IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TEVA PHARMACEUTICALS USA, INC. and
`WATSON LABORATORIES, INC.,
`
`Petitioners,
`v.
`MERCK SHARP & DOHME CORP.
`
`Patent Owner.
`
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
`Inter Partes Review No.: IPR2020-01045
`
`Declaration of Dr. Leonard Chyall, Ph.D.
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Declaration of Leonard Chyall, Ph.D.
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`Table of Contents
`INTRODUCTION ...................................................................................... 1
`I.
`II. MY EXPERIENCE AND QUALIFICATIONS ........................................ 3
`III.
`LIST OF MATERIALS CONSIDERED ................................................... 8
`IV.
`LEGAL STANDARD ................................................................................ 9
`A.
`Anticipation .................................................................................... 10
`B.
`Obviousness ................................................................................... 11
`BACKGROUND ...................................................................................... 14
`V.
`PERSON OF ORDINARY SKILL IN THE ART (“POSA”) .................. 15
`VI.
`VII. THE ’708 PATENT .................................................................................. 16
`VIII. CLAIM CONSTRUCTION ..................................................................... 21
`IX. ANTICIPATION ...................................................................................... 22
`A.
`Ground 1: WO 03/004498 anticipates Claims 1-3, 17, 19, and
`21-23 of the ’708 patent ................................................................. 22
`
`1.
`2.
`3.
`4.
`5.
`
`6.
`
`Disclosure of WO ’498 ........................................................ 23
`Claim 1 of the ’708 Patent ................................................... 33
`Claim 2 of the ’708 Patent ................................................... 36
`Claim 3 of the ’708 Patent ................................................... 36
`Claim 17 of the ’708 Patent ................................................. 37
`a)
`A pharmaceutical composition comprising ............... 38
`b)
`a therapeutically effective amount of the salt
`according to claim 2 .................................................. 38
`in association with one or more pharmaceutically
`acceptable carriers ..................................................... 39
`Claim 19 of the ’708 Patent ................................................. 39
`A method for the treatment of type 2 diabetes
`a)
`comprising ................................................................. 39
`
`c)
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`b)
`
`administering to a patient in need of such
`treatment a therapeutically effective amount of
`the salt
`according to claim 2 or a hydrate thereof. ................. 39
`Claims 21-22 of the ’708 Patent .......................................... 40
`7.
`Claim 23 of the ’708 Patent ................................................. 42
`8.
`B. Ground 2: Claims 1-3, 17, 19, and 22-23 Are Anticipated by
`the
`’871 Patent ..................................................................................... 43
`Disclosure of the ’871 Patent ............................................... 43
`1.
`2.
`Claims 1 and 2 ..................................................................... 43
`3.
`Claim 3 ................................................................................. 44
`4.
`Claims 17 and 19 ................................................................. 45
`5.
`Claim 21 ............................................................................... 47
`6.
`Claim 22 ............................................................................... 48
`7.
`Claim 23 ............................................................................... 48
`X. OBVIOUSNESS ...................................................................................... 48
`A. Ground 3: Claims 3, 17, 19, and 21-23 Would Have Been
`Obvious in View of WO ’498 ........................................................ 49
`The Level of Ordinary Skill in the Pertinent Art ................. 49
`1.
`2.
`The Scope and Content of the Prior Art .............................. 49
`a) WO ’498 (EX1004) ................................................... 49
`Claim 3 ...................................................................... 49
`b)
`c)
`Claim 17 .................................................................... 51
`“A pharmaceutical composition
`comprising” ..................................................... 51
`“A therapeutically effective amount of the
`salt according to claim 2” ................................ 51
` “In association with one or more
`pharmaceutically acceptable carriers” ............ 51
`Claim 19 .................................................................... 52
`
`d)
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` “A method for the treatment of type
`2 diabetes comprising” .................................... 52
` “administering to a patient in need of
`such treatment a therapeutically effective
`amount
`of the salt according to claim 2 or a hydrate
`thereof” ............................................................ 52
`Claim 21 .................................................................... 52
`e)
`Claim 22 .................................................................... 54
`f)
`Claim 23 .................................................................... 54
`g)
`B. Ground 4: Claims 1-3, 17, 19, and 21-23 Would Have Been
`Obvious in View of WO ’498 and Bastin ...................................... 54
`The Level of Ordinary Skill in the Pertinent Art ................. 54
`1.
