IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA STATE OF WISCONSIN By Attomey General Brad D. Schimel STATE OF ALABAMA, STATE OF ALASKA, STATE OF ARKANSAS STATE OF CALIFORNIA STATE OF COLORADO. DISTRICT OF COLUMBIA STATE OF CONNECTICUT STATE OF DELAWARE STATE OF FLORIDA, STATE OF HAWAIL STATE OF ILLINOIS STATE OF IOWA STATE OF KANSAS COMMONWEALTH OF KENTUCKY STATE OF LOUISIANA, STATE OF MAINE STATE OF MARYLAND (COMMONWEALTH OF MASSACHUSETTS STATE OF MICHIGAN STATE OF MINNESOTA, ‘STATE OF MISSISSIPPI STATE OF MISSOURI STATE OF NEBRASKA STATE OF NEW YORK STATE OF NORTH CAROLINA STATE OF 1110 ‘STATE OF OKLAHOMA. ‘COMMONWEALTH OF PENNSYLVANIA STATE OF RHODE ISLAND STATE OF SOUTH CAROLINA ‘STATE OF TENNESSEE, STATE OF UTAH STATE OF VERMONT COMMONWEALTH OF VIRGINIA STATE OF WASHINGTON Plaintiff, INDIVIOR INC. fa RECKITT BENCKISER PHARMACEUTICALS, INC.; RECKTTTBENCKISER HEALTHCARE (UK) LTD INDIVIOR PLC, fis RECKITT No, BENCKISER GROUP ple; and - MONOSOL RX, LLC Defendants comp] ‘The States of Wisconsin, Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, Floride, Hawaii, Hlinois, Jows, Kansas, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebrasks, New York, North Carolina, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Washington, the Commonwealths of Kentucky, Massachusetts, Pennsylvania, and Virgini, and the District of Columbia, by their Attomeys General, (collectively “Plaintiff States”), complain aguinst Defendants Indivior Inc., ‘kia Reckitt Benckiser Pharmaceuticals, Inc; Reckitt Benckiser Healtheare (UK) LTD.; and Indivior PLC, fia Reckitt Benckiser Group, ple (collectively “Reckitt” or “Reckitt Defendants”); and MonoSol Rx, LLC (“MonoSol” ) as follows: Action 1. Pitt States bring tis ation wih respect tothe prescription dug Suboxone ® Suboxone”) and its generic equivalent, covormulntd buprenorphine hydrochloride and naloxone hydrochloride dehydrate 'co-oamult bysihinlaalonsne”), 2, Covfurulstedbuprenorphinenloxone i combination deve prodet consisting of wo active phannacutcalingrdionts hata wed togetber us an opioid replacement therapy for the wealment of opioid dependency (eg, heroin adéicton). Defendants re engaged in the manufacture or sle of e0-formulated buprenorphine/naloxone under the brand-name Suboxone,Plaintiff States allege that Defendants employed an unlawful, multi-pronged scheme designed to prevent o delay less expensive generic version of Suboxone fom entering tne market to preserve their monopoly profits ftom the sale of Suboxone, The scheme ince product hopping, unfounded allegutions of safety issues with the Tabet form of Suboxone, intentional delays involving the U'S. Food and Drug Administation’s (he “FDA") requirement ofa Risk Balution and Miigaton Ststepy CREM", and filing a shar Citizen Peton to delay would-be competitors 4. Asarestof thir unawal scheme to kep generic versions of Suboxone off he ‘market, and in violation of feral and slate antitrust laws and state consumer-protetion laws, Defendants illegally maintained monopoly power in the market for co-formulated ‘uprenorphine/naloxone opioid treatments in the United States from October 8, 2009 unt ‘generic entry in March 2013, and continues to dominate the market for co-formulated Dbuprenorphine/naloxone fil, 5. Defendants’ scheme to delay generic competition intended and had the purpose of, preventing genetic substitution to Suboxone, and denying consumer choice for generic versions of Suboxone, 6. As a result of Defendants’ anticompetitive conduct, consumers and state ‘governments heve been limited in thir treatment options for opioid addiction and continue to be deprived of the benefits of generic competition while Defendants continue to reap monopoly profits from the sale of Suboxone, 7. Defendants’ conduet is deceptive and unconscionable, includes unfuir trade practices and unfair methods of competition, or is otherwise unlawful under the consumer protection lows of certain of the Plant States. Their conduct caused harm to Plaintiff States,govemmental entities, and consumers by forcing them to pay more for Suboxone than they ‘otherwise would in a competitive market and limits their options for the treatment of opi diction, 8. Consequently the Plaintiff States, by and through their Aitomeys Genera, bring this action to seek injunctive relief, penalties, and disgorgement for the Defendants’ unlawful monopolization of the market for using co-formulated buprenorphine/naloxone for treating opioid addiction. Saris Ve 9. This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1337 over the federal antitrust claims under the Sherman Act. This Court also has supplemental jurisdiction over the state law olaims under 28 ULS.C. § 1367 because those claims are so related to the federal claims that they form part of the same case or controversy. The exercise of supplemental jurisdiction avoids unnecessary duplication and multiplicity of actions and is i the interests of judicial economy, convenience, and aime. 10. Venue is proper in the Bastemn Distict of Pennsylvania under 15 U.S.C. § 22 and 28 USC. §§ 1391(b) and (e). Each Defendant transuets business or committed an illegal ot tortious actin this distict, or has an agent or ean be found in this district andthe interstate trade nd commerce, hereinafter desribed, is carried out in substantial pat inthis district. Parties 11. Defendant Indivior Ine. fkla Reckitt Benckiser