Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 1 of 114 PageID: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`CURIA IP HOLDINGS, LLC,
`
`Plaintiff,
`
`
`
`v.
`
`SALIX PHARMACEUTICALS, LTD.; SALIX
`PHARMACEUTICALS, INC.; BAUSCH
`HEALTH COMPANIES INC.; ALFASIGMA
`S.P.A.; ALFASIGMA USA, INC.,
`
`
`
` Defendants.
`
` Civil Action No. 21-19293
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Curia IP Holdings, LLC (“Curia” or “Plaintiff”), for its Complaint against
`
`
`
`
`
`Defendants Salix Pharmaceuticals, Ltd. (“Salix LTD”) and Salix Pharmaceuticals, Inc. (“Salix
`
`INC” collectively with Salix LTD, “Salix”), Bausch Health Companies Inc., (“Bausch Health”),
`
`and Alfasigma S.p.A. and Alfasigma USA, Inc. (collectively, or each on its own, “Alfasigma”)
`
`(Alfasigma collectively with Salix and Bausch Health, “Defendants”), hereby alleges as follows:
`
`INTRODUCTION
`
`1.
`
`Curia brings this civil action for patent infringement under the Patent Laws of the
`
`United States, 35 U.S.C. § 1 et seq., including 35 U.S.C. §§ 271, 281-85 based on Defendants’
`
`infringement of Curia’s intellectual property relating to mixtures of alpha (“α”) and beta (“β”)
`
`polymorphic forms of the compound rifaximin.
`
`THE PARTIES
`
`2.
`
`Curia is a subsidiary of a global contract research and manufacturing organization
`
`that partners with pharmaceutical and biotechnology companies to improve patient outcomes and
`
`
`
`1
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 2 of 114 PageID: 2
`
`quality of life, which provides customized solutions that span drug discovery and candidate
`
`selection, drug development, analytical testing services, active pharmaceutical ingredient
`
`(“API”) development and manufacturing, and drug product development and manufacturing in
`
`support of commercialization.
`
`3.
`
`Curia is a company organized and existing under the laws of Delaware with a
`
`principal place of business at 26 Corporate Circle, Albany, New York 12203.
`
`4.
`
`On information and belief, Salix LTD is a corporation organized and existing
`
`under the laws of Delaware having its principal place of business at 400 Somerset Corporate
`
`Blvd., Bridgewater, New Jersey 08807.
`
`5.
`
`On information and belief, Salix LTD is in the business of, among other things,
`
`licensing, developing, and marketing pharmaceutical products that it distributes in the State of
`
`New Jersey and throughout the United States.
`
`6.
`
`On information and belief, Salix INC is a corporation organized and existing
`
`under the laws of California having its principal place of business at 400 Somerset Corporate
`
`Blvd., Bridgewater, New Jersey 08807.
`
`7.
`
`On information and belief, Salix INC is in the business of, among other things,
`
`licensing, developing, and marketing pharmaceutical products that it distributes in the State of
`
`New Jersey and throughout the United States.
`
`8.
`
`9.
`
`On information and belief, Salix INC is a wholly owned subsidiary of Salix LTD.
`
`On information and belief, Salix focuses on the prevention and treatment of
`
`gastrointestinal diseases and disorders and is a wholly owned subsidiary of Bausch Health.
`
`10.
`
`On information and belief, Bausch Health is a company organized and existing
`
`under the laws of Canada having its international headquarters at 2150 St. Elzéar Blvd. West,
`
`
`
`2
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 3 of 114 PageID: 3
`
`Laval, Quebec H7L 4A8, Canada and its U.S. headquarters at 400 Somerset Corporate Blvd.,
`
`Bridgewater, NJ 08807.
`
`11.
`
`On information and belief, Bausch Health is in the business of, among other
`
`things, developing, manufacturing, and marketing pharmaceutical products that it distributes in
`
`the State of New Jersey and throughout the United States.
`
`12.
`
`On information and belief, Alfasigma S.p.A. is a corporation organized and
`
`existing under the laws of Italy having its international headquarters at Via Ragazzi del ’99, 5
`
`Bologna, Italy.
