IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

MICHIGAN REGIONAL COUNCIL OF CARPENTERS EMPLOYEE BENEFITS FUND, on Behalf ofItself and All Others Similarly Situated, Plaintiff,
v.

C.A. No.

CLASS ACTION

JURY TRIAL DEMANDED RECKITT BENCKISER INC.; RECKITT BENCKISER LLC; RECKITT BENCKISER PHARMACEUTICAL, INC.; RECKITT BENCK1SER HEALTHCARE (UK) LTD.; and RECKITT BENCKISER GROUP pIc, Defendants.

CLASS ACTION COMPLAINT

Plaintiff, Michigan Regional Council of Carpenters Employee Benefits Fund ("Plaintiff' or "the Fund") on behalf of itself and all others similarly situated, for its Complaint against Reckitt Benckiser Inc., Reckitt Benckiser LLC, Reckitt Benckiser Pharmaceuticals, Inc., Reckitt Benckiser 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 its counsel; and (c) information and belief:
I. NATURE OF THE ACTION

I.

This is a civil antitrust action challenging Defendants' unlawful exclusion of

generic competition for co-formulated buprenorphine hydrochloride and naloxone hydrochloride dehydrate ("co-formulated buprenorphine/naloxone"), sold under the brand-name Suboxone. As more fully described below, Reckitt engaged in an unlawful product-hopping scheme to maintain

and extend its monopoly power and prevent the market entry of generic products to compete against the branded pharmaceutical. Through multiple, concerted, and deliberate anti-

competitive tactics, commencing as early as 2009, Defendants have harmed Plaintiff and all other indirect purchasers of Suboxone by charging inflated and monopolistic prices for the branded drug. 2. Defendants have accomplished their anti-competitive goals through the use of

various strategies that were designed to unlawfully interfere with the regulatory process, cause delays in the approval of generic versions of Suboxone, and disrupt the market for co-formulated buprenorphine/naloxone products. Defendants' conduct constitutes a conspiracy to monopolize in violation of, and pursuant to, the Shennan Act, Section 2, 15 U.S.C. l and 2, in addition to state antitrust and consumer protection 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 like

withdrawal. Buprenorphine is generally viewed to have a less euphoric effect and less of a potential for abuse compared to methadone and is thus less likely to be diverted to the black market. Naloxone is an opioid antagonist, and acts to deter the abuse of the drug by intravenous injection. Suboxone is the brand name version of co-formulated buprenorphine/naloxone. Over $1 billion of Suboxone is sold in the United States annually. 4. Defendants used several anti-competitive tactics with the intention of foreclosing

generic competition in the market for co-formulated buprenorphine/naloxone. As described in detail below, Defendants made changes to branded Suboxone which provided no therapeutic benefit (even reducing the therapeutic benefit), ceased promoting the prior version of branded

Suboxone, removed already-distributed product from the market, and engaged in additional efforts to delay approval of competing generic versions of these products. Because a generic drug 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 generic manufacturers from launching commercially viahle competing generic versions of co-formulated buprenorphine/naloxone. These actions ensured that Plaintiff and other end-users would

continue to pay inflated prices for branded Suboxone.

II. LEGAL AND REGULATORY BACKGROUND A. The Regulatory Structure for Approval of Generic Drugs and Substitution of Generics for Brand-Name Drugs

5.

Under the Federal Food, Drug, and Cosmetic Act ("FDCA"), manufacturers who

create a new drug product must obtain the approval of the FDA to sell the new drug by filing a New Drug Application ("NDA"). 21 U.S.C. 301-92. A NDA must include submission of specific data conceming the safety and effectiveness of the drug, as well as any information on applicable patents. 21 U.S.C. 355(a) and (b). 6. When the FDA approves a brand-name manufacturer's NDA, the brand

manufacturer may list any patents that the brand manufacturer believes could reasonably be asserted against a generic manufacturer who makes, uses, or sells a generic version of the brandname drug prior to the expiration of the listed patents in the FDA's Orange Book. Patents issued after NDA approval may 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 about

patents' validity and applicability; the FDA does not have the resources to check the manufacturer's representations for accuracy or trustworthiness.

B.

The Hatch-Waxman Amendments

8.

Enacted in 1984, the Hatch-Waxman Amendments simplified the regnlatory

hurdles for prospective generic manufacturers by eliminating the need for them to file lengthy and 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 a brand-name drug may file an abbreviated new drug application ("ANDA"). ANDAs rely on the scientific findings of safety and effectiveness included in the brand-name drug manufacturer's original NDA, but must show that the generic drug contains the same active ingredient(s), dosage form, route of administration, and strength as the brand-name drug drug is bioequivalent to the brand-name drug, bioequivalent to branded drugs an "AB" rating. 9. The FDCA and Hatch-Waxman Amendments operate on the presumption that that is, that the generic

The FDA assigns generic drugs that are

bioequivalent drug products containing identical amounts of the same active ingredients in the same route of administration and dosage form, and meeting applicable standards of strength, quality, purity, and identity, are therapeutically equivalent and may be substituted for one
another, Thus, bioequivalence demonstrates that the active ingredient of the proposed generic

drug would be present in the blood of a patient to the same extent and for the same amount of time as the branded counterpart. 10. Through the Hatch-Waxman Amendments, Congress sought to expedite the entry

of generic drugs, thereby reducing healthcare expenses nationwide. Congress also wanted to protect pharmaceutical companies' incentives to create new and innovative products. 11. The Hatch-Waxman Amendments achieved both goals, substantially advancing

the rate of generic product launches and ushering in an era of historic high-profit margins for brand-name pharmaceutical companies.
In 1983, before enactment of the Hatch-Waxman

Amendments, only 35% of the top-selling drugs with expired patents had generic versions available; by 1998, nearly all did. In 1984, prescription drug revenue for branded and generics totaled $21.6 billion and generic drugs accounted for 18.6% of prescriptions. By 2009, total prescription drug revenue had soared to $300 billion and generic drugs accounted for 75% of prescriptions.
C. Citizen Petitions

12.

