UNITED STATES DISTRICT COURT 

EASTERN DISTRICT OF PENNSYLVANIA 

 

SAJ DISTRIBUTORS, INC. and 

STEPHEN L. LaFRANCE 

HOLDINGS, INC., 

individually and on behalf of all 

others similarly situated 

Plaintiffs, 

v. 

SMITHKLINE BEECHAM CORP. 

d/b/a GLAXOSMITHKLINE 

 

 Defendant. 

 

: 

: 

: 

: Civil Action No. 

: 

: 

: 

: 

: CLASS ACTION 

: COMPLAINT 

: 

: 

: JURY TRIAL DEMANDED 

: 

: 

:

CLASS ACTION COMPLAINT

1. Plaintiffs, SAJ Distributors, Inc. and Stephen L. LaFrance Holdings, Inc., bring 

this class action on behalf of all persons and entities who purchased the prescription 

medication Wellbutrin SR directly from Defendant in the United States during the 

period from January 24, 2002 to a date to be determined under Section 2 of the Sherman 

Act, 15 U.S.C. §2 (the “Class Period”).

2. Wellbutrin SR is the trade name of the drug bupropion hydrochloride in a 

certain sustained release tablet. Wellbutrin SR is a prescription antidepressant. As with 

other antidepressants, the exact mechanism of Wellbutrin SR is unknown, however it is 

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recognized as weakly inhibiting the neuronal uptake of three neurotransmitters that 

have been implicated in clinical depression: norepinephrine, serotonin, and dopamine. 

3. Sustained release bupropion is also marketed under the trade name Zyban. 

Zyban is indicated for smoking cessation. As used in this complaint, the term 

“Wellbutrin SR” includes both Wellbutrin SR and Zyban unless otherwise stated.

4. Plaintiffs allege Defendant has unlawfully extended its monopoly of 

Wellbutrin SR and its generic equivalents by making fraudulent assertions to the United 

States Patent and Trademark Office (“PTO”) during patent prosecution and by 

initiating sham litigation based on: 1) invalid patents and 2) baseless allegations of 

infringement under the Doctrine of Equivalents. This sham litigation was intended to 

delay or prevent generic manufacturers from entering the market for sustained release 

bupropion. 

5. Defendant has obtained patents based on fraudulent representations to 

the PTO, for products it has not invented, and patents that no reasonable patent owner 

would consider valid. Defendant was fully aware of the unenforceability of the patents, 

yet persisted in using sham litigation of these unenforceable patents to maintain its 

monopoly in the market for Wellbutrin SR and its generic equivalents. Defendant also 

engaged in sham litigation by asserting infringement under the Doctrine of Equivalents 

for equivalents it knowingly and purposefully disclaimed during patent prosecution. 

Defendant has attempted to enforce these facially over-broad and invalid patents and 

knowingly initiated baseless litigation no reasonable plaintiff could have expected to 

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win in order to prevent generic pharmaceutical companies from entering the market for 

sustained release bupropion in violation of the Sherman Act. 

PLAINTIFFS

6. Plaintiff Stephen L. LaFrance Holdings, Inc. (“LaFrance”) is a holding 

company with interests in retail and wholesale drug stores and distribution. LaFrance’s 

corporate office is located in Pine Bluff, Arkansas. 

7. Plaintiff SAJ Distributors, Inc. (“SAJ”) is a wholly owned subsidiary of 

LaFrance and is LaFrance’s distribution company with interests in retail and wholesale 

drug distribution. SAJ’s corporate office is located in Pine Bluff, Arkansas. SAJ and 

LaFrance are the assignees of McKesson Corp., which purchased Wellbutrin SR directly 

from the Defendant and was injured by the illegal conduct alleged herein. 

DEFENDANT

8. Defendant SmithKline Beecham Corporation, doing business as 

GlaxoSmithKline (“GSK”), is a Pennsylvania corporation with its principal place of 

business at One Franklin Plaza, Philadelphia, Pennsylvania. 

JURISDICTION AND VENUE

9. The Court has jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331 

and 1337(a). 

10. Venue is proper in this judicial district pursuant to 15 U.S.C. § 22 and 28 

U.S.C. § 1391(b) and (c) because Defendant does business in this judicial district. 

