Case 1:22-cv-00061-TSK-JPM Document 617 Filed 09/01/23 Page 1 of 58 PageID #: 47856
`Caésasb: 22eve0O0RISTSISBRI MDdoocnemti1432F2eG BARDS=Pidepe 4d?DA3Pata#:0fB56
`PagelD #: 26985
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`Exhibit 1
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`

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`Case 1:22-cv-00061-TSK-JPM Document 617 Filed 09/01/23 Page 2 of 58 PageID #: 47857
`CaéSasb: 22eve0O0RISTSISBRI MDdoocnemti1432FaeSBRI0ADS=Pideph dtDa3PatyegD 2:016857
`PagelD #: 26986
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`Vv.
`
`MYLAN PHARMACEUTICALSINC.,
`
`Defendant.
`
`Case No. 1:22-cv-00061-TSK
`
`JURY TRIAL DEMANDED
`
`HIGHLY CONFIDENTIAL —
`OUTSIDE COUNSEL’S EYES ONLY
`
`OPENING EXPERT REPORT AND DECLARATIONOFDR.
`FRANKLIN SWARTZWELDER REGARDING MYLAN’S INFRINGINGMENT OF
`U.S. PATENT NO.11,104,715
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 617 Filed 09/01/23 Page 3 of 58 PageID #: 47858
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`TABLE OF CONTENTS
`
`I.
`II.
`Il.
`IV.
`V.
`
`VI.
`
`Introduction and Summary of Opinions.............ccceeeceeeeeeeeeeeeeeeceeceaeeeeeeeeeeesaeecnaeeetneeeneeeaeees 1
`Background and Qualifications.............cecceeceeeeeeeeeceeeeeseeesneeseeesseeceaeceseessneesaeecsaeesneesneetaeees 2
`Assignment and Legal Standards ............ecceeceeeseceeeeeseeeececeaeceeessneesaeecnaeeeseeeeneesaeeenaeentneenes 5
`The Person of Ordinary Shall in thé Aftrcsc: scncss ces noms: moseaneess oases memes 8
`Scientific and Technical Background .............cceececeseceeeeeeneeeeeceaeceeeeeneesaeecaeceseeeeneesanecsaeenes 9
`A.
`Cell Culture and the Cell Culture Medium... cesses seeeseesecnseenaeceesaeeentens 10
`B.
`Large-Scale Cell Culture Operations .......... cee ceeeseeescnseenseseeeseeeseesaeenaeensesaeesaeees 12
`The 7715 Patent 0... ee eecseseeescesseessecnsecseesaeeseesseesaecnaecaaesaeeseesseesaecnaesseesaesseesaeenaeenaesaes 14
`A.
`SPSCACOce seemeeepeescees seeeeceesmeuer: seeereeermereees saseeeeseeee: GeeeeEecKeRt SEerESEREeERs Gee 14
`B. Cat0... eee eeeeeeeeeeesecnsecscesaeeseeeseeeaeenaecnsecaeesaeeseesaeesaecsaesaeesaeeseesseesatenaessaesaeeateas 18
`G.
`Claim Construction... cece seesceesseesecssecnseceessesseesseeaeenaesaaesaeeseeeseesaeenaessaesaeeeateas 20
` Mylan’s Manufacturing Process.............cescceeeeeeeeeseeeceeeeeeneeseeecaeeceaeeeeeeseeesaeesnaeeeeeeeeneeeaeess 21
`A.
`The Basal Media in Mylan’s Manufacturing Process is Chemically
`DSTCT srcmssnss sssmmeeseens SEMNEMESUMESSEEG HOENCRNSENSEES SEMMASMRESIERNDS GIRMETIOTNNTS INGORE HEN 22
`Stages of Mylan’s Manufacturing Process ..........:cecseseeeeeeeeeseeeceeeeeneeeeeeseeenaeenes 25
`B.
`Additional Processing Steps ..........e:ceeceeeceeeseeceeeeeseeeeneeseeecseeceaeeeeeesneeseessaeenenennee 31
`GC.
