Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 1 of 14
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`Debra L. Spinelli, Esq., Bar No. 9695
`DLS@pisanellibice.com
`PISANELLI BICE PLLC
`400 South 7th Street, Suite 300
`Las Vegas, Nevada 89101
`Telephone: 702-214-2100
`Facsimile: 702-214-2101
`
`Gregg LoCascio (will comply with LR IA 11-2 within 14 days)
`Justin Bova (has complied with LR IA 11-2)
`KIRKLAND & ELLIS LLP
`1301 Pennsylvania Avenue, N.W.
`Washington, D.C. 20004
`Tel: 202-389-5000
`Fax: 202-389-5200
`gregg.locascio@kirkland.com
`justin.bova@kirkland.com
`
`Ryan Kane (has complied with LR IA 11-2)
`Andrew Walter (has complied with LR IA 11-2)
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, New York 10022
`Tel: 212-446-4800
`Fax: 212-446-4900
`ryan.kane@kirkland.com
`andrew.walter@kirkland.com
`
`Counsel for Plaintiff Pacira Pharmaceuticals, Inc.
`
`UNITED STATES DISTRICT COURT
`
`DISTRICT OF NEVADA
`
`PACIRA PHARMACEUTICALS, INC.
`CASE NO.:
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`
`
`
`
`Plaintiff,
`
`COMPLAINT FOR DECLARATORY
`
`JUDGMENT
`
`v.
`
`
`JURY TRIAL DEMANDED
`RESEARCH DEVELOPMENT
`FOUNDATION,
`
`
`
`
`
`
`
`
`Defendant.
`
`Plaintiff Pacira Pharmaceuticals, Inc. (“Pacira”) seeks a declaratory judgment against
`Defendant Research Development Foundation (“RDF”) that Pacira owes no royalties to RDF with
`respect to Pacira’s EXPAREL® product made after December 24, 2021.
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`Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 2 of 14
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`NATURE OF THE ACTION
`1.
`This is an action for a declaratory judgment pursuant to the Federal Declaratory
`Judgments Act, 28 U.S.C. §§ 2201–2202, and Rule 57 of the Federal Rules of Civil Procedure.
`2.
`Pacira produces EXPAREL® (bupivacaine liposome injectable suspension), approved
`by the Food and Drug Administration (FDA) in 2011. EXPAREL® is a first-of-its-kind, single dose
`local anesthetic administered at the time of surgery to control pain and reduce or eliminate the use of
`opioids for acute postsurgical pain. The active ingredient in EXPAREL®, bupivacaine, is
`encapsulated in multivesicular liposomes allowing for gradual release of bupivacaine over time as the
`lipid membranes are absorbed, prolonging the action of bupivacaine.
`3.
`Pacira, under its former names DepoTech Corporation (“DepoTech”) and SkyePharma
`Inc. (“Skye”), and RDF are signatories to an Assignment Agreement dated February 9, 1994 (the
`“1994 Agreement”) and an Amendment Agreement dated April 15, 2004 (the “2004 Amendment”)
`(collectively the “Agreements”).
`4.
`The purpose of the 1994 Agreement was for RDF to assign certain experimental
`technology and intellectual property to Pacira for it to pursue commercialization and, in exchange,
`Pacira would make certain royalty payments to RDF under certain conditions. At the time, there was
`no EXPAREL® product. Instead, during the 1990s, the only Pacira product subject to royalties under
`the 1994 Agreement was DepoCyt®, which was a cytotoxic anticancer drug. Specifically, DepoCyt®
`was a cytarabine liposome injection used for the intrathecal treatment of lymphomatous meningitis.
`Pacira ceased manufacturing DepoCyt® in 2017.
`5.
`A dispute arose in 2003 regarding the scope of the products for which Pacira would
`owe royalties under the 1994 Agreement. The execution of the 2004 Amendment was an attempt to
`clarify and resolve the dispute.
`6.
`The 2004 Amendment requires Pacira to pay royalties on products embodying
`particularly defined inventions that are claimed in certain patents or patent applications for only as
`long as those particular patents or patent applications are unexpired.
