`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________
`
`KASHIV BIOSCIENCES, LLC
`Petitioner
`
`v.
`
`AMGEN INC.
`Patent Owner
`
`____________________
`
`Case No. IPR2019-00797
`U.S. Patent No. 9,643,997
`____________________
`
`AFFIDAVIT OF ERIC J. MARANDETT IN SUPPORT OF PETITIONER’S
`MOTION FOR PRO HAC VICE ADMISSION
`
`KASHIV EX1078
`IPR2019-00797
`
`Page 1
`
`
`
`IPR2019-00797
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`I, Eric J. Marandett, being duly sworn and upon oath, hereby attest to the
`
`following:
`
`1.
`
`I am a member in good standing of the Bar of the Commonwealth of
`
`Massachusetts.
`
`2.
`
`I have not been suspended or disbarred from practice before any court
`
`or administrative body.
`
`3.
`
`I have never had an application for admission to practice before any
`
`court or administrative body denied.
`
`4.
`
`No sanction or contempt citation has been imposed against me by any
`
`court or administrative body.
`
`5.
`
`I have read and will comply with Office Patent Trial Practice Guide
`
`and the Board’s Rules of Practice for Trials, as set forth in Title 37, Part 42 of the
`
`C.F.R.
`
`6.
`
`I will be subject to the USPTO Rules of Professional Conduct as set
`
`forth in 37 C.F.R. §§ 11.101 et seq. and the USPTO’s disciplinary jurisdiction
`
`under 37 C.F.R. § 11.19(a).
`
`7.
`
`In 2011, I applied to appear and was admitted pro hac vice before the
`
`BPAI in Patent Interference No. 105,809 (RT) between Adimab, LLC and Dyax
`
`Corp. In 2014, I applied to and was admitted pro hac vice before the PTAB in
`
`Inter Partes Review IPR2015-00291 involving Daiichi Sankyo Company Limited
`
`Page 2
`
`
`
`IPR2019-00797
`
`and Alethia Biotherapeutics Inc. In 2015, I applied to and was admitted pro hac
`
`vice before the PTAB in Inter Partes Review IPR2016-00258 involving Green
`
`Cross Corporation and Shire Human Genetic Therapies, Inc. On June 10, 2019, I
`
`was admitted pro hac vice before the PTAB in Inter Partes Reviews IPR2019-
`
`00652 and IPR2019-00653 involving Foundation Medicine, Inc. and Guardant
`
`Health, Inc. I am concurrently applying for pro hac vice admission before the
`
`PTAB in Inter Partes Review IPR2019-00791 involving Kashiv BioSciences, LLC
`
`and Amgen Inc.
`
`8.
`
`I am an experienced litigation attorney with more than twenty years of
`
`experience representing clients in patent litigation in various forums including
`
`federal district courts across the United States. I am currently the chair of the
`
`intellectual property litigation group of Choate Hall & Stewart and have been
`
`involved in many major patent litigations during the course of my career and
`
`frequently serve as lead counsel in those cases. My biography is attached hereto as
`
`Appendix A.
`
`9.
`
`I am familiar with the subject matter at issue in this proceeding. I
`
`have been intimately involved in advising Kashiv BioSciences, LLC on its IP
`
`strategies, including with respect to the patent at issue in this proceeding. I have
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`also invested a significant amount of time reviewing and analyzing relevant
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`Page 3
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`
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`materials in preparation for representing Kashiv BioSciences, LLC in this IPR and
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`the related concurrent litigation.
`
`IPR2019-00797
`
`Date:
`
`July 8, 2019
`
`Respectfully submitted,
`By:
`
` Eric J. Marandett
`
`Page 4
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`
`
`IPR2019-00797
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing AFFIDAVIT OF ERIC
`
`J. MARANDETT IN SUPPORT OF PETITIONER’S MOTION FOR PRO
`
`HAC VICE ADMISSION was served electronically in its entirety on July 8, 2019
`
`via electronic mail to the following attorneys of record:
`
` sbaughman@paulweiss.com
` mraymond@paulweiss.com
` cnyarady@paulweiss.com
` GRP-AmgenIPR@paulweiss.com
`
`Date: July 8, 2019
`
`Respectfully submitted,
`
`By: / Rolando Medina /
`Rolando Medina, Reg. No. 54,756
`Eric J. Marandett, Pro Hac Vice to be filed
`Margaret E. Ives, Pro Hac Vice to be filed
`Sophie F. Wang, Pro Hac Vice to be filed
`CHOATE HALL & STEWART LLP
`Two International Place
`Boston, MA 02110
`617-248-5000
`
`Attorneys for Petitioner
`
`Page 5
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`
`
`Eric J. Marandett
`Practice Group Leader
`
`T +1 (617) 248-5287 | emarandett@choate.com
`
`“Very business-savvy and [clients’] first port of call for litigation.”
