Wednesday, May 01, 2013

Allergan wins "enough" in Combigan® case

Allergan is the plaintiff-patentee in a Hatch-Waxman case involving several defendants, including Sandoz.
The appellant-defendants did win a partial reversal, but partial is not enough. The outcome:

we find that the district court erred in finding the claims of the ’463 patent not invalid as obvious. However, we find that the defendants failed to prove by clear and convincing evidence that claim 4 of the ’149 patent would have been obvious.

If one claim is not invalid and infringed, defendants have a problem under Hatch-Waxman.

As to secondary considerations to rebut a prima facie case of obviousness:

Finally, the court found that there were secondary considerations that support the finding of nonobviousness including long-felt need and unexpected results. We accept the district court’s factual findings regarding the existence of these secondary factors; however, we conclude that these factors do not weigh heavily in the obviousness analysis.

With respect to long-felt need, the district court’s findings are entirely conclusory. The district court, without explanation, found that there was a need for combination products and that Combigan®, at some level, met that need. Such perfunctory language provides us with little help in performing our de novo review of obviousness.

The district court also found that unexpected results weigh in favor of nonobviousness. Specifically, the court found that there was increased efficacy of the drug and a reduction in side-effects. The court found that previous attempts to treat patients twice per day with brimonidine resulted in a loss of efficacy eight to nine hours post administration. This loss of efficacy is referred to as the “afternoon trough.” The court found that a twice per day dosage regimen of Combigan® unexpectedly did not suffer from the afternoon trough issue. We agree with the court’s finding that this result was unexpected. However, we do not find that these unexpected results are sufficient to outweigh the other evidence of obviousness as to these formulation claims. 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 analysis of the formulation claims. There is extensive evidence in the prior art showing the concomitant admin- istration of brimonidine and timolol multiple times per day, that the combination had benefits over the admin- istration 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. Accordingly, we conclude that the claims of the ’463 patent are invalid as obvious.

HOWEVER, Sandoz was not so successful as to the '149 patent:

The district court also found that claim 4 of the ’149 patent was not invalid as obvious. Claim 4 is similar to the claims of the ’463 patent with the exception that it contains the additional limitation that the daily number of doses of brimonidine be reduced from 3 to 2 times a day without loss of efficacy. Sandoz has the burden to show by clear and convincing evidence that claim 4 would have been obvious. See Microsoft Corp, 131 S. Ct. at 2242. On this front, Sandoz has a problem.

The "without loss of efficacy" claim element was the problem:

Moreover, while it is true that the prior art shows concomitant administration of brimonidine and timolol was dosed twice per day, this art does not show that there was no loss of efficacy associated with that treatment, let alone an elimination of the afternoon trough.

The key point was in footnote 1:

The evidence of record does not establish that the dose reduction “from 3 to 2 times a day without loss of efficacy” limitation is an inherent property or a necessary result of the administration of 0.2% brimonidine and 0.5% timolol in a single composition. Of course, it may be true that the mere administration of 0.2% brimonidine and 0.5% timolol twice daily in any fixed combination formulation inherently produces the claimed result. Alterna- tively, it may also be true that only certain fixed- combination formulations produce this result. On the present record, we cannot draw a conclusion in favor of either proposition.


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