Complaint For Patent Infringement

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 1 of 20 PageID #: 1
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UNITED STATES DISTRICT COURT
www.overhauser.com SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ELI LILLY AND COMPANY,

ELI LILLY EXPORT S.A. AND
ACRUX DDS PTY LTD.,
Plaintiffs,
v.
AMNEAL PHARMACEUTICALS LLC,
Defendant.
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Case No. 1:14-CV-2025
COMPLAINT FOR PATENT INFRINGEMENT

Plaintiffs Eli Lilly and Company (Lilly), Eli Lilly Export S.A., and Acrux DDS Pty
Ltd. (Acrux) file this Complaint for patent infringement against Amneal Pharmaceuticals LLC
(Amneal) under 35 U.S.C. 271. This patent action concerns the pharmaceutical drug product
Axiron.
THE PARTIES
1.
Lilly is an Indiana corporation that has its corporate offices and principal place of
business at Lilly Corporate Center, Indianapolis, Indiana 46285. Lilly is engaged in the business
of research, development, manufacture, and sale of pharmaceutical products throughout the
world.
2.
Eli Lilly Export S.A. is a Swiss corporation that has its corporate office in P.O.
Box 580, 16 Chemin des Coquelicots, The Air Centre, 1214 Vernier/Geneva, Switzerland. Eli
Lilly Export S.A. is a wholly owned subsidiary of Lilly.
3.
Acrux is an Australian corporation that has its corporate offices and principal
place of business at 103-113 Stanley Street, West Melbourne VIC 3003, Australia. Acrux is
engaged in the development and commercialization of pharmaceutical products for sale
throughout the world.
4.
Amneal is a Delaware corporation with its principal place of business at 400
Crossing Boulevard, Third Floor, Bridgewater, New Jersey 08807-2863. Amneal is a generic
pharmaceutical company that develops, manufactures, markets, and distributes generic
pharmaceutical products for sale in the State of Indiana and throughout the United States.
NATURE OF THE ACTION
5.
This is an action for infringement of U.S. Patent Nos. 8,435,944 (the 944
patent), 8,419,307 (the 307 patent), 8,177,449 (the 449 patent), and 8,807,861 (the 861
patent). This action relates to Abbreviated New Drug Application (ANDA) No. 206998
submitted in the name of Amneal to the U.S. Food and Drug Administration (FDA) for
approval to market a generic version of Lillys Axiron (testosterone) product, which constitutes
an action of infringement under the United States Patent Laws, Title 35 U.S.C. 100 et seq.,
including 35 U.S.C. 271(e)(2).
SUBJECT MATTER JURISDICTION AND VENUE
6.
This action arises under the patent laws of the United States, including 35 U.S.C.
271, and the Declaratory Judgment Act, 28 U.S.C. 2201 and 2202.
7.
This Court has subject matter jurisdiction under 28 U.S.C. 1331 and 1338(a).
8.
Venue is proper in this judicial district under 28 U.S.C. 1391 and 1400(b).
PERSONAL JURISDICTION
9.
The Court has personal jurisdiction over Defendant because it regularly and
continuously transacts business within the State of Indiana. Defendant markets and sells
-2-
pharmaceutical products throughout the United States, including the State of Indiana. Defendant
maintains a broad distributorship network within Indiana. Defendant derives substantial revenue
from Indiana drug sales and has availed itself of the privilege of conducting business within the
State of Indiana.
10.
According to the website for Amneal, Amneal sells over 12 billion units of
medication annually in the U.S. alone. In fact, Amneals primary distribution facility allows it
to service customers in every corner of the U.S. in an expeditious, accurate and dependable
fashion. Amneal boasts on its website that because it is [s]trategically located in close
proximity to the UPS hub and within the Central Time Zone, Amneal is able to provide one-day
ground delivery to more than 75% of the American population.
11.
Upon information and belief, Amneal Pharmaceuticals currently sells significant
quantities of generic drug products in the state of Indiana. Those products include, for example,
generic versions of Percocet, Ultracet, and Neurontin. A list of generic products
manufactured and sold by Amneal Pharmaceuticals in the United States can be found at
http://prd03.apsiva.net/amneal/#/.
12.
According to the website for Amneal, Amneal proudly sells directly to
warehousing chains, wholesalers/distributors and mail order operations in order to make its
quality products available to all levels of retail pharmacy including independently owned,
regional chains and cooperatives.
13.
On information and belief, Amneal has directly entered into a distribution
agreement with an Indiana wholesale distributor. According to the website for Amneal, Amneal
lists A.F. Hauser, Inc. as an authorized distributor of its products. On information and belief,
A.F. Hauser, Inc. is located at 4401 East U.S. Hwy. 30, Valparaiso, Indiana 46383.
-3-
14.
On information and belief Amneal has availed itself of this forum previously for
the purpose of litigating a patent dispute. For example, Amneal filed counterclaims for
declaratory judgment in the Southern District of Indiana. Eli Lilly and Company et al. v. Accord
Healthcare, Inc. USA. et al., No. 1:14-cv-389-SEB-TAB (S.D.Ind.).
15.
Amneal has engaged in substantial and continuous contacts with Indiana that
satisfy due process and confer personal jurisdiction over Amneal in Indiana on the basis of
general jurisdiction.
16.
Amneal, either directly or through wholesalers, sells products to national and
regional retail drug, supermarket, and mass merchandise chains in Indiana, and Amneal derives
substantial revenue from these sales.
17.
Amneal develops and manufactures pharmaceutical products for the United States
market, including the State of Indiana.

