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Sun Pharmaceutical Industries Ltd. v. Saptalis Pharmaceuticals, LLC

United States District Court, D. Delaware

June 10, 2019

SUN PHARMACEUTICAL INDUSTRIES LTD. and RANBAXY SIGNATURE, LLC, Plaintiffs,
v.
SAPTALIS PHARMACEUTICALS, LLC, Defendant.

          REDACTED MEMORANDUM OPINION AND ORDER

          WILLIAM C. BRYSON UNITED STATES CIRCUIT JUDGE.

         Before the Court in this Hatch-Waxman Act patent infringement action is a motion for summary judgment filed by defendant Saptalis Pharmaceuticals, LLC (“Saptalis”). Dkt. No. 69. Plaintiff Ranbaxy Signature, LLC, is the sole owner of U.S. Patent No. 6, 890, 957 (“the '957 patent”). Dkt. No. 1, at 3. Plaintiff Sun Pharmaceutical Industries Ltd. has exclusive marketing, promotion, distribution, and sales rights to products covered by the '957 patent on a worldwide basis. Id. The plaintiffs (collectively, “Sun”) have asserted claims 1, 2, 7, and 9-15 of the '957 patent against Saptalis. Dkt. No. 70, at 3. Saptalis seeks summary judgment of non-infringement as to all of the claims asserted against it, arguing that the asserted claims of the '957 patent are not infringed, either literally or under the doctrine of equivalents. In this order, the Court construes the disputed terms of the asserted claims, but defers decision of the motion for summary judgment until after the close of discovery on July 19, 2019.

         BACKGROUND

         I. The Asserted Claims

         The '957 patent is entitled “Liquid Formulation of Metformin.” It issued on May 10, 2005, from an application that was a continuation of an application that issued as U.S. Patent No. 6, 559, 187 (“the '187 patent”). See Dkt. No. 70, at 2; Dkt. No. 79, at 4. The '957 patent claims priority to U.S. Provisional Application No. 60/223, 391, which was filed on August 7, 2000. See Dkt. No. 71-12, at 2.

         The '957 patent “relates to a liquid formulation of metformin and salts thereof” and to the use of that formulation “in treating hyperglycemia and/or diabetes.” '957 patent, col. 1, ll. 15-17. Claim 1 is the only independent claim of the '957 patent. Dkt. No. 70, at 3-4; Dkt. No. 79, at 4.

         Claim 1 states as follows:

1. A liquid pharmaceutical composition for oral administration which comprises a therapeutically effective amount of metformin or its pharmaceutically acceptable salt; a sweetener that does not increase the blood glucose level of a subject after ingestion thereof; a polyhydroxy alcohol present in an amount of about 15 to about 55% by weight; a mineral acid and bicarbonate salt both present in sufficient amounts to maintain the pH of the composition in the range of about 4.0 to about 9.0; and a pharmaceutically acceptable liquid carrier.

         In 2003, the U.S. Food and Drug Administration approved Sun's New Drug Application No. 021591 for the drug protected by the '957 patent. The agency then listed the patent in its publication entitled Approved Drug Products and Therapeutic Equivalence Evaluations, also known as “the Orange Book, ” as covering Sun's product bearing the trade name Riomet®. Dkt. No. 1, at 3. Saptalis subsequently submitted an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Riomet®. Sun then filed this action under the infringement provision of the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2), alleging that Saptalis's ANDA product infringes the '957 patent.

         II. Sun's Infringement Contentions

         In its first amended initial infringement claim charts, Sun argues that Saptalis's ANDA product meets each asserted claim limitation, either literally or under the doctrine of equivalents. The summary judgment briefing focuses on two limitations in claim 1: the sweetener limitation and the polyhydroxy alcohol limitation. Sun argues that the sweetener limitation-“a sweetener that does not increase the blood glucose level of a subject after ingestion thereof-is met by either (or both) of two ingredients in Saptalis's ANDA product, (Xxxxx) and an ingredient known as (Xxxxx) Flavor (Xxxxx) Those ingredients allegedly provide a sweetening effect without increasing the patient's blood glucose level. Sun argues that the polyhydroxy alcohol limitation-“a polyhydroxy alcohol present in an amount of about 15 to about 55% by weight”- is met by two ingredients in Saptalis's ANDA product, (Xxxxx) and (Xxxxx) which allegedly perform the same function as the polyhydroxy alcohol ingredient in the recited formulation of the '957 patent by helping to mask the unpleasant taste of the active metformin ingredient and making the formulation more viscous. Dkt. No. 71-3, at 5.

         In its original infringement contentions, Sun asserted that (Xxxxx) was the only sweetener in the accused ANDA product, and that the (Xxxxx) and (Xxxxx) in Saptalis's ANDA product were polyhydroxy alcohols. Dkt. No. 71-4, at 5. On January 14, 2019, Sun served an amended initial infringement claim chart on Saptalis, in which it amended its infringement contentions. Dkt. No. 80-1, at 64-70. In the amended infringement contentions, Sun alleged that both (Xxxxx) and (Xxxxx) Flavor (Xxxxx) satisfied the sweetener limitation. In addition, Sun's amended infringement contentions retreated from the position that (Xxxxx) and (Xxxxx) are polyhydroxy alcohols, and contended instead that they are equivalent to the polyhydroxy alcohol recited in the '957 patent. Id. In light of the amended infringement contentions, Sun argues that Saptalis's ANDA product infringes the '957 patent under the doctrine of equivalents.

         Saptalis contends that Sun amended its original infringement contentions without any explanation. Dkt. No. 70, at 4; see also Id. at 26-27. Sun responds that it provided Saptalis with a letter dated January 18, 2019, “which explained in detail why Sun's contentions were supplemented.” Dkt. No. 79, at 8; see Dkt. No. 80-1, at 52-54. To the extent that Saptalis objects to Sun's amendment of its infringement contentions, the Court rejects Saptalis's argument. Sun amended its infringement contentions early in the case, giving Saptalis ample time to address Sun's new allegations in its motion for summary judgment, and there is no suggestion that Sun's amended infringement contentions were the product of bad faith on Sun's part. See Fed. R. Civ. P. 26(e); see also Dist. Of Del., Default Standard for Discovery § 4(c), n.3 (“As these [initial claim chart] disclosures are ‘initial,' each party shall be permitted to supplement.”); AVM Techs., LLC v. Intel Corp., Civil Action No. 15-33, 2016 WL 7177614, at *2 (D. Del. Dec. 9, 2016).

         III. Claim Construction and Summary Judgment

         On October 10, 2018, the Court issued a Revised Scheduling Order assigning dates for, inter alia, claim construction briefing and a hearing on claim construction. See Dkt. No. 39. On December 28, 2018, in a letter brief to the Court, Saptalis requested that the Court modify the Revised Scheduling Order to replace the briefing and hearing on claim construction with briefing and a hearing on Saptalis's motion for summary judgment based on non-infringement. Dkt. No. 61. In its letter brief in response, Sun opposed Saptalis's request to permit early summary judgment proceedings. Dkt. No. 62. On January 4, 2019, the Court held a telephonic hearing on Saptalis's request. During the telephonic hearing, the Court granted Saptalis's request to modify the Revised Scheduling Order, permitting Saptalis to move for an early summary judgment, in conjunction with the claim construction proceedings. See Dkt. No. 64. The Court instructed the parties to address the remaining claim construction disputes in their summary judgment motion papers. Id.

         ARGUMENT

         I. ...


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