throbber
IN THE CIRCUIT COURT FOR MONTGOMERY COUNTY, ]\{ARYLAND
`
`LEWIS J. RUBIN,
`
`Plaintiff,
`
`Civil Action No.
`
`CONIPLAINT AND DEN{AND FOR JURY
`TRIAL
`
`UNITED THERAPEUTICS CORPORATION,
`LUNG BIOTECHNOLOGY INC. (formerly known
`AS LUNG RX, INC.),
`
`Address: 1040 Spring Street
`Silver Spring, Maryland 20910
`
`Defendants.
`
`n
`
`(^)
`
`PlaintiffLewis J. Rubin, MD ("Dr. Rubin"), by his undersigred anomeys, ffi6p*ptaig,r, + l="lifl
`e# #i
`!.1:, * iii
`United Therapeutics Corporation (.'UTC,) and Lung Biotechnology Inc. (.L{fidrBi6g;
`
`--agaiirst
`_ formerly known as Lung Rx, Inc. ("Lung-Rx"), a subsidiary of UTC, alleges as follows:
`
`c.)
`
`I o
`
`Introduction
`
`-
`
`1.
`
`This is an action under Maryland law for constructive fraud, negligent
`
`misrepresentation, breach of contract, and reformation ofpatent application assignments which
`
`mistakenly transferred to UTC Dr. Rubin's joint ownership interest in U.S. patent No. 9,339,507
`
`issued May l'1,2016 ("the '507 patent"), U.S. Patent No. 9,359,240 issued June 7,2016 (,,the
`
`'240 patent") and related U.S. and foreign counterparts. The'507 and'240 patents are both
`
`entitled "Trepostinil Administration By Inhalation" and directed to treatments for pulmonary
`
`arterial hypertension ("PAH"). (copies of the'507 and'240 patents are annexed as Exhibits I
`
`and 2).
`
`l
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`2.
`
`Dr. Rubin conceptualized the inventions clairned in the'507 and'240 patents and,
`
`thereafter, entered into a Services Agreement dated September 23,2003 (..2003 Services
`
`Agreement") with urc's subsidiary Lung-Rx (now Lung-Bio) to provide consulting services for
`
`further development ofhis inventions. Under the 2003 Services Agreement and subsequent
`
`consulting agreements that Dr. Rubin entered into with UTC and Lung-Bio, Dr. Rubin retained
`joint ownership with urc in his inventions claimed in the'507 and '240 patents. The'507 and
`
`'240 patents as issued, in error, reflect an assignment to UTC of Dr. Rubin's joint ownership
`
`interests in the patents. This action seeks reformation of the assignment ofthe entirety of Dr.
`
`Rubin's rights in the'507 and '240 patents to urc to reflect the parties' agreement that Dr.
`
`Rubin would assign only inventions made under the 2003 Services Agreement and therefore
`
`retain an undivided interest with UTC in the patents.
`3. Martine Rothblatt ("Rottrblatt"), a business entrepreneur and attomey, founded UTC
`and Lung-Bio in 1996 in order to develop therapies for orphan diseases such as pAH. At all
`
`relevant times, Rothblatt held the positions of chairman and cEo of UTC, and president antl cEo
`
`of Lung-Bio. From as early as 1995, prior to Dr. Rubin's affiliation with defendants, to termination
`
`ofDr. Rubin's affiliation with defendants in 2016, Rothblatt and Dr. Rubin had a close personal and
`
`business relationship (a "Confidential Relationship"). Rubin acted at the direction ofRothblatt and
`
`in reliance on his relationship of trust with Rothblatt and defendants in executing the assignment
`
`documents which are the subject ofthe claims in this action.
`
`The Parties
`
`4.
`
`Dr. Rubin is an Emeritus Professor of Medicine, University of Califomia, San Diego
`
`School of Medicine, La Jolla, CA, and presently Adjunct Professor of Medicine, Columbia
`
`2
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`University College of Physicians and Surgeons, New York, NY. Dr. Rubin resides at 146 West
`
`57th Street, Apt.678, New York, NY 10019.
`5. UTC is a corporation organized and existing under the laws ofthe State of
`
`Delaware, having a place ofbusiness at 1040 Spring Street, Silver Spring, Maryland 20910.
`6.
