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 

DECLARATION OF MAUREEN M. JAPHA IN SUPPORT OF PLAINTIFFS’ BRIEF IN 

SUPPORT OF PLAINTIFFS’ MOTION FOR INJUNCTION PENDING APPEAL

I, Maureen M. Japha, declare as follows: 

1. I am an associate at the law firm of Covington & Burling, LLP, 1201 Pennsylvania 

Ave, NW, Washington, DC 20004, 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 

Support of Plaintiffs’ Motion for a Preliminary Injunction. 

3. Attached as Exhibit A, is a true and correct copy of an August 7, 2013 Yonhap News 

Agency article entitled: “U.S. FDA Oks sale of S. Korea’s improved version of Nexium” 

(available at: http://www.globalpost.com/dispatch/news/yonhap-news-agency/130807/us-fdaCase 3:11-cv-00760-JAP-TJB Document 347 Filed 08/20/13 Page 1 of 4 PageID: 14934
2 

oks-sale-s-koreas-improved-version-nexium) (last visited, August 20, 2013). 

4. Attached as Exhibit B is a true and correct copy of U.S. Patent No. 5,714,504. 

5. Attached as Exhibit C is a true and correct copy of excerpts from the File History of 

U.S. Patent No. 5,714,504, bearing Bates numbers HAN0039508-HAN0040299. 

6. Attached as Exhibit D is a true and correct copy of an excerpt from NDA No. 202342, 

produced with Bates numbers HAN000441-HAN0000444. 

7. Attached as Exhibit E is a true and correct copy of a November 26, 2012 Report from 

KDB Daewoo Securities entitled, “Earnings surprise from domestic recovery, strong API 

exports.” 

8. Attached as Exhibit F is a true and correct copy of an April 9, 2009 Report from Bank 

of America/Merrill Lynch entitled, “Downgrade; expectations built up, but risks ignored.” 

9. Attached as Exhibit G is a true and correct copy of an Investor Relations report, 

available on Hanmi’s website, where it is identified as “2009 1Q Result – IR Presentation File” 

(available at: www.hanmipharm.com/eng/investors/quarterly.asp?yy=2009). 

10. Attached as Exhibit H is a true and correct copy of a May 5, 2013 MK Business News 

article by Sae-bom Lee, entitled “Hanmi Pharmaceutical’s Drug Obtains Tentative Approval 

from US FDA (available at: http://news.mk.co.kr/newsRead.php?year=2013&no=346884) (last 

visited August 19, 2013). 

11. Attached as Exhibit I is a true and correct copy of an August 8, 2013 article from the 

Korea Economic Daily, entitled: “Hanmi Pharm Gets IMD Permission from the US FDA,” 

(available at: english.hankyung.com/news/apps/news.view?popup=0&nid=&c1=04&nkey= 

201308080722221) (last visited August 20, 2013). 

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12. Attached as Exhibit J is a true and correct copy of an August 8, 2013 article from the 

Korea IT Times, entitled: “Hanmi Pharm Gets IMD Permission from the US FDA,” (available 

at: koreaittimes.com/story/31030/hanmi-pharm-gets-imd-permission-us-fda) (last visited August 

20, 2013). 

13. Attached as Exhibit K is a true and correct copy of an August 8, 2013 Hanmi press 

release, entitled “Hanmi’s Incrementally Modified Drug, Esomezol, Enters US market” 

(available at: www.hanmipharm.com/eng/release/board_read.asp?seq=652&board_id=7). 

14. Attached as Exhibit L is a true and correct copy of the November 7, 2011 Declaration 

of Dr. Stephen G. Davies on Claim Construction. 

15. Attached as Exhibit M is a true and correct copy of excerpts from the December 16, 

2011 deposition of Dr. Jerry L. Atwood, Ph.D. 

16. Attached as Exhibit N is a true and correct copy of the May 16, 2013 Final Pretrial 

Order in the above-captioned case. 

17. Attached as Exhibit O is a true and correct copy of Hanmi’s proposed draft labeling, 

produced with Bates numbers HAN0000098-HAN0000121. 

18. Attached as Exhibit P is a true and correct copy of excerpts from the April 26, 2013 

deposition of Dr. Jerry L. Atwood, Ph.D. 

19. Attached as Exhibit Q is a true and correct copy of excerpts from NDA No. 202342, 

produced with Bates numbers HAN0002757-HAN0002758. 

20. Attached as Exhibit R is a true and correct copy of excerpts from NDA No. 202342, 

produced with Bates numbers HAN0000831-HAN0000833. 

21. Attached as Exhibit S is a true and correct copy of a February 7, 2013 letter from 

Case 3:11-cv-00760-JAP-TJB Document 347 Filed 08/20/13 Page 3 of 4 PageID: 14936
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Parexel to FDA, regarding NDA 202342, produced with Bates numbers HAN0372373-

HAN0372374. 

22. Attached as Exhibit T is a true and correct copy of an August 6, 2013 letter from FDA 

to Hanmi USA, Inc. 

23. Attached as Exhibit U is a true and correct copy of excerpts from the November 16, 

2012 deposition of Kyu Chan Kwon. 

24. Attached as Exhibit V is a true and correct copy of an Investor Relations report, 

available on Hanmi’s website, where it is identified as “2013 2Q Result – IR Presentation File” 

(available at: www.hanmipharm.com/eng/investors/quarterly.asp). 

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

Dated: August 20, 2013 

 

 _____________________________ 

 Maureen M. Japha

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