UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`COALITION FOR AFFORDABLE DRUGS VI LLC
`Petitioner,
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`v.
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`CELGENE CORPORATION
`Patent Owner
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`________________
`
`Case IPR2015-01096
`Patent 6,315,720
`________________
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`DECLARATION OF JOSEPH T. DIPIRO, PHARM.D.
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`Case IPR2015-01096
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`CELGENE EXHIBIT 2060
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`Page 1 of 82
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
`
`COALITION FOR AFFORDABLE DRUGS VI LLC
`Petitioner,
`
`v.
`
`CELGENE CORPORATION
`Patent Owner
`
`________________
`
`Case IPR2015-01096
`Patent 6,315,720
`________________
`
`DECLARATION OF JOSEPH T. DIPIRO, PHARM.D.
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`Case IPR2015-01096
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`CELGENE EXHIBIT 2060
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`Page 1 of 82
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`TABLE OF CONTENTS
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`I.
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`QUALIFICATIONS ........................................................................................ 1
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`II. MATERIALS CONSIDERED ........................................................................ 3
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`III. LEGAL STANDARDS ................................................................................... 3
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`IV. PERSON OF ORDINARY SKILL IN THE ART .......................................... 4
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`V.
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`BACKGROUND ............................................................................................. 5
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`VI. THE CLAIMED METHODS WOULD
`NOT HAVE BEEN OBVIOUS ....................................................................... 8
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`A.
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`B.
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`There was not a known need or problem
`to be solved at the time of the ’720 patent’s inventions....................... 8
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`The asserted references do not disclose, teach, or
`suggest every element of the claimed inventions ................................ 11
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`1.
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`2.
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`Claim Construction ................................................................... 11
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`Scope and Content of the Prior Art ........................................... 14
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`(a)
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`Thalomid PI .................................................................... 14
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`(b) Cunningham .................................................................... 16
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`(c) Keravich .......................................................................... 19
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`(d) Zeldis .............................................................................. 21
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`(e) Mundt .............................................................................. 23
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`3.
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`Differences between the
`claimed inventions and the prior art ......................................... 24
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`(a)
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`Independent Claims 1 and 28 ......................................... 24
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`i.
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`Thalomid PI 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 ..................... 26
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`(b) Dependent Claims 2-27 and 29-32 ................................. 29
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`i.
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`ii.
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`Claims 5 and 6 ...................................................... 29
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`Claim 10 ............................................................... 34
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`iii. Claim 17 ............................................................... 35
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`C. A POSA would not have been motivated
`to combine the Ground 2 references ................................................... 38
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`1.
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`2.
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`A POSA would not have been motivated
`to combine Thalomid PI and Cunningham ............................... 39
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`A POSA would not have been motivated to
`combine Thalomid PI and Mundt ............................................. 41
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`VII. SUPPLEMENTAL OR AMENDED OPINIONS ......................................... 42
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`I, Joseph T. DiPiro, Pharm.D., hereby declare and state as follows:
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`1.
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`I submit this declaration on behalf of Celgene Corporation
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`(“Celgene”), Patent Owner of U.S. Patent No. 6,315,720 (the “’720 patent”) in
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`connection with this inter partes review, Case IPR2015-01096, filed by Coalition
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`for Affordable Drugs VI LLC (“CFAD”). I understand that CFAD presented two
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`“Grounds” of unpatentability in its Petition, but that the Patent Office only
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`instituted “Ground 2.” As such, my declaration responds only to the opinions set
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`forth in Ground 2 of the declaration of Jeffrey Fudin, R.Ph., Pharm.D., DAAPM,
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`FCCP, FASHP (Ex. 1021).
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`I.
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`QUALIFICATIONS
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`2.
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`I have been a registered pharmacist for nearly 38 years. I am
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`currently Dean and the Archie O. McCalley Chair and Professor at Virginia
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`Commonwealth University School of Pharmacy.
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`3.
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`Prior to holding my current position, I was Executive Dean and
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`Professor at South Carolina College of Pharmacy, the University of South
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`Carolina, and the Medical University of South Carolina. Before that, I held
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`various academic positions at the University of Georgia College of Pharmacy
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`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
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`curriculum vitae, a copy of which is attached hereto as Exhibit 1.
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`4.
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`I received a Bachelor of Science degree in pharmacy from the
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`University of Connecticut in 1978, and a Doctorate in Pharmacy from the
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`University of Kentucky, College of Pharmacy in 1981. While obtaining my
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`doctorate degree, I spent three years of residency at the Albert B. Chandler
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`Medical Center, Lexington, Kentucky. In 1990, I completed one year of
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`postdoctoral research in clinical immunology at Johns Hopkins University. A full
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`description of my formal education is provided in my curriculum vitae.
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`5.
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`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
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`field of pharmacy. I am also the author of numerous letters and book reviews
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`concerning various aspects of pharmacy, which are described in my curriculum
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`vitae.
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`6.
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`I was the editor of the American Journal of Pharmaceutical Education,
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`which is the primary journal of pharmacy education in the U.S., from 2002 to
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`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
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`and training of pharmacists.
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`II. MATERIALS CONSIDERED
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`8.
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`I have reviewed CFAD’s Petition for inter partes review regarding the
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`’720 patent, as well as Dr. Fudin’s supporting declaration (Ex. 1021). A list of any
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`additional materials that I have reviewed in connection with the preparation of this
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`declaration is attached as Exhibit 2.
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`III. LEGAL STANDARDS
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`9.
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`I have been advised by counsel for Celgene of the following legal
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`standards and set forth my opinions in the context of these standards.
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`10.
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`I understand that a patent claim may be invalid under 35 U.S.C. § 103
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`if the claim, when considered as a whole, would have been obvious to a person of
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`ordinary skill (“POSA”) as of the date of the claimed invention. For the purposes
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`of the obviousness analysis in this report, I have been asked to use October 23,
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`2000 as the date of invention.
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`11.
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`I understand that the obviousness analysis is objective, and requires
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`consideration of: (1) the scope and content of the prior art; (2) the differences
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`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.
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`13.
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`I also understand that a patent claim that has several elements is not
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`proved obvious merely by demonstrating that each of its individual elements was
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`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,
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`would have had a reason or motivation to combine two or more references or
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`modify a reference to achieve the claimed invention as a whole.
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`14.
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`I also understand that if in an invention achieves more than a
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`predictable result, then it is nonobvious.
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`IV.
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`PERSON OF ORDINARY SKILL IN THE ART
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`15. Dr. Fudin opined that “[a] POSA in pharmaceutical prescriptions as of
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`October 23, 2000, (the earliest possible priority date of the ’720 Patent) would
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`typically have either a Pharm.D. or a B.S. in pharmacy with approximately 5-10
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`years of experience and a license to practice as a registered pharmacist in any one
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`or more of the United States.” Ex. 1021 ¶ 16.
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`16. For the purposes of this declaration, I am not offering any definition
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`of a POSA. Instead, I have been asked to assume that Dr. Fudin’s definition of a
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`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.
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`I note, however, that Dr. Fudin testified that his POSA would not have
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`been capable of designing or implementing the claimed systems of the ’720 patent
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`Ex. 2061 at 193:12-194:10, 201:1-10; 246:17-247:2, 328:19-329:9. On this point,
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`I agree with Dr. Fudin. In my opinion, someone with Dr. Fudin’s POSA’s
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`qualifications would have very little, if any, experience with restricted distribution
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`systems, such as those claimed in the ’720 patent. They would certainly not be
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`able to design or implement such systems. My opinion is based on my 38 years of
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`experience in the field, including both work and teaching experience.
