Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 1 of 38

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS John Gallagher, Richard Holden, Gerald Lutz, and all others similarly situated, Plaintiffs, vs. JURY DEMAND Pfizer, Inc., Warner-Lambert Company, and Ranbaxy Inc., Defendants. Case No. _____________________ CLASS ACTION COMPLAINT

1. Plaintiffs John Gallagher, Richard Holden and Gerald Lutz (collectively Plaintiffs), individually and on behalf of all other individuals and entities similarly situated, by and through their attorneys Berman DeValerio and Zimmerman Reed, PLLP, bring this action against Defendants Pfizer Inc. (Pfizer), Warner-Lambert Co. (Warner-Lambert), and Ranbaxy Inc. (Ranbaxy) (collectively Defendants), and allege as follows: INTRODUCTION 2. Pfizer is the largest pharmaceutical company in the world and the largest biopharmaceutical company in four global markets. Pfizers best selling drug is Lipitor, a drug whose active ingredient atorvastatin calcium is used to treat high cholesterol. 3. Lipitor is the most profitable drug in the history of the pharmaceutical business. Lipitor sales have reached over $13 billion per year worldwide and more than $1 billion per month. Pfizers total annual revenue from Lipitor reached up to $7 billion per year in the United States

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 2 of 38

alone. Due to Pfizers patents of key elements in Lipitor, the drug has constituted 20-30% of Pfizers total revenues since 2006 or earlier. 4. Two of the patents that Pfizer relied upon to maintain its monopoly and protect Lipitor are: a. U.S. Patent No. 4,681,893 (the 893 patent), which protected the active ingredient in Lipitor (atorvastatin calcium). This patent expired on March 24, 2010. b. U.S. Patent No. 5,273,995 (the 995 patent), an enantiomer patent on a particular form of the Lipitor molecule. This patent was later reissued as U.S. Patent No. 40,667 (the 667 patent). This patent expired on June 28, 2011. 5. In addition, Pfizer owned two process patents. U.S. Patent No. 6,087,511 (the 511 patent) and U.S. Patent No. 6,274,740 (the 740 patent) (collectively the Process Patents). These Process Patents protected the method by which atorvastatin calcium is made. 6. For over a decade, Pfizer, including its subsidiary Warner-Lambert, has used various exclusionary means as part of an overall scheme to improperly maintain and extend monopoly power in the atorvastatin calcium market. The goal of the scheme was to prevent or delay the successful entry of competitors which would have sold generic versions of atorvastatin calcium at prices significantly lower than Lipitor. This would have caused Pfizer to lose market share and potentially billions of dollars in revenue. 7. Warner-Lambert began the exclusionary scheme by misrepresenting the effectiveness of the key ingredient in Lipitor to fraudulently obtain the 995 patent. Due to Warner-Lamberts deception of the U.S. Patent and Trademark Office (PTO), Lipitor received patent protection for longer than it would normally have had. Pfizer continued the exclusionary scheme by

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 3 of 38

engaging in sham litigation to protect its fraudulently obtained Patents. Finally, Pfizer and Ranbaxy entered into an unlawful agreement to delay the entry of generic versions of Lipitor into the United States for up to 20 months after the Lipitor patents had expired. 8. Approximately 16 million Americans rely on Lipitor every day to control high cholesterol levels. Because of Defendants exclusionary scheme, Plaintiffs and millions of other Americans have purchased substantial amounts of Lipitor at artificially inflated prices. But for Defendants illegal conduct, generic competitors would have entered the market long ago and Plaintiffs and members of the class would have had access to necessary cholesterol medication at more affordable prices. JURISDICTION AND VENUE 9. This action arises under Section 4 of the Clayton Act, 15.U.S.C. 15 and 36, to

recover treble damages and the costs of suit, including a reasonable attorneys fee, for the injuries sustained by Plaintiffs and members of the class resulting from violations of Sections 1 and 2 of the Sherman Act, 15 U.S.C. 1 and 2. The jurisdiction of this Court is based upon 28 U.S.C. 1331 and 1337(a) and 15 U.S.C. 15. 10. The Court has supplemental subject matter jurisdiction of the pendent state law

claims under 28 U.S.C. 1367. 11. Venue is proper in this District pursuant to 28 U.S.C. 1391 (a) and (b) because

during the Class Period certain Defendants resided, transacted business, were found, or had agents in this District, and because a substantial portion of the affected interstate trade and commerce described herein is and has been carried out in this District. 12. Defendants conspiracy and conduct to prolong Pfizers Lipitor monopoly and to

unreasonably restrain trade substantially affected commerce throughout the United States, and in 3

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 4 of 38

each of the states identified herein, because Defendants directly, or through their agents, engaged in activities affecting each state. Defendants have purposefully availed themselves of the laws of each of these states in connection with their activities relating to the production, marketing, sale, and/or distribution of Lipitor. Defendants produced, promoted, sold, marketed, and/or distributed Lipitor, thereby purposefully profiting from access to purchasers in each of the states. As a result of the activities described herein, Defendants: a. Caused damage to the residents of the states identified herein; b. Caused damage in each of the states identified herein by acts or omissions committed outside each state and by regularly doing or soliciting business in each state; c. Engaged in a persistent course of conduct within each state and/or derived substantial revenue from the marketing and sale of Lipitor in each state; and d. Committed acts or omissions that they knew or should have known would cause damage (and, in fact, did cause damage) in each state identified herein while regularly doing or soliciting business in these states, engaging in other persistent courses of conduct in each state and/or deriving substantial revenue from the marketing and sale of Lipitor in each state.

13.

The Defendants named herein are found or transact business within this judicial

district, and conducted interstate trade and business in this district. Venue, therefore, is appropriate within this district under 15 U.S.C. 22 and 28 U.S.C. 1391(b) and (c). 14. This Court has supplemental subject matter jurisdiction of the pendent state law

claims under 28 U.S.C. 1367. PARTIES 15. Plaintiff John Gallagher is a resident of Lansing, IL. Due to Defendants

anticompetitive and fraudulent activities, Plaintiff Gallagher paid supra-competitive prices for Lipitor during the class period.

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 5 of 38

16.

Plaintiff Richard Holden is a resident of Port Charlotte, FL. Due to Defendants

anticompetitive and fraudulent activities, Plaintiff Holden paid supra-competitive prices for Lipitor during the class period. 17. Plaintiff Gerald Lutz is a resident of Circle Pines, MN. Due to Defendants

anticompetitive and fraudulent activities, Plaintiff Lutz paid supra-competitive prices for Lipitor during the class period. 18. Defendant Pfizer, Inc., is a Delaware corporation with its principal place of business

at 235 East 42nd Street, New York, New York 10017. 19. Defendant Warner-Lambert Company is a wholly owned subsidiary of Pfizer, and is

located at 235 East 42nd Street, New York, New York 10017. Warner-Lambert was acquired by Pfizer in June, 2000, and had been the owner of record of the relevant patents covering Lipitor since their issuance. 20. Defendant Ranbaxy, Inc., is a corporation organized and existing under the laws of

the State of Delaware, and has a place of business located at 600 College Road East, Princeton, New Jersey 08540. REGULATORY AND ECONOMIC BACKGROUND A. 21. Regulatory Background A manufacturer who creates a new, pioneer drug and seeks to patent the invention

must submit an application to the PTO. In order to be patentable, the invention cannot be known or used by others and cannot be described in a printed publication more than one year prior to the application. This requirement is referred to as the novelty requirement. 22. In addition, even if the invention is new, it must still be sufficiently different from

what has been used before so that it may be said that a person having ordinary skill in the area of 5

