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Case 2:08-cv-01083-JFW-VBK
1 (.
Document 1
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FILED
1 Donald L. Ridge (SBN 132171)
zeOBFEBI5 PNl¡:16
dridgeaVmj2law.com
2 MORRSPOLICH & PU~Y LLP
CLE~~~ ~J~, ~:IS r.:lr'7 Ci-~~'~T
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1055 West Seventh Street, 24 Floor
3 Los Angeles, CA 90017
LOS ,',H f.~'
Dr
4 Telephone:
(213)488-1178
891-9100
Facsimile: (213)
Attorneys for Plaintiffs
5 ASTELLAS US LLC and '
6
ASTELLAS PHA US, INC.
Glenn W. Trost (SBN 116203)
7 gtrostaVwhitecase.com
WHItt & CASE LLP
8 633 West Fifth Street, Suite 1900
Los Angeles, CA 90071-2007
9 Telephone: (213) 620-7814
Facsimile: (212) 452-2329
10 Attorney for Item Development AB
11 Theodore S. Maceiko (SBN 150211)
tsmaceiko((j (mesday. com
12 JONES DAY
555 South Flower Street, Fiftieth Floor
1.3 Los Angeles, CA 90071
Telephone: (213) 243-2864
14 Facsimile: (213) 243-2539
Attorney for King Pharmaceuticals
15 Research and Development, Inc.
16
UNITED STATES DISTRICT COURT
17
CENTRAL DISTRICT OF CALIFORNIA - WESTERN DIVISION
18 ASTELLAS US LLC, ASTELLAS Cas~£\J 0 8 - 0 1 08' Gli~l'~~.fjr
PHARM us, INC., ITEM
19 DEVELOPMENT AB, AN KIG
COMPLAINT FOR PATENT
PHACEUTICALS RESEARCH
INFRINGEMENT,
INTENTIONAL
20 AND DEVELOPMENT, INC.
INTERFERENCE WITH
PROSPECTIVE ECONOMIC
21
Plaintiffs,
ADVANTAGE, AND UNFAIR
COMPETITION
22 v.
23 ANAZAOHEALTH CORPORATION,
NUIEW RADIOPHARMACEUTICALS,
24 INC., PAUL 1. CROWE, AND KEITH
RUSTVOLD
25
26
Defendants.
27
28
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COMPLAINT
2 Plaintiffs, Astellas US LLC and Astellas Pharma US, Inc. (collectively
3 "Astellas"), Item Development AB ("Item"), and King Pharmaceuticals Research and
4 Development, Inc. ("King"), for their complaint against Defendants AnazaoHealth
5 Corporation ("Anazao") and NuView Radiopharmaceuticals, Inc. ("NuView"), Paul 1.
6 Crowe, and Keith Rustvold (collectively "the Nu View defendants"), allege as follows:
7 SUMMARY AND NATUR OF THE ACTION
the United States, 35 U.S.C. §§ 1
8 1. This is an action under the patent laws of
patent rights exclusively licensed to Astellas,
10 unfair competition in violation of the California Business and Professions Code § 17200
9 et seq. for infringement by Defendants of
11 et seq. a~d § 4381, and interference with prospective economic advantage.
12 2. Plaintiff Astellas markets Adenoscan(ß (hereinafter "Adenoscan"), a
13 branded pharmaceutical product used as a diagnostic for myocardial perfusion imaging
14 ("MPI"). Such use is covered by patent rights Astellas licenses exclusively from
15 plaintiffs King and Item. MPI is an imaging procedure used to diagnose and assess the
16 severity of coronary artery disease. Defendant Anazao, an out-of-state pharmacy, and
17 the Nu View defendants, have embarked on an ilegal scheme to market an unbranded
18 copy of Adenoscan that contains the same active pharmaceutical ingredient, adenosine,
19 but has never been approved by the U.S. Food and Drug Administration (FDA) for any
20 purpose. In violation of the California Pharmacy Law, Nu View advertises the services
21 of Anazao to fill prescriptions for its unapproved adenosine and supply it within
22 California. Anazao and the Nu View defendants purport to sell and solicit prescriptions
23 for their unapproved product for use not as a diagnostic, but for alleged treatment of
24 "reperfusion injury" in patients suffering from myocardial infarction (heart attack).
25 Such use for treatment of reperfusion injury has never been approved by the FDA and,
26 on information and belief, is not accepted or used by physicians who routinely treat
27 myocardial infarction and is certainly not performed by the physicians routinely
28 involved in providing imaging services to whom Nu View's marketing efforts are
2
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1 directed.
2 3. On information and belief, reference to this purported therapeutic use of
3 the unapproved product is merely a ruse intended to deflect attention from Anazao' s
4 and the NuView defendants' wilful patent infringement resulting from the offers to sell
5 and sales of
that product as a substitute for Adenoscan in MPI. On information and
6 belief, Anazao and the Nu View defendants perpetuate this ruse by providing false and
7 misleading information on their websites, in their marketing materials, and even on the
8 label and information accompanying the unapproved product to suggest that it is for use
9 in reperfusion injury when, in fact, it is knowingly marketed and distributed for use in
10 MPI. Anazao and the Nu View defendants specifically target for sales and furnish their
11 product to clinics that perform the diagnostic MPI procedure but would never treat
the
12 reperfusion injury. The NuView sales representatives actively encourage the use of
13 unapproved product for MPI in a manner that constitutes infringement of plaintiffs'
14 patent rights and is completely contrary to the product information provided by Anazao
15 and NuView.