`Chambers USA
`
`Eric Marandett represents biotech, pharmaceutical and
`technology companies in high stakes patent litigation and other
`intellectual property and commercial disputes. Mr. Marandett’s
`approach to litigation combines a keen business savvy with the
`courtroom skills of a seasoned trial lawyer. In
`2017, Mr. Marandett was named to Who's Who Legal's list of top
`patent attorneys and 2017 Boston “Lawyer of the Year” for
`Intellectual Property Litigation. He was named the 2015 Boston
`“Lawyer of the Year” for Patent Litigation by Best Lawyers,
`and was included in the Patent Expert Guide in 2015 and 2017,
`placing him among “the world’s leading practitioners” in patent
`law. He is listed in the Massachusetts Super Lawyers Top 100 and
`is also listed in Chambers USA. He has been listed in The Legal
`500, and named a World’s Leading Patent Litigator by IAM 250, a
`World’s Leading Patent Practitioner by IAM Patent 1000 and an
`“IP Star” by Managing Intellectual Property.
`
`Mr. Marandett co-chairs the Firm’s Intellectual Property Litigation
`Practice Group. He is also a member of the Firm’s Executive
`Committee.
`
`PRACTICE FOCUS
`
`EDUCATION
`University of Pennsylvania
`Law School
`JD, 1992
`
`Tufts University
`BA, 1988, magna cum laude
`
`Complex Intellectual Property Disputes
`Patent infringement (including Hatch-Waxman litigation), licensing disputes and other intellectual property litigation
`on behalf of major pharmaceutical and biotech companies and clients in the high tech industry.
`
`Complex Commercial Litigation
`Securities and antitrust litigation, unfair competition, theft of trade secrets, state and federal investigations of
`Medicare and Medicaid Fraud, anti-kickback and drug record keeping violations.
`
`Intellectual Property Counseling & Due Diligence
`Assessment of freedom to operate and patentability, valuation of intellectual property, Orange Book and other
`regulatory and strategic questions in connection with collaborations, acquisitions and joint ventures, particularly in
`the life sciences industries.
`
`Post Grant Proceedings
`Represents clients in AIA post-grant review proceedings, including inter partes review and post-grant review
`proceedings.
`
`Page 6
`
`
`
`ADMISSIONS
`Massachusetts
`
`U.S. District Court,
`District of Massachusetts
`
`U.S. Court of Appeals,
`First & Federal Circuits
`
`U.S. Supreme Court
`
`PRACTICE AREAS
`Complex Intellectual
`Property Disputes
`
`Complex Commercial
`Litigation
`
`Life Sciences
`
`Antitrust
`
`Intellectual Property
`Protection
`
`CHOATE.COM
`
`REPRESENTATIVE ENGAGEMENTS
`
`PATENT LITIGATION
`• Shire LLC v. Abhai LLC, D Mass: Currently representing Shire in Hatch-Waxman
`litigation involving generic versions of ADDERALL XR®.
`
`• Momenta v. Amphastar et al.: Co-Lead Counsel to Momenta in patent infringement
`action relating to innovative methods of processing therapeutic polysaccharides.
`Obtained preliminary injunction precluding sales of generic enoxaparin by
`Amphastar Pharmaceuticals.
`
`• Wyeth v. Intervet, Inc and Boehringer Ingelheim Vetmedica, Inc, D Del: Lead counsel
`for Wyeth (now Pfizer) in patent infringement litigation involving industry leading
`genetically engineered porcine circovirus vaccines.
`
`• Pieczenik v. Abbott Laboratories, et al., D NJ: Lead counsel for Millennium in patent
`infringement action relating to combinatorial phage display libraries.
`
`• King Pharmaceuticals and Wyeth v. Teva, D NJ: Lead counsel for Wyeth in Hatch-
`Waxman patent action brought against Teva relating to prescription sleep aid
`marketed by King.
`
`• Momenta Pharmaceuticals, Inc and Sandoz, Inc v. Teva Pharmaceuticals, Ltd, et al, D
`Mass: Counsel to Momenta in patent infringement action relating to innovative
`methods of processing therapeutic polysaccharides.