`7.
`However, Pacira and RDF now dispute the interpretation of the 2004 Agreement in
`conjunction with the 1994 Agreement.
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`Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 3 of 14
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`8.
`It is clear that under the terms of the Agreements, Pacira does not owe any royalties to
`RDF with respect to Pacira’s EXPAREL® product manufactured after December 24, 2021.
`Specifically, all of the patents encompassing the technology relevant to the Agreements will have
`expired after December 24, 2021, meaning that Pacira will therefore no longer have an obligation to
`pay RDF any royalties on Pacira’s EXPAREL® product.
`9.
`Despite the plain language in the Agreements, the common-sense interpretation of their
`terms, and what both parties intended when those Agreements were signed, RDF maintains that, under
`its interpretation of the terms of the Agreements, Pacira will continue to owe royalties to RDF with
`respect to Pacira’s EXPAREL® product made after December 24, 2021. RDF maintains this position
`despite the fact that Pacira has independently, and at its own great expense, developed a novel,
`patented process for making a novel bupivacaine encapsulated multivesicular liposome product, which
`will be sold as EXPAREL®. RDF also maintains this position despite the fact that all patents relevant
`to the Agreements will expire on December 24, 2021.
`10.
`Accordingly, Pacira now seeks a declaratory judgment that Pacira does not owe any
`royalties to RDF with respect to Pacira’s EXPAREL® product made after December 24, 2021, under
`the terms of the Agreements. In the alternative, Pacira seeks a declaratory judgment that any terms of
`the Agreements that would require Pacira to pay a royalty to RDF with respect to Pacira’s EXPAREL®
`product made after December 24, 2021 are unenforceable as unconscionable and in violation of public
`policy.
`
`THE PARTIES
`11.
`Pacira is a California corporation with its principal place of business at 5 Sylvan Way,
`Suite 300, Parsippany, New Jersey 07054.
`12.
`On information and belief, RDF is a Nevada corporation with its principal place of
`business at 402 North Division Street, Carson City, NV 89703.
`
`JURISDICTION AND VENUE
`13.
`This action arises under the Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.
`14.
`An immediate, real, and justiciable controversy exists between Pacira and RDF as to
`whether Pacira owes royalties to RDF with respect to Pacira’s EXPAREL® product made after
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`Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 4 of 14
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`December 24, 2021, under the terms of the Agreements. Because this action presents an actual
`controversy with respect to Pacira’s and RDF’s rights and obligations under the Agreements, the Court
`may grant the declaratory relief sought pursuant to 28 U.S.C. § 2201 et seq.
`15.
`this action pursuant
`This Court has
`subject matter
`jurisdiction over
`28 U.S.C. § 1332(a)(1) because it is a dispute between citizens of different states and the amount in
`controversy exceeds $75,000.00, exclusive of interest and costs.
`16.
`This Court has personal jurisdiction over RDF. Among other things, on information
`and belief, RDF is a Nevada corporation with its principal place of business in this District.
`Additionally, under the 2004 Amendment, RDF agreed that jurisdiction for any dispute regarding the
`Agreements would be in Nevada.
`17.
`Venue is proper in this District pursuant to 28 U.S.C. § 1391(b) at least because RDF
`resides in this District. Additionally, under the 2004 Amendment, RDF agreed that venue for any
`dispute regarding the Agreements would be in Nevada.
`
`FACTUAL BACKGROUND
`
`I.
`
`The 1994 Agreement
`18.
`Pacira, under its former name DepoTech, and RDF are signatories to the
`1994 Agreement.
`19.
`Under the 1994 Agreement, RDF assigned DepoTech certain “Assigned Proprietary
`Property,” giving DepoTech the exclusive rights to, among other things, make, manufacture, and sell
`products employing the Assigned Proprietary Property. By its own terms, the 1994 Agreement
`assigned “no other, further, or different property or rights” except for those provided in the
`1994 Agreement.
`20.
`Under the 1994 Agreement, DepoTech was to pay RDF, during the term of the
`1994 Agreement, a royalty on Gross Revenues, where Gross Revenues was a defined term.
