`
`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 SHANNON M. BLOODWORTH
`IN SUPPORT OF MOTION FOR PRO HAC VICE ADMISSION OF
`SHANNON M. BLOODWORTH
`
`MPI EXHIBIT 1091 PAGE 1
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`MPI EXHIBIT 1091 PAGE 1
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`
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`
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`I, Shannon M. Bloodworth, declare as follows:
`
`1.
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`I am a partner in the patent litigation group at Perkins Coie LLP.
`
`2.
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`I am a member in good standing of the Bar of the States of Maryland
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`and Wisconsin, the Commonwealth of Virginia and the District of Columbia. I
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`am also admitted to practice before the United States Supreme Court, United
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`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
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`D.C. and Maryland, and the Supreme Courts of Virginia and Wisconsin.
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`3. My Bar membership numbers are VA 46671, DC 474925 and WI
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`1088470.
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`4.
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`I have been practicing law for 23 years, during which time I have
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`focused on litigating patent cases, specifically pharmaceutical patent cases.
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`5. More generally, I have represented the Petitioner and/or its various
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`related entities in litigating significant pharmaceutical patent cases, such as the
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`following patent cases:
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`• Pfizer Inc. v. Mylan Inc., No. 09-441 (U.S. District Court for the
`
`District of Delaware);
`
`• Pfizer Inc. v. Mylan Inc., No. 09-00079 (U.S. District Court for the
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`Northern District of West Virginia);
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`2
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`MPI EXHIBIT 1091 PAGE 2
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`MPI EXHIBIT 1091 PAGE 2
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`
`
`
`
`• Novo Nordisk Inc. v. Mylan Pharmaceuticals Inc., No. 09-02445
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`(U.S. District Court for the District of New Jersey);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
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`09-08824 (U.S. District Court for the Southern District of New York);
`
`• Mylan Inc. v. SmithKline Beecham Corp., No. 10-4809 (U.S. District
`
`Court for the District of New Jersey);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
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`10-7246 (U.S. District Court for the Southern District of New York);
`
`•
`
`Teva Neuroscience, Inc. v. Mylan Inc., No. 10-05078 (U.S. District
`
`Court for the District of New Jersey);
`
`• Pfizer Inc. v. Mylan Inc., No. 11-269 (U.S. District Court for the
`
`District of Delaware);
`
`•
`
`The Medicines Co. v. Mylan Inc., No. 11-cv-01285 (U.S. District
`
`Court for the Northern District of Illinois);
`
`•
`
`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);
`
`• Mylan Pharmaceuticals Inc. v. Sebelius, No. 12-1344 (U.S. District
`
`Court for the District of Columbia);
`
`3
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`MPI EXHIBIT 1091 PAGE 3
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`MPI EXHIBIT 1091 PAGE 3
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`
`
`
`
`• AstraZeneca AB v. Mylan Laboratories Ltd., No. 12-cv-01378 (U.S.
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`District Court for the District of New Jersey);
`
`• Apotex, Inc. v. Daiichi Sankyo, Inc., No12-9295 (U.S. District Court
`
`for the Northern District of Illinois);
`
`• Horizon Pharma, Inc. v. Mylan Pharmaceuticals Inc., No. 13-cv-
`
`04022 (U.S. District Court for the District of New Jersey);
`
`•
`
`Teva Pharmaceuticals Indus., Ltd. v. Sebelius, No. 14-00786 (U.S.
`
`District Court for the District of Columbia);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
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`14-167 (U.S. District Court for the Northern District of West Virginia);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
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`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);
`
`•
`
`Teva Neuroscience, Inc. v. Mylan Inc., No. 14-1166 (U.S. Court of
`
`Appeals for the Federal Circuit);
`
`• Hospira, Inc. v. Burwell, No. 14-2662 (U.S. District Court for the
`
`District of Maryland);
`
`4
`
`MPI EXHIBIT 1091 PAGE 4
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`MPI EXHIBIT 1091 PAGE 4
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`
`
`
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`• Horizon Pharma, Inc. v. Mylan Pharmaceuticals Inc., No. 15-cv-
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`03327 (U.S. District Court for the District of New Jersey);
`
`• Apotex, Inc. v. Daiichi Sankyo, Inc., No. 15-03695 (U.S. District
`
`Court for the Northern District of Illinois);
`
`• 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);
`
`• AstraZeneca Pharmaceuticals LP v. Agila Specialties Inc., No. 15-
`
`06039 (U.S. District Court for the District of New Jersey);
`
`•
`
`Sandoz, Inc. v. Daiichi Sankyo Co., No. 16-81 (U.S. District Court
`
`for the Eastern District of Virginia);
`
`• AstraZeneca Pharmaceuticals LP v. Burwell, No. 16-1336 (U.S.
`
`District Court for the District of Columbia);
`
`5
`
`MPI EXHIBIT 1091 PAGE 5
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`MPI EXHIBIT 1091 PAGE 5
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`
`
`
`
`•
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`Torrent Pharmaceuticals Ltd. v. Daiichi Sankyo, Inc., No. 16-2988
`
`(U.S. District Court for the Northern District of Illinois);
`
`• Novartis AG v. Mylan Pharmaceuticals Inc., No. 16-cv-00289 (U.S.
`
`District Court for the District of Delaware);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Dr. Reddy’s Labs., Ltd., No. 16-
`
`1267 (U.S. District Court for the District of Delaware);
`
`• Novartis AG v. Torrent Pharmaceuticals Ltd., No. 16-1352 (U.S.
