UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

OREXO AB,

Plaintiff,

v.

MYLAN PHARMACEUTICALS INC. and 

MYLAN INC., 

Defendants.

Civil Action No. 3:11–cv–3788–FLW–LHG

Hon. Freda L. Wolfson, U.S.D.J.

Hon. Lois H. Goodman, U.S.M.J.

Document Filed Electronically

 

EXPERT DECLARATION OF EDMUND J. ELDER, JR., PH.D., R.PH.

Arnold B. Calmann (abc@saiber.com)

Jeffrey Soos (js@saiber.com)

Katherine A. Escanlar (kae@saiber.com)

SAIBER LLC

One Gateway Center, 10th Floor

Newark, New Jersey 07102-5311

973-622-3333

973-286-2465 (facsimile)

Douglass C. Hochstetler 

(DHochstetler@KelleyDrye.com)

Constantine Koutsoubas 

(CKoutsoubas@KelleyDrye.com)

KELLEY DRYE & WARREN LLP

333 West Wacker Drive

26th Floor

Chicago, IL 60606

312-857-7070

312-857-7095 (facsimile)

Beth D. Jacob (BJacob@KelleyDrye.com)

Clifford Katz (CKatz@KelleyDrye.com)

Sung W. Kim (SuKim@KelleyDrye.com)

KELLEY DRYE & WARREN LLP

101 Park Avenue

Suite 1700

New York, NY 10178 

212-808-7800

212-808-7897 (facsimile)

Attorneys for Defendants/Counterclaim 

Plaintiffs Mylan Pharmaceuticals Inc. and 

Mylan Inc.

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 1 of 20 PageID: 1331
EXPERT DECLARATION OF EDMUND J. ELDER, JR., PH.D., R.PH.

I. BACKGROUND AND QUALIFICATIONS

1. Development of pharmaceutical dosage forms and drug delivery systems, 

including rapid release dosage forms, has been the focus of my career for the past 27 years. I 

obtained my Bachelor of Science degree in Pharmacy and Doctor of Philosophy (Ph.D.) degree

in Pharmaceutical Sciences from the Medical University of South Carolina in 1985 and 1989, 

respectively. My curriculum vitae including a list of my publications is attached as Exhibit A. I 

have had extensive experience formulating pharmaceutical products to enhance drug delivery

from 1985 to today. 

2. I am the Director of the Zeeh Pharmaceutical Experiment Station in the School of 

Pharmacy at the University of Wisconsin-Madison (UW). The Station works for both academia 

and pharmaceutical industry clients in developing pharmaceutical dosage forms and providing 

technical expertise regarding issues arising with pharmaceutical dosage form development and 

manufacture. As Director, I am responsible for providing pharmaceutical pre-formulation and 

formulation expertise to support pharmaceutical and biopharmaceutical development 

collaborations across the UW System campuses and for clients outside the university. I actively 

participate in educational programs sponsored by the Station and the UW School of Pharmacy in 

which I teach pharmaceutical industry scientists and others in related fields about the process and 

science of drug development. 

3. My work at the Station focuses on the development and improvement of 

pharmaceutical dosage forms. I have worked with various tablet dosage forms while at the 

Station, including rapid release formulations. I also have worked with conventional solid dosage 

forms, including tablets and capsules, and with injectable solutions and suspensions, dosage 

forms for application to the skin and inhalable dosage forms. 

4. Prior to my employment at the University of Wisconsin-Madison, I was the 

Global Pharmaceutical Development Director at Dowpharma, a business unit of The Dow 

Chemical Company that was dedicated to serving the pharmaceutical and biopharmaceutical 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 2 of 20 PageID: 1332
2

industries. In this role, I was responsible for overseeing and directing all technical aspects of the 

drug development business for nanotechnology applications, including the formulation and 

development of nanoparticles into solid dosage forms, such as tablets and capsules. I led 

numerous technology development collaborations and alliances between Dow and other 

companies, utilizing nanotechnology to achieve enhanced drug delivery. 

5. Prior to my employment at Dowpharma, I was Senior Group Leader for 

formulation and process development at Glaxo Wellcome Inc. (now GlaxoSmithKline, Inc.) 

where I oversaw and directed the work of ten formulation and process development scientists. I 

began my industrial career as a Senior Scientist, Research Investigator, and then Research 

Leader at the predecessor company, Glaxo Inc. 

6. In these various roles of increasing responsibility, I gained extensive experience 

in numerous aspects of pharmaceutical dosage form development and manufacturing including 

working on numerous enhanced drug delivery systems. I designed and conducted formulation 

studies, selected excipients for use in dosage forms, assessed whether a desired drug release was 

obtained from dosage forms and modified the composition of dosage forms to achieve a desired 

drug release, formulated dosage forms that achieved a desirable mixture of functionality, stability 

and compatibility and manufactured dosage forms for use in clinical studies. 

7. I also served as the primary interface between Glaxo and numerous external 

development and manufacturing sites that required me to provide pharmaceutical expertise used 

to develop oral dosage forms including enhanced drug delivery systems and tablets. 

8. My project management experience at Glaxo and Glaxo Wellcome included 

extensive management of both formulation and process development. I represented Glaxo’s 

Chemistry Manufacturing and Controls interests on global product development teams. I led 

several new product introduction teams, during which time I ensured that newly-developed 

technology was successfully transferred from research and development facilities to 

manufacturing facilities and solved the myriad problems that arise when a formulation and 

associated manufacturing process is moved from one location and one set of equipment and 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 3 of 20 PageID: 1333
3

people to another location and different people. I was the key liaison between the 

Pharmaceutical Development function at Glaxo and the FDA for numerous pre-approval 

inspections of manufacturing facilities in both the United States and abroad.

9. Prior to joining Glaxo, I worked in the pharmaceutical field for four years as a 

Research Pharmacist in the Pharmaceutical Development Center in the Department of 

Pharmaceutical Sciences at the Medical University of South Carolina, concurrent with my 

graduate education. My duties involved formulation development and manufacture of dosage 

forms for drug companies, including an oral dosage form requiring enhanced drug delivery. 

10. As of August 2012 I have made 52 scientific presentations on topics including 

sustained release formulations, formulation development, evaluation and optimization of drug 

product manufacturing, dissolution testing, and particle engineering in the area of 

nanotechnology.

11. I have presented lectures and seminars at Schools or Colleges of Pharmacy 

throughout the United States on topics including an overview of drug development, assessment 

and optimization of drug manufacturing processes, formulation development, excipient 

considerations in formulations, scale-up, technology transfer, and applications of particle 

engineering to nanotechnologies as a result of my participation from 1993-2005 in the Visiting 

Scientist Program for Schools of Pharmacy and Pharmaceutical Scientists. I have also 

participated as an instructor by giving over 120 lectures at continuing education Short Courses 

presented to pharmaceutical industry scientists covering the following subjects: particle 

engineering and nanotechnology, drug solubilization, stability, drug delivery and dosage form 

design. I currently serve as a guest lecturer in the Department of Pharmaceutical Sciences at the 

University of Wisconsin-Madison covering the topics of an introduction to the drug development 

process and formulation development.

12. I have been a member of the American Association of Pharmaceutical Scientists 

since 1987. I am also a member of Sigma Xi, The Scientific Research Society and a lifetime 

member of the National Eagle Scout Association. 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 4 of 20 PageID: 1334
4

13. I am on the Editorial Advisory Boards for the journals Drug Development and 

Industrial Pharmacy and Journal of Biosimilars and Biowaivers. I have reviewed journal 

articles in the pharmaceutical sciences submitted for publication to the European Journal of 

Pharmaceutics and Biopharmaceutics; the Journal of Biomedical Nanotechnology; the 

International Journal of Pharmaceutics; Pharmaceutical Research; and Drug Development and 

Industrial Pharmacy. I have also screened scientific papers submitted for the annual meetings of 

the American Association of Pharmaceutical Scientists.

14. A more detailed review of my professional background is provided in my 

curriculum vitae, attached as Exhibit A. 

15. A list of my publications is also included in my CV (Exhibit A)

16. A list of my testimony as an expert at trial or by deposition in the last 4 years is

provided as Exhibit B

II. MATERIALS REVIEWED 

17. I have reviewed the ‘910 patent as well as its entire prosecution history 

(ORM_00000009 to ORM_00000249). I have also reviewed European Patent EP 0 324 735 

(“Nystrom”) and the Revised Joint Claim Construction and Prehearing Statement. I understand 

that the ‘910 patent is Exhibit 1 to the Declaration of Constantine Koutsoubas (“Koutsoubas 

Decl.”), the prosecution history is Exhibit 2 to the Koutsoubas Declaration, and the Nystrom 

reference is Exhibit 3 to the Koutsoubas Declaration. In this declaration, I will cite to the ‘910 

patent as “ ‘910 patent,” I will cite to the Nystrom EP 0 324 735 patent as “Nystrom” and I will 

cite to pages in the ‘910 patent prosecution history by bates number.

III. BACKGROUND OF UNDERLYING TECHNOLOGY

18. Drug formulation development is a complex process requiring an understanding 

of the physiochemical properties of the drug and inactive additives (excipients) as well as the 

physiological features that the dosage form and drug will be exposed to in the body following 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 5 of 20 PageID: 1335
5

administration. Examples of some of the physiochemical properties of the drug that must be 

considered include solubility, permeability, partitioning and stability. Examples of some of the 

physiological considerations, in addition to achieving the desired therapeutic effect, include 

absorption, protein binding, metabolism and toxicity.

19. During development, the formulator will devise a development strategy for the 

drug based on their understanding of these various factors and also the target product profile, 

which includes input from marketing on desired attributes of the product that will hopefully 

eventually be administered to patients. The target product profile includes the desired disease

requiring treatment, patient population, indication(s), including efficacy, safety and tolerability 

objectives, route of administration, dose and dosing regimen, drug product presentation 

(packaging, storage conditions, stability/shelf life, etc.), markets & market size, cost and price.

