Case 1:22-cv-00141-UNA Document 1 Filed 01/31/22 Page 1 of 30 PageID #: 1
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`C.A. No. _________________
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`v.
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`AUROBINDO PHARMA LIMITED,
`AUROMEDICS PHARMA LLC and
`EUGIA PHARMA SPECIALITIES
`LIMITED,
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`Defendants
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`SANOFI-AVENTIS U.S. LLC and
`SANOFI MATURE IP,
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`Plaintiffs,
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`COMPLAINT FOR PATENT INFRINGEMENT
`Plaintiffs Sanofi-Aventis U.S. LLC (hereinafter, “Sanofi U.S.”) and Sanofi Mature IP
`(collectively, “Plaintiffs”), by their attorneys, hereby allege as follows:
`NATURE OF THE ACTION
`1.
`This is an action for patent infringement arising under the patent laws of the United
`States, Title 35, United States Code and for declaratory judgment pursuant to the Declaratory
`Judgment Act, 28 U.S.C. §§ 2201, et seq. This action relates to the Abbreviated New Drug
`Application (“ANDA”) submitted by Eugia Pharma Specialities Limited (“Eugia”) to the U.S.
`Food and Drug Administration (“FDA”) for approval to engage in the commercial manufacture,
`use, or sale of cabazitaxel injection, for intravenous infusion, a generic version of Plaintiffs’
`JEVTANA® KIT (hereinafter “JEVTANA®”), prior to the expiration of U.S. Patent Nos.
`10,583,110 (“the ’110 patent”), 10,716,777 (“the ’777 patent”), and 8,927,592 (“the ’592 patent”).
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`THE PARTIES
`2.
`Plaintiff Sanofi U.S. is a company organized and existing under the laws of the
`State of Delaware, having commercial headquarters at 55 Corporate Drive, Bridgewater, New
`Jersey 08807.
`3.
`Plaintiff Sanofi Mature IP is a company organized and existing under the laws of
`France, having its principal place of business at 54 rue La Boétie, 75008 Paris, France.
`4.
`Plaintiffs are owned by Sanofi, a global research-driven pharmaceutical company
`that discovers, develops, manufactures, and markets a broad range of innovative products to
`improve human health.
`5.
`Upon information and belief, Defendant Aurobindo Pharma Limited (“APL”) is a
`corporation organized and existing under the laws of the Republic of India, having a place of
`business at Plot No. 11, Survey no.9, Water Mark Building, Kondapur, Hitech City, Hyderabad
`500084, Telangana, India. Upon information and belief, APL is in the business of, among other
`things, manufacturing and selling generic versions of branded pharmaceutical drugs through
`various operating subsidiaries, including Eugia Pharma Specialities Ltd. and AuroMedics Pharma
`LLC, throughout the United States, including in Delaware.
`6.
`Upon information and belief, Defendant Eugia Pharma Specialities Ltd. (“Eugia”)
`is a corporation organized and existing under the laws of the Republic of India, having a place of
`business at Maitrivihar, Plot #2, Ameerpet, Hyderabad, Telangana 500038, India. Upon
`information and belief, Eugia is a wholly owned subsidiary of APL. Upon information and belief,
`Eugia is in the business of, among other things, manufacturing and selling generic versions of
`branded pharmaceutical drugs throughout the United States, including in Delaware.
`7.
`Upon
`information
`and belief, Defendant AuroMedics Pharma LLC
`(“AuroMedics”) is a limited liability company organized and existing under the laws of Delaware,
`having its corporate offices and a principal place of business at 279 Princeton-Hightstown Road,
`East Windsor, NJ 08520. Upon information and belief, AuroMedics is a wholly owned subsidiary
`of APL. Upon information and belief, AuroMedics is in the business of, among other things,
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`manufacturing and selling generic versions of branded pharmaceutical drug products throughout
`the United States, including in Delaware.
`8.
`Upon information and belief, AuroMedics is a United States agent for APL and
`Eugia regarding ANDA No. 216733.
`9.
`Upon information and belief, APL, Eugia, and AuroMedics (collectively referred
`to hereinafter as “Eugia” unless otherwise noted) collaborate with respect to the development,
`regulatory approval, marketing, sale, and/or distribution of pharmaceutical products. Upon further
`information and belief, APL, Eugia, and AuroMedics are agents of each other and/or operate in
`concert as integrated parts of the same business group. Upon information and belief, APL and
`Eugia acted in concert to develop Eugia’s Proposed ANDA Product that is the subject of ANDA
`No. 216733 and, with AuroMedics, to seek regulatory approval from the FDA to market and sell
`Eugia’s Proposed ANDA Product throughout the United States, including in Delaware.