Pharmaceuticals, Inc. ("Reckit”) is a Delaware corporation with its principal place of business located at 10710 Midlothian ‘Tumpike, Suite 430, Richmond, Virginia 23235, Reckitt Benckiser Pharmacesticals, Inc, was Ldemerged from its prior parent, the Reckitt Benckiser Group pl, into Indivior PLC in December2014, Indivior Ine, is @ wholly-ovmed subsidiary of Indivior PLC. Indivior In. is engaged in the development, manufacture, and sale of pharmaceuticals, including Suboxone, and health care products and services throughout the United States, and is in whole or in part responsible for some or al ofthe conduct alleged in this Complaint and ateibuted to Reckit, 12, Defendant Reckitt Benckiser Healthcare (UK) Lad, is @ British corporation incorporated under the laws of England and Wales, with its registered office located at 103-105 Bath Road, Slough, Berkshire, SLI 3UH. This defendant is engaged in the development and ‘manufacture of pharmaceutical, including Suboxone, and health care products and services mae and sold subject to FDA approval, and isin whole or in part responsible for some oral of ‘the conduet alleged in this Complaint and attributed to Reckitt. ‘This conduct inchudes but is not limited to the execution of the initial contract with Monosol Rx, LLC in December 2006 that ‘initiated the joint venture to create and manufacture Suboxone Film. 15, Defendant ndvior PLC, was formerly part of Reckitt Benckiser Group ple, and is 4 British corporation incorporated under the laws of England and Wels, with its registered ice located a 103-105 Bath Ros, Slough, Besar, St SUE. his defendant is engaged in the development, manuficture, and sale of pharmaceuticals, ncusing Suboxone, end het cre products and services thoughout the United States, end is in whole or in part responsible for some oral ofthe cond allege inthis Complaint and stsbuted to Reckit, Indvior PLC is ‘he succesor in intrest to Reckitt Benckiser Group ple. The Bowed of Diretors of Indivior PLC's pedecestor,Recit Benckiser Group ple, wee advised ofthe genere-impatring purpose ‘of and anticompetitive tactics related to the proguc-hoppng alleged herein and approved the scheme and its purposes. Uness identified individually, Invi In. and Indivior PLC are collectively referred to as “Reckitt”14, Defendant MonoSol Rx, LLC is a Delaware limited liability company with its principal place of business located at 6560 Melton Road, Portage, Indiana, 46368. This defendant is engaged in the development, manufacture, and sale of pharmaceuticals and health ‘whole or in part responsible for care procs and services throughout the United Sates, and some oral ofthe conuct alleged in this Complaint and atvbuted to MonoSol 15, Reckit’s actions desetibed in ths Complain are pat, and in Futerance ofthe ‘legal monopoization, attempted monopotization and unter and decaptive trade practices alleged beren, All ations described herein were authorize, ordered, o performed by Reekit's various offices, agents, employees of olier representatives while actively engnged in the management of Reckit’s fir, or that oftheir predesesors-n-intees, within the course and scope oftheir ties and employment, nd with the sot, apres and ostensible authority of Recht 16, MonoSo’s ation dsesibd inthis Complaint are pat and in urthecane of the legal monopoliztion, attempted monopoization and unfir and deceptive trade practices alleged borin. AU actions desrbed ercin were authorized, ordered, or performed by ‘MonoSol's various officers, agents, employees or other representatives while atively engaged in the management of MonoSat' afr, or tat oftheir predecessors-ininterest, within the cour and scope of thee duties and employment, and wit the atu, apparent, and ostensible sutorty of MonoSol. 17, Each ofthe Plaintiff States and citizens residing therein purchased or provided reimbursement for Suboxone Film and Suboxone Tablets at supa-competitve prices as a result ‘of Defendants’ conduct alleged herein.18, Phin Sutes bring his ation, by and through their Atomneys Genera, in their sovercign caput to enforce their ovm laws and in ther quasi-soveregn capac to protest the economic well-being of the States and thei residents in their law enforcement andlor a civil law enforcement ation fom the harm that soversign or quasisovereign capac results frm the violations of antrst end consumer protection avs. ‘Relevant Market 19, ‘The elovant product market i any drug with co-ormulated ‘naprenorphins/aloxone asthe ative ingredients forthe treatment of opioid addition. There re so fbasible substtues for eo-fomulted buprenorphinlnaloxone in the pharuacoogicl interetion of opioid dependence, This mute! ineludes Suboxone Film and Tablets and any [AB-rated goneres hat canbe substituted for them 20. Suboxone Tablets and Suboxone Film do not exhibit significa, postive peice ous clantsty of demand with any opioid dependence treatment or oer product other tan AB- rated genet versions of bunrenrphinenalxone abet. Suboxone is categorized a a schedule 1 drug and co-formuleted with an opioid antagonist to deter abuse, Until 2012, Suboxone was the only replacement maintenance therapy that could be presiribed in an office setting and taken ty patents at home. By contrast, Methadone, i # Schedule Tl dug and must be admired in 4 ctinie, Subutes, another opioid tresimentdrvg marketed by Recht isnot interchangable testuse