16 4. Also on information and belief, Anazao and NuView price their product, as
17 befits its status as an unapproved copy, at a substantial discount compared to authentic
18 Adenoscan. However, the cost savings are not passed along to patients and patients are
19 unaware that they are receiving an unapproved drug rather than authentic Adenoscan.
20 5. Defendants' conduct constitutes wilful patent infringement, intentional
21 interference with prospective economic advantage, and unfair competition that has
22 caused and wil continue to injure and cause damages to Astellas, Item, and King unless
23 enjoined by this Court.
24 THE PARTIES
25 6. Plaintiff Astellas US LLC is a Delaware limited liability corporation
26 having an office and principal place of
business at Three Parkway North, Deerfield,
27 Illinois 60015-2548.
28 7. Plaintiff Astellas Pharma US, Inc. is a Delaware corporation having an
3
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1 office and principal place of business at Three Parkway North, Deerfield, Illinois
2 60015-2548.
3 8. Plaintiff Item Development AB is a Swedish corporation having an office
4 and principal place of
King is a Delaware corporation having an office and principal
5 9. Plaintiff
6 place of
business at Svanholmsvagen 2A, Stocksund, SE-18275, Sweden.
business at 4000 CentreGreen Way, Suite 300, Cary, Nort Carolina 27513.
7 10. On information and belief, Defendant Anazao is a Florida corporation
8 having a principal place of
business at 5710 Hoover Boulevard, Tampa, Florida 33634-
9 5339.
10 11. Defendant Nu View Radiopharmaceuticals is an entity having a website
business at 1107 Snowberr
11 (ww.nuviewinfo.com) that indicates a principal place of
12 Street, Park City, Utah 84098. However, according to the website for the Secretary of
13 State of
Utah, NuView Radiopharmaceuticals is not a licensed business in Utah.
14 12. On information and belief, 1107 Snowberr Street, Park City, Utah 84098
15 is a residence within a gated community which is zoned for residential use.
16 13. On information and belief, defendant Paul J. Crowe is the founder,
17 chairman, and chief executive officer of
NuView Radiopharmaceuticals and a resident
18 of California.
19 14. On information and belief, defendant Keith Rustvold is the National Sales
20 Coordinator for Nu View Radiopharmaceuticals and a resident of California.
21 15. According to records of the Secretary of State for the State of Delaware,
22 Nu View Radiopharmaceuticals was at one time a Delaware corporation, but its current
23 status is "void." Records indicate that NuView owes a delinquent tax bil in Delaware
24 in excess of $200,000.
25
JURISDICTION AND VENUE
26
27
28
16. This is an action for pecuniary and injunctive relief for patent infringement
arising under the patent laws of
the United States, Title 35, United States Code, for
4
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1 unfair competition arising under the California Business and Professions Code § 17200
2 et seq. and § 4381, and for interference with prospective economic advantage under the
3 common law of the State of California.
the patent claim as
4 17. This Court has jurisdiction over the subject matter of
5 provided in 28 U.S.C. § 1338. This Court has supplemental jurisdiction over the state
6 law claims under 28 U.S.C. § 1367.
7 18. Personal jurisdiction by this Court over defendant Anazao and the Nu View
8 defendants is proper because Anazao and the Nu View defendants have in the past and
9 continue to transact and/or solicit business throughout the United States, including in
10 this district, and their infringing activities have occurred and continue to occur
11 throughout the United States and in this district.
12 19. According to NuView's website, NuViewmaintains a sales force in
13 California for the purpose of serving customers in the state and in this district.
14 20. Of
the states represented on the NuView website, NuView devotes more
15 sales representatives to California than any other state.
16 21. The Nu View website indicates that at least three sales representatives are
17 assigned to territories within the Central District of California. .
18 22. On information and belief, defendants Nu View and Keith Rustvold have
19 contacted physicians by telephone and in person within the Central District of
20 California and offered to sell and/or sold NuView's products.
21 23. According to NuView's website, orders for pharmaceuticals placed with
22 Nu View wil be filled by Anazao.
23 24. On information and belief, Anazao has furnished and continues to furnish
24 pharmaceuticals within the Central District of California based on orders placed with
25 NuView.
26 25. On information and belief, Anazao is licensed in the State of California as
27 a pharmacy and is also licensed as an out of state compounding pharmacy.
28 26. By seeking and obtaining these licenses in the State and by furnishing
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1
pharmaceuticals within the Central District of California, Anazao has purposely availed
2
itself of
3
the privilege of doing business within the state and in this district.
27. Venue properly lies in this district under the provisions of28 U.S.C.
4
§§ 1391 and 1400 because Anazao and NuView reside in the district for venue
5
purposes, having purposely and repeatedly availed themselves of the privilege of doing
6
business within the district, because a substantial part of
7
claim occurred in this district, and because, on information and belief, all the defendants
8
reside in the same state.
the events giving rise to the
9
10 MYOCARDIAL PERFUSION IMAGING AND
11 ASTELLAS'S ADENOSCAN PRODUCT
12 28. Myocardial perfusion imaging (MPI) is a diagnostic technique for studying
13 the blood flow in the heart. It is often used in conjunction with a radiopharmaceutical
14 tracer, for example thallium-201 or technetium, to detect the presence or assess the
15 severity of coronary artery disease.
