`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`SAMSUNG BIOEPIS CO., LTD.
`Petitioner,
`v.
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner.
`
`Patent No. 11,253,572
`
`_______________
`Inter Partes Review No. IPR2023-00884
`____________________________________________________________
`DECLARATION OF KAREN CHU
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`CONFIDENTIAL MATERIAL – SUBJECT TO PROTECTIVE ORDER
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2064 Page 1
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`IPR2023-00884
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`I, Karen Chu, declare as follows:
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`1.
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`I have personal knowledge of the facts contained in this Declaration,
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`and if called upon to do so, I could and would testify competently thereto.
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`2.
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`As I explain in detail below, I am an employee of Regeneron
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`Pharmaceuticals (“Regeneron”). I have not been compensated separately for my
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`efforts in connection with the preparation of this Declaration, but have instead
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`continued to receive my usual salary, including with respect to periods of time
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`during which I worked on this Declaration. My regular Regeneron compensation
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`is in no way contingent on the results of these or any other proceedings.
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`3.
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`I have personal knowledge of Exhibits 2004, 2008, 2013, 2020, 2036,
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`2043, 2047, 2048, 2068, and 2076 cited in this declaration, which are true and
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`correct copies or excerpts of documents I received, sent, or reviewed. They also
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`are business records created during the ordinary course of Regeneron’s business
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`operations and documenting various activities and product development, as is and
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`was our practice at Regeneron.
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`I.
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`4.
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`BACKGROUND
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`I am the Vice President, Global Program Head for Ophthalmology at
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`Regeneron and have held this position since October 2023. In this role, I am
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`responsible for the overall strategy and cross-functional alignment for
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`ophthalmology clinical development. My duties include advancing candidates
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`from preclinical development to clinical trials and developing the overall program
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`strategy for all phases of clinical development. I have worked at Regeneron since
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`2003, and I have held various positions in the clinical development group, which I
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`discuss further below.
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`5.
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`I earned my Bachelor of Science in biology from California
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`Polytechnic State University San Luis Obispo and my Master of Science in human
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`nutrition from Columbia University. I have more than 25 years of direct
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`experience in developing therapies for various diseases, including more than 20
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`years of experience in developing therapies for ophthalmic diseases.
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`II. MY ROLE IN THE DEVELOPMENT OF EYLEA®
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`6.
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`In 2003, I joined Regeneron as a Senior Clinical Trial Manager. My
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`job was to help implement and execute clinical trials. At that time, Regeneron was
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`still in the early stages of clinical development of aflibercept, the active ingredient
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`in EYLEA®, for both oncology and ophthalmology indications, and my duties
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`included overseeing a group of Clinical Trial Managers and other personnel
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`involved in the operations of Regeneron’s early phase clinical trials for that drug.
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`During clinical trials, Regeneron sometimes referred to EYLEA® as “VEGF Trap-
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`Eye” and I will also use that terminology in this Declaration.
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`7. Within my first year at Regeneron, VEGF Trap-Eye had advanced
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`from preclinical research to clinical development. It was at that time that I became
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`involved in the development of EYLEA® and my focus shifted exclusively to
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`ophthalmology. Due to the small size of Regeneron at the time, and the clinical
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`and regulatory group in particular, I became involved in the early discussions
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`around development strategy and study designs for VEGF Trap-Eye against
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`various indications, including neovascular age-related macular degeneration (“wet
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`AMD” or “AMD”) and diabetic macular edema (“DME”).
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`III. DR. YANCOPOULOS’S ROLE IN THE DEVELOPMENT OF
`EYLEA®
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`8. When I joined Regeneron, Dr. Yancopoulos was the Chief Scientific
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`Officer at the company, a position that he still holds today. Dr. Yancopoulos has
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`always taken, and continues to take, a hands-on role in research and development,
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`including the clinical development of VEGF Trap-Eye.
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`9.
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`At that time (and still to this day), members of senior management,
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`including Dr. Yancopoulos, were substantively involved in clinical development
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`planning and strategy. Regeneron employed a cross-functional team structure,
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`meaning that senior management made decisions based on the collective input of
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`the various teams working on clinical development. The various teams would
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`prepare and present data to members of senior management for discussion, who
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`then would use that data to make final decisions regarding clinical development
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`planning and strategy.
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`10. As the Chief Scientific Officer, Dr. Yancopoulos was always
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`substantively engaged in these discussions and data analysis. It was common for
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`Dr. Yancopoulos to intensely scrutinize presentations and to request additional data
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`or analysis. Due to his scientific expertise and extensive knowledge of the field,
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` as discussed below.
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`IV. REGENERON’S COLLABORATION WITH BAYER
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`11.
