Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 1 of 28 PageID: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.
`and SUNOVION PHARMACEUTICALS INC.,
`
`Plaintiffs,
`
`C.A. No. __________
`
`v.
`
`MACLEODS PHARMACEUTICALS LTD. and
`MACLEODS PHARMA USA, INC.
`
`Defendants.
`
`PLAINTIFFS SUMITOMO DAINIPPON PHARMA CO., LTD.
`AND SUNOVION PHARMACEUTICALS INC.’S
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Sumitomo Dainippon Pharma Co., Ltd. (“Sumitomo”) and Sunovion
`
`Pharmaceuticals Inc. (“Sunovion”) (collectively, “Plaintiffs”), for their complaint against
`
`Defendants Macleods Pharmaceuticals Ltd. (“Macleods Ltd.”) and Macleods Pharma USA, Inc.
`
`(“Macleods Inc.”) (collectively, “Defendants” or “Macleods”), allege as follows:
`
`NATURE OF ACTION
`
`1.
`
`This is an action for infringement of United States Patent Nos. 9,815,827 (the
`
`“’827 patent”) and 9,907,794 (the “’794 patent”) (collectively, the “Asserted Patents”) under 35
`
`U.S.C. § 271(e)(2) and for declaratory judgment of infringement under 28 U.S.C. §§ 2201 and
`
`2202 and 35 U.S.C. §§ 271 (a), (b), and (c) relating to Plaintiffs’ commercially successful
`
`product, Latuda®. A true and accurate copy of the ’827 patent is attached hereto as Exhibit A.
`
`A true and accurate copy of the ’794 patent is attached hereto as Exhibit B.
`
`1
`
`Exhibit 2010
`Slayback v. Sumitomo
`IPR2020-01053
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 2 of 28 PageID: 2
`
`THE PARTIES
`
`2.
`
`Plaintiff Sumitomo is a company organized and existing under the laws of Japan,
`
`with a principal place of business at 6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka 541-
`
`0045, Japan.
`
`3.
`
`Plaintiff Sunovion is a corporation organized and existing under the laws of
`
`Delaware, with a principal place of business at 84 Waterford Drive, Marlborough, Massachusetts
`
`01752.
`
`4.
`
`On information and belief, Defendant Macleods Ltd. is a company organized and
`
`existing under the laws of India with a principal place of business at Atlanta Arcade, Marol
`
`Church Road, Andheri (East), Mumbai, 400059, India.
`
`5.
`
`On information and belief, Defendant Macleods Inc. is a company organized and
`
`existing under the laws of the state of Delaware with a principal place of business at 666
`
`Plainsboro Road, Building 200, Suite 230, Plainsboro, New Jersey 08536.
`
`6.
`
`On information and belief, Macleods Inc. is a wholly-owned subsidiary of
`
`Macleods Ltd.
`
`7.
`
`On information and belief, Macleods is in the business of developing,
`
`manufacturing, distributing and selling generic drugs throughout the United States, including in
`
`the District of New Jersey. On further information and belief, Macleods is working to achieve
`
`final approval by the U.S. Food and Drug Administration (“FDA”) of Abbreviated New Drug
`
`Application (“ANDA”) No. 212124.
`
`JURISDICTION AND VENUE
`
`8.
`
`This action arises under the patent laws of the United States of America, United
`
`States Code, Title 35, Section 1, et seq., including §§ 271(e)(2), 271(a), 271(b), 271(c), and 28
`
`2
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 3 of 28 PageID: 3
`
`U.S.C. §§ 2201 and 2202. This Court has subject matter jurisdiction over the action under 28
`
`U.S.C. §§ 1331, 1338, 2201, and 2202.
`
`9.
`
`This Court has personal jurisdiction over Macleods Ltd. by virtue of, inter alia, its
`
`systematic and continuous contacts with this jurisdiction, as alleged herein. On information and
`
`belief, either directly or through its subsidiaries, agents, and/or affiliates, Macleods Ltd. regularly
`
`and continuously transacts business within New Jersey, including by selling pharmaceutical
`
`products in New Jersey. On information and belief, Macleods Ltd. derives substantial revenue
`
`from the sale of pharmaceutical products in New Jersey and has availed itself of the privilege of
`
`conducting business within New Jersey. Plaintiffs have been injured in New Jersey because of
`
`Macleods Ltd.’s filing of its ANDA (submitted, on information and belief, in concert with
`
`Macleods Inc.) and the causes of action Plaintiffs raise here, as alleged herein.