`
`Lung-Bio is a corporation organized and existing under the laws ofthe State of
`
`Delaware, having a place ofbusiness at 1040 spring street, Silver Spring, Maryland 20910. Lung-
`
`Bio is a wholly-owned subsidiary of UTC and was formerly known as Lung-Rx.
`
`Jurisdiction and Venue
`
`7.
`
`This court has jurisdiction over the defendants pursuant to MD. code, cts. & Jud
`
`Proc., $$ 6-102(a) and 6-103(b).
`8.
`
`Venue is proper pursuant to Md. Code, Cts. & Jud. proc., $ 6_201(a).
`
`Back
`
`und
`
`Lervis J. Rubin, MD -- Curricu lum Vitae
`9. Dr. Rubin is a Professor of Medicine, Emeritus and former Director of the Division
`of Pulmonary and critical care Medicine at the University of califomia, san Diego School of
`
`Medicine, and an Adjunct Professor ofMedicine at Columbia University College of Physicians and
`
`Surgeons. He has published over 250 peer-reviewed scientific papers and over fifty book chapters,
`
`and edited six books dealing with pulmonary circulation.
`10. Dr' Rubin has been the Principal Investigator or a Steering Committee member for
`the clinical trials leading to regulatory approval ofa currently approved pAH medical therapies.
`
`He has served on the editorial boards of the Annals of Intemal Medicine and the American Joumal
`
`ofRespiratory and Critical Care Medicine, and as senior consulting editor for the Joumal of the
`
`3
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`American College of Cardiology and the Joumal of Heart and Lung Transplantation. Dr. Rubin has
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`also seled as an advisor to tlre NIH, the FDA, and numerous medical and scientific organizations
`
`worldwide. He is a member of the American Society of Clinical Research and the recipient of the
`
`Dickinson Richards Memorial Award fiom the Arnerican Heart Associahon, the Sirnon Dack
`
`Award from the American college of cardiology, the college Medalist Award from the American
`
`college of chest Physicians, the Lifetime Achievement Award from the pulmonary Vascular
`
`Research Institute, and is listed in Thomson Reuters' list of the Most Influential Researchers in the
`
`World in 2014 and 2015. (Dr. Rubin's CV is amexed as Exhibit 3).
`
`The PPH Cure Foundation
`
`I I .
`
`In or about 1995, Martine Rothblatt, a co-founder ofdefendants, organized the ppH
`
`Cure Foundation, a non-profit foundation to promote research into PAH. Rothblatt is an attomey
`
`and an entrepreneur who had substantial success in the business world, including the organization of
`
`SiriusXM Satellite Radio. Treatments for PAH were of particular interest to Rothblatt because a
`
`close relative suffered from this life threatening disease.
`12. Dr. Rubin and a colleague, Jason yuan, submitted a grant proposal to the ppH cure
`Foundation to further PAH research, which led to a more than twenty (20) year friendship and
`
`business association between Dr. Rubin and Rothblatt, and consulting work with UTC and its
`
`subsidiaries in the development ofPAH drugs.
`13. Dr. Rubin and his colleague Jason yuan were the first recipients ofa ppH cure
`Foundation research grant for 1996-199'1 to fund research in the PAH field. Dr. Rubin contributed
`
`the cash prize awarded to him back to the PPH Cure Foundation for furthering research in this area.
`
`Dr. Rubin's stature in the medical field is reflected in news accounts ofthe ppH Cure Foundation
`
`4
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`gl arlt
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`WASHINGTON, May 15 /PRNewswire/ -- Dr. Lewis J. Rubin, Head of the
`Division of Pulmonary and Critical Care Medicine at the University of Maryland
`School of Medicine, was named today the winner of the ppH Cure Foundation,s
`I 997 Scientific Progress Award. The Award is issued each year to the researcher
`deemed to have made an outstanding contribution toward a cure for primary
`Puhnonary Hypertension (PPH).