`10.
`Upon information and belief, APL, Eugia, and AuroMedics intend to act
`collaboratively to obtain approval for Eugia’s ANDA No. 216733, and, in the event the FDA
`approves that ANDA, to commercially manufacture, use, offer for sale, sell, and/or import Eugia’s
`Proposed ANDA Product in the United States, including in Delaware.
`11.
`On information and belief, Eugia assembled and caused to be submitted to the FDA
`ANDA No. 216733 pursuant to 21 U.S.C. § 355(j) (§ 505(j) of the FDCA) (hereinafter “the Eugia
`ANDA”) concerning a proposed drug product, cabazitaxel intravenous solution, 60 mg/1.5 mL
`(40 mg/mL) (hereinafter “Eugia’s Proposed ANDA Product”). The Eugia ANDA refers to and
`relies upon Sanofi U.S.’s NDA No. 201023 for JEVTANA®.
`12.
`By letter dated December 23, 2021, Eugia notified Plaintiffs that, as a part of its
`ANDA, Eugia had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the
`FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ’777 patent, the ’110 patent, the ’592
`patent, and U.S. Patent No. 7,241,907 (“the ’907 patent”), each of which were listed in the FDA’s
`Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) for
`JEVTANA®, asserting that the ’777 patent, the ’110 patent, the ’592 patent, and the ’907 patent
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`are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and
`sale of Eugia’s Proposed ANDA Product.
`JURISDICTION AND VENUE
`13.
`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100,
`et seq., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C.
`§§ 1331 and 1338(a). Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
`14.
`This Court has personal jurisdiction over APL because, inter alia, APL, itself and
`through its subsidiaries Eugia and AuroMedics, has purposefully availed itself of the benefits and
`protections of Delaware’s laws such that it should reasonably anticipate being haled into court
`here. On information and belief, APL, itself and through its subsidiaries Eugia and AuroMedics,
`develops, manufactures, imports, markets, offers to sell, sells, and/or distributes a broad range of
`generic pharmaceutical products throughout the United States, including in Delaware, and
`therefore transacts business within Delaware relating to Plaintiffs’ claims, and/or has engaged in
`systematic and continuous business contacts within Delaware. In addition, APL is subject to
`personal jurisdiction in Delaware because, upon information and belief, it controls AuroMedics, a
`Delaware corporation, and therefore the activities of AuroMedics in this jurisdiction are attributed
`to APL.
`15.
`In addition, this Court has personal jurisdiction over APL because, among other
`things, on information and belief, upon approval of Eugia’s ANDA, APL and its subsidiaries
`AuroMedics and Eugia will market, distribute, offer for sale, sell, and/or import Eugia’s Proposed
`ANDA Product in the United States, including in Delaware, and will derive substantial revenue
`from the use or consumption of Eugia’s Proposed ANDA Product in Delaware. On information
`and belief, upon approval of Eugia’s ANDA, Eugia’s Proposed ANDA Product will, among other
`things, be marketed, distributed, offered for sale, sold, and/or imported in Delaware; prescribed by
`physicians practicing in Delaware; dispensed by pharmacies located within Delaware; and/or used
`by patients in Delaware, all of which would have substantial effects on Delaware and lead to
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`foreseeable harm and injury to Plaintiffs, including Plaintiff Sanofi U.S., which is a Delaware
`company.
`16.
`In addition, this Court has personal jurisdiction over APL because it regularly
`engages in patent litigation concerning Eugia’s ANDA products in this District, does not contest
`personal jurisdiction in this District, and has purposefully availed itself of the rights and benefits
`of this Court by asserting claims and/or counterclaims in this District. See, e.g., Pfizer Inc. v.
`Aurobindo Pharma, Ltd., C.A. No. 20-01528-CFC, D.I. 7 (D. Del. Dec. 4, 2020); Amgen Inc. v.
`Aurobindo Pharma Ltd., C.A. No. 16-00853-GMS, D.I. 10 (D. Del. Nov. 28, 2016).
`17.
`In the alternative, APL is subject to jurisdiction throughout the United States, and
`specifically in the State of Delaware pursuant to Fed. R. Civ. P. 4(k)(2).
