Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 1 of 24 PageID #: 880
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`
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`C.A. No. 14-781 (SLR)
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`))))))))))))
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`PFIZER INC., WYETH LLC, PFIZER
`PHARMACEUTICALS LLC, PF PRISM
`C.V. and PFIZER MANUFACTURING
`HOLDINGS LLC,
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`
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`Plaintiffs,
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`
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`v.
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`
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`Defendant.
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`CFT PHARMACEUTICALS LLC,
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`DECLARATION OF SOUMYAJIT MAJUMDAR, PH.D.
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`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
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`Attorneys for Plaintiffs
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`
`
`OF COUNSEL:
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`Thomas H.L. Selby
`David I. Berl
`Stanley E. Fisher
`Adam D. Harber
`Galina I. Fomenkova
`Martha C. Kidd
`Sara K. Creighton
`Barrett J. Anderson
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`July 15, 2015
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`

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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 2 of 24 PageID #: 881
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`TABLE OF CONTENTS
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`
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`I. 
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`II. 
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`III. 
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`IV. 
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`VI. 
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`Qualifications and Background ........................................................................................ 1 
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`Mandate .......................................................................................................................... 2 
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`Person of Ordinary Skill in the Art................................................................................... 3 
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`Scientific Background ..................................................................................................... 4 
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`Claim Term “pH of the composition in a solution is” ....................................................... 7 
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`A. 
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`B. 
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`C. 
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`D. 
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`Claim Language ................................................................................................... 7 
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`Patent Specification.............................................................................................. 9 
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`1. 
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`2. 
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`3. 
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`4. 
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`Specification Language ............................................................................ 9 
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`The Specification Does Not Support Dr. Kirsch’s Opinion ..................... 10 
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`The ’242 Patent Does Not Support CFT’s Proposed Construction ........... 15 
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`Purpose of the Invention ......................................................................... 15 
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`Prosecution History ............................................................................................ 16 
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`The Claim Language Makes Sense to a Person of Ordinary Skill in the Art ........ 17 
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`VII.  Claim Term “about” In Relation to pH Levels ............................................................... 20 
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`

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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 3 of 24 PageID #: 882
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`I, Soumyajit Majumdar, Ph.D., declare and state as follows:
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`1. I am currently Associate Dean for Research and Graduate Programs, Associate Professor
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`of Pharmaceutics, Associate Director of the Pii Center for Pharmaceutical Technology, and
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`Research Associate Professor in the Research Institute of Pharmaceutical Sciences at the
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`University of Mississippi. I make this declaration in support of the reply claim construction brief
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`of Plaintiffs Pfizer Inc., Wyeth LLC, Pfizer Pharmaceuticals LLC, PF PRISM C.V., and Pfizer
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`Manufacturing Holdings LLC (“Pfizer”) in the above-captioned case.
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`I.
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`Qualifications and Background
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`2. I received a Bachelor of Pharmacy in 1989 from Jadavpur University, Calcutta, India. I
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`received a Master of Pharmacy in 1991 from Jadavpur University, Calcutta, India. I received a
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`Doctor of Philosophy in Pharmaceutical Sciences and Pharmacology in 2005 from the University
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`of Missouri-Kansas City.
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`3. I began working in the area of pharmaceutical formulations during my graduate studies in
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`1989 and I have worked on the research and development of pharmaceutical products since that
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`time. After I obtained my master’s degree in 1991, I joined Sandoz, Inc. in India to work on the
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`manufacturing and development of pharmaceutical and consumer health products for the Indian
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`and European markets. During that time, the projects I worked on included development and
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`solid state and solution stability evaluation of parenteral products in addition to various other
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`pharmaceutical dosage forms. In 1999, I moved to another pharmaceutical company in India,
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`Orchid Health Care, where I was deputy manager of formulation development. At Orchid, I
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`worked on multiple formulation development projects including development of lyophilized
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`cephalosporin formulations.
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`4. In 2000, I began my Ph.D. studies at the University of Missouri-Kansas City, in the area
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`of pharmaceutical sciences. Since obtaining my Ph.D. in 2005, my academic work has focused
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`1
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 4 of 24 PageID #: 883
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`on drug delivery systems, with a particular focus on ophthalmic formulation development and
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`involved solution state stability, pH effect on stability, and pH measurements/adjustments.
