suboxone ecf pacer uscourts gov doc 153112462429

7/28/2019 Suboxone Ecf Pacer Uscourts Gov Doc 153112462429

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IN THE UNITED STATES DISTRICT COURT FORTHE EASTERNDISTRICT OF PENNSYLVANIA

MICHIGAN REGIONAL COUNCIL OFCARPENTERS EMPLOYEE BENEFITSFUND, on BehalfofItselfand AllOthersSimilarly Situated,

Plaintiff,v.

RECKITT BENCKISER INC.; RECKITTBENCKISER LLC; RECKITTBENCKISER PHARMACEUTICAL, INC.;RECKITT BENCK1SERHEALTHCARE(UK) LTD.; and RECKITT BENCKISERGROUP pIc,Defendants.

C.A. No. _

CLASSACTION

JURY TRIAL DEMANDED

CLASS ACTION COMPLAINT

Plaintiff, Michigan Regional Council ofCarpenters Employee Benefits Fund ("Plaintiff'or "the Fund") on behalf of itself and all others similarly situated, for its Complaint againstReckitt Benckiser Inc., Reckitt Benckiser LLC, Reckitt Benckiser Pharmaceuticals, Inc., ReckittBenckiser Healthcare (UK) Ltd., and Reckitt Benckiser Group pic (collectively, "Defendants" or"Reckitt"), and alleges as follows based on: (a) personal knowledge; (b) the investigation of itscounsel; and (c) information and belief:I. NATURE OF THE ACTION

I. This is a civil antitrust action challenging Defendants' unlawful exclusion ofgeneric competition for co-formulated buprenorphine hydrochloride and naloxone hydrochloridedehydrate ("co-formulated buprenorphine/naloxone"), sold under the brand-name Suboxone. Asmore fully described below, Reckitt engaged in an unlawful product-hopping scheme to maintain


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and extend its monopoly power and prevent the market entry of generic products to competeagainst the branded pharmaceutical. Through multiple, concerted, and deliberate anticompetitive tactics, commencing as early as 2009, Defendants have harmed Plaintiff and allother indirect purchasers of Suboxone by charging inflated and monopolistic prices for thebranded drug.

2. Defendants have accomplished their anti-competitive goals through the use ofvarious strategies that were designed to unlawfully interfere with the regulatory process, causedelays in the approval of generic versions of Suboxone, and disrupt the market for co-formulatedbuprenorphine/naloxone products. Defendants' conduct constitutes a conspiracy to monopolizein violation of, and pursuant to, the Shennan Act, Section 2, 15 U.S.C. l and 2, in addition tostate antitrust and consumerprotection laws.

3. Suboxone is a prescription pharmaceutical that is used to treat opioid addiction.Buprenorphine is a semi-synthetic opioid used for detoxification and to treat opiate withdrawal.It is prescribed to assist addicts reduce their use and manage addiction syndromes likewithdrawal. Buprenorphine is generally viewed to have a less euphoric effect and less of apotential for abuse compared to methadone and is thus less likely to be diverted to the blackmarket. Naloxone is an opioid antagonist, and acts to deter the abuse of the drug by intravenousinjection. Suboxone is the brand name version of co-formulated buprenorphine/naloxone. Over$1billion of Suboxoneis sold in the United States annually.

4. Defendants used several anti-competitive tactics with the intention of foreclosinggeneric competition in the market for co-formulated buprenorphine/naloxone. As described indetail below, Defendants made changes to branded Suboxone which provided no therapeuticbenefit (even reducing the therapeutic benefit), ceased promoting the prior version of branded

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Suboxone, removed already-distributed product from the market, and engaged in additionalefforts to delay approval of competing generic versions of these products. Because a genericdrug must be identical in dosage form and route of administration to its reference listed drug,these switches, along with other carefully-timed exclusionary conduct, prevented genericmanufacturers from launching commercially viahle competing generic versions of co-formulatedbuprenorphine/naloxone. These actions ensured that Plaintiff and other end-users wouldcontinue to pay inflated prices for branded Suboxone.II. LEGAL AND REGULATORY BACKGROUND

A. The Regulatory Structure for Approval of Generic Drugs and Substitution ofGenerics for Brand-Name Drugs

5. Under the Federal Food, Drug, and Cosmetic Act ("FDCA"), manufacturers whocreate a new drug product must obtain the approval of the FDA to sell the new drug by filing aNew Drug Application ("NDA"). 21 U.S.C. 301-92. A NDA must include submission ofspecific data conceming the safety and effectiveness of the drug, as well as any information onapplicable patents. 21 U.S.C. 355(a) and (b).

6. When the FDA approves a brand-name manufacturer's NDA, the brandmanufacturer may list any patents that the brand manufacturer believes could reasonably beasserted against a generic manufacturer who makes, uses, or sells a generic version of the brand-name drug prior to the expiration of the listed patents in the FDA's Orange Book. Patents issuedafter NDA approvalmay be listed within 30 days of issuance. 21 U.S.C. 355 (b)(l) and (c)(2).

7. The FDA relies completely on the brand-name manufacturer's truthfulness aboutpatents' validity and applicability; the FDA does not have the resources to check themanufacturer's representations for accuracy or trustworthiness.

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B. The Hatch-Waxman Amendments8. Enacted in 1984, the Hatch-Waxman Amendments simplified the regnlatory

hurdles for prospective generic manufacturers by eliminating the need for them to file lengthyand costly NDAs. See Drug Price Competition and Patent Term Restoration Act, Pub. L. No.98-417, 98 Stat. 1585 (1984). A manufacturer seeking approval to sell a generic version of abrand-name drug may file an abbreviated new drug application ("ANDA"). ANDAs rely on thescientific findings of safety and effectiveness included in the brand-name drug manufacturer'soriginalNDA, but must show that the generic drug contains the same active ingredient(s), dosageform, route of administration, and strength as the brand-name drug - that is, that the genericdrug is bioequivalent to the brand-name drug, The FDA assigns generic drugs that arebioequivalent to branded drugs an "AB" rating.

9. The FDCA and Hatch-Waxman Amendments operate on the presumption thatbioequivalent drug products containing identical amounts of the same active ingredients in thesame route of administration and dosage form, and meeting applicable standards of strength,quality, purity, and identity, are therapeutically equivalent and may be substituted for oneanother, Thus, bioequivalence demonstrates that the active ingredient of the proposed genericdrug would be present in the blood of a patient to the same extent and for the same amount oftime as the branded counterpart.

10. Through the Hatch-Waxman Amendments, Congress sought to expedite the entryof generic drugs, thereby reducing healthcare expenses nationwide. Congress also wanted toprotect pharmaceutical companies' incentives to create new and innovative products.

11. The Hatch-Waxman Amendments achieved both goals, substantially advancingthe rate of generic product launches and ushering in an era of historic high-profit margins forbrand-name pharmaceutical companies. In 1983, before enactment of the Hatch-Waxman

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Amendments, only 35% of the top-selling drugs with expired patents had generic versionsavailable; by 1998, nearly all did. In 1984, prescription drug revenue for branded and genericstotaled $21.6 billion and generic drugs accounted for 18.6% of prescriptions. By 2009, totalprescription drug revenue had soared to $300 billion and generic drugs accounted for 75% ofprescriptions.