`
`"We are most pleased to be able to issue this award to Dr. Rubin,,' said Martine
`Rothblatt, Program Director of the PPH Cure Foundation. ',His widely recogrized
`scientific research, robust clinical practice, esteemed teaching ability, pioneering
`scholarly publications and public interest speaking all combine in a rather
`unprecedented manner to demonstrate his outstanding leadership in the search for a
`PPH cure. "
`
`PPH is a serious, life-threatening disease of the smallest blood vessels within the
`lungs. The disease blocks blood flow through the pulmonary capillaries, resulting in
`dizziness, exhaustion and ultimately right heart failure. Most paiients are young
`women, and left untreated the disease generally causes death within tkee years of
`diagrosis. The cause ofthe disease in most people is unknown, although diet drugs
`such as Redux have been associated with a greatly increased risk of getiing ppH.
`
`Dr. Rubin, a Professor of Medicine and physiology at the University of Maryland
`School of Medicine, is a graduate of the Albert Einstein College of Medicine and
`Yeshiva University, in Niw York. After post-graduate work ai Duke University
`Medical center, he taught at the University of Texas Health science center. He is
`the co-editor (with Stuart Rich, MD) of the only textbook on prirnary pulmonary
`Hypertension (Marcel Dekker 1997), and the author ofover one hundred articles,
`monographs, book chapters and other publications on serious respiratory disorders.
`Dr. Rubin was principally involved in achieving 1996 FDA approval oi Gl*o_
`Wellcome's FLOLAN, the first drug to be approved for treatment of ppH and is a
`principal investigator in other ongoing efforls to develop new medical keatments for
`PPH' His fiailbl azing 1996 Abstract paper, Dysfunctional voltage-Gated potassium
`channels in the Pulmonary Artery Smooth Muscle cells of patients with ppH, won
`the A'rerican Heart Association's highest award for cardiopulmonary Abstract
`Papers.
`
`Dr. Rubin asked that the Foundation divert the cash portion of the Scientific
`Progress Award to the purpose of funding his colleagues, research. ',Working with
`my collaborators and, of course our patients,', said Dr. Rubin, ',gives me more than
`enough gratification and incentive."
`
`SOURCE PPH Cure Foundation
`
`)
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`PR News Wire May 15,1997
`
`ewsire. conVnews-rel eaSES
`
`Organization of UT C
`14. UTC was founded as Lung Rr, Inc. ('.Lung-Rx,,) on June 26, 1996 by Rothblatt and
`
`several fomer employees of Burroughs Wellcorne ("BW") that had been involved in the
`
`development of epoprostenol, which is marketed by BW as FLoLAN brand prostaglandin 12 (also
`
`known as Prostacyclin). The other UTC founding mernbers, James Crow phD (,.Crow,,), Shelmer
`
`Blackbum MA ("Blackburn") and Walker Long MD (,.Long',), are all former BW research
`
`sclentlsts.
`
`.l5. Dr. Rubin had also been associated with BW as a consultant with respect to its
`development of FLOLAN for treaunent of PAH. Dr. Rubin was both the Principal Investigator of
`
`the clinical development for FLOLAN, and the scientific presenter for the approval before the FDA
`
`Advisory Committee.
`16. At all relevant times, Dr. Rubin had a close personal relationship with UTC,s
`
`founding mernbers in addition to their business relationship through which he reposed trust and
`
`confidence in their integrity. He had become a personal friend of Rothblatt in connection with his
`
`work at the PPH cure Foundation prior to urc's founding and over the years, Dr. Rubin and
`
`Rothblatt periodically socialized, confided with one another on both business and personal matters,
`
`and developed a close personal relationship of trust and respect. For his part, Dr. Rubin looked to
`
`Rothblatt for advice in personal matters, including among others, divorce and real estate matters.
`
`The other UTC founding members, crow, Blackbum and tong became personal friends of Dr.
`
`Rubin tlrough his association with BW, including the development and launch of FLoLAN as the
`
`first drug for treatment of PAH.
`
`6
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`17. UTC's initial project was development of a drug which it acquired fiom BW,
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`designated BWl5-AU (chernical name teprostinil; redesignated at UTC as..UT-I5'') for
`
`subcutaneous treahnent ofPAH. Treprostinil is a prostacyclin analogue.
`18. UTC and Rothblaft invited Dr. Rubin to assume the role ofprincipal researcher for
`
`developing UT-15.
`19. UTC througlr its subsidiary Lung-Rx (now Lung-Bio) entered into a consulting
`
`agreement with Dr. Rubin with respect to the development of UT-15.