16 29. Patients undergoing MPI typically exercise on a treadmil to increase blood
17 flow to the heart.
18 30. Physicians compare images made after exercise "stress" to images made
blood flow and diagnose
19 while the heart is at rest to identify areas of inadequate
20 whether a patient has coronary artery disease and how severe the disease may be.
21 31. F or patients who are unable to exercise on a treadmil, physicians can
22 perform a so-called "pharmacologic stress" procedure.
23 32. Adenosine is a naturally occurring compound that can be used to cause
24 pharmacologic stress by vasodilation in conjunction with MPI.
25 33. When used as a vasodilator for pharmacologic stress, adenosine is typically
26 administered by intravenous infusion at a dose of 140 micrograms/kg/min over a period
27 of minutes.
28 34.
Astellas markets Adenoscan, an adenosine-based product approved by the
6
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1 Food and Drug Administration ("FDA") for use as an adjunct to thallium-201
2 myocardial perfusion scintigraphy in patients unable to exercise adequately.
3 Adenoscan contains 3 mg/ml of adenosine and is sold in 20 ml or 30 ml vials.
4 35. Sales of Astellas's Adenoscan amount to more than $300 milion per year
5 nationwide and in excess of $20 milion annually in California.
6 36. While some Adenoscan customers are associated with hospitals, many
7 purchasers of Adenoscan are free-standing out-patient clinics.
8 37. These outpatient clinics provide specialized services to patients in the form
9 of diagnostic cardiac imaging. While they may be located near a hospital, outpatient
10 clinics do not provide the range of cardiac care services found in a hospitaL.
11 38. In particular, outpatient clinics generally do not provide acute cardiac care
12 to patients suffering from a myocardial infarction (heart attack). To the contrary, if a
13 patient in an outpatient clinic suffers a myocardial infarction during a stress-imaging
14 procedure, that patient is usually quickly transferred to a hospital emergency room that
15 is better equipped to provide the full range of care required for such life-threatening
16 situations.
17 39. In outpatient clinics, Adenoscan is administered under the oversight of a
18 physician, typically a cardiologist. Nuclear medicine technologists may also be
19 involved in the actual administration and handling of Adenoscan and the associated
20 radiopharmaceutical tracer agents used in connection with MPI.
21 40. Often, nuclear medicine technologists are the point of contact for sales of
22 Adenoscan in that they are responsible for maintaining the supply of the drug in the
23 facility and ordering additional drug when supplies get low. The point of contact for
24 Adenoscan sales may also be an office manager who is not a nuclear medicine
25 technologist.
26 41. Adenoscan can be purchased directly from Astellas or through distributors.
27 Astellas has a sales force that interacts directly with physicians and technicians in
28 hospitals and outpatient clinics, providing information about Adenoscan as well as
7
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arranging for educational training programs offered by Astellas.
2
3
42. Astellas has been marketing Adenoscan throughout the United States,
including California, since the mid-1990s.
4
5
43. Only Astellas has received final FDA approval to market adenosine in the
form of Adenoscan for use in MPI.
6
7 THE '296 PATENT
8 44. On March 24, 1998, the United States Patent and Trademark Office
9 ("PTO") duly and legally issued United States Patent No. 5,731,296 ("the '296 patent")
10 to Item for "SELECTIVE VASODILATION BY CONTINUOUS ADENOSIN
the '296 patent is attached hereto as Exhibit A.
11 INUSION." A copy of
12 45. Item is the assignee of
the '296 patent by virte of documents duly
13 recorded at the United States Patent and Trademark Office.
14 46. Astellas is the exclusive licensee of certain rights in the '296 patent and
15 enjoys the right to bring suit under this patent.
16 47. The FDA-approved method of
using Astellas's Adenoscanproduct in MPI
17 is covered by one or more claims of the ' 296 patent and the ' 296 patent is listed in the
18 FDA's publication, Approved Drug Products with Therapeutic Equivalence
19 Evaluations" (known as the "Orange Book") in connection with Adenoscan.
20
21 THE '877 PATENT
22 48. On December 10, 1991, the United States Patent and Trademark Office
23 duly and legally issued United States Patent No. 5,070,877 ("the '877 patent") to
24 Medco Research, Inc. (hereinafter "Medco") for a NOVEL METHOD OF
25 MYOCARDIAL IMAGING. A copy of
26 49. Subsequently, the assets of
27 assignee of
the '877 patent is attached hereto as Exhibit B.
Medco were acquired by King. King is the
the '877 patent by virtue of documents duly recorded at the United States
28 Patent and Trademark Office.
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50. Astellas is the exclusive licensee, with right to bring suit, of certain rights
in the' 877 patent.
using Astellas's Adenoscan product in MPI
51. The FDA-approved method of
the '877 patent and the '877 patent is listed in the
4
is covered by one or more claims of
5
FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations
6
(known as the "Orange Book") in connection with Adenoscan.
7
8 NUVIEW AND ANAZAO'S ACTIVITIES IN CALIFORNIA
9 52. NuView's website describes NuView as "an emerging company focusing
10 on commercializing quality diagnostic imaging agents and targeted therapies for
11 diagnosing cancer and heart disease."