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`5. I have been a professor at the University of Mississippi since 2005. I currently teach
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`several courses, including Basic Pharmaceutics I and Industrial Pharmacy to professional
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`students, and Advanced Pharmacokinetics to graduate students.
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`6. I have received several awards including the prestigious “Lipid Based Drug Delivery
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`Outstanding Researcher Award” presented by the American Association of Pharmaceutical
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`Scientists and Pharmaceutical sciences teacher of the year awards.
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`7. I have published 54 peer reviewed articles, more than 150 poster presentations, and two
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`book chapters. A majority of my publications are with respect to ophthalmic formulations
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`including evaluation of solution stability and investigating methods to enhance the same.
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`8. During the past four years, I have testified as an expert by deposition in the following
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`cases: Alcon Pharm. Ltd., et al. v. Lupin Ltd., et al., No. 1:11-cv-00587-SLR (D. Del.); Alcon
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`Research Ltd. v Mylan Pharm. Inc., et al., No. 1:13-CV-01332-SLR (D. Del.). I also provided
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`deposition testimony in two inter partes reviews before the Patent Trial and Appeal Board:
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`Apotex Inc. v. Alcon Pharm. Ltd., No. IPR2013-00012; Apotex Inc. v. Alcon Pharm. Ltd., No.
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`IPR2013-00015. Furthermore, in the past four years, I have testified as an expert at trial and by
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`deposition in the following cases: Alcon Research Ltd. v. Barr Labs., Inc., et al., No. 1:09-cv-
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`00318-RGA (D. Del.); Allergan, Inc. v. Sandoz Inc., et al., No. 6:11-cv-00441-MHS (E.D. Tex.).
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`9. My curriculum vitae contains a complete list of my professional activities, publications,
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`presentations, honors, and courses taught, and is attached as Exhibit A.
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`II. Mandate
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`10. I have been asked by counsel for Pfizer to offer my opinion about how a person of
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`ordinary skill in the art would interpret two claim terms in United States Patent No. 7,879,828
`2
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 5 of 24 PageID #: 884
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`(“the ’828 patent”), and to respond to the claim construction opinions of Lee E. Kirsch, Ph.D, the
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`expert retained by CFT Pharmaceuticals LLC (“CFT”).
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`11. I have been informed that there are two claim terms in the ’828 patent at issue in this
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`claim construction dispute: (1) “pH of the composition in a solution is,” and (2) “about” as it
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`relates to pH values.
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`12. When preparing my opinion, I reviewed the ’828 patent, its prosecution history, Pfizer’s
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`Opening Claim Construction Brief, CFT’s Answering Claim Construction Brief, the declarations
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`of Dr. Kirsch and Ian McFarland, the exhibits to those declarations, the transcript of the
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`deposition of Dr. Kirsch, and the materials cited herein. In addition to these materials, I also
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`relied on the knowledge and skill I have gained through my academic and professional activities
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`in forming my opinions.
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`13. I am being compensated at a rate of $300 per hour for my time. My compensation in no
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`way depends on the outcome of this litigation or any part of this litigation.
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`III.
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`Person of Ordinary Skill in the Art
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`14. I have been informed and I understand that the claims of the ’828 patent should be
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`viewed from the perspective of a person of ordinary skill in the art (also referred to as a “POOS”)
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`at the time of the claimed invention. I am informed by counsel that factors for determining
`ordinary skill may include one or more of the following: (1) the educational level of the
`inventor; (2) the type of problems encountered in the art; (3) prior art solutions to those
`problems; (4) the rapidity with which innovations are made; (5) the sophistication of the
`relevant technology; and (6) the educational level of workers active in the field. To arrive
`at my conclusions regarding a person of ordinary skill in the art, I have considered the
`education and experience of the team of persons looking to solve complex chemical
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`3
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`instructed to assume that the priority date of the ’828 patent is March 14, 2005. All references to
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`a person of ordinary skill in the art refer to a person of ordinary skill as of that date.