`
`10.
`
`11.
`
`On information and belief, Macleods Ltd. wholly owns Macleods Inc.
`
`Further, this Court has personal jurisdiction over Macleods Ltd. because
`
`Macleods Ltd. has committed an act of patent infringement under 35 U.S.C. § 271(e)(2), and, on
`
`information and belief, Macleods Ltd. intends a future course of conduct that includes acts of
`
`patent infringement in New Jersey. On information and belief, Macleods Ltd., either directly or
`
`through its subsidiaries, agents, and/or affiliates, manufactures, sells, offers for sale, markets,
`
`distributes, and/or imports versions of pharmaceutical products in the United States, including
`
`New Jersey. On information and belief, Macleods Ltd. developed a generic copy of Plaintiffs’
`
`Latuda® tablets. On information and belief, Macleods Ltd., in concert with Macleods Inc., filed
`
`ANDA No. 212124, seeking approval from the FDA to sell its generic lurasidone hydrochloride
`
`tablets throughout the United States, including New Jersey.
`
`3
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 4 of 28 PageID: 4
`
`12.
`
`On information and belief, Macleods Ltd. intends to market its generic lurasidone
`
`hydrochloride tablets in New Jersey upon final approval of such products by the FDA.
`
`13.
`
`On information and belief, Macleods Ltd.’s conduct has or will cause foreseeable
`
`harm and injury to Plaintiffs.
`
`14.
`
`Additionally, Sunovion operates a facility in Fort Lee, New Jersey where it
`
`engages in, for example, administrative, regulatory, clinical development, medical affairs, and
`
`other research and development functions related to numerous pharmaceutical products,
`
`including Sunovion’s product at issue in this case, Latuda®. Sunovion employs approximately
`
`100 individuals in New Jersey, more than in any other U.S. state, except Massachusetts. Were
`
`Macleods Ltd. to sell or offer to sell its proposed generic lurasidone hydrochloride products,
`
`Plaintiffs will be injured specifically in New Jersey.
`
`15.
`
`Further, this Court has personal jurisdiction over Macleods Ltd. because
`
`Macleods Ltd. has previously been sued in this district and has not challenged personal
`
`jurisdiction, and Macleods Ltd. has affirmatively availed itself of the jurisdiction of this Court by
`
`filing counterclaims in this district. See, e.g., Otsuka Pharm. Co., Ltd. v. Macleods Pharms. Ltd.,
`
`1:15-cv-5109 (D.N.J.); AstraZeneca AB v. Macleods Pharms. Ltd., 3:16-cv-1682 (D.N.J.);
`
`Mitsubishi Tanabe Pharma Corp. v. Macleods Pharms. Ltd., 3:17-cv-13130 (D.N.J.).
`
`16.
`
`Alternatively, to the extent the above facts do not establish personal jurisdiction
`
`over Macleods Ltd., this Court may exercise jurisdiction over Macleods Ltd. pursuant to Fed. R.
`
`Civ. P. 4(k)(2) because: (a) Plaintiffs’ claims arise under federal law; (b) Macleods Ltd. would
`
`be a foreign defendant not subject to personal jurisdiction in the courts of any State; (c)
`
`Macleods Ltd. has sufficient contacts with the United States as a whole, including, but not
`
`limited to, manufacturing and selling pharmaceutical products that are distributed throughout the
`
`4
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 5 of 28 PageID: 5
`
`United States; and (d) Macleods Ltd. filed an ANDA with the FDA and sent notice of its
`
`Paragraph IV certification to an entity in New Jersey, such that this Court’s exercise of
`
`jurisdiction over Macleods Ltd. satisfies due process.
`
`17.
