`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________________
`
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL
`INDUSTRIES, INC., AND SUN PHARMA GLOBAL FZE,
`
`Petitioners,
`
`V.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`______________________
`
`Case IPR2017-008541
`
`U.S. Patent No. 9,187,405
`
`______________________
`
`FIFTH DECLARATION OF WILLIAM J. JUSKO, PH.D.
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`ALEXANDRIA, VA 22313-1450
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
`with this proceeding.
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2108
`
`
`
`I, William J. Jusko, Ph.D., declare as follows:
`
`1.
`
`I am the same William J. Jusko who submitted four prior declarations
`
`in this matter, Exhibit 2005 (“First Declaration”), Exhibit 2024 (“Second
`
`Declaration”), Exhibit 2076 (“Third Declaration”), and Exhibit 2095 (“Fourth
`
`Declaration”). My Third Declaration was served on December 5, 2017 as
`
`supplemental evidence.
`
`2.
`
`In paragraph 31 of my Fourth Declaration, I stated the following: “Dr.
`
`Benet’s human weight range artificially skews the dose lower; women are the
`
`predominant victims of MS, and the average female weight in the U.S. in 2006 was
`
`about 75 kg according to the U.S. Centers for Disease Control (Ex. 2104 at 7, Table
`
`3), yielding a dose of 0.6 mg using Dr. Benet’s methodology.”
`
`3.
`
`Exhibit 2104 was published in 2008 and reports that the average female
`
`weight in the U.S. in 2006 was about 75 kg according to the U.S. Centers for Disease
`
`Control. (Ex. 2104 at 7, Table 3.) Exhibit 2109 was published in 2005 and confirms
`
`that a person of skill in 2006 would have understood that the average female weight
`
`in the U.S. for women aged 20 to 69 was about 75.02 kg. (Ex. 2109 at 18, Table
`
`16.) 75.02 kg is the weighted average of the mean weights for the age groups
`
`covering women ages 20 to 69 in Table 16 of Exhibit 2109. The age groups of
`
`women aged 70-79 and over 80 were not included because I understand from counsel
`
`that Dr. Steinman’s view is that it would be exceptionally rare for a woman older
`
`
`
`
`
`
`
`US. Patent No. 9,187,405
`than 70 years of age to be diagnosed with multiple sclerosis.
`
`IPR2017-00854
`
`4.
`
`In signing this Declaration, I understand that it will be served as
`
`supplemental evidence in a contested case before the Patent Trial and Appeal Board
`
`of the United States Patent and Trademark Office. I acknowledge that I may be
`
`subject to cross examination in the case and that cross-examination will take place
`
`in the United States. If cross-examination is required of me, I will appear for cross-
`
`examination Within the United States during the time allotted.
`
`DATED: April 3, 2018
`
`
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