`VIII. Mylan’s Infringement of the Asserted Claims of the ’715 Patent «0.0.0... ee eeeeeeeeeneees 36
`A.
`‘““A methodof producing aflibercept harvested from a hostcell cultured in
`a chemically defined medium (CDM)”(Claims 1, 16)..........eccecceeeseeeeeeeeeeeeeeeeeees 36
`“providing a host cell genetically engineered to express aflibercept”
`(Claim 1) oo. eeeeeeeeeeenceeeeceneeeseeesaeeceaecaeeeseeesaeecsaecaeesseeesaeecasesseeseneesaeesnaeeneeseneeeneers 37
`“culturing said host cell in said CDM under conditions suitable in which
`said host cell expresses said aflibercept” (Claims 1, 16) ..........eceeeceeeneeeeeeeeeeeeneees 38
`Cumulative Concentration Limitations (Claims 1, 16) 0.0... eeeeseeseeseeeneeeeeees 40
`D.
`“harvesting aflibercept produced by said host cell” (Claims 1, 16)... 40
`E,
`Color Limitations (Claims 2, 13, 14)... eee eeecssecnsecneeseeeseeeseesaeeaecaesaeesaeens 4]
`F.
`Anti-oxidant Limitation (Claims 3 and 12) oo... eee eeeeseeeeeesecnsecneeteeeseeeaeenaees 46
`G.
`Host Cell Limitation (Claim 6)... ceceeceseeseseeeseeseecesecseseeseesseesaeenaeenaesaeeeneeas 47
`H.
`Material Change and Trivial or Nonessential Component..0...... eee ceeeeeeeeeeeeeees 47
`I.
`CLT CUBE crecememeesmass crmemseseastns GmeoURNETENSS TENEESRESNIURERSG TARREEEETENNESS EEOSERUIEMAES MEMESTSERSNI SEES 49
`
`VII.
`
`TX
`
`B.
`
`C.
`
`il
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 617 Filed 09/01/23 Page 4 of 58 PageID #: 47859
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`I.
`
`INTRODUCTION AND SUMMARYOF OPINIONS
`
`l.
`
`I have been retained on behalf of Plaintiff Regeneron Pharmaceuticals,Inc.
`
`(“Plaintiff’ or “Regeneron’’) as an independent expert witness in this case. This expert report
`
`and declaration sets forth my analyses and opinions based on my knowledge, experience, and the
`
`materials I have considered.
`
`Ds
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`In this report and declaration, I offer opinions concerning the process employed
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`by Mylan to manufacture its aflibercept product, M710.
`
`I have compared that process to the
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`processes of claims 2-3, 6, 12-14, and 16 of Regeneron’s U.S. Patent No. 11,104,715 (“the 715
`
`patent”). Based on my analysis, Mylan’s manufacturing process satisfies each and every element
`
`of these claims.
`
`I provide a brief summary of my infringementopinions below.
`
`3.
`
`As part of its cell culture process, Mylan uses host cells that have been genetically
`
`engineered to express aflibercept. The particular host cells that Mylan uses are Chinese Hamster
`
`Ovary, or “CHO,”cells.
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 617 Filed 09/01/23 Page 5 of 58 PageID #: 47860
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`fs
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`Claims 2, 13, and 14 ofthe ’715 patent recite color limitations ofthe harvest.
`
`[CEei eeeerenteeeeeneeeeeanaammy
`1
`i
`
`Regeneron Protected Material
`
`9.
`
`Claim 6 ofthe ’715 patent requires a particular type ofhostcell. po
`
`10.
`
`Based on my analysis of Mylan’s manufacturing and formulation processes, it is
`
`my opinion that the aflibercept produced by the patented processes is not materially changed by
`
`any subsequent process. None of Mylan’s purification or formulation steps are intended to
`
`modify the aflibercept protein itself. Moreover, the aflibercept produced by the patented process
`
`does not becomea trivial or nonessential component of another product; rather, aflibercept is the
`
`active ingredient in Mylan’s M710 drug product.
`
`Il.
`
`BACKGROUND AND QUALIFICATIONS
`
`11.
`
`My qualifications are described in detail in my curriculum vitae, whichis
`
`attached as Appendix A.