`
`This Court has personal jurisdiction over Macleods Inc. by virtue of, inter alia, its
`
`systematic and continuous contacts with this jurisdiction, as alleged herein. On information and
`
`belief, either directly or through its subsidiaries, agents, and/or affiliates, Macleods Inc. regularly
`
`and continuously transacts business within New Jersey, including by selling pharmaceutical
`
`products in New Jersey. On information and belief, Macleods Inc. derives substantial revenue
`
`from the sale of pharmaceutical products in New Jersey and has availed itself of the privilege of
`
`conducting business within New Jersey. Plaintiffs have been injured in New Jersey because of
`
`Macleods Inc.’s filing of its ANDA (submitted, on information and belief, in concert with
`
`Macleods Ltd.) and the causes of action Plaintiffs raise here, as alleged herein.
`
`18.
`
`On information and belief, Macleods Inc. has a principal place of business at 666
`
`Plainsboro Road, Building 200, Suite 230, Plainsboro, New Jersey 08536. On information and
`
`belief, Macleods Inc. conducts business in New Jersey as a pharmaceutical manufacturer and
`
`wholesaler (New Jersey Business Entity ID No. 0101021236). On information and belief,
`
`Macleods Inc. is currently licensed to do business with the New Jersey Department of Health as
`
`a “Manufacturer and Wholesale[r]” of pharmaceuticals in the State of New Jersey (Registration
`
`No. 5004370).
`
`19.
`
`Further, this Court has personal jurisdiction over Macleods Inc. because Macleods
`
`Inc. has committed an act of patent infringement under 35 U.S.C. § 271(e)(2), and, on
`
`information and belief, Macleods Inc. intends a future course of conduct that includes acts of
`
`patent infringement in New Jersey. On information and belief, Macleods Inc., either directly or
`
`5
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 6 of 28 PageID: 6
`
`through its subsidiaries, agents, and/or affiliates, manufactures, sells, offers for sale, markets,
`
`distributes, and/or imports versions of pharmaceutical products in the United States, including
`
`New Jersey. On information and belief, Macleods Inc. developed a generic copy of Plaintiffs’
`
`Latuda® tablets. On information and belief, Macleods Inc., in concert with Macleods Ltd., filed
`
`ANDA No. 212124, seeking approval from the FDA to sell its generic lurasidone hydrochloride
`
`tablets throughout the United States, including New Jersey.
`
`20.
`
`On information and belief, Macleods Inc. intends to market its generic lurasidone
`
`hydrochloride tablets in New Jersey upon final approval of such products by the FDA.
`
`21.
`
`On information and belief, Macleods Inc.’s conduct has or will cause foreseeable
`
`harm and injury to Plaintiffs.
`
`22.
`
`Additionally, Sunovion operates a facility in Fort Lee, New Jersey where it
`
`engages in, for example, administrative, regulatory, clinical development, medical affairs, and
`
`other research and development functions related to numerous pharmaceutical products,
`
`including Sunovion’s product at issue in this case, Latuda®. Sunovion employs approximately
`
`100 individuals in New Jersey, more than in any other U.S. state, except Massachusetts. Were
`
`Macleods Inc. to sell or offer to sell its proposed generic lurasidone hydrochloride products,
`
`Plaintiffs will be injured specifically in New Jersey.
`
`23.
`
`Further, this Court has personal jurisdiction over Macleods Inc. because Macleods
`
`Inc. has previously been sued in this district and has not challenged personal jurisdiction, and
`
`Macleods Inc. has affirmatively availed itself of the jurisdiction of this Court by filing
`
`counterclaims in this district. See, e.g., Otsuka Pharm. Co., Ltd. v. Macleods Pharms. Ltd., 1:15-
`
`cv-5109 (D.N.J.); AstraZeneca AB v. Macleods Pharms. Ltd., 3:16-cv-1682 (D.N.J.); Mitsubishi
`
`Tanabe Pharma Corp. v. Macleods Pharms. Ltd., 3:17-cv-13130 (D.N.J.).
`
`6
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 7 of 28 PageID: 7
`
`24.
`
`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b).
`
`25.
`
`Venue is proper in this district under 28 U.S.C. § 1400(b) because Macleods Ltd.