`21.
`The term Gross Revenue was defined to include “charges actually collected by
`DepoTech from sales, rental, lease, licensing, maintenance, or production of a Product,” where Product
`was a defined term.
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`Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 5 of 14
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`22.
`The term Product was defined to mean “a product or portion of a product that where
`made, used or sold embodies an invention there claimed, or which is specifically intended to be used
`to practice a method or process there claimed in an Assigned Patent (or a patent application if the
`resulting Letters Patents would constitute an ‘Assigned Patent’ hereunder) and which is manufactured
`and sold by or for DepoTech (or its licensees),” where Assigned Patent was a defined term.
`23.
`The term Assigned Patent was defined to mean “the United States of America and
`Foreign Patents included within Proprietary Property and any division, reissue, continuation or
`extension thereof,” where Proprietary Property was a defined term.
`24.
`The term Proprietary Property was defined to mean “developments, patent rights,
`copyrights, as well as all patent applications, techniques, methods, processes, apparatus, products,
`data, trade secrets, confidential information, improvements thereto, modifications thereof, and
`Know-How, whether patentable or not, related to the technology described in Exhibit 1 hereto,” where
`Exhibit 1 included a description of Proprietary Property.
`25.
`Exhibit 1 to the 1994 Agreement included within Proprietary Property the patented
`technology of “Multivesicular Liposomes having a Biologically Active Substance Encapsulated
`therein the Presence of a Hydrochloride,” “Heterovesicular Liposomes,” “Cyclodextrin Liposomes
`Encapsulating Pharmacologic Compounds and Methods for their Use,” and “Uniform Spherical
`Multilamellar Liposomes of Defined and Adjustable Size Distribution” described in certain patents
`and patent applications.
`II.
`The 2003 Dispute
`26.
`In 2003, a dispute arose between RDF and Pacira, then operating under the name Skye,
`as to the scope of certain payment obligations under the 1994 Agreement.
`27.
`The 2003 dispute included a dispute over the scope of products and related patents for
`which royalties were owed to RDF under the 1994 Agreement.
`28.
`For example, RDF and Skye disputed whether Skye was required to pay royalties to
`RDF under the terms of the 1994 Agreement in connection with multivesicular liposome (“MVL”)
`technology that does not encapsulate a biologically active substance in the presence of a hydrochloride
`(“No HCl Technology”).
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`Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 6 of 14
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`29.
`In order to resolve the dispute between RDF and Skye and to clarify and revise the
`terms of the 1994 Agreement, the parties entered into the 2004 Amendment.
`III. The 2004 Amendment
`30.
`Pacira, under its former name Skye, and RDF are signatories to the 2004 Amendment,
`which was executed April 15, 2004.
`31.
`The 2004 Amendment states that the “parties wish to clarify and revise the terms of
`the” 1994 Agreement. The effect of the 2004 Amendment was to modify certain parts of the
`1994 Agreement such that the Agreements together define the rights and obligations between Pacira
`and RDF.
`32.
`Under the 2004 Amendment, the term “Proprietary Property” was defined to mean
`“Skye’s multivesicular liposome DepoFoam technology which consists of microscopic, spherical
`particles composed of multiple non-concentric aqueous chambers encapsulating the biologically active
`substance therein in the presence or absence of any acid or salt or other compound (the ‘DepoFoam
`Technology’),” i.e., including the No HCl Technology and related patents.
` Under the
`2004 Amendment “[s]uch DepoFoam Technology shall also include (a) the Assigned Proprietary
`Property or Improvements as defined under the 1994 Agreement, and/or (b) existing and future patent
`or proprietary rights of Skye in DepoFoam Technology whether or not covered by or subject to the
`Assignment Agreement,” where Assigned Proprietary Property and Improvements were defined terms
`in the 1994 Agreement.
`33.
`Under the 1994 Agreement, the term Improvements was defined to mean “any
`improvement and/or modification of the Assigned Proprietary Property that comes within the claims
`of the Assigned Patents.” The term Assigned Proprietary Property was defined to mean “the
`Proprietary Property, including the Patent Rights, rights in Patents, and Know-how, all of which are
`assigned hereunder to DepoTech.”