`20. Under the consulting agreement, Dr. Rubin served as the chair of UTC's Steering
`
`committee for the pivotal trial of UT-15 for PAH from approximately 199g to 2001. Dr. Rubin
`
`participated with UTC's management in corununicating with potential investors in order to discuss
`
`the company's drug development plans. UT- 15 was approved by the FDA onMay 21,2002 for
`
`treatment of PAH by subcutaneous delivery. UTC now markets UT-I5 under the brand name
`
`REMODULIN,
`21. Thereafter, Dr. Rubin concluded his mnsultant agreement with UTC to pursue other
`
`projects and research in academia. After a brief hiatus, Dr. Rubin resumed his consultancy work
`
`with UTC in a collaboration which continued until mid-2016.
`
`The TRIUMPH Program
`
`The Mid-September 2003 Lunch€on
`22. In mid-September 2003, during a trip to Califomia to visit her family, Rothblatt
`
`invited Dr. Rubin to treet for a social luncheon (the "Mid-september 2003 Luncheon,,). Dr. Rubin
`
`and Rothblatt periodically conesponded and socialized together.
`
`1
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`23. During the Mid-Septe,rber 2003 Luncheo., Dr. Rubin rnentioned that he had
`
`conceived a new PAH treatment program using an inhalation rnethodology for the administration of
`
`the drug treprostinil, which he believed offered distinct advantages over known intravenous and
`
`subcutaneous PAH treatments. Dr. Rubin's proposed program was of great interest to Rothblatt and
`
`the social luncheon tumed to a discussion ofa proposed UTC developrnent prograrn relating to Dr.
`
`Rubin's new PAH treatrnent methodology.
`24. The Mid-sepember 2003 Luncheon rasted for no less than 4 hours. Dr. Rubin fully
`outlined a program to develop his new pAH treatment, providing Rothblatt with full particulars
`
`conceming his inventions which later became the subject of the claims in the .507
`
`and ,240 patents.
`
`It was understood by Rothblatt and Dr. Rubin that he was providing this disclosure on a confidential
`
`basis with a view to Dr. Rubin working with UTC to further develop his inventions. Because there
`
`was a relationship oftrust between Dr. Rubin and Rothblatt that had developed over a period of
`about 8 years at that time, he did not ask Rothblatt to sign offon a confidentiality agreement with
`
`respect to his invention disclosure.
`25. As more fully discussed at the Mid-september 2003 Luncheon, Dr. Rubin proposed
`the administration ofheprostinil by a metered dose inhaler or pulsed nebulizer that would
`
`effectively deliver the medication in a single event consisting of fewer than l g breaths. This
`
`disclosure provided the approach for UTC's program to develop Dr. Rubin's inventions, which
`UTC designated the TRIUMPH (TReprostinil lnhalation Use for the Management of lulmonary
`Arterial fllpertension) development program.
`26. Dr. Rubin recommended that his colleagues, Drs. Wemer Seeger (..Seeger,,) and
`Horst olshchewski ("olschchewski") of rransMlT Gesellschaft flir Technologiettransfer mgH,
`
`8
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`Giessen, Gemany ("TransMIT''), with wlrom he had worked on another project, join him in lhe
`
`proposed TRIUMPH developrnent program. Dr. Seeger and the TransMIT team had expertise in
`
`inhalation treatments.
`27- The Mid-September 2003 Luncheon concluded with a cornmitment by Rothblatt to
`
`undertake Dr. Rubin's proposed TRIUMPH development program. Rothblatt totd Dr. Rubin that
`
`she would promptly arrange for execution of an agreement with Dr. Rubin. It was ageed that Dn.
`
`Seeger and olshewski would work with Dr. Rubin on the TRIUMpH development program.
`
`Services and Consultins A
`ents
`28. on or about september 23, 2003, Rothblatt provided Dr. Rubin with a Services
`Agreement between urc's wholly-owned subsidiary Lung-Rx (now Long-Bio) and Dr. Rubin with
`a view to proceeding with the TRIUMpH development program. Dr. Rubin executed the Services
`
`Agreernent on September 24, 2003 and Rothblatt executed the agreernent on september 30,2003 on
`
`behalf of Lung-RX (the "2003 Services Agreernent"). Lung-Rx also entered into a services
`
`agreement with Dr. Wemer Seeger having the same terms as Dr. Rubin's 2003 Services Agreernent
`
`(the Rubin and seeger 2003 Services Agreements are armexed as Exhibit 4). Under these
`
`agreements, Drs. Rubin and Seeger assumed titles of co-chair of the TRIUMpH development
`
`program, co-Principal Investigator and co-chair of the program Steering committee.