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THE REGULATORY BACKGROUND FOR PRESCRIPTION DRUGS

11. The Federal Food, Drug and Cosmetic Act regulates the manufacture and 

distribution of drugs and medical devices in the United States, 21 U.S.C. § 301 et seq. 

Under the FDCA, premarket approval by the FDA is required before a company may 

begin selling a new drug, often referred to as a “pioneer” or “branded” drug, in 

interstate commerce in the United States. 21 U.S.C. § 355(a). Premarket approval for a 

new drug must be sought by filing a new drug application (“NDA”) with the FDA 

under § 355(b) of the FDCA, demonstrating that the drug is safe and effective for its 

intended use. 

12. New drugs that are approved for sale in the United States by the FDA are 

typically covered by patents, which provide the patent owner with the right to exclude 

others from making, using, offering for sale, selling or importing that new drug in the 

United States for the duration of the patents, plus any extension of the original patent 

period granted pursuant to the Drug Price Competition and Patent Term Restoration 

Act of 1984, 21 U.S.C. § 355 (“the Hatch-Waxman Act”). 

13. Pursuant to 21 U.S.C. § 355(b), in its NDA the pioneer drug manufacturer 

must list all patents that claim the drug for which FDA approval is being sought, or that 

claim a method of using the drug, and with respect to which a claim of patent 

infringement could reasonably be asserted against an unlicensed manufacturer or seller 

of the drug. 

14. Once the NDA is approved, any claimed patents are listed with the FDA 

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in a publication entitled Approved Drug Products with Therapeutic Equivalence 

Evaluations (commonly referred to as the “Orange Book”), where it can be easily found 

and consulted by future FDA applicants. 

15. Pursuant to 21 U.S.C. § 355(c)(2), if a pioneer drug manufacturer is issued 

a new patent claiming either the drug that is the subject of an NDA or a method for its 

use, the company must supplement its NDA by listing such new patents within 30 days 

of issuance, whereupon the FDA publishes the new patent in a supplement to the 

Orange Book. The FDA is required to accept as true all patent information it obtains 

from patent holders, such as whether a patent covers a particular drug product. If an 

unscrupulous patent holder is willing to provide false information to the FDA or files 

frivolous patent infringement actions to delay the onset of generic competition, the FDA 

is powerless to stop it. 

16. Once the FDA approves the safety and effectiveness of a new prescription 

drug, it may be used in the United States only under the direction and care of a doctor 

who writes a prescription specifying the drug, which must be purchased from a 

licensed pharmacist. The pharmacist will then dispense the drug specified by the 

physician unless a generic version is available that has been approved by the FDA for 

substitution as the bioequivalent of the prescription drug.

17. Generic drugs are drugs that the FDA has found to be “bioequivalent” to 

their corresponding brand name drug. A generic drug is bioequivalent if it provides the 

identical therapeutic benefits and has the same active chemical composition as its brand 

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name counterpart. When a generic drug is completely equivalent to a pioneer or brand 

name drug, the FDA assigns the generic drug an “AB” rating. 

18. Generic drugs are invariably priced substantially below the branded 

drugs to which they are bioequivalent. Typically, the first generic drug is sold at a 

modest discount compared to the brand name drug, with discounts increasing, as per 

normal competitive dynamics, as more companies begin selling the generic. As 

additional generic competitors come to market, the price of the generic equivalents 

continues to fall, and the combined market share of the generic manufacturers 

continues to grow. In some cases, generic competitors sell products equivalent to brand 

name prescription drugs for as little as 15 percent of the price of the brand name drug, 

and capture as much as 90 percent of the market for that drug. Unless the branded 

manufacturer lowers prices to meet competition, a branded drug loses a significant 

portion of its market share to generic competitors less than a year after the introduction 

of generic competition. 

19. Moreover, if a lower-priced generic version of a brand name drug exists, 

and the physician has not specifically indicated on the prescription “dispense as 

written” (or a similar instruction), and the consumer is covered by a typical third-party 

payor plan, the pharmacist will substitute, or at least offer to substitute, the generic 

drug. 

20. Once a physician writes a prescription for a brand name drug such as 

Wellbutrin SR, that prescription defines and limits the market to the brand name drug 

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or its AB-rated generic equivalent. A pharmacist may substitute only drugs that carry 

the FDA’s AB generic rating for a physician’s prescription for a brand name drug. 

