`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`
`Inter Partes Review No.: IPR2021-00881
`
`
`U.S. Patent No. 9,254,338 B2
`Filed: July 12, 2013
`Issued: February 9, 2016
`Inventor: George D. Yancopoulos
`
`Title: USE OF A VEGF ANTAGONIST TO TREAT
`ANGIOGENIC EYE DISORDERS
`
`
`DECLARATION OF MARY GERRITSEN, PH.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 9,254,338 B2
`
`
`
`Mylan Exhibit 1003
`Mylan v. Regeneron, IPR2021-00881
`Page 1
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`Joining Petitioner: Apotex
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`

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`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`INTRODUCTION. .......................................................................................... 1
`
`QUALIFICATIONS. ....................................................................................... 1
`
`III.
`
`SCOPE OF ENGAGEMENT. ......................................................................... 4
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART. ................................ 7
`
`V.
`
`LEGAL STANDARDS. .................................................................................. 9
`
`VI. U.S. PATENT NO. 9,254,338. ........................................................................ 9
`
`VII. PROSECUTION HISTORIES OF THE ’338 PATENT AND ITS
`EUROPEAN EQUIVALENT, EP-325. ........................................................11
`
`VIII. DISCLOSURES, KNOWLEDGE, & INFORMATION AVAILABLE
`IN THE ART BEFORE JANUARY 13, 2011. .............................................20
`
`A.
`
`REGENERON PRESS RELEASES. .............................................................20
`
`1.
`
`April 2008 Press Release. .........................................................22
`
`2. May 2008 Press Release. ..........................................................25
`
`3.
`
`4.
`
`September 2008 Press Release. ................................................28
`
`Additional Regeneron Press Releases. ......................................31
`
`CLINICALTRIALS.GOV. .........................................................................35
`
`SEC FILINGS. .......................................................................................47
`
`B.
`
`C.
`
`IX. CONCLUDING STATEMENTS. .................................................................51
`
`
`
`
`
`
`i
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`Mylan v. Regeneron, IPR2021-00881
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`I, Mary Gerritsen, Ph.D., declare as follows:
`
`I.
`
`INTRODUCTION.
`I submit this declaration on behalf of Mylan Pharmaceuticals Inc.
`
`
`(“Petitioner”). I understand that Petitioner is filing a petition with the United States
`
`Patent and Trademark Office (“USPTO”) for inter partes review of U.S. Patent No.
`
`9,254,338 B2 (the “’338 patent”) (Ex.1001).
`
`
`
`This Declaration contains my qualifications; my opinions based on my
`
`expertise, and my review of the ’338 patent and other documents cited within this
`
`Declaration; the factual basis for those opinions; and data or other information I
`
`considered in forming my opinions. The opinions and facts set forth in this
`
`Declaration are based upon information and my analysis of documents related to the
`
`’338 patent, as well as my knowledge and experience in the pharmaceutical and
`
`biotechnology industries.
`
`II. QUALIFICATIONS.
`I am a pharmacologist with over thirty years of experience in the
`
`
`pharmaceutical and biotechnology industries.
`
`
`
`In 2010, I founded Gerritsen Consulting, and I have been a consultant
`
`for the biotechnology industry on topics related to biotherapeutics and drug
`
`discovery in the therapeutic areas of oncology, immuno-oncology, ophthalmology,
`
`autoimmune diseases/inflammation, cardiovascular disease, and angiogenesis-
`
`
`
`1
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`Mylan v. Regeneron, IPR2021-00881
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`related diseases. Specifically, I have collaborated with companies in numerous areas
`
`of product development, including research strategy, target selection and
`
`assessment, preclinical pharmacology and mechanism of action studies, preparation
`
`of Investigational New Drug applications, procedures for clinical trials, and
`
`evaluation of pipeline portfolio strategies.
`
`
`
`Prior to my consulting work, I was the Vice President of Molecular and
`
`Cellular Pharmacology at Exelixis, Inc. from 2004-2010.
`
` Exelixis is a
`
`biotechnology company focused on the development of small molecular therapeutics
`
`for the treatment of oncology and metabolic disease. I supervised many of the
`
`processes involved in preclinical to early clinical development, including target
`
`identification and validation, early lead discovery and validation, lead optimization,
`
`cellular and molecular pharmacology studies, pharmacodynamic assays, and early
`
`translational medicine studies. I also collaborated with the clinical groups in the
`
`early stages of Phase I clinical trials.