`2.
`The Scope and Content of the Prior Art .............................. 54
`a) WO ’498 (EX1004) ................................................... 54
`b)
`Bastin (EX1006) ........................................................ 54
`The Differences Between the Claims and Prior Art ............ 56
`Claim 1 ...................................................................... 56
`a)
` WO ’498 and Bastin Would Have
`Rendered the Phosphoric Acid Salt Obvious* .......... 56
`Claims 2 and 3 ........................................................... 60
`Claims 17 and 19 ....................................................... 61
`Claims 21-23 ............................................................. 62
`
`
`b)
`c)
`d)
`
`3.
`
`
`* [This section is so numbered in Mylan Pharmaceuticals Inc. v. Merck Sharp &
`
`Dohme Corp., IPR2020-00040, Ex. 1002, Declaration of Dr. Mukund Chorghade,
`
`Ph.D. (Oct. 29, 2019).]
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`Declaration of Leonard Chyall, Ph.D.
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`C.
`
`3.
`
`Ground 5: Claim 4 Would Have Been Obvious in View of
`WO
`’498, Bastin, and Brittain ............................................................... 63
`1.
`The Level of Ordinary Skill in the Pertinent Art ................. 63
`2.
`The Scope and Content of the Prior Art .............................. 64
`a) WO ’498 (EX1004) and Bastin (EX1006) ................ 64
`b)
`Brittain (EX1005) ...................................................... 64
`The Differences Between the Claim and Prior Art .............. 65
`a)
`Claim 4 ...................................................................... 65
`Ground 6: Claim 4 Would Have Been Obvious in View of
`WO’498 and Brittain ...................................................................... 66
`1.
`The Level of Ordinary Skill in the Pertinent Art ................. 66
`2.
`The Scope and Content of the Prior Art .............................. 66
`a) WO ’498 (EX1004) and Brittain (EX1005) .............. 66
`The Differences Between the Claim and Prior Art.............. 66
`3.
`SECONDARY CONSIDERATIONS ...................................................... 68
`
`D.
`
`XI.
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`Declaration of Leonard Chyall, Ph.D.
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`I, Leonard Chyall, Ph.D., do hereby declare and state as follows:
`
`I have been asked to provide testimony as to what one of ordinary
`
`skill in the art would have understood with respect to the patent at issue and
`
`various prior art discussed herein. I provide this testimony below:
`
`I.
`
`INTRODUCTION
`
`I am over the age of 18 and otherwise competent to make this
`
`Declaration.
`
`I have been retained on behalf of Teva Pharmaceuticals USA, Inc.
`
`and Watson Laboratories, Inc. for the above-captioned inter partes review (“IPR”).
`
`I am being compensated for my time in connection with this IPR at a rate of $500
`
`per hour. My compensation does not depend in any way on the outcome of the IPR.
`
`It is my understanding that the Petition for Inter Partes Review in
`
`this matter (the “Petition”) involves U.S. Patent No. 7,326,708 (“the ’708 patent”)
`
`(EX1001).
`
`The ’708 patent names Stephen Howard Cypes, Alex Minhua Chen,
`
`Russell R. Ferlita, Karl Hansen, Ivan Lee, Vicky K. Vydra, and Robert M. Wenslow,
`
`Jr. as the purported inventors.
`
`For the purposes of this declaration, I have been told to assume the
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`relevant priority date of the ’708 patent is June 24, 2003—the filing date of U.S.
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`Provisional Application No. 60/482,161.1 I further understand that the ’708 patent
`
`is assigned to Merck, Sharpe & Dohme Corp. (“Merck,” “Patentee,” or “Patent
`
`Owner”).