12 53. Among the products offered by NuView is a product described as
13 "Compounded Adenosine."
14 54. NuView's website claims that "(a)denosine has been found to offer
15 beneficial outcomes to patients experiencing acute myocardial infarction (heart attack)"
16 and that "(i)n contrast to other pharmaceutical agents that have shown disappointing
17 effects in man, adenosine, a naturally occurring compound, has consistently resulted in
18 a marked reduction in heart damage and has also improved clinical outcomes in patients
19 treated early with heart attacks."
20 55. According to the NuView website, "(a)n intravenous infusion of adenosine
2 1 for 3 hours should be considered as adjunctive therapy in high-risk patients undergoing
22 reperfusion therapy."
23 56. The use of adenosine as a therapeutic in patients experiencing acute
24 myocardial infarction has not been approved by the FDA.
25 57. On information and belief, Nu View has not sought to obtain such FDA
26 approval for the use of adenosine as a therapeutic for patients suffering from acute
27 myocardial infarction.
28 58. The NuView website also contains an "Infusion Protocol Chart" describing
9
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1 an "Adenosine (3 mg/ml) Infusion Protocol for Acute Myocardial Infarction" which
2 involves intravenously pumping an undiluted preparation ofNuView's compounded
3 adenosine into a patient "to achieve a dose of70 (micrograms)/kg/min."
4 59. A patient administered an adenosine infusion according to the "Infusion
between 210 and 588 milliliters of
5 Protocol Chart" would receive a total volume of
6 adenosine. The unapproved adenosine product is not, however, offered for sale in
7 packaging adapted for the administration of such large amounts of adenosine. Instead,
8 it is offered in smaller vials suited for use as an unauthorized replacement for
9 Adenoscan in MPI procedures.
10 60. A document on the NuView Website titled "NuView Product Order Form"
1 1 offers "Compounded Adenosine 3 mg/ml" in configurations of 1 0 x 50 ml vials per box
12 or 20 x 25 ml vials per box for $1500, with a notation "Signature required, as directed
13 for cardiac reperfusion injury."
14 61. The "Product Order Form" from the NuView website also includes spaces
15 to provide a "Patient Name" associated with each order and states "Prescription filled
16 by AnazaoHealth Corporation™.''
1 7 62. According to a January 8, 2008 letter from counsel for Anazao to in-house
18 counsel for Astellas, Nu View and Anazao have entered into an agreement whereby
19 NuView markets adenosine for Anazao. On information and belief, Anazao is aware of
20 NuView's practices in marketing adenosine.
21 63. Anazao has its own website, ww.anazaohealth.com. on which it
22 advertises "Custom Pharmacy" services.
23 64. The Anazao website describes Anazao's Custom Pharmacy Services as
24 follows: "AnazaoHealth creates customized medications and compounds
25 pharmaceuticals, dietary supplements and hormones for individual patients under
26 physician care. Our custom-compounded therapeutics are individually tailored to meet
27 the special needs of
your patients."
28 65. The Anazao website also contains an order form for adenosine at a
10
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1 concentration of 3 mg/ml with the notation "Sig: As directed for cardiac reperfusion
2 injur."
3 66. Neither NuView nor Anazao's product order form or website mentions the
4 use of adenosine for myocardial perfusion imaging.
5 67. Although the use of adenosine for MPI is not mentioned on the Nu View
6 website or on its order form, Nu View, through its sales representatives, is actively
7 inducing the use of adenosine prepared by Anazao as a pharmacologic stress agent in
8 MPI and Anazao is providing its adenosine product for that use. On information and
9 belief, Anazao is aware of
NuView'
s
actions inducing the use of
its adenosine for MPI.
10 68. More specifically, the NuView defendants' sales representatives have
11 contacted nuclear technicians at free-standing outpatient imaging clinics throughout the
12 United States, in California, and in this District that perform MPI procedures and
13 offered adenosine made by Anazao as a substitute for Astellas' s Adenoscan adenosine
14 product in MPI procedures.
15 69. On information and belief, NuView and its representatives are aware that
16 these clinics do not provide acute coronary care to patients suffering from myocardial
17 infarction and that consequently, such clinics would not use adenosine for treatment of
18 reperfusion injury as described on the NuView website and in NuView's product
19 literature.
20 70. By way of example, Anazao has sent a customer invoice to California
21 Heart and Vascular Clinic in El Centro California for the purchase of adenosine, listing
22 NuView as the "salesperson" and describing the product as "Adenosine (Nuclear)."
23 MPI is considered a "nuclear" procedure. Treatment of reperfusion injury is not.
24 71. In addition, the Nu View defendants have encouraged customers to seek
25 Medicaid reimbursement for using Nu View's adenosine product in place of Adenoscan
26 for MPI. Specifically, on information and belief, in January 2008, NuView sales
27 representative, Sally Torney, wrote to a physician's office concerning NuView's
28 product as follows:
11
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1 I know you had a question about re-imbursement for the
2 Nu View adenosine. I spoke with our national sales director
3 (Keith Rustvold) about getting an EOB for insurance purposes
4 and he told me that all you need to do is bil it the same way
5 that you would for the other adenosine. There should be no
6 questions or issues. Sometimes Medicaid wil have a question
7 about it because of the difference in the vial sizes, but
8 adenosine is adenosine, and the price is the driving factor.
the "other adenosine" referred to is Adenoscan,
9 72. On information and belief
10 which is sold and used only for MPI.