`
`“committed an act of infringement” in this district. On information and belief, Macleods Ltd., in
`
`concert with Macleods Inc., submitted ANDA No. 212124 pursuant to Section 505(j) of the
`
`Federal Food, Drug, and Cosmetics Act (“FFDCA”) (codified at 21 U.S.C. § 355(j)), and, upon
`
`receiving final approval of such ANDA, will manufacture, sell, offer to sell, and/or import
`
`Macleods Ltd.’s proposed generic lurasidone hydrochloride tablets in the United States,
`
`including in the District of New Jersey. Thus, Macleods Ltd. has committed an act of
`
`infringement in this district.
`
`26.
`
`Venue is also proper in this district under 28 U.S.C. § 1400(b) because Macleods
`
`Ltd.’s subsidiary, Macleods Inc., resides in New Jersey. Further, venue is proper in this district
`
`because Macleods Ltd. has a “regular and established place of business” in this district.
`
`Macleods Ltd.’s subsidiary, Macleods Inc., has a principal place of business at 666 Plainsboro
`
`Road, Building 200, Suite 230, Plainsboro, New Jersey 08536. Further, venue is proper in this
`
`district because Macleods Ltd.’s subsidiary, Macleods Inc., is currently licensed to do business
`
`with the New Jersey Department of Health as a “Manufacturer and Wholesale[r]” of
`
`pharmaceuticals (Registration No. 5004370).
`
`27.
`
`Venue is proper in this district under 28 U.S.C. § 1400(b) because Macleods Inc.
`
`“committed an act of infringement” in this district. On information and belief, Macleods Inc., in
`
`concert with Macleods Ltd., submitted ANDA No. 212124 pursuant to Section 505(j) of the
`
`FFDCA, and, upon receiving final approval of such ANDA, will manufacture, sell, offer to sell,
`
`and/or import Macleods Inc.’s proposed generic lurasidone hydrochloride tablets in the United
`
`7
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 8 of 28 PageID: 8
`
`States, including in the District of New Jersey. Thus, Macleods Inc. has committed an act of
`
`infringement in this district.
`
`28.
`
`Venue is also proper in this district under 28 U.S.C. § 1400(b) because New
`
`Jersey is the judicial district in which Macleods Inc. resides.
`
`29.
`
`Venue is proper in this district under 28 U.S.C. § 1400(b) because Macleods Inc.
`
`has a “regular and established place of business” in this district. On information and belief,
`
`Macleods Inc. has a principal place of business at 666 Plainsboro Road, Building 200, Suite 230,
`
`Plainsboro, New Jersey 08536. Further, venue is proper in this district because Macleods Inc. is
`
`currently licensed to do business with the New Jersey Department of Health as a “Manufacturer
`
`and Wholesale[r]” of pharmaceuticals (Registration No. 5004370).
`
`30.
`
`The Court has jurisdiction to adjudicate this action under the Declaratory
`
`Judgment Act, 28 U.S.C. §§ 2201 and 2202. An actual, substantial, and justiciable controversy
`
`exists between Plaintiffs and Defendants of sufficient immediacy and reality to warrant the
`
`issuance of a declaratory judgment regarding the parties’ adverse legal interests with respect to
`
`the Asserted Patents.
`
`FACTUAL BACKGROUND
`
`Background of the ’827 Patent Invention
`
`31.
`
`Antipsychotic drug products are used in the management of psychotic symptoms
`
`associated with disorders including schizophrenia and bipolar disorder. See, e.g., ’827 patent
`
`col. 1 ll.47-49.
`
`32.
`
`Conventional drug product treatments for psychotic symptoms were known to
`
`cause unwanted serious side effects. See, e.g., ’827 patent col. 1 ll.57-63.
`
`8
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 9 of 28 PageID: 9
`
`33. Weight gain is a well-known side effect of conventional antipsychotic drug
`
`products. See, e.g., File History of U.S. Application No. 14/471,919, Notice of Allowance dated
`
`2017-07-17 (“Notice of Allowance”) at 2 (“[C]onventional antipsychotic drug[s] cause[] serious
`
`side effects such as undesired metabolic changes . . . which were considered as closely linked
`
`with a weight gain.”); see also Latuda® Prescribing Information (03/2018) at Section 5.6
`
`(“Atypical antipsychotic drugs have been associated with metabolic changes . . . includ[ing] . . .
`
`weight gain.” . . . . “Weight gain has been observed with atypical antipsychotic uses.”).
`
`34.
`
`On information and belief, the physiological relationship between antipsychotic
`
`drug product use and patient weight is complex and poorly understood.