`34.
`is United States
`the Agreements
`The
`last remaining patent covered by
`Patent No. 9,585,838 (the “’838 Patent”), entitled “Production of Multivesicular Liposomes,” which
`was issued by the United States Patent and Trademark Office on March 7, 2017. United States Patent
`Application No. 11/678,615, which issued as the ’838 Patent, was filed on February 25, 2007 and
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`Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 7 of 14
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`claims priority to United States Patent Application No. 09/192,064, filed on November 13, 1998, and
`United States Provisional Application No. 60/064,856, filed on November 14, 1997. Thus, the
`’838 Patent claims priority to a date prior to the 2004 Amendment.
`35.
`The ’838 Patent received a 1,137-day Patent Term Adjustment. It is set to expire on
`December 24, 2021. The ’838 Patent is the last remaining patent that is relevant to the Agreements.
`When the ’838 Patent expires on December 24, 2021, therefore, Pacira’s obligation to pay royalties to
`RDF ceases. The ’838 Patent’s expiration will mark the culmination of decades of royalties payments
`Pacira has made to RDF.
`36.
`Patents unrelated to the Assigned Patents and that do not claim a priority back before
`the date of the 2004 Amendment, i.e., April 15, 2004, are not subject to the Agreements by their plain
`terms. One such patent not relevant to the Agreements is United States Patent No. 11,033,495 (the
`“’495 Patent”), entitled “Manufacturing of Bupivacaine Multivesicular Liposomes.” United States
`Patent Application No. 17/156,400, which issued as the ’495 patent, was filed on January 22, 2021,
`almost seventeen years after the 2004 Amendment. The ’495 Patent does not claim priority to any
`earlier patent or patent application, nor is it related to any patents or patent applications covered by
`the Agreements. The ’495 patent was issued by the United States Patent and Trademark Office on
`June 15, 2021.
`37.
`Under the terms of the Agreements, Pacira has no obligation to pay royalties on any
`product covered by the ’495 Patent because this patent is not relevant to the Agreements.
`38.
`Under the terms of the Agreements, Pacira has no obligation to pay royalties on any
`product covered by the ’495 Patent because this novel, patented technology is not subject to the
`Agreements.
`IV.
`The Manufacture of EXPAREL®
`39.
`Since the 1990s, Pacira has worked on manufacturing MVLs with various active drug
`ingredients.
`40.
`One such manufacturing process has been used with EXPAREL® product for well over
`a decade and was FDA approved on October 28, 2011 (“Original Patented Technology”). The
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`Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 8 of 14
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`’838 Patent, which expires on December 24, 2021, and claims priority to a 1997 provisional patent
`application, covers Original Patented Technology.
`41.
`Starting in 2013, almost a decade after the 2004 Amendment was signed, Pacira began
`independently developing a novel, larger-scale process for the manufacture of EXPAREL® product.
`42.
`After over seven years, many failures, countless hours of work and innovation, and an
`investment of over $100 million, Pacira succeeded in developing a novel manufacturing process. The
`novel manufacturing process resulted in a novel MVL product with improved properties such as
`improved stability. The novel manufacturing process and novel MVL product are collectively referred
`to herein as “New Patented Technology.”
`43.
`RDF did not contribute to this New Patented Technology.
`44.
`In order to protect the novel process and MVL product, i.e., the New Patented
`Technology, Pacira filed U.S. Patent Application No. 17/156,400 on January 22, 2021, which issued
`as the ’495 patent on June 15, 2021.
`45.
`The New Patented Technology is not an “Improvement” (as defined in the
`1994 Agreement) and is not subject to the Agreements.
`46.
`The FDA approved the use of the novel manufacturing process for the commercial
`manufacture of the novel MVL product in August of 2021.
`V.
`The Current Dispute
`47.
`On August 11, 2021, Thomas Brorby, Chairman, Trustee, and counsel for RDF, sent
`an email to David Stack, Pacira’s CEO, congratulating him on the issuance of the ’495 Patent and
`approval by the FDA for the New Patented Technology.