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 from taking, any form of administrative action. This mechanism is commonly referred to as a Citizen Petition. 13. Citizen Petitions were created to provide an opportunity for individuals to express

genuine concerns about legitimate safety, scientific, or legal issues regarding a product any time before, or after, its market entry. Other than the form of such Citizen Petition, the regulations place no restrictions on the subject matter of a Citizen Petition. 14. and why. The Citizen Petition must contain a statement of what action is being requested, Such justification, if appropriate, includes scientific data and other technical

information. The submitter is required to provide a certification that the petition includes all information and views on which the petition relies, and it must also include representative data known to the petition that is unfavorable to the position advocated in the Citizen Petition. 15. FDA regulations concerning Citizen Petitions require the FDA commissioner to

respond to, but not necessarily to resolve, each Citizen Petition within 180 days of receipt. The Commissioner may approve the request in whole or in part, deny the request, or provide a tentative response with an estimate as to when it will issue a final response.

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 and clearance of the petition response. These activities strain the FDA's limited resources. For these reasons, the FDA's final response to a Citizen Petition typically takes much longer than 180 days. 17. Abusive and anti-competitive Citizen Petitions have become an increasingly

common problem in the last several years as brand name companies have come to realize the immense profits that result from delaying generic competition by even a few months. In some such cases, Citizen Petitions have been filed with respect to ANDAs that have been pending for a year 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 filing an improper Citizen Petition is usually trivial compared to the value of securing a few months delay in generic competition. 18. FDA officials have acknowledged abuses of the Citizen Petition process. Former

FDA Chief Counsel Sheldon Bradshaw noted that in his time at the agency, he had "seen several examples of citizen petitions that appear designed not to raise timely concerns with respect to the legality or scientific soundness of approving a drug application but rather to try to delay the approval simply by compelling the agency to take the time to consider arguments raised in the petition whatever their merits and regardless of whether or not the petitioner could have made those very arguments months and months before." Speech before the Generic Pharmaceutical Association Annual Policy Conference (Sept. 19, 2005).

19.

Specifically in reference to Citizen Petitions that address the approval of generic

drug products, Gary Buehler, R.Ph., Director of the Office of Generic Drugs, Center for Drug Evaluation and Research ("CDER") at the FDA, remarked in July 2006 that "very few ... have presented data or analysis that significantly altered FDA's policies." Mr. Buehler went on to observe that of 42 Citizen Petitions raising issues regarding the approvability of generic products, only three petitions led the FDA to change its policy on the basis of data or information actually submitted with the Citizen Petition. 20. The abuse of the Citizen Petition process by brand name manufacturers led

Congress to enact the FDA Amendments Act of 2007, 21 U.S.C. 355(q) (the "2007 Amendments"). In relevant part, the 2007 Amendments require the FDA to not delay approval of a pending ANDA because of a Citizen Petition unless such a delay is necessary to protect the public health. The 2007 Amendments also enabled the FDA to summarily deny any Citizen Petition where the primary purpose of the petition is to delay competition entering the market. D. 21. The Benefits of Generic Drugs 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 significant discount to the referenced listed branded drug and, as additional generic drugs enter tile marketplace, generic drug prices fall even further in comparison to the referenced listed branded drug. 22. Generic drug competition generates large savings for purchasers. A 1998

Congressional 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 the corresponding brand name products. The FDA has found that consumers whose needs can be fully satisfied with generic drugs could enjoy reductions of 52% in their daily medication costs. 7

Savings From Generic Drugs Purchased From Retail Pharrnacies, http://www.fda.gov/Drugs/ EmergencyPreparedness/BioterrorismandDrugPreparedness/ucml34205.htm (Last visited

February 21, 2013). Most recently, a September 2011 study commissioned by the Generic Pharmaceutical Association found that generic drugs saved the U.S. health care system more than $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 Services establishing 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 delay

generic competition to Suboxone, prescription drug purchasers have been unable to enjoy similar savings with respect to purchases of co-formulated buprenorphine/naloxone products.
III. JURISDICTION AND VENUE

23.

This Court has subject matter over this action pursuant to 15 U.S.C. 26, and

28 U.S.C. 1331 and 1337. This Court also has jurisdiction over this class action pursuant to 28 U.S.C. 1332(d). The amount in controversy, exclusive of interest and costs, exceeds $5 million. 24. Defendants transact business within this District. Venue is appropriate within this

District under 28 U.S.C. 1391(b) because a substantial part of the events or omissions giving rise to the claim occurred in this District.
IV. THE PARTIES

25.

Plaintiff, Michigan Regional Council of Carpenters Employee Benefits Fund is a

Taft-Hartley fund located in Troy, Michigan that provides health and welfare benefits to union membership. The Fund is responsible for reimbursing or paying for members' purchases of prescription drugs such as Suboxone. Beneficiaries of the F1Uld purchased Suboxone in the state

of Michigan, during the Class Period, for personal use other than for resale. The Fund purchased and/or provided reimbursement for some or all of the purchase price for these Suboxone purchases. Plaintiff and its beneficiaries have been injured in their business or property by having 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, and deceptive conduct described herein, both individually and in a manner that was common and typical of the Indirect Purchaser Class members (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 principal

place 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 conduct alleged herein. 27. Defendant Reckitt Benckiser LLC is a Delaware limited liability company with

its principal place of business located at Morris Corporate Center IV, 399 lnterpace 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 conduct alleged herein. 28. Defendant Reckitt Benckiser Pharmaceutical, Inc. is a Delaware corporation with

its principal place of business located at The Fairfax Building, 10710 Midlothian Turnpike, Suite 430, Riclnnond, Virginia 23235. This defendant manufactures and markets numerous consumer products, including pharmaceutical drugs subject to FDA approval, and was responsible for the conduct alleged herein.