18.
Amneal prepared and submitted ANDA No. 206998 and will benefit from the
approval of ANDA No. 206998.

FACTUAL BACKGROUND
A.
Axiron
19.
Lilly is the holder of approved New Drug Application (NDA) No. 022504 for
the manufacture and sale of testosterone metered transdermal solution, 30mg/1.5mL used to treat
males for conditions associated with a deficiency or absence of endogenous testosterone. Lilly
markets and sells testosterone metered transdermal solution, 30mg/1.5mL under the trade name
Axiron. Axiron was approved by the FDA on November 23, 2010.
B.
The 944 Patent
20.
United States Patent No. 8,435,944 (the 944 patent), entitled Method and
Composition for Transdermal Drug Delivery, was duly and legally issued by the United States
-4-
Patent and Trademark Office (PTO) on May 7, 2013. The 944 patent claims, inter alia,
methods of increasing the testosterone blood level of an adult male comprising applying a
transdermal drug delivery composition that contains testosterone. The 944 patent is listed in the
FDA publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations
(commonly known as the Orange Book) in connection with Axiron . A true and correct copy
of the 944 patent is attached as Exhibit A. Since its date of issue, Acrux has been, and continues
to be, the owner of the 944 patent. Eli Lilly Export S.A. is the exclusive licensee worldwide for
all uses of Axiron under the 944 patent. Eli Lilly Export S.A. has licensed its rights in the 944
patent to Lilly.
C.
The 307 Patent
21.
United States Patent No. 8,419,307 (the 307 patent), entitled Spreading
Implement, was duly and legally issued by the PTO on April 16, 2013. The 307 patent claims,
inter alia, a method of increasing the testosterone blood level of a person in need thereof
comprising applying a liquid pharmaceutical composition that contains testosterone. The 307
patent is listed in the Orange Book in connection with Axiron. A true and correct copy of the
307 patent is attached as Exhibit B. Since its date of issue, Acrux has been, and continues to be,
the owner of the 307 patent. Eli Lilly Export S.A. is the exclusive licensee worldwide for all
uses of Axiron under the 307 patent. Eli Lilly Export S.A. has licensed its rights in the 307
patent to Lilly.
D.
The 449 Patent
22.
United States Patent No. 8,177,449 (the 449 patent) entitled Spreading
Implement, was duly and legally issued by the PTO on May 15, 2012. The 449 patent claims,
inter alia, a method of transdermal administration of a physiologically active agent. A true and
correct copy of the 449 patent is attached as Exhibit C. Since its date of issue, Acrux has been,
-5-
and continues to be, the owner of the 449 patent. Eli Lilly Export S.A. is the exclusive licensee
worldwide for all uses of Axiron under the 449 patent. Eli Lilly Export S.A. has licensed its
rights in the 449 patent to Lilly.
E.
The 861 Patent
23.
United States Patent No. 8,807,861 (the 861 patent) entitled Spreading
Implement, was duly and legally issued by the PTO on August 19, 2014. The 861 patent
claims, inter alia, a method of transdermal administration of a physiologically active agent. A
true and correct copy of the 861 patent is attached as Exhibit D. Since its date of issue, Acrux
has been, and continues to be, the owner of the 861 patent. Eli Lilly Export S.A. is the
exclusive licensee worldwide for all uses of Axiron under the 449 patent. Eli Lilly Export S.A.
has licensed its rights in the 861 patent to Lilly.
F.
Infringement by Amneal
24.
Defendant filed or caused to be filed with the FDA ANDA No. 206998 under 21
U.S.C. 355(j) to obtain approval for the commercial manufacture, use, and sale of
Testosterone Topical Solution, 30mg/1.5mL (Amneals Generic Product) in the United
States before the expiration of the 944, 307,449 and 861 patents.
25.
Defendants ANDA No. 206998 contains certifications pursuant to 21 U.S.C.
355(j)(2)(A)(vii)(IV) (paragraph IV certifications), alleging that the claims of the 944, 307,
and 861 patents are invalid, unenforceable, and/or would not be infringed by Amneals Generic
Product.
26.
Defendant sent to Plaintiffs a letter dated October 29, 2014 (Notice Letter),
notifying Plaintiffs that Defendants ANDA No. 206998 includes a paragraph IV certification to
obtain approval to engage in the commercial manufacture, use, or sale of Amneals Generic
Product before the expiration of the 944, 307, and 861 patents, and providing information
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pursuant to 21 U.S.C. 355(j)(2)(B). Amneals Notice Letter states that it: submitted to the
U.S. Food and Drug Administration (FDA), and the FDA has received, an Abbreviated New
Drug Application (ANDA) that contains data from bioavailability or bioequivalence studies
for, and which seeks approval to engage in the commercial manufacture, use, and/or sale of,
Testosterone Topical Solution, 30mg/1.5mL, before the expiration of the Orange Book Listed
Patents.
27.
The submission of ANDA No. 206998 to the FDA constitutes infringement by
Defendant of the 944, 307,449, and 861 patents under 35 U.S.C. 271(e)(2). Moreover, any
commercial manufacture, use, sale, offer for sale, or importation of Amneals Generic Product
would infringe the 944, 307, 449, and 861 patents under 35 U.S.C. 271(a), (b), and/or (c).
28.
Defendant knows and intends that physicians will prescribe and patients will take
Amneals Generic Product for which approval is sought in ANDA No. 206998 and therefore,
will infringe at least one claim of the patents-in-suit.
29.
Defendant had knowledge of the patents-in-suit and by its promotional activities
and proposed Generic product, knew or should know that it will aid and abet anothers direct
infringement of at least one of the claims of the patents-in-suit either literally or under the
doctrine of equivalents.
30.
Defendant plans to make, use, sell, offer to sell and/or import their Generic
Product for uses that will infringe the patents-in-suit. Amneals Generic Product is a material
part of these infringing uses and has no substantial non-infringing uses.
31.
Plaintiffs commenced this action within 45 days of receiving Amneals
October 29, 2014, Notice Letter.
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COUNT I FOR PATENT INFRINGEMENT