20. The primary objective of the drug development process and particularly 

formulation development is to deliver the right drug in the right dose, at the right time, by the 

right route, to the right patient, in order to achieve the desired therapeutic effect.

21. A critical evaluation for orally administered products is having an understanding 

of how solubility and solubilization rate of the drug and dosage form can impact absorption and 

bioavailability (the amount of drug that gets into the blood stream).

22. In order for drugs to get absorbed through the mucosal barrier of the 

gastrointestinal tract (GI); which includes the mouth, esophagus, stomach, small and large 

intestines and rectum; they must first dissolve in the GI fluids. In order for a drug contained in a 

solid oral dosage form to get absorbed orally, that dosage form must begin to break apart so that 

the excipients can disintegrate to release the drug, then the drug must dissolve. Once in solution, 

the drug can be absorbed, assuming it also has adequate stability in the GI fluids and adequate 

permeability properties to cross the GI epithelium. Once absorbed, the drug is then available in 

the blood stream for circulation to the site of therapeutic action, unless it is metabolized in the 

liver immediately following absorption from the small intestines (known as first-pass 

metabolism).

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 6 of 20 PageID: 1336
6

23. The formulator must also consider the diversity of conditions to which the drug is 

exposed during transit through the GI tract. For example, significant pH differences, enzymes, 

bacteria, and volume differences exist at various locations. These are some of the physiological 

factors that can adversely affect solubility, stability and absorption of the drug.

24. Formulators have a wide range of approaches available for consideration in 

developing an appropriate dosage for administration to the patient. The most common solid oral 

dosage forms are tablets and capsules. Examples of release modifications that a formulator 

could choose to alter the delivery of drug from tablets and capsules include enteric coating for 

delayed release delivery, sustained release, and enhanced or fast release. A skilled formulator 

will have a thorough understanding of the properties of the various excipients that can be used to 

achieve the desired drug release alteration and how these excipients impact the rate of release.

25. A sublingual tablet is a form of fast disintegrating/dissolving tablet which is 

placed under the tongue to achieve rapid drug absorption into the systemic circulation. This 

delivery site is commonly used for drugs which exhibit first-pass metabolism and/or require 

rapid absorption to achieve their maximum therapeutic benefit.

26. Ordered mixing is a method for enhancing drug release which is disclosed in 

Nystrom. Nystrom describes ordered mixtures as using “adherent particles” of active substance 

(Nystrom, 1:49-2:12) where “the active substance(s) is (are) distributed uniformly over the 

surfaces of readily dissolvable carrier particles, therewith enabling the therapeutically active 

substances to dissolve more quickly. Consequently, the active substances will dissolve more 

rapidly when administered and consequently act more quickly, in a highly advantageous 

manner.” (Nystrom, 1:30-37).

27. The particles adhere to the carrier particles in the dry mixing process. Also, since 

the carrier particle described in Nystrom is “readily dissolvable”, the use of dry mixing is 

necessary; otherwise, the carrier has the potential to dissolve during the manufacturing process; 

thus, reducing the size of the carrier particle and the ratio of carrier particle size to drug particle 

size. Addition of water could also dissolve the drug or other soluble excipient, which could then 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 7 of 20 PageID: 1337
7

precipitate in an uncontrolled manner during the drying process; thus not being “distributed 

uniformly over the surfaces of readily dissolvable carrier particles” in an ordered mixture.

IV. OVERVIEW OF THE ‘910 PATENT

28. I read the ‘910 patent as being directed toward a person having at least a Bachelor 

of Science degree in chemistry, pharmacy, engineering, or a related science, or a Doctor of 

Pharmacy (Pharm.D.) degree, and a minimum of three years of experience in pharmaceutical 

formulation development. The ‘910 patent is also directed to a person with a Master of Science 

degree in Pharmaceutical Sciences or a related scientific field and at least one year of experience 

in pharmaceutical formulation development. The ‘910 patent is also directed to a person with 

Ph.D. in Pharmaceutical Sciences or a related scientific field with experience in pharmaceutical 

formulation development. 

29. In view of my education and experience, I consider myself qualified to offer my 

opinion as a person to which the ‘910 patent is directed. I also was qualified as such a person 

when the ‘910 patent was filed, which I understand was filed as a Swedish patent application in 

1998. 

30. The ‘910 patent claims an essentially water-free ordered mixture pharmaceutical 

composition that was known in the art as I described above. The claims also require the ordered 

mixture as described above where (according to both claims 1 and 19) there are “microparticles 

of at least one pharmaceutically active agent adhered to the surfaces of carrier particles” with 

“said [carrier] particles being substantially larger than said microparticles and being watersoluble.”

31. The ‘910 patent states that it is an improvement upon the prior art ordered mixture 

as described in Nystrom and it specifically points out Nystrom as disclosing the preferred 

method for “formulating rapidly dissolving ordered-mixture compositions,” column 3, lines 26-

30. There are two obvious differences between Nystrom and the ‘910 patent. First, the ‘910 

patent involves sublingual tablets and Nystrom does not mention sublingual tablets. Second, and 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 8 of 20 PageID: 1338
8

maybe more importantly for present purposes, the ‘910 patent describes and claims the use of a 

bio/mucoadhesive specifically on the surface of the carrier particles.

32. The hygroscopic properties of the bio/mucoadhesive agents described in the ‘910 

patent requires that the formulation is essentially water free as discussed at column 7, lines 

40-43:

Irrespective of the form given to the preparation, it is important 

that the preparation is essentially free from water, since its 

bio/mucoadhesion promoting character results from its practically 

instantaneous hydration when brought into contact with water or 

saliva. Premature hydration would drastically decrease the 

mucoadhesion promoting properties and result in a premature 

dissolution of the active substance.

33. As noted above, the ‘910 patent states the “bio/mucoadhesion promoting 

character results from its practically instantaneous hydration when brought into contact with 

water or saliva.” Additionally, “[p]remature hydration would drastically decrease the 

mucoadhesion promoting properties.” Water exposure affects the mucoadhesive properties by 

causing the bio/mucoadhesive agent to swell slightly which could further disrupt adjacent 

particles resulting in a change in the overall order of the compositions. In addition, the 

premature addition of water will also affect the water soluble carrier particle and will likely make 

it such that the bio/mucoadhesive is no longer “adhered to the surface” of the carrier particle. If 

part of the carrier particle dissolves prematurely, any bio/mucoadhesive particles that were 

adhered to the now-dissolved carrier particle will obviously no longer be adhered because the 

bio/mucoadhesive cannot be adhered to what is effectively a liquid. 

34. The pharmaceutical composition in the ‘910 patent must be essentially water free, 

with no water added during the process. 

35. The ‘910 patent defines the term bio/mucoadhesion promoting agent as a 

substance that “is effective in making the active agent or agents adhere to the oral mucosa.” ‘910 

patent, col. 3, lines 57-59. 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 9 of 20 PageID: 1339
9

36. Bio/mucoadhesive promoting agents are typically water-swellable polymers that 

adhere to mucous membranes. Upon contact with saliva or mucous secretions in the GI tract, the 

polymer interacts on a molecular level with macromolecules in the mucous, such as mucin.

V. OVERVIEW OF THE ‘910 PATENT PROSECUTION HISTORY

37. In my opinion, during the prosecution of the ‘910 patent, the applicants clearly 

indicated to the patent office that cross-linked polyvinylpyrrolidone was not a “bioadhesion 

and/or mucoadhesion promoting agent.”

38. In the first office action, the examiner rejected all of the relevant claims over 

Nystrom. Claim 7, as originally submitted, included microcrystalline cellulose in the list of 

possible bio/mucoadhesives; however, Claim 7 in the issued patent does not include 

microcrystalline cellulose. Claim 14, as originally submitted is identical to Claim 7 in the issued 

patent, both included cross-linked polyvinylpyrrolidone in the list of disintegrating agents.

39. The examiner explained the first office action rejection by noting that “Nystrom 

teaches essential elements of the claimed invention. The reference discloses an ordered mixture 

of drug particles in a carrier composition.” (ORM_00000159). The examiner further noted:

With regard to the constituents of the present invention, 

specifically the carrier particles, these are also well known in the 

art. Nyström clearly names the bio/mucoadhesive (microcrystalline 

cellulose), the disintegrant (polyvinylpyrrolidone) and the 

carbohydrate (mannitol) of the current invention...

(Sept. 26, 2002 Office Action, p. 6 (ORM_00000161)) (emphasis added).

40. I note, that in the Office Action, the examiner referred to “polyvinylpyrrolidone” 

rather than “cross-linked polyvinylpyrrolidone.” When I read this statement, I understood that 

the examiner to be referring to the cross-linked version of polyvinylpyrrolidone. The basis for 

this conclusion follows.

41. Cross-linked polyvinylpyrrolidone (also referred to as crospovidone) is a common 

pharmaceutical excipient classified as a “disintegrant” or “disintegrating agent.” Crospovidone 

is used in pharmaceutical formulations to help break up tablets or capsule contents once they are 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 10 of 20 PageID: 1340
10

swallowed. It performs this disintegrating function by absorbing water, which causes the 

polymeric particles to swell. This swelling action causes tablets or capsule contents containing 

the disintegrant to break apart. 

42. The functionality of cross-linked polyvinylpyrrolidone is directly contradictory to 

polyvinylpyrrolidone, another pharmaceutically acceptable ingredient commonly referred to as 

povidone or PVP. As the name clearly states, cross-linked polyvinylpyrrolidone is a cross-linked 

derivative of PVP. While the two compounds contain the same base molecule, their 

pharmaceutical properties are essentially opposite. When PVP is put into contact with water, it 

becomes sticky and tacky. For this reason, it is often referred to as a “binder.” The function of 

PVP in a pharmaceutical formulation is to hold other ingredients together during processing of 

powders into granules for encapsulation or tableting. Once the water is removed through a 

drying step, the PVP remains as a strong adhesive to keep particles together as granules. I have 

used PVP throughout my 27 year career in formulation development, and in that time, I have 

used PVP in tablet and capsule formulations as a binder. I have never used PVP as a 

disintegrant, and, I have never known any formulators to have used PVP, in its non-cross-linked 

form, as a disintegrant.

43. In response to the office action rejection of all claims, the applicants amended the 

specification and the claims to remove microcrystalline cellulose from their definition of 

bio/mucoadhesives. The applicants, however, then also took additional steps. Following some 

preliminary arguments, the applicants pointed to the change in the patent specification in their 

effort to convince the examiner to withdraw his obviousness rejection:

Moreover, applicants note the NYSTROM fails to mention mucoor bioadhesive components. In fact, NYSTROM fails to disclose 

or suggest a combination of ordered mixtures and mucoadhesive 

agents. Moreover, applicants note that one of the ordinary skill in 

the art would appreciate that microcrystalline cellulose does not 

exhibit bio/mucoadhesive properties. While it is true that this is 

stated in the specification and claims, applicants have amended the 

claims and specification to correct this obvious error. 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 11 of 20 PageID: 1341
11

(Feb. 23, 2003 Amendment, p. 6 (ORM_00000181) (emphasis added).)

44. I have reviewed the Nystrom reference, and it discloses cross-linked 

polyvinylpyrrolidone as a “disintegrant” at column 3, lines 8-18 (emphasis added):

The pharmaceutical disintegrant may comprise any substance 

which is known for this purpose by those skilled in the art. 

Particularly effective agents in this respect are those which swell 

drastically in water, through hydratization, and thus exhibit an 

increase in volume of up to 10-20 times their dry volume. 

Examples of such agents are cellulose and starch derivatives in the 

form of water-insoluble, cross-linked polymers which swell 

markedly in water. Derivatives of polyvinylpyrrolidone are other 

examples of such agents.

45. The only “[d]erivative[] of polyvinylpyrrolidone” of which I am aware is known 

as a “pharmaceutical disintegrant” is cross-linked polyvinylpyrrolidone. When I read this 

section in Nystrom, I read it as disclosing cross-linked polyvinylpyrrolidone and its use as a 

disintegrating agent. In my opinion, any formulation scientist would come to the same 

conclusion.

46. Nystrom also disclosed the combination of ordered mixtures and disintegrants. 

See Nystrom at col. 5, lines 5-14:

The pharmaceutical preparations can be composed, by combining 

the inventive ordered mixtures with the conventional 

pharmaceutical additives and excipients normally used in the 

desired forms of the preparations, with the aid of known methods 

herefor. Such additions may comprise, for instance, additional 

carriers, preservatives, lubricants, glidants, disintegrants, 

flavourants, dyestuffs and like substances, and are well known to 

the person skilled in the art. (emphasis added).

47. Reading the statements in the preceding paragraphs and combining the three key 

points: 1) noting that the Nystrom reference “fails to mention muco- or bioadhesive components” 

and that it fails to “disclose or suggest a combination of ordered mixtures and mucoadhesive 

agents” (¶ 43), 2) the Nystrom reference disclosing cross-linked polyvinylpyrrolidone (¶¶ 44-45) 

and 3) the Nystrom reference disclosing the use of disintegrants (i.e., cross-linked 

polyvinylpyrrolidone) with an ordered mixture (¶ 46), I understand these statements to say that 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 12 of 20 PageID: 1342
12

cross-linked polyvinylpyrrolidone was not a bio/mucoadhesion agent for purposes of the ‘910 

patent. 

48. I read these statements to allow the use of both microcrystalline cellulose and 

cross-linked polyvinylpyrrolidone in a pharmaceutical formulation because neither are 

bio/mucoadhesives for purposes of the ‘910 patent.

I, EDMUND J. ELDER, JR., hereby declare under penalty of perjury under 28 U.S.C. 

§ 1746 and the laws of the United States of America, that the foregoing Declaration is true and 

correct.

Dated: October 5, 2012 __________________________________

Edmund J. Elder, Jr. 

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 13 of 20 PageID: 1343
EXHIBIT A

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 14 of 20 PageID: 1344
SM Service Mark of The Dow Chemical Company

Edmund J. Elder, Jr., Ph.D., R.Ph.

7401 North Pass

Madison, WI 53719

(608) 497-0117

ed_elder@alumni.musc.edu

(Ed) University of Wisconsin-Madison

School of Pharmacy

Rennebohm Hall

777 Highland Avenue

Madison, WI 53705-2222

(608) 890-1198

eelder@pharmacy.wisc.edu

EDUCATION:

Medical University of South Carolina, Charleston, SC

Ph. D., Pharmaceutical Sciences; November 1989

B.S., Pharmacy; May 1985

Clemson University, Clemson, SC

Pre-Professional Studies, Pre-Pharmacy

1980-1982

EMPLOYMENT:

University of Wisconsin-Madison

School of Pharmacy

Director, Lenor Zeeh Pharmaceutical Experiment Station, July 2007 – present

Associate Director, Lenor Zeeh Pharmaceutical Experiment Station, April 2006 – June 2007

