throbber
Paper No. ______
`Filed: July 20, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`ASTRAZENECA AB
`
`Patent Owner
`
`
`
`Case IPR2016-01324
`
`U.S. Patent 7,456,160
`
`
`
`PATENT OWNER’S MANDATORY
`NOTICES PURSUANT TO 37 C.F.R. § 42.8
`
`
`
`
`
`
`
`

`
`Case IPR2016-01324
`U.S. Patent 7,456,160
`
`Pursuant to 37 C.F.R. § 42.8, the undersigned on behalf of and acting in a representative
`
`capacity for patent owner AstraZeneca AB, hereby submits the following mandatory notices in
`
`connection with the Petition for Inter Partes Review of United States Patent No. 7,456,160 (the
`
`“’160 patent”), Case No. IPR2016-01324.
`
`REAL PARTY-IN-INTEREST
`
`AstraZeneca AB is Patent Owner. AstraZeneca UK Limited is the beneficial owner of
`
`the ’160 patent and holder of approved New Drug Application (“NDA”) No. 21-344 for
`
`FASLODEX® (fulvestrant) intramuscular injection, in 50 mg/mL dosage forms. AstraZeneca
`
`Pharmaceuticals LP is the authorized agent for matters related to NDA No. 21-344 in the United
`
`States.
`
`RELATED MATTERS
`
`The ’160 patent has been asserted in the following actions: AstraZeneca Pharmaceuticals
`
`LP et al. v. Sandoz Inc., C.A. No. 1:14-cv-03547-RMB-KMW (D.N.J.); AstraZeneca
`
`Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc., C.A. No. 1:14-cv-05539-RMB-
`
`KMW (D.N.J.) (consolidated as 1:14-cv-03547); AstraZeneca Pharmaceuticals LP et al. v.
`
`Glenmark Pharmaceuticals Inc., USA, C.A. No. 1:15-cv-00615-RMB-KMW (D.N.J.)
`
`(consolidated as 1:14-cv-03547); AstraZeneca Pharmaceuticals LP et al. v. Agila Specialties,
`
`Inc. et al., C.A. No. 1:15-cv-06039-RMB-KMW (D.N.J.); AstraZeneca Pharmaceuticals LP et
`
`al. v. Mylan Pharmaceuticals Inc. et al., C.A. No. 1:15-cv-7009-RMB-KMW (consolidated as
`
`1:15-cv-06039); AstraZeneca Pharmaceuticals LP et al. v. Teva Pharmaceuticals USA, Inc.,
`
`C.A. No. 1:15-cv-7889-RMB-KMW (D.N.J.) (consolidated as 1:15-cv-06039); AstraZeneca
`
`Pharmaceuticals LP et al. v. InnoPharma Licensing LLC, C.A. No. 1:16-cv-1962-RMB-KMW
`
`(D.N.J.) (consolidated as 1:15-cv-06039); AstraZeneca Pharmaceuticals LP et al. v. Teva
`
`Parenteral Medicines Inc. et al., C.A. No. 1:10-cv-00018 (D. Del.) (dismissed); AstraZeneca
`
`
`
`2
`
`

`
`Case IPR2016-01324
`U.S. Patent 7,456,160
`
`Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc., C.A. No. 1:14-cv-07358 (N.D. Ill.)
`
`(dismissed); AstraZeneca Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al., C.A.
`
`No. 1:15-cv-00183 (N.D. W. Va.); AstraZeneca Pharmaceuticals LP et al. v. InnoPharma, Inc.,
`
`C.A. No. 1:16-cv-00894-RMB-KMW (D.N.J.) (dismissed).
`
`Three related patents have been involved in district court proceedings: U.S. Patent Nos.
`
`6,774,122 (the “’122 patent”); 8,329,680 (the “’680 patent”); and 8,466,139 (the “’139 patent”).
`
`Concurrently with this petition, Petitioner submitted three other petitions for inter partes
`
`review: IPR2016-01316 on the ’122 patent; IPR2016-01325 on the ’680 patent; and IPR2016-
`
`01326 on the ’139 patent.
`
`Lead counsel:
`
`LEAD AND BACK-UP COUNSEL
`AND SERVICE INFORMATION
`
`Filko Prugo (Reg. No. 73,092)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: fprugo@omm.com
`
`Back-up counsel:
`
`Caitlin Hogan (Reg. No. 61,515)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: chogan@omm.com
`
`
`Other counsel:
`
`Marc Pensabene (Reg. No. 37,416)
`
`
`
`3
`
`

`
`Case IPR2016-01324
`U.S. Patent 7,456,160
`
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: mpensabene@omm.com
`
`Kevin Murray (Reg. No. 69,529)
`O’MELVENY & MYERS LLP
`400 South Hope Street
`Los Angeles, CA 90071
`Phone: (213) 430-6100
`Email: kmurray2@omm.com
`
`Patent Owner may be served electronically using the following email addresses:
`
`
`
`fprugo@omm.com
`chogan@omm.com
`mpensabene@omm.com
`kmurray2@omm.com
`
`
`
`
`
`
`Patent Owner may be served by mailing or hand-delivery to the following address:
`
`Filko Prugo (Reg. No. 73,092)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: fprugo@omm.com
`
`Marc Pensabene (Reg. No. 37,416)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: mpensabene@omm.com
`
`Caitlin Hogan (Reg. No. 61,515)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: chogan@omm.com
`
`Kevin Murray (Reg. No. 69,529)
`O’MELVENY & MYERS LLP
`400 South Hope Street
`Los Angeles, CA 90071
`Phone: (213) 430-6100
`Email: kmurray2@omm.com
`
`Respectfully submitted,
`
`Dated: July 20, 2016
`
`/s/ Filko Prugo
`
`Filko Prugo (Reg. No. 73,092)
`
`
`
`4
`
`

`
`Case IPR2016-01324
`U.S. Patent 7,456,160
`
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: fprugo@omm.com
`
`
`
`
`
`
`
`5
`
`

`
`Case IPR2016-01324
`U.S. Patent 7,456,160
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Mandatory Notice Pursuant to
`
`37 C.F.R. § 42.8 was served on July 20, 2016 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`Brandon M. White (Reg. No. 52,354): BMWhite@PerkinsCoie.com
`
`Crystal R. Canterbury (Reg. No. 69,853): CCanterbury@PerkinsCoie.com
`
`
`
`/Shari Gordon/
`
`
`
`Shari Gordon
`Case Manager
`O’MELVENY & MYERS LLP
`
`
`
`Dated: July 20, 2016
`
`
`
`
`
`6

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

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.

throbber

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.

Become a Member

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

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket