`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`
`GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC,
`Petitioner
`
`v.
`
`CIPLA LTD.,
`Patent Owner
`
`____________________
`
`Case No. 2020-00368
`U.S. Patent No. 8,163,723
`____________________
`
`DECLARATION OF KELLEY HAYES GREENHILL
`
`
`
`
`
`IPR2020-00368 (U.S. Patent No. 8,163,723)
`Declaration of Kelley Hayes Greenhill
`
`
`
`Introduction
`I have prepared this Declaration in connection with the Petition of
`1.
`
`I.
`
`GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (“Petitioner”) for an
`
`inter partes review of U.S. Patent No. 8,163,723 (“the ’723 patent”), which I
`
`understand will be filed concurrently with this Declaration. I also understand that
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`June 14, 2002 is the purported priority date for the ’723 patent.
`
`2.
`
`I am currently the Manager of Research & Information Services at
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`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, 901 New York Avenue,
`
`NW, Washington, DC 20001-4413.
`
`3.
`
`I am over eighteen years of age and am competent to make this
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`Declaration. I make this Declaration based on my own personal knowledge and
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`based on my knowledge of library science practices.
`
`4.
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`I earned a Master of Science in Library Science (“MSLS”) from the
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`Catholic University of America in 1995, and a Bachelor of Arts in Political
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`Science from Duquesne University in 1989. I have worked as a librarian for over
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`twenty-five years. I have been employed in the Research & Information Services
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`Department at Finnegan, Henderson, Farabow, Garrett & Dunner since 2019.
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`Before that, from 1995-2015, I was employed in the Library Department of Sterne
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`Kessler Goldstein & Fox. And from 2015-2019, I was employed in the Knowledge
`
`
`
`
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`IPR2020-00368 (U.S. Patent No. 8,163,723)
`Declaration of Kelley Hayes Greenhill
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`
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`and Research Services Group (formerly, Information Research Service) at
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`Northrop Grumman Corporation.
`
`5.
`
`I am a member of the American Association of Law Libraries and a
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`member of the Law Librarians’ Society of Washington, DC.
`
`Standard Library Practice for Receiving, Cataloging, and Shelving
`II.
`Materials
`6.
`
`I have knowledge of and experience with standard library practices
`
`regarding receipt, cataloging, and shelving of materials.
`
`7.
`
`Based on standard library practice, when a library receives an item, it
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`stamps the item with the library name and often with a date that is within a few
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`days or weeks of receipt. The library will catalog the item within a matter of a few
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`days or weeks of receiving it.
`
`8.
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`After an item is cataloged, the public may access the item by
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`searching the catalog and requesting the item from the library. Standard library
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`practice is to then shelve the item within a matter of a few days or weeks of
`
`cataloging it.
`
`9.
`
`Given the matter of a few days or weeks between receiving an item
`
`and cataloging it, and the matter of a few days or weeks between cataloging an
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`item and shelving it, the total time between receiving an item and shelving it is a
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`matter of a couple of weeks or months.
`
`
`
`2
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`
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`IPR2020-00368 (U.S. Patent No. 8,163,723)
`Declaration of Kelley Hayes Greenhill
`
`
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`10. The United States Copyright Office, a part of the Library of
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`Congress, is the official U.S. government body that maintains records of copyright
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`registration in the United States including a Copyright Catalog. These records are
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`publicly accessible and are routinely used by copyright title searchers who are
`
`attempting to clear a chain of title for copyrighted works.
`
`III. Opinion Regarding Individual Documents
`53rd Edition of Physician’s Desk Reference (1999)
`A.
`11. Ex. 1010 provides a true and correct copy of an excerpt of the 53rd
`
`Edition of the Physician’s Desk Reference (“PDR 1999”), containing the labels for
`
`Flonase® and Astelin®.
`
`12. Ex. 1010 was obtained by the Research & Information Services
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`Department of Finnegan from the Social Law Library, in Boston, Massachusetts in
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`response to our request to the Social Law Library for copies of the Flonase® and
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`Astelin® labels contained in the PDR 1999. I placed the request on December 19,
`
`2019, through the Social Law Library’s website. Appended to this declaration as
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`Appendix A is a copy of bill received from the Social Law Library, which lists the
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`date of the request in the top right hand corner and the text of request in the section
`
`titled “Order Description.” (Appendix A.) The excerpt obtained from the Social
`
`Law Library includes the cover, public information page, and title page with a
`
`
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`3
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`IPR2020-00368 (U.S. Patent No. 8,163,723)
`Declaration of Kelley Hayes Greenhill
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`stamp applied by the Social Law Library that reads “RECEIVED MAR 29, 2000.”