29.

Defendant Reckitt Benckiser Healthcare (UK) Ltd. is a British corporation

incorporated under the laws of England and Wales, with its registered office located at Dansom Lan, Hull, North Humberside HU8 7DS. This defendant manufactures and markets numerous consumer products, including pharmaceutical drugs subject to FDA approval, and was responsible for the conduct alleged herein. 30. Defendant Reckitt Benckiser Group pic is a British corporation incorporated

under the laws of England and Wales, with its registered office located at Tumer House, 103-105 Bath Road, Slough, Berkshire, SLI 3UH, England. This defendant manufactures and markets numerous consumer products, includes pharmaceutical drugs subject to FDA approval, and was responsible for the conduct alleged herein. 31. "Defendants." 32. All ofDefendants' actions described in this complaint are part of, and in furtherance The five foregoing defendants are referred to herein as "Reckitt" or

of, the illegal monopolization, restraints of trade and unfair, unconscionable, and deceptive acts and practices alleged herein, and were authorized, ordered, and/or done by Defendants' various officers, agents, employees, or other representatives while actively engaged in the management of Defendants' affairs within the course and scope of their duties and employment, and/or with the actual, apparent, and/or ostensible authority of Defendants.

10

V.

DEFENDANTS' UNLAWFUL CONDUCT A. Background on Co-Formulated Buprenorphine/Naloxone 33. In October, 2002, the FDA approved the marketing and sale of Suboxone for At the time Suboxone was initially approved, the FDA

treatment of opiate dependence.'

provided Reckitt with protection from generic competition. By categorizing it as an "orphan drug", 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 the small target population associated with the disease, it lacks a sponsor to conduct the clinical trials necessary to receive FDA approval. Drug companies are provided incentives, like protection from 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 pharmaceutical company to orphan drug exclusivity. Such high sales were contrary to Reckitt's representation in its application for orphan drug status that there was not a reasonable expectation that Reckitt would 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 the

end of that exclusivity, less-expensive generic versions of Suboxone were set to enter tile market. Suboxone comprised a substantial percentage of Reckitt's revenue and profits, thus generic entry posed 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/PostmarketDmgSafetylnformationforPatientsand Providers/ucm191521.

11

36.

Before Reckitt's exclusivity on Suboxone expired, Reckitt concocted a broad anti-

competitive scheme to maintain and extend its monopoly power over co-formulated buprenorphine/naloxone, by illegally preventing generic versions from competing with Suboxone. The scheme involved manipulating the complex distribution and regulatory approval process for pharmaceutical products in the United States. Reckitt's scheme involved a number of steps.

A.
37.

Suboxone Film Developed and Marketed in Order to Prevent Generic Versions of Co-Formulated BuprenorphinelNaloxone
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 of Suboxone. Reckitt filed its application in October of 2008. In order to obtain FDA approval of Suboxone film, Reckitt relied on previous studies that demonstrated the safety and efficacy of Suboxone tablets. No efficacy studies were performed on the Suboxone film itself. Instead, Reckitt showed that the film version of Suboxone had sufficiently equivalent bioavailability compared to the tablet version of Suboxone. Reckitt expressly told the FDA that any differences between the film and the tablet were "clinically insignificant." 38. The only difference between Suboxone tablets and Suboxone film that mattered to Generic Suboxone tablets could not be considered "AB-rated"

Reckitt was its dosage form.

equivalents to branded Suboxone film. Consequently, pharmacists could not legally substitute the 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 the primary 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

12

Suboxone tablet competition and preventing the price of co-formulated buprenorphine/naloxone from dropping to competitive levels. 39. After initially having its Suboxone film application rejected by the FDA due to

concems that that Suboxone film could be abused, misused, or more easily accessed by children. Reckitt later submitted a Risk Evaluation and Mitigation Strategy ("REMS") to address these issues, and the FDA ultimately approved Suboxone film on August 30, 2010. After approval, Reckitt began to market the new Suboxone film product. 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 not manufactured by Reckitt. It is manufactured for Reckitt by MonoSol Rx LLC in Warren, New Jersey. 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 Suboxone Tablets

41.

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. One

problem is that the bioavailability of naloxone is increased in the film version relative to the tablet version. This quality increases the risk that patients will experience unwanted opioid withdrawal, 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 tablet

version, meaning that it is more susceptible to division. Reckitt learned of this problem during clinical 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.

13

43.

The Suboxone film formulation also defeated a major benefit of Suboxone, its

low potential for abuse. Suboxone film was far easier to dissolve and inject than the Suboxone tablet formulation. 44. Furthermore, Suboxone film presented a larger danger to children than the Because the Suboxone film dissolves so rapidly, children who

Suboxone tablet version.

accidently place the Suboxone film in their mouths will absorb the buprenorphine quickly and completely, and would be unable to spit it out or remove it from their system. Upon introduction into the mouth, Suboxone film turns to a gel within 30 seconds, and erodes completely over the course 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 and terminate their exposure to buprenorphine. Even when the tablets are swallowed by children, the buprenorphine is absorbed to a far lesser extent compared with the film, and can also be vomited up before it is digested. 45. The packaging of Suboxone film also presented drawbacks compared to the

packaging of the Suboxone tablets. The doses of the film were packaged in a child-resistant sleeve. Once the sleeve was initially opened, however, it no longer provided any child

resistance. Once the sleeve was opened, there was no child-resistant bottle or container into which the unused doses could be safely placed, even though Reckitt knew that a significant segment of patients took their Suboxone in divided doses. In comparison, Suboxone tablets came in a childproof bottle that a patient could safely place unused portions of split Suboxone tablets. Also, because the Suboxone film doses came in the individual sleeves, the street value of the diverted product was increased because product identity and purity could be guaranteed.

14

46.