21. Due to the nature of prescription pharmaceutical sales, the geographical 

market is the United States. 

22. The Hatch-Waxman Amendments provide that companies may seek 

approval to produce and market a generic form of a previously approved, or “pioneer” 

drug by filing only an Abbreviated New Drug Application (“ANDA”) that relies on the 

safety and effectiveness findings reported in the NDA for the previously approved 

drug. 

23. The ANDA must include information concerning patents for the 

previously approved drug, and must include one of four certifications: 

I. that no patent for the pioneer drug has been filed with the FDA (a 

“Paragraph I Certification”); 

II. that any patent listed in the FDA Orange Book for the pioneer drug has 

expired (a “Paragraph II Certification”); 

III. that the patent for the pioneer drug will expire on a particular date and 

the generic drug company does not seek to market its generic product 

before that date (a “Paragraph III Certification”); or 

IV. that the patent for the pioneer drug is invalid or will not be infringed 

upon by the generic drug company’s proposed product (a “Paragraph IV 

Certification”). 

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24. If the ANDA does not address all of the patents listed for a drug in the 

Orange Book by means of one of the above four certifications, the FDA will not approve 

the generic drug for sale. 

25. If a generic company files a Paragraph IV Certification, it must promptly 

disclose its Paragraph IV Certification to both the NDA owner and the owner of the 

patent(s) at issue. Under the terms of the Hatch-Waxman Amendments, the act of filing 

a Paragraph IV Certification constitutes a technical act of infringement and begins a 45-

day period in which a patent owner may initiate an action for patent infringement and 

thereby delay the FDA approval of a generic version of the NDA owner’s drug. If the 

patent owner fails to initiate a patent infringement action within 45 days after receiving 

the generic manufacturer’s Paragraph IV Certification the FDA may approve the 

generic manufacturer’s ANDA. However, if the patent owner initiates an infringement 

action against the ANDA filer within 45 days, the FDA is statutorily prohibited from 

approving the ANDA until the earlier of either 30 months or a final decision by a court 

that the patent is invalid or not infringed by the generic manufacturer’s ANDA. 21 

U.S.C. § 355(j)(5)(B)(iii). 

26. The Hatch-Waxman Act provides an incentive to generic pharmaceutical 

manufacturers to file Paragraph IV certifications challenging patents that may be 

invalid, not infringed by the product that is the subject of the ANDA, or unenforceable. 

If the applicant is the first to file an ANDA application containing a Paragraph IV 

challenge to a listed patent the applicant will receive a 180-day market exclusivity 

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period for that generic product that begins at the first commercial marketing of the 

generic drug unless forfeited. 21 U.S.C. 355(j)(5)(B)(iii)(IV). 

THE BUPROPION PATENTS AT ISSUE

27. GSK’s predecessor, Burroughs Wellcome Co., obtained U.S. Patent No. 

5,427,798 on June 27, 1995 (the “‘798 patent”). The ‘798 patent is drawn to a controlled 

release bupropion tablet with an enhanced shelf life. 

28. GSK’s predecessor, Burroughs Wellcome Co., obtained U.S. Patent No. 

4,687,660 on Aug 18, 1987. That patent was reissued as U.S. Patent No. RE33,994 on July 

14, 1992 (the “’994 patent”). As reissued, the patent was drawn to pharmaceutical 

compositions that resulted in a controlled release of bupropion in a simulated gastric 

buffer. 

29. Upon information and belief, GSK violated its duty of candor to the United 

States Patent and Trade Mark Office during the prosecution of the ‘798 and the ‘994 

patents by failing to disclose and/or misrepresenting to the patent examiner certain 

information material to the patentability of the ‘798 and ‘994 patents. Upon information 

and belief, GSK was aware of such information and of its materiality before the issuance 

of the ‘798 and ‘994 patents and that with intent to deceive, GSK withheld the 

information from the United States Patent and Trade Mark Office. 

30. Five generic pharmaceutical companies submitted ANDAs including 

Paragraph IV certifications for generic Wellbutrin and all were sued by GSK for patent 

infringement. 