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 6 of 38

technology related to the invention would deem the invention non-obvious. This requirement prevents inventors from obtaining patent protection, and therefore monopoly power, for small and obvious changes to the original invention. For example, changes in size or color are not ordinarily patentable. 23. Further, the application must not be anticipated in that the technology which is the

basis of the application cannot be already covered by a previous patent. For example, a smaller component of an overall technology, which is already patented, is not ordinarily patentable. 24. Once a manufacturer has obtained the necessary patents, under the Federal Food,

Drug, and Cosmetics Act (21 U.S.C. 301-392) they must obtain the approval of the Food and Drug Administration (FDA) to sell the drug by filing a New Drug Application (NDA). An NDA must include specific data concerning the safety and efficacy of the drug. 25. In addition to information on safety and efficacy, NDA applicants must submit to the

FDA a list of all patents and prior art of the drug for which FDA approval is being sought. Prior art is a term used in patent law to refer to the body of previous knowledge and technology against which a patent application is judged to determine whether the claim is sufficiently novel to merit patent protection. 26. Once the NDA is approved, the FDA lists any patents referenced as part of the NDA

application process in a publication known as the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book.). 27. In 1984, Congress amended the Food, Drug and Cosmetics Act with the enactment of

the Hatch-Waxman amendments, called the Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 980417, 98 Stat. 1585 (1984) (Hatch-Waxman). Congress enacted the Hatch-Waxman to expedite and facilitate the development and approval of generic

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 7 of 38

drugs. Generic drugs are drugs that the FDA has found to have the same active chemical composition and provide the same therapeutic effects as the pioneer, brand-name drug. Congress enacted the Hatch-Waxman Act knowing that consumers benefit from choices and competition. 28. To effectuate its purpose, Hatch-Waxman simplified the regulatory hurdles for

prospective generic manufacturers by eliminating the need for them to file a lengthy and costly NDA in order to obtain FDA approval. Instead, they are allowed to file an Abbreviated New Drug Application (ANDA), which incorporates by reference the safety and effectiveness data developed and previously submitted by the manufacturer of the original, pioneer drug. 29. Under Hatch-Waxman, a generic manufacturers ANDA must contain one of four

certifications: a. That no patent for the brand-name drug has been filed with the FDA; b. That the patent for the brand-name drug has expired; c. That the patent for the brand-name drug will expire on a particular date and the generic company does not seek to market its generic product before that date; or d. That the patent for the brand-name drug is invalid or will not be infringed by the generic manufacturers proposed product (Paragraph IV certification). 30. If a generic manufacturer files an ANDA with a Paragraph IV certification, then the

pioneer drug manufacturer has the opportunity to initiate a patent infringement action. If the patent owner initiates an infringement action against the ANDA filer within 45 days, then the FDA cannot approve the ANDA until the earlier of either (1) 30 months or (2) the issuance of a decision by a court that the patent is invalid or not infringed by the generic manufacturers ANDA.

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 8 of 38

31.

Accordingly, brand-name drug patent holders need only file a patent infringement

lawsuit within 45 days of receipt of a Paragraph IV Certification in order to automatically block, for up to 30 months, an ANDA applicants generic drug from entering the market. 32. Hatch-Waxman incentivizes generic drug companies to challenge branded drug

patents and/or to design around them. It bestows on the first ANDA filer with a Paragraph IV Certification a 180-day exclusivity period in which it may market the generic version of the drug without fear of competition. During this exclusivity period, the FDA may not grant final approval to any other generic manufacturers ANDA for the same brand-name drug. The 180 day exclusivity period does not begin to run until either the first ANDA applicant enters the market with its generic equivalent, or a court enters a final judgment that the branded drugs patent(s) are invalid and not infringed. B. 33. Economic Benefits Of Generic Drugs Manufacturers of branded drugs work extremely hard to protect their patents against

Paragraph IV Certification filers because of the economic benefits these filers receive once the ANDA process is complete. 34. Typically, if the FDA approves an ANDA, it gives Paragraph IV certification filers

an AB rating. An AB rating is particularly significant to a generic manufacturer because, under the statutory regime enacted by both Congress (i.e. the Hatch-Waxman Act) and most state legislatures (i.e., Drug Product Selection, or DPS laws), pharmacists may substitute an ABrated generic version of a drug for the brand name drug without seeking or obtaining permission from the prescribing doctor (unless the prescription is denominated Dispense as Written, or DAW). Some states even require pharmacists to substitute AB-rated generic drugs for their brand name equivalents as a means of saving money.

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 9 of 38

35.

Both Congress and state legislatures have actively encouraged generic substitution

because of their recognition that the economics of the pharmaceutical industry prevent generic manufacturers from simultaneously (a) engaging in the type of heavy promotion or detailing typically done by brand name manufacturers, and (b) providing the enormous cost savings to purchasers and consumers generated by generic drugs. 36. Generic competition enables consumers to purchase generic versions of brand name

drugs at substantially lower prices. It also allows consumers to purchase brand name drugs at reduced prices because of the increased competition. However, until generic manufacturers enter the market with an AB-rated generic, there is no bio-equivalent generic drug which competes with the brand name drug, and therefore, the brand name manufacturer can continue to profitably charge supra-competitive prices. Consequently, brand name drug manufacturers have a strong incentive to use various tactics, including the wrongful tactics described herein, to delay the introduction of AB-rated generic competition into the market. FACTUAL ALLEGATIONS 37. Lipitor belongs to a class of drugs called statins. Discovered in the 1970s, statins

lower cholesterol by successfully limiting a cholesterol producing enzyme found in the liver. In the 1970s, researchers discovered that mevastatin, naturally occurring in red yeast and rice, and lovastatin, naturally occurring in red yeast, rice and oyster mushrooms, were highly potent cholesterol inhibitors. In the early 1980s, Merck sought and gained approval for Mevacor, a brand name version of lovastatin, the first statin available in the United States. 38. Following Mercks entry into the statin market, Warner-Lambert sought to enter the

market with their version of a statin. Researchers at Warner-Lambert came up with a formulation that was similar to mevastatin and lovastatin and called it atorvastatin. 9

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 10 of 38

A. The Original Lipitor Patent: The 893 Patent 39. On March 30, 1986, Warner-Lambert filed U.S. Patent Application No. 868867 for a

group of compounds and pharmaceutical compositions which together were useful in preventing the production of cholesterol. This patent application eventually resulted in the 893 Patent. 40. Warner-Lambert stated in their patent specification for the 893 Patent, that multiple

formulations of the same compound were included within the same patent application. Importantly, Warner-Lambert stated: The compounds of structural formula I above possess two asymmetric carbon centers, one at the 4-hydroxy position of the pyran-2-one ring, and the other at the 6-position of the pyran-2-one ring where the alkylpyrrole group is attached. This asymmetry gives rise to four possible isomers, two of where are the R-cis- and Scis-isomers and the other two of which are the R-trans- and S-trans-isomers. 41. Simply stated, Warner-Lambert recognized that the chemical formula listed in

the patent application covered four different compounds. The inventor of Lipitor, Dr. Bruce David Roth, stated, this one structure is meant to represent four different stereoisomers, the R-trans, S-trans, R-CIS, and S-CIS isomers at atorvastatin acid. Isomers are two or more chemical compounds with the same chemical formula but different arrangements of atoms. Stereo-isomers are isomers in which the same types of atoms are bonded together, but where the three-dimensional configuration of those atoms differ. 42. On July 21, 1987, the PTO issued the 893 Patent. In the absence of an extension,

this patent would have expired on May 30, 2006, twenty years from the date of the first application. Later extensions lengthened this period of patent protection until March 24, 2010. 43. While the 893 Patent covered multiple formulations, Warner-Lambert focused on

developing and commercializing atorvastatin, the R-trans enantiomer of a particular compound. 10