`
`13.
`
`On information and belief, Alfasigma S.p.A. is in the business of, among other
`
`things, developing, manufacturing, and marketing pharmaceutical products that are distributed in
`
`the State of New Jersey and throughout the United States.
`
`14.
`
`On information and belief, Alfasigma USA, Inc. is a corporation organized and
`
`existing under the laws of Delaware and having offices at 550 Hills Drive, Suite 110,
`
`Bedminster, NJ 07921.
`
`15.
`
`On information and belief, Alfasigma USA, Inc. is in the business of, among
`
`other things, developing, manufacturing, and marketing pharmaceutical products that are
`
`distributed in the State of New Jersey and throughout the United States.
`
`16.
`
`On information and belief Alfasigma USA, Inc. is a wholly owned subsidiary of
`
`Alfasigma S.p.A.
`
`JURISDICTION AND VENUE
`
`17.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a).
`
`18.
`
`On information and belief, this Court has personal jurisdiction over Salix LTD,
`
`under the New Jersey state long arm statute and consistent with due process of law, by virtue of
`
`
`
`3
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 4 of 114 PageID: 4
`
`the fact that, inter alia, it maintains a presence in New Jersey, it regularly does or solicits
`
`business in New Jersey, it has continuous and systematic contacts with New Jersey relating to the
`
`subject matter of this action, it derives substantial revenue from services or things used or
`
`consumed in New Jersey, it has committed, aided, abetted, contributed to, and/or participated in
`
`the commission of a tortious act of patent infringement under 35 U.S.C. § 271(a)-(c) that has led
`
`and/or will lead to foreseeable harm and injury to Curia in the State of New Jersey, and
`
`throughout the United States.
`
`19.
`
`On information and belief, Salix LTD purposefully has conducted and continues
`
`to conduct business in New Jersey by manufacturing, importing, marketing, and distributing
`
`pharmaceutical products, either by itself or through its parent corporation, subsidiaries, and/or
`
`affiliates, throughout the United States, including in New Jersey.
`
`20.
`
`On information and belief, this Court has personal jurisdiction over Salix INC
`
`under the New Jersey state long arm statute and consistent with due process of law, by virtue of
`
`the fact that, inter alia, it maintains a presence in New Jersey, it regularly does or solicits
`
`business in New Jersey, it has continuous and systematic contacts with New Jersey relating to the
`
`subject matter of this action, it derives substantial revenue from services or things used or
`
`consumed in New Jersey, it has committed, aided, abetted, contributed to, and/or participated in
`
`the commission of a tortious act of patent infringement under 35 U.S.C. § 271(a)-(c) that has led
`
`and/or will lead to foreseeable harm and injury to Curia in the State of New Jersey, and
`
`throughout the United States.
`
`21.
`
`On information and belief, Salix INC purposefully has conducted and continues to
`
`conduct business in New Jersey by manufacturing, importing, marketing, and distributing
`
`pharmaceutical products, either by itself or through its parent corporation, subsidiaries, and/or
`
`
`
`4
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 5 of 114 PageID: 5
`
`affiliates, throughout the United States, including in New Jersey.
`
`22.
`
`On information and belief, Salix INC is 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 Number 5004435).
`
`23.
`
`On information and belief, this Court has personal jurisdiction over Bausch
`
`Health under the New Jersey state long arm statute and consistent with due process of law, by
`
`virtue of the fact that, inter alia, it maintains a presence in New Jersey, it regularly does or
`
`solicits business in New Jersey, it has continuous and systematic contacts with New Jersey
`
`relating to the subject matter of this action, it derives substantial revenue from services or things
`
`used or consumed in New Jersey, it has committed, aided, abetted, contributed to, and/or
`
`participated in the commission of a tortious act of patent infringement under 35 U.S.C. § 271(a)-
`
`(c) that has led and/or will lead to foreseeable harm and injury to Curia in the State of New
`
`Jersey, and throughout the United States.
`
`24.