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`V. BACKGROUND
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`18. By July 1998, thalidomide was a well-known teratogen. See Ex. 1006
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`at 2. Thalidomide was marketed in Europe in the late 1950s and early 1960s as a
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`sedative and a treatment for pregnant women with morning sickness. Ex. 1001 at
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`1:39-45; Ex. 2002 at 1. Tragically, thalidomide caused severe malformations in
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`children of mothers who took the drug. Ex. 1001 at 1:39-45; Ex. 2002 at 1. The
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`FDA refused to approve thalidomide in the early 1960s, preventing a similar result
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`in the United States. See Ex. 2067.
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`19. Thalidomide remained unlawful in the United States until Celgene
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`introduced Thalomid® in 1998. Ex. 1025 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. 1025 at 0002-3), which is covered by the methods
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`claimed in the ’50l patent. Ex. 206] at 377:l9—378:l.
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`20.
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`The ’720 patent was filed in October 2000. Ex. 1001 at Cover. At
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`that time, in October 2000, S.T.E.P.S.® had proven 100% successful in preventing
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`birth defects of the type associated with thalidomide.—
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` Dr. Fudin confirmed this at his deposition. Ex.
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`2061 at 380:6—38l:2.
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`21.
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`In my opinion, as described below, nothing in the prior art taught or
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`even suggested that there was any problem with S.T.E.P.S.® that needed to be
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`addressed, for thalidomide or for any other drug.
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`— Enhanced S.T.E.P.S.® was implemented for the first time with
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`the September 2001 Thalomid® labeling change. Ex. 2008; Ex. 2009 at 4.
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`23.
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`Indeed, as the ’720 patent describes, improvements were made “to
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`minimize and the simplify demands on the pharmacy, thereby improving
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`compliance with the system of distribution, and reducing the risk that the drug will
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`be dispensed to a contraindicated individual.” Ex. 1001 at 2:8-12. As stated in the
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`in the ’720 patent’s specification, “it has surprisingly been found that by having the
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`prescriber, rather than the pharmacy, verify the patient’s informed consent,”
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`increased efficiency, led to “better compliance, and hence decreased risk that the
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`adverse side effect will occur.” Ex. 1001 at 10:35-40.
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`24. The inventors effectuated these changes through the claimed
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`prescription approval code. The ’720 patent describes that to comply with the
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`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
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`computer readable storage medium, and the pharmacy is permitted to dispense the
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`drug upon successfully retrieving a prescription approval code therefrom.”).
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`VI. THE CLAIMED METHODS WOULD NOT HAVE BEEN OBVIOUS
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`A. There was not a known need or problem to be solved
`at the time of the ’720 patent’s inventions
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`25. Dr. Fudin opined that a POSA would have been motivated to arrive at
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`the claimed methods because a POSA was allegedly motivated to combine “prior
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`art restricted drug distribution methods, including counseling-based avoidance of
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`pregnancy, and a computerized tracking system that allows only registered access
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`to prescriptions when certain condition [sic] (e.g., non-pregnancy) are met.” Ex.
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`1021 ¶ 59. I disagree. In my opinion, there was no known need or problem at the
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`time of the ’720 patent’s inventions that would have motivated a POSA to arrive at
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`the ’720 patent’s claims.
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`26. My opinion is supported by the fact that the program Dr. Fudin
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`alleged a POSA would have desired to arrive at already existed. This program was
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`called S.T.E.P.S.® CFAD acknowledged this in its Petition. Pet. 14 (admitting
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`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
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`inventions, in October 2000, S.T.E.P.S.® had proven 100% successful in
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`preventing thalidomide-related birth defects. Ex. 2061 at 380:6-381:2; see also Ex.
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`2068 ¶ 7.
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`28.
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`In my opinion, Dr. Fudin has not identified any reason to modify or
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`improve upon S.T.E.P.S.® To the contrary, as Dr. Fudin agreed, S.T.E.P.S.® had
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`proven to be 100% effective from its launch in July 1998 up through (and after) the
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`filing of the ’720 patent in October 2000. Ex. 2061 at 239:23-240:11; see also Ex.
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`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-
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`381:2, 381:18-382:12; 455:11-15.
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`29.