`
`35.
`
`On information and belief, antipsychotic drug products exert different
`
`physiological effects relating to weight.
`
`36.
`
`There is a need for drug products that are effective antipsychotics but that do not
`
`cause undesirable side effects, such as weight gain.
`
`U.S. Patent No. 9,815,827
`
`37.
`
`The ’827 patent, entitled “Agent for Treatment of Schizophrenia,” issued on
`
`November 14, 2017 and names Mitsutaka Nakamura, Masaaki Ogasa, and Shunsuke Sami as
`
`inventors.
`
`38.
`
`By assignment, plaintiff Sumitomo owns all right, title, and interest in and to the
`
`’827 patent.
`
`39.
`
`40.
`
`Plaintiff Sunovion is the exclusive licensee to the ’827 patent in the United States.
`
`Plaintiff Sunovion is the holder of approved New Drug Application (“NDA”) No.
`
`200603 for lurasidone hydrochloride tablets (20 mg, 40 mg, 60 mg, 80 mg, and 120 mg), which
`
`are sold in the United States under the registered trademark Latuda®.
`
`9
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 10 of 28 PageID: 10
`
`41.
`
`In conjunction with NDA No. 200603, Sunovion has listed with the FDA ten
`
`patents for Latuda®. The listed patents are U.S. Patent Nos. 5,532,372, 8,729,085, 8,883,794,
`
`9,174,975, 9,259,423, 9,555,027, 9,815,827, 9,827,242, RE45573, and 9,907,794. The FDA has
`
`published these ten patents in the Approved Drug Products with Therapeutic Equivalence
`
`Evaluations, commonly referred to as the “Orange Book.” The Orange Book identifies drug
`
`products approved on the basis of safety and effectiveness by the FDA under the FFDCA.
`
`42.
`
`Latuda®, or approved methods of using Latuda®, are covered by at least one
`
`claim of the ’827 patent listed in the Orange Book.
`
`43.
`
`The ’827 patent is directed to methods of treating patients, including those with
`
`schizophrenia or manic depressive psychosis, with an antipsychotic without a clinically
`
`significant weight gain. The methods of treatment disclosed in the ’827 patent accomplish this
`
`through the oral administration of a particular dose, 20 mg to 120 mg, of lurasidone or a
`
`pharmaceutically acceptable salt of lurasidone (e.g., lurasidone hydrochloride) such that the
`
`patient does not experience clinically significant weight gain for specific periods of time,
`
`including after six weeks of administration. Administration of such specific doses, and for such
`
`specific periods of treatment, result in a patient not experiencing clinically significant weight
`
`gain, which was not well understood, routine, or a conventional technique in the art.
`
`Claims 40 and 43 of the ’827 patent are illustrative and recite:
`
`40. A method of treating a patient with an antipsychotic without a
`clinically significant weight gain, comprising:
`orally administering once daily to the patient a pharmaceutical
`composition comprising 20 to 120 mg of (1R, 2S, 3R, 4S)-N-[(1R,
`2R)-2-[4-(1,2-benzoisothiazol-3-ly)-1-piperazinylmethyl]-1-
`cyclohexylmethyl]-2,3-bicyclo[2.2.1]heptanedicarboximide or a
`pharmaceutically acceptable salt thereof as the sole active
`ingredient such that the patient does not experience a clinically
`significant weight gain.
`
`10
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 11 of 28 PageID: 11
`
`43. The method of claim 41, wherein the administering is
`conducted such that the patient does not experience a clinically
`significant weight gain after six weeks of administration.
`
`(’827 patent, Cls. 40, 43.)
`
`44.
`
`The claimed elements of exemplary claims 40 and 43 are found in the Latuda®
`
`Prescribing Information.
`
`45.
`
`The Latuda® Prescribing Information describes Latuda® as “an atypical
`
`antipsychotic belonging to the chemical class of benzisothiazol derivatives.” (Latuda®
`
`Prescribing Information (3/2018) at Section 11.)
`
`46.
`
`The Latuda® Prescribing Information states “LATUDA tablets are intended for
`
`oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of
`
`lurasidone hydrochloride.” (Latuda® Prescribing Information (3/2018) at Section 11; see also
`
`id. at Section 3.)
