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 DR. DAVID A. JOHNSON ON CLAIM CONSTRUCTION 

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I, David A. Johnson, MD hereby declare: 

I. EDUCATIONAL BACKGROUND AND QUALIFICATIONS 

1. I am a Professor of Medicine and Chief of Gastroenterology at the Eastern 

Virginia School of Medicine in Norfolk VA. 

2. I am boarded in gastroenterology and internal medicine. I have been active in the 

field of gastroenterology for over twenty-eight years. This involvement has included extensive 

contributions to the literature with over 600 articles, book chapters and abstracts published. I 

have given hundreds of invited lectures throughout the world and been a regular participant in 

national and international educational meetings with a particular focus and interest and expertise 

in esophageal and colon disease. 

3. I currently serve as co-editor of the American College of Gastroenterology 

Education Universe; esophageal section editor for the New England Journal of Medicine; Journal 

Watch Gastroenterology; GI editor Medscape (WebMD); GI editor Medscape Computer GI 

Consult; and Medscape GI Viewpoints. Additionally, I have served on the editorial board as 

Associate editor for the American Journal of Gastroenterology from 1988 through 2004 as well 

as the editorial boards for Digestive Diseases and Gastrointestinal Endoscopy. I am an active 

reviewer for eleven medical journals at present. I have also served as co-editor for the American 

College of Physicians Book “Dyspepsia” as well as Gastroenterologic Clinic of North America, 

“Obesity Related Issues for the Gastroenterologist” published in 2005 and again as a new issue 

update in 2010. 

4. I was recently selected by the American Board of Internal Medicine to serve on 

the Gastroenterology Subspecialty Examination Committee. In this capacity, I will help oversee 

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evaluation of all U.S. based physicians who seek board certification and re-certification in 

gastroenterology. 

5. My curriculum vitae is attached as Exhibit A. 

6. I have had extensive involvement with clinical research for my entire career. I 

continue to play a very active role in that area. This involvement includes generation of 

protocols, as well as participation in phase 1, 2, 3 and 4 studies, many of which have been pivotal 

studies leading to FDA approval of the medication or device being studied. I have been the 

primary presenter for a large number of these studies at national and international presentations. 

I have additionally served as a presenter to the FDA advisory panel. 

7. Throughout my entire career, I have held numerous consultant and advisory 

positions. These have included positions at the National Cancer Institute, Centers for Medicare 

and Medicaid(CMS), GI advisor for National Quality Forum, as consulting gastroenterology 

attending physician to Congress, as well as for a number of pharmaceutical advisory boards and 

national and international expert consensus panels. These expert consensus panels have included 

particular focus on evidence-based medicine and gastroesophageal reflux disease (“GERD”). I 

was an invited participant for the 2005 International Global Consensus Working Group on 

GERD, which involves approximately thirty invited world experts on reflux disease. I have also 

served as an active advisor and reviewer for the 2005 American College of Gastroenterology 

National Guidelines for Management of gastroesophageal reflux disease. 

8. As set forth in my curriculum vitae, I have been extensively involved in 

leadership positions both for state and national associations and societies. I have had an active 

role with Medicare, co-chairing the national GI Medicare Carrier advisory committee for nine 

years and serving as the Virginia State representative for that same tenure. I have previously 

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served as the GI Specialty Advisor for the State of Virginia for Anthem Blue Cross Blue Shield. 

I served on the American College of Gastroenterology Board of Trustees from 1995-2008 and 

was President from 2006-2007 and am on the executive committee and current Treasurer of the 

ACG/ASGE Quality Improvement Consortium National Registry project. In these positions, I 

have served not only in guiding policy but also helping to establish standards of best care and 

best practice for patients. In fact, working with State Senator Emily Couric in 2004, I was the 

physician responsible for developing the colon cancer screening bill for the State of Virginia. In 

this capacity I spent approximately two years working with Senator Couric in making 

presentations to a number of state legislative committees, meeting with the Governor, all 

ultimately leading to successful passage of a colon cancer screening benefit for citizens of 

Virginia. This represented the first such bill of its kind and set a standard for states which are 

currently pursuing similar legislation. 

9. Despite a larger commitment to leadership in state and national societies as well 

as my participation in educational activities and contributions to the literature, my primary focus 

is patient care. On a daily basis in my practice I see both hospital and office patients. As such, I 

feel particularly qualified to speak to standards of care, best practice strategy and what patients 

and physicians consider significant and meaningful care strategies and outcomes. 