`
`On information and belief, Bausch Health purposefully has conducted and
`
`continues to conduct business in New Jersey by manufacturing, importing, marketing, and
`
`distributing pharmaceutical products, either by itself or through its parent corporation,
`
`subsidiaries, and/or affiliates, throughout the United States, including in New Jersey.
`
`25.
`
`On information and belief, this Court has personal jurisdiction over Alfasigma
`
`under the New Jersey state long arm statute and consistent with due process of law, by virtue of
`
`the fact that, inter alia, it maintains a presence in New Jersey, it regularly does or solicits
`
`business in New Jersey, it has continuous and systematic contacts with New Jersey relating to the
`
`subject matter of this action, it derives substantial revenue from services or things used or
`
`consumed in New Jersey, it has committed, aided, abetted, induced, contributed to, and/or
`
`
`
`5
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 6 of 114 PageID: 6
`
`participated in the commission of a tortious act of patent infringement under 35 U.S.C. § 271(a)-
`
`(c) that has led and/or will lead to foreseeable harm and injury to Curia in the State of New
`
`Jersey, and throughout the United States.
`
`26.
`
`On information and belief, Alfasigma purposefully has conducted and continues
`
`to conduct business in New Jersey by manufacturing, importing, marketing, and distributing
`
`pharmaceutical products, either by itself or through its parent corporation, subsidiaries, and/or
`
`affiliates, throughout the United States, including in New Jersey.
`
`27.
`
`On information and belief, Alfasigma USA Inc. is 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 Number 5005131).
`
`28.
`
`This Court has personal jurisdiction over Salix and Alfasigma by virtue of the fact
`
`that Salix and Alfasigma have previously submitted to the jurisdiction of this Court and availed
`
`itself of this Court by filing actions in this jurisdiction. See, e.g., Salix Pharmaceuticals. Ltd.,
`
`Salix Pharmaceuticals, Inc., Bausch Health Ireland Ltd., and Alfasigma S.p.A. v. Sandoz, Inc.,
`
`Civil Action No. 19-18566-MG-TJB (D.N.J.).
`
`29.
`
`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b).
`
`FACTUAL BACKGROUND
`
`Rifaximin and XIFAXAN®
`
`30.
`
`Rifaximin is a rifamycin-based antibiotic that has a broad spectrum of
`
`antibacterial activity against Gram-positive and -negative, aerobic and anaerobic bacteria.
`
`31.
`
`On information and belief, rifaximin was discovered and patented in or around
`
`1980 by an Italian company known as Alfa Wassermann S.p.A. On information and belief, Alfa
`
`Wassermann became Alfasigma in 2015 following a company merger.
`
`
`
`6
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 7 of 114 PageID: 7
`
`32.
`
`On information and belief, rifaximin was first approved for sale in Italy in or
`
`around 1987 and Alfasigma sold rifaximin as Normix® on the Italian market. On information
`
`and belief, at that time, polymorphism of rifaximin was unknown.
`
`33.
`
`On information and belief, Alfasigma sold rifaximin or granted licenses
`
`permitting the sale of rifaximin in other countries worldwide for the treatment of gastrointestinal
`
`diseases. On information and belief, Alfasigma and Salix entered into a license agreement in or
`
`around 1996 whereby Alfasigma licensed to Salix the exclusive rights to make, use and sell
`
`rifaximin in the United States and Canada for the treatment of gastrointestinal and respiratory
`
`tract diseases.
`
`34.
`
`On information and belief, Alfasigma and Salix also entered into a supply
`
`agreement in 1996 whereby Alfasigma supplied Salix with bulk rifaximin.
`
`35.
`
`On information and belief, Salix has been selling a 200 mg dose of a prescription
`
`antibiotic under the tradename XIFAXAN® containing rifaximin as the API in the United States
`
`since July 2004. On information and belief, Salix has also been selling a 550 mg dose of
`
`XIFAXAN® in the United States since May 2010. On information and belief, Alfasigma is and
`
`has been aware that XIFAXAN® contains rifaximin that Alfasigma licensed or supplied to Salix.
`
`36.