`
`12.
`
`I have more than 30 years of experience in developing cell culture technology and
`
`processes. Much of my workandresearch has focused specifically on investigating and
`
`improving on mammalian cell culture products for use in biopharmaceutical manufacturing.
`
`2
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 617 Filed 09/01/23 Page 6 of 58 PageID #: 47861
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`13.=[received my Ph.D. in 1986 in Microbiology/Immunology from SUNY Buffalo,
`
`School of Medicine and Biomedical Sciences. The topic of my thesis was “The Mechanism of
`
`Activation of Murine B Lymphocytes by Lipopolysaccharide.”
`
`14.=‘From 1989 through 1999, I worked at GIBCO Life Technologies, which I now
`
`understand to be part of ThermoFisherScientific. At GIBCO, my early work focused on
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`optimization of serum-free media for the culture of various cell lines, including those for Madin-
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`Darbybovine kidney (or “MDBK’”’)cells, Madin-Darby canine kidney (or “MDCK”’)cells, and
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`fibroblast cells (i.e., cells that contribute to the formation of connective tissue). During the last
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`five years of my tenure at GIBCO, I led a Regenerative Medicine Media Development Group in
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`the development of novel products for hematopoietic stem cells for analysis and the
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`growth/expansion of human stem cells for clinical applications.
`
`15.
`
`In 1999, I joined Gencyte, LLC, where I established a stem cell product
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`development laboratory and Current Good Manufacturing Practice (or “cGMP”’) production
`
`capabilities within the company, as required by the U.S. Food & Drug Administration (“FDA”).
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`Generally, cGMP regulations require systems that properly design, monitor, and control
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`manufacturing processesandfacilities.
`
`16.
`
`‘In 2002, I co-founded Stemgenix, LLC—a spin-off of Gencyte—to focus on the
`
`development and commercialization of media products related to human stem cell research and
`
`clinical work. There, my team and I designed and commercialized a platform of over twenty
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`media and cell culture products for stem cell research and clinical stem cell transplantation
`
`markets.
`
`17.—In 2003, I joined Sigma-Aldrich Corporation/SAFC, which subsequently became
`
`MilliporeSigmain 2015, where I remained until my retirement from industry in December 2021.
`
`

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`Throughout my tenure at MilliporeSigma, I focused on the design, development, and
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`manufacture of catalog cell culture products and new custom Chinese Hamster Ovary (or
`
`“CHO”) cell culture media products for several large biotherapeutic manufacturers.
`
`18.
`
`Throughout my career, I frequently worked as a consultant with pharmaceutical
`
`companiesto assist them with their developmentofcell culture products and processes. As part
`
`of that work, I routinely assessed existing cell culture processes—and accompanying data—to
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`recommend improvements in media compositionsor other aspects oftheir cell culture processes.
`
`19.
`
`In 2016, I established an upstream processing Scientific Advisory Board (“SAB”),
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`an expert network ofscientists immersed in biological research, drug discovery, and
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`biopharmaceutical production. In this role, I organized and led two SAB events for
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`MilliporeSigma’s BioProcessing Business. The outputs for these events were then integrated
`
`into the company’s future strategic plans for the business.
`
`20.
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`In 2017, I became oneof the original members of the Advanced Mammalian
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`Biomanufacturing Innovation Center (“AMBIC”), which is a consortium of leading academic
`
`and industrial biotechnology experts focused on mammalian cell culture manufacturing at a
`
`precompetitive research level. In 2018, I was selected as the first AMBIC Mentor of the Year in
`
`recognition of outstanding project leadership and student mentorship.
`
`21.
`
`In 2020, I was elected as the Chair-Elect and 2021 Chair of the AMBIC Industrial
`
`Advisory Board (“IAB”). During that time, I led a 30-memberboard of biotherapeutic
`
`manufacturers and suppliers in determining organizational research direction and funding for the
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`consortium. As AMBIC JABchair, I also worked with the AMBIC Center Director at Johns
`
`Hopkins University and academicleadership at each of the other four memberuniversities
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`

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`PagelD #: 26992
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`(Clemson University, University of Delaware, University of Massachusetts Lowell, and the
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`University of Maryland) to ensure funding and implementation of industry research initiatives.