11 73. On information and belief, Anazao and the Nu View defendants are aware
12 of Astellas's patent rights with respect to Adenoscan.
13 74. Anazao has admitted in a letter written by its counsel to Astellas that
14 "Anazao is aware that Astellas Pharma US, Inc. ("Astellas") is either the owner or
15 exclusive licensee of
unexpired patents regarding Adenoscan(ß adenosine and bearing
16 numbers, U.S. Pat. 5,070,877 and 5,731,296, respectively."
17 75. Anazao has contacted Astellas and sought a license under the '296 and
18 '877 patents but has failed to respond to Astellas's requests for information about the
19 extent of Anazao' s sales of adenosine for MPI as opposed to reperfusion injury.
20 76. On information and belief, NuView's product configuration and references
21 to reperfusion injury on its website and in its ordering and information materials are
22 intended to conceal its active inducement of
infringement of
the '296 and '877 patents.
23 77. On information and belief, Nu View representative Sally Torney
24 communicated to a physician's office in early 2008 that "Our company (because of
you look at our prices,
25 patent restraints) can only make a 25 ML and 50 ML vial, but if
26 they are stil more than 50% less than the other adenosine."
27 78. On information and belief, the adenosine product promoted and sold by
28 Nu View and shipped by Anazao is specifically configured for use in MPI and both
12
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1 Nu View and Anazao are aware that the product wil be used for MPI by the customers
2 at nuclear imaging clinics where the product is shipped in violation of Astellas' s patent
3 rights.
4 79. NuView's sales representatives have made sales contacts both in person
5 and by telephone at clinics that use Astellas's Adenoscan product in MPI procedures.
these sales contacts, NuView's sales representatives have
6 80. As part of
7 assured Astellas's customers that NuView's product is identical to Adenoscan, even
8 though the NuView/Anazao product is not approved by the FDA for use in MPI and
9 neither the product nor the manufacturing facility has been subject to the same stringent
10 controls and regulations as Astellas' s Adenoscan.
11 81. In face-to-face sales calls on nuclear technicians, NuView's sales
12 representatives have also made direct price comparisons to Adenoscan, encouraging
13 Astellas' s customers to switch to adenosine made by Anazao based on its lower price
14 per milligram of solution.
these sales calls, NuView was
15 82. On information and belief, at the time of
16 aware that the customers were regularly purchasing Adenoscan from Astellas and
17 would continue to do so absent Nu View's actions.
18 83. As a result ofNuView's activities in California and this district,
19 physicians' offices have ceased regular purchases of Adenoscan and have instead
20 purchased adenosine made by Anazao and used it in MPI procedures in violation of
21 Plaintiffs' patent rights.
22
23
24
25
NUVIEW'S VIOLATIONS OF CALIFORNIA LAW
84. Chapter 9, Sec. 4000 et seq. of
the California Business and Professions
Code contains the California Pharmacy Law.
26
85. Adenosine is classified as a "dangerous drug" under CBPC § 4022.
27
86. California Business and Professions Code § 4076 requires that a
28
"pharmacist shall not dispense any prescription except in a container that meets the
13
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1 requirements of state and federal law and is correctly labeled" with various types of
2 information, including the directions for the use of the drug and the name of the patient.
3 87. California Business and Professions Code § 4077 states that, except under
4 certain specific circumstances, "no person shall dispense any dangerous drug upon
5 prescription except in a container correctly labeled with the information required by
6 Section 4076."
7 88. California Business and Professions Code § 4078 states that "(n)o person
8 shall place a false or misleading label on a prescription" and that "(n)o prescriber shall
9 direct that a prescription be labeled with any information that is false or misleading."
10 89. NuView and Anazao are violating at least California Business and
11 Professions Code §§ 4076-78 by soliciting and dispensing medications in containers not
12 correctly labeled with the information provided by § 4076 and by soliciting and
13 providing prescriptions that, on information and belief, lack reference to a patient name
14 as well as directions for use in MPI. On information and belief, NuView and Anazao's
15 product bears and/or is distributed with a false or misleading label that indicates the
16 drug is for use in "reperfusion injury" rather than the intended use ofMPI and NuView
17 and Anazao distribute with the product a "Medical Professional Information Sheet" that
18 falsely and misleadingly describes dosing and information for use of adenosine in
19 inhibiting "reperfusion injury" rather than MPI, the use for which the product is sold
20 and actually employed.
21 90. On information and belief, NuView is not licensed as a pharmacy or a
22 pharmacy wholesaler in the State of California, in violation of at least California
23 Business and Professions Code § 4160.
24 91. On further information and belief, the Nu View defendants are unlawfully
25 advertising the pharmacy services of Anazao in violation of California Business and
26 Professions Code § 4340.
27 92. NuView and Anazao's use of
false and misleading labeling information,
28 including its distribution of a false and misleading "Medical Professional Information
14
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1 Sheet" is also a violation of at least California Health and Safety Code §§ 111330,
2 111440, 111445, and 111450 which prohibit misbranding of drugs with false or
3 misleading labeling and further prohibit sale and delivery of such misbranded drugs.
4 93. Because Anazao and Nu View are selling adenosine for use in MPI
5 procedures and not for reperfusion injury therapy as described on their websites and in
6 their product literature, the website statements and product literature constitute false
7 advertising under at least California Health and Safety Code §§ 110390, 110395,
8 110398,110400.