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`In my opinion, a POSA would need to have had a reason to seek to
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`improve S.T.E.P.S.® I understand that Dr. Fudin testified that a POSA would have
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`sought to expand S.T.E.P.S.® to include isotretinoin, clozapine, and “future
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`drugs . . . which we don’t even know what they are.” Ex. 2061 at 381:3-15,
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`590:15-592:9. 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
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`imposed by the manufacturers. Further, Dr. Fudin testified that both distribution
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`systems were successful. Id. at 209:14-24 (Dr. Fudin opining that the Accutane
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`PPP was a “tremendous success”), 235:15-236:9 (Dr. Fudin opining that it was
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`“common knowledge” that the clozapine distribution systems should be copied for
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`thalidomide), 565:10-566:17 (Dr. Fudin testifying that Zeldis confirmed the
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`success of the isotretinoin and clozapine distribution systems).
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`31. My opinion is also supported by the fact that a POSA would not seek
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`to develop a restricted distribution system for “future drugs . . . which we don’t
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`even know what they are,” as Dr. Fudin alleged. Ex. 2061 at 590:15-592:9. I note
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`at the outset that, in my opinion, Dr. Fudin’s POSA would not have been interested
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`in developing restricted distribution systems at all. And even if Dr. Fudin’s POSA
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`would have been interested, they would have lacked the necessary skill set. Even
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`if Dr. Fudin’s POSA were interested and sufficiently skilled, they would still need
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`to first know what drug they were dealing with. In my opinion, if a POSA did not
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`know the drug they were dealing with, a POSA could not even begin to think of
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`how the drug’s distribution should be restricted.
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`32. Finally, my opinion is supported by the fact that even taking into
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`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
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`of the ’720 patent’s inventions.
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`B.
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`33.
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`The asserted references do not disclose, teach,
`or suggest every element of the claimed inventions
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`1.
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`Claim Construction
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`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
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`intrinsic record, including the record of how the applicants obtained the patent in
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`front of the Patent Office (i.e., the patent’s prosecution history).
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`34. Dr. Fudin proposed constructions for three claim terms: “consulted”;
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`“teratogenic effect”; and “adverse side effect.” Ex. 1021 ¶¶ 37-42. These terms do
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`not affect my opinions.
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`35.
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`I do explain, however, how a POSA would understand the phrase
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`“prescription approval code” in the context of the ’720 patent and its prosecution
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`history.
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`36.
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`In my opinion, a POSA reviewing the intrinsic record would
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`understand the phrase “prescription approval code” to mean: a code representing
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`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
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`prescription processing,” and that it would have been obvious to use that
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`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:
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`Claim 1 further requires an assessment, based upon the
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`risk group assignment and the information collected from
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`the patient, as to whether the risk of the side effect
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`occurring is acceptable. Upon a determination that the risk
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`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
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`filled. Thus, the prescription approval code is not merely
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`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
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`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
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`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
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`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
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`representing that an affirmative risk assessment has been made based upon risk-
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`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
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`41.
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`I understand that Ground 2 is premised on five references: Thalomid
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`PI, Cunningham, Keravich, Zeldis, and Mundt. In my opinion, each reference fails
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`to disclose many, if not all, of the elements of the ’720 patent’s claims, and also
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`fails to provide any motivation to combine the references with one another.
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`(a) Thalomid PI
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`42. Thalomid PI is the FDA-approved July 1998 package insert for
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`Thalomid®. Ex. 1006. It was used with other materials in the original S.T.E.P.S.®
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`program. Dr. Fudin acknowledged this fact during his deposition. Ex. 2061 at
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`416:24-417:6.
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`43.
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`In my opinion, Thalomid PI does not disclose several elements of the
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`’720 patent’s claims. I understand from counsel that any discussion of elements in
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`claim 1 or claim 28 applies equally to all claims of the ’720 patent because claims
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`2-27 and 29-32 depend from claims 1 and 28.