Current Responsibilities

 Key leadership position for providing laboratory services to UW and non-UW clients, including

analytical, physical/chemical characterization (pre-formulation), and early-stage formulation services

 Provide pharmaceutics expertise and chemistry, manufacturing and controls (CMC) knowledge to 

support pharmaceutical and biopharmaceutical development collaborations on and off campus

 Advise and mentor Station staff

 Apply project management and business development experience to enhance Station operational

effectiveness

 Share knowledge and expertise through Station participation in and sponsorship of educational

programs addressing the process and science of drug development in collaboration with UWMadison, School of Pharmacy, Extension Services in Pharmacy (continuing education division)

 Graduate Course Lectures:

- An Introduction to Pharmaceutical Sciences

- Approaches to Formulation of Drug Products

The Dow Chemical Company, Midland MI

DowpharmaSM

Global Pharmaceutical Development Director / Applications Development Leader, April 2004 – April 2006

Pharmaceutical Technologies Group

Pharmaceutics Director / Technical Leader, August 2000 – April 2004

Prior Responsibilities

 Co-leader (with commercial leader), new business development: BioAqueousSM Solubilization Services

 Oversight of multi-departmental technical activities for development of a drug delivery service offering

including interfacial sciences, engineering, analytical, toxicology, intellectual capital management, 

licensing, manufacturing, project management, technical service and QA/regulatory

 Lead external technology development collaborations and alliances including a multi-year

university research program

 Represent technical program during client interactions for commercial development activities

 Provide pharmaceutics expertise for various emerging corporate growth opportunities

 Serve as a mentor for potential future leadership staff through formal corporate program

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 15 of 20 PageID: 1345
page 2 Ed Elder, Jr.

August 2012

Glaxo / Glaxo Wellcome (now GlaxoSmithKline), Research Triangle Park, NC

Pharmaceutical Sciences

Sr. Group Leader, Formulation and Process Development, November 1997 – August 2000

Group Leader, Formulation Development, February 1997 – November 1997

Process Science and Technology

Research Leader, Liquids Process Development, September 1995 – February 1997

Research Leader, Pharmaceutical Technology Development, July 1994 – August 1995

Research Investigator, May 1992 – June 1994

Senior Scientist, September 1989 – April 1992

Previous Experience

 Management: Group of ten formulation and process development scientists, covering all dosage 

forms, mentoring of new CMC team leaders, department management team and division leadership 

committees

 Project Management: Chemistry manufacturing & controls (CMC) matrix team leader

- Responsible for oversight of all cross-functional CMC activities for multiple development programs

- Represented CMC interests on international product development teams

- Lead technology transfer and manufacturing site new product implementation teams.

- Key R&D contact for FDA pre-approval inspections of domestic and foreign contract manufacturing 

sites.

 Formulation and process development, optimization and scale-up using statistical experimental design

 Primary interface with external development and manufacturing sites for new dosage form

technologies including: soft gelatin capsules, effervescent products, and sterile products blow-fill-seal

technology

Burroughs Wellcome Company (now GlaxoSmithKline), Greenville, NC

Pharmaceutical Research and Development Laboratory

Pharmaceutics Graduate Student Fellow, June 1986 – August 1986

Family Pharmaceuticals of America, Inc., Mt. Pleasant, SC

Mail-service and retail pharmacy, acquired by Medi-Mail, Inc. in 1994, subsequently acquired by Bergen 

Brunswig Corporation, now AmerisourceBergen Corporation

Minor Partner, subchapter-S corporation, January 1987 – June 1994 

Part-time Pharmacist, June 1985 – August 1989

Pharmacy Intern, May 1983 – June 1985

PROFESSIONAL ACHIEVEMENTS:

52 Scientific Presentations (15 invited)

9 Publications and 1 book contribution

112 Short Course presentations (all invited), additional 17 presented at pharmaceutical companies

The Visiting Scientist Program for Schools of Pharmacy and Pharmaceutical Scientists

- Presented lectures/seminars at 14 schools/colleges of Pharmacy, 1993 – 2005

Guest Lecturer

- University of Wisconsin–Madison, Department of Pharmaceutical Sciences, 2006 – present

- South Carolina College of Pharmacy, MUSC Campus, 2007

- Medical University of South Carolina, Department of Pharmaceutical Sciences, 1991 – 1999

- University of Texas at Austin, College of Pharmacy, 2001 – 2006

- Michigan State University, ISPE Student Chapter, 2004

- Virginia Commonwealth University/Medical College of Virginia, School of Pharmacy, 1997

LICENSURE:

South Carolina Pharmacist License, 1985 – present

Wisconsin Pharmacist License, 2010 – present

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 16 of 20 PageID: 1346
page 3 Ed Elder, Jr.

