Thursday, December 1, 2011

The Significance of Motive in an Obviousness Analysis

Allergan Inc v Sandoz Canada Inc / combigan (NOC) 2011 FC 1316 Crampton J

As noted in yesterday’s day post, combigan is Allergan’s brand name for a composition of two active ingredients, brimonidine and timolol, for the treatment of glaucoma, which was claimed as such in patent 2,440,764. In a curious twist in the combigan case, the Allergan, the patentee, argued that there was no motivation to develop combigan because the FDA was generally reluctant to approve fixed combination drugs for the treatment of glaucoma because of the fear of a mid-afternoon “trough” in efficacy: [115], [62]. This is curious because this type of argument is more usually raised by the defendant, as a rebuttal to the question “If it was so obvious, why was it not done before?” The answer in this case, would be, “why do what was obvious when everyone knew the FDA would not approve it?”

That the patentee advanced this argument appears to have been due to a confusion between specific and general motivation. In Janssen-Ortho Inc. v. Novopharm Ltd., 2007 FCA 217, [25] the FCA explained the significance of this distinction as follows:

“Motivation” in this context may mean the reason why the claimed inventor made the claimed invention, or it may mean the reason why one might reasonably expect the hypothetical person of ordinary skill in the art to combine elements of the prior art to come up with the claimed invention. If within the relevant field there is a specific problem that everyone in the field is trying to solve (a general motivation), it may be more likely that the solution, once found, required inventive ingenuity. On the other hand, if there is a problem that only the claimed inventor is trying to solve (a unique or personal motivation), and no one else has a reason to address that problem, it may be more likely that the solution required inventive ingenuity. However, if commonplace thought and techniques can come up with a solution, there may be a reduced possibility that the solution required inventive ingenuity.

That is, if there is a motivation to solve a long-standing general problem, such as finding a combination treatment for glaucoma which would provide better patient compliance, it can be inferred that others also tried to solve the problem but failed. This speaks against a finding of obviousness. If there is no motivation to solve the problem, because the FDA would not approve such a combination, then failure of others cannot be inferred. On the other hand, if the question is whether the specific combination of brimonidine and timolol was obvious as a solution to the general problem, then absence of a motive to combine these particular compounds speaks against a finding of obviousness, as it can be inferred that the inventors were not simply following the suggestions of the prior art. If the two specific compounds were suggested by the prior art, and there was some motive in the prior to actually combine them this would speak strongly in favour of obviousness (as in the Federal Circuit's teaching-suggestion-motivation test).

While this was only one of many factors taken into account by Crampton J, and it is very unlikely that this point was decisive in his finding that the claimed invention was not obvious, this illustrates that it is important to be careful to recognize the distinction between general and specific motivation when arguing obviousness.

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