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 11 of 38

An R-trans enantiomer is a chemical formulation which is almost identical to a counterpart chemical formulation, the S-trans enantiomer. Often times, the body prefers one enantiomer over another and therefore, one is more effective than another. B. The Fraudulently Obtained 995 Patent 44. Although the 893 Patent would have (and did) provided Warner-Lambert with years

of patent protection, Warner-Lambert nevertheless sought to illegally extend its legal monopoly. But Warner-Lambert knew that the PTO would reject an application to patent an enantiomer already covered by the 893 Patent since such a patent would either be anticipated or obvious in light of the 893 Patent. Warner-Lambert could only obtain a follow-on patent specifically for the R-trans enantiomer if it could convince the PTO that the R-trans enantiomer had a surprising or unexpected characteristic. 45. Senior management at Warner-Lambert instructed their researchers to find this

surprising or unexpected characteristic by reviewing the existing biological data. During a senior level meeting, Warner-Lamberts management asked Roth to find any data that showed something surprising about the R-trans enantiomer which would make it patentable. 46. After looking over the old data, Roth and his team found that the R-trans

enantiomer was one hundred times more active than the S-trans enantiomer, and ten-times more active than the racemate. A racemate is a mixture which has equal amounts of R-trans and Strans enantiomers. 47. Using this data, Warner-Lambert submitted a patent application for the R-trans

enantiomer on July 21, 1989, despite it already being described within the 893 Patent. WarnerLamberts assertion was that the R-trans enantiomer was surprising because it was much more active than what they had expected it to be. In the application, Roth and Warner-Lambert

11

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 12 of 38

provided only one piece of evidence: a short table stating that Warner-Lamberts Cholesterol Synthesis Inhibition (CSI) data demonstrates the R-trans enantiomer is more active in inhibiting the synthesis of cholesterol than the S-trans enantiomer and the racemate. C. The CSI Table Is Misleading and Affirmatively False 48. Warner-Lamberts CSI table was both affirmatively false and intentionally presented

in a misleading manner. Warner-Lamberts CSI Table is misleading because it purports to present reliable and confirmed data, but does not. The CSI Table does not disclose the source of its data and fails to indicate the number of tests performed, the degree of variation in the test results, what molecules were tested, the time period over which the tests were run or whether the results presented were drawn from multiple tests. 49. The CSI table is also misleading because: (1) the tests were taken from a single run of

the same experiment but compared to data collected from the average of five separate tests, (2) the five benchmark tests, against which the CSI results were compared, were conducted over a three year period and are so variable that their average does not provide a scientifically meaningful result, and (3) the disparate values in the tests suggest that there were solubility issues that compromise the accuracy of the data. 50. Additionally, Warner-Lamberts claim that the R-trans enantiomer has surprising

activity is false. Warner-Lambert did not tell the PTO that it possessed data that expressly contradicted representations in its patent specifications. Specifically, separate tests conducted to measure how active R-trans enantiomers were, show that R-trans enantiomers were only twice as active as the S-trans enantiomer and the racemate; not 10 or 100 times more active as WarnerLambert claimed. In fact, the results from both Warner-Lamberts COR tests and ACIS tests contradicted Warner-Lamberts claim to the PTO.

12

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 13 of 38

51.

Warner-Lamberts own research reports conclude that the R-trans enantiomer was

approximately twice as active as the racemate. A May 31, 1989 report signed by Dr. Sliskovic states that the R-trans enantiomer was approximately twofold more active at inhibiting cholesterol synthesis acutely in vivo compared to the racemic mixture . . . . this is to be expected if 50% of the racemic salt is the inactive isomer. A June 1, 1989 report signed by Roth also reported a twofold increase in activity of the active enantiomer over the racemate: [a]s expected [the R-trans calcium salt] was two fold more potent than . . . the racemic calcium salt, which contains 50% inactive isomer. D. The PTOs Rejection of the 995 Patent Application 52. On March 22, 1990, pursuant to 35 U.S.C. 102(b), the PTO rejected all claims in the

initial application as anticipated by the Original 893 Patent. The PTO rejected WarnerLamberts enantiomer patent application because the invention was already covered by the claims in the 893 patent. 53. In response to this rejection, Warner-Lambert argued against anticipation on technical

grounds that the 995 application addressed specific enantiomers, and the 893 patent addressed only racemates. The PTO examiner rejected this argument as well and on November 7, 1990, issued a final rejection on anticipation grounds and stated that the 893 Patent described the Rtrans enantiomer: Applicants arguments . . . have been carefully considered, but such are not persuasive. Where a reference discloses a genus or compound of similar structure which are sufficiently limited in number, the reference is deemed to provide description of those compounds just as specifically as if they were identified by name.

13

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 14 of 38

The examiner observed that to isolate the claimed invention (the R-trans enantiomer) from the compounds disclosed in the 893 Patent, one merely has to select from the limited possibility of isomers to arrive at the claimed invention, and separate them using conventional techniques. 54. On February 29, 1991, Warner-Lambert revived its application and filed a

preliminary amendment. The amendment included a declaration by Roth (Roth Declaration). The Roth Declaration was submitted in order to overcome an obviousness rejection and support patentability of the R-trans enantiomer. To do so, the Roth Declaration claimed a surprising and unexpected tenfold increase in activity. However, the Roth Declaration simply presented more misleading and affirmatively false biological data. E. Roth Declarations Inaccuracies 55. The Roth Declaration, like the CSI Table, purported to present reliable scientific data

but did not disclose the source of that data. In fact, the source of the data was one single, deeply flawed test CSI 118. The test results were unusable for a number of reasons. 56. First, in order to obtain accurate values, the concentration of the test solutions must be

known prior to testing. However, Warner-Lambert did not determine the concentration of its test solutions prior to the CSI 118 test. Without accurate information about the concentration of the solutions, the values obtained cannot be used to demonstrate a tenfold increase in activity of the R-trans enantiomer over the racemate. 57. Second, Warner-Lamberts own lab books showed that the compounds in CSI 118 did

not dissolve completely in the stock solution. Using non-homogeneous suspensions can result in variations in the concentrations of the compound in the assay solution leading to wide variations in the results obtained. Given this limitation, the most that the CSI 118 results can be said to

