Tuesday, May 14, 2013

Golden Bonus Doctrine in US COMBIGAN Decision

Allergan, Inc v Sandoz Inc / COMBIGAN (Fed Cir 2013) rev’g 818 F.Supp.2d 974

The recent Fed Cir decision in Allergan v Sandoz / COMBIGAN provides an interesting perspective on the parallel Canadian litigation. The invention at issue is a combination of brimonidine and timolol, used for the treatment of glaucoma. Both active ingredients had previously been used for that purpose, and the primary issue in both the US and Canadian litigation was whether the combination was obvious.

In the litigation over the Canadian patent 2,440,764, Allergan v Sandoz / COMBIGAN(NOC) 2011 FC 1316 (blogged here), Crampton J held it non-obvious, largely on the basis that the improved safety profile and absence of an afternoon trough in efficacy as compared to the individual drugs were part of the inventive concept [58], and these were not obvious. Subsequently, in Allergen Inc v Apotex Inc / COMBIGAN (NOC) 2012 FC 767 (blogged here), Hughes J held that the absence of an afternoon trough in efficacy was not part of the inventive concept [147]. His view was that the inventive concept was that the specified combination would achieve the promised results [145]. Consequently, Hughes J would have held the claims obvious [189], but for a concern regarding comity with Crampton J’s prior decision. The disagreement between Crampton J and Hughes J over the nature of the inventive concept turned on a disagreement as to whether the specification as a whole should be considered in construing the inventive concept. On appeal of Hughes J’s decision, the FCA was resolved that debate in favour of considering the entire specification, as Crampton J had done: Apotex Inc v Allergan Inc / COMBIGAN (NOC) 2012 FCA 308 (blogged here). Consequently, the FCA concluded that the improved safety profile was part of the inventive concept [74], and that improved safety profile was not obvious [93]. An order of prohibition was therefore granted.

In the US litigation the district court held that the increased efficacy (absence of an afternoon trough) and reduction in side-effects (improved safety profile) were unexpected results that weighed in favour of non-obviousness (Fed Cir slip op 12, Dist Ct 998-99). In respect of the majority of claims at issue (Claim 1 of 7,323,463 was exemplary) the Fed Cir held that this did not establish non-obviousness:

While the unexpected benefits of twice a day dosing of the combination formula are relevant to Sandoz’s attack on the validity of the method claims, we do not find it similarly meaningful to our evidence in the prior art showing the concomitant administration of brimonidine and timolol multiple times per day, that the combination had benefits over the administration of either alone, and that there was a motivation to combine the two to achieve better patient compliance. KSR, 550 U.S. at 426. Whether or not that combination also solved problems associated with the afternoon trough, we find the motivation to make the combination was real. [My emphasis] Accordingly, we conclude that the claims of the ’463 patent are invalid as obvious.

In other words, if the invention was obvious for other reasons, a patent cannot be supported by the discovery of a non-obvious advantage. This is the classic “golden bonus” principle as described in Hallen v Brabantia [1991] RPC 195 at 216 (CA). This principle is perhaps not as well recognized in Canadian law as it is in English law (compare 2007 FC 455 [309-10] with 2007 FCA 217 [26]), but it is certainly a point which deserves more attention that it received in the Canadian litigation. I am still of the view that the main holding of the FCA in COMBIGAN, that it is necessary to have reference to the entire specification in order to construe the inventive concept, is correct, but the golden bonus argument may provide a different route leading to a different conclusion on the obviousness question.

The Federal Circuit decision was also interesting for a split on Claim 4 of the 7,030,149 patent. (There was no equivalent claim in the Canadian ‘764 patent.)

4. A method of reducing the number of daily topical ophthalmic doses of brimondine administered topically to an eye of a person in need thereof for the treatment of glaucoma or ocular hypertension from 3 to 2 times a day without loss of efficacy [by treatment with COMBIGAN]

In effect, the unexpected advantages were made part of the claim itself. Judge Dyk, dissenting on this point, held that this claim was also invalid, on the basis that a golden bonus cannot render an invention patentable, whether or not that bonus is made part of the claim:

Avoiding a ‘loss of efficacy’ is not a separate step, but rather a result of the claimed method. We should recognize in this case, as we did in Bristol-Myers Squibb, that ‘[n]ewly discovered results of known processes directed to the same purpose are not patentable.’

The majority held that it was not clear from the record whether the increased efficacy was an inherent property of the composition (fn 1). This disagreement raises an interesting point: is it possible to avoid the golden bonus doctrine (if that doctrine exists in Canada), by making the unexpected advantage part of the claim?

1 comment:

  1. In Canada, the availability of "use" claims means that we have an advantage over the US when claiming a newly recognized utility, even a golden bonus. The new utility can be explicitly recited, and we don't face the inherency problem Judge Dyk focused on. Of course, enforcement of such claims would raise some interesting evidentiary questions.