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 6 of 24 PageID #: 885
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`degradation problems in the context of formulating antibiotic drug products. I have been
`15. On or before March 2005, a person of ordinary skill in the art with respect to the
`’828 patent would have been comprised of a team and had either (i) a Ph.D. in
`pharmaceutical sciences, biomedical engineering, chemistry or a related field and 3‐4 years
`of experience in the development of pharmaceutical products including parenteral
`products, or (ii) a bachelors or masters degree in pharmaceutical sciences, biomedical
`engineering, chemistry or a related field and 4‐5 years of experience in the development of
`pharmaceutical products including parenteral products.
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`IV.
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`Scientific Background
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`16. I understand that the invention claimed by the ’828 patent is directed at a formulation of
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`tigecycline composition that is stable against chemical degradation. JA-1463 at col. 1:15–18;
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`JA-1464 at col. 4:49–51. Tigecycline is a broad spectrum antibiotic that is administered
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`intravenously. JA-1463 at col. 1:22–26, 46–48. The original tigecycline for injection
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`formulation of tigecycline included no excipients, and would have a pH of about 7.8 in solution.
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`Id. at col. 2:34–35. Unfortunately, tigecycline in a solution at its natural pH has the propensity to
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`degrade quickly through oxidation during manufacturing, storage, and administration. Id. at col.
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`2:23–28. The ’828 patent discloses compositions of tigecycline that are more stable than
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`previous formulations through the addition of a suitable carbohydrate—namely, lactose—and an
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`acid or buffer to reduce the pH to acidic levels. Id. at col. 1:11–14.
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`17. The invention claimed by the ’828 patent works by reducing two degradation
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`mechanisms. First, because tigecycline oxidizes relatively rapidly in solution when the pH of
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`4
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 7 of 24 PageID #: 886
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`that solution is slightly alkaline (having a pH greater than 7.0), the pH of the solution containing
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`tigecycline is lowered to an acidic level (less than about 7.0). JA-1464 at col. 4:56–57. The
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`disclosures of the ’828 patent are consistent with the understanding of the POOS regarding
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`oxidation of tetracyclines. I agree with Dr. Kirsch that tetracyclines were known to oxidize at
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`higher pH levels and that when the pH is reduced to the acidic range, oxidation is reduced. Pls.’
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`Reply Br., Ex. 1, Kirsch Dep. 19:12–20:7; 28:3–17; 73:4–8.1 The POOS would also know that
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`the lower the pH, the less likelihood there will be oxidation of the tetracycline compounds. Id.
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`18. However, when tigecycline is in an acidic solution, another degradation pathway
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`predominates: epimerization. JA-1463 at col. 2:49–50. The inventors of the ’828 patent
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`unexpectedly discovered that adding a suitable carbohydrate to acidic solutions with tigecycline
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`would reduce epimerization. JA-1464 at col. 4:57–59.
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`19. The pH level of a solution is a measure of its concentration of hydrogen ions, which
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`reflects its acidity. A more acidic solution will have a higher concentration of hydrogen ions and
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`a correspondingly low pH value. The lower the pH, the more acidic the solution; the higher the
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`pH, the more basic the solution. The pH scale ranges from 1 at the lowest and most acidic end to
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`14 at the highest and most basic end. A pH value of 7.0 is considered neutral. Because pH is a
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`measure of hydrogen ions, only solutions are said to have pH values, and a POOS would not
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`understand a solid as having a pH value.
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`20. In the formulation of an intravenous solution, different factors may affect the pH at
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`various stages. The pH of the solution depends on the formulation components, e.g. buffers and
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`acids and bases, and also on the vehicle used for reconstitution of the lyophilized powder or
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`when preparing the admixed solution from the reconstituted solution. In some cases, a
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`1 Excerpts from the transcript of the deposition of Dr. Kirsch are attached to Pfizer’s Reply Claim Construction Brief
`as Exhibit 1. For simplicity, I will hereinafter refer to that transcript as “Ex. 1, Kirsch Dep.”
`5
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 8 of 24 PageID #: 887
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`component or ingredient added to a composition will “disassociate,” which means that hydrogen
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`ions normally attached to the ingredient will detach and raise the concentration in the solution,
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`thereby lowering the pH level. In contrast, different ingredients may draw hydrogen ions from a
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`solution and thereby increase the pH level. A POOS would know that the pH of a solution is not
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`static and may change at any stage of the compounding, reconstitution, and admixture.
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`21. A POOS would know how to reconstitute a solution from a lyophilized cake, which is a
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`routine task in the creation of intravenous drugs. A POOS would also understand how to admix
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`a reconstituted solution prior to administration to a patient. I agree with Dr. Kirsch that a POOS
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`would know how to perform both of these tasks without requiring direction. Ex. 1, Kirsch Dep.
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`25:11–26:20; 107:2–108:23.
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`22. It is a simple matter for a POOS to measure the pH level of a solution. I agree with Dr.
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`Kirsch that such measurements are “fairly straightforward,” D.I. 53, Kirsch Decl. ¶ 22, “routine,”
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`that “pH measurements are made all the time,” and are “[c]ertainly within the knowledge and
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`skill” of a POOS, Ex. 1, Kirsch Dep. 25:11–26:20. The pH of a solution may be measured by
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`using digital measuring device, like that referenced by Dr. Kirsch. D.I. 53, Kirsch Decl. ¶ 22 &
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`Exhibit D.
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`23. Healthcare professionals do not ordinarily adjust the pH levels of solutions in the hospital
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`setting because they understand that the pH value has been confirmed to be within the
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`appropriate range in the laboratory setting.
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`24. Dr. Kirsch notes that “[f]or many organic compounds dissolved in aqueous solutions
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`even small changes in the pH of a solution can dramatically affect the chemical reactions that
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`occur within that solution,” and gives the example that an “increase in solution pH value of 0.1
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`in such a pH region could cause a 20% decrease in the shelf-life of the drug solution.” D.I. 53,
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`6
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 9 of 24 PageID #: 888
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`Kirsch Decl. ¶ 21. While that may be true for some solutions, there is no data in the ’828 patent
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`specification to suggest that tigecycline stability is drastically effected by small changes in pH.
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`The ’828 patent teaches a POOS that oxidation is decreased as pH levels are lowered. JA-1463
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`at col. 2:46–48 (“Indeed, it has been observed that tigecycline oxidative degradation does
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`decrease when the pH is lowered.”).
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`V.
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`Claim Term “pH of the composition in a solution is”
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`25. A POOS would interpret the term “pH of the composition in a solution is” as applying
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`independently to any of the three types of solutions disclosed in the ’828 patent specification:
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`the bulk, reconstituted, or admixed solutions. I disagree with Dr. Kirsch’s opinion that a POOS
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`would believe the patent requires that the bulk solution must always meet the claim limitations of
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`the ’828 patent, regardless of whether the solutions that follow do. D.I. 53, Kirsch Decl. ¶ 25.
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`As explained below, my conclusions rest on the claim language, the patent specification, and the
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`prosecution history as they would be understood by a POOS.
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`A.
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`Claim Language
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`26. The language of the ’828 patent claims do not limit the invention to a particular solution.
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`Claims 1, 4–5, 10–12, and 14–17 of the ’828 patent recite the term “pH of the composition in a
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`solution is.” JA-1469–70 at cols. 14:35–40, 45–48, 57–65; 15:2, 4, 7, 9. The remaining claims
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`depend from Claims 1 or 12. JA-1469–70 at cols. 14:41–44, 49–56, 66–67; 15:10–11; 16:1–10.
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`The various claims include pH ranges as limitations, including “between about 3.0 and about
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`7.0” (Claims 1 and 12), “between about 4.0 and about 5.0” (Claims 4 and 14), “between about
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`4.2 and about 4.8” (Claims 5 and 15), “between about 4.5 and about 6.0” (Claims 10 and 16),
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`and “between about 4.5 and about 5.5” (Claims 11 and 17).
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`27. The POOS would understand that within the context of the ’828 patent and lyophilized
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`formulations generally, there are three types of “solutions” that may be relevant. First, the ’828
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 10 of 24 PageID #: 889
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`patent discloses bulk solutions, which are created when the composition is first manufactured
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`and before it is lyophilized (freeze-dried). JA-1465 at col. 5:27–32. Second, it discloses
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`reconstituted solutions, which are solutions made when a lyophilized cake is reconstituted with a
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`pharmaceutically acceptable diluent. Id. at col. 5:41–43. Finally, the patent discloses admixed
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`solutions, which are those solutions further diluted for administration to a patient. Id. at col.
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`5:44–46. Dr. Kirsch agrees that the ’828 patent specification discloses these three types of
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`solutions. D.I. 53, Kirsch Decl. ¶ 24.
