`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`NOVO NORDISK A/S,
`
`Patent Owner.
`
`
`Case No. IPR2023-00724
`U.S. Patent No. 10,335,462
`
`
`DECLARATION OF DAVID L. ANSTAETT
`IN SUPPORT OF MOTION FOR PRO HAC VICE ADMISSION OF
`DAVID L. ANSTAETT
`
`
`
`
`
`
`
`MPI EXHIBIT 1092 PAGE 1
`
`MPI EXHIBIT 1092 PAGE 1
`
`
`
`
`
`I, David L. Anstaett, declare as follows:
`
`1.
`
`I am a partner in the patent litigation group at Perkins Coie LLP.
`
`2.
`
`I am a member in good standing of the Bar of the State of Wisconsin
`
`and the Commonwealth of Virginia. I am also admitted to practice before the
`
`United States Supreme Court, United States Courts of Appeals for the Fourth
`
`Circuit, D.C. Circuit, and the Federal Circuit. I am admitted to practice before
`
`the United States District Courts for D.C. and Wisconsin.
`
`3. My Bar membership numbers are VA 46614 and WI 1037884.
`
`4.
`
`I have been practicing law for 22 years, including litigating patent
`
`cases, specifically focused on pharmaceutical and life science patent cases, for
`
`approximately 14 years.
`
`5. More generally, I have represented the Petitioner and/or its various
`
`related entities in litigating significant pharmaceutical patent cases, such as the
`
`following patent cases:
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
`
`09-08824 (U.S. District Court for the Southern District of New York);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
`
`10-7246 (U.S. District Court for the Southern District of New York);
`
`2
`
`MPI EXHIBIT 1092 PAGE 2
`
`MPI EXHIBIT 1092 PAGE 2
`
`
`
`
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Sandoz Inc., Nos. 12-1567, 12-
`
`1568, 12-1569, 12-1570 (U.S. Court of Appeals for the Federal Circuit);
`
`• AstraZeneca AB v. Mylan Laboratories Ltd., No. 12-cv-01378 (U.S.
`
`District Court for the District of New Jersey);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
`
`14-cv-01278 (U.S. District Court for the District of Delaware);
`
`•
`
`In re Copaxone 40 mg Cases, No. 14-1171 (U.S. District Court for
`
`the District of Delaware);
`
`• Hospira, Inc. v. Burwell, No. 14-2662 (U.S. District Court for the
`
`District of Maryland);
`
`• BTG Int’l Ltd. v. Actavis Labs. FL, Inc., No. 15-cv-05909 (U.S.
`
`District Court for the District of New Jersey);
`
`•
`
`The Medicines Co. v. Mylan Inc., No. 15-1113, 15-1151, 15-1181
`
`(U.S. Court of Appeals for the Federal Circuit);
`
`• AstraZeneca AB v. Mylan Laboratories Ltd., No. 15-1889 (U.S. Court
`
`of Appeals for the Federal Circuit);
`
`• AstraZeneca Pharmaceuticals LP v. Mylan Pharmaceuticals Inc.,
`
`No. 15-183 (U.S. District Court for the Northern District of West Virginia);
`
`3
`
`MPI EXHIBIT 1092 PAGE 3
`
`MPI EXHIBIT 1092 PAGE 3
`
`
`
`
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
`
`17-00007 (U.S. District Court for the Northern District of West Virginia);
`
`• Biogen Int’l GmbH v. Mylan Pharmaceuticals Inc., No. 17-00116
`
`(U.S. District Court for the Northern District of West Virginia);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
`
`17-249 (U.S. District Court for the District of Delaware);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Sandoz Inc., No. 17-cv-1575 (U.S.
`
`Court of Appeals for the Federal Circuit);
`
`•
`
`Yeda Research & Development Co. v. Mylan Pharmaceuticals Inc.,
`
`Nos. 17-1594, 17-1595, 17-1596 (U.S. Court of Appeals for the Federal Circuit);
`
`• AstraZeneca AB v. Mylan Laboratories Ltd., No. 18-193 (U.S.
`
`District Court for the Northern District of West Virginia);
`
`• AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 18-01562 (U.S.
`
`District Court for the District of Delaware);
`
`• AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 19-00203 (U.S.
`
`District Court for the Northern District of West Virginia);
`
`• BTG Int’l Ltd. v. Amneal Pharmaceuticals LLC, No. 19-1147 (U.S.
