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UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`COALITION FOR AFFORDABLE DRUGS VI LLC
`Petitioner,
`
`v.
`
`CELGENE CORPORATION
`Patent Owner
`
`________________
`
`Case IPR2015-01102
`Patent 6,315,720
`________________
`
`DECLARATION OF JOSEPH T. DIPIRO, PHARM.D.
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`
`
`
`
`
`
`
`
`
`Case IPR2015-01102
`
`CELGENE EXHIBIT 2060
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`Page 1 of 86
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`TABLE OF CONTENTS
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`I.
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`QUALIFICATIONS ........................................................................................ 1
`
`II. MATERIALS CONSIDERED ........................................................................ 3
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`III. LEGAL STANDARDS ................................................................................... 3
`
`IV. PERSON OF ORDINARY SKILL IN THE ART .......................................... 4
`
`V.
`
`BACKGROUND ............................................................................................. 5
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`VI. THE CLAIMED METHODS WOULD
`NOT HAVE BEEN OBVIOUS ....................................................................... 8
`
`A.
`
`B.
`
`There was not a known need or problem to be
`solved at the time of the ’720 patent’s inventions ............................... 8
`
`The asserted references do not disclose, teach,
`or suggest every element of the claimed inventions ........................... 11
`
`1.
`
`2.
`
`Claim Construction ................................................................... 11
`
`Scope and Content of the Prior Art ........................................... 14
`
`(a)
`
`Powell ............................................................................. 14
`
`(b) Dishman .......................................................................... 17
`
`(c) Cunningham .................................................................... 20
`
`(d) Mundt .............................................................................. 23
`
`3.
`
`Differences between the
`claimed inventions and the prior art ......................................... 24
`
`(a)
`
`Independent Claims 1 and 28 ......................................... 24
`
`i.
`
`Dishman would not have
`disclosed, taught, or suggested the
`claimed prescription approval code ..................... 25
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`ii.
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`Cunningham would not have
`disclosed, taught, or suggested the
`claimed prescription approval code ..................... 27
`
`(b) Dependent Claims 2-27 and 29-32 ................................. 30
`
`i.
`
`ii.
`
`Claims 5 and 6 ...................................................... 30
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`Claim 10 ............................................................... 37
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`iii. Claim 17 ............................................................... 38
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`C. A POSA would not have been motivated
`to combine the asserted references ...................................................... 40
`
`1.
`
`2.
`
`A POSA would not have been motivated to
`combine Cunningham, Dishman, and Powell ........................... 41
`
`A POSA would not have been motivated to
`combine Mundt with Dishman or Powell ................................. 45
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`VII. SUPPLEMENTAL OR AMENDED OPINIONS ......................................... 46
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`I, Joseph T. DiPiro, Pharm.D., hereby declare and state as follows:
`
`1.
`
`I submit this declaration on behalf of Celgene Corporation
`
`(“Celgene”), Patent Owner of U.S. Patent No. 6,315,720 (the “’720 patent”) in
`
`connection with this inter partes review, Case IPR2015-1102, filed by Coalition
`
`for Affordable Drugs VI LLC (“CFAD”). I understand that CFAD presented only
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`one “Ground” of unpatentability in its Petition, and that the Patent Office instituted
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`that Ground. As such, my declaration is a full response to the opinions set forth in
`
`the declaration of Jeffrey Fudin, R.Ph., Pharm.D., DAAPM, FCCP, FASHP (Ex.
`
`1027).
`
`I.
`
`QUALIFICATIONS
`
`2.
`
`I have been a registered pharmacist for nearly 38 years. I am
`
`currently Dean and the Archie O. McCalley Chair and Professor at Virginia
`
`Commonwealth University School of Pharmacy.
`
`3.
