Allergan, Inc. v. Sandoz, Inc. et al.


Docket No. 2011-1619, -1620, -1635, -1639

DYK (d), PROST, O’MALLEY
May 1, 2013

Brief summary: Claim to method of treatment found not obvious due to “no loss of efficacy” limitation.

Summary: Sandoz appealed DC finding that Allergan’s claims related to the eye-drop product Combigan® (combination of “the well-known alpha2-agonist Alphagen® (0.2% brimondine)” and “the wel-known beta-blocker Timoptic® (0.5% timolol)” were not obvious. Allergan appealed certain claim construction findings. Claim 1 of U.S. Pat. No. 7,323,463 (affirmed as obvious) encompassed “[A] composition comprising about 0.2% timolol by weight and about 0.5% brimonidine by weight as the sole active agents, in a single composition.” Claim 4 of U.S. Pat. No. 7,030,149 (reversed as not obvious) encompassed “[a] method of reducing the number of daily topical ophthalmic doses of brimondine…from 3 to 2 times a day without loss of efficacy….” The DC found claim 1 (and similar claims) obvious because there was no motivation to combine the components as “the FDA did not view patient compliance as a factor for approval”, “the formulation arts are unpredictable”, “there were some teachings in the prior art that taught away from the claimed invention”, and secondary considerations (long-felt need and unexpected results). The FC panel found the motivation conclusion incorrect since, while “FDA approval may be relevant to the obviousness requirement” (Knoll Pharm., FC 2004), “[m]otivation to combine may be found in many different places and forms”. The panel pointed out that “some degree of unpredictability” is acceptable “so long as there was a reasonable probability of success” (Pfizer, FC 2007) (and the difficulties encountered during development were related to preservative and therefore “irrelevant”). The DC teaching away conclusions were also dismissed because it did not consider “what, if any, impact [those] aspects of the prior art would have on the clear motivation to combine expressed in” other prior art (e.g., DC “did not find that the prior art as a whole taught away”). And, while there was some evidence of unexpected results, the FC panel did not find those “sufficient to outweigh the other evidence of obviousness”. Regarding ‘149 claim 4, the FC panel found that “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”. The fact that timolol had been combined with other ophthalmic drugs (not alpha2 agonists) to treat glaucoma with a reduced number of doses was not persuasive as the panel saw “no reason why the success of unrelated drugs” would make ‘149 claim 4 obvious (“cannot equate a greater reduction in intraocular pressure with ‘no loss of efficacy'”). Judge Dyk’s dissent argued that claim 4 should be found obvious because “a newly-discovered result or property of an existing (or obvious) method of use is not patentable” (citing Abbott, FC 2006; Brassica, FC 2002; and Bristol-Myers, FC 2001) and “‘loss of efficacy’ is not a separate step, but rather a result of the claimed method”. Finally, the claim construction findings of the DC were affirmed.

This entry was posted in Claim Construction, Generics / ANDA, Obviousness. Bookmark the permalink.

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