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`In the latter part of 2006, Regeneron entered a collaboration with
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`Bayer Schering Pharmaceuticals, now called Bayer, for the global development
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`and commercialization of VEGF Trap-Eye. Exhibit 2068 is a true and correct copy
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`of an October 18, 2006 joint press release announcing the collaboration of Bayer
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`and Regeneron on the development of VEGF Trap-Eye for the treatment of
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`angiogenic eye diseases.
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`12. As part of the collaboration, Regeneron and Bayer established joint
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`committees, each of which comprised a co-chair and a collection of members from
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`each company. Ex.2069. The Joint Steering Committee (JSC) included senior-
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`level employees from both Regeneron and Bayer. Ex.2069. From its inception,
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`
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`Dr. Yancopoulos served as the co-chair of the JSC. Several lower-level
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`committees—the Joint Development Committee, the Joint Finance Committee, the
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`Joint Commercial Committee—also were created and each reported up to the JSC.
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`Ex.2069.
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`13. The Bayer collaboration did not change the practice and structure of
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`Regeneron’s internal team meetings or decision-making process. Typically,
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`Regeneron personnel would confer internally about ideas or decisions regarding
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`the VEGF Trap-Eye clinical development program before discussing the same with
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`Bayer personnel.
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`14.
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`5
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`15.
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`I also note that because Dr. Yancopoulos led the discovery and
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`
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`development of VEGF Trap-Eye, he therefore was knowledgeable about the
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`formulation, pharmacology, stability, and manufacturing of VEGF Trap-Eye.
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`V. THE CLEAR-IT-2 AND VIEW CLINICAL TRIALS
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`16. Around the same time that Regeneron entered into its collaboration
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`with Bayer, I was promoted to Associate Director of Clinical Sciences and
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`subsequently to Director, Therapeutic Area Project Management. With these
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`promotions, I became more involved in providing support and input to members of
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`senior management to facilitate decision-making of clinical trial designs.
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`17.
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`In March 2007, Regeneron received the interim results of the Phase II
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`study for AMD called CLEAR-IT-2. Exhibit 2004, which I have reviewed, is a
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`true and correct copy of a press release published by Regeneron announcing the
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`interim results of CLEAR-IT-2 for AMD dated March 27, 2007.
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`18. At that time, Regeneron and Bayer were discussing the clinical
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`development plan and study design of the Phase III studies in AMD, later referred
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`to as “VIEW.” The design of the VIEW trials was very important to Regeneron.
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`Regeneron’s senior management, including Dr. Yancopoulos, Dr. Leonard
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`Schleifer (co-founder and Chief Executive Officer), Dr. Neil Stahl (Head of
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`Research), and Robert Terifay (Senior Vice President of Commercial)commonly
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`joined internal team meetings regarding those trials. They also would meet
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`separately to go over the interim CLEAR-IT-2 results. Exhibit 2008 is a true and
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`correct copy of an email dated April 2, 2007, to myself and others that documents
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`an internal meeting related to planning the VIEW trials.
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`19.
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`In addition to Regeneron’s internal discussions, Regeneron discussed
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`VIEW and the CLEAR-IT-2 results with Bayer. Regeneron thought that Bayer
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`could bring value to the collaboration through their strategic input on
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`commercializing VEGF Trap-Eye abroad and capabilities conducting global
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`clinical trials.
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`20. As the Director of Therapeutic Area Project Management, I
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`participated in discussions related to the design of the Phase III AMD trials (“the
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`VIEW trials”) and the Phase II DME trial (“DA VINCI”). During these
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`discussions, members of senior management considered the interim CLEAR-IT-2
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`results and the recently released clinical trial results of ranibizumab (Lucentis®)
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`for the treatment of AMD and DME when evaluating which dosing regimens to
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`test in the VIEW trials.
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`21. Dr. Yancopoulos was always substantively engaged in the team and
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`management-level discussions about the design of the dosing regimen for the
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`VIEW trials.
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`However, Dr. Yancopoulos was opposed to as-needed dosing regimens and instead
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`wanted to test an extended fixed dosing regimen—2 mg VEGF Trap-Eye every 8
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`weeks after three initial doses of 2 mg every 4 weeks (“2q8”)—in addition to a 2
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`mg every 4 weeks dosing regimen (“2q4”). Ultimately, Dr. Yancopoulos made the
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`final decision regarding the study design of the VIEW trials which, as described
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`below, included the 2q8 dosing regimen.