`
`As explained below, it is my opinion that Claims 1-4, 17, 19, and 21-
`
`23 of the ’708 patent2 are anticipated or would have been obvious to the skilled
`
`artisan as of the priority date of the ’708 patent. Therefore, those claims are
`
`invalid.
`
`
`I have not been asked to analyze whether this is indeed the correct priority
`
`1
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`date but rather to assume that it is for the purposes of my declaration. I understand
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`that Patent Owner has recently contended that the priority date is earlier than June
`
`24, 2003. EX1015, 10. I express no opinion at this time as to whether June 24,
`
`2003 is, in fact, the correct priority date. However, should this become an issue
`
`during the proceeding, I reserve the right to offer my opinion on this matter if
`
`asked to do so.
`
`2
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`I have not been asked to express an opinion about any other claim of the
`
`’708 patent, nor do I express such an opinion because I have not undertaken such
`
`an analysis.
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`Declaration of Leonard Chyall, Ph.D.
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`II. MY EXPERIENCE AND QUALIFICATIONS3
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`
`
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`I am a Ph.D. chemist with expertise in the study of organic materials
`
`and the synthesis, characterization and analytical testing of pharmaceutical drug
`
`substances and drug products, and I have been an expert in these fields since well
`
`before June 24, 2003. I am an independent consultant and the president of Chyall
`
`Pharmaceutical Consulting, LLC (“Chyall Pharma”), my pharmaceutical
`
`consulting business.
`
`
`
`In formulating my opinions, I have relied upon my training,
`
`knowledge, and experience in the relevant art. A copy of my current curriculum
`
`vitae is attached to this Declaration as EX1003 and it provides a description of my
`
`academic and employment history.4
`
`
`
`As an expert in the relevant field since prior to June 24, 2003, I am
`
`qualified to provide an opinion as to what a Person of Ordinary Skill in the Art
`
`(“POSA” or “the skilled artisan”) would have understood, known, or concluded as
`
`of June 24, 2003. Indeed, since 1986, I have accumulated significant training and
`
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`I reserve the right to explain my background and qualifications during any
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`deposition or in any subsequent Reply.
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`I reserve the right to supplement my academic and employment history
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`during any subsequent deposition.
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`experience in the study of organic materials and their synthesis and
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`characterization. Since 2000 I have accumulated significant expertise in the
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`preparation, characterization and analytical testing of pharmaceutical drug
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`substances and drug products.
`
`
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`I obtained my A.B. degree from Oberlin College in 1986 with a
`
`major in chemistry, and my Ph.D. in chemistry from the University of Minnesota
`
`in 1991. My doctoral research focused on the synthesis and characterization of
`
`novel organic molecules, and my dissertation focused on understanding the
`
`reactivity of high-energy cyclopropane molecules. I was a postdoctoral fellow from
`
`1992-1996 in the chemistry department at Purdue University, where I studied the
`
`properties and reactivity of organic molecules. My research involved both small
`
`molecular weight molecules as well as large biological molecules. Following my
`
`postdoctoral fellowship, I worked as a research chemist at Great Lakes Chemical
`
`Corporation, which is now known as Chemtura Corporation. My research involved
`
`the identification, characterization, and development of new products for the
`
`company.
`
`
`
`In 2000, I became a research investigator at SSCI, Inc. (“SSCI”), and
`
`in 2003, I became a senior research investigator. In 2006, SSCI was purchased by
`
`Aptuit, Inc. (“Aptuit”). I held various positions at Aptuit culminating in the
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`position of Director prior to my departure from the company. In May 2011, I left
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`Aptuit and founded Chyall Pharma. In addition to my consulting business, I am
`
`employed as a lecturer at Purdue University, where I teach organic chemistry to
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`undergraduate students. My curriculum vitae, attached as EX1003, sets forth
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`additional details concerning my background and qualifications.
