IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR2015-01776
`Patent No. 7,582,621
`
`DECLARATION OF JENNIFER AUGSBURGER
`IN SUPPORT OF PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2102 - 1/7
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR2015-01776
`Patent No. 7,582,621
`
`DECLARATION OF JENNIFER AUGSBURGER
`IN SUPPORT OF PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2102 - 1/7
`
`
`
`
`I, Jennifer Augsburger, hereby declare as follows:
`
`IPR2015-01776
`
`1.
`
`I am an IP attorney specialist with the firm of Covington & Burling
`
`LLP, which is counsel for Anacor Pharmaceuticals, Inc. (“Patent Owner”). I submit
`
`this declaration in support of Patent Owner’s Response to Coalition for Affordable
`
`Drugs X LLC’s Petition for Inter Partes Review of Patent No. 7,582,621. I have
`
`personal knowledge of the facts stated herein.
`
`2.
`
`Attached as Exhibit 2043 to Patent Owner’s Response is a true and
`
`correct copy of Office of Toxic Substances, Environmental Protection Agency,
`
`“Preliminary Investigation of Effects on the Environment of Boron, Indium, Nickel,
`
`Selenium, Vanadium and Their Compounds,” EPA-65/2-75-005A, (August 1975)
`
`that is publically available as a PDF document at
`
`http://nepis.epa.gov/Exe/ZyPDF.cgi/9101277V.PDF?Dockey=9101277V.PDF.
`
`3.
`
`Attached as Exhibit 2048 to Patent Owner’s Response is a true and
`
`correct copy of EPA Correspondence, 1992 Labeling Rev., Amended Biobor Label
`
`that is publically available as a PDF document linked from
`
`https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:102:::NO::P102_REG_NUM:6521
`
`7-1 and available directly at
`
`https://www3.epa.gov/pesticides/chem_search/ppls/065217-00001-19920403.pdf.
`
`4.
`
`Attached as Exhibit 2074 to Patent Owner’s Response is a true and
`
`correct copy of FDA Approved Label for SPORANOX®, (Supplement 034, Action
`
`- 1 -
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2102 - 2/7
`
`
`
`
`Date 07/14/2004) that is publically available as PDF documents linked from
`
`IPR2015-01776
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.
`
`Set_Current_Drug&ApplNo=020083&DrugName=SPORANOX&ActiveIngred=IT
`
`RACONAZOLE&SponsorApplicant=JANSSEN%20PHARMS&ProductMktStatus
`
`=1&goto=Search.Label_ApprovalHistory and available directly at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf
`
`(letter) and
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf
`
`(label).
`
`5.
`
`Attached as Exhibit 2075 to Patent Owner’s Response is a true and
`
`correct copy of FDA Approved Label for LAMISIL®, (Supplement 012, Action Date
`
`01/21/2004) that is publically available as PDF documents linked from
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.
`
`Set_Current_Drug&ApplNo=020539&DrugName=LAMISIL&ActiveIngred=TERB
`
`INAFINE%20HYDROCHLORIDE&SponsorApplicant=NOVARTIS&ProductMktS
`
`tatus=1&goto=Search.Label_ApprovalHistory and available directly at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20539slr012ltr.pdf
`
`(letter) and
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20539slr012_lamisil_lbl.
`
`pdf (label).
`
`- 2 -
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2102 - 3/7
`
`
`
`
`
`IPR2015-01776
`
`6.
`
`Attached as Exhibit 2076 to Patent Owner’s Response is a true and
`
`correct copy of FDA Approved Label for Gris-PEG®, (Supplement 046, Action Date
`
`03/26/2003) that is publically available as PDF documents linked from
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.
`
`Set_Current_Drug&ApplNo=050475&DrugName=GRIS%2DPEG&ActiveIngred=
`
`GRISEOFULVIN%2C%20ULTRAMICROSIZE&SponsorApplicant=VALEANT%
`
`20PHARMS%20INC&ProductMktStatus=1&goto=Search.Label_ApprovalHistory
`
`and available directly at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50475slr046ltr.pdf
`
`(letter) and
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475slr046_gris-
`
`peg_lbl.pdf (label).
`
`7.
`
`Attached as Exhibit 2077 to Patent Owner’s Response is a true and
`
`correct copy of FDA Approved Label for Penlac®, (Supplement 004, Action Date
`
`12/03/2004) that is publically available as PDF documents linked from
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.