II. SCOPE OF DECLARATION 

10. I understand that this litigation involves AstraZeneca patents 5,714,504 (the “ 

’504” patent) and 5,877,192 (the “ ’192” patent), which claim salts of the (–)-enantiomer of 

omeprazole, formulations containing those salts and methods of treatment using these salts and 

the non-salt form of the (–)-enantiomer of omeprazole. 

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11. I am aware that AstraZeneca markets the magnesium salt of the (–)-enantiomer of 

omeprazole as Nexium®. The active ingredient of Nexium® (the magnesium salt of the (–)-

enantiomer of omeprazole) is also known as esomeprazole magnesium. 

12. I understand that Hanmi has applied for permission from the U.S. Food and Drug 

Administration to sell a version of Nexium® prior to the expiration of the ’504 and ’192 patents. 

I also understand that AstraZeneca sued Hanmi for infringement of the ‘504 and ‘192 patents. 

13. I have been asked by counsel for AstraZeneca to provide my opinion on the 

knowledge and understanding of a person of ordinary skill in the art, and the understanding such 

a person would have of the following terms from the claims of the ’504” patent: 

 “administration of” and “administration to;” 

 “a mammal including man in need of such treatment;” 

and the ’192 patent: 

 “administering to a mammal in need of treatment.” 

14. Counsel for AstraZeneca has provided me with the following documents, which I 

have reviewed and considered in providing my opinions stated herein: 

 the ’504 patent and its prosecution history; 

 the ’192 patent and its prosecution history; 

 parent applications and prosecution histories to the ’504 and ’192 patents including U.S. 

Application 08/256,174, WO 94/27988 and SE 9301830; 

 the Parties Joint Claim Construction and Prehearing Statement including Exhibits A 

through D; and 

 the Nexium® Product Label. 

15. I have not testified as an expert at trial or by deposition during the past four years. 

I am being paid five-hundred dollars per hour for my time spent in study and testimony in this 

matter. 

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16. I reserve the right to prepare exhibits to summarize or support the opinions set 

forth below. 

III. SCIENTIFIC BACKGROUND 

17. Should the court determine that it would be helpful, I am prepared to provide a 

tutorial on scientific and medical aspects of the gastrointestinal system; gastrointestinal diseases, 

including acid-related gastrointestinal disease and gastrointestinal inflammatory disease; and 

protein pump inhibitors (“PPIs”), including Nexium®, and their therapeutic applications and 

usage. 

IV. OPINIONS 

A. The Person of Ordinary Skill in the Art 

18. Counsel has informed me that the claims of a patent define the scope of rights 

under the patent. Patents typically include several claims, and the claims are intended to define 

the invention by one or more of its characteristics. Different aspects of the invention can be 

defined in different claims. A claim that makes reference to an earlier claim must be read as a 

definition of an aspect of the invention that includes the definition in the earlier claim, and adds 

to it, or further limits it. 

19. Counsel has informed me that only certain claims of the ’504 and ’192 patents are 

at issue in this litigation. The asserted claims of the ’504 patent (claims 1–7 and 10) are 

generally directed to “pharmaceutical formulation[s]” containing an “alkaline salt” of (–)-

omeprazole and methods of use thereof for “inhibiting gastric acid secretion” and “treatment of 

gastrointestinal inflammatory disease.” The asserted claims of the ’192 patent (1–7, 10–19 and 

21–23) are generally directed to methods for the “treatment of gastric acid related diseases” with 

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(–)-omeprazole “or a pharmaceutically acceptable salt thereof” and to methods for the 

“production of a medicament for treating gastric acid related diseases” containing the same. 

20. I have been instructed by counsel for AstraZeneca that the court determines the 

meaning of claim terms in a judicial process known as claim construction. I understand that the 

claims of a patent must be read from the viewpoint of a hypothetical person of ordinary skill in 

the art. As mentioned above, I have been asked to address claim terms that pertain to concepts of 

pharmaceutical administration and treatment of patients with diseases or disorders of the upper 

gastrointestinal tract. In my opinion, a hypothetical person of ordinary skill in the art would 

have skills in both chemistry and in treating disorders of the upper gastrointestinal tract. The 

skills in treating disorders of the upper gastrointestinal tract of a hypothetical person of ordinary 

skill in the art would in my opinion require at least an M.D. degree, post-graduate training in 

medicine, a fellowship in gastroenterology and experience in treating any number of diseases or 

disorders of the upper gastrointestinal tract. This person would also be licensed and board 

certified in gastroenterology. 