`18.
`For at least the above reasons, it would not be unfair or unreasonable for APL to
`litigate this action in this District, and APL is subject to personal jurisdiction in this District.
`19.
`This Court has personal jurisdiction over Eugia because Eugia, itself and through
`its agents APL and AuroMedics, has purposefully availed itself of the benefits and protections of
`Delaware’s laws such that it should reasonably anticipate being haled into court here. On
`information and belief, Eugia, itself and through its agent AuroMedics and parent company APL,
`develops, manufactures, imports, markets, offers to sell, sells, and/or distributes a broad range of
`generic pharmaceutical products throughout the United States, including in Delaware, and
`therefore transacts business within Delaware relating to Plaintiffs’ claims, and/or has engaged in
`systematic and continuous business contacts within Delaware. In addition, Eugia is subject to
`personal jurisdiction in Delaware because, upon information and belief, AuroMedics, a Delaware
`corporation, is an agent of Eugia, and therefore the activities of AuroMedics in this jurisdiction
`are attributed to Eugia.
`20.
`In addition, this Court has personal jurisdiction over Eugia because, among other
`things, on information and belief: (1) Eugia and its agent AuroMedics filed Eugia’s ANDA for the
`purpose of seeking approval to engage in the commercial manufacture, use, sale, or offer for sale
`of Eugia’s Proposed ANDA Product in the United States, including in Delaware; and (2) upon
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`approval of Eugia’s ANDA, Eugia, its agent AuroMedics, and its parent company APL will
`market, distribute, offer for sale, sell, and/or import Eugia’s Proposed ANDA Product in the United
`States, including in Delaware, and will derive substantial revenue from the use or consumption of
`Eugia’s Proposed ANDA Product in Delaware. On information and belief, upon approval of
`Eugia’s ANDA, Eugia’s Proposed ANDA Product will, among other things, be marketed,
`distributed, offered for sale, sold, and/or imported in Delaware; prescribed by physicians practicing
`in Delaware; dispensed by pharmacies located within Delaware; and/or used by patients in
`Delaware, all of which would have substantial effects on Delaware and lead to foreseeable harm
`and injury to Plaintiffs, including Plaintiff Sanofi U.S., which is a Delaware company.
`21.
`In addition, this Court has personal jurisdiction over Eugia because it regularly
`engages in patent litigation concerning Eugia’s ANDA products in this District, does not contest
`personal jurisdiction in this District, and has purposefully availed itself of the rights and benefits
`of this Court by asserting claims and/or counterclaims in this District. See, e.g., Pfizer Inc. v.
`Aurobindo Pharma, Ltd., C.A. No. 20-01528-CFC, D.I. 7 (D. Del. Dec. 4, 2020).
`22.
`In the alternative, Eugia is subject to jurisdiction throughout the United States, and
`specifically in the State of Delaware pursuant to Fed. R. Civ. P. 4(k)(2).
`23.
`For at least the above reasons, it would not be unfair or unreasonable for Eugia to
`litigate this action in this District, and Eugia is subject to personal jurisdiction in this District.
`24.
`This Court has personal jurisdiction over AuroMedics because, on information and
`belief, AuroMedics is a limited liability company organized and existing under the laws of the
`Delaware, is qualified to do business in Delaware, and has appointed a registered agent for service
`of process in Delaware. Therefore, AuroMedics has consented to general jurisdiction in Delaware.
`25.
`For these reasons, and for other reasons that will be presented to the Court if
`jurisdiction is challenged, the Court has personal jurisdiction over APL, Eugia, and AuroMedics.
`26.
`Venue is proper in this district for AuroMedics under 28 U.S.C. § 1400(b) because,
`inter alia, AuroMedics is a corporation organized and existing under the laws of the State of
`Delaware.
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`27.
`Venue is proper in this district for APL and Eugia under 28 U.S.C. §§ 1391 and
`1400(b) because, inter alia, APL and Eugia are corporations existing under the laws of India and
`may be sued in any judicial district. 28 U.S.C. § 1391(c)(3).
`JEVTANA® AND THE PATENTS-IN-SUIT
`28.
`Sanofi U.S. holds approved NDA No. 201023 for cabazitaxel injection, 60 mg/
`1.5 mL (40 mg/mL), which is prescribed and sold in the United States under the trademark
`JEVTANA® KIT. The FDA approved NDA No. 201023 on June 17, 2010. JEVTANA® is
`approved for use in combination with prednisone for the treatment of patients with metastatic
`castration-resistant prostate cancer previously treated with a docetaxel-containing treatment
`regimen.
