UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

ASTRAZENECA AB, ASTRAZENECA LP, 

KBI-E INC., and POZEN INC.,

 Plaintiffs,

 v.

DR. REDDY’S LABORATORIES INC. and 

DR. REDDY’S LABORATORIES LTD.,

 Defendants. 

CIVIL ACTION NO.

11-cv-02317-JAP-DEA

(Consolidated for discovery purposes

with Civil Action No.

11-cv-04275-JAP-DEA)

ASTRAZENECA AB, ASTRAZENECA LP, 

KBI-E INC., and POZEN INC.,

 Plaintiffs,

 v.

LUPIN LTD. and LUPIN 

PHARMACEUTICALS INC.,

 Defendants.

CIVIL ACTION NO.

11-cv-04275-JAP-DEA

DECLARATION OF ERICA N. ANDERSEN IN SUPPORT OF 

PLAINTIFFS’ OPENING MARKMAN SUBMISSION

I, Erica N. Andersen, declare as follows:

1. I am an associate in the law firm of Covington & Burling LLP. The following 

facts are within my personal knowledge and, if called and sworn as a witness, I could and would

testify competently to them. I submit this declaration in support of AstraZeneca AB; 

AstraZeneca LP; KBI-E Inc.; and Pozen Inc.’s (“Plaintiffs’”) Opening Markman Submission.

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2

2. Attached hereto as Exhibit 1 is a true and correct copy of U.S. Patent No. 

6,926,907.

3. Attached hereto as Exhibit 2 is a true and correct copy of the May 31, 2002 Initial

Application, submitted during prosecution of U.S. Patent No. 6,926,907.

4. Attached hereto as Exhibit 3 is a true and correct copy of the November 19, 2004 

Response, submitted during prosecution of U.S. Patent No. 6,926,907.

5. Attached hereto as Exhibit 4 is a true and correct copy of the October 17, 2003 

Preliminary Amendment, submitted during prosecution of U.S. Patent No. 6,926,907.

6. Attached hereto as Exhibit 5 is a true and correct copy of U.S. Patent No. 

6,875,872.

7. Attached hereto as Exhibit 6 is a true and correct copy of the Parties’ Joint Claim 

Construction and Prehearing Statement, AstraZeneca AB v. Dr. Reddy’s Laboratories, et al., Civ. 

Action No. 11-2317 (D.N.J. March 21, 2012) (JAP) (DEA) (Dkt. No. 50).

8. Attached hereto as Exhibit 7 is a true and correct copy of U.S. Patent No. 5,714,504.

9. Attached hereto as Exhibit 8 is a true and correct copy of U.S. Patent No. 

6,369,085.

10. Attached hereto as Exhibit 9 is a true and correct copy of U.S. Patent No. 

7,411,070.

11. Attached hereto as Exhibit 10 is a true and correct copy of U.S. Patent No. 

7,745,466.

12. Attached hereto as Exhibit 11 is a true and correct copy of the Declaration of 

Frans W. Langkilde, dated April 24, 2001, submitted during prosecution of U.S. Patent No. 

6,369,085.

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13. Attached hereto as Exhibit 12 is a true and correct copy of U.S. Application No. 

09/077,719, submitted during prosecution of U.S. Patent No. 6,369,085.

14. Attached hereto as Exhibit 13 is a true and correct copy of the April 29, 2005 

Final Rejection from the prosecution of U.S. Patent No. 7,411,070.

15. Attached hereto as Exhibit 14 is a true and correct copy of the November 21, 2005 

Non-Final Rejection from the prosecution of U.S. Patent No. 7,411,070.

16. Attached hereto as Exhibit 15 is a true and correct copy of the August 10, 2006 

Final Rejection from the prosecution of U.S. Patent No. 7,411,070.

17. Attached hereto as Exhibit 16 is a true and correct copy of the April 19, 2007 

Appeal Brief, submitted during prosecution of U.S. Patent No. 7,411,070.

18. Attached hereto as Exhibit 17 is a true and correct copy of the August 14, 2007 

Non-Final Rejection from the prosecution of U.S. Patent No. 7,411,070.

19. Attached hereto as Exhibit 18 is a true and correct copy of page 130 of the James 

Trefil, Encyclopedia of Science and Technology, The Reference Works, Inc. (2001).

20. Attached hereto as Exhibit 19 is a true and correct copy of page 199 of The 

American Heritage Stedman’s Medical Dictionary, Houghton Mifflin Co. (2002).

21. Attached hereto as Exhibit 20 is a true and correct copy of Vesa-Pekka Lehto et 

al., The comparison of seven different methods to quantify the amorphous content of spray dried 

lactose, 167 Powder Technology 2:85–93 (Sept. 15, 2006).

22. Attached hereto as Exhibit 21 is a true and correct copy of Andrea Heinz et al.,

Characterizing an Amorphous System Exhibiting Trace Crystallinity: A Case Study with 

Saquinavir, 8 Crystal Growth & Design 1:119–27 (Jan. 2008).

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23. Attached hereto as Exhibit 22 is a true and correct copy of Birju Shah, Vasu 

Kumar Kakumanu & Arvind K. Bansal, Analytical Techniques for Quantification of 

Amorphous/Crystalline Phases in Pharmaceutical Solids, 95 J. of Pharmaceutical Sciences

8:1641–65 (Aug. 2006).

24. Attached hereto as Exhibit 23 is a true and correct copy of page 139 of Stephen R. 

Byrn, Ralph R. Pfeiffer, Joseph G. Stowell, Solid State Chemistry of Drugs (2d ed. 1999).

I declare under penalty of perjury that the forgoing is true and correct

Executed on May 9, 2012 at Washington, D.C. 

By: _____________________________

 Erica N. Andersen

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