21. I have also been informed that claim language should be interpreted in a way a 

person of ordinary skill would understand that language. I understand that the claim construction 

process begins with an assessment of the ordinary meaning of the words of the claim. In 

addition, I have been informed that the specifications and file histories of the ’504 and ’192 

patents, including the prior art references submitted to or considered by the patent office, should 

be considered to better understand the claims. I have reviewed the file histories of the ’504 and 

’192 patents. 

22. Counsel has asked me to comment on how a person of ordinary skill in the art 

would understand certain claim language used in the claims of the ’504 and ’192 patents. 

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B. ’504 Patent Claim Language 

1. “administration [of/to]” 

a. Ordinary meaning 

23. The language “administration of” appears in claim 6 and the language 

“administration to” appear in claims 7 of the ’504 patent. 

24. A person of ordinary skill would understand the terms “administration of” and 

“administration to” as referring to the means by which a treatment is delivered to a patient. For 

example, a drug may be administered as an oral tablet or pill, oral liquid, anal suppository, 

transdermal patch, intranasal spray, injection (e.g., parenteral, subcutaneous, intravenous) and 

various other suitable means. In each case, administration refers to a means employed to deliver 

the intended medication to the target patient in an effective manner. 

25. I understand that Hanmi has proposed that “administration” of/to should be 

construed as requiring “the prescription by a physician or other licensed healthcare professional, 

dispensing and ingestion.” 

26. While administration of a drug may involve healthcare professionals (e.g., 

prescription by a physician, dispensing by a physician or pharmacist or injection of a medicine to 

a patient) it is certainly not so limited. For example, omeprazole is itself one of many examples 

of a drug that may be obtained over-the-counter (as Prilosec® OTC) and administered orally 

without a prescription or involvement of a healthcare professional. The language 

“administration of” or “administration to” applies equally well to OTC omeprazole as it would to 

a physician-prescribed, physician-dispensed and would be understood the same by a person of 

ordinary skill. This common meaning of “administration”—well understood by persons of 

ordinary skill—would be illogical under Hanmi’s construction. 

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b. The ’504 patent specification and prosecution history 

27. The term “administration” is used throughout the ’504 patent specification in a 

manner consistent with the ordinary meaning discussed above. 

28. Throughout the ’504 patent specification “administration” is always used in the 

context of describing a means by which a treatment is delivered. The specification describes a 

number of these means, including “pharmaceutical formulations for oral, rectal, parenteral or 

other modes of administration.” Col. 5, lines 12-15. 

29. In each of the claims in the ’504 patent where the term “administration” appears, 

that term is always modified by the term “oral,” indicating that as used in the ’504 patent, 

“administration” refers to the means of delivery of the medicine (i.e., by mouth). Claims 1, 6-7 

and 8-9. 

30. The ’504 patent specification also describes various pharmaceutical formulations 

and preparations to facilitate and/or improve the administration of esomeprazole via oral, rectal, 

and parenteral routes (e.g., “[i]n the preparation of a pharmaceutical formulations in form of 

dosage units for oral administration the optically pure compound may be mixed with solid, 

powered carrier...”; “[d]osage units for rectal administration may be prepared in the form of 

suppositories...”; “[l]iquid preparation for oral administration may be prepared in the form of 

syrups or suspensions...”; “[s]olutions for parenteral administrations may be prepared... in 

pharmaceutically acceptable solvents...”) Col. 5, line 12 to col. 6, line 25. 

31. The use of “administration of” or “administration to” as a means of delivery of 

medicine in the ’504 patent is further confirmed by the explicit description of “route of 

administration”. Col. 6, lines 21-24. 

32. I cannot identify any portion of the ’504 patent specification that would limit 

“administration” to a prescription or the involvement of any “licensed healthcare professional.” 

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33. Furthermore, the use of the word “patients” in the ’504 patent does not necessarily 

require the participation of a physician or healthcare professional. Col. 2, lines 12-37 and col. 6, 

lines 21-25 cited by Hanmi. 

34. “Patients” as described in the sections cited by Hanmi, indicates nothing more 

than a person with a condition that may benefit from treatment. For example, the specification 

states that the claimed compounds may be used “in patients on NSAID therapy.” Non-steroidal 

anti-inflammatory drugs (NSAIDs) are common drugs used for pain relief and include many 

over the counter medications like aspirin, ibuprofen and naproxen. Thus, “patients on NSAID 

therapy” is not limited to patients under the supervision of a healthcare professional. 

35. “Patients” as used in the ’504 patent, does not necessarily indicate or suggest that 

the participation of a physician or other healthcare professional is required. And, nowhere does 

the ’504 patent specification or its file history limit treatment of a “patient” to require the 

involvement of a healthcare professional. 