`
`XIFAXAN® has been approved by the United States Food and Drug
`
`Administration (“FDA”) and is indicated for the reduction in risk of overt hepatic
`
`encephalopathy recurrence and treatment of irritable bowel syndrome with diarrhea in adults.
`
`XIFAXAN® is also indicated for the treatment of traveler’s diarrhea in adults and pediatric
`
`patients 12 years of age and older.
`
`37.
`
`Since in or about 1987, the FDA has required a New Drug Application
`
`sponsor/applicant, like Salix, to search for crystalline forms of the API during the drug approval
`
`
`
`7
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 8 of 114 PageID: 8
`
`process. (FDA, Guideline for Submitting Supporting Documentation In Drug Applications For
`
`the Manufacture of Drug Substances (“FDA 1987 Guidance”) at 34 (“[a]ppropriate analytical
`
`procedures should be used to determine whether (or not) polymorphism occurs.”).) The FDA
`
`1987 Guidance further requires that information be provided to the FDA that ensures that “a
`
`change in solid-state form does not occur when the drug substance is manufactured and stored
`
`according to the NDA directions.” (FDA 1987 Guidance at 33.)
`
`38.
`
`On information and belief, various research and studies published in 2003-2006
`
`revealed the existence of different polymorphic forms of rifaximin, including the α, β, gamma
`
`(“γ”), delta (“δ”), and epsilon (“ε”) forms and that the addition of moisture can convert the α
`
`polymorph into the β polymorph.
`
`39.
`
`The FDA issued further guidance in or about July 2007 titled, Draft Guidance for
`
`Industry, ANDAs: Pharmaceutical Solid Polymorphism (“FDA 2007 Guidance”), emphasizing
`
`the importance of pharmaceutical solid polymorphism and stating that “polymorphism can affect
`
`the quality, safety, and efficacy of the drug product” (FDA 2007 Guidance at 2) and that “issues
`
`relating to polymorphic forms may be relevant to new drug applications (NDAs) ….” (FDA
`
`2007 Guidance at 1, n. 2.)
`
`40.
`
`On information and belief, studies comparing the therapeutic effects of different
`
`rifaximin formulations, and a decision from the Milan District Court in Italy in 2014, confirmed
`
`that Normix® and other rifaximin formulations marketed by Alfasigma under other trade names
`
`contained only the α form of rifaximin. (See e.g., Blandizzi et al., “Is generic rifaximin still a
`
`poorly absorbed antibiotic? A comparison of branded and generic formulations in healthy
`
`volunteers.” Pharmacological Research 85 (2014) 39–44 at Abstract; Blandizzi et al. “Impact of
`
`crystal polymorphism on the systemic bioavailability of rifaximin, an antibiotic acting locally in
`
`
`
`8
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 9 of 114 PageID: 9
`
`the gastrointestinal tract, in healthy volunteers,” Drug Design, Development and Therapy 2015:9
`
`at 2).
`
`41.
`
`On information and belief, Norgine Pty Ltd., another licensee of Alfasigma’s
`
`rifaximin, represented to the Australian regulatory agency in 2012 that “[i]n clinical trials
`
`conducted since the existence of polymorphism was discovered, the drug has always been used
`
`as the alpha form. Evidence has been provided that the alpha form does not convert into other
`
`polymorphic forms during manufacture or storage of Xifaxan tablets.” See, e.g., November 2012
`
`Australian Public Assessment Report for Rifaximin at 9-10.
`
`42.
`
`On information and belief, when manufactured, the XIFAXAN® product which
`
`incorporates the rifaximin that Alfasigma licensed and/or sold to Salix also contains only the α
`
`form of rifaximin. On information and belief, prior to at least 2017, Salix has represented to the
`
`FDA that XIFAXAN® contains only a single, α, polymorph of rifaximin and the rifaximin
`
`contained in XIFAXAN® does not convert to another polymorph, such that a product having the
`
`same active ingredient as XIFAXAN® should have “the same polymorph of rifaximin.” See, e.g.,
`
`Salix Citizen Petition, May 14, 2008, p.2, fn. 2.
`
`Curia’s Rifaximin Development
`
`43.