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`22. My responsibility at Regeneron included overseeing the conduct of
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`VIEW 1. Exhibit 2076 is a true and correct copy of the VIEW 1 study design as of
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`May 24, 2007. The final study design included four arms: (1) 2 mg of VEGF
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`Trap-Eye every 4 weeks (“2q4”), (2) 0.5 mg VEGF Trap-Eye every 4 weeks
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`(“0.5q4”), (3) 2 mg VEGF Trap-Eye every 8 weeks after three initial doses of 2 mg
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`every 4 weeks (“2q8”), and (4) 0.5 mg Lucentis® administered every 4 weeks
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`(“Rq4”). The objective of the VIEW trials was to compare the efficacy of VEGF
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`
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`Trap-Eye administered at various doses and frequencies to monthly administration
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`of 0.5 mg of Lucentis® over 52 weeks.
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`23. Exhibit 2076 lists the exclusion criteria, the primary endpoints, and
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`the VEGF Trap-Eye formulation used in VIEW 1. Ex.2076, 17, 21-23, 76-77. Dr.
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`Yancopoulos decided to proceed with the VIEW clinical trials based on a thorough
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`understanding of the protocol laid out in Exhibit 2076. This was consistent with his
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`usual practice. Before deciding to proceed with a clinical trial design, Dr.
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`Yancopoulos always reviewed the entire protocol in detail with me or other
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`members of the clinical development team. He explored with members of that
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`team the reasoning behind each aspect of the clinical trial protocol.
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`24.
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`In August 2007, I and others working under the direction of Dr.
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`Yancopoulos began executing VIEW 1 in the United States and Canada. VIEW 2,
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`which employed the same study design as VIEW 1, was executed abroad by Bayer.
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`27. The 1-year results from the VIEW trials became available internally
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`around mid-November 2010. Around that time, Dr. Yancopoulos and other
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`members of senior management received the results. Dr. Yancopoulos and other
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`members of the team considered the VIEW trials to be successes. The combined
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`results from VIEW 1 and VIEW 2 further indicated that the 2q8 VEGF Trap-Eye
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`dosing regimen was statistically non-inferior to monthly Lucentis® both in terms
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`of (1) achieving a gain in visual acuity as measured by the improvement in letters
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`at 52 weeks versus baseline, and (2) maintaining visual acuity over time as
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`measured by the percentage of patients losing 15 or more letters at 52 weeks versus
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`baseline in subjects with AMD. Ex.2043, 4-6.
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`28. On November 22, 2010, Regeneron and Bayer published a press
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`release announcing the 1-year results of the VIEW trials. The dosing regimens and
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`the visual acuity results mentioned in that press release are Dr. Yancopoulos’s
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`work.
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`VI. THE DA VINCI TRIAL
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`29. Dr. Yancopoulos was substantively involved in designing the Phase II
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`DA VINCI study for DME, including the clinical protocol.
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`30. While the design of the DA VINCI trial was not finalized until 2008, I
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`recall that the clinical team and senior management were considering potential
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`dosing regimens in both AMD and DME when the VIEW dosing regimen was
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`selected in 2007. The same 2q8 dosing regimen from the VIEW trials (2 mg
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`VEGF Trap Eye every 8 weeks after three initial doses of 2 mg every 4 weeks) was
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`accordingly also included in the Phase II DME study.
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`31. Exhibit 2036, which is a true and correct copy of a slide titled “DME
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`Target Product Profile” (a document summarizing qualities needed for VEGF
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`Trap-Eye product to be commercially successful), confirms my recollection on this
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`point. Exhibit 2013, which is a true and correct copy of an eventual “Clinical
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`Study Concept” for testing VEGF Trap-Eye in DME, further confirms my
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`recollection.
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`32. Ultimately, with the same thorough understanding of the protocol that
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`he had for the VIEW trials, Dr. Yancopoulos decided to go forward with the study
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`design and clinical protocol of the DA VINCI study. Dr. Yancopoulos made the
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`decision to include five arms in DA VINCI: (1) 0.5 mg VEGF Trap-Eye every 4
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`weeks (“0.5q4”), (2) 2 mg VEGF Trap-Eye every 4 weeks (“2q4”), (3) 2 mg
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`VEGF Trap-Eye every 8 weeks after three initial doses of 2 mg every 4 weeks
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`(“2q8”), (4) three initial doses of 2 mg VEGF Trap-Eye every 4 weeks then as-
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`needed dosing (“2.0 PRN”), and (5) laser photocoagulation. Ex.2048, 40. Exhibit
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`2048, which is a true copy of version VGFT-OD-0706.02 of the study protocol for
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`DA VINCI, lists both the dosing regimens that Dr. Yancopoulos decided to test
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`and the primary endpoint—the change in visual acuity from baseline at the 24-
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`week point. Exhibit 2048 also lists the exclusion criteria, the secondary endpoints,
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`and the formulation used for DA VINCI. Ex.2048, 7, 36-39, 83. Dr. Yancopoulos
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`would have been aware of these aspects of the clinical study protocol when he
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`made the decision to proceed with the DA VINCI study.