`29. The 2003 Services Agreernent provides that UTC shalr have ownership of,.any
`patentable or unpatentable inventions, discoveries, and ideas which are made or conceived in whole
`
`or in part by or on behalfofDr. Rubin lz the course ofor as a resulr of the services performed
`
`under this Agreement, or that relate directly to, or intolve the use of confdenttal Information.,'
`
`Services Agreement, fl 9(a)(italics added).
`
`9
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`30. The 2003 services Agreement defines "confidential Information" as..[a]ll
`infonr.ration and know-how which Dr. Rubin in any way obtains from Lung Rx and all inventiols,
`
`discovery and ideas . . . which shall become the property oflung Rx pursuant to Section 9,,,
`
`namely, "inventions, discoveries and ideas" made under the 2003 services Agreement. (2003
`
`Services Agreernent, Jl 8.a). Dr. Rubin's invention disclosures at the Mid-september 2003
`
`Luncheon (the "pre-2003 Services Agreement Inventions") were known to Dr. Rubin prior to the
`luncheon and were Nor obtained from Lung-Rx. Therefore, Dr. Rubin,s pre-2003 Services
`Agreernent lnventions are Nor within the scope of Lung-Rx,s ..confidential
`
`Information', and
`
`subject to assigrunent to Lung-Rx under the 2003 Services Agreement. (2003 Services Agreement,
`
`tT8.b)
`
`31. on october 22, 2003, Drs. Rubin, Seeger, and olschewski met at Rothblatt's New
`York city apartment to discuss the TRTMPH development progam. At the meeting, Rubin,
`
`Seeger and Rothblatt outlined on a white board Dr. Rubin's invention and proposed development
`
`program for conducting necessary trials for FDA approval.
`32- During the period from 2004 through 200g, at the direction ofDr. Rubin, UTC
`conducted Phase 2 (proof of concept) trials, and Phase 3 (pivotal, registration) clinical trials in the
`
`united states and Europe which led to FDA approval for inhaled treprostinil.
`33. As hereinafter described, on or about May 15, 2006, urc filed a ..provisional patent
`Application" in the United states patenr and rradernark office (.,USpro,,) which disclosed Dr.
`
`Rubin's pre-2003 Services Agreement Inventions (the "provisional Application,,). The provisional
`
`Applicationultimatelyissuedasthe'507and,240patents.Seepars.40-55,infra.
`
`l0
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`34. The Provisional Application, as well as the '507 ad '240 patents, name Dr. Rubin
`as ajoint inventor with Lung-Rx employees Horst olschewski and Robert Roscigno, and Dr. Seeger
`
`and his tearn, Thomas Schmehl, Carl Sterrift and Robert Voswinckel.
`35. Under the U.S. Patent Law, as a named joint inventor, Dr. Rubin owns an
`undivided interest in the '507 and .240 patents.
`
`Supersedin g Consul tins
`36- on or about December r5, 200g, Dr. Rubin entered into a consulting Agreement
`with UTC that supersedes any and all prior agreements between UTC and Dr. Rubin ..relating to the
`
`nts
`
`subject matter of this Agreernent" including the 2003 Services Agreernent (the..200g consulting
`
`Agreement", fl 10(b); copy annexed as Exhibit 5). In the 200g consulting Agreement, Dr. Rubin
`
`agreed (as he did in the 2003 Services Agreernent) to serve as co-chair of the TRIUMpH program
`along with Dr' Seeger and "to provide such services as needed for clinical, regulatory commercial
`
`and general consulting services in the areas ofinhaled treprostinil, oral heprostinil, tadalafil and
`
`other areas as mutually agreed." (Exhibit 5 at ![ 1). The 200g consulring Agreement provides that
`it is govemed by the laws of the State of Maryland and any dispute under the agreement shall be
`decided in courts ofthe State ofMaryland. (Exhibit 5 at t[ l0(a)).
`37 .