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`44. First, in my opinion, Thalomid PI does not disclose the claimed
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`prescription approval code, as required by claim 1.e. and claim 28.e. See generally
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`Ex. 1006. My opinion is supported by the fact that the Board declined to institute
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`Ground 1 because it found that Thalomid PI did not disclose at least the claimed
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`prescription approval code. Paper 21 at 12-13. My opinion is also supported by
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`Dr. Fudin’s testimony, where he agreed that Thalomid PI does not disclose a
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`prescription approval code. Ex. 2061 at 419:5-11.
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`45. Second, in my opinion, Thalomid PI does not disclose that the
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`informed consent is verified by the prescriber at the time the patient is registered in
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`the computer readable storage medium, as required by claims 5 and 6. See
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`generally Ex. 1006. My opinion is supported by the fact that Thalomid PI does not
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`say anything about the prescriber verifying the informed consent. Instead,
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`Thalomid PI only discloses that the prescriber ensures that the patient completes
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`the informed consent.
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`46. My opinion is also supported by the fact that, as explained in detail
`
`below: (1) the S.T.E.P.S. program materials disclose that the pharmacist, not the
`
`prescriber, is the actor responsible for verifying informed consent and registering
`
`the patient; and (2) the S.T.E.P.S. program materials disclose that the timing of any
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`actions by the prescriber regarding informed consent occur before, not at the same
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`time as, patient registration.
`
`47. Third, in my opinion, Thalomid PI does not disclose genetic testing,
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`as required by claim 10. See generally Ex. 1006; 2061 at 471:4-472:4. My
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`opinion is supported by the clear disclosures of Thalomid PI, which fail to disclose
`
`genetic testing, despite disclosing other types of testing such as pregnancy testing
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`and peripheral neuropathy testing. Ex. 1006 at 2, 10, 11-12.
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`Page 18 of 82
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`48. Fourth, in my opinion, Thalomid PI does not disclose conducting
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`surveys telephonically using an integrated voice response (“IVR”) system to obtain
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`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, as described below, the documents describing the
`
`original S.T.E.P.S. program teach that the surveys were paper forms that the
`
`patient filled out in the prescriber’s office as part of an interactive risk-counseling
`
`activity.
`
`(b) Cunningham
`
`49. Cunningham is U.S. Patent No. 5,832,449, which issued to David W.
`
`Cunningham. Ex. 1009. I note that Dr. Fudin did not mention Cunningham in the
`
`“state of the art” section of his declaration. Ex. 1021 ¶¶ 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.
`
`50.
`
`In my opinion, Dr. Fudin’s reliance on Cunningham is based solely on
`
`the existence of the words “approval code.” Ex. 1021 ¶¶ 214-216. The code in
`
`Cunningham, however, is only a number associated with a particular free sample to
`
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`- 16 -
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`Page 19 of 82
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`
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`verify that the sample has the correct identification and date range. Ex. 1009 at
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`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.
`
`51. 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. 1009 at Abstract. As Dr. Fudin
`
`indicated, teratogens like thalidomide and other harmful drugs are not available as
`
`samples. Ex. 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.
`
`52. Moreover, it is my opinion that Cunningham does not disclose any
`
`elements of the ’720 patent’s claims, including the elements relevant to this
`
`proceeding. 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.
`
`
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`- 17 -
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`Page 20 of 82
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`53. First, in my opinion, Cunningham does not disclose the claimed
`
`prescription approval code, as required by claim 1.e. and claim 28.e. See generally
`
`Ex. 1009. My opinion is supported by the fact that Cunningham does not disclose
`
`using an approval code in connection with side effects. Nor could Cunningham do
`
`so, given that it fails to disclose collecting any patient data or registering patients in
`
`any system to control pharmaceutical prescription distribution. Dr. Fudin
`
`acknowledged this support for my opinion at his deposition. Ex. 2061 at 432:14-
`
`20, 428:11-16.
`
`54.
`
`In my opinion, without access to any patient data, Cunningham cannot
`
`possibly disclose the claimed prescription approval code—i.e., 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 generated
`
`only upon a determination that the risk of a side effect occurring is acceptable.