9 94. Anazao and NuView's website statements and product literature further
10 constitute false advertising under California Business and Professions Code § 17500.
11 95. Anazao and Nu View are also violating California Health and Safety Code
12 § 110403, which prohibits any person from advertising any drug "represented to have
13 any effect in . . . (h Jeart and vascular diseases" unless such advertisements are limited to
14 medical professionals or if
the drug is approved for the particular curative or therapeutic
15 effect advertised. Anazao and Nu View are advertising the alleged effects of their
16 adenosine product in treatmentof cardiac "reperfusion injury" through product
17 literature and statements on their respective websites that are not limited in their
18 audience to medical professionals.
19
20
21
NUVIEW'S FALSE AND MISLEADING COMPARISONS TO ADENOSCAN
96. Nu View, through its representatives, has repeatedly compared its
22
adenosine product made by Anazao to Astellas' s Adenoscan product and assured
23
potential customers that the two products are interchangeable.
24
97. The adenosine-based drug product advertised and sold by Nu View and
25
Anazao is one that Anazao formulates itself under a practice known as "pharmacy
26
compounding" and constitutes an unapproved drug.
27
28
98. By definition, pharmacy compounding "involves making a new drug
whose safety and efficacy have not been demonstrated with the kind of data that FDA
15
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1 ordinarily would require in reviewing a new drug application." Federal and State Role
2 in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect
3 Patients, Hearing Before the Comm. on Health Educ., Labor and Pensions, 108th Congo
4 39 (2004) (Statement of
Steven K. Galson, M.D., M.Ph., Acting Director, Center for
5 Drug Evaluation and Research, U.S. Food and Drug Administration, Department of
6 Health and Human Services) (hereinafter "Galson Statement"); see also FDA's
7 Compliance Policy Guide, Section 460.200 (June 22,2002)
8 (http://ww.fda.gov/oralcompliance_ref/cpg/cpgdrg/cpg460-20O.html). Nor has the
9 FDA determined that compounded drg products have been manufactured under
10 rigorous good manufacturing practice requirements.
11 99. The FDA frowns upon pharmacy compounding of commercially available
12 FDA drug products such as Astellas's Adenoscan product. "(C)opying commercially13 approved products in compounding pharmacies circumvents important public health
14 requirements and undermines the drug approval process--the evidence based system of
15 drug review that consumers and health professionals rely on for safe and effective
16 drugs." Galson Statement at 40.
17 100. NuView and Anazao's misleading marketing and promotion of Anazao's
18 adenosine drug product results in deception and potential harm to patients, the ultimate
19 consumers of the product. Patients are unlikely to know that they are being
20 administered an unapproved copy rather than an authentic FDA-approved drg and any
21 cost savings associated with the lower priced NuView and Anazao product are unlikely
22 to be passed along to patients.
23 101. While substitution of
"generic" drugs for a branded alternative is common
24 and is sanctioned under California Law, Anazao's product is not a "generic" drug in
25 that it is not subject to the FDA approval process for generic drugs and has not been
26 manufactured in an FDA inspected and regulated facility for the manufacture of generic
27 drugs. To the extent that the Defendants refer to or seek to create the impression that
28 their unapproved adenosine product is a "generic" equivalent of Adenoscan, such
16
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1 actions are false and misleading.
3 COUNT I
2
4 INDUCEMENT OF INFRINGEMENT OF U.S. PATENT NOS. 5,731,296
5 AND 5,070,877 BY ANAZAO AND THE NUVIEW DEFENDANTS
6 102. Paragraphs 1-101 are incorporated herein by reference.
7 103. The use of continuous adenosine infusion for MPI infringes one or more
8 claims of
the '877 patent. Thus, on
the '296 patent and one or more claims of
9 information and belief, Defendants' customers have directly infringed the '296 and '877
10 patents by using adenosine purchased from Defendants in MPI.
11 104. The Nu View defendants and Anazao, have actively and knowingly aided
the '296 and '877 patents.
12 and abetted the direct infringement of
13 105 . Aware of Astellas' s patent rights, the Nu View defendants and Anazao
the '296 and '877 patents by
14 have actively and knowingly induced infringement of
15 intentionally encouraging the use of, offering for sale, and selling adenosine made by
16 Anazao for use as a substitute for Adenoscan in MPI.
17 106. Even if customers were to use adenosine to treat cardiac reperfusion injury
18 by continuous infusion at 70 mcg/kg/min according to the methods set forth on the
19 websites of Anazao and Nu View and in their product literature, such use would infringe
20 one or more claims of the ' 296 patent.
21 107. Through at least their website solicitations and corresponding product
22 literature, both Anazao and the Nu View defendants thus actively and knowingly induce
23 and encourage direct infringement of
the '296 patent in violation of35 U.S.C. § 271(b)
24 even to the extent that Anazao or Nu View contends that any of their customers actually
25 used their adenosine product for treatment of cardiac reperfusion injury rather than
26 MPI.
27 108. As a consequence of
these infringing activities by Anazao and NuView,
28 Plaintiffs have been damaged in an amount not yet determined.
17
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1 109. Plaintiffs will continue to be damaged as a consequence of Defendants'
2 infringing activities unless those activities are preliminarily and permanently enjoined.