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`28. The term “pH of the composition in a solution” as used in the ’828 patent applies to any
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`of these three disclosed solutions independently of each other. None of the ’828 patent claims
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`limit the term to a particular solution. Dr. Kirsch agrees that “the language standing on its own
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`implicates any solution whatsoever,” D.I. 53, Kirsch Decl. ¶ 24; see also Ex. 1, Kirsch Dep.
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`44:20–45:18, and “there’s no limitation in Claim 1 when it refers to solution as to which of those
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`three solutions are implicated,” id. 41:3–8. Dr. Kirsch is right: the claim language itself would
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`be understood by the POOS to apply to any “solution” that met the requirements of the claims.
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`29. At his deposition, Dr. Kirsch cited Claim 2—which recites “[t]he composition of claim 1
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`wherein the composition is lyophilized,” JA-1469 at col. 14:41–42—in support of his opinion
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`that Claim 1 applies only to the bulk solution. He concluded that Claim 2 implies that the
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`“solution” in Claim 1 be the bulk solution. Ex. 1, Kirsch Dep. 61:23–62:6. I disagree because
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`Claim 1 is broader in scope than Claim 2 in that, while Claim 2 may only implicate a solution
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`that is subsequently lyophilized, Claim 1 on its own (without Claim 2) applies to any solution.
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`Dr. Kirsch agrees that the language of Claim 1 applies to all three solutions, D.I. 53, Kirsch Decl.
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`¶ 24; Ex. 1, Kirsch Dep. 44:20–45:18, and further agrees that Claim 1 is broader in scope than
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`Claim 2, id. 63:24–64:1.
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 11 of 24 PageID #: 890
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`B.
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`Patent Specification
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`30. A POOS would understand that the ’828 patent specification is consistent with, and
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`supports, the term “pH of the composition in a solution” applying independently to all three
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`solutions in the patent. As I explain below, there are four primary reasons a POOS would read
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`the specification this way: (1) the specification language states that each solution is
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`independently a “composition of the invention,” (2) Dr. Kirsch’s citations to the contrary are not
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`limiting and are consistent with my interpretation, (3) the prosecution history of a related patent
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`is also consistent with my construction, and (4) the purpose of the invention is to provide for
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`stability in reconstituted and admixed solutions.
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`1.
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`Specification Language
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`31. The ’828 patent specification does not limit the term “pH of the composition in a solution
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`is” to a particular solution. Nowhere does the specification expressly define the term by
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`reference to the bulk solution, nor is there specific language that directs a POOS to understand
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`that the term “solution” as it is used in the claims means only the bulk solution.
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`32. The ’828 patent specification discusses all three solutions as “compositions of the
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`invention.” In particular, the specification states: “The compositions of the invention include
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`solutions, such as those prepared prior to lyophilization, containing tigecycline, a suitable
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`carbohydrate, and an acid or buffer.” JA-1465 at col. 5:27–29. A POOS would understand that
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`language to apply to the bulk solution, but because of the words “such as” and “include” would
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`also understand that “compositions of the invention” are not limited to the bulk solution.
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`33. Consistent with that interpretation, the specification later states: “Compositions of the
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`invention also include solutions made from the lyophilized powder or cake by, for example,
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`reconstitution with saline or other pharmaceutically acceptable diluents.” JA-1465 at col. 5:41–
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`44. A POOS would understand from this language that the invention includes reconstituted
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`9
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 12 of 24 PageID #: 891
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`solutions. In addition, a POOS would recognize that the words “also include” mean that the
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`reconstitution solution is an independent composition of the invention from the bulk solution. A
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`POOS would further know that there is no language requiring that the reconstituted solutions
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`discussed be derived from bulk solutions that were within the claimed pH ranges.
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`34. The ’828 patent specification also states: “Compositions of the invention further include
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`solutions resulting from diluting those reconstituted solutions with pharmaceutically acceptable
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`diluents for use in intravenous bags.” JA-1465 at col. 5:44–47. A POOS would know from this
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`language that the invention includes admixed solutions, and that the words “further include”
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`mean that the admixed solution is an independent composition of the invention from the bulk and
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`reconstituted solutions discussed earlier. A POOS would understand that there is no language
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`requiring that the admixed solutions be derived from reconstituted solutions that were derived
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`from bulk solutions that were within the claimed pH ranges. The specification identifies the
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`admixed solution as independent from the bulk and reconstitution solutions in other places. Id.
