Horatio Wash. Depot Techs. LLC v. Tolmar, Inc.
United States District Court for the District of Delaware
November 1, 2018, Decided; November 1, 2018, Filed
Civil Action No. 17-1086-LPS
REPORT AND RECOMMENDATION
Presently before the Court is Defendants TOLMAR, Inc., TOLMAR Pharmaceuticals, Inc., and TOLMAR Therapeutics, Inc.'s (collectively "Defendants" or "TOLMAR") motion to dismiss for failure to state a claim (the "Motion"), filed pursuant to Federal Rule of Civil Procedure 12(b)(6). (D.I. 12) Defendants argue that Plaintiff Horatio Washington Depot Technologies LLC's ("Plaintiff' or "Horatio") Complaint, (D.I. 1), which alleges infringement of United States Patent Nos. 5,932,547 (the "'547 patent"), 6,124,261 (the "'261 patent"), and 6,235,712 (the "'712 patent") (together the "asserted patents" or "patents-in-suit"), should be dismissed for various reasons. For the reasons that follow, the Court recommends that Defendants' Motion be GRANTED-IN-PART [*2] and DENIED-IN-PART.
A. Factual Background
Plaintiff is the owner of the asserted patents by assignment and has the right to sue for past damages. (Id. at ¶¶ 17-19) The asserted patents are all titled "Non-Aqueous Polar Aprotic Peptide Formulations[,]" and were issued between 1999 and 2001. (Id.) The '547 and '261 patents (the "formulation patents") "are directed to stable, non-aqueous formulations of a peptide compound and solvent," while "the '712 patent is directed to methods of preparing those formulations and treating prostate cancer using those formulations." (D.I. 13 at 4) At the time of the filing of this action in August 2017, the three asserted patents had already expired on June 13, 2017. (Id. at 3) Further information about the patents and products reading on the patents is set forth in Section III. According to the Complaint, Defendant "TOLMAR Pharmaceuticals, Inc. holds approved New Drug Applications ('NDA')" for various doses of its branded drug Eligard® (the "accused product"). (D.I. 1 at ¶ 23) "Eligard is indicated for use in the palliative treatment of advanced prostate cancer" and "contains leuprolide acetate, a luteinizing hormone-release hormone (LH-RH) related compound as its active pharmaceutical [*3] ingredient." (Id.) Plaintiff alleges that Defendants directly, indirectly and willfully infringed the patents-in-suit relating to the making, using, selling or offering for sale of Eligard. (Id. at ¶¶ 29-109)
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2018 U.S. Dist. LEXIS 187074 *; 2018 WL 5669168
HORATIO WASHINGTON DEPOT TECHNOLOGIES LLC, Plaintiff, v. TOLMAR, INC., TOLMAR PHARMACEUTICALS, INC., and TOLMAR THERAPEUTICS, INC., Defendants.
Subsequent History: As Amended November 26, 2018.
Patent interpreted by Horatio Wash. Depot Techs. LLC v. Tolmar, Inc., 2018 U.S. Dist. LEXIS 216086 (D. Del., Dec. 26, 2018)
Adopted by, Dismissed by, in part, Motion denied by, in part, Objection overruled by Horatio Wash. Depot Techs. LLC v. Tolmar, Inc., 2019 U.S. Dist. LEXIS 45453 (D. Del., Mar. 20, 2019)
Costs and fees proceeding at, Motion denied by Horatio Wash. Depot Techs. LLC v. Tolmar, Inc., 2019 U.S. Dist. LEXIS 145315 (D. Del., Aug. 27, 2019)
patents, infringement, notice, patentee, acetate, leuprolide, compound, peptide, solvent, manufacture, recommends, quotation, aprotic, polar, Pharmaceuticals, packaging, Depot, non-aqueous, compliance, discovery, indirect, unmarked, expired, syringe, stable