`
`Appended to this declaration as Appendix B is a copy of the Social Law Library
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`processing procedures regarding stamping. (Appendix B.)
`
`13. Ex. 1010 is in a condition that creates no suspicion about its
`
`authenticity. Specifically, the text on each page appears to flow seamlessly from
`
`one page to the next and there are no visible alterations to the document. It was
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`found within the custody of a library, the Social Law Library, a place where, if
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`authentic, it would likely be found.
`
`14. Ex. 1010 has a date stamp of March 29, 2000, which indicates the date
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`that the PDR 1999 was received and checked-in to the Social Law Library.
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`Assuming at most a week for transfer to the shelf, the PDR 1999 would have been
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`physically available no later than the first week of April 2000, and thus both the
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`Flonase® and Astelin® labels would have been available at that time.
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`15. Based on this evidence, it is my opinion that Ex. 1010 is an authentic
`
`document publicly accessible to and in actual use by researchers no later than the
`
`first week of April 2000.
`
`
`
`4
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`IPR2020-00368 (U.S. Patent No. 8,163,723)
`Declaration of Kelley Hayes Greenhill
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`
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`54th Edition of Physician’s Desk Reference (2000)
`B.
`16. Ex. 1014 provide a true and correct copy of an excerpt of the 54th
`
`Edition of the Physician’s Desk Reference (“PDR 2000”), containing the labels for
`
`Flonase® and Astelin®.
`
`17. Ex. 1014 was provided to the Research & Information Services
`
`Department of Finnegan by Social Law Library, in Boston, Massachusetts in
`
`response to our request for copies of the Flonase® and Astelin® labels contained in
`
`the PDR 2000. I placed the request on December 19, 2019, through the Social
`
`Law Library’s website. Appended to this declaration as Appendix A is a copy of
`
`bill received from the Social Law Library, which lists the date of the request in the
`
`top right hand corner and the text of request in the section titled “Order
`
`Description.” (Appendix A.) The excerpt obtained from the Social Law Library
`
`includes the cover, public information page, and title page with a stamp that reads
`
`“RECEIVED FEB 1, 2000.” Appended to this declaration as Appendix B is a
`
`copy of the Social Law Library processing procedures regarding stamping.
`
`(Appendix B.)
`
`18. Ex. 1014 is in a condition that creates no suspicion about its
`
`authenticity. Specifically, the text on each page appears to flow seamlessly from
`
`one page to the next and there are no visible alterations to the document. It was
`
`
`
`5
`
`
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`IPR2020-00368 (U.S. Patent No. 8,163,723)
`Declaration of Kelley Hayes Greenhill
`
`
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`found within the custody of a library, the Social Law Library, a place where, if
`
`authentic, it would likely be found.
`
`19. Ex. 1014 has a date stamp of February 1, 2000, which indicates the
`
`date that the PDR 2000 was received and checked-in to the Social Law Library.
`
`Assuming at most a week for transfer to the shelf, the PDR 2000 would have been
`
`physically available no later than the second week of February 2000, and thus both
`
`the Flonase® and Astelin® labels would have been available at that time.
`
`20. Based on this evidence, it is my opinion that Ex. 1014 is an authentic
`
`document publicly accessible to and in actual use by researchers no later than the
`
`second week of February 2000.
`
`Sports Illustrated v. 93 July-Sept (2000)
`C.
`21. Ex. 1056 is an excerpted version of the September 18, 2000 edition of
`
`Sports Illustrated.
`
`22. Ex. 1056 was provided to the Research & Information Services
`
`Department of Finnegan by Dean’s Cards, in Cincinnati, Ohio in response to our
`
`request for a copy of the magazine. It includes the cover, table of contents, and the
`
`issue date indicates that it was published on September 18, 2000.
`
`23. Ex. 1056 is in a condition that creates no suspicion about its
`
`authenticity. Specifically, the text on each page appears to flow seamlessly from
`
`
`
`6
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`
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`IPR2020-00368 (U.S. Patent No. 8,163,723)
`Declaration of Kelley Hayes Greenhill
`
`
`
`one page to the next and there are no visible alterations to the document. It was
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`found within the custody of a leading seller of sports cards and magazines, a place
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`where, if authentic, it would likely be found.
`
`24. The front page of the magazine demonstrates that Ex. 1056 was
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`published on September 18, 2000. During this time period Sports Illustrated was
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`published weekly. Assuming at most a day for transfer from the publisher to the
`
`newsstands, the Ex. 1056 would have been physically available no later than
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`September 19, 2000, and thus the Flonase® Ad would have been available at that
`
`time.