Patients themselves did not prefer Suboxone film to Suboxone tablets. Many

patients, in fact, preferred the tablets by a wide margin because the film formulation was more irritating to a patient's oral mucosa than the tablet. b. 47. Reckitt Introduced Suboxone Film for Anti-competitive Reasons

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 film would garner it any additional sales or revenues, lower its costs, or increase its efficiencies over the tablet formulation, Reckitt did not anticipate that it would be able to charge more for

Suboxone film than for Suboxone tablets. Instead, Reckitt anticipated that it would lose sales and revenues, increase its costs, and decrease its efficiency by developing and manufacturing Suboxone film, which was exactly what happened. 48. The lower sales and higher costs, however, did not matter to Reckitt. It was

willing to sacrifice a portion of its profits on Suboxone because the development of the Suboxone film formulation protected the majority of its profits by thwarting, delaying, and mitigating the impact of competition from generic Suboxone tablets by raising potential competitors' costs and excluding them from the most efficient means of distributing their generic Suboxone tablet products, by way of the automatic pharmacy substitution mechanism.
B.

Aftcr Suboxone Film Was Introduced, Reckitt Destroyed the Demand for Suboxone Tablets Once the FDA approved Suboxone film, Reckitt set about to destroy the demand

49.

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

15

50.

First, Reckitt raised the price for Suboxone tablets.

This maneuver made it

unattractive for patients and payers, which in turn drove demand to the Suboxone film

formulation.
51. Reckitt then refrained from packaging Suboxone tablets in childproof unit-dose

packaging, 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 not implement the unit-dose packaging, despite the fact that it knew as early as 2007, that pediatric exposure rates for Suboxone were very high. This was done simply to degrade the quality of Suboxone tablets relative to Suhoxone film. 52. Once generic Suboxone tablets were poised to enter the market, Reckitt

announced 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 start

selling their generic versions of Suboxone tablets, the prescription base for Suboxone tablets will have been almost entirely destroyed due to Reckitt's scheme. The vast majority of prescriptions are already being written for the film version of Suboxone. 54. Reckitt employed this scheme with one goal in mind: to destroy the demand and

the prescription base for Suboxone tablets and prevent generic versions of Suboxone tablets from effectively competing with branded Suboxone. With the new Suboxone film, generic versions of Suboxone tablets are unable to take advantage of the automatic generic substitution at pharmacies. C. 55. Reckitt Worked to Prevent Approval of Generic Suboxone Tablets 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 of their required ANDAs for the generic Suboxone tablets. Reckitt took advantage and, in effect, 16

sabotaged the process by which the generic Suboxone tablet ANDA filers needed to finalize and submit an FDA-required shared REMS. On January 6, 2012, the FDA communicated that it was going to require ANDA filers and Reckitt to submit a shared REMS. The FDA required the shared REMS, but did not anticipate or authorize that Reckitt would use this requirement of a shared REMS in order to delay and thwart ANDA approval. Because the FDA had just approved Reckitt's Suboxone tablet REMS in December of20ll, the FDA anticipated that a shared REMS could be developed rapidly. 56. Because Reckitt knew that a joint submission to the FDA was the last prerequisite

to 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 offered veiled pretexts in an attempt to disguise its overtly anti-competitive intentions. 57. Drug companies holding generic Suboxone tablet ANDAs have documented, in

writing, Reckitt's sabotage of the joint process. These generic drug companies formed the Buprenorphine 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. The members of the group reported to the FDA that Reckitt: (i) (ii) (iii) feigned cooperation with the shared REMS process; refused to participate in meetings with the generic ANDA filers; refused to discuss substantive issues with the generic ANDA filers regarding the shared REMS when it did attend meetings;

17

(iv)

placed unreasonable conditions on its cooperation with the shared REMS development process, knowing that the ANDA filers could not agree to them (like assuming Reckitt's tort liability by contract, which had nothing to do with the development of a joint REMS and would have caused the ANDA filers' liability insurers to disclaim coverage);

(v)

refused to share information with the generic ANDA filers about the existing REMS program that was essential to the shared REMS development process;

(vi)

raised last minute issues immediately prior to a shared REMS being submitted to the FDA in August of 2012, in order to cause still further delay; and

(vii) 58.

stopped participating altogether in September of2012.

Reckitt's actions sabotaged the shared REMS development and significantly

delayed the FDA's approval of one or more Suboxone tablet ANDAs. D. 59. Reckitt Files a Sham Citizen Petition with the FDA The generic Suboxone tablet ANDA filers resorted to filing a REMS program of

their own to the FDA of August of2012. Once this occurred, Reckitt knew that it was likely that the FDA would accept the generics-only shared REMS, as submitted or with modification, and then approve one or more generic Suboxone tablet ANDAs. In order to prevent that from taking place, Reckitt filed a sham Citizen Petition with the FDA to try to further delay FDA approval of ANDAs for Suboxone tablets. In its petition, Reckitt asked the FDA to withhold approval of generic 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 that Reckitt did not stop marketing branded Suboxone tablets for safety reasons. 18

60.

The sham petition was filed to interfere with competition by delaying the FDA

approval of generic Suboxone tablet ANDAs. Reckitt filed the petition only after its tactics to sabotage the shared REMS development process was no longer assured to work. Prior to the filing of Reckitt's petition, Reckitt did not share with the generic ANDA filers any of the information contained in Reckitt's petition. Reckitt, instead, kept the information set forth in its petition in its back pocket, surprising the generic ANDA filers at the last minute. TIle purported safety-related bases of Reckitt's petition to the FDA, Reckitt's secrecy and its own failure to take the actions it sought to require of the genetic ANDA filers demonstrates the anti-competitive nature of Reckitt's petition. If Reckitt had sincere concerns about safety, it would have been forthcoming about them and would not have kept the concerns a secret. If Reckitt had sincere concerns about safety, it would have adjusted its own products, not just seek the adjustment of products produced by other companies. 61. Reckitt's sham petition was baseless in other ways. First, the petition lacked

regulatory, scientific, and medical bases. Second, the FDA itselflacked the statutory authority to withhold 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 impose on the generic ANDA filers. Fourth, Reckitt's petition lacked clinically meaningful evidence that 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 to hinder lawful competition, and was a sham. 62. Substantial evidence demonstrates that Reckitt's petition lacked a reasonable

basis. Reckitt's requirement that generic ANDA filers include a pediatric exposure education