`
`Thereafter, on or about Janu ary 27 , 2or 4 , Dr. Rubin entered into a consulting
`
`agreement with UTC, which expressly terminates the 200g consulting Agreement and supersedes
`all prior agreements among the parties with respect to inhaled and oral treprostinil, including the
`2003 Services Ageement (the "2014 consulting Agreement" at fl 9.2; copy annexed as Exhibit 6).
`ln the 2014 consulting Agreement, Dr. Rubin again agreed ,.to provide such services needed for
`clinical, regulatory, commercial and general consulting services in the areas ofinhaled treprostinil,
`
`l1
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`oral treprostinil, and other areas as mutually agree d." (Id.atp.9). The 2014 consulting Agreer.Dent
`
`also provides that it is govemed by the laws of the State of Maryland and any dispute under the
`
`agreement shall be decided in coufis of the State of M Nyland. (Id. At fl 9.1).
`38- on or about March 6, 2014, Dr. Rubin entered into another consulting agreement
`with Lung-Bio (the "2014 Lung-Bio consulting Agreement"; annexed as Exhibit 7). The 2014
`
`Lung-Bio Consulting Agreement supersedes all prior agreements among the parties with respect to
`
`inhaled and oral treprostinil, including the 2003 services Agreem ent. (Id. atll9.2). In the 2014
`
`Lung-Bio consulting Agreement, Dr. Rubin again agreed "to provide such services needed for
`clinical, regulatory cornmercial and general consulting services in the areas ofinhaled treprostinil,
`
`oral treprostinil, and other areas as mutually agre d,]' (Id. atp.9). The 2014 Lung-Bio consulting
`
`Agreernent also provides that it is govemed by the laws of the State of Maryland and any dispute
`
`under the agreanent shall be decided in courts of the State of Maryland. (1d. At T 9.1).
`39' UTC ttrough its subsidiary Lung-Bio presently markets inhaled treprostinil under
`brand name TYVASO.
`
`U.S. Patent Nos.9.339.5 07 and 9.3
`
`Assi
`
`nlent of Patent
`40. On May 15, 2006, UTC filed a provisional patent Application, No. 60/g00,016, in
`the United States Patent and Trademark office ("USPTo") entitled ',Treprostinil Administration By
`Inhalation" (the "Provisional Application") which disclosed Dr. Rubin,s pre-2003 services
`
`ts
`
`Agreement Inventions. The Provisional Application also disclosed research data developed in the
`TRIUMPH program at the direction of Dr. Rubin relating to the eflicacy of Dr. Rubin,s inventions
`for treatment of PAH.
`
`t2
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`4l - urc did Nor consult with or provide Dr. Rubin with a copy of the provisional
`Application. The Provisional Application was filed in the USpro without Dr. Rubin,s knowledge.
`42- The Provisional Application named as 'Joint inventors" ofthe disclosed subject
`matter, Dr. Rubin, members of Dr. Seeger's TransMIT team (namely Horst olschewski, Thomas
`
`Schmehl, wemer Seeger and Robert voswinckel), and UTC personnel that worked together on the
`
`TRruMPH development program (Robert Roscigno and Carl Sterritt).
`43- Thereafter, UTC provided Dr. Rubin with an Assignment which transferred rights in
`the Provisional Application to UTC (the "Provisional Assignment',). The provisional Assignment
`
`was overbroad insofar as it assigned Dr. Rubin's pre-2003 Services Agreement Inventions to UTC
`
`as well as developrnents jointly made under the 2003 Services Agreement.
`44- Dr. Rubin executed the Provisional Assignment on Jtly 24,2006 based on the
`misrepresentation by UTC that the Provisional Assignment and the Provisiooal Application (which
`
`UTC did not provide to Dr. Rubin for review) were in proper form and consistent with the parties,
`
`2003 Services Agreement. Based upon his long-standing personal relationship with Rothblatt and
`
`other UTC colleagues, Dr. Rubin justifiably relied on UTC and Rothblatt to provide him with a
`
`Provisional Assignment in accord with the parties' 2003 services Ag-eement. (A copy of the
`
`Provisional Assignment is annexed as Exhibit 8).
`
`The '507 and '240 Patents
`45- On May 14,2007, UTC filed U.S. patent Applicarion Ser. No. l11748,205, with a
`claim ofpriority fiom the Provisional Application (the "'205 Application,,). The .205 Application
`
`incorporates the specification ofthe Provisional Application, and includes additional disclosures
`
`conceming studies relating to the TRIUMpH development program. The .205 Application names
`
`13
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`the same inventors as the Provisional Application.