`
` My publications are identified in my curriculum vitae (EX1003). I
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`have authored or co-authored 23 publications in peer-reviewed scientific journals.
`
`My most recent publications relate to research topics in the pharmaceutical
`
`sciences. In particular, these publications relate to the structural characterization
`
`and properties of drug substances. I am a named inventor on U.S. Patent Nos.:
`
`6,348,633; 6,632,442; 6,905,693; 8,183,369; and 8,563,571. My patented
`
`inventions include certain crystalline forms of the semi-synthetic opioid analgesic
`
`oxymorphone hydrochloride (U.S. Patent No. 8,563,571) and of the PARP enzyme
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`inhibitor 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-
`
`2H-phthalazin-1-one (U.S. Patent No. 8,183,369), as well as pharmaceutical
`
`compositions thereof. I have given numerous presentations at various scientific and
`
`technical meetings that are described in my curriculum vitae.
`
`
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`Through my education and research and consulting experience, I
`
`obtained extensive education and training in chemistry with specific experience in
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`the areas of organic chemistry and pharmaceutical sciences. I worked on numerous
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`projects providing research and consulting services related to the development of
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`pharmaceutical drug substances and pharmaceutical products. I managed protocol
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`studies conducted for clients who sought to identify suitable solid forms of their
`
`drug candidates. I conducted numerous investigations that concerned solid form
`
`screening and characterization. I have managed research projects that involved
`
`assessing the stability of particular crystalline and amorphous forms of
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`pharmaceutical compounds in order to identify forms appropriate for further
`
`development. In addition to the solid form work described above, I have managed
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`client projects involving synthetic chemistry, pharmaceutical salt screening, and
`
`studies concerning organic molecules used as nutritional supplements, food
`
`additives, and personal care products.
`
`
`
` I investigated the reactivity of pharmaceutical drug substances and
`
`excipients as a function of the processes used to manufacture the corresponding
`
`drug products. I worked on the development of pharmaceutical products for oral,
`
`parenteral, topical, and transdermal administration. I understand and am familiar
`
`with various technologies used to synthesize drug substances and manufacture
`
`drug products. I conducted reverse engineering studies (i.e., deformulation studies)
`
`to identify the composition of commercial drug products and the methods by which
`
`they are manufactured.
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`I have extensive experience with the characterization of
`
`pharmaceutical solids, particularly as it relates to the characterization of crystalline
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`drug substances. I have extensive knowledge and experience with the
`
`methodologies and instrumentation used to characterize pharmaceutical ingredients
`
`and drug products. I have studied solid materials using techniques including X-ray
`
`crystallography (or “single-crystal X-ray diffraction”), X-ray powder diffraction
`
`analysis (XRPD), optical microscopy, differential scanning calorimetry (DSC),
`
`thermogravimetric analysis (TGA), solubility measurements, Karl Fischer (KF)
`
`analysis, solid state NMR spectroscopy (SS-NMR), and vibrational spectroscopy,
`
`among numerous other techniques. I am an expert in the synthesis and
`
`characterization of crystalline materials, which include crystalline hydrates,
`
`solvates, and anhydrates. I also have expertise in the characterization of amorphous
`
`solids.
`
`
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`I have extensive experience in reviewing the research activities of
`
`other scientists and laboratories operating within the discipline of pharmaceutical
`
`chemistry. I am very familiar with the scientific aspects of drug substance and drug
`
`product characterization and validation activities that are found in the CMC
`
`sections of NDAs and ANDAs as required by the FDA, as well as cGMP practices
`
`required by the FDA in approved facilities.5
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`5 I reserve the right to further explain my background and qualifications in
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`deposition where needed.
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`Declaration of Leonard Chyall, Ph.D.
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`I am a member of the American Chemical Society.
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`III. LIST OF MATERIALS CONSIDERED
`
`
`
`In formulating my opinions, I have considered the materials
`
`referenced in this Declaration and the Exhibit List below. I have also reviewed the
`
`’708 patent (EX1001) and its prosecution history, as well as each of the documents
`
`cited herein in light of the general knowledge in the state of the art as of June 24,
`
`2003.
