Allergan Sales, LLC v. Sandoz. Inc.

Case Name: Allergan Sales, LLC v. Sandoz. Inc., Nos. 2017-1499, 2017-1500, 2017-1558, 2017-1559, 2017 U.S. App. LEXIS 26312 (Fed. Cir. Dec. 22, 2017) (Circuit Judges Moore, Mayer, and Hughes presiding; Opinion by Hughes, J.) (Appeal from E.D. Tex., Gilstrap, J.) 

Drug Product and Patent(s)-in-Suit: Combigan® (brimonidine tartrate / timolol maleate); U.S. Patents Nos. 7,030,149 (“the ’149 patent”), 7,320,976 (“the ’976 patent”), and 8,748,425 (“the ’425 patent”)

Nature of the Case and Issue(s) Presented:  Combigan was a “fixed combination” ophthalmic solution consisting of 0.2% brimonidine tartrate and 0.68% timolol maleate for twice-daily dosage used to lower intraocular pressure in glaucoma and ocular hypertension patients. The district court found the asserted claims of the patents not invalid as obvious. The court also found that claim 4 of the ’149 patent satisfied the written-description requirement. The court finally determined that Sandoz’s ANDA did not infringe claim 4 of the ’149 patent or claim 1 of the ’976 patent, but did infringe claims 1-8 of the ’425 patent. Sandoz appealed the district court’s validity and infringement determinations. Allergan cross-appealed the district court’s finding of non-infringement. The Federal Circuit found no reversible error in the district court’s finding of validity, but it found that the accused proposed generic drug contemplated administering dosages of a specific composition that was not claimed in any of the patents. Thus, the Federal Circuit affirmed-in-part and reversed-in-part.

Why Allergan Prevailed on Validity:  The asserted claims claimed the  concomitant administration of brimonidine and timolol ophthalmic composition twice daily—something the Federal Circuit said was obvious in view of the prior art. But the court noted that each asserted claim, however, expressly recited an additional efficacy limitation that further restricted the method of administering the composition twice daily: (i) “without loss of efficacy” in claim 4 of the ’149 patent; (ii) “a therapeutically effective amount” in claim 1 of the ’976 patent; and (iii) “reduc[ing] the incidence of one or more adverse events” in claim 1 of the ’425 patent. This limitation saved the claims, the court said, since the prior art showed that the combined dose, delivered twice daily, shows decreased efficacy.

Why Sandoz Prevailed on Non-infringement: The Federal Circuit found the ’425 patent not infringed. The proposed generic contained 0.68% timolol maleate, as did Combigan. However, the asserted claims of the ’425 patent recited administration of 0.5% timolol free base. Allergan raised only literal infringement arguments. But the district court relied on the equivalency of the two compounds in finding literal infringement—that is, 0.5% timolol free base recited in claims 1-8 was chemically equivalent to 0.68% timolol maleate contained in the proposed generic. The Federal Circuit said that chemical equivalency was not sufficient for literal infringement of these claims and overturned the district court’s infringement finding. The court said that under the Hatch-Waxman Act, submission of an ANDA was infringement only if the ANDA product contained the drug claimed in the patent. That was not the case here.