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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`ACRUX DDS PTY LTD., ACRUX LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
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`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`_______________
`
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`DECLARATION OF AYDIN H. HARSTON IN SUPPORT OF
`PETITIONER’S RESPONSE TO PATENT OWNER’S
`OBJECTIONS TO EVIDENCE
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`
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`1 Case IPR2017-01429 has been joined with the instant proceeding.
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`Page 1 of 6
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`ACRUX DDS PTY LTD. et al.
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`EXHIBIT 1670
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`IPR Petition for
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`U.S. Patent No. 7,214,506
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`
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`I, Aydin H. Harston, declare and state as follows:
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`I am a member of the Bar of the District of Columbia and an attorney with
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`the firm Rothwell, Figg, Ernst & Manbeck, PC, attorneys for Acrux DDS Pty.
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`Ltd. and Acrux Limited (“Petitioner”). I submit this declaration in support of the
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`Response to Patent Owner’s Objections to Evidence, served on November 8,
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`2017. I have personal knowledge of the facts stated in this declaration and have
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`personally reviewed each of the attached documents. If called upon to do so, I
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`could, and would, competently testify on the matters set forth herein.
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`1.
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`Attached hereto as Exhibit 1504(a) is a true and accurate copy of
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`Administrative and Correspondence Documents, Application Number
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`203567Orig1s000, available at
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`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567Orig1s000Admi
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`ncorres.pdf, last accessed on November 15, 2017. I obtained this document by
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`going to the United States Food and Drug Administration (“FDA”) website at
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`https://www.fda.gov/; clicking on the tab labeled “Drugs” at the top of the page;
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`under “Spotlight” on the right side of the page, clicking “Search Drugs@FDA;”
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`entering “Jublia” into the search prompt and clicking “Search;” clicking on the
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`drop-down tab labeled “Approval Date(s) and History, Letters, Labels, Reviews for
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`NDA 203567;” under “Original Approvals or Tentative Approvals,” clicking the
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`link for “Review;” and, finally, clicking “Administrative Document(s) &
`2
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`Page 2 of 6
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`
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`Correspondence” at the bottom of the list on the final page. Exhibit 1504(a) is a
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`true and accurate copy of the PDF document that appeared on the FDA’s website. I
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`note that these documents are communications between Dow Pharmaceutical
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`Sciences (acquired by Valeant Pharmaceuticals International, Inc.) and the FDA
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`and, presumably, are available to Patent Owners. Exhibit 1504(a) is served in
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`response to Patent Owner’s objections to Exhibit 1504. Exhibit 1504 is the
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`Meeting Minutes for IND 77732, Division of Dermatology and Dental Products:
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`Office of Drug Evaluation III (2012), which appears on pages 108-132 of Exhibit
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`1504(a). Originally filed Exhibit 1504 is a true and accurate copy of pages 108-132
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`of Exhibit 1504(a).
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`2.
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`Originally filed Exhibit 1512 is a true and accurate copy of
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`“Dermatologic conditions of the foot,” authored by Lucia Seminario-Vidal, Wendy
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`Cantrell, DNP, and Boni E. Elewski, MD, Orthopaedic Knowledge Online Journal
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`2014, 12(8), located at https://www.aaos.org/OKOJ/vol12/issue8/FOO060/, last
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`accessed October 31, 2017.
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`3.
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`Attached hereto as Exhibit 1514(a) is a library-stamped copy of
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`“Pharmacokinetics of antimycotics with emphasis on local treatment.” Ulrich
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`Tauber, in Antifungal Drugs (Vassil St. Georgiev ed.), 544: 414-426 (1988),
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`obtained from the University of California at Berkeley. Exhibit 1514(a) is served
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`in response to Patent Owner’s objections to Exhibit 1514.
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`3
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`Page 3 of 6
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`Originally filed Exhibit 1519 is a true and accurate copy of Label for
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`4.
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`Lamisil® (terbinafine) DermGel™, 1% Gel, Jock Itch Product 6g Tube. Novartis
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`Consumer Health, Inc., NDA 21-958, available at
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`https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021958lbl.pdf, last
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`accessed on November 15, 2017. I obtained this document by going to the FDA
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`website at https://www.fda.gov/; clicking on the tab labeled “Drugs” at the top of
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`the page; under “Spotlight” on the right side of the page, clicking “Search
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`Drugs@FDA;” entering “Lamisil” into the search prompt and clicking “Search;”
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`clicking on “LAMISIL AT” and then “LAMISIL AT (TERBINAFINE) for the
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`topical gel; clicking on the drop-down tab labeled “Approval Date(s) and History,
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`Letters, Labels, Reviews for NDA 203567;” and under “Original Approvals or
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`Tentative Approvals,” clicking the link for “Label.” Exhibit 1519 is a true and
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`accurate copy of the PDF document that appeared at that link on the FDA’s
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`website.
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`5.
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`Attached hereto as Exhibit 1520(a) is a true and accurate copy of
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`Approval Package for Application Number ANDA 77-511, dated July 2, 2007,
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`available at
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`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/077511Orig1Approv_P
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`art1.pdf, last accessed Nov. 16, 2017. I obtained this document by going to the
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`FDA website at https://www.fda.gov/; clicking on the tab labeled “Drugs” at the
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`4
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`Page 4 of 6
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`top of the page; under “Spotlight” on the right side of the page, clicking “Search
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`Drugs@FDA;” entering “77511” into the search prompt and clicking “Search;”
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`clicking on the drop-down tab labeled “Approval Date(s) and History, Letters,
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`Labels, Reviews for ANDA 077511;” and under “Original Approvals or Tentative
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`Approvals,” clicking the link for “Review.” Exhibit 1520(a) is a true and accurate
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`copy of the PDF document that appeared at that link. Originally filed Exhibit
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`1520 is the Label for Terbinafine Hydrochloride Cream, 1%, which displays
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`labeling information similar to that on pages 15-22 of Exhibit 1520(a). Exhibit
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`1520(a) is served in response to Patent Owner’s objections to Exhibit 1520.
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`6.
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`Originally filed Exhibit 1521 is a true and accurate copy of Final
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`Printed Labeling for Center for Drug Evaluation and Research Application No. 21-
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`022, Penlac™ Nail Lacquer (Ciclopirox) Topical Solution, 8%, available at
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`https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-
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`022_Penlac%20Nail%20Lacquer%20Tropical%20Solution_prntlbl.pdf, last
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`accessed on Nov. 16, 2017. I obtained this document by going to the FDA website
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`at https://www.fda.gov/; clicking on the tab labeled “Drugs” at the top of the page;
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`under “Spotlight” on the right side of the page, clicking “Search Drugs@FDA;”
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`entering “Penlac” into the search prompt and clicking “Search;” clicking on the
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`drop-down tab labeled “Approval Date(s) and History, Letters, Labels, Reviews for
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`NDA 021022;” under “Original Approvals or Tentative Approvals,” clicking the
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`5
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`Page 5 of 6
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`link for “Review;” and, finally, clicking on “Printed Labeling.” Exhibit 1521 is a
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`Case IPR2017-00190
`Patent 7,214,506 B2
`
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`true and accurate copy of the PDF document that appeared at that link on the
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`FDA’s website.
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` declare under penalty of perjury that the foregoing is true and correct. Executed
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` I
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`this 21st day of November, 2017, in Washington, D.C.
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`___/Aydin H. Harston/_______
`Aydin H. Harston, Ph.D.
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`6
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`Page 6 of 6
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