ft Jocks maloxone, the opioid antagonist tht deter abuse, Zabsolv (a generic ‘nuprenorpine/loxone table) and Bunavail (generic buprenorphinenaloxone fim) entexed the mask aftr generic Suboxone Tablets. Zabsolv and Bunavail are not AB-rated to the Film oe Tobe 21. —‘Therelevant geographic market is the United States and is teritores22. Before October 8, 2009, Suboxone was the only co-fonmulated ‘buprenorphina/aaloxone opioid treatment because of its orphan drug status, so Reckitt enjoyed 100% market share in the United States and territories. After the exclusivity period expired, Reckitt’ branded Suboxone products, including the Suboxone Film it introduced in September 2010, remained the sole source of co-formulsted buprenosphine!naloxone until two generic ‘manufacturers introduced generic tablets in March, 2013. An additional generic tablet ‘manufacturer was approved ia September, 2016. When Suboxone-branded Tablets and Film ‘were sold alongside one another, Reckitt successfully converted most of the Suboxone market to ite Film, for which there are no generic substitutes. After the introduction of the two generic tablet products ia 2013, Reckit’s market share for co-formulated buprenorpbinc/naloxone dropped to 68 percent ‘Trade and Commerce 23, Since 2002, Reckitt has sold Suboxone in interstate commerce throughout the United States, 24, Reckitt sold Suboxone in interstate commerce in each of the States. Reckitt's ‘unlawful activities alloged in this Complaint occurred in and had 2 substantial effest upon interstate commerce, According to Reckitt’s ovm annual reports, Reckitt’s revenues for ‘Suboxone sold in the United States surpassed $2 billion, 25, MonoSol entered into sores of agreements with Reckitt beginning in 2006, for the development and manufacture of Suboxone Film. Mono$ol manufactures all Suboxone Film sold in interstate commerce in each ofthe States, MonoSol’s unlawful activities alleged inthis Complaint have occurred in and have had a substantia effect on interstate commerce. MonoSol hans received fixed payments as well as royalties associated with the sales of Suboxone:ual Background 1. Generie Drug Approval Process 26, The manufacture and commercial sale of phaemsceuticl drugs ere regulated by the FDA under the Federal Food, Drug, and Cosmetic Act, 21 US.C. §301 et soq. The manufacturer of a new drug must submit a new drug gpliation NDA") that demonstrates, among other things, a drug's safety, clinically proven effectvensss, composition, and patent coverage 21. To speed the eniry of generic drugs and to facilitate price competition with branded drugs, Congress passe the Drug Price Competition and Patent Term Restoration Act of 1984 (he “Hatch-Wexman Act), Under the Hatch-Waxman Act, genetic dug manufacturers ‘may receive FDA approval for gonerc drugs without replicating the costly and tin-consuming linia ras involved in an NDA. 28, Instead of submiting an NDA, a gevetic drug manufacturer may submit an abbreviated new drug application “ANDA”) and incorporate data such os clinical studies, that {he NDA filer submited tothe FDA. 29. ‘To be approved, an ANDA must demonsrate thatthe gener drug: () as the same active ingredients as; Q) is pharmaceutically equivalent to (same dosage form and strength; and (0) is bioequivaent to (exhibiting the same drug absorption charctristis) the previously approved drug. 30. Oral drags that are proven to be both pharmaceutically equivalent and bicequivalent to a branded oral drug recive an “AB” sting ftom the FDA, indicating they are therapouticlly equivalent to other drugs withthe same rating in the same catogory. In most circumstances, only oral drugs that camy the FDA"s AB generic rating in a particular eategorynay be substituted by pharmacists fora physician's presrption fora brand-name drug, without the physician’ appeova 5 31. The FDA publishes ist of al approve raps and therapeutic equivalents in the Approved Drug Produets with Therapeutic Hguivalnce valuations (commonly ered t0 38 ‘he “Orange Book"). 32, Onve the TDA approves an ANDA fo a generic drug dnd determines that its [ABerated wo the branded drug, stat laws gover how the generic may be subsite forthe rand name drug prescribed by physicians. In most States and under most health plans, a ‘hurmacst may (and often must) substiute an AB-rted generis drug fr a prescribed brad same dv TL. Suborone's Orphan Drug Designation 38, In 2002, Reckit introduced Suboxone as « sublingual tablet (‘Suboxone “Tables. At that time, the two component ingrediests of Suboxone were not mibjet to any patent protection. Naloxone was ist approved bythe FDA in 1971, and buprenorphine was Sst approved by the DA in 1982 as an njostable analgesic drug, Reet wcknowledged that it had no knowledge of ny existing patent protection for Suboxone Tablets atthe time of ts FDA application. 