`
`
`
`From 2003-2004, I was a consultant with Frazier Health Care Ventures
`
`in which I was involved in the founding of MacuSight, Inc., a pharmaceutical
`
`company focused on angiogenesis disorders, specifically focused on age-related
`
`macular degeneration and diabetic macular edema. I was an inventor on several of
`
`the patents that were the basis for the foundation of the company which included
`
`U.S. Patent Nos. 8,222,271, 8,486,960, and 9,452,156.
`
`
`
`2
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`From 2002-2003, I was the Senior Director, Vascular Biology with
`
`Millennium Pharmaceuticals (formerly COR Therapeutics) where I was responsible
`
`for development of the strategic plan for vascular biology and oversaw numerous
`
`small molecule development programs
`
`in
`
`the
`
`therapeutic
`
`indications of
`
`atherosclerosis, peripheral vascular disease, and fibrosis.
`
`
`
`Prior to the above, I was Associate Director of the Department of
`
`Cardiovascular Research at Genentech, Inc. from 1997-2001. Separately, I was a
`
`senior investigator in the angiogenesis group whose focus was the identification of
`
`novel targets for protein-based therapeutics. Throughout my time at Genentech, I
`
`was involved in the drafting and filing of over 1,000 patent applications in which
`
`over forty such applications issued as patents.
`
`
`
`Before joining Genentech, I was a Principal Staff Scientist and Group
`
`Leader, Institute for Inflammation and Autoimmunity at Bayer Pharmaceuticals
`
`(formerly Miles Pharmaceuticals) from 1990-1997. During this time, I led the
`
`screening efforts for small molecule inhibitors of leukocyte adhesion, cyclo-
`
`oxygenase, and cytokine release/action while also supervising six laboratories within
`
`the Institute. Additionally, I developed collaborations with other industrial
`
`development laboratories as well as academic laboratories in order to promote
`
`advances in target discovery and assay development.
`
`
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`3
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`Mylan v. Regeneron, IPR2021-00881
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` Prior to my roles in the pharmaceutical and biotechnology industry, I
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`received a Bachelor of Science degree in Zoology and a Ph.D. in Endocrinology and
`
`Pharmacology from the University of Calgary. I completed my post-doctoral studies
`
`in Pharmacology at the University of California, San Diego. Following my post-
`
`doctoral work, I was an Assistant and later an Associate Professor of Physiology at
`
`New York Medical College from 1980-1989. During this time, I conducted research
`
`in therapeutic areas including stroke, inflammation, ophthalmology, and diabetic
`
`vascular disease.
`
` Throughout my career, I have more than 100 publications in peer-
`
`reviewed journals, written numerous book chapters, and authored three books. I am
`
`currently, or have been, a member of numerous professional organizations, and I
`
`have been presented with numerous awards and honors throughout my career.
`
` Additional information about my professional and educational
`
`experience, and other background information, is described in my curriculum vitae
`
`(Ex.1061).
`
`III. SCOPE OF ENGAGEMENT.
`I have been retained by Petitioner as a technical expert to offer my
`
`
`analysis and opinions regarding various issues related to certain prior art references
`
`as they relate to the ’338 patent, discussed in more detail below.
`
`
`
`4
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` My time spent on this project is compensated at $350 per hour. My
`
`compensation does not depend in any way on the outcome of Petitioner’s petition
`
`for inter partes review of the ’338 patent. Furthermore, I have no financial interest
`
`in this matter.
`
` My opinions and views set forth in this Declaration are based on my
`
`education and training, my experience in academia and the pharmaceutical and
`
`biotechnology industries, and on the materials I have reviewed for this case.
`
`
`
`I have reviewed the ’338 patent and relevant sections of its prosecution
`
`history before the USPTO, (see Ex.1017, ’338 FH). I have also reviewed and
`
`considered various other documents in arriving at my opinions, and cite them in this
`
`Declaration.
`
`
`
`5
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`
`I have been asked to consider the level of education, skill set and
`
`training possessed by persons of ordinary skill in the field relevant to the ’338 patent
`
`as of at least January 13, 2011.1, 2
`
`
`
`I have also been asked to consider, from the perspective of the person
`
`of ordinary skill in the art as of at least January 13, 2011, whether certain references
`
`or documents were available as printed publications, or, in other words, whether
`
`certain references or documents would have been publicly accessible to persons
`
`interested and ordinarily skilled in the subject matter or art, exercising reasonable
`
`diligence, before 2011.