19

program did not have a statutory or regulatory basis. Reckitt itself had not included such an education 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 to

impose on the generic ANDA filers, Reckitt chose to ignore the FDA's public positions. The FDA wrote to Reckitt in March of 2010, saying that the FDA had concluded that since so many patients took Suboxone in divided daily doses, the unit-dose packaging might exacerbate the already high incidence of accidental pediatric buprenorphine exposure. "Because patients are known to divide tablets, it may be expected that patients will remove films from the package and have partial doses that are neither in the child-resistant pouch nor in a child-resistant medication bottle," the FDA told Reckitt. 64. As to Reckitt's request that the FDA withhold approval for the generic ANDA

filers 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 the FDA to make that determination. Reckitt knew that it did not remove Suboxone tablets from the market for reasons of safety, it simply sought to hinder and delay the competition in the market for co-formulated buprenorphine/naloxone.
E.
Direct Evidence of Anti-competitive Effects of Defendants' Actions

65.

As a result of the Defendants' conspiracy to maintain monopoly control through

anti-competitive conduct, generic manufacturers have been blocked from effectively competing in the market for co-formulated buprenorphine/naloxone. 66. Because competing co-formulated buprenorphine/naloxone products would be

AB-rated equivalents to Defendants' branded Suboxone products (and therefore eligible for automatic substitution) and priced below Defendants' branded Suboxone products, Plaintiff and the Indirect Purchaser Class would have 20 substituted genenc co-formulated

buprenorphine/naloxone products for the more expensive branded Suboxone immediately upon entry into the market. 67. Defendants' agreements and anti-competitive conduct allowed Reckitt to set the

cost of Suboxone at artificially inflated monopoly prices in the United States. This conduct has harmed Plaintiff and all indirect purchasers of co-formulated buprenorphine/naloxone products by preventing access to less-expensive generic substitutes for Suboxone and forcing indirect purchasers to pay inflated prices for the branded drug. Defendants' conduct has had the direct anti-competitive effects of foreclosing competition in the market for co-formulated buprenorphine/naloxone products and maintaining supra-competitive and monopolistic prices for Suboxone. 68. There is no pro-competitive justification, countervailing efficiency, increase to

consumer welfare, or legitimate business reason for Defendants' conduct. Defendants' conduct has precluded, rather than expanded, competition. 69. Generic manufacturers of co-formulated buprenorphine/naloxone products had

extensive experience in the pharmaceutical industry, including having successfully obtained approval for ANDAs and successfully selling generic pharmaceutical products. 70. Generic manufacturers of co-formulated buprenorphine/naloxone products had

sufficient financial capacity to manufacture product and were ready, willing, and able to do so. 71. As a result of Defendants' acquisition, possession, and maintenance of its

monopoly power through unlawful means, generic manufacturers were prevented from entering the market with generic formulations of buprenorphine/naloxone products, consumers were deprived of access to lower-cost generic versions ofbranded Suboxone and forced to pay inflated

21

prices for the branded drug. Accordingly, Defendants' conduct had direct anti-competitive effects, for which defining a relevant market is not necessary. VI. RELEVANT MARKET AND MARKET POWER 72. In the alternative, the relevant product market in which to assess the effects of

Defendants' conduct is the market for Suboxone and its AB-rated equivalents, i.e., the coformulated buprenorphine/naloxone market. Because of the competitive relationship between branded drugs and their generic competitors, such products comprise a distinct product market for antitrust purposes. 73. Co-formulated buprenorphine/naloxone is a semi-synthetic opioid that is widely

prescribed for the treatment for opioid dependency and addition. Suboxone is the branded version of co-formulated buprenorphine/naloxone. Defendants have marketed two iterations of Suboxone, including: (I) a Suboxone tablet; and (2) Suboxone film. 74. Several generic pharmaceutical manufacturers have sought FDA approval for a

generic co-formulated buprenorphine/naloxone tablet that is an AB-rated equivalent to the Suboxone tablet. These attempts have been thwarted and delayed by the anti-competitive tactics by Reckitt as alleged herein. 75. The generic co-formulated buprenorphine/naloxone products are AB-rated to their

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

22

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 automatically

substitutable 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 not Als-rated to co-formulated buprenorphine/naloxone products, is not sufficient to prevent the anticompetitive effects of Defendants' conduct relating to co-formulated buprenorphine/naloxone. 77. Generic co-formulated buprenorphine/naloxone products were set to be priced Upon entry of Als-rated generic co-formulated

substantially below branded Suboxone.

buprenorphine/naloxone, these lower-priced products, within a matter of months, would divert the 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 in the United States, and the fact that the marketing, sales, and distribution of pharmaceuticals occur 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's Moreover, through their anti-competitive, exclusionary conduct,

regulatory requirements.

Defendants have erected additional, artificial barriers to entry in the relevant markets. 80. market. At all relevant times, Defendants possessed monopoly power in the relevant

VII.