34. Instead of exclusivity through patent protection, Reckitts Suboxone Tablets were granted 7-year period of exclusivity as en “orphan drug” by the FDA. 35. A dnug can be designsted as an “orphan drug” when the FDA determines that cite (a) the drug is intended for the safe and effective treatment, diagnosis or prevention of & rare disease or disorder that affects fewer than 200,000 people in the United States; or (b) the disease or disorder affects greater than 200,000 people, but the manufacturer is not reasonably 10expected to recover the costs of developing and marketing the treatment dng from sles inthe United Sates 36, Reckitt argued thi ts drag Suboxone would be used forthe treatment of fewer ‘than 200,000 people but the FDA rejected tha argument. stead the FDA granted oman drug status to Suboxone Tablets base on Reckit?'s representations that t would be unikly to recover the costs of developing and marketing the drug, After designation as an orphan drug by the FDA, the FDA approves the drug for meting. tis then eligible for a peiod of omen drug regulatory exclusivity for 7 years, allowing it to be markoted asa brand-name drug. fee from scneric competition. 37. Suboxone was designated san orn drug in 19%, but was not approved for 7- year marketing exclusivity uni 2002, Rests 7-year exclusivity expire on Oxtber 8, 2009, ‘During tha ime, Reokit was able to sae soblingual tablet Suboxone without any threat of competition fom any generic co-formulatedbuprenorpinelnaloxone forthe teatient of opioid dition. 38. Although Recht soored an orphan eog designation for Suboxone Tablets onthe tnss ofa cos reovery designation, Rest quickly began earning profits on Suboxone Tables, caming sore than $2 billion by 2010. Is suoessorin interest Indvir ne. derived almost all ofits reve from the sles of Suboxone TUL, Reckit’s Produet-Hopping Scheme A. Suboxone Tabet Market Share Threatened by Generic Entry 39, As the orphan drug exclusivity period for Suboxone Tablets neard expiration, Reet knew generic manufacturers would seek FDA approval to sell lower-priced genes ‘version of eo formulated buprenorphinenaloxone indirect competition o Sboxone Tablets u40, As ABlraed generic drugs Become available, lower-priced genetic competitors axe rpily substituted for thet and-name counterparts because the Hatch-Wanmian Act and ‘most state drug product selection ls permit or require) pharmacis to substitute an AB-ated acneric drug forte branded version ules the pression i specially designated terse. 41, Manufacturers of brand-name drgs typically Yose 80 percent or more of their sales o AB-rted generic compton soon aera generic competitr etrs the market, Until an [ABuatod generic becomes FDA approved, however, a branded manufacturer may continue ta char supra-compettve prices. 42, Reokitt was concemed that generic entry would significantly reduce the company’s sles and rvenue of is Suboxone Tablets, In is wnnual reports between 2008 and 2010, Reokit stated: + “As wit all scription drugs, the protection of this business has afte tem unless replaced with new treatments of forms, Therefore, the revenue and income of this business may not be sustained going forward unless replaced with nor treatments or forms, on which the Company is stivly working” + “The Group contimies to search for ways to oft the impact of the loss of exclusivity [of Suboxone] inthe USA atthe end of September 2009, up to 0% of the revenues and profits of that business might be lost to genetic competition in 2010, withthe possibilty of futher erosion hereafter.” Lis well own that by fr the largest prt ofthe Pharnaceticas busines, the Suboxone Tablets in the USA, can bscome subject to generis competition atany time.” BR‘+ “The expiny of the Group's exclusive license for Suboxone in the United business States in 2009 and in the ofthe world in 2016 could expose to competition fom generic variants.” 49, FDA regulations allow branded manufacturers to sock FDA approval to modify the dosage form and strength ofthis exiting products. Changing the dosage form and strength of «branded drug changes its pharmaceutical equivalence and will alter the AB-tating of any proposed or available generic substitutes, Faced with the impending loss of exclusivity and selatd drops in profit B, Suboxone Film Enters the Market 46, In July 2007, Reckitt informed the FDA thet it planned to file « new drug application to mark Suboxone ina sobingv! Ft rrr48. MonoSol encouraged Reckit and olher pharmaceutical companies to en itlegal and anticompetitive produet- hopping on its website “Patient-fiendly delivery with no generie substitution” “Partneing with MonoSol Rx offers pharmaceutical companies the ability to introduce products that ate highly differentiated from other dosage forms, both in performance and marketability, cresting fresh, dynamic revenue senerating opportunities” Mock quote used in advertisement: “We launched this brand 5 years ago. wet ot just leting it go over the cif. 1's time forthe new strategy.” “Pharma formation represent rovenue-Hifeeycle extensions for products ‘ith patent lives that have expire or are approaching expiration” “if ptient-frendly delivery, patent expiry, or launching the next blockbuster json your agenda, the time is ight to consider the advantages of PharinFilm.” “eoaise Pharm is a unique, paten-potected delivery technology, it ean 1 steetegy for extending the life of a brand as generic incursion “PharmFilm drug technology allows: no generic substitution.”