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`25. Based on this evidence, it is my opinion that Ex. 1056 is an authentic
`
`document publicly accessible to and in actual use by researchers no later than
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`September 19, 2000.
`
`
`
`
`
`
`
`7
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`
`
`Declaration of Kelley Hayes Greenhill
`U.S. Patent No; 8,163,723
`
`IV. Conclusion
`
`26.
`
`In signing this declaration, I understand that the declaration will be
`
`filed as evidence before the United States Patent and Trademark Office. I
`
`acknowledge that I may be subject to cross-examination in this case and that cross(cid:173)
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`examination will take place within the United States. If cross-examination is
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`required of me, I will appear for cross-examination within the United States during
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`the time allotted for cross-examination.
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`27.
`
`I declare that all statements made herein of my knowledge are true,
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`that all statements made on information and belief are believed to be true, and that
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`these statements were made with the knowledge that willful false statements and
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`. the like so made are punishable by fine or imprisonment, or both, under Section
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`1001 of Title 18 of the United States Code.
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`Executed on
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`l ['?..) (?A21> , in Washington, D.C.
`
`reenhill
`
`8
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`
`
`Appendix A
`Appendix A
`
`
`
`
`GSK Exhibit 1070 - Page 10 of 17
`
`
`
`The Social Law Library
`John Adams Courthouse
`One Pemberton Square, Suite 4100
`Boston, MA 02108-1792
`
`ORDER #: CC-20199
`12/19/2019
`Full Member
`FI133
`
`Client/Matter:04012 / 9009-00000/S Cyr
`
`Kelley Hayes Greenhill
`Finnegan, Henderson, Farabow, Garrett & Dunner,
`LLP
`901 New York Avenue, NW Washington, DC
`20001-4413
`
`CONTACT:
`Kelley Hayes Greenhill
`VOX: (202) 216-5021
`FAX:
`kelley.hayesgreenhill@finnegan.com
`
`Completed Products
`Item Description
`40
`FAX/EMAIL
`
`Unit Price
`$1.20
`
`Quantity/Amt
`3
`
`Items
`
`Subtotal
`$3.60
`
`Order Description
`Please provide the following from the 1998 edition of the PDR, 1999 edition of the
`PDR and the 2000 edition of the PDR. Please provide copies of the cover page, date
`stamp, table of contents, label page and entry pages for Flonase and Astelin. Also,
`please provide a certificate signed by the reference librarian for each edition. Please let
`me know if you have any questions. Kelley
`
`Total: $3.60
`Paid: $0.00
`
`Balance: $3.60
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Appendix B
`Appendix B
`
`GSK Exhibit 1070 - Page 12 of 17
`
`
`
`Processing Procedures
`
`1.
`
`Before you begin, assemble the following materials on the CDA
`workstation.
`(These materials are required for steps 2 through 8.)
`
`-Long, narrow "Social Law Library" stamps.
`
`SOCIAL LAW LIB
`socml; LAW LIBRARY
`
`—Square stamp which prints oval "Social Law Library 1804" impression.
`
`
`
` eBaeemmmp-ydgnstid
`not to be preceded by a zero.
`
`Single digit dates are
`
`This is wrong,
`
`AUG 0-4- 2002
`
`This is correct,
`
`AUG 42002
`
`(It must be well inked so that the impressions made
`—Black stamp pad.
`are clear. Red ink is used only with the "DISCARDED FROM COLLECTION"
`stamp.)
`
`-Roll of beepers.
`
`—Bookplates.
`
`—Bar code labels.
`
`‘
`
`GSK Exhibit 1070 - Page 13 of 17
`
`
`
`
`1;
`l".""‘ if ‘93” is 'E‘ffirgo e
`I: "tin".
` 1","
`glace the beeper on
`put the beeper over it.
`
`W N
`
`ote:
`
`To prevent damage to contents, do not affix beepers to the inside
`front cover of “home—made” binders or other plastic binders sent by
`publishers without first removingxthe plastic sheet lifter from the
`binder.
`‘.\
`
`For books with dust jackets, place‘beeper in the middle of the
`first blank page, which is usually opposite the front cover.
`this page is not blank, see Elaine.
`
`If
`
`For publications housed in slash—view folders, place beeper in the
`middle of the first blank page of the publication, not on the
`folder.
`
`If "Plain" has
`Check the Instructions Form for "Bookplate" information.
`been checked,
`follow the instructions in step A. If a "Fund" bookplate is
`indicated,
`follow the instructions in step B.
`If a “Gift of” bookplate
`is indicated,
`follow the instructions in step C.