14

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 15 of 38

determine is whether a compound has any activity, not whether a compound has increased activity as compared to another compound. 58. Third, an acceptable CSI test should record similar results for the racemic sodium salt

and the racemic calcium salt. Yet, in CSI 119, the results of the racemic sodium salt (.00977) and racemic calcium salt (.257) are vastly different, almost a twenty-five-fold difference. These results indicate that something was significantly wrong with the test. 59. Finally, the claim in the Roth Declaration of ten times activity was also affirmatively

false because the activity of the isolated R-trans enantiomer was not in fact ten times greater than the racemate. Had Warner-Lambert employed an acceptable scientific testing process, the data would have revealed the R-trans enantiomer had at best a twofold advantage over the racemate. F. The Final Deception 54. Warner-Lambert was aware of the numerous problems with CSI 118 identified above

and knew that the results of CSI 118 were not scientifically sound. Yet, in the face of radically different values for the sodium and calcium salts, solubility problems and unknown solution concentrations, they used this questionable and unreliable data to support the false claim that the isolated R-trans enantiomer has ten times greater inhibition of cholesterol synthesis than the racemate, and specifically claimed this as a surprising level of activity which, in turn, supports patentability. 55. On September 16, 1991, the PTO examiner issued a final rejection of the follow-on

patent application, rejecting all claims under 35 U.S.C. 102(b) as being anticipated by the 893 Patent for the reasons set forth in the two rejections issued in 1990. 56. On January 15, 1992, Warner-Lambert appealed the examiners rejection to the Board

of Appeals, claiming [t]he R isomer as claimed appears to be at least 100 times more active than

15

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 16 of 38

its corresponding S isomer and more than 10 times more active than the mixture. Under ordinary circumstances, one would have expected only a two-fold difference between the particular R isomer and the mixture. Warner-Lambert represented that the present invention describes the particular R isomer which is found to have greater than 10 times the activity of the compound described in the prior art reference, namely, the racemic mixture, the compound of the present invention . . . does not produce substantially the same result since it has greater than 10 times the activity than the reference compound, and the R isomer is the most desired and the most surprisingly active isomer of the two possibilities if one is to select from the trans compounds . . . . 57. On March 24, 1992, the PTO examiner filed an answer to Warner-Lamberts appeal.

The examiner alleged no new grounds for denial of the application, but reiterated the previously disclosed grounds, stating even if a preferred isomer were not disclosed [by the 893 Patent], one skilled in the art expects one of the individual isomers to be more active than the other since this, too, is knowledge contemporary in the art. 58. On October 19, 1992, the Board of Appeals overturned the examiners rejection for

anticipation of the application, concluding that the893 Patent did not technically anticipate the R-trans enantiomer. However, the Board recommended to the examiner that upon remand the patent should be rejected on the basis of obviousness: Upon further prosecution of this application before the examiner, we recommend that the examiner analyze the claimed subject matter under the provisions of the 103 of 35 USC. An obviousness rejection of claims directed to an optically pure isomer appears to be in order when, as here, (1) the product of the prior art is known to be racemic and (2) where methods for resolving the racemic mixture into the pure optically active isomers are known to those skill[ed] in the art. 59. On March 16, 1993, without any further formal proceedings or briefing, the PTO

issued a Notice of Allowability for the follow-on, isolated R-trans enantiomer patent application. 16

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 17 of 38

The PTO relied on the Roth Declaration and the CSI Table to find that the R-trans enantiomer was not obvious in light of the 893 Patent. But for Warner-Lamberts fraud, the 995 Enantiomer Patent would never have been issued. 60. Warner-Lamberts false claims and data were made with the specific intent that the

PTO rely on those claims in order to issue a follow-on patent, and with knowledge they were false and misleading. Roth and Warner-Lambert knew that a person skilled in the art would read the CSI table and the Roth Declaration as a representation that the results in the table fairly reflected all of the scientifically reliable CSI data available to Defendants for the relevant compounds, and that the data as a whole provided reasonable grounds for the findings set forth in the CSI Table. Roth and Warner-Lambert intended that the CSI table and the Roth Declaration should be read as suggesting a ten-fold increase in activity and therefore supporting patentability. G. Pfizers Sham Litigation 61. On June 17, 1996, Warner-Lambert submitted a new drug application under 505(b)

of the Federal Food, Drug and Cosmetic Act (FDCA) and 314.50 of Title 21 Code of Federal Regulations, seeking approval to sell atorvastatin calcium. The formulation developed for FDA approval and commercialization was atorvastatin calcium, i.e., the isolated R-trans enantiomer formulated as a calcium salt. On December 17, 1996, the FDA approved atorvastatin calcium named Lipitor, for the treatment of high cholesterol. 62. Following approval, Warner-Lambert listed both the 893 Original Lipitor Patent and

the 995 Enantiomer Patent in the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). The Orange Book lists all FDA approved drugs including any generic drugs which are equivalent. By listing both patents in the Orange Book, a generic company seeking approval for an ANDA for generic atorvastatin calcium would need to file a

17

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 18 of 38

Paragraph IV certification as to both the 893 and 995 patents if it wished to enter the market before the expiration of the patents. 63. In August 2002, Ranbaxy filed ANDA No. 76-477 with the FDA to seek approval to

market a generic version of Lipitor. Ranbaxy was the first company to make Paragraph IV Certifications as to all five patents listed at that time in the Orange Book the 893, 995, 104, 156 and 971 Patents. Because it was the first to file an ANDA with a Paragraph IV Certification for each listed patent, the Hatch-Waxman Act afforded Ranbaxy a 180-day exclusivity period to sell a generic version of Lipitor beginning on the earlier of (1) the date that of first commercial marketing of the drug, or (2) for each listed patent, on the date of a final court judgment declaring that patent invalid, unenforceable, or not infringed. During this 180day exclusivity period, no other drug manufacturer could market a generic Lipitor product. 64. In response to Ranbaxys application, Pfizer sued Ranbaxy for infringement of only

the 893 and the 995 patents. See Pfizer Inc. v. Ranbaxy Laboratories Ltd., 03-cv-209 (D. Del. 2003) (the Lipitor Case). Because Pfizer listed the 104 and 971 patents in the Orange Book but did not file patent infringement suits against any generic ANDA filed who submitted Paragraph IV Certifications to those patents, Pfizer was able to ensure that (1) Ranbaxys firstto-file exclusivity would not be triggered by a court decision, and(2) Pfizer could prevent the launch of all other generics for an indefinite period by entering into an anticompetitive agreement with Ranbaxy whereby Ranbaxy agrees to delay the launch of its generic product. 65. During the Lipitor Case, Pfizer moved for leave to amend its pleadings to add claims,

under 35 USC 271(g), that Ranbaxy had also intended to infringe the Process Patents (the 511 and 740 patents). Pfizer requested a declaratory judgment of infringement under 28 USC 2201.

18

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 19 of 38

66.