`
`Prior to holding my current position, I was Executive Dean and
`
`Professor at South Carolina College of Pharmacy, the University of South
`
`Carolina, and the Medical University of South Carolina. Before that, I held
`
`various academic positions at the University of Georgia College of Pharmacy
`
`including Assistant Dean, Head of the Department of Clinical and Administrative
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`Sciences, and Professor of Pharmacy. I also held various academic positions at the
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`Medical College of Georgia, including Assistant Dean for Pharmacy Programs and
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`Director of Surgical Research. In addition, I also worked for nearly twenty years
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`as a research investigator with the Veterans Administration Medical Center in
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`Augusta, Georgia. A full description of my work history is provided in my
`
`curriculum vitae, a copy of which is attached hereto as Exhibit 1.
`
`4.
`
`I received a Bachelor of Science degree in pharmacy from the
`
`University of Connecticut in 1978, and a Doctorate in Pharmacy from the
`
`University of Kentucky, College of Pharmacy in 1981. While obtaining my
`
`doctorate degree, I spent three years of residency at the Albert B. Chandler
`
`Medical Center, Lexington, Kentucky. In 1990, I completed one year of
`
`postdoctoral research in clinical immunology at Johns Hopkins University. A full
`
`description of my formal education is provided in my curriculum vitae.
`
`5.
`
`I have given over 100 presentations in the field of pharmacy. I am the
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`author or co-author of over 130 papers, over 25 book chapters, and 39 books in the
`
`field of pharmacy. I am also the author of numerous letters and book reviews
`
`concerning various aspects of pharmacy, which are described in my curriculum
`
`vitae.
`
`6.
`
`I was the editor of the American Journal of Pharmaceutical Education,
`
`which is the primary journal of pharmacy education in the U.S., from 2002 to
`
`2014. I am also the President-elect of the American Association of Colleges of
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`Pharmacy.
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`7.
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`I am an expert in the practice of pharmacy, including the education
`
`and training of pharmacists.
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`II. MATERIALS CONSIDERED
`
`8.
`
`I have reviewed CFAD’s Petition for inter partes review regarding the
`
`’720 patent, as well as Dr. Fudin’s supporting declaration (Ex. 1027). A list of any
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`additional materials that I have reviewed in connection with the preparation of this
`
`declaration is attached as Exhibit 2.
`
`III. LEGAL STANDARDS
`
`9.
`
`I have been advised by counsel for Celgene of the following legal
`
`standards and set forth my opinions in the context of these standards.
`
`10.
`
`I understand that a patent claim may be invalid under 35 U.S.C. § 103
`
`if the claim, when considered as a whole, would have been obvious to a person of
`
`ordinary skill (“POSA”) as of the date of the claimed invention. For the purposes
`
`of the obviousness analysis in this report, I have been asked to use October 23,
`
`2000 as the date of invention.
`
`11.
`
`I understand that the obviousness analysis is objective, and requires
`
`consideration of: (1) the scope and content of the prior art; (2) the differences
`
`between the prior art and the claims at issue; (3) the level of ordinary skill; and (4)
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`secondary considerations of nonobviousness.
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`12.
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`I understand that for a claim to be obvious, there must be some
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`teaching or suggestion in one or more prior art references of each and every
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`element of the claim.
`
`13.
`
`I also understand that a patent claim that has several elements is not
`
`proved obvious merely by demonstrating that each of its individual elements was
`
`individually known in the prior art. Instead, I understand that in order to prove
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`obviousness, there must be a showing that a POSA, as of the date of the invention,
`
`would have had a reason or motivation to combine two or more references or
`
`modify a reference to achieve the claimed invention as a whole.
`
`14.
`
`I also understand that if in an invention achieves more than a
`
`predictable result, then it is nonobvious.
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`IV. PERSON OF ORDINARY SKILL IN THE ART
`
`15. Dr. Fudin opined that “[a] POSA in pharmaceutical prescriptions as of
`
`October 23, 2000 (the earliest possible priority date of the ’720 Patent) would
`
`typically have either a Pharm.D. or a B.S. in pharmacy with approximately 5-10
`
`years of experience and a license to practice as a registered pharmacist in any one
`
`or more of the United States.” Ex. 1027 ¶ 16.