`
`In 2016, Curia’s predecessor, Albany Molecular Research, Inc., completed the
`
`acquisition of Prime European Therapeuticals S.p.A f/k/a Euticals S.p.A (“Euticals”), an Italian
`
`chemical company that developed and supplied API to pharmaceutical companies. Under the
`
`terms of the acquisition, Curia has the ability to enforce Euticals’ intellectual property and
`
`technology rights, including the rights related to Euticals’ prior work on rifaximin.
`
`44.
`
`In April 2012, Euticals was approached with a proposal to develop an amorphous
`
`form of rifaximin. At that time, on information and belief, no company had yet filed an
`
`Abbreviated New Drug Application (“ANDA”) seeking approval to market generic rifaximin in
`
`
`
`9
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 10 of 114 PageID: 10
`
`the United States. This made developing another form of rifaximin an attractive commercial
`
`activity and an opportunity that was time sensitive because of the advantage of being the first-to-
`
`file an ANDA with the FDA seeking approval of a generic product.
`
`45.
`
`By May 2012, Euticals had found a potential customer in the United States for
`
`rifaximin.
`
`46.
`
`During Euticals’s review of the information available on rifaximin, Euticals
`
`understood that the α and β forms of rifaximin had low bioavailability, whereas, in contrast, the γ
`
`and amorphous forms, were known to have a higher bioavailability.
`
`47.
`
`Believing that a mixture of α and β forms would be more desirable than the
`
`amorphous form, Euticals worked to instead develop a mixture of α and β polymorphs of
`
`rifaximin.
`
`Curia’s Patents
`
`48.
`
`In conjunction with Euticals’s research and development of the mixture of α and β
`
`forms for rifaximin, several patent applications were submitted to the United States Patent and
`
`Trademark Office (“USPTO”).
`
`49.
`
`On November 17, 2015, the USPTO issued U. S. Patent No. 9,186,355 (the “’355
`
`patent”), entitled “Rifaximin Crystalline Forms And Methods Of Preparation Thereof” from
`
`United States patent application number 14/673,297 that claims priority to provisional
`
`application number 61/858,884 filed on July 26, 2013. Independent claim 1 of the ’355 patent
`
`recites: “A rifaximin composition comprising mixed crystalline polymorphs rifaximin α and
`
`rifaximin β containing about 3-12% (w/w) of the rifaximin β crystalline polymorph in mixture
`
`with a remaining percentage of the rifaximin α crystalline polymorph and from about 2% to
`
`about 5% by weight water relative to the weight of the total composition wherein the aqueous
`
`dissolution rates of the α and β forms provide a fast acting portion and a slow acting portion of
`
`
`
`10
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 11 of 114 PageID: 11
`
`rifaximin antibiotic.” Dependent claims 2-9 of the ’355 patent depend directly or indirectly from
`
`claim 1. The ’355 patent is currently assigned to and owned by Curia. A true and correct copy
`
`of the ’355 patent is attached as Exhibit A.
`
`50.
`
`On February 11, 2020, the USPTO issued U. S. Patent No. 10,556,915 (the “’915
`
`patent”), entitled “Polymorphic Mixture of Rifaximin and its Use for the Preparation of Solid
`
`Formulations” from United States patent application number 15/300,879 that claims priority to
`
`European patent application number 14162587 filed on March 31, 2014. Independent claim 1 of
`
`the ’915 patent recites: “A Rifaximin polymorphic mixture of α/β form in a relative ratio of
`
`85/15±3, characterized by an X-Ray spectrum with characteristic 2theta values at (relative
`
`intensity): 5.32 (11%), 5.78 (19%), 6.50 (27%), 7.24 (45%), 7.82 (61%), 8.80 (100%), 10.50
`
`(59%), 11.02 (35%), 11.58 (32%), 13.08 (20%), 14.42 (26%), 17.32 (48%), 17.68 (93%), 18.58
`
`(79%), 19.52 (61%), 21.04 (52%), 21.60 (30%), and 21.92 (46%).” Dependent claims 2-3 of the
`
`’915 patent depend from claim 1. Independent claim 4 requires the same “characteristic 2theta
`
`values at (relative intensity)” as claim 1 but further requires that the claimed rifaximin
`
`polymorphic mixture be “produced by drying wet Rifaximin at atmospheric pressure, at a
`
`temperature between 38 and 42° C. to reach a final water content of 6±2%.” The ’915 patent is
`
`currently assigned to and owned by Curia. A true and correct copy of the ’915 patent is attached
`
`as Exhibit B.
