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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD., ACRUX LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`_______________
`
`
`DECLARATION OF AYDIN H. HARSTON IN SUPPORT OF
`PETITIONER’S RESPONSE TO PATENT OWNER’S
`OBJECTIONS TO EVIDENCE
`
`
`
`
`                                                            
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`

`

`
`Page 1 of 6
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1670
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`

`

`I, Aydin H. Harston, declare and state as follows:
`
`Case IPR2017-00190
`Patent 7,214,506 B2

`
`I am a member of the Bar of the District of Columbia and an attorney with
`
`the firm Rothwell, Figg, Ernst & Manbeck, PC, attorneys for Acrux DDS Pty.
`
`Ltd. and Acrux Limited (“Petitioner”). I submit this declaration in support of the
`
`Response to Patent Owner’s Objections to Evidence, served on November 8,
`
`2017. I have personal knowledge of the facts stated in this declaration and have
`
`personally reviewed each of the attached documents. If called upon to do so, I
`
`could, and would, competently testify on the matters set forth herein.
`
`1.
`
`Attached hereto as Exhibit 1504(a) is a true and accurate copy of
`
`Administrative and Correspondence Documents, Application Number
`
`203567Orig1s000, available at
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567Orig1s000Admi
`
`ncorres.pdf, last accessed on November 15, 2017. I obtained this document by
`
`going to the United States Food and Drug Administration (“FDA”) website at
`
`https://www.fda.gov/; clicking on the tab labeled “Drugs” at the top of the page;
`
`under “Spotlight” on the right side of the page, clicking “Search Drugs@FDA;”
`
`entering “Jublia” into the search prompt and clicking “Search;” clicking on the
`
`drop-down tab labeled “Approval Date(s) and History, Letters, Labels, Reviews for
`
`NDA 203567;” under “Original Approvals or Tentative Approvals,” clicking the
`
`link for “Review;” and, finally, clicking “Administrative Document(s) &
`2
`

`
`Page 2 of 6
`
`

`

`Correspondence” at the bottom of the list on the final page. Exhibit 1504(a) is a
`
`Case IPR2017-00190
`Patent 7,214,506 B2

`
`true and accurate copy of the PDF document that appeared on the FDA’s website. I
`
`note that these documents are communications between Dow Pharmaceutical
`
`Sciences (acquired by Valeant Pharmaceuticals International, Inc.) and the FDA
`
`and, presumably, are available to Patent Owners. Exhibit 1504(a) is served in
`
`response to Patent Owner’s objections to Exhibit 1504. Exhibit 1504 is the
`
`Meeting Minutes for IND 77732, Division of Dermatology and Dental Products:
`
`Office of Drug Evaluation III (2012), which appears on pages 108-132 of Exhibit
`
`1504(a). Originally filed Exhibit 1504 is a true and accurate copy of pages 108-132
`
`of Exhibit 1504(a).
`
`2.
`
`Originally filed Exhibit 1512 is a true and accurate copy of
`
`“Dermatologic conditions of the foot,” authored by Lucia Seminario-Vidal, Wendy
`
`Cantrell, DNP, and Boni E. Elewski, MD, Orthopaedic Knowledge Online Journal
`
`2014, 12(8), located at https://www.aaos.org/OKOJ/vol12/issue8/FOO060/, last
`
`accessed October 31, 2017.
`
`3.
`
`Attached hereto as Exhibit 1514(a) is a library-stamped copy of
`
`“Pharmacokinetics of antimycotics with emphasis on local treatment.” Ulrich
`
`Tauber, in Antifungal Drugs (Vassil St. Georgiev ed.), 544: 414-426 (1988),
`
`obtained from the University of California at Berkeley. Exhibit 1514(a) is served
`
`in response to Patent Owner’s objections to Exhibit 1514.
`

`
`3
`
`Page 3 of 6
`
`

`

`Originally filed Exhibit 1519 is a true and accurate copy of Label for
`
`Case IPR2017-00190
`Patent 7,214,506 B2