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`at col. 6:59–61 (“Once admixed, the tigecycline solution is ready for patient administration.”).
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`35. I conclude that a POOS would understand the specification to explain that all three
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`solutions are independently compositions of the invention. Nowhere is the term “solution”
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`limited as Dr. Kirsch suggests.
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`2.
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`The Specification Does Not Support Dr. Kirsch’s Opinion
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`36. Dr. Kirsch commits a number of errors in forming his opinion that “a person of ordinary
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`skill in the art would understand that with respect to the pH, the patent is asserting that the
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`preferred properties of improved stability occur when the product had a pH in the bulk solution
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`within the ranges recited in the claims (as well as other recited components),” D.I. 53, Kirsch
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`Decl. ¶ 43, and a POOS would reject his opinion as incorrect.
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`10
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`Case 1:14-cv-00781-SLR Document 61 Filed 07/15/15 Page 13 of 24 PageID #: 892
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`37. First, Dr. Kirsch cites as support for his opinion that the invention is better at achieving
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`stability “when dissolved, lyophilized, reconstituted, and/or diluted than compositions of
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`tigecycline not made according to the invention.” JA-1463 at col. 1:18–21. He opines that
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`because “a compound cannot be reconstituted and further diluted without first having been
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`dissolved in the bulk solution and lyophilized,” that this means the specification requires that
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`“the claimed compositions are the result of the manufacturing process.” D.I. 53, Kirsch Decl.
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`¶ 26. In my opinion, a POOS would understand the language Dr. Kirsch cites to mean exactly
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`the opposite. Because it uses an “and/or” between the different stages of the invention, a POOS
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`would understand that sentence to mean that the claims can apply independently to the dissolved,
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`lyophilized, reconstituted, or diluted compositions of the invention. This passage also does not
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`require the bulk solution to be within a specific pH range. So even though a reconstituted
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`solution must first be lyophilized (and an admixed solution first be reconstituted), that would not
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`mean the bulk solution had to be within the claimed pH range.
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`38. Second, Dr. Kirsch cites the specification language that states “[b]y lyophilizing an
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`aqueous solution containing tigecycline and a suitable carbohydrate at an acidic pH, we have
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`prepared tigecycline compositions that are more stable against both oxidative degradation and
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`epimerization than existing compositions. Because the pH is acidic, oxidative degradation has
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`been minimized.” JA-1464 at col. 4:52–57. From that, he concludes that the “present invention .
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`. . requires that the pH limitation be met before lyophilization.” D.I. 53, Kirsch Decl. ¶ 29. In
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`my opinion, the language does not support that conclusion, because it only discusses acidic
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`solutions; it nowhere mentions that the bulk solution must be within the specific pH ranges
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`claimed. As discussed in more detail below, a POOS would not understand the patent to
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`foreclose the possibility that solutions reconstituted and admixed from a bulk solution that is
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`more acidic than the claimed ranges could infringe.
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`39. Third, Dr. Kirsch in his declaration interprets “[s]uch compositions are also expected to
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`possess reconstitution and admixture stability times greater than that of existing compositions,”
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`JA-1464 at col. 4:63–65, to refer to the lyophilized state mentioned in the prior sentence, D.I. 53,
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`Kirsch Decl. ¶ 30. I understand that at his deposition, Dr. Kirsch agreed that the term “[s]uch
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`compositions” actually refers to the phrase “[c]ompositions of the invention,” Ex.1, Kirsch Dep.
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`80:6–14, and that “compositions of the invention” includes all three solutions disclosed in the
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`specification, id. 51:19–52:3; 52:14–23 (reconstituted solutions); 54:2–6 (admixed solutions). I
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`agree that a POOS would read the language “[s]uch compositions” to refer in whole to
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`“[c]ompositions of the invention,” rather than only to the lyophilized state of the invention. That
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`interpretation is also consistent with the specification’s disclosure that compositions of the
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`invention include bulk, reconstituted, and admixed solutions. JA-1465 at col. 5:27–29, 41–47.