Ranbaxy opposed Pfizers motion to add the Process Patent claims, arguing that

Pfizer had not made a sufficient allegation of immediacy and reality to establish the existence of an actual controversy (D.I. 44). 67. In an opinion issued in April 2004, the Court agreed with Ranbaxy, stating that,

because of the uncertainty surrounding Ranbaxys ANDA efforts, Pfizers attempt to join claims under its 511 and740 patents by invoking the Declaratory Judgment Act, 28 U.S.C. 2201, are premature. 68. In 2005, after a bench trial, the district court found that Ranbaxys proposed generic

would infringe both the 893 and995 Patents. In August 2006, the Federal Circuit affirmed the district courts finding that Ranbaxys proposed generic would infringe Pfizers 893 Patent, but reversed the Courts findings with respect to the 995 form Patent, and invalidated claim 6 of the 995 Patent. The Federal Circuit did not address the district courts determination that the 995 Patent was not invalid for obviousness, nor did it address any of the other claims in the patent but stated that claim six of the patent was technically invalid. 69. As a result of the Federal Circuits decision, Pfizers patent protection for Lipitor was

shortened from June 28, 2011 to March 24, 2010, the expiration for the 893 Patent. 70. Thereafter, in January 2007, Pfizer filed a reissue application with the Patent and

Trademark Office (PTO), seeking to amend the 995 patent to correct the technical defects found by the Federal Circuit and, thus, extend patent protection for Lipitor until June 28, 2011. Ranbaxy filed a protest with the PTO against Pfizers reissue application in May, 2007. 71. In August 2007, the PTO issued a First Office Action rejecting Pfizers reissue

application on grounds set forth in Ranbaxys protest. Namely, the PTO found that certain claims in the 995 Patent were anticipated, obvious, or constituted double-patenting. Pfizer filed

19

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 20 of 38

a response in an attempt to appeal this decision, which was again rejected by the PTO in April 2008. 72. Consequently, Ranbaxy intended to enter, and could have entered, the market with its

generic immediately after March 24, 2010. 73. However, on March 24, 2008, nearly five years after it first attempted to attach the

process patents to the Lipitor Case, and knowing that a court had already ruled that it lacked standing under 28 USC 2201 and 2208, Pfizer again sued Ranbaxy for declaratory judgment of infringement of the Process Patents on the same grounds as those on which it based its original motion to amend the Lipitor Case pleadings. 74. Ranbaxy moved to dismiss for lack of subject matter jurisdiction arguing that the

final judgment in the Lipitor Case, which permanently enjoined Ranbaxy from engaging in the manufacture, use, offer to sell or sale of its generic version of Lipitor until the expiration of the 893 patent, made any harm to Pfizer from alleged infringement of the 511 and 740 Patents much less imminent now than in the Lipitor case when the Court found no imminent threat of harm or injury. 75. The Court never had an opportunity to make a substantive ruling on Ranbaxys

Motion to Dismiss however, because on June 18, 2008, the parties entered into an illegal agreement which divided the markets an extended Pfizers monopoly. The Process Patent litigation was a sham designed to create the false impression to outsiders that Ranbaxy had incentive to enter into the Agreement with Pfizer in order to avoid potential damages resulting from losing that litigation when, in fact, there was no real case or controversy and, consequently, Ranbaxy faced no real risk.

20

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 21 of 38

E. Pfizer and Ranbaxy Divide the Markets 76. On or about June 18, 2008, Pfizer announced that it had entered into the Agreement

with Ranbaxy to settle the Lipitor Case. As of the date of the Agreement, Ranbaxys 180-day exclusivity period with respect to the 995 patent had been triggered and had expired, and its 180-day exclusivity period with respect to the 893 patent was set to automatically terminate on March 24, 2010, upon the expiration of that patent. 77. As of the date of the Agreement, there was no Hatch-Waxman impediment that would

have prevented a launch by Ranbaxy of a generic Lipitor on or after March, 24, 2010. The only means by which Pfizer could have prevented a launch by Ranbaxy on or after March 24, 2010 was by seeking an injunction. As far as Pfizer knew in 2008, obtaining such an injunction would have required a showing that Pfizer was likely to succeed on the merits of patent infringement claims that it had never previously asserted against Ranbaxy. 78. Under the terms of the Agreement, Ranbaxy was given a license to sell generic

versions of Lipitor in the United States, effective November 30, 2011 twenty months after the only valid Lipitor patent would have expired and Ranbaxy would have otherwise been able to sell its generic. Additionally, Ranbaxy was given a license to sell generic versions of Lipitor on varying dates in several additional countries. Pfizer also forgave debts owed by Ranbaxy flowing from a court judgment or judgments Pfizer won against Ranbaxy on infringement claims unrelated to the Lipitor patents. 79. The Agreement further provided that Ranbaxy would refrain from any further

challenges to the validity of patents related to Lipitor, including the reissue application for the 995 Patent then pending before the PTO.

21

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 22 of 38

80.

In January 2009, the PTO, without objection by Ranbaxy, issued a Notice of

Allowance accepting Pfizers application for the 995 patent and reissuing the same as the 667 patent. Ranbaxy launched its generic version of Lipitor in the American market in November 2011. 81. By delaying Ranbaxys generic version of Lipitor in the United States which, in the

absence of the Agreement, would have been sold lawfully as early as March 24, 2010, but in no event later June 28, 2011, Pfizer was able to sell Lipitor exclusively for up to 20 additional months, resulting in extra sales of Lipitor worth approximately $10 billion. In return, Pfizer granted Ranbaxy the right to distribute generic substitute for Lipitor in foreign markets earlier than it would have been able to do so otherwise. 82. The Agreement between Pfizer and Ranbaxy is an agreement to divide the markets in

that Ranbaxy agreed it would not sell its generic in the United States until November 2011 in exchange for being able to sell in other countries. 83. The Agreement between Pfizer and Ranbaxy is a combination and attempt to

monopolize in that the Agreement unlawfully extends Pfizers exclusivity in the domestic atorvastatin calcium market, excludes competition by other generics and fixes the price of both the generic and branded versions of Lipitor. 84. The Agreement denies purchasers, including Plaintiff and the Class, access to a

generic substitute for Lipitor in the United States for up to 20 months following the expiration of the 893 Patent. Consequently, Lipitor purchasers in the United States paid inflated prices for Lipitor for at least a 20 month period. 85. The Agreement between Pfizer and Ranbaxy is an abuse of the Hatch-Waxman Act in

that it unlawfully delays the start of Ranbaxys period of exclusivity and Ranbaxy agreed to

22

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 23 of 38

misuse its exclusivity to delay other generic competitors from entering the market with their generic Lipitor products. It also constitutes a market allocation agreement between competing providers of Lipitor and its generic equivalent to illegally restrain trade in violation of the Sherman Act. EFFECT ON INTERSTATE COMMERCE 86. At all material times, Lipitor, manufactured and sold by Pfizer, was shipped across

state lines and sold to customers located outside its state of manufacture. 87. During the relevant time period, in connection with the purchase and sale of Lipitor,

monies as well as contracts, bills and other forms of business communication and transactions were transmitted in a continuous and uninterrupted flow across state lines. 88. During the relevant time period, various devices were used to effectuate the illegal

acts alleged herein, including the United States mail, interstate and foreign travel, and interstate and foreign telephone commerce. The activities of Defendants, as charged in this Complaint, were within the flow of and have substantially affected interstate commerce. RELEVANT MARKET 89. Direct proof exists that Pfizer had monopoly power over the price of atorvastatin

calcium. Such direct evidence will include, inter alia, (a) manufacturers and/or market-wide transactional data that will show a significant, non-transitory decline in atorvastatin calcium prices upon entry of generic atorvastatin calcium that had not occurred until generic entry, and (b) abnormally high price-cost margins enjoyed by Pfizer prior to the entry of generic competition. This direct evidence of monopoly power obviates the need to define a relevant product market in assessing whether Pfizer had monopoly power. 23

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 24 of 38

90.

