UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`
`HAYMAN CREDES MASTER FUND, L.P.;
`
`HAYMAN ORANGE FUND SPC — PORTFOLIO A;
`
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`
`HAYMAN INVESTMENTS, LLC;
`
`NXN PARTNERS, LLC;
`
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS; and ERICH SPANGENBERG,
`Petitioner,
`
`V.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`Case: IPR2016—01993
`
`U.S. Patent No. 8,399,514
`
`DECLARATION OF RICHARD BRUDNICK
`
`Page 1 of 11
`
`Biogen Exhibit 2015
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`
`HAYMAN CREDES MASTER FUND, L.P.;
`
`HAYMAN ORANGE FUND SPC — PORTFOLIO A;
`
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`
`HAYMAN INVESTMENTS, LLC;
`
`NXN PARTNERS, LLC;
`
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS; and ERICH SPANGENBERG,
`Petitioner,
`
`V.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`Case: IPR2016—01993
`
`U.S. Patent No. 8,399,514
`
`DECLARATION OF RICHARD BRUDNICK
`
`Page 1 of 11
`
`Biogen Exhibit 2015
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Case No. IPR2015-01993
`
`Patent 8,399,514
`
`TABLE OF CONTENTS
`
`Introduction ................................................................................................... .. 1
`
`Background Information ............................................................................... .. 2
`
`III.
`
`License Agreement Between Fumaphann AG and Biogen, Inc ................... .. 3
`
`IV.
`
`Stock Purchase Agreement Between the Sellers of Fumapharrn AG
`and Biogen Idec MA Inc. .............................................................................. .. 7
`
`Conclusion ..................................................................................................... .. 9
`
`Page 2 of 11
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`
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`Case No. IPR20l5-01993
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`Patent 8,399,514
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`1, Richard B1'L1dI1iCl(, declare as follows:
`
`Introduction
`
`1.
`
`I am the Senior Vice President of Corporate Development & Strategy
`
`at Biogen Inc] I have held this position since August 2014.
`
`2.
`
`Before my cu1'rent position, I served as the Vice President of Business
`
`Development at Biogen Inc. since October 2011.
`
`3.
`
`Between July 2009 and October 2011, I was the Senior Director of
`
`Business Development at Biogen Inc. I was also the Senior Director of Business
`
`Development at Biogen Inc. between October 2001 and February 2008.
`
`4.
`
`I graduated from the Massachusetts Institute of Technology (“MIT”)
`
`in 1978 with a bachelor of science degree in management science. I obtained a
`
`master’s degree in management science in 1980 from the Sloan School of
`
`Management at MIT.
`
`1 Biogen Inc. was formerly known as Biogen Idec. Inc. and Idec Pharmaceuticals
`
`Corp. For simplicity, I refer only to Biogen Inc. in discussing my employment
`
`history.
`
`Page 3 of 11
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`Case No. IPR2015-01993
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`Patent 8,399,514
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`5.
`
`My business career spans more than thirty years. While at Biogen
`
`Inc., I have led several major transactions, including those relating to Tecfidera®,
`
`Zinbryta®, and Sprinraza®. I have also negotiated a strategic neurology alliance
`
`with Ionis, the formation of a biosirnilar joint venture with Samsung (Bioepis), and
`
`an Alzheimer’s alliance with Eisai.
`
`6.
`
`I have participated in many commercial transactions throughout my
`
`career. Before joining Biogen Inc., for example, I was the Chief Executive Officer
`
`of a regional pharmaceutical distribution business. I helped grow that business to
`
`over $200 million in annual sales before selling it to a strategic buyer. I also co-
`
`founded two companies and served as a strategy consultant for Bain & Company.
`
`7.
`
`8.
`
`My curriculum vitae is provided as Exhibit 2023.
`
`All facts in this declaration are based on my personal knowledge
`
`unless otherwise stated.
`
`Background Information
`
`9.
`
`I understand that U.S. Patent No. 8,399,514 (“the ’5l4 patent,” Ex.
`
`1001) is at issue in this proceeding.
`
`10.
`
`I understand that the ’5l4 patent concerns the use of pharmaceutical
`
`compositions of certain fumaric
`
`acid derivatives
`
`(dimethyl
`
`fumarate
`
`and
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`Page 4 of 11
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`Case No. IPR20l 5-01993
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`Patent 8,399,514
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`monomethyl fumarate) to treat multiple sclerosis (“MS") in which the fumaric acid
`
`derivative is administered in a therapeutically effective dose of about 480 mg/day.
`
`ll.
`
`I understand that the ’5l4 patent’s priority application was filed on
`
`February 8, 2007.
`
`12.
