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EXHIBIT A
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1 BRYAN CAVE LLP

K. Lee Marshall, admitted pro hac vice
2 Robert Padway, California Bar No. 48439
Berrie Goldman, California Bar No. 246061
3 Two Embarcadero Center, Suite 1410
San Francisco, CA 94111
4 Telephone: (415) 675-3400
Facsimile: (415) 675 3434
5 E-Mail: robert.padway@bryancave.com
klmarshall@bryancave.com
6 berrie.goldman@bryancave.com

7 BRYAN CAVE LLP

Ameer Gado, admitted pro hac vice
8 Benjamin J. Sodey, admitted pro hac vice
One Metropolitan Square
9 211 North Broadway, Suite 3600
St. Louis, MO 63102-2750
Two Embarcadero Center, Suite 1410

10 Telephone: (314) 259-2000

Facsimile: (314) 259-2020
San Francisco, CA 94111-3907

11 Email: aagado@bryancave.com
benjamin.sodey@bryancave.com
Bryan Cave LLP

12
Attorneys for Plaintiff ALZHEIMER’S INSTITUTE OF AMERICA, INC.
13
14 UNITED STATES DISTRICT COURT
15 NORTHERN DISTRICT OF CALIFORNIA
16
ALZHEIMER’S INSTITUTE OF AMERICA, Case No. 3:10-cv-00482-EDL
17 INC.,
DEMAND FOR JURY TRIAL
18 Plaintiff,
19 v. [PROPOSED] SECOND AMENDED
COMPLAINT FOR DAMAGES AND
20 ELAN PHARMACEUTICALS, INC., INFRINGEMENT
ELI LILLY AND COMPANY, AND
21 THE JACKSON LABORATORY
22 Defendants.
23
24 PLAINTIFF’S COMPLAINT
25 COMES NOW Plaintiff Alzheimer’s Institute of America, Inc. (“AIA”), by and through its
26 attorneys, and for its Complaint against Elan Pharmaceuticals, Inc. (“Elan”), Eli Lilly and
27 Company (“Lilly”), and The Jackson Laboratory (“Jackson Lab”) (collectively, “Defendants”),
28 states as follows:

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1 Nature of the Action

2 1. This Complaint seeks a judgment finding that Defendants have infringed and

3 continue to infringe upon AIA’s U.S. Patent Nos. 5,455,169 (the “’169 Patent”), 5,795,963 (the
4 “’963 Patent”), 6,818,448 (the “’448 Patent”), and 7,538,258 (the “’258 Patent”) (collectively, the
5 “Patents-in-Suit”). The Patents-in-Suit cover a wide range of Alzheimer’s Disease-related
6 technology, including, but not limited to: nucleic acids coding for the Swedish mutation; vectors,
7 cell lines, and transgenic mice expressing the Swedish mutation containing nucleic acids; and
8 polypeptides encoded by the Swedish mutation containing nucleic acids. The claimed technology
9 providing important insights and tools for Alzheimer’s Disease research, including the ability to
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10 screen for potential Alzheimer’s Disease drug candidates, such as, for example, beta-secretase
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11 inhibitors. True and accurate copies of the Patents-in-Suit are attached hereto, respectively, as
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12 Exhibits A, B, C, and D.
13 Jurisdiction and Venue

14 2. This Court has subject matter jurisdiction over this Complaint pursuant to 28

15 U.S.C. §§ 1331 and 1338(a), and under the patent laws of the United States, 35 U.S.C. § 1, et seq.
16 3. Venue is proper in this judicial district under the provisions of 28 U.S.C.

17 §§ 1391(b) and 1400(b).

18 Intradistrict Assignment
19 4. This action is excepted from intradistrict assignment because it is an

20 intellectual property matter. Civil L.R. 3-5(b) and 3-2(c).