`
`
`
`I have formed certain opinions on these issues, which I set forth in
`
`greater detail below. In sum, it is my opinion that each of the references I discuss in
`
`
`1 I have been asked to assume that the priority date of the ’338 patent is January 13,
`
`2011, the date of the earliest filed provisional application that appears on the ’338
`
`patent cover page. However, I note that the Applicant of the application that issued
`
`as the ’338 patent argued that the priority date of the ’338 patent was November
`
`2011. (See Ex.1017, ’338 FH, 9/11/15 Amendment, 7). I have formed no opinion
`
`regarding the merit of the ’338 patent’s claim to any priority date.
`
`2 I provide my understanding of the qualifications for a person of ordinary skill in
`
`the art relevant to the ’338 patent in ¶¶ 22-24, below.
`
`
`
`6
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`this declaration are printed publications in that they were publicly accessible to
`
`persons interested and ordinarily skilled in the subject matter or art of the ’338
`
`patent, exercising reasonable diligence, before Jan. 13, 2011. Moreover, my
`
`opinions in this regard are repeatedly confirmed by other contemporaneous prior art
`
`documents, which expressly cite the references I have been asked to evaluate. (See
`
`¶¶ 47, 54, 62, 73, 82-87, 97, below).
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART.
` As I mentioned above, it is my understanding that my analysis is to be
`
`conducted from the perspective of a person of ordinary skill in the art at the time of
`
`the invention.
`
`
`
`I also understand that in defining a person of ordinary skill in the art the
`
`following factors may be considered: (1) the educational level of the inventor; (2)
`
`the type of problems encountered in the art; (3) prior art solutions to those problems;
`
`(4) rapidity with which innovations are made; and (5) sophistication of the
`
`technology and educational level of active workers in the field.
`
`
`
`I understand that a person of ordinary skill in the art is a hypothetical
`
`person who is presumed to be aware of all pertinent art, thinks along the lines of
`
`conventional wisdom in the art, and is a person of ordinary creativity at the time of
`
`the invention. I further understand that the relevant timeframe for assessing the ’338
`
`
`
`7
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`patent’s claims from the perspective of a person of ordinary skill in the art is assumed
`
`to be January 13, 2011 (the earliest possible priority date for the ’338 patent).
`
` With respect to the ’338 patent, a person of ordinary skill in the art
`
`would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye
`
`disorders, including the administration of therapies to treat said disorders; and (2) the
`
`ability to understand results and findings presented or published by others in the
`
`field, including the publications discussed herein. Typically, such a person would
`
`have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education
`
`but considerable professional experience in the medical, biotechnological, or
`
`pharmaceutical field), with practical academic or medical experience in: (i)
`
`developing treatments for angiogenic eye disorders, such as age-related macular
`
`degeneration (“AMD”), including through the use of VEGF antagonists, or (ii)
`
`treating of same, including through the use of VEGF antagonists.
`
` A person of ordinary skill in the art would have been aware of the
`
`references and teachings described below, as well as other important information
`
`and references relating to angiogenic eye disorders, the causes of said disorders, and
`
`useful treatments for said disorders.
`
`
`
`8
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`V. LEGAL STANDARDS.
`I am not a lawyer and do not purport to offer any legal opinions. In
`
`
`forming my opinions set forth herein, I have been asked to apply certain standards
`
`regarding printed publications.
`
`
`
`I understand that a reference, publication, document, etc. is a “printed
`
`publication” if the document is “publicly accessible.” I also understand that a
`
`reference is considered “publicly accessible” if it was disseminated or otherwise
`
`made available to the extent that persons interested and ordinarily skilled in the
`
`subject matter or art, exercising reasonable diligence, can locate it.
`
` Thus, a reference that could be classified as a “printed publication”
`
`before the priority date of the ’338 patent would be considered prior art to the ’338
`
`patent.
`
`VI. U.S. PATENT NO. 9,254,338.