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`33. At the end of 2008, personnel working under the direction of
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`Regeneron, and Dr. Yancopoulos, began executing the DA VINCI trial in the
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`United States, Canada, and Australia.
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`35. This summary of the 24-week DA VINCI results was circulated to
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`senior management in early February 2010. Shortly thereafter, senior members of
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`management attended data review meetings to discuss further. Consistent with
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`usual practice, senior members of Regeneron management, including Dr.
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`Yancopoulos, analyzed the data and requested the preparation of additional
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`analyses and/or figures that would help in their interpretation and appreciation of
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`the clinical trial results. The general consensus was that the preliminary DA
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`VINCI results indicated that the 2q8 VEGF Trap-Eye dosing regimen achieved an
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`improvement in visual acuity in subjects with DME at 24 weeks versus baseline.
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`36. Consistent with standard practice, Regeneron announced these interim
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`results, including the visual acuity data, in a press release dated February 18, 2010.
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`Ex.2020. The dosing regimens and the preliminary visual acuity results mentioned
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`in that press release are Dr. Yancopoulos’s work.
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`37. The secondary endpoint of the DA VINCI study was at 52 weeks.
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`The final, 52-week DA VINCI results were available internally in early December
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`2010. Shortly thereafter, senior members of management, including Dr.
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`Yancopoulos, received summaries of the results. The internal consensus was that
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`the 1-year results indicated that DME patients receiving the 2q8 dosing regimen
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`could achieve significant visual acuity gains at 52 weeks versus baseline.
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`Regeneron published these results, which are Dr. Yancopoulos’s work, in a press
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`release dated December 20, 2010.
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`VII. THE APRIL 2010 ARVO ABSTRACT
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`38. Regeneron has always sought to share information with the scientific
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`community and public regarding treatments in its development pipeline. Clinical
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`investigators typically present interim and final clinical trial results from
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`Regeneron’s clinical trials at scientific conferences, such as those held by the
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`Association for Research in Vision and Ophthalmology (ARVO) and the American
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`Society of Retina Specialists. As just one example, Exhibit 2047 is a true and
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`correct copy of a presentation on the 1-year results of the CLEAR-IT-2 study for
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`AMD presented at the 2008 Retina Society Meeting on September 28, 2008.
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`Regeneron also typically published its final clinical trial results in scientific
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`journals.
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`39. When sharing clinical trial results at a scientific conference,
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`Regeneron’s practice was for a medical director or a therapeutic head with deep
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`knowledge of the clinical trial design and execution to draft an abstract for
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`submission. Regeneron typically then worked with a clinical investigator
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`involved in collecting the underlying data to submit the abstract and present
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`clinical trial results at the scientific conference.
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`40.
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`In his role as Chief Scientific Officer, Dr. Yancopoulos would have
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`known whether Regeneron planned to report clinical trial results, and he would
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`have known how Regeneron planned to share those results with the public. I recall
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`a number of instances in which Dr. Yancopoulos reviewed abstracts before their
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`submission.
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`41. Consistent with Regeneron’s standard practice, the 24-week
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`preliminary DA VINCI results were summarized into an abstract and submitted to
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`an Association for Research in Vision and Ophthalmology (ARVO) conference
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`scheduled for April 2010. Ex.1010. I understand from reviewing Exhibits 2021-
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`2023 that Alyson Berliner, the DA VINCI study director, Ex.2018, drafted that
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`abstract and asked Dr. David Brown to review, submit, and present it at the ARVO
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`conference, Ex.2021, Ex.2022, Ex.2023. It was consistent with the Regeneron’s
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`practice for Alyson Berliner to draft an abstract reporting the interim results of DA
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`VINCI with input from clinical investigators, such as Dr. David Brown, who
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`would review, submit, and present, at scientific conferences.
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`42. The dosing regimens and the visual acuity results recited in the 2010
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`ARVO abstract correspond to the results reported in the February 18, 2010 Press
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`Release and are Dr. Yancopoulos’ work. As indicated above, I was closely
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`involved in discussions about the design of the DA VINCI trial and played a role in
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`overseeing its execution. I do not recall Dr. Brown or Dr. Major (the other person
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`named as an author on the 2010 ARVO abstract (Ex.1010)) playing a role in the
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`clinical study design or clinical protocol beyond executing the protocol at their
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`sites and presenting the results.
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`I declare that all statements made herein of my own knowledge are true and
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`that all statements made on information and belief are believed to be true, and that
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`these statements were made with knowledge that willful false statements and the
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`like so made are punishable by fine or imprisonment, or both, under section 1001
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`of Title 18 of the United States Code.
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`Dated:
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`_______________________
`Karen Chu
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2064 Page 18
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