21 The Parties

22 5. AIA is a corporation organized and existing under the laws of Florida and having
23 its principal place of business at 7837 Parallel Parkway, Kansas City, KS, 66112. AIA is the
24 owner of the Patents-in-Suit.
25 6. Elan is a Delaware corporation having its principal place of business at 800
26 Gateway Boulevard, South San Francisco, California 94080. Upon information and belief, Elan
27 has committed acts of patent infringement in this district.
28

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1 7. Lilly is an Indiana corporation having its principal place of business at Lilly

2 Corporate Center, Indianapolis, Indiana 46285. Upon information and belief, Lilly has, in the
3 course of its collaborations, committed acts of patent infringement in this district.
4 8. The Jackson Lab is a non-profit corporation organized and existing under the laws

5 of Maine and having its principal place of business at 600 Main Street, Bar Harbor, Maine 04609.
6 The Jackson Lab does business in California as The Jackson Laboratory, West, and maintains a
7 research facility within 100 miles of this Court at 4910 Raley Boulevard, Sacramento, California
8 95838, and, upon information and belief, has committed acts of patent infringement in this district.
9 Facts
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10 9. Elan describes itself as a “leader in Alzheimer’s disease research.” Elan’s research

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11 is focused on stopping the “production and accumulation of a toxic protein, beta amyloid, in the
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12 brains of Alzheimer’s disease patients.” In the course of Elan’s research and drug discovery
13 efforts, Elan has used, among other things, enzyme inhibition assays, cell line assays, and animal
14 models including the Swedish mutation. Elan has used AIA’s patented technology to identify and
15 validate potential drug candidates for the treatment of Alzheimer’s disease.
16 10. Several recently-issued Elan patents describe Elan’s use of enzyme inhibition

17 assays, cell line assays, and animal models including the Swedish Mutation for Elan’s drug
18 discovery efforts. As just one example of many, U.S. Patent No. 7,553,831 describes certain cell
19 lines expressing amyloid precursor protein (“APP”) with the Swedish mutation as the “preferred
20 cells for analysis of beta-secretase activity.” Elan’s ’831 Patent also describes the use of: (i)
21 Swedish mutation variants of APP for “assays that demonstrate inhibition of beta-secretase
22 mediated cleavage of APP; (ii) synthetic peptides of residues 590-596 of the Swedish mutation to
23 raise antibodies useful in immunoassays of APP and its cleavage products; (iii) a model APP
24 substrate, MBP-C125SW, to analyze compounds for inhibitory activity of beta-secretase; (iv)
25 human embryonic kidney cell line HEKp293 “transfected with APP751 containing the naturally
26 occurring double mutation Lys651Met652 to Asn651Leu652 (numbered for APP751), commonly
27 called the Swedish mutation”; (v) mouse animal models that “express mutations in APP, such as
28 APP695-SW.”

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1 11. As described in Elan’s U.S. Patent No. 7,514,408, Elan is screening libraries of

2 compounds in these enzyme inhibition assays for their ability “to bind to, or preferably, to inhibit
3 beta-secretase activity.” Such compounds are “then further analyzed for potency in such assays.”
4 Further use of the Swedish mutation technology includes the use of host cells co-transfected with
5 the Swedish mutation form of APP “for screening for therapeutic agents that are able to traverse
6 cell membranes.” Inhibitor compounds “can then be tested for prophylactic and therapeutic
7 efficacy in transgenic animals predisposed to an amyloidogenic disease, such as . . . mice bearing a
8 Swedish mutation of APP.” Upon information and belief, Elan has used AIA’s patented
9 technology at each stage of its drug identification and development efforts and that the
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10 identification of promising Alzheimer’s disease drug candidates may not have been possible
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11 without the use of the inventions claimed in AIA’s Patents.

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12 12. Like Elan, Lilly is active in Alzheimer’s disease research, including research

13 focused on the beta-amyloid cascade hypothesis. Several recently-issued Lilly patents describe
14 Lilly’s use of cell line assays including the Swedish Mutation for Lilly’s drug discovery efforts.
15 As just one example of many, U.S. Patent No. 7,585,885 describes certain cell lines expressing
16 APP-SW for use in a routine whole cell assay. Lilly appears to have used this technique
17 repeatedly to identify potential therapeutic candidate compounds, described in, for example, U.S.
18 Patent Nos. 7,468,365; 7,390,801; 7,153,847; 6,958,330; 6,906,056; 6,861,558; 6,849,650;
19 6,838,455; 6,774,125; 6,767,918; 6,696,438; and 6,667,305. Upon information and belief, Lilly
20 has used AIA’s patented technology at each stage of its drug identification and development
21 efforts and that the identification of promising Alzheimer’s disease drug candidates may not have
22 been possible without the use of the inventions claimed in AIA’s Patents.
23 13. Upon information and belief, Elan and Lilly have collaborated on certain