CLASS ACTION ALLEGATIONS

81. Plaintiff, on behalf of itself and the classes of indirect purchasers it seeks to

represent, demands monetary, equitable, injunctive, and declaratory relief against Defendants

23

based on allegations of anti-competitive conduct in the market for Suboxone and AB-rated generic equivalents. 82. Plaintiff brings this action on behalf of itself 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 time during the period October 8, 2009 to the present. Excluded from tile United States Indirect Purchaser Class are Defendants and their officers, directors, management, employees, subsidiaries, or affiliates, and all governmental entities. 83. Injunctive relief is appropriate under Rule 23(b)(2) because, as alleged herein

Defendants have acted on grounds generally applicable to the United States Indirect Purchaser Class, thereby making appropriate final injunctive relief with respect to the United States Indirect Purchaser Class as a whole. 84. Plaintiff brings this action on behalf of itself 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 from Reckitt, other than for resale, at any time during the period October 8, 2009 through and until the anti-competitive effects of Defendants' conduct cease (tile "Class Period") in Arizona, Arkansas, California, Florida, Kansas, Maine, Michigan, Minnesota, Mississippi, Missouri, Nevada, Nebraska, New Hampshire, New Mexico, New York, North Carolina, South Dakota, Tennessee, Utah, West Virginia, and Wisconsin. Excluded from the State Indirect Purchaser Class are Defendants and 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 is impracticable. Further, the Indirect Purchaser Classes are readily identifiable from information and records that are required by law to be maintained by pharmacies, drugstores, pharmaceutical

24

benefit managers, and managed care organizations, as well as records in the possession of the Defendants. 86. Plaintiffs claims are typical of the claims of the members of the Indirect

Purchaser Classes. Plaintiff and all members of the Indirect Purchaser Classes were damaged by the same wrongful conduct of Defendants, i.e., they paid artificially inflated prices for coformulated buprenorphine/naloxone products and were deprived of the benefits of competition from cheaper generic versions of Suboxone as a result of Defendants' wrongful conduct. 87. Plaintiff will fairly and adequately protect and represent the interests of the

Indirect Purchaser Classes. The interests of Plaintiff are coincident with, and not antagonistic to, those of the Indirect Purchaser Classes. 88. Plaintiff is represented by counsel who are experienced and competent in the

prosecution of class action antitrust litigation and have particular experience with indirect purchaser class action antitrust litigation involving pharmaceutical products. 89. Questions of law and fact common to the members of the Indirect Purchaser

Classes predominate over questions that may affect only individual class members because Defendants have acted on grounds generally applicable to the Indirect Purchaser Classes, thereby making monetary and equitable relief with respect to the Indirect Purchaser Classes as wholes appropriate. Such generally applicable conduct is inherent in Defendants' wrongful conduct. 90. Questions oflaw and fact common to 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 States through their actions and conduct; whether Defendants maintained and conspired to maintain monopoly power by delaying generic entry or harming competition in the market for co-formulated buprenorphine/naloxone products;

(ii)

25

(iii) (iv)

whether there is a non-pretextual pro-competitive justification for Defendants' product hopping and other exclusionary conduct; 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 relevant market; to the extent a relevant market or markets must be defined, what that definition is or those definitions are; whether Defendants' product hopping strategy was improper and prevented or delayed competition; whether Defendants' citizen petition was improper and prevented or delayed competition;

(v) (vi) (vii)

(viii) whether Defendants unlawfully excluded competitors and potential competitors from the market for Suboxone and AB-rated generic
bio-equivalents;

(ix)

whether Defendants' conduct caused antitrust injury to the business or property of Plaintiff and the members of the Indirect Purchaser Classes; and whether Defendants' conduct constituted unfair, unconscionable, and deceptive acts and practices.

(x) 91.

Class action treatment is a superior method for the fair and efficient adjudication

of the controversy. Such treatment will permit a large number of similarly situated persons to prosecute their common claims in a single forum simultaneously, efficiently, and without the unnecessary duplication of evidence, effort, or expense that numerous individual actions would engender. The benefits of proceeding through the class mechanism, including providing injured persons or entities a method for obtaining redress on claims that could not practicably be pursued individually, substantially outweigh potential difficulties in management of this class action. 92. Plaintiff knows of no special difficulty to be encountered in the maintenance of

this action that would preclude its maintenance as a class action.

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VIII. CLAIMS FOR RELIEF COUNT I Monopolization and Attempted Monopolization, Sherman Act, Section 2, 15 U.S.C. 2
93. 94. 95. Plaintiff repeats the allegations of the preceding paragraphs as if set forth herein. At all relevant times, Defendants have possessed monopoly power. During the Class Period, Defendants have willfully and unlawfully attempted to,

conspired to, and actually maintained and extended their monopoly power through their continued efforts to (I) convert the market to new versions of Suboxone, on the eve of generic entry, in order to delay or prevent generic competition to Suboxone, thereby foreclosing generic manufacturers from the market; and (2) manipulate the FDA regulatory processes to delay or prevent generic competition to Suboxone. 96. Defendants' conduct has had the direct and intended result of precluding generic

competitors from entering the market and depriving consumers of less-expensive generic formulations of branded Suboxone. Accordingly, there is direct evidence of the anti-competitive effects of Defendants' monopoly power and unlawful conduct, and no relevant market definition is required. 97.

In the alternative, Defendants maintain monopoly power in the United States

market for co-formulated buprenorphine/naloxone. Defendants' conduct has impeded the sale of substitutable generic co-formulated buprenorphine/naloxone in that relevant market, and thus has allowed Defendants to sell Suboxone at artificially inflated prices. 98. Defendants' conduct was intended to suppress, rather than promote, competition

on the merits, and it has had precisely the intended effect. Defendants have a specific intent to conspire to monopolize and actually monopolize the market for co-formulated

27

buprenorphine/naloxone, and have taken affirmative exclusionary steps in furtherance of their unlawful and monopolistic conduct. 99. commerce. 100. As a direct and proximate cause of Defendants' unlawful, anti-competitive Defendants' conduct occurred in, and has had a substantial effect on, interstate

conduct, Plaintiff and the United States Indirect Purchaser Class have been injured by paying more for Suboxone than they would have absent Defendants' misconduct and anti-generic strategies. Their injury further consists of being deprived of the ability to purchase cheaper generic substitutes to Suboxone. Plaintiff continues to suffer and will suffer this injury in the future because of Defendants' commitment to ongoing anti-generic strategies designed to keep generic AB-rated substitutes for Suboxone off the market. 101. The injury suffered by the Plaintiff and the United States Indirect Purchaser Class

is the type the antitrust laws were designed to prevent and flows from Defendants' unlawful conduct. 102. Plaintiff and the United States Indirect Purchaser Class seek equitable and

injunctive relief pursuant to Section 16 of the Clayton Act, 15 U.S.C. 26, to correct for the anticompetitive market effects caused by the unlawful conduct of Defendants and other relief so as to assure that similar anti-competitive conduct does not occur in the future. COUNT II
Monopolization and Attempted Monopolization and Conspiracy to Monopolize under State Law

103. 104.