— itt end MonoSol’s development of the new sublingual Film was intended to arkot share by extending, Reckitt's thwart generic entry, and to maintain Suboxone’s exclusivity on a co-formalated buprenorphine!naloxone product. tent, which was issued as patent number Sl. In April 2008, MonoSol applied for a 8,017,150 entitled “Polyethylene Oxide-Rased Films and Drug Delivery Systems Made ‘Therefrom” and was listed by Reckit in the FDA’s Orange Book. and 8,603,514 52, Reckit listed the ‘150 patent a well as patent mumbers 8,475.8 in the FDA Orange Book, and alleged tht they cover Suboxone Film, The eatliest patent expires in 2023, and all ate the subject of several lawsuits brought by MonoSol and Reckitt against the many companies that sought FDA approval to make generic Suboxone Film, These patents are also the subjest of multiple inter-partes proceedings challenging their validity Reckitt and MonoSol have also sued their potential Suboxone Film rivals for infkingement on too editional patent, patent numbers 8,900,497, and 8,906,277, which were not listed in the 1.8, District Coust of Delaware has invalidated the 32 patent 54, Throughout the Suboxone Film development process, MonoSol was aware that opment was crucial to bring the the timing of both FDA approval and final product de Film to market prior to the entry of genetic co-formulated buprenorphine/naloxonelablets. MonoSol actively strategized with Rockit to minimize various manufacturing delays to beat the generic tablets to market. 55. On October 20, 2008, Reckitt submited NDA 022410 to the FDA to market the sublingual Film version of Suboxone, which was reecived by the FDA on October 21, 2008, Because Suboxone Film is in a different dosage form than Suboxone Tablets, the two are not pharmaceutically equivalent 56. Without pharmaceutical equivalency, drugs cannot be AB-reted substitutes for ‘one another, Thus, any tablet form of generic co-formulated buprenorphine/naloxone would not ‘be an AB-rated genetic substitute for Suboxone Film, and typically » pharmacist may not automatically provide « patient with generic co-formlated buprenorphine/naloxone tablets when presented with a prescription for Suboxone Fim. 57. On August 21, 2009, less than two months before the October 2009 expiration of exclusivity onthe tablet formulation, the FDA rejected Reckit’s application to market Suboxone Film due to concems that the Film could be abused by patients or others and could result in accidental exposure to children, 58, The Food and Drug Administration Amendments Act of 2007 gives the FDA the authority to require « Risk Hvaluation and Miigation Strategy CREM"), which i «document submitted by the manafacturet thst contains a risk management plan oF rik-misimization strategy that goes beyond the profesional Inbeing to ensure that the benefits ofa drag outweigh the sks, 59, In response to the FDAYs rejection of the Suboxone Film application, Reckitt sums arevised REMS to the FDA to ares safety concems rated tothe il form, 60, The FDA approved Reckit’s NDA for Suboxone Film on August 30, 2010 16G61, MonoSol remained active inthe NDA everything possible to enable FDA. approval as quickly as posh, 62, Reokit’s Film offers no significant actual benefits for patients over its Tablet jproval process and committed to doing, FDA approval of Suboxone Film was based on the studies Reckitt used to establish safety and cfficacy of the Tablets, and Reckit’s representation that the Film had sufficient equivalent bioavailability tthe Tablets, The FDA confirmed that Reckt’s NDA contained no new cfficacy studies. Infact, Reckitt even represented tothe FDA that any differences between the two formulations were “clnialy insignificant” Until August 2012 the dosage strengths ofthe too Suboxone products were identical 63, The most important Sactr identified by Reckitt in bringing Suboxone Film to market was avoiding competition from generic entrants 64, Suboxone Film has disadvantages compare to Suboxone Tablets: Film is easier to conceal and sauggle into jails and prisons; + Increased naloxone bioavailability i the Film version, ineteasing the tsk of unwanted opioid withdrawal symptoms; «Film's rapid dissolution oreatos barriers to removal if accidentally ingested + Film is more dangerous because less unplessant taste compared to Tablets, snaking children fess Ikely to spitit out «Film is more likely to become stuck on the tongue if accidentally ingested by child + Films increasod stength of 12mg inereased dosage exposure to children;65. ‘The FDA found that Suboxone Film had no demonstrable safety advantage over ‘Suboxone Tablets, The FDA also concluded thatthe studies Reckit offered to the contrary were flawed, stating: “almost all ofthe safety expecenoe withthe proposed ev foulton was esved ftom a single study. This sty had a mumber of favs, ineluding inadequate Uaining of penomnel conducting safety exams, inconsistent recording of fading, treatment of prtcipants with dosing regimens not recommended inthe proposed labeling an high rop-ut rates" “ater roviw of the clinical indy report end database forthe study RB-US- (07-0001 [used to support Reckit’s NDA for Suboxone Film], ou over conclusion is atthe study was poory designed and conducted and was not _wefil for demonstrating any diffrence inthe safety profile or abuse potenti ofthe two fomalatons" and “Thece wis no postive controlar (Suboxone Tablet group) inthis study. So it would be impossible to cisim any potential advantages of Suboxone stip [Film) over the current Suboxone Tablet product.” 