`I understand that the ’338 patent issued on February 9, 2016 to
`
`
`Regeneron Pharmaceuticals, Inc. and is titled “USE OF A VEGF ANTAGONIST
`
`TO TREAT ANGIOGENIC EYE DISORDERS,” with George D. Yancopoulos
`
`listed as the sole inventor. (Ex.1001, ’338 patent, cover). I also understand that the
`
`’338 patent issued from U.S. Application No. 13/940,370 (“the ’370 Application”),
`
`a continuation-in-part of International Application No. PCT/US2012/020855, filed
`
`January 11, 2012, and claims priority to U.S. Provisional Application No.
`
`
`
`9
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`61/432,245, filed on January 13, 2011, U.S. Provisional Application No. 61/434,836,
`
`filed on January 21, 2011, and U.S. Provisional Application No. 61/561,957, filed
`
`on November 21, 2011. (Id.).
`
`
`
`I understand that the ’338 patent contains two independent claims and
`
`twenty-four dependent claims. The independent claims are listed below:
`
`
`
`
`
`
`
`
`
`10
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`(Ex.1001, ’338 patent, 23:2-18; id., 24:3-15 (emphasis added to highlight the
`
`differences between the claims)). Claim 14 is very similar to claim 1 with the only
`
`difference (highlighted in yellow) being that the VEGF antagonist (aflibercept) is
`
`described by reference to the nucleic acid SEQ ID NO rather than the amino acid
`
`SEQ ID NO as in claim 1. (Id.). I also understand that claims 2-13 depend from
`
`claim 1, directly or indirectly (id., 23:19-24:2), and claims 15-26 depend from claim
`
`14, directly or indirectly (id., 24:16-53).
`
`VII. PROSECUTION HISTORIES OF THE ’338 PATENT AND ITS
`EUROPEAN EQUIVALENT, EP-325.
`I have reviewed the prosecution history for the ’338 patent, which I
`
`
`understand appears at Ex.1017. It is my understanding that the ‘370 Application
`
`was filed on July 12, 2013 (Ex.1017, ’338 FH, 7/12/2013 Transmittal of New
`
`Application, 1) and originally included twenty claims directed towards a method of
`
`treating “an angiogenic eye disorder” with a “VEGF antagonist.” (Id., 7/12/2013
`
`Original Application, 22-23).
`
`
`
`I have also reviewed EP 2 663 325 (Ex.1062, EP-325), which appears
`
`to be the European equivalent to the ’370 Application, which issued as the ’338
`
`patent. (Id., cover). EP-325 claims the same priority chain as the ’370
`
`Application—specifically, EP-325 claims priority to International Application No.
`
`PCT/US2012/020855, filed January 11, 2012, that claims priority to U.S.
`
`Provisional Application No. 61/432,245, filed on January 13, 2011, U.S. Provisional
`
`
`
`11
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`Application No. 61/434,836, filed on January 21, 2011, and U.S. Provisional
`
`Application No. 61/561,957, filed on November 21, 2011. (Id.).
`
` As originally filed, it is my understanding that EP 325 included claims
`
`similar to those prosecuted in the ’370 Application that issued as the ’338 patent.
`
`(See id., [0020]-[0024]; Ex.1063, EP-325-FH, 7/5/2013 Amendments, 19-20;
`
`Ex.1017, ’338 FH, 7/12/2013 Original Application, 22-23). I have prepared the
`
`following chart to illustrate the similarities between the ’370 Application claims and
`
`the EP 325 claims:
`
`’370 Application Original Claims
`
`EP-325 Original Claims
`
`
`1. A method for treating an angiogenic
`eye disorder in a patient, said method
`comprising sequentially administering
`to the patient a single initial dose of a
`VEGF antagonist, followed by one or
`more secondary doses of the VEGF
`antagonist, followed by one or more
`tertiary doses of the VEGF antagonist;
`
`is
`secondary dose
`wherein each
`administered 2 to 4 weeks after the
`immediately preceding dose; and
`
`tertiary
`each
`wherein
`is
`dose
`administered at least 8 weeks after the
`immediately preceding dose.
`
`2. The method of claim 1, wherein only
`a single secondary dose is administered
`to the patient, and wherein the single
`secondary dose is administered 4 weeks
`
`
`1. A method for treating an angiogenic
`eye disorder in a patient, said method
`comprising sequentially administering
`to the patient a single initial dose of a
`VEGF antagonist, followed by one or
`more secondary doses of the VEGF
`antagonist, followed by one or more
`tertiary doses of the VEGF antagonist;
`
`is
`secondary dose
`wherein each
`administered 2 to 4 weeks after the
`immediately preceding dose; and
`
`is
`dose
`tertiary
`each
`wherein
`administered at least 8 weeks after the
`immediately preceding dose.