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THE DOCTRINE OF EQUIVALENTS

31. The Doctrine of Equivalents (DOE) prevents the unscrupulous copyist 

from practicing fraud on a patent by making unimportant and insubstantial changes in 

order to take the copied matter outside of the claim and the law. 

32. The DOE roughly states that if two inventions do the same thing in the 

same manner to yield the same result that they are the same, even though they may 

differ in name, form, or shape. 

33. The DOE has an important limitation in the Doctrine of Prosecution 

History Estoppel (also known as “File Wrapper Estoppel”), which states that a patentee 

is not able to use the DOE to recapture subject matter surrendered during prosecution 

of the patent by claiming that the surrendered material is an equivalent of the patented 

invention. 

GSK WRONGFULLY ALLEGED INFRINGEMENT UNDER THE DOE TO ILLEGALLY DELAY

GENERIC WELLBUTRIN SR FROM ENTERING THE MARKET

34. In 1993, GSK filed the application that would issue as the ‘798 patent. 

35. During prosecution of this patent application, the patent examiner initially 

rejected all of the patent claims for lack of enablement noting that one of the disclosed 

excipients, hydroxypropyl methylcellulose (“HPMC”), is critical to the invention and 

should be incorporated into the independent claims. 

36. An excipient is a usually inert substance used as a vehicle for a drug. In 

the present case, the excipients at issue also delay the release of the drug into the 

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gastrointestinal tract. 

37. In response to the rejection, GSK submitted narrowing amendments to the 

patent examiner. These amendments narrowed the scope of the claims from covering 

all pharmaceutical means for achieving a specified release rate of bupropion to covering 

only HPMC, the single controlled release means divulged in the patent disclosure. 

38. Hydroxypropyl cellulose (“HPC”) had been recognized as a release 

controlling substitute excipient for HPMC since before the prosecution of the 

application that would issue as the ‘798 patent. 

39. Polyvinyl alcohol (“PVA”) has been known as a hydrogel material of the 

type that can be used to control the release of a drug such as bupropion since before the 

prosecution of the application that would issue as the ‘798 patent. 

40. The Supreme Court has repeatedly held, as long ago as 1921, that the DOE 

cannot be used to capture subject matter disclaimed during prosecution of the patent. 

41. Since 1997 the Supreme Court has twice visited the subject of how 

Prosecution History Estoppel should be applied, and in both cases held that a 

narrowing amendment made for reasons of patentability necessarily surrenders the 

subject matter between the non-amended and amended claims. 

42. A narrow exception to Prosecution History Estoppel exists if the claimed 

equivalent was unforeseeable at the time of patent prosecution. 

43. GSK knew that HPC was a substitute for HPMC at the time the 

application that would issue as the ‘798 patent was filed. 

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44. GSK also knew when the application that would issue as the ‘798 patent 

was filed that PVA could be used as a controlled release excipient. 

45. On September 28, 2000, GSK initiated litigation against Impax 

Laboratories Inc., a generic drug manufacturer, in the United States District Court for 

the Northern District of California for infringing the ‘798 patent under the DOE for 

Impax’s ANDA for generic Wellbutrin SR that used HPC instead of the literally claimed 

HPMC as the release controlling excipient (the “Impax Litigation”). 

46. When GSK filed the Impax Litigation, it was aware of two things: 1) at the 

time of filing the application that would issue as the ‘798 patent, HPC was a recognized 

substitute for HPMC; and 2) that by narrowing the patent claims during prosecution, 

GSK abandoned any subject matter that existed between the original and amended 

claims. 

47. GSK, with full knowledge that no equivalents existed for the invention of 

the ‘798 patent that would cover the use of HPC as a release controlling excipient, 

proceeded with the baseless Impax litigation in order to invoke the 30-month FDA stay, 

thereby preventing a generic version of Wellbutrin SR from coming to market and 

consequently, illegally extending its monopoly on Wellbutrin SR and its generic 

equivalents while the litigation progressed. 

48. On August 21, 2002, the United States District Court for the Northern 

District of California held in the Impax Litigation that Prosecution History Estoppel 

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prevented GSK from capturing HPC as an equivalent of HPMC. This ruling was 

upheld on appeal to the Federal Circuit on January 29, 2004. 