`
`47.
`
`The Latuda® Prescribing Information describes Latuda® as indicated for
`
`treatment of adult and adolescent patients age 13 to 17 years with schizophrenia, monotherapy
`
`treatment of adult and pediatric patients age 10 to 17 years with major depressive episodes
`
`associated with bipolar I disorder (bipolar depression), and adjunctive treatment with lithium or
`
`valproate in adult patients with major depressive episodes associated with bipolar I disorder
`
`(bipolar depression). (Latuda® Prescribing Information (3/2018) at Section 1.)
`
`48.
`
`It further describes the dosage and administration for Latuda®. With respect to
`
`adult patients with schizophrenia, the Latuda® Prescribing Information states “[t]he
`
`recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not
`
`required. LATUDA has been shown to be effective in a dose range of 40 mg per day to 160 mg
`
`per day . . . The maximum recommended dose is 160 mg per day.” (Latuda® Prescribing
`
`Information (3/2018) at Section 2.1.) With respect to adolescent patients with schizophrenia, the
`
`11
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 12 of 28 PageID: 12
`
`Latuda® Prescribing Information states “[t]he recommended starting dose of LATUDA is 40 mg
`
`once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a
`
`dose range of 40 mg per day to 80 mg per day . . . The maximum recommended dose is 80 mg
`
`per day.” (Id.)
`
`49. With respect to adults with depressive episodes associated with bipolar I disorder,
`
`the Latuda® Prescribing Information states “the recommended starting dose of LATUDA in
`
`adults is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or
`
`valproate. Initial dose titration is not required. LATUDA has been shown to be effective in a
`
`dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with
`
`lithium or valproate . . . The maximum recommended dose, as monotherapy or as adjunctive
`
`therapy with lithium or valproate, is 120 mg per day.” (Latuda® Prescribing Information
`
`(3/2018) at Section 2.2.) With respect to pediatric patients with depressive episodes associated
`
`with bipolar I disorder, the Latuda® Prescribing Information states that “[t]he recommended
`
`starting dose of LATUDA is 20 mg given once daily as monotherapy. Initial dose titration is not
`
`required. The dose may be increased after one week based on clinical response. LATUDA has
`
`been shown to be effective in a dose range of 20 mg per day to 80 mg per day as monotherapy . .
`
`. . The maximum recommended dose is 80 mg per day.” (Id.)
`
`50. When 20 mg to 120 mg of Latuda® is orally administered to patients, they do not
`
`experience a clinically significant weight gain. For example, the Latuda® Prescribing
`
`Information describes the following:
`
`12
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 13 of 28 PageID: 13
`
`(Latuda® Prescribing Information (3/2018) at Section 5.6.)
`
`51.
`
`The change in weight results shown in Tables 9 and 11 reflect the change in
`
`weight after six weeks of administration of Latuda® as described in short-term, placebo-
`
`controlled schizophrenia and short-term, flexible-dosed, placebo-controlled monotherapy bipolar
`
`depression studies, respectively, described in the Latuda® Prescribing Information. (See also
`
`Latuda® Prescribing Information (3/2018) at Section 14.) The label also describes the weight
`
`gain seen in patients from longer term, open-label studies. (Latuda® Prescribing Information
`
`(3/2018) at Section 5.6.)
`
`52.
`
`The therapeutic use of Latuda® represents an improvement over prior art methods
`
`of treating patients with an antipsychotic drug product, including those patients with
`
`schizophrenia and bipolar disorder.
`
`U.S. Patent No. 9,907,794
`
`53.
`
`The ’794 patent issued March 6, 2018 and names Kazuyuki Fujihara as the
`
`inventor.
`
`13
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 14 of 28 PageID: 14
`
`54.
`
`By assignment, plaintiff Sumitomo owns all right, title, and interest in and to the
`
`’794 patent.
`
`55.
`
`56.
`
`Orange Book.
`
`Plaintiff Sunovion is the exclusive licensee to the ’794 patent in the United States.
`
`Latuda® tablets are covered by at least one claim of the ’794 patent listed in the
`
`57.
`
`The claims of the ’794 patent are directed to tablets containing between 20 mg
`
`and 120 mg of lurasidone hydrochloride.