`
`Petitioner
`Exhibit #
`1001
`1002
`1003
`1004
`1005
`1006
`
`1007
`1008
`1009
`1010
`
`1011
`
`Description
`
`U.S. Patent No. 7,326,708
`
`Declaration of Dr. Leonard Chyall
`
`CV of Dr. Leonard Chyall
`
`WO 03/004498 to Edmonson
`
`Brittain, “Polymorphism in Pharmaceutical Solids”
`
`Bastin et al. “Salt Selection and Optimisation [sic] Procedures for
`Pharmaceutical New Chemical Entities”
`U.S. Patent No 6,699,871
`
`Orange Book Entry for Janumet®
`
`Orange Book Entry for Januvia®
`
`Complete copy of the prosecution history of the ’708 patent as
`available for download from the USPTO website
`U.S. Patent No. 4,572,909
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`1012
`1013
`1014
`1015
`
`1016
`
`1017
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`Declaration of Leonard Chyall, Ph.D.
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`U.S. Provisional Application No. 60/303,475, filed July 6, 2001
`
`Prescribing Information for Janumet®
`
`Prescribing Information for Januvia®
`
`Merck Sharpe & Dohme’s Responses and Objections to
`Defendants’ First Set of Joint Interrogatories (1-10)
`
`Brown et al., Chemistry: The Central Science, 8th Revised Edition
`615-618 (2002)
`
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.,
`IPR2020-00040, Ex. 1002, Declaration of Dr. Mukund
`Chorghade, Ph.D. (Oct. 29, 2019)
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`
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`I have read, agree with, and adopt as my own the opinions in the
`
`Declaration of Dr. Mukund Chorghade, Ph.D. (“Chorghade Declaration”), filed as
`
`Ex. 1002 in Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.,
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`IPR2020-00040. Those opinions appear verbatim in Paragraphs 29 through 183 of
`
`my Declaration below, using the same paragraph numbers used in the Chorghade
`
`Declaration.
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`I have intentionally omitted Paragraphs 22-28.
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`IV. LEGAL STANDARD
`
`
`
`Although I am not a lawyer, I have been informed by counsel and
`
`provide my general understanding of the law of anticipation and obviousness. I used
`
`these principles in conducting my analysis and drawing any conclusions.
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`I understand that the first step in determining whether a patent claim
`
`would have been anticipated or obvious is to construe the claims to determine claim
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`scope and meaning. I understand that in IPR proceedings, the claims must generally
`
`be given “the meaning that the term would have to a person of ordinary skill in the
`
`art in question at the time of the invention.”
`
`A. Anticipation
`
`
`
`
`I understand that anticipation requires that each and every element of
`
`the claimed invention be disclosed expressly or inherently in a single prior art
`
`reference. I also understand that a reference can anticipate a claim even if it does
`
`not expressly spell out all the limitations arranged or combined as in the claim. For
`
`example, I understand that an element may be inherent in the prior art where the
`
`prior art necessarily functions in accordance with or includes the claimed limitations.
`
`I am also informed that inherency may exist even if a POSA would not appreciate
`
`or recognize the inherent characteristics of the prior art, as the discovery of a
`
`previously unappreciated property does not make an old composition patentable.
`
` Moreover, a reference anticipates a claim if it discloses the claimed
`
`invention such that a skilled artisan could take its teachings in combination with his
`
`own knowledge of the particular art and be in possession of the invention. In an
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`anticipation inquiry, it is proper to take into account not only specific teachings of
`
`the reference but also the inferences which one skilled in the art would reasonably
`
`be expected to draw therefrom. It is also my understanding that proof of efficacy is
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`not required in order for a reference to be enabled for purposes of anticipation, or
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`for that matter, anticipation does not require actual performance of suggestions in a
`
`disclosure. I also understand that a prior art reference must enable a POSA to make
`
`and use a claimed invention in order to anticipate a patent claim, although I
`
`understand that in an IPR, prior art references are presumed to be enabled.