`29.
`United States Patent No. 8,927,592 (copy attached as Exhibit A) is entitled
`“Antitumoral Use of Cabazitaxel” and was duly and legally issued by the United States Patent and
`Trademark Office on January 6, 2015. At the conclusion of IPR2016-00712, an inter partes review
`certificate amending the ’592 patent to replace substitute claims 27-30 with claims 31-34 issued
`on August 23, 2021. The ’592 patent is owned by Sanofi Mature IP. The ’592 patent is directed
`to methods for increasing survival of certain prostate cancer patients with cabazitaxel, including
`the use of JEVTANA® in accordance with the labeling approved by the FDA.
`30.
`The ’592 patent is listed in the Orange Book for JEVTANA® (NDA No. 201023).
`The FDA was notified before September 22, 2021 of the inter partes review certificate and the use
`code was updated to correspond to the amended claims.
`31.
`Claims 31-34 of the ’592 patent are materially different from and patentably distinct
`from all originally issued claims of the ’592 patent (claims 1-30) because, among other things,
`claims 31-34 of the ’592 patent require administration of cabazitaxel with the intentional purpose
`of prolonging survival and administration of a premedication regimen, neither of which was a
`limitation in any original issued claim of the ’592 patent.
`32.
`United States Patent No. 10,583,110 (copy attached as Exhibit B) is entitled
`“Antitumoral Use of Cabazitaxel” and was duly and legally issued by the United States Patent and
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`Trademark Office on March 10, 2020. It is owned by Sanofi Mature IP. The ’110 patent is related
`to the ’592 patent by a chain of continuation applications and relies on the same provisional patent
`applications. The ’110 patent is directed to methods for increasing survival of certain prostate
`cancer patients with cabazitaxel, including the use of JEVTANA® in accordance with the labeling
`approved by the FDA.
`33.
`The claims of the ’110 patent are materially different from and patentably distinct
`from all originally issued claims of the ’592 patent (claims 1-30), because, among other things, the
`claims of the ’110 patent require administration of cabazitaxel with the intentional purpose of
`prolonging survival and administration of a premedication regimen, neither of which was a
`limitation in any issued claim of the ’592 patent.
`34.
`United States Patent No. 10,716,777 (copy attached as Exhibit C) is entitled
`“Antitumoral Use of Cabazitaxel” and was duly and legally issued by the United States Patent and
`Trademark Office on July 21, 2020. It is owned by Sanofi Mature IP. The ’777 patent is a
`continuation of the ’110 patent and relies on the same provisional patent applications. The ’777
`patent is directed to methods for increasing survival of certain prostate cancer patients with
`cabazitaxel, including the use of JEVTANA® in accordance with the labeling approved by the
`FDA.
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`35.
`The claims of the ’777 patent are materially different and patentably distinct from
`all originally issued claims of the ’592 patent (claims 1-30), because, among other things, the
`claims of the ’777 patent require administration of cabazitaxel with the intentional purpose of
`prolonging survival and administration of an H2 antagonist, neither of which was a limitation in
`any issued claim of the ’592 patent.
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`36.
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`herein.
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`COUNT I: INFRINGEMENT OF U.S. PATENT NO. 10,583,110
`UNDER 35 U.S.C. § 271(e)
`Plaintiffs incorporate each of the preceding paragraphs 1 – 35 as if fully set forth
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`37.
`Eugia, via its Notice Letter and prior litigation conduct, has indicated its intent to
`engage in the commercial manufacture, use, offer for sale, sale, marketing, distribution, and/or
`importation of its Proposed ANDA Product prior to the expiration of the ’110 patent.
`38.
`By submitting and maintaining its ANDA for the purpose of obtaining approval to
`engage in the commercial manufacture, use, offer to sell, or sale of its Proposed ANDA Product
`prior to the expiration of the ’110 patent, Eugia has committed an act of infringement of one or
`more claims of the ’110 patent under 35 U.S.C. § 271(e)(2)(A).
`39.
`On information and belief, Eugia intends to engage in the commercial manufacture,
`use, offer for sale, sale, marketing, distribution, and/or importation of its Proposed ANDA Product
`with proposed labeling immediately and imminently upon final approval of its ANDA.
`40.
