IP Law Daily Non-obviousness affirmed, infringement reversed in suit over generic Combigan
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Friday, December 22, 2017

Non-obviousness affirmed, infringement reversed in suit over generic Combigan

By Mark Engstrom, J.D.

In a patent infringement suit over a generic version of the glaucoma drug Combigan, a federal district court did not err in finding that multiple claims of three Allergan patents—U.S. Patent Nos. 7,030,149, 7,320,976, and 8,748,425—were not invalid as obvious, the U.S. Court of Appeals for the Federal Circuit has ruled. The asserted claims did not recite the inherent results of administering an obvious combination, the circuit court concluded, and claim 4 of the ’149 patent did not fail to satisfy the written description requirement. Nevertheless, the district court had erroneously found that Sandoz Inc., Alcon Laboratories, and Alcon Research had literally infringed eight claims of the ’425 patent. According to the Federal Circuit, the district court had improperly relied on the equivalency of one compound in the ’425 patent and another compound in the proposed generic. Because chemical equivalency was insufficient for literal infringement, the infringement finding was clearly erroneous. Combigan was not the drug that was "claimed in" the ’425 patent, the Federal Circuit concluded, so the defendants’ abbreviated new drug application did not infringe under Section 271(e)(2)(A) (Allergan Sales, LLC v. Sandoz, Inc., December 22, 2017, Hughes, T.).

Procedural posture. Allergan held an approved new drug application (ANDA) for Combigan, an eye medication that lowers intraocular pressure in patients with glaucoma and ocular hypertension. According to Allergan, 10 patent claims (claims 1–8 of the ’425 patent, claim 1 of the ’976 patent, and claim 4 of the ’149 patent) protect Combigan and its administration.

Sandoz, Alcon Laboratories, and Alcon Research (collectively, "Sandoz") filed and maintained an abbreviated new drug application (ANDA) to gain approval for the marketing of generic versions of Combigan. Allergan sued Sandoz for direct, induced, and contributory infringement, asserting several patents in three different actions, only two of which proceeded to a consolidated trial on the three patents in suit.

The district court found that: (1) none of the asserted claims were invalid as obvious; (2) claim 4 of the ’149 patent satisfied the written description requirement; and (3) Sandoz’s ANDA did not infringe claim 4 of the ’149 patent or claim 1 of the ’976 patent. However, the district court also found that the ANDA infringed claims 1–8 of the ’425 patent. Sandoz appealed the findings of infringement and no invalidity, and Allergan cross-appealed the finding of non-infringement.

Obviousness. Sandoz argued that the district court had erred because all of the asserted claims merely recited the inherent results of administering an obvious combination. The Federal Circuit disagreed. The concomitant administration of a brimonidine and timolol ophthalmic composition twice daily was obvious in view of the prior art, the court conceded, but each asserted claim expressly recited an additional efficacy limitation that further restricted the method of administering the composition twice daily, and those limitations were not disclosed by a prior-art reference, according to the court. To the contrary, the prior art showed that the combination dosed twice daily produced a loss of efficacy in the afternoon.

In addition, the efficacy limitations were not inherent in the administration of the ophthalmic composition, a finding that was adequately supported by the record. Accordingly, the asserted claims merely recited administrations that satisfied the efficacy limitations; they did not recite administrations that resulted in a loss of efficacy.

In light of those findings, the Federal Circuit concluded that the district court had not erred in its finding that Sandoz had failed to present clear and convincing evidence to overcome the presumption that the asserted claims were valid.

Written description. Based on expert testimony that claim 4 of the ’149 patent encompassed "hundreds" of brimonidine and timolol combinations, Sandoz argued that claim 4 was invalid for lack of a written description. The Federal Circuit disagreed. According to the court, a sufficient description of a genus required the disclosure of either a representative number of species that fell within the scope of the genus, or structural features that were common to the members of the genus so that a person of skill in the art could visualize or recognize the members of the genus. In this case, the specification disclosed a representative embodiment of the claimed genus, and a person of ordinary skill in the art would have immediately discerned the claimed limitation, according to the court. Therefore, the district court did not err in finding that claim 4 satisfied the written description requirement.

Literal infringement. The district court erroneously concluded that the proposed generic literally infringed claims 1–8 of the ’425 patent because the generic contained 0.5 percent timolol free base. According to the Federal Circuit, claims 1–8 were narrowly and specifically drawn, reciting the administration of 0.2 percent brimonidine tartrate and 0.5 percent timolol free base. However, both Combigan and the proposed generic contained 0.68 percent timolol maleate, an ophthalmic compound that was distinct from 0.5 percent timolol free base.

In its finding of literal infringement, the district court had relied on the equivalency of 0.5 percent timolol free base (recited in claims 1–8) and 0.68 percent timolol maleate (contained in the proposed generic). Because chemical equivalency was insufficient for the literal infringement of those claims, the district court had "clearly erred."

The Hatch-Waxman Act provided for a technical infringement upon submission of an ANDA, the court noted, but only for a drug that was "claimed in a patent." In this case, Combigan contained a 0.2 percent brimonidine tartrate and 0.68 percent timolol maleate solution, but claims 1–8 expressly recited 0.5 percent timolol free base, not 0.68 percent timolol maleate. Therefore, as a matter of law, Combigan was not the drug that was "claimed in" the ’425 patent, and Sandoz’s ANDA did not infringe under Section 271(e)(2)(A).

Cross appeal. Allergan argued that the district court had erred in finding that Sandoz’s proposed generic did not infringe claim 4 of the ’149 patent and claim 1 of the ’976 patent, but the Federal Circuit disagreed. Both claims specifically recited 0.2 percent brimonidine, the court explained, but the proposed generic contained 0.2 percent brimonidine titrate, a distinct pharmaceutical compound that reduced to 0.132 percent brimonidine. Therefore, the district court did not err in finding that Allergan did not show literal infringement of those claims.

The case is Nos. 2017-1499, 2017-1500, 2017-1558, and 2017-1559.

Attorneys: Jonathan Elliot Singer (Fish & Richardson, PC) for Allergan Sales, LLC. John C. O’Quinn (Kirkland & Ellis LLP) for Sandoz Inc., Alcon Laboratories Inc., and Alcon Research, Ltd.

Companies: Allergan Sales, LLC; Sandoz, Inc.; Alcon Laboratories, Inc.; Alcon Research, Ltd.

MainStory: TopStory Patent FedCirNews

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