C. Citizen Petitions12. Section 5050) of the FDCA creates a mechanism by which a person may file a

petition with the FDA requesting, among other things, that the agency take, or refrain fromtaking, any form of administrative action. This mechanism is commonly referred to as a CitizenPetition.

13. Citizen Petitions were created to provide an opportunity for individuals to expressgenuine concerns about legitimate safety, scientific, or legal issues regarding a product any timebefore, or after, its market entry. Other than the form of such Citizen Petition, the regulationsplace no restrictions on the subjectmatter of a Citizen Petition.

14. The Citizen Petition must contain a statement of what action is being requested,and why. Such justification, if appropriate, includes scientific data and other technicalinformation. The submitter is required to provide a certification that the petition includes allinformation and views on which the petition relies, and it must also include representative dataknown to the petition that is unfavorable to the position advocated in the Citizen Petition.

15. FDA regulations concerning Citizen Petitions require the FDA commissioner torespond to, but not necessarily to resolve, each Citizen Petition within 180 days of receipt. TheCommissioner may approve the request in whole or in part, deny the request, or provide atentative responsewith an estimate as to when it will issue a final response.

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16. Reviewing and responding to Citizen Petitions is a resource-intensive and time-consuming task because the FDA must research the petition's subject, examine scientific,medical, legal, and sometimes economic issues, and coordinate internal agency review andclearance of the petition response. These activities strain the FDA's limited resources. For thesereasons, the FDA's final response to a Citizen Petition typically takes much longer than 180days.

17. Abusive and anti-competitive Citizen Petitions have become an increasinglycommon problem in the last several years as brand name companies have come to realize theimmense profits that result from delaying generic competition by even a few months. In somesuch cases,Citizen Petitions have been filed with respect to ANDAs that have been pending for ayear or more, long after the brand name manufacturer received notice of the ANDA filing.Lawful or not, delaying competition is a lucrative strategy for an incumbent manufacturer.Given the market's preference for generic products over brand name products, the cost of filingan improper Citizen Petition is usually trivial compared to the value of securing a few monthsdelay in generic competition.

18. FDA officials have acknowledged abuses of the Citizen Petition process. FormerFDA Chief Counsel Sheldon Bradshaw noted that in his time at the agency, he had "seen severalexamples of citizen petitions that appear designed not to raise timely concernswith respect to thelegality or scientific soundness of approving a drug application but rather to try to delay theapproval simply by compelling the agency to take the time to consider arguments raised in thepetition whatever their merits and regardless of whether or not the petitioner could have madethose very arguments months and months before." Speech before the Generic PharmaceuticalAssociationAnnual Policy Conference (Sept. 19,2005).

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19. Specifically in reference to Citizen Petitions that address the approval of genericdrug products, Gary Buehler, R.Ph., Director of the Office of Generic Drugs, Center for DrugEvaluation and Research ("CDER") at the FDA, remarked in July 2006 that "very few . . . havepresented data or analysis that significantly altered FDA's policies." Mr. Buehler went on toobserve that of 42 Citizen Petitions raising issues regarding the approvability of genericproducts, only three petitions led the FDA to change its policy on the basis of data or informationactually submitted with the Citizen Petition.

20. The abuse of the Citizen Petition process by brand name manufacturers ledCongress to enact the FDA Amendments Act of 2007, 21 U.S.C. 355(q) (the "2007Amendments"). In relevant part, the 2007 Amendments require the FDA to not delay approvalof a pending ANDA because of a Citizen Petition unless such a delay is necessary to protect thepublic health. The 2007 Amendments also enabled the FDA to summarily deny any CitizenPetitionwhere the primary purpose of the petition is to delay competition entering the market.

D. The Benefits of Generic Drugs21. Generic drugs are typically sold at substantial discount to the referenced listed

branded drug. The first generic drug that enters the market is generally priced at a significantdiscount to the referenced listed branded drug and, as additional generic drugs enter tilemarketplace, generic drug prices fall even further in comparison to the referenced listed brandeddrug.

22. Generic drug competition generates large savings for purchasers. A 1998Congressional Budget Office Report estimates that, in 1994 alone, consumers saved $8 billion to$10 billion on prescriptions at retail pharmacies by purchasing generic drugs instead of thecorresponding brand name products. The FDA has found that consumers whose needs can befully satisfied with generic drugs could enjoy reductions of 52% in their daily medication costs.

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Savings From Generic Drugs Purchased From Retail Pharrnacies, http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucml34205.htm (Last visitedFebruary 21, 2013). Most recently, a September 2011 study commissioned by the GenericPharmaceutical Association found that generic drugs saved the U.S. health care system morethan $931 billion from 2001-2010 and that the savings for 2010 alone were nearly $158 billion.The study also cites data from the Federal Centers for Medicare and Medicaid Servicesestablishing that a mere 2% increase in generic utilization would save Medicare an additional$1.3 billion annually, As a result of Defendants' unlawful tactics and agreements to delaygeneric competition to Suboxone,prescription drug purchasers have been unable to enjoy similarsavingswith respect to purchases of co-formulated buprenorphine/naloxoneproducts.III. JURISDICTION AND VENUE

23. This Court has subject matter over this action pursuant to 15 U.S.C. 26, and28 U.S.C. 1331 and 1337. This Court also has jurisdiction over this class action pursuant to28 U.S.C. 1332(d). The amount in controversy, exclusive of interest and costs, exceeds$5million.

24. Defendants transact business within this District. Venue is appropriatewithin thisDistrict under 28 U.S.C. 1391(b) because a substantial part of the events or omissions givingrise to the claim occurred in this District.IV. THE PARTIES

25. Plaintiff, Michigan Regional Council of Carpenters Employee Benefits Fund is aTaft-Hartley fund located in Troy, Michigan that provides health and welfare benefits to unionmembership. The Fund is responsible for reimbursing or paying for members' purchases ofprescription drugs such as Suboxone. Beneficiaries of the F1Uld purchased Suboxone in the state

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ofMichigan, during the Class Period, for personal use other than for resale. The Fund purchasedand/or provided reimbursement for some or all of the purchase price for these Suboxonepurchases. Plaintiff and its beneficiaries have been injured in their business or property byhaving paid more for Suboxone than they would have absent the Defendants' illegal and anticompetitive conduct alleged herein. Plaintiff was injured by the illegal, anti-competitive, anddeceptive conduct described herein, both individually and in a manner that was common andtypical of the Indirect PurchaserClassmembers (defined infra). Pursuant to 29 U.S.C. 1132(d),the Fund is entitled to bring suit in its own name.

26. Defendant Reckitt Benckiser Inc. is a Delaware corporation with its principalplace of business located at Morris Corporate Center IV, 399 Interpace Parkway, Parsippany,New Jersey 07054. This defendant manufactures and markets numerous consumer products,including pharmaceutical drugs subject to FDA approval, and was responsible for the conductallegedherein.

27. Defendant Reckitt Benckiser LLC is a Delaware limited liability company withits principal place of business located at Morris Corporate Center IV, 399 lnterpace Parkway,Parsippany, New Jersey 07054. This defendant manufactures and markets numerous consumerproducts, including pharmaceutical drugs subject to FDA approval, and was responsible for theconduct allegedherein.