`
`4.
`
`Lamisil® (terbinafine) DermGel™, 1% Gel, Jock Itch Product 6g Tube. Novartis
`
`Consumer Health, Inc., NDA 21-958, available at
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021958lbl.pdf, last
`
`accessed on November 15, 2017. I obtained this document by going to the FDA
`
`website at https://www.fda.gov/; clicking on the tab labeled “Drugs” at the top of
`
`the page; under “Spotlight” on the right side of the page, clicking “Search
`
`Drugs@FDA;” entering “Lamisil” into the search prompt and clicking “Search;”
`
`clicking on “LAMISIL AT” and then “LAMISIL AT (TERBINAFINE) for the
`
`topical gel; clicking on the drop-down tab labeled “Approval Date(s) and History,
`
`Letters, Labels, Reviews for NDA 203567;” and under “Original Approvals or
`
`Tentative Approvals,” clicking the link for “Label.” Exhibit 1519 is a true and
`
`accurate copy of the PDF document that appeared at that link on the FDA’s
`
`website.
`
`5.
`
`Attached hereto as Exhibit 1520(a) is a true and accurate copy of
`
`Approval Package for Application Number ANDA 77-511, dated July 2, 2007,
`
`available at
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/077511Orig1Approv_P
`
`art1.pdf, last accessed Nov. 16, 2017. I obtained this document by going to the
`
`FDA website at https://www.fda.gov/; clicking on the tab labeled “Drugs” at the
`

`
`4
`
`Page 4 of 6
`
`

`

`top of the page; under “Spotlight” on the right side of the page, clicking “Search
`
`Case IPR2017-00190
`Patent 7,214,506 B2

`
`Drugs@FDA;” entering “77511” into the search prompt and clicking “Search;”
`
`clicking on the drop-down tab labeled “Approval Date(s) and History, Letters,
`
`Labels, Reviews for ANDA 077511;” and under “Original Approvals or Tentative
`
`Approvals,” clicking the link for “Review.” Exhibit 1520(a) is a true and accurate
`
`copy of the PDF document that appeared at that link. Originally filed Exhibit
`
`1520 is the Label for Terbinafine Hydrochloride Cream, 1%, which displays
`
`labeling information similar to that on pages 15-22 of Exhibit 1520(a). Exhibit
`
`1520(a) is served in response to Patent Owner’s objections to Exhibit 1520.
`
`6.
`
`Originally filed Exhibit 1521 is a true and accurate copy of Final
`
`Printed Labeling for Center for Drug Evaluation and Research Application No. 21-
`
`022, Penlac™ Nail Lacquer (Ciclopirox) Topical Solution, 8%, available at
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-
`
`022_Penlac%20Nail%20Lacquer%20Tropical%20Solution_prntlbl.pdf, last
`
`accessed on Nov. 16, 2017. I obtained this document by going to the FDA website
`
`at https://www.fda.gov/; clicking on the tab labeled “Drugs” at the top of the page;
`
`under “Spotlight” on the right side of the page, clicking “Search Drugs@FDA;”
`
`entering “Penlac” into the search prompt and clicking “Search;” clicking on the
`
`drop-down tab labeled “Approval Date(s) and History, Letters, Labels, Reviews for
`
`NDA 021022;” under “Original Approvals or Tentative Approvals,” clicking the
`

`
`5
`
`Page 5 of 6
`
`

`

`link for “Review;” and, finally, clicking on “Printed Labeling.” Exhibit 1521 is a
`
`Case IPR2017-00190
`Patent 7,214,506 B2

`
`true and accurate copy of the PDF document that appeared at that link on the
`
`FDA’s website.
`
` declare under penalty of perjury that the foregoing is true and correct. Executed
`
` I
`
`this 21st day of November, 2017, in Washington, D.C.
`
`
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`

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`___/Aydin H. Harston/_______
`Aydin H. Harston, Ph.D.
`
`6
`
`Page 6 of 6
`
`

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