`
`B. Obviousness
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`
`
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`I understand that a patent claim is invalid if the differences between
`
`the claimed invention and prior art are such that the subject matter as a whole
`
`would have been obvious at the time the invention was made to a POSA.
`
`
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`I have been told the following factors (sometimes referred to as the
`
`Graham factors) are used in making an obviousness determination: a) the scope and
`
`content of the prior art; b) the differences between the prior art and the claimed
`
`invention; c) the level of ordinary skill in the pertinent art; and d) any secondary
`
`considerations evidencing non-obviousness. The obviousness analysis looks to the
`
`state of the art that existed at the time the invention was made. Moreover,
`
`obviousness does not require absolute predictability of success; all that is required
`
`is a reasonable expectation of success. Moreover, I have been informed that the
`
`person of ordinary skill need only have a reasonable expectation of success of
`
`developing the claimed invention. Finally, obviousness cannot be avoided simply
`
`by a showing of some degree of unpredictability in the art so long as there was a
`
`reasonable probability of success.
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`Declaration of Leonard Chyall, Ph.D.
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`I also understand that obviousness can be established by combining
`
`or modifying the teachings of the prior art. A claimed invention can be obvious
`
`when, for example, there is some teaching, suggestion, or motivation in the prior
`
`art that would have led a POSA to modify the prior art reference or to combine
`
`prior art reference teachings to arrive at the claimed invention.6
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`
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`I also understand that the prior art references themselves do not have
`
`to provide an explicit teaching, suggestion, or motivation to combine prior art
`
`teachings; rather, the analysis may rely on interrelated teachings, market demands,
`
`the background knowledge possessed by a POSA, and/or common sense. Moreover,
`
`the POSA can also take account of the inferences and creative steps that he or she
`
`would employ. Put another way, the motivation to combine or modify prior art
`
`references can come from any reason to do so and is not limited to the reasons that
`
`may have motivated the patentee.
`
`
`
`I am also informed that a combination of familiar elements
`
`according to known methods is likely to be obvious when it does no more than yield
`
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`As a general matter, in my view in science and technology a POSA would
`
`not view any single disclosure as complete, and thus, look no further. Were that the
`
`case, society would have halted progress long ago. Instead, ordinary artisans
`
`always seek improvement in their respective fields.
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`Declaration of Leonard Chyall, Ph.D.
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`predictable results. I also understand that when a POSA would have reached the
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`claimed invention through routine experimentation, the invention may be deemed
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`obvious.
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`I understand that various rationales are utilized to determine whether
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`a claim is obvious, including, among others: (i) simple substitution or
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`interchangeability of one known element for another to obtain predictable results;
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`(ii) use of known techniques to improve similar methods or products in the same
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`way; (iii) applying a known technique to a known method or product ready for
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`improvement to yield predictable results; (iv) “obvious to try”—choosing from a
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`finite number of identified, predictable solutions, with a reasonable expectation of
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`success; and (v) known work in one field of endeavor prompting variations of it for
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`use in either the same field or a different one based on design incentives or other
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`market forces if the variations would have been predictable to one of ordinary skill
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`in the art.
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`As stated above, I understand that secondary considerations of non-
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`obviousness are part of the obviousness inquiry. I understand that these secondary
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`considerations may include failure of others, copying, unexpectedly superior
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`results, perception in the industry, commercial success, and long-felt but unmet
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`need. I also understand that for secondary considerations of non-obviousness to be
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`applicable, they must have a nexus to the claimed subject matter. I understand that
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`this nexus (i.e., link) includes a connection between the subject matter of the claim
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`and the alleged secondary considerations.
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`I understand that I cannot use hindsight in any obviousness analysis.