49. On January 25, 2002, GSK brought a patent infringement suit against Excel 

Pharmaceuticals Inc., a generic drug manufacturer, in the United States District Court 

for the Eastern District of Virginia. GSK alleged that Excel was infringing the ‘798 

patent under the DOE for its ANDA submission for generic Wellbutrin SR that used 

PVA instead of the literally claimed HPMC as the release controlling excipient in a 

bupropion compound (the “Excel Litigation”). 

50. When GSK filed the Excel Litigation it was aware of two things: 1) that 

PVA was recognized as a release controlling excipient at the time the application that 

would issue as the ‘798 patent was filed; and 2) that by narrowing the patent claims 

during prosecution, GSK abandoned any subject matter that existed between the 

original and amended claims. 

51. GSK, with full knowledge that no equivalents existed for the invention of 

the ‘798 patent that would cover the use of PVA as a release controlling excipient, 

proceeded with the baseless Excel litigation in order to invoke the 30-month FDA stay, 

preventing a generic version of Wellbutrin SR from coming to market and 

consequently, illegally extending their monopoly on Wellbutrin SR and its generic 

equivalents while the litigation progressed. 

52. On August 2, 2002, the United States District Court for the Eastern District 

of Virginia held that Prosecution History Estoppel prevented GSK from capturing PVA 

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as an equivalent of HPMC. This ruling was remanded for additional fact finding by the 

Federal Circuit on January 29, 2004, before being voluntarily dismissed under Federal 

Rule of Civil Procedure 41(a) by GSK on April 29, 2004. 

GSK ATTEMPTS TO ENFORCE FRAUDULENT AND NONENABLED PATENTS

53. One of the requirements for the grant of a patent is that the invention 

must be enabled. 

54. To be enabled, the patent must teach those within the relevant art how to 

make and use the invention in its entirety without undue experimentation. 

55. The rationale underlying the enablement requirement is that in exchange 

for the limited monopoly one receives as a patent that the public must be taught how to 

make and use the invention so that upon the expiration of the patent, the public as a 

whole has received knowledge it otherwise would not have and can continue to make 

and use the invention. 

56. In the ‘798 patent, GSK disclosed a Wellbutrin SR tablet made using a 

specific grade of HPMC (HPMC 2910). 

57. The claims of the ‘798 patent were not limited to the specific grade of 

HPMC disclosed, and instead attempted to capture all grades of HPMC that would 

release Wellbutrin in a defined manner. 

58. GSK brought suit against two companies, Andrx Pharmaceuticals Inc. 

(“Andrx”) and EON Labs Manufacturing Inc. (“EON”) for patent infringement in 

response to the filing of Paragraph IV certifications by these companies stating that the 

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use of another grade of HPMC did not infringe the ‘798 patent or that the patent was 

invalid. 

59. On February 28, 2002, the United States District Court for the Southern 

District of Florida granted Andrx summary judgment that the patent was limited to the 

specific grade of HPMC in the specification and was not infringed by the Andrx ANDA. 

60. GSK appealed the summary judgment grant to the United States Court of 

Appeals for the Federal Circuit. On September 22, 2003 the Federal Circuit held that the 

patent was not limited to the specific grade of HPMC described in the specification and 

the grant of summary judgment was vacated and remanded. 

61. On August 22, 2003, the United States District Court for the Southern 

District of New York denied EON summary judgment that the patent was invalid for 

claiming more than was described in the specification. 

62. In May of 2004, without receiving payment of any kind from the 

defendant, Andrx, GSK dismissed the lawsuit with Andrx. 

63. In addition to the above claims, GSK’s ‘798 patent claimed a bupropion 

containing tablet with a shelf life of at least one year. 

64. The written description of the ‘798 patent divulged bupropion compounds 

containing HPMC with or without either cysteine hydrochloride or glycine 

hydrochloride. 

65. It was left unclear from the patent if HPMC by itself was responsible for 

the extended shelf life, or if the stability was a function of either cysteine hydrochloride 

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or glycine hydrochloride being used in conjunction with HPMC. Neither the written 

description nor the claims of the ‘798 patent described how the shelf life stability was 

accomplished. 

66. One wishing to use the invention after expiration of the patent would 

have not learned from the patent what variables, if any, were critical in stabilizing the 

bupropion. 

67. By failing to teach those in the proper field of art how to create a 

bupropion tablet with the shelf life claimed in the ‘798 patent, GSK taught nothing to 

the public in exchange for the grant of the patent. 