`
`51.
`
`On August 18, 2020, the USPTO issued U. S. Patent No. 10,745,415 (the “’415
`
`patent”), entitled “Polymorphic Mixture of Rifaximin and its Use for the Preparation of Solid
`
`Formulations” from United States patent application number 16/567,852 that also claims priority
`
`to European patent application number 14162587 filed on March 31, 2014. Independent claim 1
`
`of the ’415 patent recites: “A method of treating a subject suffering from traveler’s diarrhea
`
`
`
`11
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 12 of 114 PageID: 12
`
`comprising: selecting a subject in need of treatment of traveler’s diarrhea; administering to said
`
`subject a pharmaceutical composition comprising a therapeutically effective amount of
`
`Rifaximin in an α/β polymorphic mixture of 85/15±3 in an amount sufficient to treat the
`
`traveler’s diarrhea, wherein the Rifaximin α/β polymorphic mixture is characterized by an X-Ray
`
`spectrum with characteristic 2theta values at: 5.32, 5.78, 6.50, 7.24, 7.82, 8.80, 10.50, 11.02,
`
`11.58, 13.08, 14.42, 17.32, 17.68, 18.58, 19.52, 21.04, 21.60, and 21.92.” Dependent claims 2-8
`
`of the ’415 patent depend directly or indirectly from claim 1. Independent claim 9 requires the
`
`same pharmaceutical composition but it administered for the treatment of “hepatic
`
`encephalopathy.” Dependent claims 10-16 depend directly or indirectly from claim 9. The ’415
`
`patent is currently assigned to and owned by Curia. A true and correct copy of the ’415 patent is
`
`attached as Exhibit C.
`
`52.
`
`On March 30, 2021, the USPTO issued U. S. Patent No. 10,961,257 (the “’257
`
`patent”), entitled “Polymorphic Mixture of Rifaximin and its Use for the Preparation of Solid
`
`Formulations” from United States patent application number 16/567,852 that also claims priority
`
`to European patent application number 14162587 filed on March 31, 2014. Independent claim 1
`
`of the ’257 patent recites: “A Rifaximin polymorphic mixture of α/β form in a relative ratio of
`
`85/15±3, characterized by an X-Ray spectrum with characteristic 2theta values at: 5.32, 5.78,
`
`6.50, 7.24, 7.82, 8.80, 10.50, 11.02, 11.58, 13.08, 14.42, 17.32, 17.68, 18.58, 19.52, 21.04, 21.60,
`
`and 21.92. Dependent claims 2-10 of the ’257 patent depend directly or indirectly from claim 1.
`
`Independent claim 11 requires the same Rifaximin polymorphic mixture of claim 1 but further
`
`requires that the claimed polymorphic mixture be “produced by drying wet Rifaximin at
`
`atmospheric pressure, at a temperature between 38 and 42° C. to reach a final water content of
`
`6±2%.” The ’415 patent is currently assigned to and owned by Curia. A true and correct copy
`
`
`
`12
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 13 of 114 PageID: 13
`
`of the ’257 patent is attached as Exhibit D.
`
`53.
`
`The ’355 patent, the ’915 patent, the ’415 patent, and the ’257 patent
`
`(collectively, the “Curia Rifaximin Polymorphic Mixture Patents”) all contain claims directed to
`
`mixtures containing certain ratios of the α and β polymorphic forms of rifaximin.
`
`Polymorphic Conversion of the API in XIFAXAN®
`
`54.