Plaintiff repeats the allegations of the preceding paragraphs as if set forth herein. At all relevant times, Defendants have possessed monopoly power.

28

105.

During the Class Period, Defendants have willfully and unlawfully attempted to,

conspired to, and actually maintained and extended their monopoly power through their continued efforts to (1) convert the market to new versions of Suboxone, on the eve of generic entry, in order to delay or prevent generic competition to Suboxone, thereby foreclosing generic manufacturers from the market; and (2) manipulate the FDA regulatory processes to delay or prevent generic competition to Suboxone. 106. Defendants' conduct has had the direct and intended result of precluding generic

competitors from entering the market and depriving consumers of less-expensive generic formulations of branded Suboxone. Accordingly, there is direct evidence of the anti-competitive effects of Defendants' monopoly power and unlawful conduct, and no relevant market definition is required. 107. In the alternative, Defendants maintain monopoly power in the United States

market for co-formulated buprenorphine/naloxone. Defendants' conduct has impeded the sale of substitutable generic co-formulated buprenorphine/naloxone in that relevant market, and thus has allowed Defendants to sell Suboxone at artificially inflated prices. 108. Defendants' conduct was intended to suppress, rather than promote, competition

on the merits, and it has had precisely the intended effect. Defendants have a specific intent to conspire to monopolize and actually monopolize the market for co-formulated

buprenorphine/naloxone, and have taken affirmative exclusionary steps in furtherance of their unlawful and monopolistic conduct. 109. Defendants' conduct occurred in part, and has had a substantial effect on, trade

and commerce in the states of Arizona, California, Kansas, Maine, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Mexico, New York, North Carolina, South Dakota,

29

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 of Arizona Rev. Stat. 44-l402, et seq., with respect to purchases of Suboxone 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 of Cal. Bus. & Prof. Code 16700, et seq., with respect to purchases of Suboxone in California by members of the State Indirect Purchaser Class. c. Defendants have intentionally and wrongfully engaged in monopolization, attempted monopolization and a conspiracy to monopolize in violation of Kan. Stat. Ann. 50-lOl, et seq., with respect to purchases of Suboxone in 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 of Me. Rev. Stat. Ann. 10, 1101, et seq., with respect to purchases of Suboxone in Maine by members of the State Indirect Purchaser Class. e. Defendants have intentionally and wrongfully engaged in monopolization, attempted monopolization and a conspiracy to monopolize in violation of Mich. Compo Laws Ann. 445.772, et seq., with respect to purchases of Suboxone in Michigan by members of the State Indirect Purchaser Class.

30

f.

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

g.

Defendants have intentionally and wrongfully engaged in monopolization, attempted monopolization and a conspiracy to monopolize in violation of Miss. Code Aim. 75-2l-3, et seq. with respect to purchases of Sub oxone in Mississippi by members of the State Indirect Purchaser Class.

h.

Defendants have intentionally and wrongfully engaged in monopolization, attempted monopolization and a conspiracy to monopolize in violation of Neb. Code Aim. 59-802, et seq., with respect to purchases of Suboxone in Nebraska 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 of Nev. Rev. Stat. Aim. 598A.060, et seq., with respect to purchases of Suboxone in Nevada by members of the State Indirect Purchaser Class.

j.

Defendants have intentionally and wrongfully engaged in monopolization, attempted monopolization and a conspiracy to monopolize in violation of N.M. Stat. Aim. 57-1-2, et seq., with respect to purchases of Suboxone in 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

31

New York General Business Law 340, et seq., with respect to purchases of Suboxone in New York by members ofthe State Indirect Purchaser Class. I. Defendants have intentionally and wrongfully engaged in monopolization, attempted monopolization and a conspiracy to monopolize in violation of N.C. Gen. Stat. 75-2.l, et seq., with respect to purchases of Suboxone in North Carolina by 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 of S.D. Codified Laws Ann. 37-1, et seq., with respect to purchases of with respect to purchases of Suboxone in South Dakota by members of the State Indirect Purchaser Class. n. Defendants have intentionally and wrongfully engaged in monopolization, attempted monopolization and a conspiracy to monopolize in violation of Tenn. Code Ann. 47-25-IOI, et seq., with respect to purchases of Suboxone 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 of Utah Code Ann. 76-10-911, et seq., with respect to purchases of Suboxone 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 of W.Va. Code 47-18-3, et seq., with respect to purchases of Suboxone in West Virginia by members of the State Indirect Purchaser Class.

32

q.

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

1I0.

As a direct and proximate cause of Defendants' unlawful, anti-competitive

conduct, Plaintiff and the State Indirect Purchaser Class have been injured and have suffered damage to their business and property by reason of Defendants' misconduct and anti-generic strategies. Such injury consists of paying more for Suboxone during the Class Period than they would have absent Defendants' misconduct. Such injury further consists of being deprived of the ability to purchase cheaper generic snbstitntes to Suboxone. 111. Plaintiff continues to suffer and will suffer this injury in the future because of

Defendants' commitment to ongoing anti-generic strategies, designed to keep generic AB-rated substitutes for Suboxone off the market. 112. TIle injury suffered by the Plaintiff and the State Indirect Purchaser Class is the

type 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 Class

seek treble damages and injunctive and declaratory relief pursuant to the aforementioned state antitrust laws.