28. Defendant Reckitt Benckiser Pharmaceutical, Inc. is a Delaware corporation withits principal place of business located at The Fairfax Building, 10710MidlothianTurnpike, Suite430, Riclnnond, Virginia 23235. This defendant manufactures and markets numerous consumerproducts, including pharmaceutical drugs subject to FDA approval, and was responsible for theconduct allegedherein.

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29. Defendant Reckitt Benckiser Healthcare (UK) Ltd. is a British corporationincorporated under the laws of England and Wales, with its registered office located at DansomLan, Hull, North Humberside HU8 7DS. This defendant manufactures and markets numerousconsumer products, including pharmaceutical drugs subject to FDA approval, and wasresponsible for the conduct alleged herein.

30. Defendant Reckitt Benckiser Group pic is a British corporation incorporatedunder the laws ofEngland andWales, with its registered office located at Tumer House, 103-105Bath Road, Slough, Berkshire, SLI 3UH, England. This defendant manufactures and marketsnumerous consumer products, includes pharmaceutical drugs subject to FDA approval, and wasresponsible for the conduct alleged herein.

31. The five foregoing defendants are referred to herein as "Reckitt" or"Defendants."

32. All ofDefendants' actions described in this complaint are part of, and in furtheranceof, the illegal monopolization, restraints of trade and unfair, unconscionable, and deceptive actsand practices alleged herein, and were authorized, ordered, and/or done by Defendants' variousofficers, agents, employees, or other representatives while actively engaged in the management ofDefendants' affairs within the course and scope of their duties and employment, and/or with theactual, apparent,and/or ostensible authority ofDefendants.

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V. DEFENDANTS' UNLAWFUL CONDUCTA. Background on Co-Formulated Buprenorphine/Naloxone

33. In October, 2002, the FDA approved the marketing and sale of Suboxone fortreatment of opiate dependence.' At the time Suboxone was initially approved, the FDAprovided Reckitt with protection from generic competition. By categorizing it as an "orphandrug", Reckitt was granted a 7-year exclusivity period for Suboxone. See 21 U.S.C. 360aa-dd.A drug is considered "orphaned" when a potentially therapeutic drug is found, but due to thesmall target population associated with the disease, it lacks a sponsor to conduct the clinical trialsnecessary to receive FDA approval. Drug companies are provided incentives, like protectionfrom generics, so that pharmaceutical companies can recoup development costs.

34. During Suboxone's 7-year exclusivity period, Reckitt was able to reap over$1 billion per year in sales, far above the commercial potential that entitles a pharmaceuticalcompany to orphan drug exclusivity. Such high sales were contrary to Reckitt's representationin its application for orphan drug status that there was not a reasonable expectation that Reckittwould be able to recover the costs associated with developing the drug.

35. Reckitt's Suboxone exclusivity was set to expire in October of 2009. With theend of that exclusivity, less-expensive generic versions of Suboxone were set to enter tilemarket.Suboxone comprised a substantial percentage of Reckitt's revenue and profits, thus generic entryposed a significant threat to Reckitt's revenue. Due to the relatively high price of Suboxone,generic competition promised competitive relief for patients and purchasers of Suboxone.

http://www.fda.gov/Drugs/DrugSafety/PostmarketDmgSafetylnformationforPatientsandProviders/ucm191521.

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36. Before Reckitt 's exclusivity on Suboxone expired, Reckitt concocted a broad anti-competitive scheme to maintain and extend its monopoly power over co-formulatedbuprenorphine/naloxone, by illegally preventing generic versions from competing withSuboxone. The scheme involved manipulating the complex distribution and regulatory approvalprocess for pharmaceutical products in the United States. Reckitt 's scheme involved a numberof steps.

A. Suboxone Film Developed and Marketed in Order to Prevent GenericVersions of Co-Formulated BuprenorphinelNaloxone37. Two years prior to the expiration of its orphan drug exclusivity, Reckitt

announced that it was planning to file an application to market a sublingual film version ofSuboxone. Reckitt filed its application in October of 2008. In order to obtain FDA approval ofSuboxone film, Reckitt relied on previous studies that demonstrated the safety and efficacy ofSuboxone tablets. No efficacy studies were performed on the Suboxone film itself. Instead,Reckitt showed that the film version of Suboxone had sufficiently equivalent bioavailabilitycompared to the tablet version of Suboxone. Reckitt expressly told the FDA that any differencesbetween the film and the tablet were "clinically insignificant."

38. The only difference between Suboxone tablets and Suboxone film that mattered toReckitt was its dosage form. Generic Suboxone tablets could not be considered "AB-rated"equivalents to branded Suboxone film. Consequently, pharmacists could not legally substitutethe less-expensive generic Suboxone tablets when presented with a prescription for Suboxone

film. The substitution ofless expensive AB-rated generic equivalents to brand name drugs is theprimary means by which generic drugs reduce costs for patients. By introducing Suboxone film,Reckitt caused the prescription base of Suboxone tablets to disappear, in effect, hobbling generic

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Suboxone tablet competition and preventing the price of co-formulated buprenorphine/naloxonefrom dropping to competitive levels.

39. After initially having its Suboxone film application rejected by the FDA due toconcems that that Suboxone film could be abused,misused, or more easily accessedby children.Reckitt later submitted a Risk Evaluation and Mitigation Strategy ("REMS") to address theseissues, and the FDA ultimately approved Suboxone film on August 30, 2010. After approval,Reckitt began tomarket the new Suboxone filmproduct.

40. Reckitt began touting the benefits of Suboxone film over the Suboxone tablets.This action was contrary to Reckitt's economic self-interest as Suboxone film is notmanufactured by Reckitt. It is manufactured for Reckitt by MonoSol Rx LLC in Warren, NewJersey. Reckitt is charged substantial sums to have the Suboxone film manufactured for it,charges that Reckitt does not incur with Suboxone tablets.

a. Suboxone Film Is Demonstrably Inferior to SuboxoneTablets41. Suboxone film did not offer new medical or clinical benefits above and beyond

those offered by the existing Suboxone tablets, a fact that the FDA expressly recognized.Instead, Suboxone film has numerous disadvantages compared to Suboxone tablets. Oneproblem is that the bioavailability of naloxone is increased in the film version relative to thetablet version. This quality increases the risk that patients will experience unwanted opioidwithdrawal, which is the main condition that Suboxone is supposed to stem.

42. Another problem with Suboxone film is that it is easier to conceal than the tabletversion, meaning that it is more susceptible to division. Reckitt learned of this problem duringclinical studies as nearly 6,000 strips (46%of the drug that was dispensed to study patients) went"missing" after the clinical studies that Reckitt performed to obtain FDA approval.

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43. The Suboxone film formulation also defeated a major benefit of Suboxone, itslow potential for abuse. Suboxone film was far easier to dissolve and inject than the Suboxonetablet formulation.