`
`16. For the purposes of this declaration, I am not offering any definition
`
`of a POSA. Instead, I have been asked to assume that Dr. Fudin’s definition of a
`
`POSA is correct and to offer my opinions through the eyes of that POSA. As such,
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`any use of the word POSA in this declaration refers to Dr. Fudin’s definition of a
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`POSA.
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`17.
`
`I note, however, that Dr. Fudin testified that his POSA would not have
`
`been capable of designing or implementing the claimed systems of the ’720 patent
`
`Ex. 2061 at 193:12-194:10, 201:1-10; 246:17-247:2, 328:19-329:9. On this point,
`
`I agree with Dr. Fudin. In my opinion, someone with Dr. Fudin’s POSA’s
`
`qualifications would have very little, if any, experience with restricted distribution
`
`systems, such as those claimed in the ’720 patent. They would certainly not be
`
`able to design or implement such systems. My opinion is based on my 38 years of
`
`experience in the field, including both work and teaching experience.
`
`V. BACKGROUND
`
`18. By July 1998, thalidomide was a well-known teratogen. See Ex. 1006
`
`at 901. Thalidomide was marketed in Europe in the late 1950s and early 1960s as
`
`a sedative and a treatment for pregnant women with morning sickness. Ex. 1001 at
`
`1:39-45; Ex. 2002 at 1. Tragically, thalidomide caused severe malformations in
`
`children of mothers who took the drug. Ex. 1001 at 1:39-45; Ex. 2002 at 1. The
`
`FDA refused to approve thalidomide in the early 1960s, preventing a similar result
`
`in the United States. See Ex. 2067.
`
`19. Thalidomide remained unlawful in the United States until Celgene
`
`introduced Thalomid® in 1998. Ex. 1031 at 0002-3. When the FDA finally
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`approved Thalomid®, it did so based on the condition that it would be distributed
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`pursuant to S.T.E.P.S.® (Ex. 1031 at 0002-3), which is covered by the methods
`
`claimed in the ’50l patent. Ex. 2061 at 377: 19-37811.
`
`20.
`
`The ’720 patent was filed in October 2000. Ex. 1001 at Cover. At
`
`that time, in October 2000, S.T.E.P.S.® had proven 100% successful in preventing
`
`birth defects of the type associated with thalidomide.—
`
`
`
`—Dr. Fudin confirmed this at his deposition. Ex.
`
`2061 at 380:6—38l:2.
`
`21.
`
`In my opinion, as described below, nothing in the prior art taught or
`
`even suggested that there was any problem with S.T.E.P.S.® that needed to be
`
`addressed, for thalidomide or for any other drug. Nevertheless, I understand from
`
`counsel for Celgene that the ’720 patent’s inventors (both employees of Celgene)
`
`developed the methods claimed in the ’720 patent, based on confidential
`
`information, as part of the development of Enhanced S.T.E.P.S.® -
`
`— Enhanced S.T.E.P.S.® was implemented for the first time with
`
`the September 2001 Thalomid® labeling change. Ex. 2008; Ex. 2009 at 4.
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`23.
`
`Indeed, as the ’720 patent describes, improvements were made “to
`
`minimize and simplify the demands on the pharmacy, thereby improving
`
`compliance with the system of distribution, and reducing the risk that the drug will
`
`be dispensed to a contraindicated individual.” Ex. 1001 at 2:8-12. As stated in the
`
`’720 patent’s specification, “it has surprisingly been found that by having the
`
`prescriber, rather than the pharmacy, verify the patient’s informed consent,”
`
`increased efficiency, led to “better compliance, and hence decreased risk that the
`
`adverse side effect will occur.” Ex. 1001 at 10:35-40.
`
`24. The inventors effectuated these changes through the claimed
`
`prescription approval code. The ’720 patent describes that to comply with the
`
`methods described therein, the pharmacist “need only retrieve the approval code.”