(Direct Infringement of U.S. Patent No. 8,435,944)
32.
Plaintiffs incorporate by reference and reallege Paragraphs 1-31 above as though
fully restated herein.

33.
Pursuant to 35 U.S.C. 271(e)(2), Defendants submission of ANDA No. 206998
to the FDA seeking approval of Amneals Generic Product before expiration of the 944 patent
was an act of infringement of the 944 patent by Defendant.
34.
If ANDA No. 206998 is approved by the FDA, Defendants commercial
manufacture, use, offer to sell, sale in the United States, or importation into the United States of
Amneals Generic Product would directly infringe, either literally or under the doctrine of
equivalents, one or more claims of the 944 patent under 35 U.S.C. 271.
35.
Unless Defendant is enjoined by the Court, Plaintiffs will be substantially and
irreparably harmed by Defendants infringement of the 944 patent. Plaintiffs do not have an
adequate remedy at law.
COUNT II FOR PATENT INFRINGEMENT
(Inducement To Infringe U.S. Patent No. 8,435,944)
36.
Plaintiffs incorporate by reference and reallege Paragraphs 1 through 35 above as
though fully restated herein.

37.
Defendant has knowledge of the 944 patent.
38.
Upon FDA approval of ANDA No. 206998, Defendant will intentionally
encourage acts of direct infringement of the 944 patent by others, with knowledge that its acts
are encouraging infringement.
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COUNT III FOR PATENT INFRINGEMENT

(Contributory Infringement of U.S. Patent No. 8,435,944)
39.

40.
If ANDA No. 206998 is approved, Defendant intends to and will offer to sell, sell,
or import into the United States Amneals Generic Product.

41.
On information and belief, Defendant has had and continues to have knowledge
that Amneals Generic Product is especially adapted for a use that infringes the 944 patent.
42.
that there is no substantial non-infringing use for Amneals Generic Product.

COUNT IV FOR PATENT INFRINGEMENT
43.

44.
45.
46.
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COUNT V FOR PATENT INFRINGEMENT

47.

48.
49.
COUNT VI FOR PATENT INFRINGEMENT
50.

51.

52.
53.

COUNT VII FOR PATENT INFRINGEMENT
(Infringement of U.S. Patent No. 8,177,449)
54.