COUNT III
(Unfair and Deceptive Trade Practices Under State Law)

114. 115.

Plaintiff repeats the allegations of the preceding paragraphs as if set forth herein. During the relevant period, Defendants have willfully and unlawfully engaged in

unfair and deceptive trade practices by: (1) fraudulently representing to consumers and the FDA that their multiple reformulations of Suboxone, including changes from tablets to film, added 33

some therapeutic or safety benefit for consumers justifying the changes; (2) destroying demand for its Suboxone tablets; (3) sabotaging the generic ANDA approval process; and (4) slowing down the generic ANDA approval process by filing a sham Citizen Petition with the FDA. 116. Defendants' unfair, fraudulent, and deceptive trade practices were designed with

the specific intent to injure competing generic drug manufacturers by preventing their entry into the market for co-formulated buprenorphine/naloxone products. Defendants' trade practices had the intended and actual effect of: (1) forcing their generic competitors to spend millions of dollars 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 undertaken

with the specific intent to destroy or substantially lessen competition in the market for coformulated buprenorphine/naloxone products. Defendants' deceptive trade practices had the intended and actual effect of forcing consumers to pay supra-competitive and artificially inflated prices for Suboxone
in

the

absence

of

competing

genenc

co-formulated

buprenorphine/naloxone product. 118. Defendants' conduct occurred in part, and has had a substantial effect on, trade

and 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 conduct constitutes unfair and deceptive trade practices, and accordingly: a. Defendants have engaged in unfair competition or unfair or deceptive acts or practicesin violationof Ark. Code Ann. 4-88-101, et seq.

34

b.

Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation of Cal. Bus. & Prof. Code 17200, et seq.

c.

Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation of Fla. Stat. 501.201, et seq.

d.

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

e.

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

f.

Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation of Minn. Stat. 8.31, et seq.

g.

Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation of Missouri Stat. 407.0l0, et seq.

h.

Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation of Neb. Rev. Stat. 59-1601, et seq.

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

J.

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

k.

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

1.

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

35

m,

Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation of73 Pa. Stat. Ann. 201-1, et seq.

n.

Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation ofR.I. Gen. Laws 6-13.l-I, et seq.

o.

Defendants have engaged in unfair competition or unfair or deceptive acts or practicesin violationofSD. Code Laws 37-24-1, et seq.

p.

Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation of Utah Code 13-11-1, et seq.

q.

Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation of West Virginia Code 46A-6-1 01, et seq.

119.

As a direct and proximate cause of Defendants' unlawful and deceptive trade

practices, Plaintiff and the State Indirect Purchaser Class have been injured and have suffered damage to their business and property by reason of Defendants' misconduct and anti-generic strategies. Such injury consists of paying more for Suboxone during the Class Period than they would have absent Defendants' misconduct. Such injury further consists of being deprived of the ability to purchase less expensive generic substitutes to Suboxone. 120. Plaintiff continues to suffer and will suffer this injury in the future because of

Defendants' commitment to ongoing anti-generic strategies designed to keep generic AB-rated substitutes for Suboxone off the market. 121. For the conduct alleged herein, constituting deceptive trade practices that have

injured competitors and destroyed or substantially lessened competition, Plaintiff and the State Indirect Purchaser Class seek damages, interest, and injunctive and declaratory relief, pursuant to the aforementioned state consumer protection statutes.

36

~.

DEMAND FOR JUDGMENT

WHEREFORE, 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 and
declare Plaintiff as the representative of the Indirect Purchaser Classes; Enter joint and several judgments against Defendants in favor of Plaintiff and the Indirect Purchaser Classes; Adjudge the acts alleged herein, pursuant to Fed. R. Civ. P. 57 and 18 U.S.C. 2201(a), to be unlawful pursuant to Section 2 of the Sherman Act, 15 U.S.C. 2 and the aforementioned state antitrust and consumer protection statutes; Award the State Indirect Purchaser Classes damages as provided by law in an amount to be determined at trial; Permanently enjoin the Defendants pursuant to Sections 4 and 16 of the Clayton Act, 15 U.S.C. l5(a) and 26, from continuing their unlawful contract, so as to assure that similar anti-competitive conduct does not occur in the future; Award Plaintiff and the Indirect Purchaser Classes their costs of suit, including reasonable attorneys' fees as provided by law; and Grant such other further relief as is necessary to correct for the anti-competitive market effects caused by the unlawful conduct of Defendants and as the Court deems just.

37

Dated: April 5, 2013 BY:

TRUJILLO RODRIGUEZ & RICHARDS, LLC

)A/~~

IRA NEIL RICHARDS PA ill NO. 50879 1717 Arch Street, Suite 3838 Philadelphia, PA 19103 Telephone: (215) 731-9004 Facsimile: (215)731-9044 Email: ira@trrlaw.com CHRISTOPHER M. BURI<E WALTER W. NOSS SCOTT+SCOTT, ATTORNEYS AT LAW, LLP 707 Broadway, Strite 1000 San Diego, CA 9210 I Telephone: (619) 233-4565 Facsimile: (619) 233-0508 Email: cburke@scott-scott.com wnoss@scott-scott.com JOSEPH P. GUGLIELMO DONALD A. BROGGI PENELOPE D. ABDIEL SCOTT+SCOTT, ATTORNEYS AT LAW, LLP The Chrysler Building 405 Lexington Ave, 40th Floor New York, NY 10174 Telephone: (212) 223-6444 Facsimile: (212) 223-6334 Email: jgnglielmo@scott-scott.com dbroggi@scott-scott.com pabdiel@scott-scott.com DAVID R. SCOTT SCOTT+SCOTT, ATTORNEYS AT LAW, LLP 156 South Main Street P.O. Box 192 Colchester, CT 06415 Telephone: (860) 537-5537 Facsimile: (860) 537-4432 Email: david.scott@scott-scott.com

Attorneysfor Plaintiff

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