`
`2. The method of claim 1, wherein only
`a single secondary dose is administered
`to the patient, and wherein the single
`secondary dose is administered 4 weeks
`
`
`
`12
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`’370 Application Original Claims
`after the initial dose of the VEGF
`antagonist.
`
`3. The method of claim 1, wherein only
`two secondary doses are administered to
`the patient, and wherein each secondary
`dose is administered 4 weeks after the
`immediately preceding dose.
`
`4. The method of claim 3, wherein each
`tertiary dose is administered 8 weeks
`after the immediately preceding dose.
`
`5. The method of claim 1, wherein at
`least 5 tertiary doses of the VEGF
`antagonist are administered
`to
`the
`patient, and wherein the first four
`tertiary doses are administered 8 weeks
`after the immediately preceding dose,
`and wherein each subsequent tertiary
`dose is administered 8 or 12 weeks after
`the immediately preceding dose.
`
`
`EP-325 Original Claims
`after the initial dose of the VEGF
`antagonist.
`
`3. The method of claim 1, wherein only
`two secondary doses are administered to
`the patient, and wherein each secondary
`dose is administered 4 weeks after the
`immediately preceding dose.
`
`4. The method of claim 3, wherein each
`tertiary dose is administered 8 weeks
`after the immediately preceding dose.
`
`5. The method of claim 1, wherein at
`least 5 tertiary doses of the VEGF
`antagonist are administered
`to
`the
`patient, and wherein the first four
`tertiary doses are administered 8 weeks
`after the immediately preceding dose,
`and wherein each subsequent tertiary
`dose is administered 8 or 12 weeks after
`the immediately preceding dose.
`
`
`
`13
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`’370 Application Original Claims
`
`EP-325 Original Claims
`
`
`6. The method of claim 1, wherein the
`angiogenic eye disorder is selected from
`the group consisting of: age related
`macular
`degeneration,
`diabetic
`retinopathy, diabetic macular edema,
`central retinal vein occlusion, branch
`retinal vein occlusion, and corneal
`neovascularization.
`
`7. The method of claim 6, wherein the
`angiogenic eye disorder is age related
`macular degeneration.
`
`8. The method of claim 1, wherein the
`VEGF antagonist is an anti-VEGF
`antibody or fragment thereof, an anti-
`VEGF receptor antibody or fragment
`thereof, or a VEGF receptor-based
`chimeric molecule.
`
`9. The method of claim 8, wherein the
`VEGF antagonist is a VEGF receptor-
`based chimeric molecule.
`
`10. The method of claim 9, wherein the
`chimeric
`receptor-based
`VEGF
`molecule
`comprises VEGFR1R2-
`FcΔC1(a) encoded by the nucleic acid
`sequence of SEQ ID NO:1.
`
`11. The method of claim 9, wherein the
`VEGF
`receptor-based
`chimeric
`molecule comprises (1) a VEGFR1
`component comprising amino acids 27
`to 129 of SEQ ID NO:2; (2) a VEGFR2
`component comprising amino acids
`130-231 of SEQ ID NO:2; and (3) a
`
`
`6. The method of claim 1, wherein the
`angiogenic eye disorder is selected from
`the group consisting of: age related
`macular
`degeneration,
`diabetic
`retinopathy, diabetic macular edema,
`central retinal vein occlusion and
`corneal neovascularization.
`
`
`7. The method of claim 6, wherein the
`angiogenic eye disorder is age related
`macular degeneration.
`
`8. The method of claim 1, wherein the
`VEGF antagonist is an anti-VEGF
`antibody or fragment thereof, an anti-
`VEGF receptor antibody or fragment
`thereof, or a VEGF receptor based
`chimeric molecule.
`
`9. The method of claim 8, wherein the
`VEGF antagonist is a VEGF receptor-
`based chimeric molecule.
`
`10. The method of claim 9, wherein the
`VEGF
`receptor-based
`chimeric
`molecule
`comprises VEGFR1R2-
`FcΔC1(a) encoded by the nucleic acid
`sequence of SEQ ID NO:1.