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`22.
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`Most recently, in 2021, I organized andled the Innovation Summit for
`
`MilliporeSigma Process Solutions Division, which had over one hundred members.
`
`23.
`
`Iam being compensated for my workin this case at a rate of $350 per hour plus
`
`expenses. My compensationis in no waytied to the outcomeofthis case or the content of my
`
`testimony.
`
`I have nottestified as an expert at trial or by deposition in the last four years.
`
`I.
`
`ASSIGNMENT AND LEGAL STANDARDS
`
`24.
`
`‘It is my understanding that Mylan has submitted Biologics License Application
`
`(“BLA”) No. 761274 to the FDA requesting permission to market a biosimilar version of
`
`Regeneron’s EYLEA(aflibercept) product in the United States, which Mylan refers to as M710.
`
`See MYL-AFL-BLA0001752 at 1754 (“This application is being submitted for Viatris’ and
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`Janssen Pharmaceuticals’ codeveloped product, M710, a proposed biosimilar to Eylea®
`
`(Regeneron Pharmaceuticals Inc., United States and Bayer Healthcare Pharmaceuticals Inc.,
`
`Germany).’’).
`
`25.
`
`[have been asked to compare Mylan’s process for manufacturing its biosimilar
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`M710 product to claims 2-3, 6, 12-14, and 16 of the ’715 patent (the “Asserted Claims”) using
`
`the claim constructions discussed in Section IV, infra.
`
`I understand that this comparisonis
`
`called an infringement analysis and that for Mylan to infringe a particular claim of the ’715
`
`patent, Mylan’s biosimilar product—orthe process used to manufacture Mylan’s biosimilar
`
`product—must meetorsatisfy all the limitations recited in the claim,literally or under the
`
`doctrine of equivalents.
`
`26.
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`In the absence of an express claim construction from the Court, I have been
`
`informed that in performing an infringementanalysis, I am to use the ordinary and customary
`
`5
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`

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`meaning that the claim terms would have had to the hypothetical Person of Ordinary Skill in the
`
`Art (“POSA”)as of the relevant date. My opinions with respect to the qualifications of the
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`POSAasofthe dates relevant to the ’715 patent are discussed in Section IV,infra.
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`27.
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`[have been informedthatto literally infringe a patent claim, an accused product
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`or process must haveor perform each and every limitation of the claim exactly as recited.
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`However, even in the absenceofliteral infringement, I have been informed that an accused
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`product or process may nonetheless infringe under the doctrine of equivalents if the differences
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`between the accused product or process and the claimed invention would have been insubstantial
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`to the hypothetical person of ordinary skill in the art. The difference between an accused product
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`or process and a claimed invention can be considered insubstantial if the missing element or step
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`in the accused productor process performs substantially the same function in substantially the
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`same wayto achievesubstantially the sameresult as the claimed invention.!
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`28.
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`[have been informedthat a biosimilar manufacturer who seeks FDA approval to
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`market a biosimilar product that falls within the scope of a claim infringes that claim as a matter
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`of law. Thus, if a BLA specification overlaps the scope of a given claim limitation, the
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`biosimilar has infringed that limitation. For example,it is my understandingthat if a biosimilar
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`applicant seeks approval to manufacture and sell a product containing anywhere between 0.0—
`
`0.6% of a particular substance, then that proposed product would infringe a claim requiring that
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`the composition contain less than 0.25% of the substance.
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`I have been informedthat for
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`purposesofthis inquiry, it does not matter whether the product as ultimately manufactured, or
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`every batch of the product as ultimately manufactured, meets the limitations of the claim. The
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`
`
`' As discussed below,it is my opinion that Mylanliterally infringes all of the Asserted Claims.
`reserve the right in the future to offer an opinion regarding Mylan’s infringement under the
`doctrine of equivalents.
`
`|
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`

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`Case 1:22-cv-00061-TSK-JPM Document 617 Filed 09/01/23 Page 10 of 58 PageID #:
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`47913
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