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`40. Fourth, Dr. Kirsch cites the specification’s description of various compositions of the
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`invention, JA-1465 at col. 5:27–29, 41–47, as support for his opinion that “reconstituted
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`solutions and admixtures can be compositions of the invention – as long as they are derived from
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`a lyophilized cake derived from a bulk solution meeting the claim limitations.” D.I. 53, Kirsch
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`Decl. ¶ 31. I disagree with his conclusion because nowhere in that description does the
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`specification require that the reconstituted or admixed solutions that are “compositions of the
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`invention” be linked to a bulk solution that itself met the claimed pH ranges. And Dr. Kirsch
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`agrees that this part of the specification does not define a required pH range, Ex. 1, Kirsch Dep.
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`54:12–23, and that earlier in the same column of the specification, the patent clarifies that the
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`ranges about 3.0 to about 7.0, about 4.0 to about 5.0, and about 4.2 to about 4.8 were from “one
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`embodiment,” id. 80:25–81:16. Rather, the specification language Dr. Kirsch cites is consistent
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`with the understanding that bulk, reconstituted, and admixed solutions can independently
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`infringe the ’828 patent pH ranges.
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`41. Fifth, Dr. Kirsch relies on a procedure for making the claimed invention as evidence that
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`the patent requires the bulk solution meet the claimed pH ranges. D.I. 53, Kirsch Decl. ¶ 32. A
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`POOS would not agree with Dr. Kirsch’s conclusion because, in connection with the disclosed
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`method, the specification explains: “Compounds of the invention may be prepared via a number
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`of acceptable methods. The methods described below are exemplary and not meant to limit the
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`invention.” JA-1465 at col. 6:6–8. A POOS would understand that the procedure described does
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`not limit the invention. Dr. Kirsch testified at his deposition that a POOS would believe that this
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`explanation—that the methods do not limit the invention—was “added by a patent attorney,”
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`Ex. 1, Kirsch Dep. 68:5–9, and was intended to be ambiguous and indefinite, id. 68:24–69:13.
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`To the extent Dr. Kirsch is suggesting that the POOS would ignore the plain language of the
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`patent, or place less value on certain language because the POOS perceived it to have been
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`written by a lawyer, I disagree. A POOS would consider all the language of the specification as
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`important to understanding the invention. A POOS would also understand that the ’828
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`invention could be made in other ways. For those reasons, I conclude that the procedure relied
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`on by Dr. Kirsch does not limit the term “solution” to the bulk solution.
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`42. Sixth, Dr. Kirsch cites to the examples at the end of specification to support his opinion,
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`D.I. 53, Kirsch Decl. ¶¶ 33–35, 40, but, again, a POOS would not understand these examples to
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`limit the invention. The specification includes a condition that “[t]he following six examples
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`illustrate various embodiments of the invention and are not intended to limit the invention in any
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`way.” JA-1465 at col. 6:63–65. A POOS would not have ignored specific language stating that
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`examples do not limit the invention. I agree with Dr. Kirsch that the examples would not act as
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`limitations on the claims in isolation. Id. 90:8–24. For that reason, this language shows that a
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`POOS would not understand the examples to restrict “solution” in the claims to the bulk solution.
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`43. Seventh, Dr. Kirsch concludes that because “two control samples” in Example 1 did not
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`have pH adjustments—unlike the compositions of the invention against which they were
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`compared—this supports his opinion that compositions of the invention must be within the
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`claimed pH ranges. D.I. 53, Kirsch Decl. ¶ 34. The controls are not “compositions of the
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`invention” because, regardless of specific pH levels, they did not include an acid or buffer as
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`required by all the claims of the ’828 patent. Dr. Kirsch agrees that the controls lack an acid or
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`buffer and therefore are not “compositions of the invention regardless of what the pH was in
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`those formulations.” Ex. 1, Kirsch Dep. 92:2–7. The inference Dr. Kirsch draws is thus
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`unsupported: by referring to these solutions as “controls,” the inventors were not commenting
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`on whether a specific pH was required for the bulk solution. In addition, it is also my opinion
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`that a POOS would not connect the unaltered pH range of the controls with the term “solution”
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`in the claims and conclude that the compositions that are adjusted must necessary fall within the
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`claimed pH ranges. Again, the specification expressly says that the examples do not limit the
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`invention. JA-1465 at col