68. GSK purposefully obfuscated the patent during prosecution in an attempt 

to obtain patent protection without teaching the public how to practice the invention in 

order to prevent generic drug manufacturers from practicing the invention upon the 

patent’s expiration. 

69. On July 26, 2000, EON Labs Manufacturing Inc. (“EON”), a generic drug 

manufacturer, submitted an ANDA for generic Wellbutrin SR containing a Paragraph 

IV certification that the ‘798 patent was invalid or not infringed by the EON compound. 

70. On November 29, 2000, GSK filed suit against Eon in the United States 

District Court for the Southern District of New York for infringing the ‘798 patent by 

submitting the ANDA for generic Wellbutrin SR (the “EON I Litigation”). 

71. By initiating this litigation, GSK received the 30-month stay preventing 

EON from marketing generic Wellbutrin SR. 

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72. On January 24, 2002, EON received tentative approval for the generic 

Wellbutrin SR ANDA submitted on July 26, 2000. 

73. The grant of tentative approval indicated that EON would have received 

final approval to begin marketing of generic Wellbutrin SR if not for the legal 

impediment of the then outstanding GSK litigation. 

74. On August 22, 2003 the United States District Court for the Southern 

District of New York declared claim 1 of the ‘798 patent invalid for lack of enablement. 

75. GSK not only knew at the onset of the EON I litigation that the ‘798 patent 

was nonenabled and therefore unenforceable, but in fact had written and prosecuted 

the patent in such a way as to yield nothing to the public in exchange for the grant of a 

patent. GSK, however, still attempted to assert the invalid ‘798 patent in order to 

invoke the 30-month FDA stay, preventing a generic version of Wellbutrin SR from 

coming to market and consequently, illegally extending their monopoly on Wellbutrin 

SR and its generic equivalents. 

76. GSK has also fraudulently misrepresented facts material to patentability to 

the PTO to obtain the ‘994 patent. 

77. The ‘994 patent is a reissue patent of U.S. Patent 4,687,660 (the “’660 

patent”). 

78. A reissue patent examination is conducted when requested by the patent 

holder to remedy a defect in the patent that makes it fully or partially inoperative or 

invalid. 

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79. A patent reexamination may be requested by anyone that submits prior 

art published materials that are material to patentability. 

80. Prior to the initiation of the reissue examination, the ‘660 patent was being 

reexamined in response to the discovery of two prior art patents that, when combined, 

made the invention of the ‘660 patent obvious and unpatentable. 

81. To request a reissue examination, the patent holder must assert not only 

that there was an error made during prosecution of the patent that makes it fully or 

partially inoperative or invalid, but also must specifically indicate the exact error. 

82. The error alleged by the patent holder to support the reissue application 

was that the original patent failed to address the highly desired claims of a sustained 

release bupropion compound. 

83. The ‘660 patent as issued gave two examples of a bupropion containing 

pill and one of a psuedoephedrine containing sustained release compound and the 

claims would have encompassed sustained release bupoprion without it needing to be 

specifically claimed. 

84. The patentee realized during the reexamination proceeding that the ‘660 

patent would most likely be held invalid over the newly discovered prior art. 

85. To save some of the patent coverage that was in the original patent, the 

patentee conjured a story that somehow the highly desired claims to a controlled release 

bupropion had been omitted and that this omission went unnoticed for nearly two 

years, even though for almost all of this two year period the patent had been involved 

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in a reexamination. 

86. Claims to a controlled release pseudoephedrine compound, also described 

in the ‘660 patent specification, were not prosecuted. 

87. During the reissue procedure, the patentee decided that the claims that 

had issued in the ‘660 patent, and that were also at issue in the reexamination, were no 

longer of interest and cancelled all of them, electing to concentrate on the newly 

discovered claims that were alleged to have been accidentally omitted. 

88. If it was not for this fraudulent, revisionist view of what the ‘660 patent 

was intended to claim there would have been no issuance of the ‘994 patent. 

89. Not only is the ‘994 patent invalid for being fraudulently obtained, but it is 

also invalid for being nonenabled. 