`
`Court of Appeals for the Federal Circuit);
`
`4
`
`MPI EXHIBIT 1092 PAGE 4
`
`MPI EXHIBIT 1092 PAGE 4
`
`
`
`
`
`•
`
`Teva Pharmaceuticals USA Inc. v. FDA, No. 20-808 (U.S. District
`
`Court for the District of Columbia);
`
`• Mylan Pharmaceuticals Inc. v. Biogen MA Inc., No. 20-1673 (U.S.
`
`Court of Appeals for the Federal Circuit);
`
`• Biogen Int’l GmbH v. Mylan Pharmaceuticals Inc., No. 20-1933
`
`(U.S. Court of Appeals for the Federal Circuit);
`
`• Biogen Int’l GmbH v. Mylan Pharmaceuticals Inc., No. 21-1567
`
`(U.S. Supreme Court);
`
`• AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 21-1729 (U.S.
`
`Court of Appeals for the Federal Circuit);
`
`• AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 22-35 (U.S.
`
`District Court for the Northern District of West Virginia);
`
`• Otsuka Pharmaceutical Co., Ltd. v. Mylan Laboratories Ltd., No. 22-
`
`464 (U.S. District Court for the District of Delaware);
`
`• Novo Nordisk Inc. v. Mylan Pharmaceuticals Inc., No. 22-1040 (U.S.
`
`District Court for the District of Delaware);
`
`•
`
`In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-3038
`
`(U.S. District Court for the District of Delaware);
`
`5
`
`MPI EXHIBIT 1092 PAGE 5
`
`MPI EXHIBIT 1092 PAGE 5
`
`
`
`
`
`• Novo Nordisk Inc. v. Viatris Inc., No. 23-101 (U.S. District Court for
`
`the District of Delaware);
`
`• AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 23-1164 (U.S.
`
`Court of Appeals for the Federal Circuit); and
`
`• AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 23-1267 (U.S.
`
`Court of Appeals for the Federal Circuit).
`
`6.
`
`I have never been disbarred, suspended, sanctioned, or cited for
`
`contempt by any court or administrative body. I am not currently suspended in
`
`any bar, or by any court or administrative body.
`
`7.
`
`I have never had a court or administrative body deny my application
`
`for admission to practice.
`
`8.
`
`I am familiar with the subject matter of this proceeding. In addition
`
`to U.S. Patent No. 10,335,462 (the “’462 patent”) and its prosecution history, I
`
`am familiar with the technology at issue and Ozempic®, the pharmaceutical
`
`product for which the ’462 patent is listed in FDA’s publication Approved Drug
`
`Products with Therapeutic Equivalence Evaluations, commonly referred to as
`
`the “Orange Book.” I have been litigating issues surrounding Ozempic® and
`
`the ’462 patent in In re: (Semaglutide) Patent Litigation, No. 22-MD-3038 (D.
`
`Del.), on behalf of Mylan Pharmaceuticals Inc.
`
`6
`
`MPI EXHIBIT 1092 PAGE 6
`
`MPI EXHIBIT 1092 PAGE 6
`
`
`
`
`
`9.
`
`In connection with my work on the Ozempic® litigation, I have
`
`become familiar with the prior art references that are the subject of this
`
`proceeding.
`
`10. Given my familiarity with the underlying facts and my litigation
`
`experience with the Federal Rules of Evidence, I have experience and expertise
`
`important to representing Mylan’s interests in this matter.
`
`11. I have read and will comply with the Office Patent Trial Practice
`
`Guide and the Board’s Rules of Practice for Trials, as set forth in Part 42 of 37
`
`C.F.R.
`
`12. I agree to be subject to the United States Patent and Trademark Office
`
`Rules of Professional Conduct set forth in 37 C.F.R. §§ 11.101 et seq. and
`
`disciplinary jurisdiction under 37 C.F.R. § 11.19(a).
`
`13. I have previously applied for, and been granted, admission pro hac
`
`vice before the United States Patent and Trademark Office in IPR2015-00643,
`
`IPR2015-00644, IPR2015-00830, and IPR2018-01403.
`
`14. I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true; and further that these statements are made with the
`
`knowledge that willful false statements and the like are punishable by fine,
`
`imprisonment, or both, under Section 1001 of Title 18 of the United States Code.
`
`7
`
`MPI EXHIBIT 1092 PAGE 7
`
`MPI EXHIBIT 1092 PAGE 7
`
`
`
`
`
`
`
`Dated: December 18, 2023
`
`
`
`David L. Anstaett
`
`
`
`8
`
`MPI EXHIBIT 1092 PAGE 8
`
`MPI EXHIBIT 1092 PAGE 8
`
`
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