Assuming, arguendo, that a relevant market needs to be defined, the relevant market

is all atorvastatin calcium products i.e., Lipitor (in all its forms and dosage strengths), and bioequivalent atorvastatin calcium products. The relevant geographic market is the United States and its territories. A firm that was the only seller of such products in the United States could and would impose a significant, non-transitory price increase without losing sufficient sales to render the price increase unprofitable, as demonstrated by Pfizers ability to profitably charge supracompetitive prices during the period in which it lacked generic competition. 91. Through the anticompetitive conduct alleged herein, Defendant was able to profitably

charge supra-competitive prices for atorvastatin calcium without losing substantial sales, and thus, by definition, maintained monopoly power with respect to atorvastatin calcium sold in the United States. 92. Pfizers share of the relevant market during the class period was 100%. CLASS ACTION ALLEGATIONS 93. Plaintiffs, individually and on behalf of themselves and all Class members, seek

damages, measured as overcharges, trebled, against Defendants based on allegations of anticompetitive conduct in the market for Lipitor and AB-rated generic equivalents. 94. Plaintiffs bring this action on behalf of themselves and, under Fed. R. Civ. P. 23, as

representatives of a Class defined as follows: All persons or entities in Arizona, California, Delaware, the District of Columbia, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Maine, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Vermont, West Virginia and Wisconsin who, as end payors or third-party payors, indirectly purchased and/or reimbursed for Lipitor and/or ABrated equivalents in any form from any of the Defendants at any time during the

24

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 25 of 38

period from March 25, 2010 through and until the anticompetitive effects of Defendants conduct ceases (the Class Period.). 95. For purposes of the Class definition, persons and entities purchased or were

reimbursed for Lipitor if they paid for, ore reimbursed someone who paid, some or the entire purchase price. Excluded from the Class are (1) Defendants and their officers, directors, management employees, subsidiaries, or affiliates, and all governmental entities (except for government funded employee benefit plans); (2) all persons or entities who purchased Lipitor or its generic equivalent for purposes of resale or directly from a Defendant solely to the extent of such purpose for resale or as a direct purchase; (3) insured individuals covered by plans imposing a flat dollar co-pay that is the same dollar amount for generic as for brand-name drug purchases; (4) fully insured health plans (i.e., plans that purchase insurance from another third party payor covering 100% of the plans reimbursement obligations to its members); (5) insured individuals who purchase only generic atorvastatin calcium (and not Lipitor) and whose health plans imposed a flat dollar co-pay applicable to generic drug; (6) all judges presiding in this case; and (7) all counsel of record. 96. Members of the Class are so numerous that joinder is impracticable. Plaintiffs

believe that the members of the class number in the thousands. Further, members of the class can readily identify themselves by reference to their medical and pharmacy records. 97. Plaintiffs claims are typical of the claims of the class. Plaintiffs and all members of

the Class were damaged by the same wrongful conduct of Defendants, i.e., they paid artificially inflated prices for atorvastatin calcium and were deprived of the benefits of competition from cheaper generic versions of Lipitor as a result of Defendants wrongful conduct.

25

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 26 of 38

98.

Plaintiffs will fairly and adequately protect and represent the interests of the End

Payor Class. The interests of the Plaintiffs are coincident with, and not antagonistic to, those of the End Payor Class. 99. Plaintiffs are represented by counsel who are experienced and competent in the

prosecution of class action antitrust litigation, and have particular experience with class action antitrust litigation involving pharmaceutical products and in class action consumer law litigation. 100. Questions of law and fact common to the members of the End Payor Class

predominate over questions that may affect only individual Class members. Defendants have acted on grounds generally applicable to the entire End Payor Class thereby making overcharge damages with respect to the End Payor Class as a whole appropriate. Such generally applicable conduct is inherent in Defendants wrongful conduct. 101. Questions of law and fact common to the End Payor Class include: a. Whether Defendants willfully obtained and or maintained monopoly power over Lipitor and its generic equivalents. b. Whether Defendants improperly listed the 995 patent in the Orange Book; c. Whether Defendants unlawfully excluded competitors and potential competitors from the market for Lipitor and its AB-rated generic bioequivalents; d. Whether Defendants unlawfully delayed or prevented generic manufacturers from coming to market in the United States; e. Whether Defendants maintained monopoly power by delaying generic entry; f. Whether the law requires definition of a relevant market when direct proof of monopoly power is available, and if so the definition of the relevant market; g. Whether the agreement between Pfizer and Ranbaxy is anticompetitive and unlawful including as an unreasonable restraint of trade, the willful acquisition or maintenance of monopoly power and/or otherwise in violation of state antitrust and consumer laws;

26

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 27 of 38

h. Whether, and to what extent, Defendants conduct caused antitrust injury (i.e., overcharges) to Plaintiffs and the members of the Class; and i. The quantum of aggregate overcharge damages to the Class. 102. 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 outweighs any potential difficulties in management of this class action. 103. Plaintiffs know of no special difficulty to be encountered in the maintenance of this

action that would preclude its maintenance as a class action. CAUSES OF ACTION COUNT I VIOLATIONS OF SECTION 2 OF THE SHERMAN ACT AGAINST ALL DEFENDANTS (15 U.S.C. 2) 104. Plaintiff incorporates and realleges paragraphs 1 103 in this Complaint, as though

fully set forth below. 105. Defendants combined, conspired and contracted between and among themselves to

unreasonably and unlawfully restrain and monopolize trade. Pfizer did, in fact, monopolize trade in the United States in the market for atorvastatin calcium and eliminated competition in the sale of Lipitor and its generic equivalents in the United States.

27

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 28 of 38

106.

Defendants, their agents, affiliates and co-conspirators, both known and unknown,

entered into and engaged in a continuing unlawful trust in restraint of trade and commerce in Lipitor and its generic equivalents, in violation of the Sherman Act by entering into agreements to extend patent monopolies and to divide markets and allocate customers. 107. The purpose and effect of such agreements was to fix, raise, stabilize and maintain the

prices for Lipitor and its generic equivalents at supra-competitive levels, which increased prices paid by Plaintiff and members of the Class. 108. During the class period, Plaintiff and members of the Class purchased Lipitor, and by

reason of the alleged violation of the antitrust laws, paid more for these drugs than they would have paid in the absence of the illegal trust, combination and agreement. As a proximate result thereof, Plaintiff and members of the Class have been injured in their business and property and have suffered damages in an amount to be proven at trial. COUNT II VIOLATIONS OF SECTION 2 OF THE SHERMAN ACT AGAINST PFIZER (15 U.S.C. 2) 109. Plaintiff incorporates and realleges Paragraphs 1 103 in this Complaint, as though

fully set forth below. 110. Defendant Pfizer used various, willful and exclusionary means as part of a scheme

described herein to improperly maintain and extend its monopoly power in the atorvastatin calcium market, as detailed above. 111. The goal, purpose and/or effect of Pfizers scheme was to prevent, delay and/or

minimize the success of the entry of generic atorvastatin calcium competitors which would have sold generic atorvastatin calcium in the United States at prices significantly below Pfizers prices

28

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 29 of 38

for Lipitor, which would have effectively caused the average market price of atorvastatin calcium to decline dramatically. 112. As a result of Pfizers illegal conduct, Plaintiff and the Class paid more than they

would have paid for atorvastatin calcium, absent Pfizers illegal conduct. But for Pfizers illegal conduct, competitors would have begun marketing versions of atorvastatin calcium well before they actually did, and/or would have been able to market such versions more successfully. 113. If manufacturers of generic atorvastatin calcium entered the market and competed

with Lipitor in a full and timely fashion, Plaintiff and members of the class would have substituted lower priced generic atorvastatin calcium for the higher priced brand name Lipitor and/or would have received lower prices on some or all of their remaining Lipitor purchases. 114. During the relevant period, Plaintiff and members of the Class purchased substantial

amounts of Lipitor directly from Pfizer. As a result of Pfizers illegal conduct alleged herein, Plaintiff and members of the class were compelled to pay, and did pay, artificially inflated prices for their atorvastatin calcium requirements. Plaintiff and members of the Class paid prices for atorvastatin calcium that were substantially greater than the prices that they would have paid absent the illegal conduct alleged herein, because: (1) Class members were deprived of the opportunity to purchase lower priced generic atorvastatin calcium instead of expensive brand name Lipitor; (2) Class members were forced to pay artificially inflated prices for generic atorvastatin calcium; and/or (3) the price of branded Lipitor was artificially inflated by Defendants conduct.