66, Fusthermore, the EDA. expressed concems that the Suboxone Film actually presented increased safety issues: “It should be noted that the proposed filmstrip product cannot ‘be spit out easily and dissolves quickly. Therefore, to the extent that some cases may be mitigated by the child spitting out the Tablet before ful absorption, the filmsteip product could ‘be more hazardous than the Table.” This concer was besed upon the fact that once in the ‘mouth, the Suboxone Film hydtates into a gel in 30 seconds and is completely absorbed in 3 ssinutes, releasing all of the buprenorphine contained in the Film. Suboxone Tablets, however, 1Bnay take up t9 10 minutes to fully dissolve, Many children wo accidentally ingest Suboxone ‘Tablets spit fem out quickly, bt even when they do succeed in swallowing the Tables, the buprenorphine is absorbed toa fr lesser extent inthe tablet formulation than inthe Fil, These factors make Suboxone Tablets potenilly less dangerous than Film in aecidental pediatic exposure 67. ‘The FDA also noted the possible increase of potential for abuse with the Fil; that the Film is both easier to conceal or divert, and that itis easier to dissolve end inj “Taken together, these findings suggest that expanded use of this product will result in significant abuse and diversion that needs to be considered with any anticipated benefits the drug say offer.” In fact, almost 6,000 Suboxone Film strips (46 percent of those dispensed fo study subjects) were “missing” afer the limited clinical studies performed by Reckitt to gain FDA approval 68, Reoktt is avare of the advantages that Suboxone Tablets have over Suboxone Fil, as evidenced bythe fact that Reckit markets Suboxone exchsively in tablet form in almost all of the countries where itis sold, This cootinus tobe tru even after Reckitt removed the ‘Tablets fiom the U.S. market, For instance, Reckit is curently applying 10 sell Suboxone Tablets in Chin, rather than in the Film, Reckitt Converts the Market From Tablets fo Film 68. Reckt’s reformulation, as devised by MonoSol, was designed forthe purpose of defeating the AB-rated substttablty that generic co-formulated. buprenorphine/naloxone tablets would enjoy once Suboxone’s orphan drug exclusivity period expired October 8, 2009.72, To complete their plan to extend Suboxone’ exclusivity by the patent protection jmed for the Film, Reektt then engaged in a multi-faceted campaign to convert the co- formulated buprenorphine/nsloxone market to Suboxone Film. Reckitt purposefully based its campaign to convert the market on unfounded safety concems about the Tablets, including concerns regarding accidental exposure to children. These conoems were a sham developed to convince prescribers and payors thatthe Suboxone ‘lm provided increased safety 2074, Reckitt communiceted to the public and to the medical community that single- dose or unit-dose packagiig was necessary to prevent potential exposure to multiple doses inthe case of accidental pediatric exposure, Reckitt then began marketing Suboxone Film in packaging, red with consulting frm Venebio Group, LLC to develop its “Film 75. Rockitt part is safee” platform, Venebio’s website states that the project “evaluated effectiveness of inovaive phumaceuical caging in reixing politic pave.” 76, Reckitt’s Suboxone Tablets have been sold in unit-dose packaging outside of the United States since 2005. Reckitt did not make any attempt to convert its tablet packaging to unitdose packaging in the United States, Rather, despite its claimed safety concerns, Reckitt continued to sell Tablets in multi-unit bots, contrary to its practices in other countries, until it withdrew its Tablets from the United States market upon the entry of generic versions. 77. Reckitt began a multi-front offensive to drive the Film to market before the ter With their version of the Suboxone Tablet ; sgeneros could7, 80. 81. In September 2012, Reckitt issued a press release advising the public and prescribing physicians that Reckitt intended to withdraw the Tablets rom tie market within the stated that the withdrawal was due next six months, Reskit’s press release false mie.” Reckitt was aware that its assertions of podiaric sulety “pediatric exposure safety is concems regang the Tablet formation were unfounded82. Reckitt also sought a declaration from the FDA that Suboxone Tablets were being, voluntarily pulled stom the market by Reckitt du to safety issues. 83. As another putt of its plan to convert the market fom Tablets to Film, Reckitt utilized a patient assistance aati called “Here to Help,” that provided qualified individuals with fee of 1ow-cost rugs, 84, Finally, Reckitt induced conversion ofthe market to the Film by raising the price before the introduction of the AB-rated generic tablet product into the of its Suboxone Tab rmatket, As a result, the Filo was initially cheaper than the branded tablets, Reckitt also developed programs that provided discounts and rebates to consumers who purchased the Film. dat engaged in each of theve actious with the puspose of converting the prescription market for Suboxone fiom Tablets to the Film to thwart generic competition once ———<— ABerated generic substittes beca87. Reckit’s prockict-hopping scheme was successful. By mid-2012, the Film accounted for over 70 percent of Suboxone prescriptions, and by the time the generic tablets Suboxone prescriptions were written for received PDA approval in February 2013, 85 percent o the Film instead of for Suboxone Tablets 88, Reckitt wihirow Suboxone Tablets from the market on March 18, 2013. TV. Reckitt Delays Generic Entry 89, ANDAs for approval to sell generio Suboxone were filed in 2009, Although the comphan drug exclusivity period on branded Suboxone Tablets expired on October 8, 2009, genetic buprenorphine/naloxone tablets did not gain RDA approval until February 2013. This delay was due in large part to Reckit’s tactics, which were intended to delay generic entry while Rect continued and completed its produet-hopping scheme. 