`
`58.
`
`Claims 1 and 15 of the ’794 patent are illustrative and recite:
`
`1. A tablet for oral administration, comprising:
`from 20 mg to 120 mg of N-[ 4-[ 4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-
`tetramethylene-butyl]-(1’R, 2’S, 3’R, 4’S)-2,3-bicyclo[2,2, 1]heptane-dicarboxyimide
`hydrochloride (lurasidone) as an active ingredient;
`a pregelatinized starch;
`a water-soluble excipient;
`a water-soluble polymer binder; and
`a lubricant,
`wherein the tablet includes lurasidone at a content ratio of 20 to 45% (wt/wt);
`wherein the tablet has a dissolution rate of 80% or more at 30 minutes as measured
`according to Japanese Pharmacopoeia, Dissolution test, Method 2, where the tablet is
`subjected to the Dissolution test using paddle rotation at a rotation rate of 50 rpm in 900
`mL of a diluted McIlvaine buffer having a pH of 3.8 to 4.0;
`wherein the tablet has a similar dissolution profile to a second tablet comprising from 20
`mg to 120 mg of lurasidone,
`wherein similarity of the dissolution profiles is exhibited by the tablet and a second tablet
`having a similarity factor f2 value of 50 or more,
`wherein the tablet and the second tablet are prepared according to the same method, and
`comprise the same ratio of lurasidone, pregelatinized starch, water-soluble excipient,
`water-soluble polymer binder, and lubricant, and the second tablet has a different
`lurasidone content than the tablet.
`
`(’794 patent, Cl 1.)
`
`15. A tablet for oral administration, comprising:
`granules comprising:
`from 20 mg to 120 mg of N-[ 4-[ 4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-
`(2R,3R)-2,3-tetramethylene-butyl]-(1’R, 2’S, 3’R, 4’S)-2,3-bicyclo[2,2,
`1]heptane-dicarboxyimide hydrochloride (lurasidone) as an active ingredient;
`a pregelatinized starch;
`
`14
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 15 of 28 PageID: 15
`
`a water-soluble excipient; and
`a water-soluble polymer binder, and
`a lubricant blended with the granules,
`wherein the tablet includes lurasidone at a content ratio of 20 to 45% (wt/wt);
`wherein the tablet has a dissolution rate of 80% or more at 30 minutes as measured
`according to Japanese Pharmacopoeia, Dissolution test, Method 2, where the tablet is
`subjected to the dissolution test using paddle rotation at a rotation rate of 50 rpm in 900 mL
`of a diluted McIlvaine buffer having a pH of 3.8 to 4.0;
`wherein the tablet has a similar dissolution profile to a second tablet comprising from 20
`mg to 120 mg of lurasidone,
`wherein similarity of the dissolution profiles is exhibited by the tablet and a second tablet
`having a similarity factor f2 value of 50 or more,
`wherein the tablet and the second tablet are prepared according to the same method, and
`comprise the same ratio of lurasidone, pregelatinized starch, water-soluble excipient, water-
`soluble polymer binder, and lubricant, and the second tablet has a different lurasidone
`content than the tablet.
`
`(’794 patent, Cl. 15.)
`
`ACTS GIVING RISE TO THIS ACTION
`
`59.
`
`On information and belief, Macleods submitted to the FDA ANDA No. 212124
`
`under Section 505(j) of the FFDCA, seeking the FDA’s approval to engage in the commercial
`
`manufacture, use, and/or sale of lurasidone hydrochloride tablets (20 mg, 40 mg, 60 mg, 80 mg,
`
`and 120 mg) (Macleods’s “Proposed ANDA Product”) prior to the expiration of the Asserted
`
`Patents. On information and belief, ANDA No. 212124 contains data from bioavailability or
`
`bioequivalence studies for such tablets.
`
`60.
`
`On information and belief, Macleods sent a letter to Plaintiffs regarding the ’827
`
`and ’794 patents (“Macleods’s Notice Letter”), purporting to be a notice pursuant to Section
`
`505(j)(2)(B)(iv) of the FFDCA. Macleods’s Notice Letter purports to inform Plaintiffs that
`
`Macleods’s ANDA contains a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
`
`Macleods’s Notice Letter bears the date July 31, 2018.