`On information and belief, the proposed labeling for Eugia’s Proposed ANDA
`Product will be substantially identical to the JEVTANA® label and instructs and encourages
`physicians to practice the claimed methods of the ’110 patent.
`41.
`The JEVTANA® label states that the indication is “treatment of patients with
`metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing
`treatment regimen.” (JEVTANA® label at § 1, copy attached as Exhibit D).
`42.
`The Dosage and Administration Section of the JEVTANA® label provides
`instructions on the recommended doses of JEVTANA®, which involve “the discretion of the
`treating healthcare provider,” and refer such healthcare providers to the Clinical Studies Section
`of the label. (JEVTANA® label at § 2). The Clinical Studies Section of the JEVTANA® label
`describes, among other things, the pivotal TROPIC clinical study in which cabazitaxel was shown
`to prolong overall survival of these patients. (JEVTANA® label at § 14). The Clinical Studies
`Section of the JEVTANA® label reports a difference in overall survival as the median time to death
`for the patients in the JEVTANA® + Prednisone arm vs. the Mitoxantrone + Prednisone arm of the
`TROPIC clinical study, provides a “p value” of <0.0001 for the difference, and reports a hazard
`ratio of 0.70, explicitly noting that it favors cabazitaxel. (JEVTANA® label at § 14.1, Table 5 and
`Figure 1). These data show a statistically significant increase in overall survival for the patients
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`in the JEVTANA® + Prednisone arm, corresponding to a 30% reduction in risk of death.
`(JEVTANA® label at § 14.1, Table 5 and Figure 1). A treatment shown to increase overall survival
`in a controlled clinical study is understood as prolonging the lives (i.e., increasing the life
`expectancies) of individual patients as compared to those patients receiving the control arm therapy
`from the clinical study. In other words, a finding of increased overall survival in a clinical study,
`as is true for the TROPIC study presented in the JEVTANA® label, demonstrates that the therapy
`will prolong the lives of individual patients. The JEVTANA® label therefore instructs physicians
`that JEVTANA® increases survival and encourages physicians to administer the drug to those
`patients for that purpose in accordance with the claimed methods of the ’110 patent. (JEVTANA®
`label at §§ 1, 2, 14).
`43.
`The recommended dose of cabazitaxel in the JEVTANA® label is 20 mg/m2
`administered as a one-hour intravenous infusion every three weeks. A dose of 25 mg/m2 “can be
`used in select patients.” Patients at 20 mg/m2 who require dose reduction should receive 15 mg/m2,
`and patients at 25 mg/m2 who require dose reduction should receive 20 mg/m2. (JEVTANA® label
`at § 2). The JEVTANA® label therefore instructs and encourages physicians to administer
`15 mg/m2, 20 mg/m2, or 25 mg/m2 of cabazitaxel in accordance with the claimed methods of the
`’110 patent.
`44.
`The JEVTANA® label instructs physicians to “[p]remedicate at least 30 minutes
`prior to each dose of JEVTANA with the following intravenous medications to reduce the risk
`and/or severity of hypersensitivity: . . . antihistamine (dexchlorpheniramine 5 mg, or
`diphenhydramine 25 mg or equivalent antihistamine), corticosteroid (dexamethasone 8 mg or
`equivalent steroid), H2 antagonist.” (JEVTANA® label at § 2.1). The JEVTANA® label therefore
`instructs and encourages physicians to administer the premedications recited in the ’110 patent
`claims in accordance with the claimed methods of the ’110 patent.
`45.
`Thus, on information and belief, the use of Eugia’s Proposed ANDA Product in
`accordance with its proposed labeling will directly infringe at least one claim of the ’110 patent
`under 35 U.S.C. § 271(a).
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`46.
`On information and belief, Eugia has actual knowledge of the ’110 patent, as
`demonstrated by at least Eugia’s certification of the type described in Section 505(j)(2)(A)(vii)(IV)
`of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) described in Eugia’s Notice Letter, and will
`actively induce direct infringement of at least one claim of the ’110 patent under 35 U.S.C.
`§ 271(b) when its ANDA is approved and its Proposed ANDA Product is marketed, sold,
`distributed, and/or imported.
`47.
`The foregoing acts by Eugia constitute and/or will constitute infringement of the
`’110 patent and/or active inducement of infringement of the ’110 patent under 35 U.S.C. § 271(b).
`48.