55.
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56.
57.
COUNT VIII FOR PATENT INFRINGEMENT
58.

59.
60.
COUNT IX FOR PATENT INFRINGEMENT
61.

62.

63.
64.

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COUNT X FOR PATENT INFRINGEMENT

65.

66.
67.
68.
COUNT XI FOR PATENT INFRINGEMENT
69.

70.
71.
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COUNT XII FOR PATENT INFRINGEMENT

72.

73.

74.
75.

COUNT XIII FOR DECLARATORY JUDGMENT
76.

77.
This declaratory judgment claim arises under the United States Patent Laws, 35
U.S.C. 100 et seq., including 35 U.S.C. 271(a)-(c), and the Declaratory Judgment Act,
28 U.S.C. 2201 and 2202. Subject matter jurisdiction is proper under 28 U.S.C. 1331 and
1338(a).
78.
Defendant submitted ANDA No. 206998, seeking authorization to commercially
manufacture, use, offer for sale, and sell Amneals Generic Product in the United States.
Defendants Generic Product has no substantial non-infringing uses.
79.
Defendant has made, and will continue to make, substantial preparation in the
United States to manufacture, use, sell, offer to sell, or import Amneals Generic Product prior to
expiration of the 944 patent.
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80.
Defendant intends to engage in the commercial manufacture, use, sale, or offer for
sale within the United States or importation into the United States of Amneals Generic Product
upon receipt of final FDA approval of ANDA No. 206998, unless enjoined by the Court.
81.
Defendants commercial manufacture, use, sale, or offer for sale within or
importation into the United States of Amneals Generic Product would infringe one or more
claims of the 944 patent under 35 U.S.C. 271(a), (b), and/or (c).
82.
Defendants threatened actions in actively aiding, abetting, encouraging, and
inducing sales of Amneals Generic Product would infringe and contribute to or induce direct
infringement of one or more claims of the 944 patent.
83.
84.

85.
There is a justiciable case or controversy between Plaintiffs and Defendant
regarding whether Defendants commercial manufacture, use, sale, offer for sale, or importation
into the United States of Amneals Generic Product according to ANDA No. 206998 would
infringe one or more claims of the 944 patent.
86.
If Defendants infringement of the 944 patent is not enjoined, Plaintiffs will
suffer substantial and irreparable harm from which there is no remedy at law.
COUNT XIV FOR DECLARATORY JUDGMENT
87.
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88.
1338(a).
89.
90.
91.
92.
93.
94.
95.
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96.
97.
COUNT XV FOR DECLARATORY JUDGMENT
98.

99.
U.S.C. 100 et seq., including 35 U.S.C. 271(a)-(c), and the Declaratory Judgment Act, 28
U.S.C. 2201 and 2202. Subject matter jurisdiction is proper under 28 U.S.C. 1331 and
1338(a).
100.
101.
102.
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103.
104.
105.
106.

107.
108.
COUNT XVI FOR DECLARATORY JUDGMENT
109.

110.
1338(a).
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111.
112.
113.
114.
115.
116.
117.

118.
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119.
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs respectfully request that this Court enter judgment in their
favor as follows:
a)
United States Patent Nos. 8,435,944; 8,419,307; 8,177,449; and 8,807,861 are
valid and enforceable;
b)
Under 35 U.S.C. 271(e)(2)(A), Defendant infringed United States Patent Nos.

8,435,944; 8,419,307; 8,177,449; and 8,807,861 by submitting ANDA
No. 206998 to the FDA to obtain approval to commercially manufacture, use,
offer for sale, sell, or import into the United States Amneals Generic Product
prior to expiration of said patents;
c)
Defendants threatened acts of commercial manufacture, use, offer for sale, or

sale in, or importation into, the United States of Amneals Generic Product prior
to the expiration of United States Patent Nos. 8,435,944; 8,419,307; 8,177,449;
and 8,807,861 would constitute infringement of said patents;
d)
The effective date of any FDA approval of Amneals Generic Product shall be no
earlier than the latest of the expiration date of United States Patent Nos.
8,435,944; 8,419,307; 8,177,449; and 8,807,861 and any additional periods of
exclusivity, in accordance with 35 U.S.C. 271(e)(4)(A);
e)
Defendant, and all persons acting in concert with Defendant shall be enjoined
from commercially manufacturing, using, offering for sale, or selling Amneals
Generic Product within the United States, or importing Amneals Generic Product
into the United States, until the expiration of United States Patent Nos. 8,435,944;
8,419,307; 8,177,449; and 8,807,861, in accordance with 35 U.S.C.
271(e)(4)(B) and 283;
f)
This is an exceptional case and Plaintiffs should be awarded their costs, expenses,
and disbursements in this action, including reasonable attorney fees, pursuant to
35 U.S.C. 285 and 271(e)(4);
g)
Plaintiffs are entitled to any further appropriate relief under 35 U.S.C.