`48.
`In the August 11, 2021 communication, Thomas Brorby stated “[w]e appreciate . . .
`your corporate strategy for extending the patent period beyond December 24, 2021.”
`49.
`On August 26, 2021, David Stack responded, “We look forward to seeing how
`commercially successful the new process is and are hopeful that it will provide great value to our
`shareholders,” which includes RDF, “in the future.” He also requested clarification as to what Brorby
`meant by “extending the patent period” and stated that “this new patent provides protection for our
`new manufacturing process.”
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`50.
`On September 2, 2021, Thomas Brorby responded and asserted that “the 495 Patent on
`Exparel effectively replaces the 838 Patent and extends the patent period of the Exparel patent to 2041,
`resulting in a seamless continuation of our respective rights and obligations under the Assignment
`Agreement.”
`51.
`On September 9, 2021, Anthony Molloy, Pacira’s General Counsel, replied and
`reiterated that “the ’495 Patent relates to a new manufacturing process.”
`52.
`In the September 9, 2021 communication, Anthony Molloy further stated: “The
`invention claimed in the new patent was conceived of and filed more than a decade after both the
`1994 Assignment Agreement and 2004 Amendment. The ’495 Patent provides patent protection for
`this new process; it does not ‘effectively replace’ the ’838 Patent and/or extend the term of the
`’838 Patent. As such, there is no connection between the ’495 Patent and Pacira’s ‘obligations under
`the Assignment Agreement.’”
`53.
`In the September 9, 2021 communication, Anthony Molloy further stated: “Based on
`our understanding of the 1994 Assignment Agreement and 2004 Amendment, and our mutual
`understanding upon us successfully extending the term of the ’838 Patent, Pacira’s royalty obligations
`to Research Development Foundation will end with the expiration of the ’838 Patent in
`December 2021. The issuance of the new ’495 Patent does not change this.”
`54.
`On September 14, 2021, Thomas Brorby responded and asserted that the ’495 Patent
`and EXPAREL® product “extend royalty payment obligations of Pacira to RDF at least until 2041.”
`Thomas Brorby also asserted that Pacira’s royalty obligations to RDF would continue “[o]n any
`product which utilizes the DepoFoam Technology” “[s]o long as a patent or patent application which
`embodies DepoFoam Technology remains unexpired.”
`55.
`On September 27, 2021, Anthony Molloy again stated that “Pacira’s royalty obligations
`to RDF will end with the expiration of the ’838 Patent in December 2021.”
`56.
`On October 7, 2021, Thomas Brorby responded and reiterated his assertion that “RDF
`is entitled to continue to receive royalties from Exparel after expiration of the ’838 patent.” Thomas
`Brorby also asserted that Pacira’s royalty obligations could continue, in perpetuity, on any product
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`which utilizes multivesicular liposome technology so long as a patent or patent application embodying
`that technology remains unexpired.
`57.
`On November 9, 2021, Anthony Molloy responded and stated that “[t]he plain meaning
`of the 1994 Agreement and the 2004 Amendment, including the language of Section 1.4 of the
`2004 Amendment, do not support your positions. Instead, they demonstrate that royalty obligations
`to RDF will end with the expiration of the ’838 Patent.”
`58.
`On November 15, 2021, Thomas Brorby responded and again disagreed with Anthony
`Molloy’s communication.
`59.
`RDF incorrectly asserts that Pacira owes royalties on EXPAREL® product for as long
`as Pacira generates revenue on the product and has any patent related thereto. Under RDF’s incorrect
`interpretation of the Agreements, Pacira would owe royalties until at least 2041 (and potentially
`indefinitely), which amounts to at least 47 years of royalty obligations.
`60.
`Under RDF’s improper interpretation, RDF seeks to claim royalties with respect to the
`New Patented Technology independently developed by Pacira, which Pacira spent over seven years
`and $100 million creating and perfecting.
`61.
`Under RDF’s improper interpretation, and contrary to the plain language of the
`Agreements, RDF further seeks to claim royalties until an indefinite point in the future on technology
`unrelated to what it initially provided to Pacira.