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`Ex. 1001 at 13:55-64; see also Ex. 1002 at 0085 (“[W]hen the patient presents a
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`prescription to the pharmacy, all the registered pharmacy need do is consult the
`
`computer readable storage medium, and the pharmacy is permitted to dispense the
`
`drug upon successfully retrieving a prescription approval code therefrom.”).
`
`VI. THE CLAIMED METHODS WOULD NOT HAVE BEEN OBVIOUS
`
`A. There was not a known need or problem to be solved
`at the time of the ’720 patent’s inventions
`
`25. Dr. Fudin opined that a POSA would have been motivated to arrive at
`
`the claimed methods because a POSA was allegedly motivated to combine “prior
`
`art restricted drug distribution methods, including counseling-based avoidance of
`
`pregnancy, and a computerized tracking system that allows only registered access
`
`to prescriptions when certain condition [sic] (e.g., non-pregnancy) are met.” Ex.
`
`1027 ¶ 59. I disagree. In my opinion, there was no known need or problem at the
`
`time of the ’720 patent’s inventions that would have motivated a POSA to arrive at
`
`the ’720 patent’s claims.
`
`26. My opinion is supported by the fact that the program Dr. Fudin
`
`alleged a POSA would have desired to arrive at already existed. This program was
`
`S.T.E.P.S.® CFAD acknowledged this in its Petition in co-pending IPR2015-
`
`01096. IPR2015-01096, Paper 1 at 14 (admitting that Zeldis described S.T.E.P.S.®
`
`as such a program).
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`27.
`
`As Dr. Fudin acknowledged, at the time of the ’720 patent’s
`
`inventions, in October 2000, S.T.E.P.S.® had proven 100% successful in
`
`preventing thalidomide—related birth defects. Ex. 2061 at 380:6—38l:2; see also Ex.
`
`2068‘1[7-
`
`_
`
`
`
`28.
`
`In my opinion, Dr. Fudin has not identified any reason to modify or
`
`improve upon S.T.E.P.S.® To the contrary, as Dr. Fudin agreed, S.T.E.P.S.® had
`
`proven to be 100% effective from its launch in July 1998 up through (and after) the
`
`filing of the ’720 patent in October 2000. Ex. 2061 at 239:23—240:l 1; see also Ex.
`
`2068 ‘][ 7. He also agreed that there was nothing in the prior art to suggest that
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`S.T.E.P.S.® had problems that required any improvements. Ex. 2061 at 380:6-
`
`38l:2, 38l:l8—382:l2; 455211-15.
`
`29.
`
`In my opinion, a POSA would need to have had a reason to seek to
`
`improve S.T.E.P.S.® I understand that Dr. Fudin testified that a POSA would have
`
`sought to expand S.T.E.P.S.® to include isotretinoin, clozapine, and “future drugs .
`
`.
`
`. which we don’t even know what they are.” Ex. 2061 at 38123-15, 590: 15-59229.
`
`I disagree.
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`30. My opinion is supported by the fact that, as of October 2000, both
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`isotretinoin and clozapine were already being distributed pursuant to restrictions
`
`imposed by the manufacturers. Further, Dr. Fudin testified that both distribution
`
`systems were successful. Id. at 209:14-24 (Dr. Fudin opining that the Accutane
`
`PPP was a “tremendous success”), 235:15-236:9 (Dr. Fudin opining that it was
`
`“common knowledge” that the clozapine distribution systems should be copied for
`
`thalidomide), 565:10-566:17 (Dr. Fudin testifying that Zeldis confirmed the
`
`success of the isotretinoin and clozapine distribution systems).
`
`31. My opinion is also supported by the fact that a POSA would not seek
`
`to develop a restricted distribution system for “future drugs . . . which we don’t
`
`even know what they are,” as Dr. Fudin alleged. Ex. 2061 at 590:15-592:9. I note
`
`at the outset that, in my opinion, Dr. Fudin’s POSA would not have been interested
`
`in developing restricted distribution systems at all. And even if Dr. Fudin’s POSA
`
`would have been interested, they would have lacked the necessary skill set. Even
`
`if Dr. Fudin’s POSA were interested and sufficiently skilled, they would still need
`
`to first know what drug they were dealing with. In my opinion, if a POSA did not
`
`know the drug they were dealing with, a POSA could not even begin to think of
`
`how the drug’s distribution should be restricted.