August 2012

PROFESSIONAL MEMBERSHIP/ACTIVITIES/AWARDS

United States Pharmacopoeia (USP)

2010-2015 Compounding Expert Committee

American Association of Pharmaceutical Scientists (AAPS), 1990–present (student member 1987–1989)

Annual Meeting paper screener (PT Section), 1994 – 2000, 2006 – 2009, (FDD Section) 2011

Co-Chair 2004 Annual Meeting Short Course, Particle Engineering Technologies: Theory and Practice

Moderator (PT Podium Session: Pharmaceutical Processing and Scale-up), Tenth Annual Meeting 

and Exposition, Miami Beach, FL, 1995

Planning Committee and Moderator (PT Section), 1995 Southeast Regional Meeting, RTP, NC

AAPS Special Appreciation Award, 1994 – Co-Chair, 1994 Southeast Regional Meeting, Durham, NC

Controlled Release Society (CRS), member 2001 – 2006

European Federation for Pharmaceutical Sciences (EUFEPS), member 2003–2008, 2009 – present

Sigma Xi, The Scientific Research Society, member 1988 – present

Editorial Advisory Board 

Drug Development and Industrial Pharmacy, 2006 – present

Journal of Biosimilars & Biowaivers, 2012 – present

Journal Article Reviewer

Drug Development and Industrial Pharmacy, 2000 – present

European Journal of Pharmaceutics and Biopharmaceutics, 2007, 2010, 2011

International Journal of Pharmaceutics, 2007, 2009, 2010

Journal of Biomedical Nanotechnology – Special Issue on “Nanotechnology in Advanced Drug 

Delivery”, 2006

Journal of Drug Delivery Science & Technology, 2008

Journal of Pharmacy & Pharmacology, 2009, 2011

Pharmaceutical Research, 2008

Grant Reviewer

National Science Foundation, Office of Industrial Innovation, Small Business Innovation 

Research/Technology Transfer, SBIR/STTR Phase I, Food Safety, Drug, and Nutraceutical

Manufacturing Panel, 2006

University of Minnesota, Center for Nanostructure Applications, 2007, 2008

University of Wisconsin–Madison, Extension Services in Pharmacy, Pharmaceutical Industry Courses

Applied Drug Development I (introduction) Short Course, 2008-2010

Applied Drug Development II (pre-formulation) Short Course, 2007-present

Applied Drug Development III (formulation) Short Course, 2008-present

CMC Project Team Leader Short Course, 2010-present

Land O’Lakes June R&D Conference, planning committee 2008-present, chair 2013

Nanoparticles Short Course, 2007-2008

Medical University of South Carolina (MUSC), Lifetime Member, MUSC Alumni Association

Alumni Association Planning Committee, College of Pharmacy, Class of 1985, Reunion 2000

Chairman, College of Graduate Studies Annual Fund, 1998 – 1999

Alumni Association Student Research Day Judge, 1996 – 1998

The Rho Chi Society (Pharmacy Honorary), College of Pharmacy, 1987

Roche Pharmacy Communications Award, College of Pharmacy, 1985

McKesson Presidential Award, College of Pharmacy, 1985

ISPE Award for Outstanding Service to the Technology Transfer Task Team, November 2003 (book

contributions)

The Dow Chemical Company, Special Recognition Award, December 2002 (creation and launch of

BioAqueousSM Solubilization Services)

Boy Scouts of America

Troop 628 Madison, WI

Advancement Chair, 2012 – Present

Troop Committee Secretary, 2010 – 2012

Cubmaster, Pack 628 Madison, WI, 2008 – 2010

Eagle Scout, Troop 1429 Charleroi, PA, July 26, 1976, Life Member, National Eagle Scout Association

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 17 of 20 PageID: 1347
page 4 Ed Elder, Jr.

August 2012

PUBLICATIONS

LT Schulz, EJ Elder, KJ Jones, A Vijayan, BD Johnson, JE Meadow, LC Vermulen (2010) Stability of

Sodium Nitroprusside and Sodium Thiosulfate 1:10 Intravenous Admixture, Hospital Pharmacy, 45(10):

779-784, 2010. 

ME Matteucci, BK Brettmann, TL Rogers, EJ Elder, RO Williams III, and KP Johnston, Design of Potent

Amorphous Drug Nanoparticles for Rapid Generation of Highly Supersaturated Media, Molecular

Pharmaceutics, 4(5): 782-793, 2007. 

EJ Elder, JC Evans, BD Scherzer, JE Hitt, GB Kupperblatt, SA Saghir, and DA Markham, Preparation,

Characterization, and Scale-up of Ketoconazole with Enhanced Dissolution and Bioavailability, Drug 

Development and Industrial Pharmacy, 33:7, 755 - 765, 2007. 

EJ Elder, JE Hitt, TL Rogers, CJ Tucker, SA Saghir, S Svenson, and JC Evans, Particle Engineering of

Poorly Water Soluble Drugs by Controlled Precipitation in Polymeric Drug Delivery Volume II -

Polymeric Matrices and Drug Particle Engineering, Svenson, S., (Ed.), ACS Symposium Series, Vol. 

924, American Chemical Society, Washington, DC, 2006.