`
`55. Second, in my opinion, Cunningham does not disclose: (a) 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; (b) genetic
`
`testing, as required by claim 10; and (c) 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
`
`
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`- 18 -
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`Page 21 of 82
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`
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`Ex. 1009. Again, without patient data, these limitations of claims 5, 6, 10, and 17
`
`cannot be disclosed.
`
`(c) Keravich
`
`56. Keravich is entitled “Challenges of thalidomide distribution in a
`
`hospital setting.” Ex. 1018 at 1721. Dr. Fudin relies on Keravich as allegedly
`
`relevant to the additional limitations of claims 5, 6, 17, and 27. Ex. 1021 ¶¶ 66-68
`
`(citing Ex. 1018), ¶¶ 123-126 (citing Ex. 1018), ¶ 177 (claim 6), ¶ 178 (claim 17),
`
`¶¶ 189-190 (claim 27) ¶¶ 217-224 (claims 5 and 6). Dr. Fudin does not rely on
`
`Keravich anywhere else.
`
`57. Keravich comments on aspects of the original S.T.E.P.S.® program as
`
`of 1999. In my opinion, Keravich 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.
`
`58. First, in my opinion, Keravich does not disclose the claimed
`
`prescription approval code, as required by claim 1.e. and claim 28.e. See generally
`
`Ex. 1018. My opinion is supported by the clear disclosures of Keravich, which fail
`
`to disclose the generation of any code, let alone the claimed prescription approval
`
`code. Further, Dr. Fudin confirmed that Keravich does not disclose the claimed
`
`prescription approval code at his deposition. Ex. 2061 at 420:7-9.
`
`
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`- 19 -
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`Page 22 of 82
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`59. Second, in my opinion, Keravich 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. 1018. As explained in more detail below, my opinion is supported by the fact
`
`that: (1) Keravich discloses that the pharmacist, not the prescriber, is responsible
`
`for verifying informed consent and registering the patient; and (2) Keravich
`
`discloses that the timing of any actions by the prescriber regarding informed
`
`consent occur before, not at the same time as, patient registration. Ex. 1018 at
`
`1722. I also note that Dr. Fudin agreed that Keravich does not disclose having the
`
`prescriber verify informed consent at the time the patient is registered in the
`
`computer readable storage medium. Ex. 2061 at 422:16-20.
`
`60. Third, in my opinion, Keravich does not disclose genetic testing, as
`
`required by claim 10. See generally Ex. 1018. My opinion is supported by the
`
`clear disclosures of Keravich, which fail to disclose genetic testing despite
`
`disclosing other types of testing, such as pregnancy testing. Id. at 1722.
`
`61. Fourth, in my opinion, Keravich 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. 1018. My opinion is supported by the fact
`
`that Keravich discloses only paper surveys that the patient completes at the
`
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`- 20 -
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`Page 23 of 82
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`
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`prescriber’s office as part of interactive risk counseling. See Ex. 1018 at 1172. As
`
`described in detail below, any tasks performed by telephone in Keravich have
`
`nothing to do with the disclosed surveys.
`
`(d) Zeldis
`
`62. Zeldis is entitled “S.T.E.P.S.™: A Comprehensive Program for
`
`Controlling and Monitoring Access to Thalidomide.” Ex. 1012 at 319. The only
`
`claim limitation that Dr. Fudin relied on Zeldis for is the additional limitation of
`
`claim 5. Ex. 1021 ¶ 219. Dr. Fudin does not rely on Zeldis to argue that any of the
`
`other claims of the ’720 patent would have been obvious.
`
`63. Zeldis describes the original S.T.E.P.S.® program as of 1999. In my
`
`opinion, Zeldis 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.
`
`64. First, in my opinion, Zeldis does not disclose the claimed prescription
`
`approval code, as required by claim 1.e. and 28.e. See generally Ex. 1012. My
`
`opinion is supported by the clear disclosures of Zeldis, which fail to disclose the
`
`generation of any code, let alone the claimed prescription approval code. Further,
`
`the claimed prescription approval code
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