44. Furthermore, Suboxone film presented a larger danger to children than theSuboxone tablet version. Because the Suboxone film dissolves so rapidly, children whoaccidently place the Suboxone film in their mouths will absorb the buprenorphine quickly andcompletely, and would be unable to spit it out or remove it from their system. Upon introductioninto the mouth, Suboxone film turns to a gel within 30 seconds, and erodes completely over thecourse of three minutes, releasing all of the buprenorphine. Suboxone tablets, on the other hand,take much longer to dissolve (often up to 10 minutes), meaning children can spit them out andterminate their exposure to buprenorphine. Even when the tablets are swallowed by children, thebuprenorphine is absorbed to a far lesser extent compared with the film, and can also be vomitedup before it is digested.

45. The packaging of Suboxone film also presented drawbacks compared to thepackaging of the Suboxone tablets. The doses of the film were packaged in a child-resistantsleeve. Once the sleeve was initially opened, however, it no longer provided any childresistance. Once the sleeve was opened, there was no child-resistant bottle or container intowhich the unused doses could be safely placed, even though Reckitt knew that a significantsegment of patients took their Suboxone in divided doses. In comparison, Suboxone tabletscame in a childproof bottle that a patient could safely place unused portions of split Suboxonetablets. Also, because the Suboxone film doses came in the individual sleeves, the street value ofthe diverted product was increased because product identity and purity could be guaranteed.

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46. Patients themselves did not prefer Suboxone film to Suboxone tablets. Manypatients, in fact, preferred the tablets by a wide margin because the film formulation was moreirritating to a patient's oral mucosa than the tablet.

b. Reckit t Introduced Suboxone Film for Anti-competitiveReasons47. From Reckitt's perspective, Suboxone film was more costly and more difficult to

have manufactured than the Suboxone tablet. Reckitt did not anticipate that the Suboxone filmwould garner it any additional sales or revenues, lower its costs, or increase its efficiencies overthe tablet formulation, Reckitt did not anticipate that it would be able to charge more forSuboxone film than for Suboxone tablets. Instead, Reckitt anticipated that it would lose salesand revenues, increase its costs, and decrease its efficiency by developing and manufacturingSuboxone film, which was exactly what happened.

48. The lower sales and higher costs, however, did not matter to Reckitt. It waswilling to sacrifice a portion of its profits on Suboxone because the development of theSuboxone film formulation protected the majority of its profits by thwarting, delaying, andmitigating the impact of competition from generic Suboxone tablets by raising potentialcompetitors' costs and excluding them from the most efficient means of distributing their genericSuboxone tablet products, by way of the automatic pharmacy substitutionmechanism.

B. Aftcr Suboxone Film Was Introduced, Reckitt Destroyed the Demand forSuboxone Tablets49. Once the FDA approved Suboxone film, Reckitt set about to destroy the demand

for Suboxone tablets. Reckitt took affirmative and costly steps to replace Suboxone tablets -facing imminent generic competition - with the film.

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50. First, Reckitt raised the price for Suboxone tablets. This maneuver made itunattractive for patients and payers, which in turn drove demand to the Suboxone filmformulation.

51. Reckitt then refrained from packaging Suboxone tablets in childproof unit-dosepackaging, even though it had used that unit-dose packaging configuration since 2005 for its coformulated buprenorphine/naloxone tablets in Canada and the United Kingdom. Reckitt did notimplement the unit-dose packaging, despite the fact that it knew as early as 2007, that pediatricexposure rates for Suboxone were very high. This was done simply to degrade the quality ofSuboxone tablets relative to Suhoxone film.

52. Once generic Suboxone tablets were poised to enter the market, Reckittannounced in September of2012 that it was discontinuing the sale of Suboxone tablets entirely.

53. Due to these anti-competitive actions, by the time the generic manufacturers startselling their generic versions of Suboxone tablets, the prescription base for Suboxone tablets willhave been almost entirely destroyed due to Reckitt 's scheme. The vast majority of prescriptionsare already being written for the film version of Suboxone.

54. Reckitt employed this scheme with one goal in mind: to destroy the demand andthe prescription base for Suboxone tablets and prevent generic versions of Suboxone tablets fromeffectively competing with branded Suboxone. With the new Suboxone film, generic versions ofSuboxone tablets are unable to take advantage of the automatic generic substitution atpharmacies.

C. Reckitt Worked to Prevent Approval of Generic Suboxone Tablets55. Reckitt further engaged in anti-competitive activity by taking steps to block,

delay, and thwart would-be generic Suboxone tablet sellers from obtaining FDA approval oftheir required ANDAs for the generic Suboxone tablets. Reckitt took advantage and, in effect,

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sabotaged the process by which the generic Suboxone tablet ANDA filers needed to finalize andsubmit an FDA-required shared REMS. On January 6, 2012, the FDA communicated that it wasgoing to require ANDA filers and Reckitt to submit a shared REMS. The FDA required theshared REMS, but did not anticipate or authorize that Reckitt would use this requirement of ashared REMS in order to delay and thwart ANDA approval. Because the FDAhad just approvedReckitt's Suboxone tablet REMS in December of20ll, the FDA anticipated that a shared REMScould be developed rapidly.

56. Because Reckitt knew that a joint submission to the FDA was the last prerequisiteto FDA approval of the pending Suboxone tablet ANDAs and that it was a required participant,Reckitt sabotaged the joint process to delaying it and drawing it out for as long as possible.Reckitt refused to participate, asserted pretextual conditions on its participation, and offeredveiled pretexts in an attempt to disguise its overtly anti-competitive intentions.

57. Drug companies holding generic Suboxone tablet ANDAs have documented, inwriting, Reckitt's sabotage of the joint process. These generic drug companies formed theBuprenorphine Products Manufacturers Group. The members of the group are Actavis, Inc.,Amneal Pharmaceuticals LLC, Ethyphann USA Corp., Mylan Inc., Roxane Laboratories Inc.,Sandoz Inc., Sun Pharmaceuticals Industries, Ltd., and Teva Pharmaceuticals USA, Inc. Themembers of the group reported to the FDA that Reckitt:

(i) feigned cooperation with the shared REMS process;(ii) refused to participate in meetings with the generic ANDA filers;(iii) refused to discuss substantive issues with the generic ANDA filers

regarding the shared REMS when it did attend meetings;

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(iv) placed unreasonable conditions on its cooperation with the shared REMSdevelopment process, knowing that the ANDA filers could not agree tothem (like assuming Reckitt's tort liability by contract, which hadnothing to do with the development of a joint REMS and would havecaused the ANDA filers' liability insurers to disclaim coverage);

(v) refused to share information with the generic ANDA filers about theexisting REMS program that was essential to the shared REMSdevelopment process;

(vi) raised last minute issues immediately prior to a shared REMS beingsubmitted to the FDA in August of 2012, in order to cause still furtherdelay; and

(vii) stopped participating altogether in September of2012.58. Reckitt's actions sabotaged the shared REMS development and significantly

delayed the FDA's approval of one ormore Suboxone tablet ANDAs.D. Reckitt Files a Sham Citizen Petition with the FDA59. The generic Suboxone tablet ANDA filers resorted to filing a REMS program of

their own to the FDA ofAugust of2012. Once this occurred, Reckitt knew that it was likely thatthe FDA would accept the generics-only shared REMS, as submitted or with modification, andthen approve one or more generic Suboxone tablet ANDAs. In order to prevent that from takingplace, Reckitt filed a sham Citizen Petition with the FDA to try to further delay FDA approval ofANDAs for Suboxone tablets. In its petition, Reckitt asked the FDA to withhold approval ofgeneric Suboxone tablets unless (i) the ANDA contains a pediatric exposure education program,(ii) the product has a child-resistant unit-dose packaging, and (iii) the FDA determines thatReckitt did not stop marketing branded Suboxone tablets for safety reasons.