`
`32. Finally, my opinion is supported by the fact that even taking into
`
`consideration Dr. Fudin’s alleged general motivation, he still provided no
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`motivation to arrive at the specifically claimed inventions, in particular, the
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`claimed prescription approval code. In my opinion, no such motivation existed as
`
`of the ’720 patent’s inventions.
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`B.
`
`33.
`
`The asserted references do not disclose, teach,
`or suggest every element of the claimed inventions
`
`1.
`
`Claim Construction
`
`I have been advised by counsel for Celgene that, in this proceeding,
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`claims are given their broadest reasonable interpretation in light of the patent’s
`
`intrinsic record, including the record of how the applicants obtained the patent in
`
`front of the Patent Office (i.e., the patent’s prosecution history).
`
`34. Dr. Fudin proposed constructions for three claim terms: “consulted”;
`
`“teratogenic effect”; and “adverse side effect.” Ex. 1027 ¶¶ 37-42. These terms do
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`not affect my opinions.
`
`35.
`
`I do explain, however, how a POSA would understand the phrase
`
`“prescription approval code” in the context of the ’720 patent and its prosecution
`
`history.
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`36.
`
`In my opinion, a POSA reviewing the intrinsic record would
`
`understand the phrase “prescription approval code” to mean: a code representing
`
`that an affirmative risk assessment has been made based upon risk-group
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`assignment and the information collected from the patient, and that is generated
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`only upon a determination that the risk of a side effect occurring is acceptable.
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`37. Based on a review of the prosecution history, it is clear that the
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`applicants successfully distinguished their invention over the prior art by using
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`“prescription approval code” in this manner. Specifically, the Patent Office had
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`rejected the ’720 patent’s claims, finding that the Boyer reference (Ex. 1005)
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`disclosed the claimed prescription approval code. The Patent Office stated that
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`Boyer “teaches a method of an automated pharmacy system … that improves
`
`prescription processing,” and that it would have been obvious to use that
`
`automation, “which includes a step for generating a prescription number or code
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`associated with said prescription by a computer workstation.” Ex. 1002 at 0091-
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`92. The applicants responded:
`
`Claim 1 further requires an assessment, based upon the
`
`risk group assignment and the information collected from
`
`the patient, as to whether the risk of the side effect
`
`occurring is acceptable. Upon a determination that the
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`risk is acceptable, and only upon such a determination, a
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`prescription approval code is generated, which must be
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`retrieved by the pharmacy before the prescription may be
`
`filled. Thus, the prescription approval code is not merely
`
`a number that is associated with the prescription, but
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`instead represents the fact that a determination has been
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`made that the risk of the side effect occurring is
`
`acceptable, and that approval—an affirmative decision—
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`has been made for the prescription to be filled.
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`Ex. 1002 at 0106-107 (emphasis original).
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`38. The applicants argued that “Boyer does not disclose or suggest such
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`an approval code.” Id. at 0107. Indeed, the applicants noted that Boyer’s code “is
`
`simply an identifier for the prescription, and is not an approval code, as recited in
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`Applicants’ claims.” Id. (emphasis original). Thus, the applicants defined
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`“prescription approval code” during prosecution to mean: a code representing that
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`an affirmative risk assessment has been made based upon risk-group assignment
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`and the information collected from the patient, and that is generated only upon a
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`determination that the risk of a side effect occurring is acceptable.
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`39. Based on the distinction drawn between the claimed prescription
`
`approval code and a numerical code that is associated with a prescription, it is my
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`opinion that Dr. Fudin’s opinion—that the claimed prescription approval code is
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`just a number and could even be a credit card—is not reasonable. Ex. 2061 at
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`432:21-24.
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`40.