90. A related type of enablement issue occurs when a patent attempts to 

capture all means of accomplishing the goal of the invention but only divulges a limited 

number of examples of how to practice the invention. These are called genus/species 

issues since a number of species are described but a wider genus is claimed. Although 

these types of claims are not per se improper, in order to capture a genus in this manner 

the patentee must ensure that enough species are divulged and that the members of the 

genus behave similarly so that accurate predictions could be made as to how other 

similar species would react if used in the manner divulged. 

91. GSK’s ‘994 patent disclosed two Wellbutrin-containing “sustained 

release” formulations but attempted to capture all pharmaceutical compositions that 

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caused the release of bupropion from a tablet in a defined manner. 

92. Chemistry in general, and pharmaceutical chemistry in particular, are 

recognized as relatively unpredictable arts. 

93. During prosecution of the patent, the patentee acknowledged that it was 

improper to hold that chemical structures generally obviated another chemical 

structure. 

94. The description of two ways of making a controlled release bupropion 

composition is insufficient to justify a grant of a patent covering all pharmaceutical 

means of controlling the release of bupropion, which would include those yet to be 

discovered only after arduous experimental efforts. 

95. GSK purposefully obfuscated the patent application during prosecution to 

obtain a patent monopoly covering more than was invented. 

96. By claiming more than GSK was entitled to, the patent discouraged 

innovation in the field of controlled release pharmaceuticals since it would appear that 

one could expend great amounts of time and money to invent a novel excipient only to 

have it fall within the literal range of the ‘994 patent. 

97. On July 26, 2000, EON submitted an ANDA for generic Wellbutrin SR 

containing a Paragraph IV certification that the ‘994 patent was invalid or not infringed 

by the EON pharmaceutical. 

98. On November 29, 2000, GSK filed suit in the United States District Court 

for the Southern District of New York against EON, a generic drug manufacturer, for 

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infringing the ‘994 patent by submission of an ANDA proposing their marketing of a 

controlled release bupropion compound (the “EON II litigation”). 

99. By initiating this litigation, GSK received the 30-month stay preventing 

EON from marketing the generic Wellbutrin. 

100. On January 24, 2002, EON received tentative approval for the generic 

Wellbutrin ANDA submitted on July 26, 2000. 

101. The grant of tentative approval indicated that EON would have received 

final approval to begin marketing of generic Wellbutrin SR if not for the legal 

impediment of the then outstanding GSK litigation 

102. On August 13, 2002 the United States District Court for the Southern 

District of New York invalidated the ‘994 patent for lack of enablement. 

103. GSK not only knew at the onset of the EON II litigation that the ‘994 

patent was nonenabled and therefore unenforceable, but in fact had written and 

prosecuted the patent in such a way as to attempt to capture patent protection for an 

invention it had not invented. GSK, however, still attempted to assert the faulty ‘994 

patent in order to invoke the 30-month FDA stay, preventing a generic version of 

bupropion from coming to market and consequently, illegally extending their 

monopoly on Wellbutrin SR and its generic equivalents while the litigation progressed. 

104. After the 30-month stay expired in November 2003, EON received final 

approval of the generic Wellbutrin SR ANDA from the FDA and announced that the 

product would be marketed. This announcement was made even though GSK 

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continued to prosecute the patent infringement litigation against EON. 

105. GSK further delayed the introduction of EON’s generic Wellbutrin SR by 

obtaining an injunction in the United States District Court for the Southern District of 

New York in November, 2003. 

106. EON appealed the injunction to the Federal Circuit and it was stayed on 

January 14, 2004. 

107. If not for the 30-month stay invoked by GSK filing the baseless EON II 

litigation and the additional period of exclusivity gained for GSK by obtaining an 

improper injunction, EON would have been able to market generic Wellbutrin on 

January 24, 2002, nearly two years earlier than they actually began marketing the drug. 

CLASS ALLEGATIONS

108. Plaintiffs bring this action on their own behalf under Rule 23(b)(3) of the 

Federal Rules of Civil Procedure with respect to damages sought herein, as 

representatives of the Class defined as follows: 

All persons or entities in the United States that purchased 

Wellbutrin SR directly from GSK during the period of 

January 24, 2002 to a date to be determined. 

 

Excluded from the Class are all governmental entities. 

109. While the exact size of the Class is unknown to Plaintiffs at the present 

time, the members of the Class are numerous and geographically dispersed throughout 

the United States and joinder is impracticable. 