`If Eugia’s infringement of the ’110 patent is not permanently enjoined, Plaintiffs
`will suffer substantial and irreparable harm for which there is no remedy at law.
`
`COUNT II: DECLARATORY JUDGMENT OF INFRINGEMENT OF
`U.S. PATENT NO. 10,583,110 UNDER 35 U.S.C. § 271(B)
`
`Plaintiffs incorporate each of the preceding paragraphs 1 – 48 as if fully set forth
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`49.
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`herein.
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`50.
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`On information and belief, Eugia intends to engage in the commercial manufacture,
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`use, offer for sale, sale, marketing, distribution, and/or importation of its Proposed ANDA Product
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`with proposed labeling immediately and imminently upon final approval of its ANDA and prior
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`to the expiration of the ’110 patent. Therefore, a case or controversy exists between Eugia and
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`Plaintiffs as to infringement of the ’110 patent.
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`51.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution,
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`and/or importation of Eugia’s Proposed ANDA Product would infringe one or more claims of the
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`’110 patent.
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`52.
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`On information and belief, the proposed labeling for Eugia’s Proposed ANDA
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`Product will be substantially identical to the JEVTANA® label and instructs and encourages
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`physicians to practice the claimed methods of the ’110 patent.
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`53.
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`The JEVTANA® label states that the indication is “treatment of patients with
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`metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing
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`treatment regimen.” (JEVTANA® label at § 1).
`
`54.
`
`The Dosage and Administration Section of the JEVTANA® label provides
`
`instructions on the recommended doses of JEVTANA®, which involve “the discretion of the
`
`treating healthcare provider,” and refer such healthcare providers to the Clinical Studies Section
`
`of the label. (JEVTANA® label at § 2). The Clinical Studies Section of the JEVTANA® label
`
`describes, among other things, the pivotal TROPIC clinical study in which cabazitaxel was shown
`
`to prolong overall survival of these patients. (JEVTANA® label at §, 14). The Clinical Studies
`
`Section of the JEVTANA® label reports a difference in overall survival as the median time to death
`
`for the patients in the JEVTANA® + Prednisone arm vs. the Mitoxantrone + Prednisone arm of the
`
`TROPIC clinical study, provides a “p value” of <0.0001 for the difference, and reports a hazard
`
`ratio of 0.70, explicitly noting that it favors cabazitaxel. (JEVTANA® label at § 14.1, Table 5 and
`
`Figure 1). These data show a statistically significant increase in overall survival for the patients
`
`in the JEVTANA® + Prednisone arm, corresponding to a 30% reduction in risk of death.
`
`(JEVTANA® label at § 14.1, Table 5 and Figure 1). A treatment shown to increase overall survival
`
`in a controlled clinical study is understood as prolonging the lives (i.e., increasing the life
`
`expectancies) of individual patients as compared to those patients receiving the control arm therapy
`
`from the clinical study. In other words, a finding of increased overall survival in a clinical study,
`
`as is true for the TROPIC study presented in the JEVTANA® label, demonstrates that the therapy
`
`will prolong the lives of individual patients. The JEVTANA® label therefore instructs physicians
`
`that JEVTANA® increases survival and encourages physicians to administer the drug to those
`
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`Case 1:22-cv-00141-UNA Document 1 Filed 01/31/22 Page 13 of 30 PageID #: 13
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`patients for that purpose in accordance with the claimed methods of the ’110 patent. (JEVTANA®
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`label at §§ 1, 2, 14).
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`55.
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`The recommended dose of cabazitaxel in the JEVTANA® label is 20 mg/m2
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`administered as a one-hour intravenous infusion every three weeks. A dose of 25 mg/m2 “can be
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`used in select patients.” Patients at 20 mg/m2 who require dose reduction should receive 15 mg/m2,
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`and patients at 25 mg/m2 who require dose reduction should receive 20 mg/m2. (JEVTANA® label
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`at § 2). The JEVTANA® label therefore instructs and encourages physicians to administer
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`15 mg/m2, 20 mg/m2, or 25 mg/m2 of cabazitaxel in accordance with the claimed methods of the
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`’110 patent.
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`56.
