Tuesday, April 12, 2011

Obvious to Try – In Two Jurisdictions

Merck Sharp & Dohme Corp v Teva UK Ltd [2011] EWCA Civ 382 (08 April 2011) affm’g [2009] EWHC2952 (Pat)
Merck & Co. Inc. v Apotex Inc. / cosopt (NOC) 2010 FC 1042 O'Reilly J

In 2010 FC 1042 O'Reilly J refused an order of prohibition on a generic version of Merck’s Cosopt product for the treatment of glaucoma, on the basis that the co-formulation of dorzolamide and timolol claimed in Merck’s patent 2,065,965 was obvious. A prior art publication by Merck’s own researchers (the “Nadin” article) disclosed that dorzolamide and timolol had an additive effect, but did not specifically disclose co-formulation, as opposed to sequential administration. The question was whether co-formulation was obvious in light of that disclosure. O’Reilly J applied the “obvious to try” analysis. It seems (from the brief reasons) that it was conceded that it was obvious to try, and O’Reilly J found that there were no significant hurdles to be overcome – “co-formulation was routine” – and the co-formulation was therefore obvious. In [2009] EWHC 2952 (Pat) Floyd J held the same in an infringement action on the corresponding European patent patent EP 0 509 752 B1 for essentially the same reasons. (The main difficulty is that the two products perform optimally at different pH, so some experimentation was needed in arriving at an appropriate compromise, but there was no real difficulty in so doing.) Floyd J's decision was affirmed by [2011] EWCA Civ 382, which was released last Friday.

So far, so good. OReilly J’s decision is a good illustration of the application of the “obvious to try” analysis to hold that a claim invalid, and it is a nice bonus to see courts in different jurisdictions coming to the same conclusion on the same facts.

I have one quibble with the EWCA decision. Merck decided not to argue that the leap from co-adminstration to co-formulation was qualitatively inventive; instead it argued that the time between the publication of the Nadin article and the priority date was so short (six days) that the skilled team would have been unable to carry out the requisite experiments, routine though they might be [EWCA 31]. The EWCA rejected this, saying, inter alia, “If by reference to the relevant state of the art the invention is obvious then it matters not that it may take time to perform the necessary routine tests. It is a matter of simple comparison between the relevant art and the claimed invention” [36]. It is questionable whether this statement is consistent with Canadian law, as the Supreme Court in Sanofi [69] held that it is relevant to ask “[w]hat is the extent, nature and amount of effort required? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine?” It is not merely a simple comparison between the relevant art and the claimed invention. In Canadian law the quantity of experimentation – the “amount of effort” – is relevant, not only the quality. As the Sanofi excerpt indicates, trials that are prolonged and arduous will not be considered routine, even if individually they may not require special skill. This is consistent with the view that a “patient searcher is as much entitled to the benefits of a monopoly as someone who hits upon an invention by some lucky chance or inspiration" American Cyanamid Co. v Berk Pharmaceuticals Ltd., 1976} R.P.C. 231, at 257, quoted with approval in Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning v Halocarbon (Ontario) Ltd. [1979 2 SCR 929. (This is not to say that the co-formulation in this case should have been held to be inventive in Canadian law. The basis for the decision of O’Reilly was there was no evidence of undue experimentation, and Floyd J’s decision might have been upheld on the same basis.)

This might seem like an overly technical reading of the EWCA decision, and perhaps it is. After all, the mere fact that it takes time to perform routine trials (if a fixed incubation period is required for what is otherwise a simple test, for example) would not render an invention obvious in Canadian law. However, the English courts have more than once indicated that routine work, no matter how prolonged and arduous, cannot amount to invention. This was expressed succinctly by Aldous LJ for the CA in Biogen Inc v Medeva PLC Court of Appeal (Civil Division) [1995] FSR 4: “There is no idea, no principle. A mere commercial decision is not an invention.” This was reversed by the House of Lords on the facts, [1996] UKHL 18 [53] but apparently agreeing with Hobhouse LJ on this point. My own view is that the Canadian position is preferable as a matter of policy, as it is more consistent with the incentive rationale for patent protection. But it should in any event be recognized that there is a principled point of difference here, and UK law should not be blindly followed.

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