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`It is my opinion that “prescription approval code” means: a code
`
`representing that an affirmative risk assessment has been made based upon risk-
`
`group assignment and the information collected from the patient, and that is
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`generated only upon a determination that the risk of a side effect occurring is
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`acceptable. I apply this definition in my opinions below.
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`2.
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`Scope and Content of the Prior Art
`
`41.
`
`I understand that the Petition is premised on thirteen references:
`
`Powell, Dishman, Cunningham, Mundt, Mann, Vanchieri, Shinn, Linnarsson,
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`Grönroos, Soyka, Hamera, Kosten, and Menill. I address only Powell, Dishman,
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`Cunningham, and Mundt in this declaration as these are the only references that
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`Dr. Fudin has relied upon for the opinions I respond to. In my opinion, Powell,
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`Dishman, Cunningham, and Mundt each fail to disclose many, if not all, of the
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`elements of the ’720 patent’s claims, and also fail to provide any motivation to
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`combine the references with one another.
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`(a) Powell
`
`42. Powell is entitled “Guideline for the clinical use and dispensing of
`
`thalidomide.” Ex. 1006 at 901. Powell contains “recommendations” for providing
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`thalidomide to patients in the United Kingdom under “named patient” legislation,
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`which allowed prescriptions that were not approved in the UK at that time, such as
`
`thalidomide, to be administered to patients. Ex. 1006 at 901.
`
`43. Powell does not mention the clozapine distribution systems, despite
`
`being published after those systems were disclosed in the literature. See generally
`
`Ex. 1006. Dr. Fudin acknowledged this fact during his deposition. Ex. 2061 at
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`262:1-11. In my opinion, this undermines any argument that a POSA would have
`
`been motivated to combine Powell with Dishman (which discusses clozapine
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`distribution systems). In my opinion, if a POSA would have been motivated to
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`combine Powell and Dishman, then Powell would have at least mentioned the
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`clozapine distribution systems. It did not.
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`44. Moreover, it is my opinion that Powell does not disclose several
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`elements of the ’720 patent claims. I understand from counsel that any discussion
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`of elements in claim 1 or claim 28 applies equally to all claims of the ’720 patent
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`because claims 2-27 and 29-32 depend from claims 1 and 28.
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`45. First, Powell does not disclose the claimed prescription approval
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`code, as required by claims 1.e. and 28.e. See generally Ex. 1006. My opinion is
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`supported by the clear disclosures of Powell, which fail to disclose the generation
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`of any code, let alone the claimed prescription approval code. Further, Dr. Fudin
`
`confirmed that Powell does not disclose the claimed prescription approval code at
`
`his deposition. Ex. 2061 at 271:23-272:19; 420:10-14.
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`46. Second, Powell does not disclose that the informed consent is verified
`
`by the prescriber at the time the patient is registered in the computer readable
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`storage medium, as required by claims 5 and 6. See generally Ex. 1006. My
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`opinion is supported by the fact that Powell does not mention registries, and also
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`does not mention keeping any information in, or retrieving any information from,
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`any computer readable storage medium. See generally Ex. 1006. Dr. Fudin
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`acknowledged these facts at his deposition. Ex. 2061 at 261:18-25. Thus, Powell
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`cannot disclose registering patients in a computer readable storage medium and,
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`therefore, cannot disclose the prescriber verifying informed consent at the time of
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`patient registration.
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`47. My opinion is also supported by the fact that Powell does not disclose
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`that there is any verification of the informed consent, let alone that the prescriber
`
`does it. See generally Ex. 1006. In my opinion, if any verification of informed
`
`consent is completed, it is done by the manufacturer. Indeed, Powell teaches that
`
`the supplier must verify information, including patient information, before it
`
`dispenses thalidomide to hospitals on a “named patient” basis. Id. at 904. Powell
`
`teaches that the prescriber, on the other hand, only gives the patient “an
`
`information sheet” and counseling. Id. at 902.