`
`11. The method of claim 9, wherein the
`VEGF
`receptor-based
`chimeric
`molecule comprises (1) a VEGFR1
`component comprising amino acids 27
`to 129 of SEQ ID NO:2; (2) a VEGFR2
`component comprising amino acids
`130-231 of SEQ ID NO:2; and (3) a
`
`
`
`14
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`’370 Application Original Claims
`multimerization component comprising
`amino acids 232-457 of SEQ ID NO:2.
`
`12. The method of claim 1, wherein all
`doses of the VEGF antagonist are
`administered to the patient by topical
`administration
`or
`by
`intraocular
`administration.
`
`13. The method of claim 12, wherein all
`doses of the VEGF antagonist are
`administered
`to
`the patient by
`intraocular administration.
`
`14. The method of claim 13, wherein
`the
`intraocular
`administration
`is
`intravitreal administration.
`
`15. The method of claim 11, wherein all
`doses of the VEGF antagonist are
`administered to the patient by topical
`administration
`or
`by
`intraocular
`administration.
`
`
`EP-325 Original Claims
`multimerization component comprising
`amino acids 232-457 of SEQ ID NO:2.
`
`12. The method of claim 1, wherein all
`doses of the VEGF antagonist are
`administered to the patient by topical
`administration
`or
`by
`intraocular
`administration.
`
`13. The method of claim 12, wherein all
`doses of the VEGF antagonist are
`administered
`to
`the patient by
`intraocular administration.
`
`14. The method of claim 13, wherein
`the
`intraocular
`administration
`is
`intravitreal administration.
`
`15. The method of claim 11, wherein all
`doses of the VEGF antagonist are
`administered to the patient by topical
`administration
`or
`by
`intraocular
`administration.
`
`
`
`15
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`’370 Application Original Claims
`16. The method of claim 15, wherein all
`doses of the VEGF antagonist are
`administered
`to
`the patient by
`intraocular administration.
`
`17. The method of claim 16, wherein
`the
`intraocular
`administration
`is
`intravitreal administration.
`
`18. The method of claim 17, wherein all
`doses of the VEGF antagonist comprise
`from about 0.5 mg to about 2 mg of the
`VEGF antagonist.
`
`19. The method of claim 18, wherein all
`doses of the VEGF antagonist comprise
`0.5 mg of the VEGF antagonist.
`
`20. The method of claim 18, wherein all
`doses of the VEGF antagonist comprise
`2 mg of the VEGF antagonist.
`
`EP-325 Original Claims
`16. The method of claim 15, wherein all
`doses of the VEGF antagonist are
`administered
`to
`the patient by
`intraocular administration.
`
`17. The method of claim 16, wherein
`the
`intraocular
`administration
`is
`intravitreal administration.
`
`18. The method of claim 17, wherein all
`doses of the VEGF antagonist comprise
`from about 0.5 mg to about 2 mg of the
`VEGF antagonist.
`
`19. The method of claim 18, wherein all
`doses of the VEGF antagonist comprise
`0.5 mg of the VEGF antagonist.
`
`20. The method of claim 18, wherein all
`doses of the VEGF antagonist comprise
`2 mg of the VEGF antagonist.
`
`
`(Ex.1017, ’338 FH, 7/12/2013 Original Application, 22-23; Ex.1063, EP-325-FH,
`
`1/23/2012 Claims, 19-20).
`
` As I describe in more detail in the following paragraphs, several
`
`references were cited as prior art against EP-325, confirming, in my opinion their
`
`public availability and relevance to the ’338 patent.
`
` According to the prosecution history of EP-325, the International
`
`Searching Authority identified a September 28, 2008 Regeneron Press Release as a
`
`
`
`16
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`“prior art document” that it “considered” in its May 22, 2012 written opinion
`
`(referencing the document as “D13”)):
`
`
`
`
`
`
`(Ex.1063, EP-325-FH, 5/14/2012 International Searching Authority Written
`
`
`
`Opinion, 3-4; id., 7/19/2012 International Search Report, 1; see also id., 9/5/2016
`
`Third Party Observations, 2 (D13)). The International Search Authority then
`
`continued to discuss “D13” as the “closest prior art”:
`
`(Id., 5/14/2012 International Searching Authority Written Opinion, 5).
`
` The European Patent Office cited to this same Regeneron Press Release
`
`(as “D13”) in reaching its conclusions in its August 21, 2014 Communication:
`
`
`
`
`
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`
`
`(Ex.1063, EP-325-FH, 8/21/2014 Communication, 8; see also id., 3-5).