`
`I understand that Petitioner has cited U.S. Patent No. 7,320,999
`
`(“Joshi ’999,” Ex. 1030) as prior art to the ’5l4 patent. Drs. Joshi and Strebel, the
`
`named inventors of Joshi ’999, were shareholders of Fumapharm AG.
`
`13.
`
`I understand that Joshi
`
`’999 claims priority to a German priority
`
`application filed on November 19, l998. (Ex. 1030 at page 1, pt. (30).)
`
`III.
`
`License Agreement Between Fumapharm AG and Biogen, Inc.
`
`14.
`
`Exhibit 2016 is a true and correct copy of a License Agreement
`
`between Fumapharm AG and Biogen, lnc.,2 which became effective on September
`
`25, 2003.
`
`2 The License Agreement identifies Biogen, Inc., a Massachusetts corporation, as
`
`“Biogen Inc.” (without a comma). I understand that this is a typographical error
`
`because to the best of my knowledge no Massachusetts corporate entity named
`
`Page 5 of 11
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`Case No. IPR201 5-01993
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`15.
`
`I was involved in negotiating the terms of the License Agreement. For
`
`example,
`
`I was aware of Fumapharm AG’s work with FAG-201 (dimethyl
`
`fumarate as enteric-coated microtablets in capsules (Ex. 2016 at page 13)) and
`
`identified Fumapharm AG as a potential collaboration partner for Biogen. I also
`
`developed a relationship with Fumapharm AG, negotiate Fumapharm AG, and
`
`eventually participated in the completion of the License Agreement with
`
`Fumapharm AG.
`
`16.
`
`The License Agreement was structured as a collaboration agreement.
`
`Fumapharm AG owned FAG—201 (later known as BG000l2), know—how, and
`
`related intellectual property rights and sought a partner to fiirther develop this
`
`compound in psoriasis, MS and other promising indications. (Ex. 2016 at page 9,
`
`A(3).) FAG-201 contained dimethyl fumarate as its sole active ingredient. (Id. at
`
`page 13-.)
`
`17.
`
`As reflected in the License Agreement, Fumapharm AG negotiated for
`
`terms that would ensure that it owned all intellectual property rights resulting from
`
`“Biogen Inc.” (without a comma) existed when this agreement was signed. (Ex.
`
`20133
`
`Page 6 of 11
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`the collaboration. Terms effectuating that intent appear throughout the License
`
`Agreement.
`
`18.
`
`For
`
`example,
`
`the License Agreement
`
`defines Collaboration
`
`Technology, Inventions, and Improvements in ways that reflect their ownership by
`
`Furnapharm AG:
`
`0
`
`Collaboration Technology is defined as all Collaboration Patents and
`
`Collaboration Know—How, and the definition expressly states that
`
`Fumapharm AG owns the Collaboration Technology. (Ex. 2016 at
`
`page 11.)
`
`0
`
`Inventions are defined as any discovery or finding that directly relates
`
`to the use,
`
`formulation, or manufacture of any composition or
`
`pharmaceutical formulation containing a fiimaric acid derivative for
`
`use in diagnosing, treating, or preventing any disease or condition in
`
`humans.
`
`(Id.
`
`at page 15.) The definition expressly states
`
`that
`
`Fumapharm AG owns the Inventions. (Id.)
`
`0
`
`Improvements are defined as any pharmaceutical formulation, use, or
`
`manufacture containing one or more furnaric acid derivatives that is
`
`not already claimed by a valid patent of Fumapharm AG. In addition,
`
`Page 7 of 11
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`the definition expressly states
`
`that Fumapharm AG owns
`
`the
`
`Improvements. (Id. at page 14.)
`
`19.
`
`Clauses throughout the License Agreement reiterate that Fumapharm
`
`AG would own the Collaboration Technology, Inventions, and Improvements.
`
`0
`
`0
`
`Clause 43.3 provides that Fumapharm AG is the sole owner of the
`
`Collaboration Technology. (Id. at page 47.)
`
`Clause 46.l(c) provides that Fumapharm AG will be the sole owner of
`
`all Collaboration Technology. (Id. at page 51.) Clause 46.l(c) also
`
`assigns all of Biogen,
`
`Inc.’s
`
`rights
`
`in and to Inventions and
`
`Improvements
`
`relating
`
`to
`
`the Collaboration Technology
`
`to
`
`Fumapharm AG. (Id)
`
`0
`
`Clause 48.2 provides that Fumapharm AG will continue to own all
`
`Collaboration Technology after termination or expiration of the
`
`License Agreement. (Id. at page 58.)
`
`20.
`
`In addition, Fumapharrn Patents included any and all patents or patent
`
`applications that were controlled by Furnapharm AG as of the effective date of the
`
`License Agreement and which claimed compositions or uses of the Licensed
`
`Product. (Ex. 2016 at pages 13-14.) Joshi
`
`’999, which issued from a chain of
`
`Page 8 of 11
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`applications originally filed in November 1998, falls within the definition of
`
`Fumapharm Patents.