24 Alzheimer’s disease research involving use of the Swedish mutation. For example, U.S. Published
25 Patent Application No. 2006/0223761, which is assigned to both Elan and Lilly, describes the
26 identification of numerous compounds that were assayed for their ability to inhibit beta-amyloid
27 production in a cell line possessing the Swedish mutation. Similarly, U.S. Patent No. 7,608,749,
28 which is also assigned to both Elan and Lilly, describes the use of transgenic mice containing the

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1 Swedish mutation. Although both Elan and Lilly are aware of the Patents-in-Suit, they have not
2 obtained a license to practice the inventions claimed therein.
3 14. The Jackson Lab uses and sells transgenic mice as a research tool, including use in

4 Alzheimer’s disease research. As just one example of many, Strain B6.129-Tg(APPSw)40Btla/J

5 is described as expressing “all mRNA and protein isoforms of the human amyloid beta (A4)
6 precursor protein APP containing the Familial Alzheimer Disease (FAD) Swedish mutation
7 K670N/M671L.” The Jackson Lab appears to possess and distribute transgenic mouse lines
8 including, for example, Stock Nos. 003375; 004462; 004807; 005300; 005864; 005866; 006004;
9 006005; 006293; 006406; 006409; 006472; 006554; 006555; 007002; 007027; 007049; 007051;
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10 007052; 008609; 008730 and 009126.

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11 COUNT I
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12 Patent Infringement of U.S. Patent No. 5,455,169

13 15. AIA incorporates by reference each and every allegation set forth in paragraphs 1

14 through 14 of its Second Amended Complaint as if fully set forth and restated herein.
15 16. The ’169 Patent entitled “Nucleic acids for diagnosing and modeling Alzheimer’s

16 disease” was duly and regularly issued on October 3, 1995. AIA is the sole and exclusive owner
17 of the ’169 Patent. At all relevant times, the owner of the ’169 Patent has complied with 35
18 U.S.C. § 287(a).
19 17. Elan, Lilly, and the Jackson Lab, without the authority or consent of AIA, have

20 been and continue to, upon information and belief, use in the United States, including, but not
21 limited to, in this judicial district, technologies which infringe upon the ’169 Patent. Upon
22 information and belief, Defendants’ infringement of the ’169 Patent is knowing and willful.
23 18. Elan’s, Lilly’s, and the Jackson Lab’s infringement of the ’169 Patent has caused

24 and continues to cause irreparable harm and other harm to AIA.

25 COUNT II

26 Patent Infringement of U.S. Patent No. 5,795,963

27 19. AIA incorporates by reference each and every allegation set forth in paragraphs 1

28 through 18 of its Second Amended Complaint as if fully set forth and restated herein.

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1 20. The ’963 Patent entitled “Amyloid precursor protein in alzheimer’s disease” was

2 duly and regularly issued on August 18, 1998. The inventor of the ’963 Patent assigned all right,
3 title and interest in, to and under the ’963 Patent to AIA. AIA is the sole and exclusive owner of
4 the ’963 Patent. At all relevant times, the owner of the ’963 Patent has complied with 35 U.S.C. §
5 287(a).
6 21. Elan and Lilly, without the authority or consent of AIA, have been and continue to,

7 upon information and belief, use technologies in the United States, including, but not limited to, in
8 this judicial district, technologies which infringe upon the ’963 Patent. Upon information and
9 belief, Defendants’ infringement of the ’963 Patent is knowing and willful.
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10 22. Elan’s and Lilly’s infringement of the ’963 Patent has caused and continues to
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11 cause irreparable harm and other harm to AIA.

