Allergan, Inc. v. Sandoz, Inc., Lupin Ltd., Lupin Pharmaceuticals, Inc., Hi-Tech Pharmacal Co., Inc.

Docket No. 2014-1275

August 4, 2015

Brief Summary: DC conclusion of non-obviousness affirmed based on unexpected results and prior art’s teaching away. DC conclusions of no lack of written description or enablement also affirmed, as was its conclusion that Hi-Tech’s product having a pH upper limit of 7.2 infringed Allergan’s claimed pH of “about 7.3”.

Summary:   Sandoz appealed ED TX DC holding the claims of US 7,851,504; 8,278,353; 8,299,118; 8,309,605; and 8,338,470 were not shown to be invalid for obviousness and the ‘353 / ‘118 patents were not invalid for lacking an adequate written description. Lupin challenged the DC determination that the patents were not invalid for lack of enablement. Hi-Tech challenged the DC finding that it infringed the ‘504, ‘605 and ‘479 patent literally and under the DOE. The patents relate to Allergan’s once-daily topical solution Lumigan® 0.01% (0.01% by weight bimatoprost (a “prostaglandin analog that effectively lowers intraocular pressure, but can cause hyperemia, i.e., red eye”) and 200 ppm benzalkonium chloride (BAK; a preservative for inhibiting bacterial growth)) for treating glaucoma. Allergan’s predecessor bimatoprost product, Lumigan® 0.03% (0.03% by weight bimatoprost, 50 ppm BAK), was found to cause red eye. Lumigan® 0.01% (having a “three-fold lower bimatoprost concentration and a four-fold higher BAK concentration”) was developed to solve this problem. Regarding the finding of non-obviousness, the DC concluded the prior art showed ophthalmic formulations to be unpredictable, reducing bimatoprost to 0.01% would result in less IOP-lowering efficacy and would not result in less red eye, that BAK would decrease the permeability of a neutral prostaglandin analog (like bimatoprost) and should be minimized in ophthalmic formulations due to side effects (increased IOP and red eye; thereby teaching away), and that there was evidence of long-felt need, unexpected results “of a different kind, not just of different degree”, and commercial success. Sanodz et al. argued that under Galderma (FC 2013 (“prior art disclosure of 0.01%-1% adaptalene encompassed the claimed composition comprising 0.3% adaptalene”)) the prior art disclosure of 0.001%-1% bimatoprost and 0-1000 ppm BAK for treating glaucoma rendered the claims obvious. The opinion explained that, under Galderma, “where there is a range disclosed in the prior art, and the claimed invention falls within that range, the relevant inquiry is whether there would have been a motivation to select the claimed composition from the prior art ranges”. If so, “the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations.”   The FC found no error with the DC conclusion because “the record shows that the claimed amounts of the two different ingredients could and did materially and unpredictably alter the property of the claimed formulation” and the “unexpected results…differed in kind, not just in degree, from the prior art” (citing In re Applied Materials, FC 2012 and KSR and noting “This is not a case where the claims merely recite the unknown properties of an otherwise obvious formulation.” (Santarus, FC 2012)). It also agreed with the DC regarding the prior art’s teaching away (“that BAK should be minimized in ophthalmic formulations to avoid safety problems”); the key question in the analysis being whether the skilled artisan would have been “discouraged from following the path set out in the reference” (In re Gurley, FC 1994). It also agreed with the DC conclusion regarding written description but nevertheless found error with the DC’s reliance on an “undisclosed clinical protocol” (Lockwood, FC 1997). The FC panel did not agree with Lupin’s enablement arguments because “a patent does not need to guarantee that the invention works for a claim to be enabled” (Alcon, FC 2014). It also agreed with the DC conclusion that Hi-Tech’s ANDA formulation having a pH upper limit of 7.2 infringed certain claims including a limitation of a “pH of about 7.3” (“it is not clearly erroneous for [about 7.3] to include a value that differs from it by one one decimal place”). The DC determinations were therefore affirmed.

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

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