`46. UTC did NOT consult with or provide Dr. Rubin with a copy of the .205
`
`Application. The '205 Application was filed in the USpro without Dr. Rubin's knowledge.
`47 . On or about June 11,2007 ,Dr. Rubin attended a conference at UTC's colporate
`
`oftices to review the status of the TRIUMPH development program and trial data for presentation to
`
`the FDA (the "2007 conference"). In attendance at the 2007 conference with Dr. Rubin were
`
`Rothblatt, Eugene Sullivan ("Sullivan"), the chief Medical officer of Lung-Rx, and red staub
`
`("Staub"), Lung-Rx's executive responsible for implementing the TRIUMpH development
`
`program.
`
`48. Dr. Rubin had a long standing working relationship with participants at the 2007
`conference. Apart from the working relationship, Dr. Rubin assisted Rothblatt in recruiting
`
`sullivan, a former FDA scientist, for the position as chief Medical officer of Lung-Rx. Dr. Rubin
`
`also worked with Staub in the TRIUMPH development program for at least three (3) years.
`49. At the conclusion of the 2007 conference, Dr. Rubin was presented with formal
`documents for execution in connection with the '205 Application, including a,.Declaration of
`
`Invention" and "Assignment" (the "2007 Assignment"). Dr. Rubin executed these documents based
`
`on the misrepresentation by UTC that the formal documents and the .205 Application (which UTC
`
`did not provide to Dr. Rubin for review) were in proper form and consistent with the parties' 2003
`
`Services Agreement. Based upon his long-standing personal relationship with Rothblatt and other
`
`UTC colleagues, Dr. Rubin justifiably relied on UTC and Rothblatt to provide him with a 2007
`
`Assignment in accord with theparties'2003 Services Ageement. (copies of the Declaration of
`
`Invention and 2007 Assignment are annexed as Exhibits 9 and l0).
`
`14
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1170, p. 14 of 20
`
`

`

`50. The 2007 Assiglnent was ovelbroad insofar as jt assigred Dr. Rubin's pre-2003
`
`Service Agreement Inventions to UTC as well as developments jointly made under the Services
`
`Agreement.
`51. Dr. Rubin viewed his affiliation with UTC as part of an impo(ant collaboration to
`
`further research in PAH diseases which had been the focus ofhis entire medical and scientific
`
`career. Dr. Rubin had engaged socially and professionally with UTC's founding mernbers over
`
`many years prior to the founding of UTC and the 2003 Services Agreement, furthering his
`
`reasonable beliefthat UTC and Rothblatt were trustworthy and acting in his best interests.
`52. Dr. Rubin's view that Rothblatt was a trusted friend is reflected in many years of
`
`social encounters and advice she offered him on personal non-business matters. In tum, Rothblatt
`
`periodically sought out Dr. Rubin's advice conceming her family mernber's PAH medical condition.
`
`Dr. Rubin's fiiendship with Rothblatt is reflected in an exchange of e-mails in July and August
`
`2009, where Rothblatt, in referring to their relationship stated: "I too have always teasured our
`
`friendship."
`53. In June 201 l, UTC honored Dr. Rubin on the occasion ofthe l5s anniversary ofthe
`founding of the company for his substantial contributions to the development oftreafinents for
`
`PAH.
`
`54. Dr. Rubin's standing with UTC is also reflected in a gigantic mural of the members
`
`of the company's Scientific Advisory Board at the enhance to UTC's Silver Spring headquarters,
`
`which was commissioned by Rothblatt. Dr. Rubin is prominently present in the mural.
`55. The '507 and '240 patents issued from the .205 Application through a chain of
`
`related continuation applications. Particulars concerning the continuation applications from which
`
`l5
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1170, p. 15 of 20
`
`

`

`these patents issued are as follows:
`
`U.S. Patent No. 9.3 39,507
`
`U.S. Patent No. 9 358 240
`
`Date of Patent:
`Application No.