`62.
`Thus, Pacira and RDF dispute whether Pacira owes royalties to RDF with respect to
`Pacira’s EXPAREL® product made after December 24, 2021.
`63.
`RDF’s improper royalty claim would amount to millions of dollars in royalty payments
`into the future. But because there has yet to be a resolution of the parties’ dispute as to whether
`royalties are owed, Pacira intends to continue paying royalties to RDF on EXPAREL® product after
`December 24, 2021 under protest.
`
`COUNT 1
`(Declaratory Judgment That No Royalties Are Owed Under the Terms of the Agreements)
`64.
`Pacira repeats and realleges each and every allegation contained in paragraphs 1
`through 63 of this Complaint as if fully set forth herein.
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`65.
`RDF has alleged and continues to allege that Pacira owes royalties to RDF with respect
`to Pacira’s EXPAREL® product made after December 24, 2021.
`66.
`Under a proper interpretation of the Agreements, Pacira does not owe royalties on
`Pacira’s EXPAREL® product made after December 24, 2021, or under New Patented Technology.
`67.
`The Court should enter judgment declaring that Pacira does not owe royalties to RDF
`with respect to Pacira’s EXPAREL® product made after December 24, 2021, or under New Patented
`Technology, under the terms of the Agreements.
`68.
`As a result of the acts described in the foregoing paragraphs, there exists a substantial
`controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
`69.
`A judicial declaration is necessary and appropriate so that Pacira may ascertain its
`rights and obligations regarding the Agreements.
`70.
`Pacira is entitled to a judicial declaration that it does not owe royalties to RDF with
`respect to Pacira’s EXPAREL® product made after December 24, 2021, or under New Patented
`Technology, under the terms of the Agreements.
`
`COUNT 2
`(Declaratory Judgment that Terms of the Agreements are Unenforceable)
`71.
`Pacira repeats and realleges each and every allegation contained in paragraphs 1
`through 70 of this Complaint as if fully set forth herein.
`72.
`RDF has alleged and continues to allege that Pacira owes royalties to RDF with respect
`to Pacira’s EXPAREL® product made after December 24, 2021, including through at least 2041. The
`Court should enter judgment declaring that Pacira does not owe royalties to RDF with respect to
`Pacira’s EXPAREL® product made after December 24, 2021, or under New Patented Technology
`because any terms of the Agreements are unenforceable as unconscionable and in violation of public
`policy to the extent they require royalty payments with respect to Pacira’s EXPAREL® product made
`after December 24, 2021 or under New Patented Technology.
`73.
`RDF has asserted that the Agreements “provide that Pacira’s payment obligations to
`RDF will continue: 1. On any product which utilizes the DepoFoam Technology, 2. So long as a patent
`or patent application which embodies DepoFoam Technology remains unexpired, 3. Regardless of
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`whether such patent is existing or future, 4. Regardless of whether the patent was developed and/or
`filed by Pacira or RDF.”
`74.
`Upon information and belief, RDF interprets “DepoFoam Technology” to include all
`multivesicular liposome technology, regardless of when it was created or the particular attributes of
`the specific multivesicular liposome.
`75.
`Upon information and belief, under RDF’s assertions, royalty obligations under the
`Agreements could extend for an infinite amount of time.
`76.
`Upon information and belief, under RDF’s assertions, royalty obligations under the
`Agreements extend to all multivesicular liposome technology regardless of whether it relates to
`patented technology provided by RDF or whether it was even in existence at the time the
`2004 Amendment was signed.
`77.
`Upon information and belief, under RDF’s assertions, royalty obligations could lay
`dormant and spring into existence with the filing of a new patent application or grant of a new patent
`years or decades later.
`78.
`To the extent any terms of the Agreements could result in royalty obligations for an
`infinite amount of time, such terms of the Agreements are unenforceable as unconscionable.
`79.