`
`
`
`SOCIAL LAW LIBRARY
`HOS/[T )N ‘ LMSSACI l US E'I‘TS
`
`I
`
`Iu-zcmnm DEC 4 2000
`
`GSK Exhibit 1070 - Page 14 of 17
`
`
`
`If there is a fund name on the "Processing Instructions"
`B.
`stamp the current date on an appropriate pre—printed fund
`form,
`bookplate.
`The date should be stamped after the word "Received".
`If there isn't a pre—printed bookplate for that fund, use a fund
`stamp with a "fund" bookplate.
`Place the bookplate over the
`beeper.
`
`Pre—printed bookplates exist for the following funds:
`
`Cargill
`Davis
`Fox
`
`Hyland
`Meserve
`Reardon
`Sarrouf
`
`1
`
`‘
`
`'
`
`Stamps must be used with a "Fund" bookplate for the
`following funds:
`«
`
`Gollub
`
`Hemenway
`Hutchins, E.
`Hutchins, H.
`Lawrence
`
`Lawrence Legacy
`Nutter
`Viera
`Weinstein
`White Memorial
`
`Wyman
`
`See Appendix B for sample bookplates for both pre—printed and
`stamped bookfunds.
`
`CAUTION:
`
`Do not stamp a "Fund" bookplate when a fund
`has a pre—printed bookplate.
`If you cannot find an appropriate pre-printed
`bookplate, see Elaine.
`
`If there is a "Gift ofm" name on the "Processing
`C.
`Instructions" form,
`type the name exactly as it is written onto a
`"Gift ofm" bookplate.
`The current date should be stamped after the
`word "Received".
`Place the bookplate over the beeper. This is a
`“Gift ofm” Social Law Library bookplate:
`
`
`
`SOCIAL LAW' LIBRARY
`m vs-n IN. .‘I.\.\W\(2llll§I-2‘I‘N
`
`3
`
`Gil-1 M: ”#11311“—
`IIIEIJ'n'EI-JEC 4- 2m. -_-
` ‘35:”:- -__—
`
`GSK Exhibit 1070 — Page 15 'of 17
`
`
`
`4 ~
`
`smmMBWEJpfiSBmfliie-Vplmmeflwifih‘m-flsmm
`1804" stamp. The impression should be placed on the center portion of the
`title page and should be made with black ink.
`(See pages 4A & 4B for
`examples.) Occasionally the first page within the text is not the title
`page.
`If the first page is not the title page, i.e. it does not contain
`author, title, and copyright information,
`locate the title page by
`skimming through the beginning of the volume.
`If you are unable to find
`a title page, see Elaine for assistance.
`
`
`
`5 . Wflfimfimmemug-the'bottom margin, stamp
`this page with the small narrow "Social Law Library 5 mp.
`does not have a page 151,
`then stamp a page approximately one third into
`
`e
`
`the W1
`
`SQSEAL LEE-J LEBRAR‘!
`
`CAUTION:
`
`If necessary, adjust the
`Do not stamp over the text.
`placement of the stamp in order to avoid obscuring words.
`
`6 .
`
`LosabenpagE‘ZSfl-mmmFGn-the—bottomdnarfiémétflnp-
`this page with the small narrow "Social Law Library" stamp. If the volume
`does not have a page 251,
`then stamp a page approximately two thirds into
`
`W was, Law LEBRARY
`
`CAUTION:
`
`If necessary, adjust the
`Do not stamp over the text.
`placement of the stamp in order to avoid obscuring words.
`
`GSK Exhibit 1070 - Page 16 of 17
`
`
`
`
` s amp, 5 amp a e text o“oc .
`
`
`the impression prints upright, as illustrated below.
`If the volumeehas
`tabs or is looseleaf, omit this step— do not stamp the text block.
`
`CAUTION:
`
`Hold the volume firmly while stamping so that the image does
`not blur.
`
`
`
`You will no longer need the supplies you originally assembled. The
`stamps, beepers, etc. can now be put away.
`The supplies needed for the
`remaining processing steps vary from volume to volume. All supplies are
`stored in .Processing Unit II.
`
`CAUTION: Steps #10-#11 do not apply to “home-made”
`binders. Title, volume number, location, call
`number and Social Law Library should be typed on the
`card that is inserted into the spine pocket of these
`binders.
`
`Example:
`
`
`COLORADO REGISTER
`PROPOSED REGULATIONS
`PREVIOUS YEAR
`
`v.1
`
`STATES
`RFC
`1835
`1977
`.A22
`
`SOCIAL LAW LIBRARY
`
`L_—-——~—--——--——-"-—-—"—"""“
`
`GSK Exhibit 1070 - Page 17 of 17
`
`