`Filing Date:
`
`May 11,2016
`t3/469,854
`May 11,2012
`
`June 7, 2016
`12t59t,200
`Nov. 12,2009
`
`Rubin's First Knorvledqe of the Claims in This Action
`56. Prior to the issuance ofthe .507 and .240 patents, on February l, 2016, UTC
`through its counsel advised Dr. Rubin that it had filed U.S. Application ser. No. l5101 I ,999 in the
`USPTo on Febru Ny 1,2016. This application claims prioriry from the ,205 Application. UTC
`
`requested that Dr. Rubin execute a new Declaration of Invention to comply with formalities under
`
`the t eahy-Smith America Invents Act.
`57 .
`
`on February 2, 20r6,Dr. Rubin sought advice from UTC regarding the status of
`
`patent applications filed by UTC relating to the TRIITMpH development program and, for the first
`
`time, was advised that UTC asserted ownemhip of all rights in all patent filings. Thereafter. the
`
`'507 and '240 patents issued in May and June 2016.
`58. The 2003 Services Agreement and subsequent consulting Agreements between
`Dr. Rubin and UTC reserve to Dr. Rubin joint ownership rights with UTC in the subject patents.
`
`The'507 and '240 patents as issued reflect an assignment of Dr. Rubin,s pre-2003 Services
`
`Agreement Inventions to UTC in error. Therefore, Dr. Rubin seeks reformation of the
`
`Provisional Assignment and 2007 Assignment to correct the mutual mistake of the parties
`
`regarding the overbreadth of the assignments. Rubin also seeks damages as appropriate for
`UTC's breach of the 2003 Services Agreement and superseding consulting agreements. urc has
`declined to engage in any good faith discussion conceming the assignments and Dr. Rubin,s
`
`16
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1170, p. 16 of 20
`
`

`

`collcems relating to tlreir overbreadth.
`
`FIRST CAUSE OF ACTION
`(Constructivc Fraud)
`59. Dr. Rubin repeats and realleges each ofthe averments contained in paragraphs r
`through 58 as if fully set forth herein.
`60. UTC had a legal and,/or equitable duty to Dr. Rubin due to the special relationship
`
`between the parties arising from Dr. Rubin's personal and professional association with Rothblatt
`
`begiruring prior to the founding ofurc, and a tong history of comrnunications and negotiations
`
`between the parties.
`61. UTC was in a position oftrust and confidence with Dr. Rubin, and Dr. Rubin was
`justified in rellng upon UTC's representations that it was appropriate for Dr. Rubin to execute the
`
`Provisional Assignment and 2007 Assignment.
`62. Despite this position of trust and confidence, UTC abused its relationship with Dr.
`
`Rubin and acted in a manner adverse to Dr. Rubin, including the request, which Dr. Rubin acted
`
`upon, to execute the "overbroad" Provisional Assignmort and 2007 Assignment, deceiving Dr.
`
`Rubin and causing injury to Dr. Rubin in an amount to be established at trial.
`63- UTC's breach of its duty to Dr. Rubin violated UTC's special relationship, and./or
`
`injured public confidence or public interests.
`
`SECOND CAUSE OFACTION
`(Negligent Misrepresentation)
`64. Dr. Rubin repeats and realleges each ofthe averments contained in paragraphs 1
`through 63 as if fully set forth herein.
`65. UTC owed Dr. Rubin a special duty of care due to the relationship ofthe parties
`
`t7
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1170, p. 17 of 20
`
`

`

`when it negligently represented that the Provisional Assignrnent and 2007 Assigmr.rent properly
`
`reflected the parties' agreement as set forth in the 2003 Services Agreement.
`66. UTC intended Dr. Rubin to rely upon its representations, and knew that Dr. Rubin
`would rely on the representations to his loss or injury.
`67 - Dr. Rubin justifiably relied on UTC's representations and suffered damage as result
`in an amount to be established at trial.
`
`THIRD CAUSE OFACTION
`(Reformation rMutual Mistake)
`68. Dr. Rubin repeats and realleges each ofthe averments contained in paragraphs l
`through 67 as if fully set forlh herein,
`69. Dr. Rubin and UTC agreed in the 2003 services Agreement to terms relating to
`ownership of patents under the TRIUMpH development program, which are different from the
`assignment in the entirety ofall rights under the '507 and .240 patents that urc presented to Dr.
`Rubin in the Provisional Assignment and the 2007 Assignment.
`70. The provisional Assignment and 2007 Assignment should

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