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60. The sham petition was filed to interfere with competition by delaying the FDAapproval of generic Suboxone tablet ANDAs. Reckitt filed the petition only after its tactics tosabotage the shared REMS development process was no longer assured to work. Prior to thefiling of Reckitt's petition, Reckitt did not share with the generic ANDA filers any of theinformation contained in Reckitt's petition. Reckitt, instead, kept the information set forth in itspetition in its back pocket, surprising the generic ANDA filers at the last minute. TIlepurportedsafety-relatedbases of Reckitt's petition to the FDA, Reckitt's secrecy and its own failure to takethe actions it sought to require of the genetic ANDA filers demonstrates the anti-competitivenature of Reckitt's petition. If Reckitt had sincere concerns about safety, it would have beenforthcoming about them and would not have kept the concerns a secret. If Reckitt had sincereconcerns about safety, it would have adjusted its own products, not just seek the adjustment ofproducts produced by other companies.

61. Reckitt's sham petition was baseless in other ways. First, the petition lackedregulatory, scientific, and medical bases. Second, the FDA itselflacked the statutory authority towithhold the approval of generic Suboxone tablet ANDAs for the reasons cited by Reckitt.Third, the FDA lacked the statutory authority to require the actions that Reckitt sought to imposeon the generic ANDA filers. Fourth, Reckitt's petition lacked clinically meaningful evidencethat lent support to its assertions or that bore on the approvability of generic Suboxone ANDAs.In short, Reckitt's petition could not affect FDA policy and procedure, was meant solely tohinder lawful competition, and was a sham.

62. Substantial evidence demonstrates that Reckitt's petition lacked a reasonablebasis. Reckitt's requirement that generic ANDA filers include a pediatric exposure education

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program did not have a statutory or regulatory basis. Reckitt itself had not included such aneducation program in its own NDA or in any subsequent supplement to its NDA.

63. For the unit-dose packaging requirement that Reckitt sought for the FDA toimpose on the generic ANDA filers, Reckitt chose to ignore the FDA's public positions. TheFDA wrote to Reckitt in March of 2010, saying that the FDA had concluded that since so manypatients took Suboxone in divided daily doses, the unit-dose packaging might exacerbate thealready high incidence of accidental pediatric buprenorphine exposure. "Because patients areknown to divide tablets, it may be expected that patients will remove films from the package andhave partial doses that are neither in the child-resistant pouch nor in a child-resistant medicationbottle," the FDA told Reckitt.

64. As to Reckitt's request that the FDA withhold approval for the generic ANDAfilers unless it determine that Reckitt did not stop marketing Suboxone tablets for safety reasons,this request is similarly baseless. No statutory or regulatory basis exists for Reckitt to seek theFDA tomake that determination. Reckitt knew that it did not remove Suboxone tablets from themarket for reasons of safety, it simply sought to hinder and delay the competition in the marketfor co-formulated buprenorphine/naloxone.

E. Direct Evidence ofAnti-competitive Effects ofDefendants' Actions65. As a result of the Defendants' conspiracy to maintain monopoly control through

anti-competitive conduct, generic manufacturers have been blocked from effectively competingin the market for co-formulated buprenorphine/naloxone.

66. Because competing co-formulated buprenorphine/naloxone products would beAB-rated equivalents to Defendants' branded Suboxone products (and therefore eligible forautomatic substitution) and priced below Defendants' branded Suboxone products, Plaintiff andthe Indirect Purchaser Class would have substituted genenc co-formulated

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buprenorphine/naloxone products for the more expensive branded Suboxone immediately uponentry into the market.

67. Defendants' agreements and anti-competitive conduct allowed Reckitt to set thecost of Suboxone at artificially inflated monopoly prices in the United States. This conduct hasharmed Plaintiff and all indirect purchasers of co-formulated buprenorphine/naloxone productsby preventing access to less-expensive generic substitutes for Suboxone and forcing indirectpurchasers to pay inflated prices for the branded drug. Defendants' conduct has had the directanti-competitive effects of foreclosing competition in the market for co-formulatedbuprenorphine/naloxone products and maintaining supra-competitive andmonopolistic prices forSuboxone.

68. There is no pro-competitive justification, countervailing efficiency, increase toconsumer welfare, or legitimate business reason for Defendants' conduct. Defendants' conducthas precluded, rather than expanded,competition.

69. Generic manufacturers of co-formulated buprenorphine/naloxone products hadextensive experience in the pharmaceutical industry, including having successfully obtainedapproval forANDAs and successfully selling generic pharmaceuticalproducts.

70. Generic manufacturers of co-formulated buprenorphine/naloxone products hadsufficient financial capacity tomanufacture product and were ready,willing, and able to do so.

71. As a result of Defendants' acquisition, possession, and maintenance of itsmonopoly power through unlawful means, generic manufacturers were prevented from enteringthe market with generic formulations of buprenorphine/naloxone products, consumers weredeprived of access to lower-cost generic versions ofbranded Suboxone and forced to pay inflated

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prices for the branded drug. Accordingly, Defendants' conduct had direct anti-competitiveeffects, for which defining a relevant market is not necessary.VI. RELEVANTMARKETANDMARKET POWER

72. In the alternative, the relevant product market in which to assess the effects ofDefendants' conduct is the market for Suboxone and its AB-rated equivalents, i.e., the coformulated buprenorphine/naloxone market. Because of the competitive relationship betweenbranded drugs and their generic competitors, such products comprise a distinct product marketfor antitrustpurposes.

73. Co-formulated buprenorphine/naloxone is a semi-synthetic opioid that is widelyprescribed for the treatment for opioid dependency and addition. Suboxone is the brandedversion of co-formulated buprenorphine/naloxone. Defendants have marketed two iterations ofSuboxone, including: (I) a Suboxone tablet; and (2) Suboxone film.

74. Several generic pharmaceutical manufacturers have sought FDA approval for ageneric co-formulated buprenorphine/naloxone tablet that is an AB-rated equivalent to theSuboxone tablet. These attempts have been thwarted and delayed by the anti-competitive tacticsby Reckitt as alleged herein.

75. The generic co-formulated buprenorphine/naloxoneproducts are AB-rated to theirSuboxone branded equivalents only. Thus, under most automatic substitution laws and rules,they are automatically substitutable for their Suboxone branded equivalents only. For example, ageneric co-formulated buprenorphine/naloxone tablet is AB-rated to the branded Suboxone tabletand is, thus, automatically substitutable only for the Suboxone tablet. However, because ageneric co-formulated buprenorphine/naloxone tablet would not be identical in dosage form to

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branded Suboxone film, the generic co-formulated buprenorphine/naloxone tablet is not ABrated to, and, therefore, not automatically substitutable for, Suboxone film.