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`The JEVTANA® label instructs physicians to “[p]remedicate at least 30 minutes
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`prior to each dose of JEVTANA with the following intravenous medications to reduce the risk
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`and/or severity of hypersensitivity: . . . antihistamine (dexchlorpheniramine 5 mg, or
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`diphenhydramine 25 mg or equivalent antihistamine), corticosteroid (dexamethasone 8 mg or
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`equivalent steroid), H2 antagonist.” (JEVTANA® label at § 2.1). The JEVTANA® label therefore
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`instructs and encourages physicians to administer the premedications recited in the ’110 patent
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`claims in accordance with the claimed methods of the ’110 patent.
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`57.
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`Thus, on information and belief, the use of Eugia’s Proposed ANDA Product in
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`accordance with its proposed labeling will directly infringe at least one claim of the ’110 patent
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`under 35 U.S.C. § 271(a).
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`58.
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`On information and belief, Eugia has actual knowledge of the ’110 patent, as
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`demonstrated by at least Eugia’s certification of the type described in Section 505(j)(2)(A)(vii)(IV)
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`of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) described in Eugia’s Notice Letter, and will
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`actively induce direct infringement of at least one claim of the ’110 patent under 35 U.S.C.
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`Case 1:22-cv-00141-UNA Document 1 Filed 01/31/22 Page 14 of 30 PageID #: 14
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`§ 271(b) when its ANDA is approved and its Proposed ANDA Product is marketed, sold,
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`distributed, and/or imported.
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`59.
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`The foregoing acts by Eugia constitute and/or will constitute active inducement of
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`infringement of the ’110 patent under 35 U.S.C. §§ 271(b).
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`60.
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`If Eugia’s infringement of the ’110 patent is not permanently enjoined, Plaintiffs
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`will suffer substantial and irreparable harm for which there is no remedy at law.
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`COUNT III: INFRINGEMENT OF U.S. PATENT NO. 10,716,777
`UNDER 35 U.S.C. § 271(e)
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`Plaintiffs incorporate each of the preceding paragraphs 1 – 60 as if fully set forth
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`61.
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`herein.
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`62.
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`Eugia, via its Notice Letter and prior litigation conduct, has indicated its intent to
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`engage in the commercial manufacture, use, offer for sale, sale, marketing, distribution, and/or
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`importation of its Proposed ANDA Product prior to the expiration of the ’777 patent.
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`63.
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`By submitting and maintaining its ANDA for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer to sell, or sale of its Proposed ANDA Product
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`prior to expiration of the ’777 patent, Eugia has committed an act of infringement of one or more
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`claims of the ’777 patent under 35 U.S.C. § 271(e)(2).
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`64.
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`On information and belief, Eugia intends to engage in the commercial manufacture,
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`use, offer for sale, sale, marketing, distribution, and/or importation of its Proposed ANDA Product
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`with proposed labeling immediately and imminently upon final approval of its ANDA.
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`65.
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`On information and belief, the proposed labeling for Eugia’s Proposed ANDA
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`Product will be substantially identical to the JEVTANA® label and instructs and encourages
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`physicians to practice the claimed methods of the ’777 patent.
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`66.
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`The JEVTANA® label states that the indication is “treatment of patients with
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`metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing
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`treatment regimen.” (JEVTANA® label at § 1).
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`67.
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`The Dosage and Administration Section of the JEVTANA® label provides
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`instructions on the recommended doses of JEVTANA®, which involve “the discretion of the
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`treating healthcare provider,” and refer such healthcare providers to the Clinical Studies Section
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`of the label. (JEVTANA® label at § 2). The Clinical Studies Section of the JEVTANA® label
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`describes, among other things, the pivotal TROPIC clinical study in which cabazitaxel was shown
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`to prolong overall survival of these patients. (JEVTANA® label at § 14). The Clinical Studies
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`Section of the JEVTANA® label reports a difference in overall survival as the median time to death
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`for the patients in the JEVTANA® + Prednisone arm vs. the Mitoxantrone + Prednisone arm of the
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`TROPIC clinical study, provides a “p value” of <0.0001 for the difference, and reports a hazard
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`ratio of 0.70, explicitly noting that it favors cabazitaxel. (JEVTANA® label at § 14.1, Table 5 and
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`Figure 1). These data show a statistically significant increase in overall survival for the patients
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`in the JEVTANA® + Prednisone arm, corresponding to a 30% reduction in risk of death.
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`(JEVTANA® label at § 14.1, Table 5 and Figure 1). A treatment shown to increase overall survival
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`in a controlled clinical study is understood as prolonging the lives (i.e., increasing the life
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`expectancies) of individual patients as compared to those patients receiving the control arm therapy
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`from the clinical study. In other