`
`•
`
`Iovate Health Sciences v. Allmax Nutrition, D Mass: Lead counsel for Iovate in patent
`infringement action relating to novel nutritional supplements.
`
`• Tiber Laboratories, LLC v. Hawthorn Pharmaceuticals, Inc, D Northern District of
`Georgia & Tiber Laboratories, LLC v. Cypress Pharmaceuticals, Inc, Southern District
`of Mississippi Jackson Division: Lead counsel for Cypress and Hawthorn in patent
`infringement relating to cough and cold medicine.
`
`• Housey Pharmaceuticals, Inc v. Abbott Pharmaceutical Corp et.al., D Del Counsel for
`Eisai Co, Ltd: Counsel to Eisai, Inc and Eisai Research Institute of Boston, Inc
`(collectively “Eisai”), one of 11 major pharmaceutical companies sued for
`infringement of four patents to certain cell-based screening assays.
`
`•
`
`The Read Corporation, et al v. Powerscreen International, PLC, et al, D Mass:
`Obtained judgment on appeal reversing $34 million verdict against Powerscreen.
`
`• Sapidyne Instruments, Inc v. Gyros US, Inc, D Mass: Lead counsel for Sapidyne in
`patent infringement action involving antibody affinity assays.
`
`• Genetics Institute v. Baxter International, Inc, D Mass: Counsel for Genetics Institute
`in patent infringement and breach of contract litigation relating to development of
`recombinant Factor VIII.
`
`• Amgen, Inc v. Hoechst Marion Roussel, Inc and Transkaryotic Therapies, Inc, D Mass:
`Along with co-counsel, represented defendants TKT and HMR in patent
`infringement litigation brought by Amgen to prevent TKT from commercializing its
`patented gene-activated erythropoietin product.
`
`Page 7
`
`
`
`CHOATE.COM
`
`• Biogen v. Berlex Laboratories, D Mass: Along with co-counsel, represented Berlex
`Laboratories in patent infringement litigation involving recombinant beta interferon
`for treatment of multiple sclerosis.
`
`Other Intellectual Property and Commercial Litigation
`• Children’s Medical Center Corporation v. Celgene Corporation, D Mass: Lead counsel
`to Celgene in breach of contract litigation regarding exclusive license agreement
`related to Revlimid and Pomalyst.
`
`• HCRP v. Shionogi Pharmaceuticals, NY Ct: Counsel to Shionogi Pharmaceuticals in
`contract action related to manufacturing and marketing of Fenoglide.
`
`• Alnylam Pharmaceuticals, Inc. vs. Dicerna Pharmaceuticals, Inc.: Counsel to Alnylam
`Pharmaceuticals in trade secret misappropriation lawsuit brought against Dicerna
`Pharmaceuticals.
`
`• Tekmira v. Alnylam & AlCana: Counsel to AlCana in trade secret litigation brought
`against AlCana and its research collaboration partner Alnylam Pharmaceuticals by
`Tekmira Pharmaceuticals Corp. Technology at issue involves novel lipid
`nanoparticles used as drug delivery vehicle for Alnylam’s short interfering RNA
`therapeutics.
`
`• Applera Corp., d/b/a Celera Genomics Group v. Wyeth, Montgomery County Maryland
`Circuit Court: Lead counsel for Wyeth in breach of contract dispute relating to
`Celera’s genomics database products.
`
`• Alamo Pharmaceuticals v. Astellas Pharma Inc, Central D of CA: Counsel to Astellas
`Pharma in breach of contract and unfair competition litigation relating to drug
`formulation collaboration.
`
`• Baxter HealthCare, Inc v. Genetics Institute, Inc, Delaware Chancery Court: One of
`three partners representing Genetics Institute in contract dispute relating to the
`manufacture of recombinant Factor VIII for treatment of hemophilia A.
`
`• KiOR, Inc v. George Huber, et al., D Mass: Counsel to KiOR in breach of contract and
`misappropriation of trade secrets litigation involving biomass catalytic conversion
`technology.
`
`Patent Trial and Appeal Board and Appellate Proceedings
`• Daiichi Sankyo Company Limited v. Alethia Biotherapeutics, Inc., PTAB: Counsel to
`Alethia Biotherapeutics in IPR proceeding challenging patent directed to methods of
`impairing osteoclast differentiation.
`
`• Foundation Medicine, Inc. v. Guardant Health, Inc., PTAB: Counsel to Foundation
`Medicine in IPR proceedings challenging patents directed to methods for detecting
`genetic mutations.