90. Inlate 2011, while certain potential generic competitors (erred to collectively as “Buprenorphine Products Manufactucrs Group") were awaiting FDA. approval of their [ANDAs for genetic co-formulated buprenorphinelnaioxone tablets, Reckit submited a REMS for Suboxone Tablets, which was wpproved by the FDA in December 2011 91. On January 6, 2012, the FDA ordered Reckitt to cooperate with the Buprenorphine Products Manufactures Group in a shared REMS. Shared REMS are utilized like individual REMS~to address safety concerns of pharmaccutical produets. When multiple ‘manufecturers are marketing a generic product that is en AB-rated substitute for a reference 24‘diug, the FDA requires that the mamufactucers work together to submit a shared REMS, The ‘companies’ filing ANDAs and comprising the Buprenorphine Products Manufacturers Group ‘were Actavis, Ine Amneal Pharmaceuticals LLC; Ethypharm USA Corp; Mylan Inc.; Roxane “Laboratories Ine; Sandoz Inc; Sun Pharmaceuticals Industries, Ltd; and Teva Pharmaceuticals USA, Ine, 92. Approved NDA holders must participate in a shared REMS process with ANDA. applicants, and NDA holders may not use safety concems to block or delay ANDA approval under 21 US.C.§ 355-10. 93, Although Reckitt’s Suboxone Tablet REMS was only approved by the FDA in December 2011, Reckitt did not cooperate with the generic manufacturers inthe finalization and submission of shared REMS. Reckit also did not indicate outright that it refused to participate in the shared REMS process. Instead, Reckitt engaged in multiple delay tactics and made iisleading statements to conceal its true intent, which was to prolong the approval of the ANDAs for genetic Suboxone Tablets 94, "The Buprenorphine Products Manufacturers Group met with Reckitt for several ‘months in a good-faith effort to negotiate @ shared REMS. In communications to the FDA, the Group ultimately eported that Reckitt: ‘* Had no incentive or desire to enter into a shared REMS; ‘+ Merely feigned cooperation with the shared REMS development process and ‘wed deceptive tuctcs for months to hide its tr intent, which was to delay. the genetic industry ftom oblaining ANDA approvals; 1+ Refused to partoipate in meetings with the generic ANDA filers, providing only legal staff to attend the meotings until various legal issues were esolved; 254+ Refused to discuss any substantive issues porting to the shared REMS with tho generic ANDA files; + Placed conitions on itt cooperation with the shared REMS development process tat it knew the ANDA filers ould not agree to—for instance, Reckitt sitempted to fore the generic companies o asrume its tort laity by cont, despite the fat that such fbility had nothing to do with he shared REMS process and would have caused the generic companies’ liblty insurers to deny covereees 4+ Rofusd to share information with the generic ANDA. filers regarding the existing REMS; Raised lastmimite issues to cause further delay once & shared REMS was ready tobe submited in August 20125 + Stopped participating altogether in September 2012, Reckitt fubely represented to the FDA. and the Buprenorpkine Products “Manuiacuers Group tit it would cooperate, Reckitt never intended to participate in sine shared REMS program with the generic mamafictrers, engaging inthe process forthe sole pos of delaying gsnero approval 96. Because the FDA could not approve the ANDA applications without an approved REMS, Reckit’s refs to cooperate wns intends to andi in fat delay generic enty pas the dat when entry otherwise would have ecu 97, Reckit’s refusal t0 cooperate succesfully delayed submission of the shared REMS until August of 2012, when the genetic ANDA flrs finally obaincd an unprecedented waiver allowing them to submit a sbared REMS program of their own without Reckitt's 6‘cooperation. Absent such delay tactics, the shered REMS program would have been completed no later than May 6, 2012. 98, ~ Reckitt knew that once the FDA approved the ANDAs, generic Suboxone Tablets ‘would become available and immediately substitutable for branded Suboxone Tablets. ‘To gain to complete its product hop scheme, Reckit engaged in another delay acti by ibe Vers CHRISTINA M. MOYLAN Assistant Attomey General Office of Maine Attorney Ceneral Consumer Protection Division 6 State House Station “Augusta, ME 04333-0006 207 /626-8800 christina moylan@maine-gorFOR PLAINTIFF STATE OF MARYLAND BRIAN B. FROSH ATTORNEY GENERAL. Ellen S, Cooper Assistant Attomey General Chief, Antitrust Division Office ofthe Attomey General, State of Maryland 200 St, Paul Plae, 19" Floor Baltimore, MD 21202 Telephone: (410) 576-6470 Fax: (410) 516-7830 Ena: eeooper@oag.state.md.usFOR PLAINTIFF COMMONWEALTH OF MASSACHUSETTS: MAURA HEALEY ATTORNEY GENERAL fae tte William T. Matiaek (MA BBO No. 352109) ‘Assistant Attorney General Chief, Antitrust Division Matthew M. Lyons (MA BBO No. 657685) Carol E. Head (MA BBO No. 652170) ‘Assistant Atorneys General ‘Aattrust Division (One Ashburton Place Boston, MA 02108 Tel: (617) 727-2200 Fax: (617) 722-0186 (fax) William. Matlack@statema.us