`
`(See Ex. 1030 at col. 8:14-63 (claiming the use of a
`
`LICENSED PRODUCT (Ex. 2016 at 15)); Ex. 2021 (assignment from Rajendra
`
`Kumar Joshi and Hans—Peter Strebel to Fumapharm AG); Ex. 2022 (change of
`
`address for Fumapharm AG).)
`
`21.
`
`Fumapharm AG gave Biogen, Inc. access to FAG—20l only after the
`
`parties executed the License Agreement in September 2003.
`
`22.
`
`I understand that after Biogen, Inc. obtained access to FAG—201, Dr.
`
`Gilmore O’Neill conceived of certain subject matter that led to the ’5l4 patent by
`
`no later than February 2004. The License Agreement covered that subject matter
`
`developed by Dr. O’Neill. Specifically, Dr. O’Neill’s inventions developed after
`
`receiving access
`
`to FAG-201
`
`fell within the definitions of
`
`Inventions,
`
`Improvements,
`
`and Collaboration Technology as defined in the License
`
`Agreement, all of which were owned by Fumapharm AG. (E. g., Ex. 2016 at pages
`
`l1,14,15, 51.)
`
`Stock Purchase Agreement Between the Sellers of Fumapharm AG and
`Biogen Idec MA Inc.
`
`23.
`
`Following the positive results of a Phase Ilb study with BG000l2
`
`Page 9 of 11
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`Case No. IPR20lS-01993
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`Patent 8,399,514
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`sclerosis, Biogen Idec MA Inc. announced that it would acquire Fumapharrn AG
`
`and all of its assets.3 (Ex. 2019.)
`
`24.
`
`Exhibit 2017 is a true and correct copy of the Stock Purchase
`
`Agreement between the Sellers of Fumapharm AG and Biogen Idec MA Inc.,
`
`which became effective on May 26, 2006.
`
`25. When the Stock Purchase Agreement was negotiated, I was employed
`
`by Biogen Idec Inc. and was familiar with the circumstances surrounding the
`
`agreement. In addition, in 2013 and 2014, I helped negotiate follow—on agreements
`
`regarding contingent payments related to revenues of the drug product Tecfidera'®,
`
`which required me to review and understand the details of the Stock Purchase
`
`Agreement.
`
`26. Under
`
`the Stock Purchase Agreement, Biogen Idec MA Inc.
`
`purchased 100% of the share capital of Fumapharrn AG, and Fumaphann AG
`
`became an affiliate of Biogen Idec MA Inc. (Ex. 2017 at 2.)
`
`27.
`
`The transaction was completed on June 15, 2006, and ownership of
`
`Fumapharm AG’s intellectual property rights was transferred to Biogen Idec MA
`
`Inc. by Virtue of the Stock Purchase Agreement. (Ex. 2020 at 13.) To ensure that
`
`3 Biogen Idec MA Inc. was previously known as Biogen, Inc. (Ex. 2018.)
`
`Page 10 of 11
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`Patent 8,399,514
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`all of Fumapharm AG’s intellectual property rights were transferred to Biogen Idec
`
`MA Inc., all of the Sellers, including Drs. Joshi and Strebel, were required to
`
`assign all of their ownership interests to Fumaphann AG before the stock transfer
`
`date. (Ex. 2017 11 37.7.) Thus, Biogen Idec MA Inc. acquired Joshi ’999 and the
`
`subject 1na.tter of the ’5 14 patent through the Stock Purchase Agreement.
`
`Conclusion
`
`28.
`
`Joshi ’999 and the subject matter of the ’5l4 patent have always been
`
`commonly owned. Fumapharm AG first owned these intellectual property assets
`
`under the License Agreement. Subsequently, after Biogen Idec MA Inc. acquired
`
`Fumapharm AG in 2006, Biogen Idec MA Inc. owned Joshi ’999 and the subject
`
`matter of the ’5 14 patent from that time forward, including up to the present date.
`
`29.
`
`I declare that all statements made herein of my knowledge are true,
`
`and that all statements made on information and belief are believed to be true, and
`
`that these statements were made with the knowledge that willful false statements
`
`and the like so made are punishable by fine or imprisonment, or both, under
`
`Section 1001 ofTitle 18 ofthe United States Code. _.,_,.»7(
`Jffifljl
`/
`//_'.tq,.r'
`// \_\‘:T. ’.-I' "
`Dated:
`;‘Lf'*l at M . W Z
`By/"
`,-*"a:z<'.'£*”"§’e’L»j//
`’\""/
`Richard/Bmdniclc
`
`Page 11 of 11
`
`
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