`
`All XIFAXAN® manufactured since November 17, 2015 and sold in the United
`
`States shall hereinafter be referred to as “Salix’s XIFAXAN®.” On information and belief,
`
`Salix’s XIFAXAN® contained only the α polymorphic form of rifaximin at the time of
`
`manufacture. On information and belief, that α polymorphic form of rifaximin in Salix’s
`
`XIFAXAN® partially converts to the β polymorphic form during storage, transportation and
`
`other handling, resulting in a polymorphic mixture that falls within the scope of the claims of the
`
`Curia Rifaximin Polymorphic Mixture Patents.
`
`55.
`
`On information and belief, Defendants each have known since about 2015 that the
`
`α polymorphic form of rifaximin that Alfasigma licensed to Salix to include in Salix’s
`
`XIFAXAN® partially converts to the β polymorphic form during storage, transportation, or other
`
`handling, resulting in a polymorphic mixture that falls within the scope of the claims of the Curia
`
`Rifaximin Polymorphic Mixture Patents.
`
`56.
`
`On information and belief, Defendants each have known of the Curia Rifaximin
`
`Polymorphic Mixture Patents at least since in or about 2015 because Alfasigma filed a Notice of
`
`Opposition (“EP opposition”) to Curia’s European counterpart patent EP 2,927,235 (“EP ’235”)
`
`titled “Polymorphic mixture of rifaximin and its use for the preparation of solid formulations” on
`
`or about November 8, 2017. EP ’235 is a family member of the ’915, ’415, and ’257 patents.
`
`57.
`
`On information and belief, Defendants each have known about one or more of the
`
`Curia Rifaximin Polymorphic Mixture Patents but have knowingly continued to sell Salix’s
`
`
`
`13
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 14 of 114 PageID: 14
`
`XIFAXAN® which contains a mixture of the α and β forms of rifaximin.
`
`58.
`
`On information and belief, Salix’s XIFAXAN® or Defendants, at least by selling
`
`Salix’s XIFAXAN®, have infringed and will continue to infringe one or more claims of the Curia
`
`Rifaximin Polymorphic Mixture Patents, as set forth in detail below.
`
`COUNT ONE
`
`(Patent Infringement, ’355 patent)
`
`59.
`
`Curia re-alleges and incorporates by reference the allegations contained in the
`
`preceding paragraphs 1-58 of this Complaint as if stated in their entirety herein, and incorporates
`
`them herein by reference.
`
`60.
`
`The sale of Salix’s XIFAXAN® tablets have infringed and continue to infringe
`
`one or more claims of the ’355 patent, in violation of 35 U.S.C. § 271(a).
`
`61.
`
`Salix’s XIFAXAN® 200 mg and 550 mg tablets and/or related products and
`
`dosage forms fell and continues to fall within the scope of one or more claims of the ’355 patent.
`
`62.
`
`Salix’s XIFAXAN® infringed and continues to infringe one or more claims of the
`
`’355 patent literally and/or under the doctrine of equivalents, by, among other things, making,
`
`using, offering for sale, selling, and/or importing within this judicial district and elsewhere in the
`
`United States, without license or authority.
`
`63.
`
`Defendants’ manufacture, use, sale, offer for sale, or importation of Salix’s
`
`XIFAXAN® in accordance with, and as directed by, its product labeling has infringed and
`
`continues to infringe one or more claims of the ’355 patent.
`
`64.
`
`Alfasigma has infringed and continues to infringe the ’355 patent in violation of
`
`35 U.S.C. § 271(c) by contributing to infringement of the ’355 patent, literally and/or under the
`
`doctrine of equivalents, by, among other things, selling, offering for sale, and/or importing
`
`within this judicial district and elsewhere in the United States, without license or authority,
`
`
`
`14
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 15 of 114 PageID: 15
`
`rifaximin that is incorporated into Salix’s XIFAXAN® that upon storage, transportation or other
`
`handling falls within the scope of one or more claims of the ’355 patent, with knowledge of the
`
`’355 patent and knowing that the rifaximin incorporated into Salix’s XIFAXAN® are especially
`
`made or especially adapted for use in the infringement of the ’355 patent, and not staple articles
`
`or commodities of commerce suitable for substantial noninfringing use.
`
`65.