`
`Set_Current_Drug&ApplNo=021022&DrugName=PENLAC&ActiveIngred=CICL
`
`OPIROX&SponsorApplicant=VALEANT%20BERMUDA&ProductMktStatus=1&g
`
`oto=Search.Label_ApprovalHistory and available directly at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21022s004ltr.pdf
`
`- 3 -
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2102 - 4/7
`
`
`
`
`(letter) and
`
`IPR2015-01776
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf (label).
`
`8.
`
`Attached as Exhibit 2099 to Patent Owner’s Response is a true and
`
`correct copy of Center for Drug Evaluation and Research, Guidance for Industry:
`
`Clinical Development and Labeling of Anti-Infective Drug Products (1992) that is
`
`publically available as a PDF document linked from
`
`http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/u
`
`cm064980.htm and available directly at
`
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
`
`Guidances/UCM070975.pdf.
`
`9.
`
`Attached as Exhibit 2109 to Patent Owner’s Response is a true and
`
`correct copy of EPA Correspondence, 1997 Labeling Rev., Amended Biobor Label
`
`that is publically available as a PDF document linked from
`
`https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:102:::NO::P102_REG_NUM:6521
`
`7-1 and available directly at
`
`https://www3.epa.gov/pesticides/chem_search/ppls/065217-00001-19970327.pdf.
`
`10. Attached as Exhibit 2112 to Patent Owner’s Response is a true and
`
`correct copy of Crane & Sanders, Evaluation of a Biocidal Turbine-Fuel-Additive,
`
`Aviation Medical Report—AM 67-21, pp. 1-10 (Federal Aviation Administration,
`
`Office of Aviation Medicine 1967) that is publically available as a PDF document
`
`- 4 -
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2102 - 5/7
`
`
`
`
`linked from
`
`IPR2015-01776
`
`https://www.faa.gov/data_research/research/med_humanfacs/oamtechreports/1960s/1
`
`967/ and available directly at
`
`http://www.faa.gov/data_research/research/med_humanfacs/oamtechreports/1960s/m
`
`edia/am67-21.pdf.
`
`11. Attached as Exhibit 2143 to Patent Owner’s Response is a true and
`
`correct copy of FDA Approved Label for VELCADE® (Action Date 05/13/2003) that
`
`is publically available as PDF documents linked from
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.
`
`Set_Current_Drug&ApplNo=021602&DrugName=VELCADE&ActiveIngred=BOR
`
`TEZOMIB&SponsorApplicant=MILLENNIUM%20PHARMS&ProductMktStatus=
`
`1&goto=Search.Label_ApprovalHistory and available directly at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21602ltr.pdf (letter)
`
`and http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021602lbl.pdf (label).
`
`12. Attached as Exhibit 2170 to Patent Owner’s Response is a true and
`
`correct copy of U.S. Dept. of Health & Human Services, Health, United States, 2015
`
`(May 2016) that is publically available as a PDF document at
`
`http://www.cdc.gov/nchs/data/hus/hus15.pdf.
`
`13. Attached as Exhibit 2173 to Patent Owner’s Response is a true and
`
`correct copy of FDA Center for Drug Evaluation and Research, Dermatologic and
`
`- 5 -
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2102 - 6/7
`
`
`
`IPR20 1 5-01776
`
`Ophthalmic Drugs Advisory Committee Meeting, Nov. 4, 1999 (Transcript) that is
`
`publically available as a PDF document linked from
`
`http://www.fda.gov/ohrms/dockets/ac/cder99t.htm#Dermatologic%20and%200phtha
`
`lmic%20Drugs%20Advisory%20Committee and available directly at
`
`http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3 564t1 .pdf.
`
`14. Attached as Exhibit 2193 to Patent Owner’s Response is a true and
`
`correct copy of European Commission Scientific Committee on Consumer Products,
`
`Opinion on Toluene (April 15, 2008) that is publically available as a PDF document
`
`at http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_133.pdfi
`
`I declare under penalty of perjury that the foregoing is true and correct to the
`
`best of my knowledge.
`
`Date: June 5, 2016
`
`Respectfully submitted,
`
`1!
`
`Je nifer Augsbfir
`
`
`
`By
`
`-5-
`
`CFAD v. Anacor, |PR2015-01776 ANACOR EX. 2102 - 7/7
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2102 - 7/7
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