76. Co-formulated buprenorphine/naloxone products are not automaticallysubstitutable for other treatments, and, therefore, replaceable products, at the pharmacy counter.Thus, the presence of other products indicated for the treatment of similar conditions, but notAls-rated to co-formulated buprenorphine/naloxone products, is not sufficient to prevent the anticompetitive effects ofDefendants' conduct relating to co-formulated buprenorphine/naloxone.

77. Generic co-formulated buprenorphine/naloxone products were set to be pricedsubstantially below branded Suboxone. Upon entry of Als-rated generic co-formulatedbuprenorphine/naloxone, these lower-priced products, within a matter of months, would divertthe overwhelming majority of sales from branded Suboxone products.

78. The relevant geographic market in which to assess the effects of Defendants'conduct is the United States. The FDA's regulatory process for approving drugs for sale only inthe United States, and the fact that the marketing, sales, and distribution of pharmaceuticalsoccur on a nationwide basis, establish the boundaries of the geographic market.

79. There are substantial barriers to entry in the relevant market, including the FDA'sregulatory requirements. Moreover, through their anti-competitive, exclusionary conduct,Defendants have erected additional, artificial barriers to entry in the relevant markets.

80. At all relevant times, Defendants possessed monopoly power in the relevantmarket.VII. CLASS ACTION ALLEGATIONS

81. Plaintiff, on behalf of i tself and the classes of indirect purchasers it seeks torepresent, demands monetary, equitable, injunctive, and declaratory relief against Defendants

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based on allegations of anti-competitive conduct in the market for Suboxone and AB-ratedgeneric equivalents.

82. Plaintiffb rings this action on behalf of i tself and, under Fed. R. Civ. P. 23(a) and(b)(2) as representative of a United States Indirect Purchaser Class, defined as follows:

All persons or entities in the United States and its territories who reimbursed for,or purchased Suboxone indirectly from Reckitt, other than for resale, at any timeduring the period October 8, 2009 to the present. Excluded from tile UnitedStates Indirect Purchaser Class are Defendants and their officers, directors,management, employees, subsidiaries, or affiliates, and all governmental entities.83. Injunctive re lief is appropriate under Rule 23(b)(2) because, as alleged herein

Defendants have acted on grounds generally applicable to the United States Indirect PurchaserClass, thereby making appropriate final injunctive reliefwith respect to the United States IndirectPurchaser Class as a whole.

84. Plaintiff brings this action on behalf of i tself and, under Fed. R Civ. P. 23(a) and(b)(3) as representative of a State Indirect Purchaser Class, defined as follows:

All persons or entities who reimbursed for, or purchased, Suboxone, indirectly fromReckitt, other than for resale, at any time during the period October 8, 2009 throughand until the anti-competitive effects of Defendants' conduct cease (tile "ClassPeriod") in Arizona, Arkansas, California, Florida, Kansas, Maine, Michigan,Minnesota, Mississippi, Missouri, Nevada, Nebraska, New Hampshire, NewMexico, New York, North Carolina, South Dakota, Tennessee, Utah, West Virginia,and Wisconsin. Excluded from the State Indirect Purchaser Class are Defendantsand their officers, directors, management, employees, subsidiaries, or affiliates,fully-insured health plans, i.e., plans that purchased insurance from another thirdparty payor covering 100% of the Plan's reimbursement obligations to its members,and all governmental entities.85. Members of the United States and State Indirect Purchaser Classes (collectively,

"Indirect Purchaser Classes") are so numerous and geographically dispersed that joinder isimpracticable. Further, the Indirect Purchaser Classes are readily identifiable from informationand records that are required by law to be maintained by pharmacies, drugstores, pharmaceutical

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benefit managers, and managed care organizations, as well as records in the possession of theDefendants.

86. Plaintiffs claims are typical of the claims of the members of the IndirectPurchaser Classes. Plaintiff and all members of the Indirect Purchaser Classes were damaged bythe same wrongful conduct of Defendants, i.e., they paid artificially inflated prices for co-formulated buprenorphine/naloxone products and were deprived of the benefits of competitionfrom cheaper generic versions ofSuboxone as a result ofDefendants' wrongful conduct.

87. Plaintiff will fairly and adequately protect and represent the interests of theIndirect Purchaser Classes. The interests of Plaintiff are coincidentwith, and not antagonistic to,those of the Indirect PurchaserClasses.

88. Plaintiff is represented by counsel who are experienced and competent in theprosecution of class action antitrust litigation and have particular experience with indirectpurchaser class action antitrust litigation involving pharmaceutical products.

89. Questions of law and fact common to the members of the Indirect PurchaserClasses predominate over questions that may affect only individual class members becauseDefendants have acted on grounds generally applicable to the Indirect Purchaser Classes, therebymaking monetary and equitable relief with respect to the Indirect Purchaser Classes as wholesappropriate. Such generally applicable conduct is inherent in Defendants' wrongful conduct.

90. Questions oflaw and fact commonto the Indirect Purchaser Classes include:(i) whether Defendants unlawfully prevented or delayed generic

manufacturers from coming to market with a generic coformulated buprenorphine/naloxone product in the United Statesthrough their actions and conduct;(ii) whether Defendants maintained and conspired to maintainmonopolypower by delaying generic entry or harming competitionin themarket for co-formulated buprenorphine/naloxone products;

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(iii) whether there is a non-pretextual pro-competitive justification forDefendants' product hopping and other exclusionaryconduct;(iv) whether direct proof of Defendants' monopoly power is available,and if available, whether it is sufficient to prove Defendants'monopoly power without the need to also define a relevantmarket;(v) to the extent a relevant market or markets must be defined, whatthat definition is or those definitions are;(vi) whether Defendants' product hopping strategy was improper andprevented or delayed competition;(vii) whether Defendants' citizen petition was improper and preventedor delayed competition;(viii) whether Defendants unlawfully excluded competitors and potential

competitors from the market for Suboxone and AB-rated genericbio-equivalents;(ix) whether Defendants' conduct caused antitrust injury to thebusiness or property of Plaintiff and the members of the IndirectPurchaserClasses; and(x) whether Defendants' conduct constituted unfair, unconscionable,and deceptive acts andpractices.

91. Class action treatment is a superior method for the fair and efficient adjudicationof the controversy. Such treatment will permit a large number of similarly situated persons toprosecute their common claims in a single forum simultaneously, efficiently, and without theunnecessary duplication of evidence, effort, or expense that numerous individual actions wouldengender. The benefits of proceeding through the class mechanism, including providing injuredpersons or entities a method for obtaining redress on claims that could not practicably be pursuedindividually, substantially outweighpotential difficulties in management of this class action.

92. Plaintiff knows of no special difficulty to be encountered in the maintenance ofthis action thatwould preclude its maintenance as a class action.