`
`
`
`Indeed, multiple Third-Party Observations were submitted during
`
`prosecution of EP 325. The first Third Party Observation included reference to,
`
`among other things, Regeneron Press Releases, a ClinicalTrials.gov record (VIEW2
`
`study), and Regeneron’s Form 10-Q from November 2007—all submitted as “prior
`
`art”:
`
`
`
`18
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`(Ex.1063, EP-325-FH, 9/5/2016 Third Party Observations, 2; see also id., 3-4). The
`
`second Third Party Observation additionally identified the following:
`
`
`
`(Id., 9/7/2016 Third Party Observations, 2).
`
` The European Patent Office’s and Third Parties’ reliance on the above-
`
`mentioned documents confirms, in my opinion, that each was publicly accessible in
`
`that they were disseminated or otherwise made available to the extent that persons
`
`interested and ordinarily skilled in the subject matter or art of the ’338 patent,
`
`exercising reasonable diligence, could locate them. I further note that, as far as I can
`
`tell from reviewing the EP-325 file history, Regeneron never contested the public
`
`availability of those documents.
`
` Separately, I find it important to note that, while prosecuting the ’338
`
`patent, the Applicants relied extensively on Heier-2012, a reference that, in my
`
`opinion, further confirms
`
`the public accessibility of Petitioner’s asserted
`
`ClinicalTrials.gov reports, NCT-795, and NCT-377:
`
`
`
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`
`
`(Ex.1018, Heier-2012, 2539; see also Ex.1017, ’338 FH, 9/11/2015 Amendment, 7
`
`(“The attached Heier et al. article is a peer reviewed article published in
`
`‘Ophthalmology . . . .’”)).
`
`VIII. DISCLOSURES, KNOWLEDGE, & INFORMATION AVAILABLE IN
`THE ART BEFORE JANUARY 13, 2011.
`A. REGENERON PRESS RELEASES.
`In my experience in the pharmaceutical and biotechnology industries,
`
`
`companies like Regeneron and Bayer routinely issue press releases that include
`
`information on product development and/or clinical trials. These press releases can
`
`include information regarding, among other things, the specific product in
`
`development, the study design of a clinical trial, and preliminary or final results from
`
`a specific clinical trial or trials. A person of ordinary skill in the art would be
`
`interested in this type of information regarding ongoing product development within
`
`the industry, including information regarding the development of products of a direct
`
`
`
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`competitor. For example, this type of information continually updates the
`
`competitive landscape for a particular market and would assist the person of ordinary
`
`skill in the art in evaluating the same. As these press releases are a rich source of
`
`information about the ongoing development for a particular treatment, persons of
`
`ordinary skill in the art routinely review such press releases, whether as a result of
`
`exercising diligence, received from email alerts (e.g., Google Alerts), or website
`
`updates (e.g., Seeking Alpha, Evaluate Pharma, and FiercePharma). Indeed, I
`
`myself have searched for, reviewed and relied upon such press releases throughout
`
`my professional career.
`
` Regeneron’s and Bayer’s press releases regarding VEGF Trap-Eye
`
`were no different, and, in my opinion, a person of ordinary skill in the art would
`
`have sought out this information. As specifically noted below, the Regeneron and
`
`Bayer press releases regarding VEGF Trap-Eye disclosed the ongoing development
`
`of VEGF Trap-Eye as a therapy for angiogenic eye disorders, including different
`
`treatment regimens using VEGF Trap-Eye.
`
` Not only would a person of ordinary skill in the art have been interested
`
`in, and sought out, the information contained in the Regeneron and Bayer press
`
`releases, but this person would have been able to easily obtain these press releases
`
`directly from Regeneron’s website on the date of each release. In fact, companies
`
`routinely publish press releases and other information on the company website under
`
`
`
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`a “News” menu or something similar (e.g., “Media” menu or “Investors & Media”
`
`menu) in order to disseminate them to the public in an easily accessible manner.
`
`Press releases are well-known to the community interested in the subject matter of
`
`the reference as a source of useful information. Additionally, documents such as
`
`press releases typically appear in web search results when a person of ordinary skill
`
`in the art conducts a search using various search engines (e.g., via Google, Google
`
`Scholar).
`
` Thus, as of the date of each press release, a person of ordinar