TAKEDA PHARMACEUTICALS U.S.A., INC. v. SPIRIDON SPIREAS

CourtDistrict Court, E.D. Pennsylvania
DecidedSeptember 4, 2019
Docket2:17-cv-00452
StatusUnknown

This text of TAKEDA PHARMACEUTICALS U.S.A., INC. v. SPIRIDON SPIREAS (TAKEDA PHARMACEUTICALS U.S.A., INC. v. SPIRIDON SPIREAS) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
TAKEDA PHARMACEUTICALS U.S.A., INC. v. SPIRIDON SPIREAS, (E.D. Pa. 2019).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA TAKEDA PHARMACEUTICALS U.S.A., INC., et al., Plaintiffs, CIVIL ACTION NO. 17-452 v. SPIRIDON SPIREAS, Defendant. TABLE OF CONTENTS I. INTRODUCTION .................................................................................................................. 4 II. BACKGROUND .................................................................................................................... 6 A. Spireas And Bolton Develop And Patent Their Liquisolid Technology And Form Hygrosol Pharmaceutical Corporation To Market The Technology ................................ 6 B. Mutual PA And United Enter Into An Agreement (“1998 Agreement”) With Spireas, Bolton, And Hygrosol To License The Liquisolid Technology To Develop Generic Drug Products ..................................................................................................... 7 C. Spireas and Bolton Receive Four (4) Liquisolid Technology Patents ........................... 10 D. Spireas Begins Working for Mutual PA, And Mutual PA And United License The Liquisolid Technology from Hygrosol to Develop Felodipine and Propafenone ...........11 E. Mutual PA And United Remit Royalty Payments To Hygrosol For Felodipine And Propafenone Drugs Pursuant To The 1998 Agreement .................................................. 13 F. In 2011, Mutual PA And United Sue Spireas, Bolton, And Hygrosol In State Court .... 16 G. Takeda Pharmaceuticals Acquires Mutual PA And United In 2012, And Sells The Generic Drug Business Of Mutual PA And United To Sun Pharmaceutical in 2013 .... 17 H. In 2013, The Internal Revenue Service (“IRS”) Challenges Spireas’ Treatment Of The Hygrosol Royalty Payments ................................................................................... 18 I. Ensuing Procedural History Of This Case ..................................................................... 19 III. STANDARD OF REVIEW .................................................................................................. 24 IV. ANALYSIS ........................................................................................................................... 25 A. Mutual Delaware Has Standing To Sue Under The 1998 Agreement ........................... 26 B. United Has Standing To Sue Under The 1998 Agreement ............................................ 27 C. Genuine Disputes Of Material Fact Exist As To Whether United Paid Royalties To Hygrosol Under The 1998 Agreement ...................................................................... 31 1. Enough Evidence Has Been Offered To Create Genuine Disputes Of Material Fact As To Whether United Made Royalty Payments Under The 1998 Agreement From 2002 To 2013 ............................................................ 32 2. Genuine Disputes Of Material Fact Exist As To Whether Mutual Delaware, A Successor To United, Made Royalty Payments Under The 1998 Agreement ... 35 D. Genuine Disputes Of Material Fact Exist As To Whether Spireas Received Royalty Payments From Hygrosol For Felodipine And Propafenone Under The 1998 Agreement ...................................................................................................... 36 1. Hygrosol Received Royalty Payments Under The 1998 Agreement And Then Distributed The Royalty Payments To Spireas And Bolton ........................ 38 2. Whether The Royalty Payment Passed Through Hygrosol Before Reaching Spireas Has No Effect On Mutual Delaware’s Claim For Money Had And Received ................................................................................................................ 40 3. On Its Claim for Breach of Contract, Mutual Delaware Is Entitled To Seek Royalty Payments Made By United To Hygrosol Under The 1998 Agreement ... 41 E. The October 2018 Settlement Agreement Between Takeda, Spireas, And Hygrosol Does Not Preclude Mutual Delaware’s Claims ..................................... 45 F. Genuine Disputes Of Material Fact Exist As To Whether Mutual Delaware And United Made Royalty Payments Under The 1998 Agreement Voluntarily As A Result Of An Unprovoked Mistake Of Law............................................................... 48 G. Spireas Is Not Entitled To Summary Judgment Based On Claim Preclusion ................ 49 H. Genuine Disputes Of Material Fact Preclude Judgment As A Matter Of Law On Spireas’ “Companion” Motion For Summary Judgment On Mutual Delaware’s Claim For Money Had And Received Based On False Pretenses ............................................ 52 1. Mutual Delaware Is Not Required To Prove Fraud In Order To Maintain Its Claim For Money Had And Received .............................................................. 53 2. Genuine Disputes Of Material Fact Have Been Shown As To Whether Spireas Made Material Misrepresentations to Mutual PA And/Or United In Connection With The 1998 Agreement ................................................................. 54 3. Genuine Disputes Of Material Fact Have Been Shown As To Whether Mutual PA And/Or United Justifiably Relied On Spireas’ Representations That They Were Selling Drugs That Contained The Patented Technology .......... 56 V. CONCLUSION ..................................................................................................................... 59 OPINION Slomsky, J. September 3, 2019 I. INTRODUCTION On June 12, 1998, Defendant Spiridon Spireas (“Spireas”), his business partner, Dr. Sanford Bolton (“Bolton”),1 and the company they formed together, Hygrosol Pharmaceutical Corp. (“Hygrosol”), executed a licensing agreement (the “1998 Agreement”) with Mutual Pharmaceutical Company, Inc., a Pennsylvania corporation (“Mutual PA”), and its sister

corporation, United Research Laboratories, Inc. (“United” or “URL”). Under the 1998 Agreement, Spireas and Bolton, through Hygrosol, granted Mutual PA and United the exclusive right to license their patent-pending “liquisolid technology” to use in formulating and developing generic drug products. Liquisolid technology is a process through which non-soluble drugs can be dissolved and converted into powder or pill form. In March of 2000, Mutual PA and United licensed Spireas’ and Bolton’s now-patented liquisolid technology to develop generic propafenone and felodipine drug products, the active ingredients in the drugs Rythmol and Plendil, which are used respectively to treat irregular heart rates and high blood pressure. Under the terms of the 1998 Agreement, Spireas successfully

developed formulations for felodipine and propafenone drug products for Mutual PA and United, after which Mutual PA and United began manufacturing and selling the drugs. In exchange for granting Mutual PA and United the right to their liquisolid technology, Spireas and Bolton received hundreds of millions of dollars from Mutual PA and United as royalties on the felodipine and propafenone products.

1 Dr. Bolton is not a party to this action. In 2011, Dr. Bolton passed away and his estate now holds “any rights and bears any obligations imposed” on him under the 1998 Agreement. (Doc. No. 64-1 at 5.) In 2017, Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”), the successor-in-interest to Mutual PA, uncovered testimony that Spireas had given in a tax court proceeding unrelated to this case. During those proceedings, Spireas testified that the formulations he made for propafenone and felodipine under the 1998 Agreement did not use his and Bolton’s patented liquisolid technology. Consequently, Takeda filed this case, alleging that Spireas had breached the 1998

Agreement by misrepresenting the formulations of felodipine and propafenone. Takeda sought to recoup the $150 million in royalties that were paid to Spireas under the 1998 Agreement.

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TAKEDA PHARMACEUTICALS U.S.A., INC. v. SPIRIDON SPIREAS, Counsel Stack Legal Research, https://law.counselstack.com/opinion/takeda-pharmaceuticals-usa-inc-v-spiridon-spireas-paed-2019.