Matthew-Lyons@state.ma.us Carol Head@state:ma.usFOR PLAINTIFF STATE OF MICHIGAN BILL SCHUETTE, ATTORNEY GENERAL Bes Fowler (P53464) Assistant Attomey General P.O, Box 30755 Lansing, MI 48909 ‘Telephone: (517) 373-1160 ax: (517) 395.6755 Email: FowlerDI@mi Sune Mtoe LigationFOR PLAINTIFF STATE OF MINNESOTA, LORI SWANSON ATTORNEY GENERAL. “ustin R, Erickson ‘Assistant Attomey General Office ofthe Minnesote Attomey General 1400 Bremer Tooter 445 Minnesota Street, ‘St.Paul, MN 55101 “Telephone: (651) 757-1119 ax: (651) 296-9663, Ena justinerckson@eg.tate.mn.usBY: MOOD, ATTORNEY GENERAL "Y GENERAL, State of MississippiFOR PLAINTIFF STATE OF MISSOURL (CHRIS KOSTER ATTORNEY GENERAL, ‘Arny Haywfod “Assistant Al ‘Missouri Atomey General's Office 7.0. Box 861 St Louis, MO 63188 Telephone: (314) 240-4902 Fax: 14) 340-7957 Email: amy.haywood@ago.m0.g0vFOR PLAINTIFE STATE OF NEBRASKA, ex rel. DOUGLAS J. PETERSON, ATTORNEY GENERAL Abigail M. Stempson Collin Kessner Assistant Attomeys General [Nebraska Attomey General's Office 2115 State Capitol Lincoln, NE. 68509 Tel: 402-471-3833 Fax: 402-471-4725 abigail stompson@nebraska.gov collin kessner@nebraske.govFOR PLAINTIFF STATE OF NEW YORK, ERIC T, SCHINEIDERMAN Attorney General of the State of New York Qe —— BY: Elinor R, Hotta Deputy Bureau Chief, Antitrust Bureau ‘Amy E. MeFarlane Semi Zain Assistant Attomeys General Attorneys for Plaintiff State of New York 120 Broudway, 26" Floor ‘New York, NY 10271 (212) 416-8269 (voice) (212) 416-6015 (fx) Elinor Hoffimann@ag.ny.g0vFOR PLAINTIFF STATI OF NORTH CAROLINA. Respectfully submitted, ROY COOPER ‘Attomey General of North Carolina Kina DY La iKinberey A. Dama - Seo Dep Avormey Gener Now Crna Dep af tte Conant roteton Divison Tra Wea Edonen Sect alah NC 27608 ales: 019) 166013 Fo 19) Te-e0%0 nl kcraeds gorFOR PLAINTIFF STATE OF OHIO MIKE DEWINE, ATTORNEY GENERAL ‘Beth A. Finnerty Assistant Section Chie "Thomas N. Anger Associate Assistant Atiomey General Brian P. Jordan Assistant Attomey Generel Ohio Attomey Generl’s Office Antitrust Seation 150 East Gay Street, 22"! Floor Columbus, OH 43215 ‘Telephone: (614) 466-4328 Fac (614) 995-0266 nui: beth innerty@ahioattomeygeneral. gov thomas. anger@ohiosttomeygeneral.gov tian jordan@ohioattomeygeneea. gov (OH Suboxone Complaint Signature Block:12218384_1FOR PLAINTIFF STATE OF OKLAHOMA E. SCOTT PRUNTT ATTORNEY GENERAL, Iulie A. Bays, OK Bat No. 17316 Assist Attorney Gener Mats MePhecson, OK Bar No, 32070 ‘AssitantAtorney Geral 313 NE 21" Street Okabe City, OK 73105 Telephone: (405) 522-3082 ax (405) 522-0085 Ena Jlbays@oegok govFOR PLAINTIFF STATE OF RHODE ISLAND PETER F. KILMARTIN ATTORNEY GENERAL Edmund P. Murray, Ir oF Special Assistant Atiomey General Rhode Island Depariment of Attorney General 150 South Main Street Providence, RI 02903 ‘Telephone: (401) 274-4400 ext. 2401 ‘Pax: (401) 222-2995 ‘Emma: emurmay @riagti.gov» V. ALAN WILSON ‘Attorney General forthe State of South Carolina Federal ID No. 10457 Email: awilson@scag.gov oun W. Melnrosit ‘Chief Deputy Attorney General Federal ID No. 2842 Enuil:jmcintosh@scag.gov Rosser D.CooK Solicitor General Federal ID No. 285, Email: beook@scag.go¥ . HAVIRD JONES, IR. Senior Assistant Deputy Attomey General Federal ID No. 2227 Email: sjones@scag.gov CHawrente L. NEBSE Assistant Attorney General Federal ID No. 12412 Email: eneese@seag.g0v CLARK KIRKLAND, JR. Assistant Attomey General Federal ID No. 12410 Email: cktklandjr@scag.gov (OFFICE OF THE ATTORNEY GENERAL 1000 Assembly Street Rembert C. Dennis Building Post Office Box 11549 Columb, South Carolina 29211-1549 Phone: 803.734.3970 ‘Attomeys for Alan Wilson, in his offical capacity as Attorney General of the State of South Carolina(ON BEHALF OF THE STATE OF TENNESSEE: HERBERT H. SLATERY IIL ‘Anomey General ad Reporter of Tennessee Br Gee fleuae) Ehis tere Assistant Atom Geer JENNIFER PEACOCK Senior Cosel CYNTHIA KINSER Deputy Atorey General Oe te ntoney General nd Reporter Po. Box 2207 ashi TN 37202 Telco) 741722 rin. Meriekiiag.tn.nov, AenniferPencocki@agtn.vov Cynthia Kinseni@iay.ta.owFOR PLAINTIFF STATE OF UTAH. SEAN D. REYES ATTORNEY GENERAL me De ca Ronald J. Ockey, Assistant Attorney General, Antitrust Section Chief Edward Vasquez, Assistant Attorney General Brian Christensen, Assistant Attorney General Offie of the Attorney General of Utah “ax, Financial Services and Antitrust Division 160 Fast 300 South, 5 Floor P.O. ox 140874 Salt Lake City, UT 84114-0874 ‘Tel; 601-244-4636 ax: 801-366-0315 lsomonisishi@utah gow oskeviuah. gov ‘vasqueautsh gov behristensen! @utah.gow ATTORNEYS FOR THE STATE OF UTAHFOR PLAINTIFF STATE OF VERMONT WILLIAM H. SORRELL, ATTORNEY GENERAL TiS. Abrams Assistant Attomey General ‘Vermont Attomey General's Office 109 State Street Montpelier, Vermont 05609 ‘Telephone: 802-828-1106 Email jillabrams@vermont.govFOR PLAINTIFF COMMONWEALTH OF VIRGINIA MARK R, HERRING ATTORNEY GENERAL, fooh Li rn Clb Sirah Oxenham Allen Senior Assistant Autrey General Ottis ofthe Atomey General 202 North 9" Street Richmond, VA23219 ‘elspione: (804) 786-6557 Fax (804) 786-0012 Binal: SOAllendioagstate.va.nsOR PLAINTIFF STATE OF WASHINGTON ROBERT W. FERGUSON ATTORNEY GENERAL ‘cHIED ZA eat ‘Assistant Attorney General State of Washington Attomey General's Office 800 Fifth Avenue, Suite 2000 Seattle, WA 98104 ‘Telephone: 206.442.4499 Fe: 206.464.6338 ‘nal: chiedzang@atg.wa gov