Sun Pharm. Indus. Ltd. v. Saptalis Pharms., LLC

Riomet®/metformin HCl

August 6, 2020

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Sun Pharm. Indus. Ltd. v. Saptalis Pharms., LLC, No. 18-648-WCB, 2020 WL 5077412 (D. Del. Aug. 6, 2020) (Bryson, J.) 

Drug Product and Patent(s)-in-Suit: Riomet® (metformin HCl); U.S. Patent No. 6,890,957 (“the ’957 patent”)

Nature of the Case and Issue(s) Presented to District Court: Riomet was an oral diabetes medicine that, when used together with diet and exercise, helped to improve blood sugar control in adults with type 2 diabetes mellitus. After Saptalis submitted an ANDA seeking approval to market a generic version of Riomet, plaintiffs Sun and Ranbaxy filed suit for infringement under the Hatch-Waxman Act. Earlier in the case, Saptalis had moved for summary judgment of non-infringement against Plaintiff, which the court had granted. Then, Defendants moved for an exceptional-case determination and attorneys’ fees pursuant to 35 U.S.C. § 285. The court denied Defendant’s motion, as none of their claims, either viewed alone or in conjunction with other claims, merited an exceptional-case finding and an award of attorneys’ fees.

Why Plaintiff Prevailed: Defendant argued that this case was exceptional and stood out from other patent cases for two reasons. First, Defendants pointed to the lack of substantive strength in Plaintiff’s litigating position. The court rejected this argument, finding that when it evaluated whether a party had taken unreasonable litigating positions, it was important to note at the outset that the fact that the party's position did not prevail―or would not have prevailed had the case been litigated to conclusion―was insufficient by itself to warrant an award of fees. The court found that Plaintiff’s theory of infringement under the doctrine of equivalents was not so meritless to render the case exceptional. Additionally, the court noted that it had rejected all except one of Defendants summary-judgment arguments, further emphasizing that the issues were factually complex and required extensive analysis. As such, Plaintiff’s doctrine-of-equivalents theory was not so inapplicable to render this an exceptional case warranting fees.

Second, Defendants argued that the manner in which Plaintiff litigated the case made the case exceptional, pointing to Plaintiff’s: (i) taking inconsistent positions regarding what constituted “polyhydroxy alcohols;” (ii) abandoning its proposed construction of the claim term “by weight;” (iii) abandoning its appeal; (iv) falsely reporting the expiration date of the asserted patents; (v) failing to disclose its expert in violation of the court's protective order; and (vi) attempting to delay or avoid summary-judgment proceedings. The court found none of Defendants’ positions to be persuasive, noting that Plaintiff’s amendments to its infringement positions were proper, Plaintiff did not abandon a construction but rather adopted a construction that was earlier held by the court to be permissible, abandoned its appeal because it made economic sense, which is an acceptable reason to do so, did not falsely report the expiration date of the asserted patent but rather made a mistake without the need for court intervention, inadvertently failed to disclose, with no prejudice to Defendant, its experts because it was in the process of changing counsel, and while Plaintiff initially filed a motion to transfer, it voluntarily withdrew the motion and agreed to litigate the case in Delaware.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

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