`
`61.
`
`62.
`
`Plaintiff Sunovion received Macleods’s Notice Letter on August 2, 2018.
`
`Plaintiff Sumitomo received Macleods’s Notice Letter on August 6, 2018.
`
`15
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 16 of 28 PageID: 16
`
`63.
`
`Plaintiffs commenced this action within 45 days after receiving Macleods’s
`
`Notice Letter.
`
`64.
`
`On information and belief, Macleods’s proposed label for its Proposed ANDA
`
`Product (“Proposed Macleods Label”) will refer to the product as, inter alia, an atypical
`
`antipsychotic for the treatment of schizophrenia in adults and adolescents (13 to 17) and
`
`depressive episodes associated with Bipolar (I) Disorder (bipolar depression) in adults, and will
`
`describe the strength of the generic lurasidone hydrochloride tablets as 20 mg, 40 mg, 60 mg, 80
`
`mg, and 120 mg. On information and belief, the Proposed Macleods Label will instruct
`
`physicians and healthcare providers to administer Macleods’s Proposed ANDA Product for, inter
`
`alia, the treatment of schizophrenia and depressive episodes associated with bipolar I disorder
`
`(bipolar depression).
`
`65.
`
`On information and belief, the Proposed Macleods Label will contain data relating
`
`to patient weight gain, obtained from clinical studies involving, inter alia, Latuda® (20 mg, 40
`
`mg, 60 mg, 80 mg, and 120 mg). On information and belief, the weight gain data in the
`
`Proposed Macleods Label demonstrate that patients receiving Latuda® and/or Macleods’s
`
`Proposed ANDA Product do not experience clinically significant weight gain.
`
`66.
`
`On information and belief, the Proposed Macleods Label will encourage
`
`physicians and healthcare providers to administer generic lurasidone hydrochloride in order to
`
`treat, inter alia, schizophrenia and manic depressive psychosis, without the patient experiencing
`
`clinically significant weight gain.
`
`67.
`
`On information and belief, the Proposed Macleods Label will induce and
`
`contribute to the direct infringement of the ’827 patent by encouraging physicians and healthcare
`
`providers to administer generic lurasidone hydrochloride in order to treat, inter alia,
`
`16
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 17 of 28 PageID: 17
`
`schizophrenia and manic depressive psychosis, without the patient experiencing clinically
`
`significant weight gain.
`
`68.
`
`On information and belief, such administration will directly infringe the ’827
`
`patent’s claims.
`
`69.
`
`On information and belief, Macleods became aware of the ’794 patent no later
`
`than when it was issued by the Patent Office and/or listed in the Orange Book as covering the
`
`approved formulation of Latuda®.
`
`70.
`
`On information and belief, Macleods’s Proposed ANDA Product will directly
`
`infringe one or more claims of the ’794 patent either literally or under the doctrine of
`
`equivalents.
`
`71.
`
`On information and belief, following approval of ANDA No. 212124, Macleods
`
`will sell its approved generic version of Plaintiffs’ Latuda® tablets (20 mg, 40 mg, 60 mg, 80
`
`mg, and 120 mg) throughout the United States, including in New Jersey.
`
`72.
`
`Since receiving Macleods’s Notice Letter, Plaintiffs have attempted to procure a
`
`copy of ANDA No. 212124 from Macleods. Because the terms of the proposed Offer for
`
`Confidential Access would not allow Plaintiffs to meaningfully process the information
`
`contained in the ANDA, Plaintiffs could not agree to the terms of the original Offer. On August
`
`31, counsel for Plaintiffs sent Macleods’s counsel a letter in an attempt to negotiate Plaintiffs’
`
`access to ANDA No. 212124. To date, Macleods has not responded and an agreement could not
`
`be reached prior to the expiry of the period set forth in 21 U.S.C. § 355(j)(5)(B)(iii).
`
`73.
`
`Plaintiffs are not aware of any other means for obtaining information regarding
`
`Macleods’s proposed lurasidone hydrochloride tablets 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.
`
`In the absence of such information, Plaintiffs resort to the judicial process and the aid of
`
`17
`
`

`

`Case 2:18-cv-13833 Document 1 Filed 09/12/18 Page 18 of