4 COUNT II
3
5 CONTRIBUTORY INFRINGEMENT OF U.S. PATENT NOS. 5.73L296
6 AND 5.070.877 BY ANAZAO AND THE NUVIEW DEFENDANTS
7 110. Paragraphs 1-109 are incorporated herein by reference.
8 111. The activities of Anazao and the Nu View defendants in providing
9 adenosine for use in MPI also constitute contributory infringement of one or more
10 claims of
the '877 patent under 35 U.S.C. §
the '296 patent and one or more claims of
11 271(c).
12 112. Anazao and the NuView defendants have offered for sale and sold an
13 adenosine product for use in practicing the patented methods claimed in the '296 and
the claimed inventions, knowing
14 '877 patents, which use constitutes a mat~rial part of
15 that the adenosine product is especially made or adapted for use in infringing the
16 patents, and that the adenosine product is not a staple article or commodity of
17 commerce suitable for substantial noninfringing use. On information and belief,
18 Defendants' customers have directly infringed the '296 and '877 patents by using
19 adenosine purchased from Defendants in MPI.
20 113. On information and belief, there is no substantial use of Defendants'
21 unapproved adenosine product for reperfusion injury and certainly no such use by the
22 customers to whom defendants direct their adenosine sales efforts.
23 114. Even if customers were to use adenosine to treat cardiac reperfusion injury
24 by continuous infusion at 70 mcg/kg/min according to the methods set forth on the
25 websites of Anazao and Nu View and in their product literature, such use would infringe
26 one or more claims of
the '296 patent.
27 115. Thus, even if Anazao and Nu View were to prove a substantial use of
28 adenosine to treat cardiac reperfusion injury, that use would stil fall within the scope of
18
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the '296 patent and would not constitute a substantial
1 one or more claims of
2 noninfringing use.
3 116. As a consequence ofthe.se infringing activities by Defendants, Plaintiffs
4 have been damaged in an amount not yet determined.
5 117. Plaintiffs wil continue to be damaged as a consequence of Defendants'
6 infringing activities unless those activities are preliminarily and permanently enjoined.
7
8 COUNT III
9 WILLFUL PATENT INFRINGEMENT OF U.S. PATENT NOS. 5~73L296
10 AND 5~070~877 BY ANAZAO AND THE NUVIEW DEFENDANTS
11 118. Paragraphs 1-116 are incorporated herein by reference.
12 119. In proceeding to make, offer, and sell their unauthorized compounded
13 version of Adenoscan, Defendants have knowingly and recklessly disregarded the '296
14 and '877 patents and Astellas's exclusive marketing rights under that patent.
15 120. Defendants' activities constitute wilful patent infringement warranting
16 imposition of
treble damages under 35 U.S.C. § 284.
17 121. Defendants' flagrant disregard of the ' 296 and' 877 patents makes this an
18 exceptional case warranting imposition of attorney fees against Anazao and Nu View
19 under 35 U.S.C. § 285.
20
21 COUNT
IV
22 INTENTIONAL INTERFERENCE WITH PROSPECTIVE ECONOMIC
23 ADVANTAGE BY ANAZAO AND THE NUVIEW DEFENDANTS
24 122. Paragraphs 1-120 are incorporated herein by reference.
25 123. Anazao and Nu View had knowledge of the existing business relationships
26 between Astellas and Astellas' s customers that would likely have resulted in future
27 economic benefit to Astellas. Despite this knowledge, Anazao and Nu View
28 intentionally interfered with these relationships by proceeding to market, offer for sale,
19
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1
and sell to Astellas' s customers an unauthorized compounded adenosine for use in MPI
2
according to business practices that are prohibited by California Law.
124. Anazao and NuView's actions have caused actual disruption of Astellas's
3
4
business relationships and resultant economic harm to Plaintiffs in an amount not yet
5
determined.
6
7
125. Plaintiffs wil continue to be damaged as a consequence of Defendants'
actions unless those actions are preliminarily and permanently enjoined.
9 COUNT V
8
10 UNFAIR COMPETITION BY ANAZAO AND THE NUVIEW DEFENDANTS
11 UNER THE CALIFORNIA BUSINESS AND PROFESSIONS CODE &17200, ET
12 SEQ. AND CALIFORNIA BUSINESS AND PROFESSIONS CODE & 4381
13 126. Paragraphs 1-124 are incorporated herein by reference.
14 127. In marketing, offering for sale, and selling its unauthorized compounded
15 adenosine for continuous infusion for MPI to customers as described herein, NuView
16 and Anazao have engaged in unlawful, unfair or fraudulent business practices in
17 violation of
the Business and Professions Code § 17200, et seq.
18 128. As set forth in detail above, Defendants' unlawful conduct has included
19 numerous violations of California law, including violations of California Pharmacy
20 Law.
21 129. Violations of
California Pharmacy Law constitute unfair competition
22 pursuant to Business and Professions Code § 17200, et seq. and California Business and
23 Professions Code § 4381.
24 130. Defendants' conduct, even where not unlawful, offends public policy as it
25 has been established by statutes and the common law. As set forth above, Anazao and
26 the Nu View defendants' scheme to develop and perpetuate an elaborate ruse concerning
27 the use of adenosine to treat cardiac reperfusion injury to deflect attention from the
28 unlawful and infringing acts of marketing and providing unapproved adenosine for use
20
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1 in MPI is immoral, unethical, unscrupulous and substantially injurious to consumers as
2 well as to Plaintiffs.