`
`Court of Appeals for the Federal Circuit);
`
`• Horizon Pharma, Inc. v. Mylan Pharmaceuticals Inc., No. 16-cv-
`
`04921 (U.S. District Court for the District of New Jersey);
`
`• Apotex, Inc. v. Daiichi Sankyo, Inc., Nos. 16-2073, 16-2075, 16-2076,
`
`16-2078 (U.S. Court of Appeals for the Federal Circuit);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
`
`17-00007 (U.S. District Court for the Northern District of West Virginia);
`
`• Novartis Pharmaceuticals Corp. v. Mylan Pharmaceuticals Inc., No.
`
`17-54 (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);
`
`6
`
`MPI EXHIBIT 1091 PAGE 6
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`MPI EXHIBIT 1091 PAGE 6
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`
`
`
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., No.
`
`17-249 (U.S. District Court for the District of Delaware);
`
`• Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., No. 17-374
`
`(U.S. District Court for the District of Delaware);
`
`• Novartis Pharmaceuticals Corp. v. Mylan Pharmaceuticals Inc., No.
`
`17-cv-00389 (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);
`
`• Pozen Inc. v. Dr. Reddy’s Labs. Inc., No. 17-2473 (U.S. Court of
`
`Appeals for the Federal Circuit);
`
`• ViiV Healthcare Co. v. Mylan Pharmaceuticals Inc., No. 17-1671
`
`(U.S. District Court for the District of Delaware);
`
`• AstraZeneca AB v. Mylan Laboratories Ltd., No. 18-193 (U.S.
`
`District Court for the Northern District of West Virginia);
`
`• Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., No. 18-
`
`cv-01043 (U.S. District Court for the District of Delaware);
`
`7
`
`MPI EXHIBIT 1091 PAGE 7
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`MPI EXHIBIT 1091 PAGE 7
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`
`
`
`
`• 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);
`
`• Novartis Pharmaceuticals Corp. v. Mylan Pharmaceuticals Inc., No.
`
`19-1118 (U.S. District Court for the District of Delaware);
`
`• Novo Nordisk Inc. v. Mylan Institutional LLC, No. 19-01551 (U.S.
`
`District Court for the District of Delaware);
`
`• BTG Int’l Ltd. v. Amneal Pharmaceuticals LLC, No. 19-1147 (U.S.
`
`Court of Appeals for the Federal Circuit);
`
`• Horizon Pharma, Inc. v. Dr. Reddy’s Labs. Inc., No. 19-1607 (U.S.
`
`Court of Appeals for the Federal Circuit);
`
`• Merck Sharp & Dohme B.V. v. Mylan API US LLC, No. 20-61 (U.S.
`
`District Court for the Northern District of West Virginia);
`
`•
`
`In re Sugammadex, No. 20-2576 (U.S. District Court for the District
`
`of New Jersey);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. FDA, No. 20-808 (U.S. District
`
`Court for the District of Columbia);
`
`8
`
`MPI EXHIBIT 1091 PAGE 8
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`MPI EXHIBIT 1091 PAGE 8
`
`
`
`
`
`• 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);
`
`• Otsuka Pharmaceutical Co., Ltd. v. Mylan Laboratories Ltd., No. 22-
`
`1125 (U.S. District Court for the District of Delaware);
`
`• Otsuka Pharmaceutical Co., Ltd. v. Mylan Laboratories Ltd., No. 22-
`
`1226 (U.S. District Court for the District of Delaware);
`
`• Otsuka Pharmaceutical Co., Ltd. v. Mylan Laboratories Ltd., No. 22-
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`1367 (U.S. District Court for the District of Delaware);
`
`9
`
`MPI EXHIBIT 1091 PAGE 9
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`MPI EXHIBIT 1091 PAGE 9
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`
`
`
`
`• 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)
`
`• 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.
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`I have never been disbarred, suspended, sanctioned, or cited for
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`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
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`product for which the ’462 patent is listed in FDA’s publication Approved Drug
`
`10
`
`MPI EXHIBIT 1091 PAGE 10
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`MPI EXHIBIT 1091 PAGE 10
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`
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`
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`Products with Therapeutic Equivalence Evaluations, commonly referred to as
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`the “Orange Book.” I have been litigating issues surrounding Ozempic® and the
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`’462 patent in In re: (Semaglutide) Patent Litigation, No. 22-MD-3038 (D.
`
`Del.), on behalf of Mylan Pharmaceuticals Inc.
`
`9.
`
`I 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
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`experience with the Federal Rules of Evidence, I have experience and expertise
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`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
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`vice before the United States Patent and Trademark Office in IPR2015-00643,
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`IPR2015-00644, IPR2015-00830, IPR2016-01332, 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
`
`11
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`MPI EXHIBIT 1091 PAGE 11
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`MPI EXHIBIT 1091 PAGE 11
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`
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`
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`believed to be true; and further that these statements are made with the
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`knowledge that willful false statements and the like are punishable by fine,
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`imprisonment, or both, under Section 1001 of Title 18 of the United States Code.
`
`
`
`Dated: December 15, 2023
`
`
`
`Shannon M. Bloodworth
`
`
`
`12
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`MPI EXHIBIT 1091 PAGE 12
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`MPI EXHIBIT 1091 PAGE 12
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`
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