UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
`
`WOCKHARDT BIO AG,
`Petitioner,
`v.
`
`JANSSEN ONCOLOGY, INC.
`Patent Owner.
`
`_______________________
`
`Case IPR2016-01582
`Patent 8,822,438 B2
`
`_______________________
`
`DECLARATION OF IAN JUDSON, MD
`IN SUPPORT OF JANSSEN ONCOLOGY, INC.’S
`PATENT OWNER RESPONSE
`
`
`
`
`
`
`
`JANSSEN EXHIBIT 2028
`Wockhardt v. Janssen IPR2016-01582
`
`
`
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
`
`WOCKHARDT BIO AG,
`Petitioner,
`v.
`
`JANSSEN ONCOLOGY, INC.
`Patent Owner.
`
`_______________________
`
`Case IPR2016-01582
`Patent 8,822,438 B2
`
`_______________________
`
`DECLARATION OF IAN JUDSON, MD
`IN SUPPORT OF JANSSEN ONCOLOGY, INC.’S
`PATENT OWNER RESPONSE
`
`
`
`
`
`
`
`JANSSEN EXHIBIT 2028
`Wockhardt v. Janssen IPR2016-01582
`
`
`
`
`
`I, Ian Judson, M.D. hereby declare as follows:
`
`1.
`
`I am over the age of eighteen (18) and am otherwise competent to
`
`make this Declaration. I have personal knowledge of the facts set forth in this
`
`Declaration and am competent to testify to the same. I am a Consultant Medical
`
`Oncologist at the Royal Marsden. I was appointed Senior Lecturer at the Royal
`
`Marsden and The Institute of Cancer Research (ICR) in 1989, and became
`
`Professor of Cancer Pharmacology in 2001. I have been involved in the early
`
`development of a number of anti-cancer drugs including carboplatin,
`
`temozolomide, raltitrexed, imatinib and abiraterone acetate.
`
`2.
`
`I have been asked by counsel for Patent Owner Janssen Oncology
`
`Inc. (“Janssen”) to provide a short declaration as background for the panel of
`
`Administrative Patent Judges of the Patent Trial and Appeal Board of the United
`
`States Patent and Trademark Office (“Panel”) as it considers issues relating to the
`
`patentability of U.S. Patent No. 8,822,438 (the ’438 Patent) (Ex. 1001) in an inter
`
`partes review requested by Wockhardt Bio AG (hereinafter “Wockhardt”) in
`
`Case No. IPR2016-01582. Other than compensation for discussions leading to
`
`this declaration, I have personally received no funding from Janssen Oncology
`
`Inc. but I have received what is termed Rewards to Discoverers payments from
`
`the ICR for my involvement in the development of abiraterone.
`
`
`
`
`
`
`
`3.
`
`I was the principal investigator for a series of phase one trials carried
`
`out in 1998-1999 in which the 17α-hydroxylase/C17,20-lyase inhibitor
`
`abiraterone acetate (CB7630) was tested in humans for the first time. I was
`
`assisted by Professor David Dearnaley, a Clinical Oncologist at the Royal
`
`Marsden with a special interest in prostate cancer, and a number of investigators
`
`from other hospitals. The ICR / Royal Marsden were initially partnered with
`
`Boehringer Ingelheim for this project, and Boehringer Ingelheim assisted by
`
`synthesising a batch of clinical grade abiraterone acetate for the phase one trials.
`
`4.
`
`The trials involved three studies conducted to determine the dose of
`
`abiraterone acetate that would result in suppression of testosterone and to obtain
`
`safety, pharmacokinetic and endocrine data. The scope of the studies, including
`
`the numbers of patients and duration of treatment was restricted by the limited
`
`supply of clinical grade abiraterone acetate. The results of these phase one trials
`
`were eventually reported in O'Donnell et al., BJC, 90, 2317-2325 (2004). I have
`
`been asked to refer to this publication as “O’Donnell” (Ex. 1003).
`
`5.
`
`The studies showed that specific inhibition of the CYP17 enzyme by
`
`abiraterone acetate could reduce testosterone levels in both castrate and non-
`
`castrate males to below castrate levels. This was proof-of-principle of the action
`
`of the drug on testosterone levels.
`
`
`
`3
`
`
`
`
`
`6.
`
`Abiraterone acetate proved to be well tolerated. Mild side effects
`
`included headache, flushing and low mood. Cortisol levels were in general
`
`maintained. Although the response to an injection of synthetic ACTH (described
`
`as the “Synacthen test” in O’Donnell (Ex. 1003)) was reduced, this was not
`
`thought at the time to be a major concern, since cortisol levels were maintained
`
`and there was still some response to ACTH. Our conclusion, as summarised in
`
`page 2323 of O’Donnell (Ex. 1003), was that there were three possibilities: (i)
`
`that concomitant therapy with glucocorticoid would be required on a continuous
`
`basis, (ii) that glucocorticoid would be needed only at times of physiological
`
`stress, when patients became symptomatic, or (iii) that there would be no
`
`requirement for glucocorticoid at all. Regarding (ii), the option discussed at the
`
`time, if there had been concerns (which there were not), was to give patients a
`
`steroid warning card, and a supply of hydrocortisone tablets to take in an
`
`emergency, such as infection, trauma etc. At the time, hydrocortisone was the
`
`standard steroid administered as a glucocorticoid replacement with ketoconazole
`
`and aminoglutethimide, which were inhibitors of steroid synthesis that were
`
`known to reduce cortisol levels.
`
`7.
`
`Subsequent to the completion of the study and submission of the
`
`final report at the end of 1999, Boehringer Ingelheim decided not to continue
`
`their involvement in the project. Attempts to find an alternative commercial
`
`
`
`4
`
`
`
`
`
`partner for clinical development proved extremely difficult. In the years
`
`following 2000, a number of major multinational pharmaceutical companies were
`
`approached. On one trip to the United States I visited several such companies in
`
`Princeton and Philadelphia. In these meetings, we presented the results of the
`
`phase one trials reported in O’Donnell. Following these meetings, none of these
`
`companies proved willing to support taking abiraterone acetate into further
`
`clinical trials.
`
`8.
`
`During a similar period, we submitted the O’Donnell manuscript to
`
`various medical journals, including Clinical Cancer Research, but were met with
`
`scepticism and the study was not published (as O’Donnell) until 2004, in the
`
`British Journal of Cancer. No further data were generated or analysis performed
`
`after the rejections and before the eventual publication in O’Donnell.
`
`9.
`
`In response to our submission of the O’Donnell manuscript to
`
`Clinical Cancer Research, I received a Clinical Cancer Research Peer Review
`
`Letter dated May 12, 2003, a true and correct copy of which was filed as Exhibit
`
`2030 in IPR2016-01582 on March 17, 2017.
`
`10.
`
`In April 2004, Cougar Biotechnology Inc. signed a licence
`
`agreement giving it rights to develop and commercialise abiraterone acetate. I
`
`took part in initial discussions with Cougar at the end of 2003 / early 2004 but
`
`played no significant role in the subsequent clinical development of the drug.
`
`
`
`5
`
`
`
`The first clinical trials sponsored by Cougar Biotechnology Inc. started in
`
`December 2005 and were led by my colleague Professor Johann de Bono at the
`
`Royal Marsden.
`
`I l.
`
`I declare under penalty of perjury under the laws of the United States
`
`of America that the foregoing is true and correct.
`
`Executed on 7
`
`141
`
`'
`.
`/v((""°4'20l7 in
`By:
`
`/'
`
`ACTIVE 220Z89l04v Z
`
`lan Judson, M.D.
`
`
`
`
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