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`In connection with my opinions, I did not use hindsight, nor did I use the claims
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`and/or the disclosure of the ’708 patent as a blueprint for piecing together the prior
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`art to arrive at the claimed invention. As part of the obviousness analysis, and to
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`avoid hindsight, I thought back to the time of invention (i.e., the relevant priority
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`date (discussed further below)) and considered the thinking of POSA, guided only
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`by the prior art references and the then-accepted wisdom in the field.
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`V. BACKGROUND
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` Medicinal chemistry is a subject that deals with the design,
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`synthesis, evaluation, and development of chemical compounds which exert
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`beneficial effects upon living systems. Medicinal chemists must have a firm
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`understanding of organic and synthetic chemistry as well as knowledge of other
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`disciplines such as biological, medical, and pharmaceutical sciences.
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` Medicinal chemists study relationships between the structure of a
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`particular compound or group of compounds and their properties, including their
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`interactions with biological systems. These relationships are called structure-
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`activity relationships (“SAR”). The rationale behind SAR is that the structure of a
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`chemical implicitly determines its physico-chemical and biological properties.
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`The goal of the medicinal chemist is to optimize not only the
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`pharmacological properties, such as potency, but also the drug-like properties of the
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`molecules in order to identify a compound suitable for therapeutic use.
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`VI. PERSON OF ORDINARY SKILL IN THE ART (“POSA”)
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`In arriving at my opinions, I have relied on my experience in the
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`relevant art and have considered the point of view of a POSA as of the relevant
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`priority date. It is my understanding that a POSA is a hypothetical person who is
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`presumed to be aware of all pertinent art, thinks along conventional wisdom in the
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`art, and is a person of ordinary creativity.
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`As of the relevant priority date, a POSA in the relevant field would
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`have had (i) a Ph.D. in chemistry, biochemistry, medicinal chemistry, pharmacy,
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`pharmaceutics, or a related field, and at least two years of relevant experience in
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`drug development, including an understanding of salt selection in drug
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`development; (ii) a master’s degree in the same fields and at least five years of the
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`same relevant experience; or (iii) a bachelor’s degree in the same fields and at least
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`seven years of the same relevant experience.
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`A POSA would also have knowledge of the scientific literature
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`concerning the same as of the priority date. A POSA may also work as part of a
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`multidisciplinary team and draw upon not only his or her own skills, but also take
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`advantage of certain specialized skills of others in the team to solve a given problem.
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`In determining the qualifications of a POSA, I considered, among
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`other factors, the field of the alleged invention and use thereof described in the ’708
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`patent and my experience with the educational level of practitioners in related
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`fields. In addition, my opinion is based upon my background, education, and
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`personal experience.
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`Based on my experience, I had the understanding and capabilities of
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`a POSA as defined above prior to, and on, the relevant priority date, and all
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`testimony and opinions provided herein is from that perspective, including that
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`relevant timeframe.
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`VII. THE ’708 PATENT
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`I have reviewed and considered the ’708 patent in view of general
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`knowledge in the relevant field measured from the relevant priority date for
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`the’708 patent from the perspective of a POSA as defined above. Again, I
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`reviewed the ’708 patent not for the purposes of using any hindsight in my
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`analysis, but so that I could understand the scope of the claims, the nature of the
`alleged invention,7 and other matters germane to my analysis (e.g., claim
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`For example, I have been informed that the second Graham factor requires
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`evaluation of the “differences between the prior art and the claims at issue.” To
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`provide such an analysis, an understanding of the “claims at issue” is needed,
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`construction issues, priority date issues, and determining the definition of a
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`POSA).
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`I understand Patent Owner contends that the ’708 patent purportedly
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`covers the Janumet® and Januvia® products by listing it in the Orange Book. See
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`EX1008 and EX1009.
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`The ’708 patent, entitled “Phosphoric Acid Salt of a Dipeptidyl
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`Peptidase-IV Inhibitor,” issued on February 5, 2008 from U.S. Appl. No. 10/874,992
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`(“the ’992 application”), and ultimately claims a benefit of priority from U.S.
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`Provisional Application No. 6