29

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 30 of 38

COUNT III VIOLATIONS OF SECTION 1 OF THE SHERMAN ACT AGAINST ALL DEFENDANTS (15 U.S.C. 1) 115. Plaintiff incorporates and realleges paragraphs 1 103 in this Complaint, as though

fully set forth below. 116. Beginning in or about march of 2008, Pfizer and Ranbaxy engaged in a continuing

illegal contract, combination and conspiracy in restraint of trade, the purpose and effect of which was to: (1) allocate all sales of atorvastatin calcium in the United States to Pfizer; (2) prevent the sale of a generic version of atorvastatin calcium in the United States until at least November 30, 2011, thereby protecting Lipitor from any generic competition for up to 20 months; and (3) fix the price at which Plaintiff and the class members would pay for Lipitor at the higher, branded price. 117. By entering into these unlawful conspiracies, Defendants have unlawfully conspired

in restraint of trade and committed a violation of Section 1 of the Sherman Act, 15 U.S.C. 1. Defendants agreements are horizontal market allocation and price fixing agreements between actual and potential competitors and thus are per se violations of Section 1. In the alternative, Defendants agreements are unreasonable restraints of trade in violation of Section 1 when viewed under a quick look or rule of reason mode of analysis. 118. Plaintiff and all members of the Class have been injured in their business and

property by reason of Defendants unlawful contract, combination and conspiracy. Plaintiff and the Class members have paid more on their purchases of Lipitor than they would have paid absent Defendants illegal conduct, and/or were prevented from substituting a cheaper generic alternative for their purchases of the more expensive Lipitor.

30

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 31 of 38

119.

As a result of Defendants illegal conduct, Plaintiff and members of the Class paid

more than they would have paid for atorvastatin calcium, absent Defendants illegal conduct. But for Defendants illegal conduct, competitors would have begun marketing generic versions of atorvastatin calcium well before November 30, 2011, and/or would have been able to market such versions more successfully. 120. If manufacturers of generic atorvastatin calcium entered the market and competed

with Lipitor in a full and timely fashion, Plaintiff and members of the Class would have substituted lower-priced generic atorvastatin calcium for the higher-priced brand name Lipitor and/or would have paid lower prices on some or all of their remaining Lipitor purchases. 121. During the relevant period, Plaintiff and the other members of the Class purchased

substantial amounts of Lipitor directly from Pfizer. As a result of Pfizers illegal conduct, alleged herein, Plaintiff and the members of the Class were compelled to pay, and did pay, artificially inflated prices for their atorvastatin calcium requirements. Plaintiff and members of the Class paid prices for atorvastatin calcium that were substantially greater than the prices that they would have paid absent the illegal conduct alleged herein, because: (1) Class members were deprived of the opportunity to purchase lower priced generic atorvastatin calcium instead of expensive brand name Lipitor; (2) Class members were forced to pay artificially inflated prices for generic atorvastatin calcium; and/or (3) the price of branded Lipitor was artificially inflated by Defendants conduct. COUNT IV VIOLATIONS OF ANTITRUST AND/OR CONSUMER PROTECTION STATUTES OF THE INDIRECT PURCHASER STATES 122. Plaintiff incorporates and realleges paragraphs 1 103 in this Complaint, as though

fully set forth below. 31

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 32 of 38

123.

Defendants conduct described herein constitutes unlawful acts of monopolization

and attempts to monopolize, as well as prohibited practices and unconscionable conduct under the antitrust and/or unfair and deceptive trade practices acts of the Indirect Purchaser States, as follows: a. Arizona: The aforementioned practices by Defendants were and are in violation of the Arizona Uniform State Antitrust Act, Ariz. Rev. Stat. 44-1401, et seq., the Arizona Consumer Fraud Act, Ariz. Rev. Stat. 44-1521, et seq., and the Constitution of the State of Arizona, Article 14, 15; b. California: The aforementioned practices by Defendants were and are in violation of the Cartwright Act, Cal. Bus. & Prof. Code 16700, et seq., and the California Unfair Competition Act, Cal. Bus. & Prof. Code 17200, et seq.; c. District of Columbia: The aforementioned practices by Defendants were and are in violation of the District of Columbia Antitrust Act, D.C. Code 28-4501, et seq., and the District of Columbia Consumer Protection Procedures Act, D.C. Code Ann. 28-3901, et seq. d. Florida: The aforementioned practices by Defendants were and are in violation of the Florida Antitrust Act, Fla. Stat. Ann. 542.15, et seq., and the Florida Deceptive and Unfair Trade Practices Act, Fla. Stat. Ann. 501.201, et seq.; e. Hawaii: The aforementioned practices by Defendants were and are in violation of Hawaii Revised Statues 480-2, 480-3, and 480-4. f. Iowa: The aforementioned practices by Defendants were and are in violation of the Iowa Competition Law, Iowa Code 553.4, 553.5 (1997); g. Kansas: The aforementioned practices by Defendants were and are in violation of

32

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 33 of 38

the Kansas Monopolies and Unfair Trade Act, Kan. Stat. Ann. 50-101, et seq., and the Kansas Consumer Protection Act, Kan. Stat. Ann 50-623, et seq.; h. Kentucky: The aforementioned practices by Defendants were and are in violation of the Kentucky Consumer Protection Act, Ky. Rev. Stat. Ann. 367.110, et seq., and the Kentucky Unfair Trade Practices Act, Ky. Rev. Stat. Ann 365.020, et seq.; i. Louisiana: The aforementioned practices by Defendants were and are in violation of the Louisiana Monopolies Law, La. Rev. Stat. Ann. 51:121, et seq., and the Louisiana Unfair Trade Practices and Consumer Protection Law, La. Rev. Stat. Ann. 51:1401, et seq.; j. Maine: The aforementioned practices by Defendants were and are in violation of the Maine Monopolies and Profiteering Statute, Me. Rev. Stat. Ann. tit. 10, 1101, et seq., and the Maine Unfair Trade Practices Act, Me. Rev. Stat. Ann. tit. 5, 207, et seq.; k. Massachusetts: The aforementioned practices by Defendants were and are in violation of the Massachusetts Antitrust Act, Mass. Gen. Laws, ch. 93, and the Massachusetts Consumer Protection Act, Mass. Gen. Laws ch. 93A; l. Michigan: The aforementioned practices by Defendants were and are in violation of the Michigan Antitrust Reform Act, Mich. Comp. Laws 445.771, et seq., and the Michigan Consumer Protection Act, Mich. Comp. Laws 445.901, et seq.; m. Minnesota: The aforementioned practices by Defendants were and are in violation of the Minnesota Antitrust Law of 1971, Minn. Stat. 325D.49, et seq., and the