110. Plaintiffs’ claims are typical of the members of the Class, in that Plaintiffs 

Case 2:04-cv-05525-LS Document 1 Filed 11/30/04 Page 22 of 26
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paid supracompetitive prices for Wellbutrin SR and purchased Wellbutrin SR from 

GSK. 

111. Plaintiffs will fairly and adequately protect and represent the interests of 

the Class. The interests of Plaintiffs coincide with, and are not antagonistic to, those of 

the Class. 

112. In addition, Plaintiffs’ counsel are experienced and competent in the 

prosecution of complex class action antitrust litigation. 

113. Questions of law and fact common to the members of the Class 

predominate over questions, if any, that may affect only individual members. 

114. Questions of law and fact common to the Class include: 

i. Whether GSK has illegally monopolized the market for Wellbutrin SR 

and its generic equivalents; 

ii. Whether GSK’s conduct caused sale prices of Wellbutrin SR to be at 

artificially high and non-competitive levels; 

iii. Whether, and to what extent, GSK caused injury to the business or 

property of Plaintiffs and the Class and, if so, the appropriate measure 

of the damages. 

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

adjudication of the controversy. Among other things, class action 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 

Case 2:04-cv-05525-LS Document 1 Filed 11/30/04 Page 23 of 26
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evidence, effort, and expense that numerous individual actions would engender. The 

benefits of proceeding through the class mechanism, including providing injured 

persons or entities with a method for obtaining redress for claims that it might not be 

practicable to pursue individually, substantially outweigh any difficulties that may 

arise in management of this class action. 

116. Plaintiffs know of no difficulty to be encountered in litigation of this 

action that would preclude its maintenance as a class action. 

VIOLATION ALLEGED

117. Plaintiffs incorporate by reference the preceding allegations. 

118. GSK violated Section 2 of the Sherman Act by defrauding the United 

States Patent and Trademark Office into issuing invalid patents and attempting to 

enforce invalid patents through sham litigation on which no reasonable litigant could 

have expected to prevail, solely to prevent low-cost generic versions of Wellbutrin SR 

from entering the market. 

119. GSK violated Section 2 of the Sherman Act by using sham litigation 

alleging infringement under the DOE when no reasonable plaintiff could have expected 

a positive outcome on the facts of the case. 

120. Plaintiffs and the Class have, as a consequence of GSK’s anti-competitive 

behavior, sustained substantial losses and damage to their business and property in the 

form of paying prices for Wellbutrin SR that were higher than they would have been 

but for Defendant’s monopolization and attempts to monopolize that product market in 

Case 2:04-cv-05525-LS Document 1 Filed 11/30/04 Page 24 of 26
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the United States. The full amount of such damages is presently unknown and will be 

determined after discovery and upon proof at trial.

DEMAND FOR RELIEF

WHEREFORE, Plaintiffs respectfully request a judgment against GSK for the 

following relief: 

1. Certification of the Class pursuant to Rule 23 of the Federal Rules of Civil 

Procedure, certifying Plaintiffs as the representatives of the Class, and designating their 

counsel as counsel for the Class; 

2. A judgment for the damages sustained by Plaintiffs and the Class defined 

herein, and for any additional damages, penalties and other monetary relief provided 

by applicable law, including treble damages; 

3. The costs of this suit, including reasonable attorneys’ fees; and 

4. Such other and further relief as the Court deems just and proper. 

Case 2:04-cv-05525-LS Document 1 Filed 11/30/04 Page 25 of 26
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JURY TRIAL DEMANDED

Plaintiffs demand a trial by jury. 

Date: November ____, 2004 By:________________________ 

 Dianne M. Nast 

 Michael G. Nast 

 RodaNast, P.C. 

 801 Estelle Drive 

 Lancaster, Pennsylvania 17601 

 (717) 892-3000 

 (717) 892-1200 facsimile 

 Michael L. Roberts 

 Roberts Law Firm, P.A. 

 P.O. Box 241790 

 20 Rahling Circle 

 Little Rock, Arkansas 72223-1790 

 (501) 821-5775 

 (501) 821-4474 facsimile 

Case 2:04-cv-05525-LS Document 1 Filed 11/30/04 Page 26 of 26