36. “Administration” as used in the ’504 patent is entirely consistent with the ordinary 

meaning of the term discussed above. 

2. “a mammal including man in need of such treatment” 

a. Ordinary meaning 

37. The language “a mammal including man in need of such treatment” appears in 

claim 7 of the ’504 patent. 

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38. I understand that Hanmi asserts that this term should be construed as requiring 

that the need for treatment of a “gastrointestinal inflammatory disease [be] recognized and/or 

appreciated by the physician or other healthcare professional.” 

39. The meaning of the first part of the language, “a mammal including man”, is 

clear: it refers to humans. 

40. With respect to the remainder of the claim language “in need of such treatment,” a 

person of ordinary skill would understand this term to mean a person with a condition who may 

benefit from treatment—in other words, it refers to a class of patient or limits humans to a 

particular class or group (e.g., persons with a gastrointestinal inflammatory disease). While the 

“need” for a medical treatment may be assessed by a physician, as noted above, many drugs may 

be obtained over-the-counter and administered without a prescription or involvement of any 

“licensed healthcare professional.” 

41. The term does not require recognition or appreciation by anyone, let alone a 

healthcare professional. 

b. The ’504 patent specification and prosecution history 

42. Nowhere does the specification limit claim 7, “[a] method for the treatment of 

gastrointestinal inflammatory disease comprising the oral administration to a mammal including 

man in need of such treatment of a pharmaceutical formulation”, to require recognition or 

appreciation by a healthcare professional or anyone else. 

43. Nothing in the claims, specification or prosecution history would indicate to a 

person of ordinary skill in the art that the language “in need of such treatment” in claim 7 refers 

to anything other than a class of people with a condition (i.e., gastrointestinal inflammatory 

disease) that may benefit from the administration of the claimed composition. 

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44. A person “in need of such treatment” as used in the ’504 patent is entirely 

consistent with the ordinary meaning such language would have to a person of ordinary skill in 

the art. 

C. ’192 Patent Claim Language 

1. “administering to a mammal in need of treatment” 

a. Ordinary meaning 

45. The term “administering to a mammal in need of treatment” appears in asserted 

claims 1–7, 10, 11 and 23 of the ’192 patent. 

46. For the same reasons delineated while discussing the terms “administration 

[of/to]” as used in the ’504 patent (paragraphs 23-27 above), and “a mammal including man in 

need of such treatment” as used in the ’504 patent (paragraphs 37-41 above), a person of 

ordinary skill would understand the term “administering to an a mammal in need of treatment” as 

the suitable means by which a drug or therapy is delivered to a person with a condition who may 

obtain a benefit from treatment with that drug or therapy. In my opinion, a person of ordinary 

skill in the art would understand “administering” to refer to the means of delivery and “mammal 

in need of treatment” as language that limits the patient class. 

47. I understand that Hanmi asserts that this term should be construed to mean “the 

prescription by a physician or other licensed healthcare professional, dispensing and delivery by 

any suitable means.” 

48. Again, administration of a drug may involve healthcare professionals (e.g., 

prescription by a physician, dispensing by a physician or pharmacist or injection of a medicine to 

a patient), and the “need” of treatment may be assessed by a healthcare professional, but neither 

term is so limited. As noted above, omeprazole is just one of numerous examples of drugs that 

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may be obtained over-the-counter (as Prilosec® OTC) and administered orally without a 

prescription or involvement of a healthcare professional. 

49. The term “administering to a mammal in need of treatment” does not require 

recognition or appreciation by anyone, including a healthcare professional. 

b. The ’192 patent specification and prosecution history 

50. The ’192 patent specification uses “administering” to refer to the means by which 

the compounds of the invention may be delivered. For example, dependent claims 7, 8 and 9 

limit independent method claims 1 and 2 to those in which the compound is “administered 

orally”, “administered parenterally” or “administered by intravenous infusion”. Similarly, 

claims 19 and 20, which depends from claim 12, limits the method to those in which the 

“medicament” is produced for “oral administration” or “administered parenterally”. 

51. The specification further supports this understanding, explaining that “[a]ny 

suitable route of administration may be employed for providing the patient with an effective 

dosage of [esomeprazole].” Col. 4, lines 3-5. Including for example, “oral, parenteral, 

subcutaneous, intramuscular, rectal, transdermal and the like.” Col. 4, lines 5-8 and lines 19-21. 

52. Nowhere do the claims or the specification indicate that a “licensed healthcare 

professional” must be involved either for assessing “need” of a patient or for “administration,” 

and such a limitation would be inconsistent with the usage of “administration” in reference to the 

means of delivery in the patent. 

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