`
`Defendants became aware of the existence of the ’355 patent on or after its
`
`issuance date of November 17, 2015. Defendants have willfully continued to make, use, offer
`
`for sale, sell, or import rifaximin and/or Salix’s XIFAXAN® or contribute thereto and intends to
`
`continue those acts.
`
`66.
`
`Defendants’ infringement of the ’355 patent has been and continues to be willful
`
`and deliberate. Defendants, with knowledge of the ’355 patent and its infringement, engaged in
`
`and continues to engage in objectively reckless conduct by selling and continuing to sell
`
`infringing products or contributing thereto in the face of an objectively high risk that Defendants,
`
`alone or together, were infringing Curia’s valid ’355 patent.
`
`67.
`
`Curia has suffered irreparable injury as a direct and proximate result of
`
`Defendants’ infringement for which there is no adequate remedy at law. Unless Defendant is
`
`enjoined, Curia will continue to suffer such irreparable injury as a direct and proximate result of
`
`Defendants’ conduct.
`
`COUNT TWO
`
`(Patent Infringement, ’915 patent)
`
`
`
`68.
`
`Curia re-alleges and incorporates by reference the allegations contained in the
`
`preceding paragraphs 1-67 of this Complaint as if stated in their entirety herein, and incorporates
`
`them herein by reference.
`
`
`
`15
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 16 of 114 PageID: 16
`
`69.
`
`Salix’s XIFAXAN® tablets have infringed and continue to infringe one or more
`
`claims of the ’915 patent, in violation of 35 U.S.C. § 271(a).
`
`70.
`
`Salix’s XIFAXAN® 200 mg and 550 mg tablets and/or related products and
`
`dosage forms fell and continues to fall within the scope of one or more claims of the ’915 patent.
`
`71.
`
`Salix’s XIFAXAN® infringed and continues to infringe one or more claims of the
`
`‘915 patent literally and/or under the doctrine of equivalents, by, among other things, making,
`
`using, offering for sale, selling, and/or importing within this judicial district and elsewhere in the
`
`United States, without license or authority.
`
`72.
`
`Defendants’ manufacture, use, sale, offer for sale, or importation of Salix’s
`
`XIFAXAN® in accordance with, and as directed by, its product labeling has infringed and
`
`continues to infringe one or more claims of the ’915 patent.
`
`73.
`
`Alfasigma has infringed and continues to infringe the ’915 patent in violation of
`
`35 U.S.C. § 271(c) by contributing to infringement of the ’915 patent, literally and/or under the
`
`doctrine of equivalents, by, among other things, selling, offering for sale, and/or importing
`
`within this judicial district and elsewhere in the United States, without license or authority,
`
`rifaximin that is incorporated into Salix’s XIFAXAN® that upon storage, transportation or other
`
`handling falls within the scope of one or more claims of the ’915 patent, with knowledge of the
`
`’915 patent and knowing that the rifaximin incorporated into Salix’s XIFAXAN® are especially
`
`made or especially adapted for use in the infringement of the ’915 patent, and not staple articles
`
`or commodities of commerce suitable for substantial noninfringing use.
`
`74.
`
`Defendants became aware of the existence of the ’915 patent on or after its
`
`issuance date of February 11, 2020. Defendants have willfully continued to make, use, offer for
`
`sale, sell or import rifaximin and/or Salix’s XIFAXAN® or contribute thereto and intends to
`
`
`
`16
`
`

`

`Case 2:21-cv-19293-ES-MAH Document 1 Filed 10/25/21 Page 17 of 114 PageID: 17
`
`continue those acts.
`
`75.
`
`Defendants’ infringement of the ’915 patent has been and continues to be willful
`
`and deliberate. Defendants, with knowledge of the ’915 patent and its infringement, engaged in
`
`and continue to engage in objectively reckless conduct by selling and continuing to sell
`
`infringing products or contributing thereto in the face of an objectively high risk that Defendants,
`
`alone or together, were infringing Curia’s valid ’915 patent.
`
`76.
`
`Curia has suffered irreparable injury as a direct and proximate result of
`
`Defendants’ infringement for which there is no adequate remedy