`
`• Adimab, LLC v. Dyax Corp, PTAB.: Counsel to Adimab in patent interference dispute
`with Dyax Corp. relating to antibody display.
`
`•
`
`Saudi Arabian Oil Co. v. SK Innovation Co. Ltd., PTAB: Counsel to Saudi Arabian Oil Co.
`in an IPR proceeding challenging a patent directed to polycarbonates.
`
`Page 8
`
`
`
`CHOATE.COM
`
`• Green Cross Corp. v. Shire Human Genetic Therapies, Inc., PTAB: Counsel for Shire
`in defending patents relating to novel methods for purifying recombinantly
`produced proteins for enzyme replacement therapy.
`
`• Kashiv BioSciences, LLC v. Amgen Inc., PTAB: Counsel for Kashiv in IPR proceedings
`challenging patents related to methods of protein refolding and purification.
`
`• Green Cross Corp. v. Shire Human Genetic Therapies, Inc., Fed Cir: Counsel for Shire
`in defending appeal of IPR decision.
`
`PUBLICATIONS AND PRESENTATIONS
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`“Accomplishing Your Deposition Goals,” webinar panelist, Practicing Law Institute,
`March 2019.
`
`“Protecting Your Trade Secrets: From HQ To Across The Globe,” moderator,
`Consero IP Forum for Life Sciences, December 2018.
`
`“IP Litigation Trends,” panelist, Boston Bar Association Life Sciences Conference,
`September 2018.
`
`“Fundamentals of Taking and Defending Depositions 2018,” speaker, Practicing
`Law Institute, March 2018.
`
`“In the Hot Seat—Upcoming Cases in the Supreme Court and Federal Circuit,”
`moderator, BIO IPCC Fall Conference, November 2017.
`
`“Licensing and Collaboration Agreements: Traps for the Unwary,” moderator, BIO
`IPCC Fall Conference, November 2016.
`
`“The Supreme Court Speaks...Again,” moderator, BIO IPCC Fall Conference,
`November 2015.
`
`“Ariosa V. Sequenon Signals Trouble Ahead For Life Sciences,” co-author, IP
`Law360, November 2015.
`
`“Will The Pendulum Swing Back In IPR Proceedings?”, co-author, IP Law360, April
`2015.
`
`“Safe Harbor Provisions Broadly Construed, Due for High Court Review, Panelists
`Say,” moderator, BIO IPCC Fall Conference, November 2014.
`
`“Secondary Consideration for Pharma Patents get 2nd Look,” co-author, IP
`Law360, November 2014.
`
`“How Federal Circuit’s Commil Ruling Could Affect Drug Patents,” co-author, IP
`Law360, December 2013.
`
`“Trade Secrets in Life Sciences: Challenges and Opportunities in a Collaborative
`and Mobile Environment,” co-author, Bloomberg BNA, November 2013.
`
`Page 9
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`
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`CHOATE.COM
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`“Is There a New Paradigm for Indirect Infringement?” moderator, BIO IP Counsels
`Committee Fall Conference and Meeting, November 2013.
`
`“Adopt IP Protections to Ensure Regulatory Exclusivity for Orphan Drugs,” co-
`author, ACC Docket, August 2013.
`
`“Q&A with Choate’s Eric Marandett,” featured, IP Law360, June 2013.
`
`“Managing Outside Counsel Efficiently and Effectively,” panelist, The Consero
`Group’s Pharmaceuticals & Biotechnology IP Forum, Palm Beach Garden, FL,
`December 2012.
`
`“The Trade Secret Minefield,” moderator, BIO IP Counsels Fall Conference and
`Meeting, Charleston, SC, November 2012.
`
`“Avoiding Trade Secret Litigation in the Life Sciences,” co-author, IP Law360, August
`2012.
`
`“Finance & BD: Strategies for Building & Realizing Value in the Evolving Biotech
`Landscape,” panelist, MassBio, April 2012.
`
`”Preempting Patent Litigation With 3rd-Party Submissions,” co-author, IP Law360,
`February 2012.
`
`PROFESSIONAL AND COMMUNITY INVOLVEMENT
`
`Mr. Marandett is a member of the American Bar Association Intellectual Property and
`Litigation sections, the American Intellectual Property Law Association, the Boston Bar
`Association and the Massachusetts Bar Association. In addition, he is counselor of the
`Boston IP Inn of Courts. Mr. Marandett is also active in the Dana Farber Leadership
`Council.
`
`Page 10
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`