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12 COUNT III

13 Patent Infringement of U.S. Patent No. 6,818,448

14 23. AIA incorporates by reference each and every allegation set forth in paragraphs 1

15 through 22 of its Second Amended Complaint as if fully set forth and restated herein.
16 24. The ’448 Patent entitled “Isolated cell comprising HAPP 670/671 DNAS

17 sequences” was duly and regularly issued on November 16, 2004. The inventor of the ’448 Patent
18 assigned all right, title and interest in, to and under the ’448 Patent to AIA. AIA is the sole and
19 exclusive owner of the ’448 Patent. At all relevant times, the owner of the ’448 Patent has
20 complied with 35 U.S.C. § 287(a).
21 25. Elan and Lilly, without the authority or consent of AIA, have been and continue to,

22 upon information and belief, use technologies in the United States, including, but not limited to, in
23 this judicial district, technologies which infringe upon the ’448 Patent. Upon information and
24 belief, Defendants’ infringement of the ’448 Patent is knowing and willful.
25 26. Elan’s and Lilly’s infringement of the ’448 Patent has caused and continues to

26 cause irreparable harm and other harm to AIA.

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1 COUNT IV

2 Patent Infringement of U.S. Patent No. 7,538,258

3 27. AIA incorporates by reference each and every allegation set forth in paragraphs 1

4 through 26 of its Second Amended Complaint as if fully set forth and restated herein.
5 28. The ’258 Patent entitled “Transgenic mouse expressing an APP 670/671 mutation”

6 was duly and regularly issued on May 26, 2009. AIA is the sole and exclusive owner of the ’258
7 Patent. At all relevant times, the owner of the ’258 Patent has complied with 35 U.S.C. § 287(a).
8 29. Elan, Lilly, and the Jackson Lab, without the authority or consent of AIA, have

9 been and continue to, upon information and belief, use in the United States, including, but not
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10 limited to, in this judicial district, technologies which infringe upon the ’258 Patent. Upon
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11 information and belief, Defendants’ infringement of the ’258 Patent is knowing and willful.
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12 30. Elan’s, Lilly’s, and the Jackson Lab’s infringement of the ’258 Patent has caused

13 and continues to cause irreparable harm and other harm to AIA.

14 PRAYER
15 WHEREFORE, Plaintiff Alzheimer’s Institute of America respectfully prays that the Court

16 enter judgment in its favor and award the following relief against Defendants:
17 A. Find that Defendants infringed upon the Patents-in-Suit and will continue to

18 infringe said patents unless enjoined therefrom;

19 B. Find that the infringement of Defendants upon the Patents-in-Suit was

20 knowing and willful;

21 C. Enjoin Defendants and their respective officers, directors, employees,

22 agents, licensees, representatives, affiliates, related companies, servants, successors and assigns,
23 and any and all persons acting in privity or in concert with any of them, preliminarily and
24 permanently, from further infringing upon the Patents-in-Suit;
25 D. Order that an accounting be made to establish damages arising out of

26 Defendants’ infringement of the Patents-in-Suit;

27 E. Award AIA actual damages pursuant to 35 U.S.C. § 284, in an amount to be

28 determined at trial, as a result of Defendants’ infringement upon the Patents-in-Suit;

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1 F. Award AIA treble damages pursuant to 35 U.S.C. § 284 in an amount to be

2 determined at trial, as a result of Defendants’ knowing and willful infringement upon the Patents-
3 in-Suit;
4 G. Award AIA its costs and reasonable attorneys’ fees incurred in connection

5 with this action; and

6 H. Award and grant AIA such other and further relief as the Court deems just

7 and proper under the circumstances.

8 DEMAND FOR JURY TRIAL

9 Plaintiff demands a jury trial.

Two Embarcadero Center, Suite 1410

10
San Francisco, CA 94111-3907

11 Dated: February 7, 2011 BRYAN CAVE LLP

Bryan Cave LLP

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13 By: /s/ Berrie R. Goldman
Berrie R. Goldman
14 Attorneys for Plaintiff
ALZHEIMER’S INSTITUTE OF AMERICA
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