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UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

ASTRAZENECA AB, AKTIEBOLAGET 

HÄSSLE, ASTRAZENECA LP, KBI INC., 

and KBI-E INC., 

Plaintiffs and 

Counterclaim-Defendants,

 v. 

HANMI USA, INC., HANMI 

PHARMACEUTICAL CO., LTD., HANMI 

FINE CHEMICAL CO., LTD, and HANMI 

HOLDINGS CO., LTD., 

 

Defendants and 

Counterclaim-Plaintiffs. 

Civil Action No. 3:11-CV-00760-JAP-TJB 

Judge Joel A. Pisano 

Magistrate Judge Tonianne J. Bongiovanni 

DECLARATION OF PATRICK L. CHEN IN SUPPORT OF PLAINTIFFS’ BRIEF IN 

OPPOSITION TO HANMI’S MOTION IN LIMINE NO. 1 (TO PRECLUDE 

TESTIMONY OF DR. WEISSINGER AND STRIKE HER EXPERT REPORT) 

I, Patrick L. Chen, hereby declare as follows, 

1. I am an associate at the law firm of Fitzpatrick, Cella, Harper & Scinto, 1290 

Avenue of the Americas, New York, New York 10104-3800, counsel for Plaintiffs AstraZeneca

AB, Aktiebolaget Hässle, AstraZeneca LP, KBI Inc., and KBI-E Inc. in connection with the 

present action. 

2. I make this Declaration on my personal knowledge in support of Plaintiffs’ Brief 

in Opposition to Hanmi’s Motion in limine No. 1 (To Preclude Testimony of Dr. Weissinger and

Strike Her Expert Report). 

3. Attached as Exhibit 1 is a true and correct copy of Hanmi’s May 25, 2011 Initial 

Non-Infringement and Invalidity Contentions. 

4. Attached as Exhibit 2 is a true and correct copy of AstraZeneca’s July 25, 2011 

Responses to Hanmi’s Invalidity Contentions. 

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5. Attached as Exhibit 3 is a true and correct copy of Hanmi’s December 9, 2011 

First Amended Non-Infringement and Invalidity Contentions. 

6. Attached as Exhibit 4 is a true and correct copy of Hanmi’s January 30, 2013 

Second Amended Non-Infringement and Invalidity Contentions. 

7. Attached as Exhibit 5 is a true and correct copy of the February 19, 2013 Expert 

Report of Jerry L. Atwood, Ph.D. 

8. Attached as Exhibit 6 is a true and correct copy of the April 8, 2013 Reply Expert 

Report of Jerry L. Atwood, Ph.D. 

9. Attached as Exhibit 7 is a true and correct copy of the “Guideline for Submitting 

Supporting Documentation in Drug Applications for the Manufacture of Drug Substances” from 

the Center for Drug Evaluation and Research, FDA, dated February 1987. 

10. Attached as Exhibit 8 is a true and correct copy of a 1989 article titled “The FDA 

Perspective on the Development of Stereoisomers” published in the journal Chirality by Wilson 

DeCamp. 

11. Attached as Exhibit 9 is a true and correct copy of a 1989 article titled 

“Considerations in the Development of Stereoisomeric Drugs: FDA Viewpoint” published in the 

Drug Information Journal by Judi Weissinger. 

12. Attached as Exhibit 10 is a true and correct copy of a document titled “FDA’s 

Policy Statement for the Development of New Stereoisomeric Drugs” from the Center for Drug 

Evaluation and Research, Food and Drug Administration dated May 1992. 

13. Attached as Exhibit 11 is a true and correct copy of the April 17, 2013 deposition 

of Dr. Paul A. Bartlett. 

14. Attached as Exhibit 12 is a true and correct copy of literature produced by Hanmi 

on April 25, 2013. 

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15. Attached as Exhibit 13 is a true and correct copy of the April 24, 2013 Expert 

Report of Judi Weissinger, Ph.D. 

16. Attached as Exhibit 14 is a true and correct copy of the April 26, 2013 deposition 

of Dr. Jerry L. Atwood. 

17. Attached as Exhibit 15 is a true and correct copy of an email exchange between 

April 25 and April 28, 2013 regarding Dr. Weissinger’s deposition. 

18. Attached as Exhibit 16 is a true and correct copy of an email exchange between 

April 25 and April 28 regarding Dr. Weissinger’s deposition. 

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

Dated: May 6, 2013 

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