in this case is a lengthy and analytical one, the IPKat fully expects comments on it, both from other other members of the blogging team and from the patent profession. His own view, for what it is worth, is that it is too easy to justify in intellectual terms the invalidation of "selection patents" which can be adjudged meritorious in practical terms, and that it is a good thing that the law has come a long way since the dark days of the Patents Act 1949.

Left: do cats cause psychosis? See link below

Schizophrenia explained here
NICE clinical guidelines on schzophrenia here
Do cats cause schizophrenia? Click here

Full post as published by IPKat on October 13, 2008 (boomark / email).