3 131. As a consequence of Defendants, including Defendants' violation of
4 California Business and Professions Code § 4381, Plaintiffs have suffered damages in
5 an amount not yet determined.
Defendants'
6 132. Plaintiffs wil continue to be injured as a consequence of
7 actions unless those actions are preliminarily and permanently enjoined.
8
9 REQUEST FOR RELIEF
10 WHEREFORE, Plaintiffs pray for judgment against Defendants as follows:
11 A. that Defendants have actively induced infringement and/or committed acts
the '296 and' 877
12 of contributory infrngement with respect to one or more claims of
13 patents;
14 B. that Defendants, their officers, agents, attorneys, and employees, and those
15 acting in privity or concert with them or any of them, be preliminarily and permanently
16 enjoined from further acts of infringement;
17 C. that Plaintiffs have been irreparably harmed by Defendants' infringement
18 of
the '296 and '877 patents;
the '296 and '877 patents was willful and
19 D. that Defendants' infringement of
20 deliberate;
21 E. that Defendants be ordered to account for and pay to Astellas, Item, and
22 King all damages caused to Astellas, Item and King by reason of infringement of the
23 '296 and '877 patents, including Astellas's lost profits, and that such damages be
24 trebled by reason of
the '296 and '877 patents
the deliberate and wilful infringement of
25 pursuant to 35 U.S.C. § 284;
26 F. that Astellas, Item, and King be granted reasonable attorney fees pursuant
27 to 35 U.S.C. § 285;
the
28 G. that Defendants have unfairly competed with Plaintiffs in violation of
21
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1 California Business and Professions Code § 17200;
2 H.. that Defendants, their officers, agents, attorneys, and employees, and those
3 acting in privity or concert with them or any of them, be preliminarily and permanently
4 enjoined pursuant to California Business and Professions Code § 17203 from further
5 violation of the California Business and Professions Code § 17200 and that Defendants
6 be ordered to disgorge moneys received by virtue of their unfair practices;
7 1. that Defendants have violated California Business and Professions Code
8 §4381;
9 J.
that Plaintiffs should be awarded actual and treble damages, reasonable
suit pursuant to California Business and Professions Code
10 attorneys' fees and costs of
11 § 4381(b) and (c);
12K. that Defendants be preliminarily and permanently enj oIned from further
13 violation of
the California Pharmacy Law pursuant to California Business and
14 Professions Code § 4381(b) and (c);
15 L. that compensatory and punitive damages be awarded against Defendants in
16 favor of Astellas, Item, and King for Defendant's intentional interference with
17 prospective economic advantage; and
18M. that Plaintiffs be granted such other and further relief as the case may
19 require and the Court may deem just and proper, together with costs in this action.
20
21 Dated: February 15,2008
22
23
24
MORRS POLICH & PURDY LLP
~,ll-.';z
By l'
. pdnald L. Ridge
i'
25
26
Attorneys for Plaintiff, ASTELLAS US LLC and
ASTELLÃS PHARMA US,INC.
27
28
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Charles E. Lipsey
Ii pseyaVfinegan. com
charles.
2
FINNEGAN,lIENDERSON, FARBOW,
GARRETT & DUNNER, L.L.P.
4
Two Freedom Square
11955 Freedom Drive
Reston, VA 20190-5675
5
Facsimile: (571) 203-2777
6
Susan H. Griffen
susan. griffen~finnegan. com
3
Telephone: (571) 203-5675
7
David P. Frazier
8
FINNEGANHENDERSON, FARBOW,
GARRTT & DUNNER, L.L.P.
9
10
11
12
13
14
david. frazier(ãHìnnegan.com
901 New York Avenue, N.W.
Washington, D.C. 20001
Telephone: (202) 408-4000
Facsimile: (202) 408-4400
Attorneys for Plaintiff, ASTELLAS US LLC and
ASTELLÃS PHARM US, INC
Glenn W. Trost
gtrostaVwhitecase. com
WHITE & CASE LLP
15
633 West Fifth Street, Suite 1900
Los Angeles, CA 90071-2007
16
Facsimile: (212) 452-2329
17
18
19
Telephone: (213) 620-7814
Jean E. Shimotake
jshimotake~whitecase. com
John P. Scheibeler
j~cheibeler~whitecase.com
WHITE & CASE LLP
the Americas
New York, NY 10036
1155 Avenue of
20
21
Telephone: (212) 819-8830
Facsimile: (212) 354-8113
22
Attorneys for Plaintif Item Development AB
23
Theodore S. Maceiko
24
25
26
tsmaceikocmi cmesday .com
JONES DAY
555 South Flower Street, Fiftieth Floor
Los Angeles, CA 90071
Telephone: (213) 243-2864
Facsimile: (213) 243-2539
27
28
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F. Dominic Cerrito
1
2
3
4
5
6
fdcerritoaVj onesday. com
Jonathan A. Muenkel
j amuenkel~jonesday .com
JONES DÃY
222 E. 41 st Street
New York, NY 10017 .
Telephone: (212) 326-3413
Facsimile: (212) 755-7306
Attorneys for Plaintiff King Pharmaceuticals
Research and Deverõpment, Inc. .
7
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