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VIII. CLAIMS FORRELIEFCOUNT I

Monopolization and Attempted Monopolization,Sherman Act, Section 2, 15 U.S.C. 2

93. Plainti ff repeats the allegations of the preceding paragraphs as if set forth herein.94. At all relevant times, Defendants have possessed monopoly power.95. During the Class Period, Defendants have willfully and unlawfully attempted to,

conspired to, and actually maintained and extended their monopoly power through theircontinued efforts to (I ) convert the market to new versions of Suboxone, on the eve of genericentry, in order to delay or prevent generic competition to Suboxone, thereby foreclosing genericmanufacturers from the market; and (2) manipulate the FDA regulatory processes to delay orprevent generic competition to Suboxone.

96. Defendants' conduct has had the direct and intended result of precluding genericcompetitors from entering the market and depriving consumers of less-expensive genericformulations ofbranded Suboxone. Accordingly, there is direct evidence of the anti-competitiveeffects ofDefendants' monopoly power and unlawful conduct, and no relevant market definitionis required.

97. In the alternative, Defendants maintain monopoly power in the United Statesmarket for co-formulated buprenorphine/naloxone. Defendants' conduct has impeded the sale ofsubstitutable generic co-formulated buprenorphine/naloxone in that relevant market, and thus hasallowed Defendants to sell Suboxone at artificially inflated prices.

98. Defendants' conduct was intended to suppress, rather than promote, competit ionon the merits, and it has had precisely the intended effect. Defendants have a specific intent toconspire to monopolize and actually monopolize the market for co-formulated

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buprenorphine/naloxone, and have taken affirmative exclusionary steps in furtherance of theirunlawful andmonopolistic conduct.

99. Defendants' conduct occurred in, and has had a substantial effect on, interstatecommerce.

100. As a direct and proximate cause of Defendants' unlawful, anti-competitiveconduct, Plaintiff and the United States Indirect Purchaser Class have been injured by payingmore for Suboxone than they would have absent Defendants' misconduct and anti-genericstrategies. Their injury further consists of being deprived of the ability to purchase cheapergeneric substitutes to Suboxone. Plaintiff continues to suffer and will suffer this injury in thefuture because of Defendants' commitment to ongoing anti-generic strategies designed to keepgeneric AB-rated substitutes for Suboxoneoff the market.

101. The injury sufferedby the Plaintiff and the United States Indirect Purchaser Classis the type the antitrust laws were designed to prevent and flows from Defendants' unlawfulconduct.

102. Plaintiff and the United States Indirect Purchaser Class seek equitable andinjunctive relief pursuant to Section 16of the Clayton Act, 15U.S.C. 26, to correct for the anti-competitive market effects caused by the unlawful conduct of Defendants and other relief so asto assure that similar anti-competitiveconduct does not occur in the future.

COUNT IIMonopolization and Attempted Monopolization and Conspiracy

to Monopolize under State Law103. Plaintiffrepeats the allegations of the preceding paragraphs as if set forth herein.104. At all relevant times, Defendants havepossessed monopoly power.

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105. During the Class Period, Defendants have willfully and unlawfully attempted to,conspired to, and actually maintained and extended their monopoly power through theircontinued efforts to (1) convert the market to new versions of Suboxone, on the eve of genericentry, in order to delay or prevent generic competition to Suboxone, thereby foreclosing genericmanufacturers from the market; and (2) manipulate the FDA regulatory processes to delay orprevent generic competition to Suboxone.

106. Defendants' conduct has had the direct and intended result of precluding genericcompetitors from entering the market and depriving consumers of less-expensive genericformulations of branded Suboxone. Accordingly, there is direct evidence of the anti-competitiveeffects ofDefendants' monopoly power and unlawful conduct, and no relevant market definitionis required.

107. In the alternative, Defendants maintain monopoly power in the United Statesmarket for co-formulated buprenorphine/naloxone. Defendants' conduct has impeded the sale ofsubstitutable generic co-formulatedbuprenorphine/naloxone in that relevant market, and thus hasallowedDefendants to sell Suboxone at artificially inflated prices.

108. Defendants' conduct was intended to suppress, rather than promote, competitionon the merits, and it has had precisely the intended effect. Defendants have a specific intent toconspire to monopolize and actually monopolize the market for co-formulatedbuprenorphine/naloxone, and have taken affirmative exclusionary steps in furtherance of theirunlawful andmonopolistic conduct.

109. Defendants' conduct occurred in part, and has had a substantial effect on, tradeand commerce in the states of Arizona, California, Kansas, Maine, Michigan, Minnesota,Mississippi, Nebraska, Nevada, New Mexico, New York, North Carolina, South Dakota,

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Tennessee, Utah, West Virginia, and Wisconsin. By engaging 111 the foregoing conduct,Defendants have violated the following state antitrust laws:

a. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofArizona Rev. Stat. 44-l402, et seq., with respect to purchases ofSuboxone in Arizona by members of the State Indirect Purchaser Class.

b. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofCal. Bus. & Prof. Code 16700, et seq., with respect to purchases ofSuboxone in California bymembers of the State Indirect Purchaser Class.

c. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofKan. Stat. Ann. 50-lOl, et seq., with respect to purchases of Suboxonein Kansas by members of the State Indirect Purchaser Class.

d. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofMe. Rev. Stat. Ann. 10, 1101, et seq., with respect to purchases ofSuboxone in Maine bymembers of the State Indirect Purchaser Class.

e. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofMich. Compo Laws Ann. 445.772, et seq., with respect to purchases ofSuboxone in Michigan by members of the State Indirect Purchaser Class.

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f. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofMinn. Stat. 325D.52, et seq., and Minn. Stat. 8.31, et seq., withrespect to purchases of Suboxone in Minnesota by members of the StateIndirect Purchaser Class.

g. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofMiss. Code Aim. 75-2l-3, et seq. with respect to purchases of Suboxonein Mississippi bymembers of the State Indirect Purchaser Class.

h. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofNeb. Code Aim. 59-802, et seq., with respect to purchases of Suboxonein Nebraska bymembers of the State Indirect Purchaser Class.

i. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofNev. Rev. Stat. Aim. 598A.060, et seq., with respect to purchases ofSuboxone in Nevadabymembers of the State Indirect Purchaser Class.

j. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofN.M. Stat. Aim. 57-1-2, et seq., with respect to purchases of Suboxonein New Mexico by members of the State Indirect Purchaser Class.

k. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation of

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New York General Business Law 340, et seq., with respect to purchasesof Suboxone in New York by members of the State Indirect Purchaser Class.

I. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofN.C. Gen. Stat. 75-2.l, et seq., with respect to purchases of Suboxone inNorth Carolinaby members of the State Indirect Purchaser Class.

m. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofS.D. Codified Laws Ann. 37-1, et seq., with respect to purchases of withrespect to purchases of Suboxone in South Dakota by members of the StateIndirect Purchaser Class.

n. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofTenn. Code Ann. 47-25-IOI, et seq., with respect to purchases ofSuboxone in Tennessee by members of the State Indirect Purchaser Class.

o. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofUtah Code Ann. 76-10-911, et seq., with respect to purchases ofSuboxone in Utah by members of the State Indirect Purchaser Class.

p. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofW.Va. Code 47-18-3, et seq., with respect to purchases of Suboxone inWest Virginia by members of the State Indirect Purchaser Class.