271(e)(4); and
h)
Plaintiffs are entitled to any further and additional relief that this Court deems just
and proper.
Respectfully submitted,
Dated: December 10, 2014
By:
/s/ Jan M. Carroll

Jan M. Carroll, No. 4187-49
-19-
BARNES & THORNBURG LLP

11 South Meridian Street
Indianapolis, Indiana 46204-3535
(317) 236-1313
Of counsel:
Charles E. Lipsey
L. Scott Burwell
FINNEGAN, HENDERSON, FARABOW,
GARRETT & DUNNER, LLP
Two Freedom Square
11955 Freedom Drive
Reston, VA 20190-5675
(571) 203-2700
Laura P. Masurovsky
Danielle A. Duszczyszyn
901 New York Avenue, NW
Washington, DC 20001-4413
(202) 408-4000
Alissa Lipton
Two Seaport Lane
Boston, MA 02210-2001
(617) 646-1600
Attorneys for Plaintiffs,
Eli Lilly and Company, Eli Lilly Export S.A. and
Acrux DDS Pty Ltd.
INDS02 1350161v1
-20-

Complaint For Patent Infringement

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Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 1 of 20 PageID #: 1

ELI LILLY AND COMPANY,

Case No. 1:14-CV-2025

COMPLAINT FOR PATENT INFRINGEMENT

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 2 of 20 PageID #: 2

Amneal is a Delaware corporation with its principal place of business at 400

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 3 of 20 PageID #: 3

Upon information and belief, Amneal Pharmaceuticals currently sells significant

According to the website for Amneal, Amneal proudly sells directly to

On information and belief, Amneal has directly entered into a distribution

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 4 of 20 PageID #: 4

Amneal, either directly or through wholesalers, sells products to national and

market, including the State of Indiana.

approval of ANDA No. 206998.

The 944 Patent

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 5 of 20 PageID #: 5

The 307 Patent

The 449 Patent

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 6 of 20 PageID #: 6

The 861 Patent

Defendants ANDA No. 206998 contains certifications pursuant to 21 U.S.C.

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 7 of 20 PageID #: 7

The submission of ANDA No. 206998 to the FDA constitutes infringement by

Defendant had knowledge of the patents-in-suit and by its promotional activities

Plaintiffs commenced this action within 45 days of receiving Amneals

October 29, 2014, Notice Letter.

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 8 of 20 PageID #: 8

COUNT I FOR PATENT INFRINGEMENT

Plaintiffs incorporate by reference and reallege Paragraphs 1-31 above as though

fully restated herein.

Pursuant to 35 U.S.C. 271(e)(2), Defendants submission of ANDA No. 206998

If ANDA No. 206998 is approved by the FDA, Defendants commercial

Unless Defendant is enjoined by the Court, Plaintiffs will be substantially and

Plaintiffs incorporate by reference and reallege Paragraphs 1 through 35 above as

though fully restated herein.

Defendant has knowledge of the 944 patent.

Upon FDA approval of ANDA No. 206998, Defendant will intentionally

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 9 of 20 PageID #: 9

COUNT III FOR PATENT INFRINGEMENT

Plaintiffs incorporate by reference and reallege Paragraphs 1 through 38 above as

though fully restated herein.

or import into the United States Amneals Generic Product.

that there is no substantial non-infringing use for Amneals Generic Product.

Plaintiffs incorporate by reference and reallege Paragraphs 1-42 above as though

fully restated herein.

Pursuant to 35 U.S.C. 271(e)(2), Defendants submission of ANDA No. 206998

If ANDA No. 206998 is approved by the FDA, Defendants commercial

Unless Defendant is enjoined by the Court, Plaintiffs will be substantially and

Case 1:14-cv-02025-SEB-DML Document 1 Filed 12/10/14 Page 10 of 20 PageID #: 10

COUNT V FOR PATENT INFRINGEMENT

Plaintiffs incorporate by reference and reallege Paragraphs 1 through 46 above as

though fully restated herein.

Defendant has knowledge of the 307 patent.

Upon FDA approval of ANDA No. 206998, Defendant will intentionally

Plaintiffs incorporate by reference and reallege Paragraphs 1 through 49 above as

though fully restated herein.

or import into the United States Amneals Generic Product.

that there is no substantial non-infringing use for Amneals Generic Product.