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Friday, July 29, 2016

Hospira v Genentech - revocation of patents confirmed on appeal

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Hospira v Genentech - revocation of patents confirmed on appeal

The Court of Appeal handed down its decision yesterday in Hospira v Genentech (with the first instance decision reported by this Kat here).  As is often the case when an appeal decision upholds a first instance judgment, there is not meat in the decision - the whole matter is dealt with in just 56 paragraphs - and correspondingly not much to say about it.  (Regrettably, notes Merpel, the product-by-process discussion of the first instance decision, which induced a not insignificant number of comments on this blog, is not discussed in the appeal judgement.)

Genentech appealed against the first instance decision revoking a pair of patents on the grounds that the claimed subject matter is obvious.  The matter came down to an obvious to try and could-would argument; Birss J, at first instance, found that it was obvious to screen a particular selection of possible drug formulations to determine which is most stable.  Genentech argued (a) that it was not obvious to try the particular formulations and (b) that even if it were, the skilled person would not expect the particular claimed formulation to be stable from that selection of possible candidates, and so the skilled person would have no reasonable expectation of success and would not therefore arrive at the claimed invention.  

Floyd LJ agreed with Birss J, stating (in paragraphs 50 and 51):
Given that the screening methods were part of the common general knowledge, that the tests involved were routine, that the excipients were common general knowledge excipients and that there was no a priori reason why a successful lyophilised formulation could not be made, it seems to me that it was beyond argument that the claimed combination in this case was one that could be made by the skilled team. The question is whether this is the type of case where it is necessary to go further and ask whether the skilled person would necessarily have made the precise combination claimed. In an empirical field it will be seldom be possible to predict in advance that any individual experiment will work. In many cases, the fact that a routine screening exercise could be carried out will be inadequate to establish obviousness.  
Nevertheless, on the facts of an individual case such as the present, the team may have a reasonable degree of confidence that a series of experiments will produce some which will work. To impose a requirement that the skilled team must be able to predict in advance which would be the successful combinations is wholly unrealistic. It would lead to the grant of patents for a whole variety of combinations which in fact involved no inventive effort. 
Finally, in paragraph 53, the judgement concludes:
It is always necessary to remind oneself that it is not the function of this court to second-guess the judge's finding of obviousness. The judge was evaluating a large number of inter-dependent factors. Despite Mr Tappin's very clear and well sustained arguments, I do not think that the judge fell into any error of principle which would justify this court in undertaking its own evaluation.
 Lord Justice Kitchin and Lord Justice David Richards concurred.

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