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q. Defendants have intentionally and wrongfully engaged in monopolization,attempted monopolization and a conspiracy to monopolize in violation ofWis. Stat. 133.03, et seq., with respect to purchases of Suboxone inWisconsin by members of the State Indirect Purchaser Class.

1I0. As a direct and proximate cause of Defendants' unlawful, anti-competitiveconduct, Plaintiff and the State Indirect Purchaser Class have been injured and have suffereddamage to their business and property by reason of Defendants' misconduct and anti-genericstrategies. Such injury consists of paying more for Suboxone during the Class Period than theywould have absent Defendants' misconduct. Such injury further consists of being deprived ofthe ability to purchase cheaper generic snbstitntes to Suboxone.

111. Plaintiff continues to suffer and will suffer this injury in the future because ofDefendants' commitment to ongoing anti-generic strategies, designed to keep generic AB-ratedsubstitutes for Suboxone of f the market.

112. TIle injury suffered by the Plaintiff and the State Indirect Purchaser Class is thetype the antitrust laws were designed to prevent and flows from Defendants' unlawful conduct.

113. For the conduct alleged herein, Plaintiff and the State Indirect Purchaser Classseek treble damages and injunctive and declaratory relief pursuant to the aforementioned stateantitrust laws.

COUNT II I(Unfair and Deceptive Trade Practices Under State Law)

114. Plaintiffrepeats the allegations of the precedingparagraphs as if set forth herein.115. During the relevant period, Defendants have willfully and unlawfully engaged in

unfair and deceptive trade practices by: (1) fraudulently representing to consumers and the FDAthat their multiple reformulations of Suboxone, including changes from tablets to film, added

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some therapeutic or safety benefit for consumers justifying the changes; (2) destroying demandfor its Suboxone tablets; (3) sabotaging the generic ANDA approval process; and (4) slowingdown the generic ANDA approvalprocess by filing a sham Citizen Petitionwith the FDA.

116. Defendants' unfair, fraudulent, and deceptive trade practices were designed withthe specific intent to injure competing generic drug manufacturers by preventing their entry intothe market for co-formulated buprenorphine/naloxone products. Defendants' trade practices hadthe intended and actual effect of: (1) forcing their generic competitors to spend millions ofdollars reformulating their generic co-formulated buprenorphine/naloxone products; and (2)actually foreclosing generic competition to Suboxone.

117. Defendants' unfair, fraudulent, and deceptive trade practices were undertakenwith the specific intent to destroy or substantially lessen competition in the market for coformulated buprenorphine/naloxone products. Defendants' deceptive trade practices had theintended and actual effect of forcing consumers to pay supra-competitive and artificially inflatedprices for Suboxone in the absence of a competing genenc co-formulatedbuprenorphine/naloxone product.

118. Defendants' conduct occurred in part, and has had a substantial effect on, tradeand commerce in the states of Arkansas, California, Florida, Kansas, Maine, Minnesota,Missouri, Nevada, Nebraska, New Hampshire, New Mexico, New York, North Carolina,Pennsylvania, Rhodes Island, South Dakota, Utah, West Virginia. The foregoing conductconstitutes unfair and deceptive trade practices, and accordingly:

a. Defendants have engaged in unfair competition or unfair or deceptive actsor practicesin violationofArk. CodeAnn. 4-88-101, et seq.

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b. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofCal. Bus. & Prof. Code 17200, et seq.

c. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofFla. Stat. 501.201, et seq.

d. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofKan. Stat. 50-623, et seq.

e. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation of 5Me. Rev. Stat. 207, et seq.

f. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofMinn. Stat. 8.31, et seq.

g. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofMissouri Stat. 407.0l0, et seq.

h. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofNeb. Rev. Stat. 59-1601, et seq.

L Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofN.H. Rev. Stat. 358-A:I, et seq.

J. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofN.M. Stat. 57-12-1, et seq.

k. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofN.Y. Gen. Bus. Law 349, et seq.

1. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofN.C. Gen. Stat. 75-1.1, et seq.

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m, Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation of73 Pa. Stat. Ann. 201-1,etseq.

n. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofR.I. Gen.Laws 6-13.l-I, etseq.

o. Defendants have engaged in unfair competition or unfair or deceptive actsor practicesin violationofSD. CodeLaws37-24-1, et seq.

p. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation ofUtah Code 13-11-1,et seq.

q. Defendants have engaged in unfair competition or unfair or deceptive actsor practices in violation of West VirginiaCode 46A-6-101, et seq.

119. As a direct and proximate cause of Defendants' unlawful and deceptive tradepractices, Plaintiff and the State Indirect Purchaser Class have been injured and have suffereddamage to their business and property by reason of Defendants' misconduct and anti-genericstrategies. Such injury consists of paying more for Suboxone during the Class Period than theywould have absent Defendants' misconduct. Such injury further consists of being deprived ofthe ability to purchase less expensive generic substitutes to Suboxone.

120. Plaintiff continues to suffer and will suffer this injury in the future because ofDefendants' commitment to ongoing anti-generic strategies designed to keep generic AB-ratedsubstitutes for Suboxone off themarket.

121. For the conduct alleged herein, constituting deceptive trade practices that haveinjured competitors and destroyed or substantially lessened competition, Plaintiff and the StateIndirect Purchaser Class seek damages, interest, and injunctive and declaratory relief, pursuant tothe aforementioned state consumerprotection statutes.

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~ . DEMAND FOR JUDGMENTWHEREFORE, Plaintiff, on behalf of itself and the Indirect Purchaser Class, respectfully

prays that the Court:Determine that this action may be maintained as a class action pursuant to Fed. R. Civ. P.23(a), (b)(2), and (b)(3), and direct that reasonable notice ofthis action, as provided by Fed.R. Civ. P. 23(c)(2) be given to the United States and State Indirect Purchaser Classes anddeclare Plaintiffas the representative of the Indirect Purchaser Classes;Enter joint and several judgments against Defendants in favor of Plaintiff and the IndirectPurchaser Classes;Adjudge the acts alleged herein, pursuant to Fed. R. Civ. P. 57 and 18U.S.C. 2201(a), tobe unlawful pursuant to Section 2 of the Sherman Act, 15 U.S.C. 2 and the aforementionedstate antitrust and consumer protection statutes;Award the State Indirect Purchaser Classes damages as provided by law in an amount to bedetermined at trial;Permanently enjoin the Defendants pursuant to Sections 4 and 16 of the Clayton Act, 15U.S.C. l5(a) and 26, from continuing their unlawful contract, so as to assure that similaranti-competitive conduct does not occur in the future;Award Plaintiff and the Indirect Purchaser Classes their costs of suit, including reasonableattorneys' fees as provided by law; andGrant such other further relief as is necessary to correct for the anti-competitive marketeffects caused by the unlawful conduct ofDefendants and as the Court deems just.

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Dated: April 5, 2013

BY:

TRUJILLO RODRIGUEZ & RICHARDS, LLC) A / ~ ~IRA NEIL RICHARDSPA i l l NO. 508791717 Arch Street, Suite 3838Philadelphia, PA 19103Telephone: (215) 731-9004Facsimile: (215)731-9044Email: [email protected]. BURI

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