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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`COALITION FOR AFFORDABLE DRUGS VI LLC,
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`Petitioner,
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`v.
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`CELGENE CORPORATION
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`Patent Owner
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`________________
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`Case IPR2015-01103
`Patent 6,315,720
`________________
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`DECLARATION OF JOHN FREEMAN
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`Case IPR2015-01103
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`CELGENE EXHIBIT 2069
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`Page 1 of 4
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`I, John Freeman, hereby declare and state as follows:
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`1.
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`I submit this declaration on behalf of Celgene Corporation
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`(“Celgene”), Patent Owner of U.S. Patent No. 6,315,720 (the “’720 patent”) in
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`connection with this inter partes review, Case IPR2015-01103.
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`I.
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`BACKGROUND
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`2.
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`I am currently the Corporate Vice President, Head of Global Drug
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`Safety & Risk Management for Celgene Corporation. I have held this position
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`since I became employed by Celgene in September 2005.
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`3.
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`In my role as Head of Global Drug Safety & Risk Management, I lead
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`the group responsible for monitoring various safety aspects of Celgene’s products.
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`Specifically, my team is responsible for the assessment of data concerning the safe
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`use of Celgene’s products, both in the marketplace and in clinical development.
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`My team works to ensure compliance with regulatory requirements with regard to
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`the safety profile of Celgene’s products, and to make safety information available
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`to various regulatory agencies. These responsibilities involve the development and
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`implementation of procedures relating to the restricted distribution of Celgene’s
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`products pursuant to regulatory requirements.
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`4.
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`Prior to joining Celgene, I served as Global Head of Drug Safety
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`Operations at Amgen, where I oversaw safety issues relating to Amgen’s products.
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`- 1 -
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`Page 2 of 4
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`5.
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`In 1986, I received a degree in pharmacology form the University of
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`Leeds in Leeds, United Kingdom. Subsequently, I received a post graduate
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`diploma (1989) in Clinical Science and a Master’s Degree in Clinical Research
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`(1998), both from the Welsh School of Pharmacy, University of Wales, Cardiff,
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`United Kingdom. I also received a law degree from the College of Law in London
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`in 2003.
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`6.
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`I am familiar with the restricted-distribution system known as the
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`System for Thalidomide Education and Prescribing Safety, or S.T.E.P.S.®
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`S.T.E.P.S.® was introduced with Celgene’s Thalomid® brand thalidomide capsules
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`in July of 1998.
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`7.
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`Since July of 1998, there has not been a single birth defect in
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`connection with Thalomid®, in the United States or elsewhere. There have also
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`been zero birth defects associated with two of Celgene’s other products, Revlimid®
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`and Pomalyst®, both of which are believed to be teratogenic by the U.S. Food and
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`Drug Administration.
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`8.
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`Several materials associated with the original, 1998 S.T.E.P.S.®
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`program are described below.
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`- 2 -
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`Page 3 of 4
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`II.
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`S.T.E.P.S.® MATERIALS
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`9.
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`Exhibit 2063 is a true and correct copy of the Patient Registration
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`Form that was used and distributed by Celgene in connection with the original
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`S.T.E.P.S.® program.
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`10. Exhibit 2064 is a true and correct copy of the Dear Pharmacist Letter
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`that was used and distributed by Celgene in connection with the original
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`S.T.E.P.S.® program.
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`11. Exhibit 2065 is a true and correct copy of the Pharmacy Registration
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`Card that was used and distributed by Celgene in connection with the original
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`S.T.E.P.S.® program.
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`
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`Executed this 12th day of February 2016. I declare under penalty of perjury
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`that the foregoing is true and correct.
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`- 3 -
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`Page 4 of 4
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