`
`48. Third, Powell does not disclose genetic testing, as required by claim
`
`10. See generally Ex. 1006. My opinion is supported by the fact that Powell is
`
`entirely silent on genetic testing, despite mentioning other types of testing such as
`
`pregnancy testing and peripheral neuropathy testing. Ex. 1006 at 901-02.
`
`49. Fourth, Powell does not disclose conducting surveys telephonically
`
`using an integrated voice response (“IVR”) system to obtain information regarding
`
`a patient’s behavior and compliance with the claimed risk avoidance measures, as
`
`required by claim 17. See generally Ex. 1006. My opinion is supported by the fact
`
`that Powell does not disclose any surveys at all. See generally Ex. 1006.
`
`- 16 -
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`Page 19 of 86
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`

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`
`
`(b) Dishman
`
`50.
`
` Dishman is entitled “Pharmacists’ role in clozapine therapy at a
`
`Veterans Affairs medical center.” Ex. 1007 at 899. Dishman describes a program
`
`in which specialized pharmacists play an active role in treating veterans with the
`
`psychoactive drug clozapine. See Ex. 1007 at 899. More particularly, Dishman is
`
`focused on the role of “pharmacists with specialized training in
`
`psychopharmacology” in clozapine therapy for patients in a specific VA hospital in
`
`San Diego, and that hospital’s interactions with the VA’s National Clozapine
`
`Coordinating Center (“NCCC”). See Ex. 1007 at 899. As such, it is my opinion
`
`that Dishman focuses on a narrow universe, i.e., one hospital within the VA
`
`system.
`
`51. The NCCC is a physical location where physicians “review each
`
`clozapine candidate’s file before granting approval for use and review weekly
`
`tracking sheets that report patient status.” Ex. 1007 at 900. In short, the NCCC is
`
`responsible for VA clozapine therapy. Ex. 1007 at Abstract.
`
`52. Dishman further teaches that the specialized pharmacists have broad
`
`responsibilities for VA clozapine therapy. For example, the specialized pharmacist
`
`is responsible for screening potential clozapine patients and providing physicians
`
`at the NCCC with information before treatment is permitted. Ex. 1007 at 900.
`
`- 17 -
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`Page 20 of 86
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`

`
`
`
`“After NCCC approval, the pharmacist enrolls the patient into the hospital’s
`
`clozapine tracking system, and clozapine therapy is begun.” Ex. 1007 at 900.
`
`53.
`
`In my opinion, Dishman does not discuss the broader scope of
`
`restricted distribution addressed by the ’720 patent, which is not limited to a single
`
`institutional setting. In my opinion, a POSA would have understood that an article
`
`focused on specialized pharmacists’ role in clozapine therapy for veterans in a
`
`single institutional setting is irrelevant to the claimed inventions. My opinion is
`
`supported by the fact that neither restricted distribution nor regulating
`
`pharmaceutical prescriptions are included in Dishman’s “index terms.” See Ex.
`
`1007 at 899. In my opinion, these facts undermine any motivation to combine
`
`Dishman with the other asserted references.
`
`54. Moreover, it is my opinion that Dishman does not disclose several
`
`elements of the ’720 patent’s claims. I understand from counsel that any
`
`discussion of elements in claim 1 or claim 28 applies equally to all claims of the
`
`’720 patent because claims 2-27 and 29-32 depend from claims 1 and 28.
`
`55. First, Dishman does not disclose the claimed prescription approval
`
`code, as required by claims 1.e. and 28.e. See generally Ex. 1007. My opinion is
`
`supported by the clear disclosures of Dishman, which fail to disclose the
`
`generation of any code, let alone the claimed prescription approval code. Further,
`
`- 18 -
`
`Page 21 of 86
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`

`
`
`
`Dr. Fudin confirmed that Dishman does not disclose the claimed prescription
`
`approval code at his deposition. Ex. 2061 at 420:18-20.
`
`56. Second, Dishman does not disclose that the informed consent is
`
`verified by the prescriber at the time the patient is registered in the computer
`
`readable storage medium, as required by claims 5 and 6. See generally Ex. 1007;
`
`Ex. 1007. My opinion is supported by the fact that Dishman does not disclose any
`
`informed consent, let alone that any informed consent was verified.