33

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 34 of 38

Minnesota Consumer Fraud Act, Minn. Stat 325F.67, et seq.; n. Mississippi: The aforementioned practices by Defendant were and are in violation of the Mississippi antitrust statute, Miss. Code Ann. 75-21-1 et seq.; o. Nebraska: The aforementioned practices by Defendant were and are in violation of the Nebraska Antitrust Act, Neb. Rev. Stat. 59-801, et seq., and the Nebraska Consumer Protection Act, Neb. Rev. Stat. 59-1601, et seq.; p. Nevada: The aforementioned practices by Defendants were and are in violation of the Nevada Unfair Trade Practices Act, Nev. Rev. Stat. 598A, et seq.; q. New Jersey: The aforementioned practices by Defendants were and are in violation of the New Jersey Antitrust Act, N.J. Stat. Ann. 56:9-1, et seq., and the New Jersey Consumer Fraud Act, N.J. Stat. Ann. 56:8-1, et seq.; r. New Mexico: The aforementioned practices by Defendants were and are in violation of the New Mexico Antitrust Act, N.M. Stat. Ann. 57-1-1, et seq., and the New Mexico Unfair Practices Act, N.M. Stat. Ann. 57-12-1, et seq.; s. New York: The aforementioned practices by Defendants were and are in violation of the Donnelly Act, N.Y. Gen. Bus. Law 340, et seq., and the New York Deceptive Acts and Practices Act, N.Y. Gen. Bus. Law 349, et seq.; t. North Carolina: The aforementioned practices by Defendants were and are in violation of North Carolinas antitrust law, N.C. Gen. Stat. 75-1, et seq. and North Carolinas Unfair and Deceptive Trade Practices Act, N.C. Gen. Stat. 751.1, et seq.; u. North Dakota: The aforementioned practices by Defendants were and are in violation of the North Dakota Antitrust Act, N.D. Cent. Code 51-08.1-01, et

34

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 35 of 38

seq., and the North Dakota Consumer Fraud Act, N.D. Cent. Code 51-15-01, et seq.; v. South Dakota: The aforementioned practices of Defendants were and are in violation of South Dakotas antitrust law, S.D. Codified Laws 37-1-3, et seq., and the South Dakota Deceptive Trade Practices and Consumer Protection Act, S.D. Codified Laws 37-24-1, et seq.; w. Tennessee: The aforementioned practices of Defendants were and are in violation the Tennessee Trade Practices Act, Tenn. Code Ann. 47-25-101, et seq., and the Consumer Protection Act, Tenn. Code Ann. 47-18-101, et seq.; x. Vermont: The aforementioned practices of Defendants were and are in violation of the Vermont Consumer Fraud Act, Vt. Stat. Ann. tit. 9, 2451, et seq.; y. West Virginia: The aforementioned practices by Defendants were and are in violation of the West Virginia Antitrust Act, W.Va. Code 47-18-1, et seq., and the West Virginia Consumer Credit and Protection Act, W. Va. Code 46A-6101, et seq.; and z. Wisconsin: The aforementioned practices by Defendants were and are in violation of the Wisconsin Antitrust Act, Wis. Stat. 133.01, et seq., and the Wisconsin Unfair Trade Practices Act, Wis. Stat. 100.20, et seq. 124. Plaintiff and the other members of the Class have been injured in their business or

property by reason of Defendants antitrust violation alleged in this Count. Their injury consists of being deprived of the ability to purchase less expensive, generic versions of atorvastatin calcium, and paying higher prices for atorvastatin calcium and generic versions of atorvastatin calcium than they would have paid but for Defendants improper actions. The injury to Plaintiff

35

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 36 of 38

and the Class is the type of injury antitrust laws were designed to prevent, and the injury flows from Defendants unlawful conduct. 125. Plaintiff and the Class, pursuant to laws of the Indirect Purchaser States, hereby seek

a declaratory judgment that Defendants conduct in seeking to prevent competition through scheme set forth herein is unlawful. Plaintiff and the Class further seek equitable and injunctive relief pursuant to the laws of the Indirect Purchaser States to correct for the anti-competitive market effects and other harms to purchasers caused by the unlawful conduct of Defendants, and other relief so as to assure that similar conduct does not occur in the future. COUNT V FOR RESTITUTION, DISGORGEMENT AND CONSTRUCTIVE TRUST FOR UNJUST ENRICHMENT BY DEFENDANTS 126. Plaintiff incorporates and realleges paragraphs 1 103 in this Complaint, as though

fully set forth below. 127. As a result of their unlawful conduct described above, Defendants have been and will

continue to be unjustly enriched. Specifically, Defendants have been unjustly enriched, to the detriment of Plaintiff and the Class by the receipt of, at a minimum, unlawfully inflated prices and/or illegal monopoly profits on their sale of Lipitor. 128. Defendants have benefitted from their unlawful acts and it would be inequitable for

Defendants to be permitted to retain any of their ill-gotten gains resulting from the overpayments for atorvastatin calcium made by Plaintiff and the Class. 129. Plaintiff and members of the Class are entitled to the amount of Defendants ill-gotten

gains resulting from Defendants unlawful, unjust and inequitable conduct. Plaintiff and the Class are entitled to the establishment of a constructive trust consisting of all ill-gotten gains from which Plaintiff and the Class members may make claims on a pro rata basis. 36

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 37 of 38

PRAYER FOR RELIEF Wherefore, Plaintiffs, and the proposed Class, prays for judgment against all Defendants, jointly and severally, as follows: 1. Certifying the Class pursuant to the Federal Rules of Civil Procedure, certifying Plaintiffs as the representatives of the Class, and designating their counsel as counsel for the Class; 2. Declaring the Defendants conduct to be in violation of the antitrust and/or the unfair or deceptive practices statutes in the applicable states; 3. Granting Plaintiff and the Class damages, including multiple damages and equitable relief as permitted by law; 4. Granting Plaintiffs and the Class their costs of prosecuting this action, together with interest and reasonable attorneys fees, experts fees and costs; and 5. Granting such other relief as this Court may deem just and proper. JURY TRIAL DEMANDED Pursuant to Federal Rule of Civil Procedure 38(b), Plaintiff demands a trial by jury of all claims in this Complaint so triable. Respectfully submitted, DATED: March 21, 2012 /s/ Glen DeValerio Glen DeValerio (BBO 122010) Nathaniel L. Orenstein (BBO 664513) BERMAN DEVALERIO One Liberty Square Boston, MA 02109 Telephone: (617) 542-8300 Facsimile: (617) 542-1194 Email: gdevalerio@bermandevalerio.com norenstein@ bermandevalerio.com Todd A. Seaver (BBO 645874) BERMAN DEVALERIO One California Street, Suite 900 37

Case 1:12-cv-10517-RWZ Document 1 Filed 03/21/12 Page 38 of 38

San Francisco, CA 94111 Telephone: (415) 433-3200 Facsimile: (415) 433-6382 Email: tseaver@bermandevalerio.com David M. Cialkowski Anne T. Regan Brian C. Gudmundson Aditya Bharadwaj ZIMMERMAN REED, PLLP 1100 IDS Center 80 South Eighth Street Minneapolis, MN 55402 Telephone (612) 341-0400 Facsimile (612)341-0844 Email: david.cialkowski@zimmreed.com anne.regan@zimmreed.com brian.gudmundson@zimmreed.com adi.bharadwaj@zimmreed.com ATTORNEYS FOR PLAINTIFFS AND THE CLASS

38