`To the extent any terms of the Agreements could result in royalty obligations for all
`multivesicular liposome technology regardless of whether it relates to patented technology provided
`by RDF or whether it was even in existence at the time the 2004 Amendment was signed, such terms
`of the Agreements are unenforceable as unconscionable.
`80.
`To the extent any terms of the Agreements could result in royalty obligations lying
`dormant and springing into existence with the filing of a new patent application or grant of a new
`patent, such terms of the Agreements are unenforceable as unconscionable.
`81.
`To the extent any terms of the Agreements require Pacira to pay royalties to RDF with
`respect to Pacira’s EXPAREL® product made after December 24, 2021, or under New Patented
`Technology, such terms of the Agreements are unenforceable as unconscionable.
`82.
`To the extent any terms of the Agreements could result in royalty obligations for an
`infinite amount of time, such terms of the Agreements are unenforceable as against public policy.
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`Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 13 of 14
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`83.
`To the extent any terms of the Agreements could result in royalty obligations for all
`multivesicular liposome technology regardless of whether it relates to patented technology provided
`by RDF or whether it was even in existence at the time the 2004 Amendment was signed, such terms
`of the Agreements are unenforceable as against public policy.
`84.
`To the extent any terms of the Agreements could result in royalty obligations lying
`dormant and springing into existence with the filing of a new patent application or grant of a new
`patent, such terms of the Agreements are unenforceable as against public policy.
`85.
`To the extent any terms of the Agreements require Pacira to pay royalties to RDF with
`respect to Pacira’s EXPAREL® product made after December 24, 2021, or under New Patented
`Technology, such terms of the Agreements are unenforceable as against public policy.
`86.
`As a result of the acts described in the foregoing paragraphs, there exists a substantial
`controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
`87.
`A judicial declaration is necessary and appropriate so that Pacira may ascertain its
`rights and obligations regarding the Agreements.
`88.
`Pacira is entitled to a judicial declaration that any terms of the Agreements that would
`require Pacira to pay a royalty to RDF with respect to Pacira’s EXPAREL® product made after
`December 24, 2021 or under New Patented Technology are unenforceable.
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`PRAYER FOR RELIEF
`WHEREFORE, Pacira respectfully requests the following:
`a)
`That the Court enter a judgment declaring that Pacira does not owe any royalties to
`RDF with respect to Pacira’s EXPAREL® product made after December 24, 2021, under the terms of
`the Agreements.
`b)
`That the Court enter a judgment declaring that Pacira does not owe any royalties to
`RDF with respect to Pacira’s EXPAREL® product made using New Patented Technology, under the
`terms of the Agreements.
`c)
`That the Court enter judgment declaring that any terms of the Agreements that would
`require Pacira to pay a royalty to RDF with respect to Pacira’s EXPAREL® product made after
`December 24, 2021 or under New Patented Technology are unenforceable.
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`Case 2:21-cv-02241 Document 1 Filed 12/23/21 Page 14 of 14
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`d)
`That the Court award a refund of any royalties Pacira pays under protest on Pacira’s
`EXPAREL® product made after December 24, 2021, or under New Patented Technology, and order
`RDF to repay such.
`e)
`That the Court award Pacira any and all other relief to which Pacira may show itself to
`be entitled; and
`f)
`That the Court award Pacira any other relief as the Court may deem just, equitable, and
`proper.
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`JURY DEMAND
`Pacira hereby demands a trial by jury on all issues so triable.
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`DATED this 23rd day of December, 2021.
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`PISANELLI BICE PLLC
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`/s/ Debra L. Spinelli
`By:
`Debra L. Spinelli, Esq., #9695
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`400 South 7th Street, Suite 300
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`Las Vegas, Nevada 89101
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`Gregg LoCascio, Esq.
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`Justin Bova, Esq.
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`KIRKLAND & ELLIS LLP
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`1301 Pennsylvania Avenue, N.W.
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`Washington, D.C. 20004
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`Ryan Kane, Esq.
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`Andrew Walter, Esq.
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`KIRKLAND & ELLIS LLP
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`601 Lexington Avenue
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`New York, New York 10022
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`Counsel for Plaintiff Pacira Pharmaceuticals, Inc.
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