JC Evans, BD Scherzer, CD Tocco, GB Kupperblatt, JN Becker, DL Wilson, SA Saghir, and EJ Elder, 

Preparation of Nanostructured Particles of Poorly Water Soluble Drugs via a Novel Ultra-Rapid 

Freezing Technology in Polymeric Drug Delivery Volume II - Polymeric Matrices and Drug Particle 

Engineering, Svenson, S., (Ed.), ACS Symposium Series, Vol. 924, American Chemical Society, 

Washington, DC, 2006.

TL Rogers, IB Gillespie, JE Hitt, KL Fransen, CA Crowl, CJ Tucker, GB Kupperblatt, JN Becker,

DL Wilson, C Todd, CF Broomall, JC Evans, and EJ Elder, Development and Characterization of a 

Scalable Controlled Precipitation Process to Enhance the Dissolution of Poorly Water-Soluble Drugs,

Pharmaceutical Research, 21(11), 2048-2057, 2004. 

RD Connors and EJ Elder, Using a Portfolio of Particle Growth Technologies to Enable Delivery of Drugs

With Poor Water Solubility, Drug Delivery Technology, 4(8), 78-83, 2004. 

EJ Elder, JE Hitt, TL Rogers, CJ Tucker, SA Saghir, S Svenson, and JC Evans, Particle Engineering of

Poorly Water Soluble Drugs by Controlled Precipitation, Polymeric Materials Science and Engineering, 

89:741, 2003. 

JC Evans, BD Scherzer, CD Tocco, GB Kupperblatt, JN Becker, DL Wilson, SA Saghir, and EJ Elder, 

Preparation of nanostructured particles of poorly water soluble drugs via a novel ultra-rapid freezing 

technology, Polymeric Materials Science and Engineering, 89:742, 2003. 

BOOK CONTRIBUTIONS

EJ Elder (contributor), Dosage Forms (Clinical Supplies and Commercial Product): APIs, Excipients and 

Raw Materials, Chapter 5.3 in Technology Transfer (ISPE Good Practice Guide), ISPE, Tampa, FL,

2003.

DOCTORAL DISSERTATION

EJ Elder, Development of a Dry Coating Method for Formulating Sustained-Release Products, Medical

University of South Carolina, Charleston, SC, 1989

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 18 of 20 PageID: 1348
EXHIBIT B

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 19 of 20 PageID: 1349
Edmund J. Elder, Jr., Ph.D., R.Ph. 

Aug 2012 CONFIDENTIAL

CONSULTING ACTIVITIES 

Testimony by deposition: 

1. February 2008

05-cv-340 (KAJ) IN RE Tricor Direct Purchaser Antitrust Litigation

United States District Court for the District of Delaware

On behalf of plaintiff, Louisiana Wholesale Drug Company Inc

2. August 2009

Interference No. 105,685; Jerussi et al. (Sepracor Inc.) v. Hadfield et al. (Wyeth)

United States Patent and Trademark Office

On behalf of Wyeth 

3. February 2010

09-cv-831 (KSH) Endo Pharmaceuticals Inc. et al v. Impax Laboratories Inc.

09-cv-836 (KSH) Endo Pharmaceuticals Inc. et al v. Sandoz Inc.

09-cv-838 (KSH) Endo Pharmaceuticals Inc. et al v. Barr Laboratories Inc.

United States District Court for the District of New Jersey

On behalf of defendants, Impax, Sandoz & Barr

4. March 2010

08-cv-453 (GMS) AstraZeneca LP et al v. Mylan Pharmaceuticals Inc.

United States District Court for the District of Delaware

On behalf of defendant, Mylan Pharmaceuticals Inc

5. September 2011

10-cv-4008 (FLW) Medeva Pharma Suisse AG et al v. Par Pharmaceuticals Inc et al

United States District Court for the District of New Jersey

On behalf of defendant, Par Pharmaceuticals Inc

6. October 2011

08-cv-6304 (WJM) WARNER CHILCOTT LABORATORIES IRELAND LIMITED et al v. IMPAX

LABORATORIES, INC. et al (Mylan)

United States District Court for the District of New Jersey

On behalf of defendant, Mylan Pharmaceuticals Inc

7. March 2012

T-2010-10 (Canada) AstraZeneca Canada Inc et al v. Ranbaxy Pharmaceuticals Canada Inc et al

Federal Court [Canada] Toronto

On behalf of defendant, Ranbaxy Pharmaceuticals Canada Inc

Testimony at Trial:

1. May 2010

08-cv-453 (GMS) AstraZeneca LP et al v. Mylan Pharmaceuticals Inc.

United States District Court for the District of Delaware

On behalf of defendant, Mylan Pharmaceuticals Inc

2. February 2012

08-cv-6304 (WJM) WARNER CHILCOTT LABORATORIES IRELAND LIMITED et al v. IMPAX

LABORATORIES, INC. et al (Mylan)

United States District Court for the District of New Jersey

On behalf of defendant, Mylan Pharmaceuticals Inc

Case 3:11-cv-03788-FLW-LHG Document 95-6 Filed 10/05/12 Page 20 of 20 PageID: 1350