`
`57. My opinion is further supported by the fact that Dishman discloses
`
`that the pharmacist is the gatekeeper who takes an active role in risk assessment,
`
`and provides the clinical care necessary to meet all the requirements of clozapine
`
`therapy, including enrolling the patient into the hospital’s clozapine tracking
`
`system. Ex. 1007 at 900. Dr. Fudin acknowledged this fact at his deposition. Ex.
`
`2061 at 294:22-298-10. Thus, even if Dishman does disclose informed consent, it
`
`is my opinion that it would teach that the pharmacists, not the prescribing
`
`physicians, verify informed consent. The prescribing physicians, on the other
`
`hand, only perform a patient evaluation, which comes before the patient is
`
`registered, not at the same time. Ex. 1007 at 900 (teaching that the patient is
`
`registered by the pharmacist after NCCC approval).
`
`58. Third, Dishman does not disclose genetic testing, as required by claim
`
`10. Ex. 1007. My opinion is supported by the fact that Dishman is entirely silent
`
`- 19 -
`
`Page 22 of 86
`
`

`
`
`
`on genetic testing, despite mentioning other types of testing, such as white blood
`
`cell count testing. Ex. 1007 at 900-01.
`
`59. Fourth, Dishman does not disclose conducting surveys telephonically
`
`using an IVR system to obtain information regarding a patient’s behavior and
`
`compliance with the claimed risk avoidance measures, as required by claim 17.
`
`See generally Ex. 1007. My opinion is supported by the fact that Dishman does
`
`not disclose any type of survey at all. Id.
`
`(c) Cunningham
`
`60.
`
` Cunningham is U.S. Patent No. 5,832,449, which issued to David W.
`
`Cunningham. Ex. 1008. I note that Dr. Fudin did not mention Cunningham in the
`
`“state of the art” section of his declaration. Ex. 1027 ¶¶ 43-59. In my opinion, that
`
`makes sense because Cunningham is not part of the relevant art. My opinion is
`
`supported by the fact that Cunningham does not relate to restricted distribution of
`
`pharmaceutical drugs or to the assessment of risks associated with those drugs. Dr.
`
`Fudin acknowledged this support for my opinion at his deposition. Ex. 2061 at
`
`428:4-16, 432:14-20.
`
`61.
`
`In my opinion, Dr. Fudin’s reliance on Cunningham is based solely on
`
`the existence of the words “approval code.” Ex. 1027 ¶¶ 103-105. The code in
`
`Cunningham, however, is only a number associated with a particular free sample to
`
`verify that the sample has the correct identification and date range. Ex. 1008 at
`
`- 20 -
`
`Page 23 of 86
`
`

`
`
`
`9:52-65; 10:67-11:6. As discussed above, the applicants successfully distinguished
`
`the claims of the ’720 patent from the Boyer reference, which, like Cunningham,
`
`disclosed a “prescription number associated with [a] prescription.” Ex. 1005 at
`
`12:61-62; See supra at VI.B.1.
`
`62. Further, in my opinion, Cunningham also does not relate to general
`
`pharmacy practice. Instead, it is directed to drug marketing, in particular
`
`marketing through the use of free product samples. In my opinion, Cunningham is
`
`also irrelevant because it does not relate to teratogens or other harmful drugs, much
`
`less efforts to control access to teratogens or other harmful drugs. Instead, in my
`
`opinion, Cunningham is focused on a “method of dispensing, tracking, and
`
`managing pharmaceutical product samples.” Ex. 1008 at Abstract. As Dr. Fudin
`
`indicated, teratogens like thalidomide and other harmful drugs are not available as
`
`samples. 2061 at 437:11-438:25. As such, it is my opinion that a POSA would not
`
`consider Cunningham to be part of the relevant art.
`
`63. Moreover, it is my opinion that Cunningham does not disclose any
`
`elements of the ’720 patent’s claims, including the elements r

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