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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Taro Pharmaceuticals U.S.A., Inc.,
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`v.
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`Apotex Technologies, Inc.
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`Patent No. 7,049,328 B2
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`Title: USE FOR DEFERIPRONE
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`SUPPLEMENTAL DECLARATION OF JAYESH MEHTA, M.D.
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Apotex Tech.
`Ex. 2020
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`I, Jayesh Mehta, M.D., declare as follows:
`1.
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`I am the same Jayesh Mehta who submitted a declaration dated May
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`14, 2017, in support of Taro Pharmaceuticals U.S.A., Inc.’s Petition for inter
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`partes review of U.S. Patent No. 7,049,328 (“my first declaration”). I submit this
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`supplemental declaration to respond to objections that Patent Owner submitted on
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`December 12, 2017, regarding my first declaration. I reserve the right to further
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`respond to those objections and to further supplement this declaration.
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`2.
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`As of the earliest priority date of the ’328 patent, my relevant
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`experience was that of a person of at least ordinary skill in the art, based either on
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`the definition of that term that I proposed in my first declaration at paragraph 17 or
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`on the definition of that term proposed by Dr. Coates in his September 8, 2017,
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`declaration at paragraph 27. All of the statements of my opinion set forth in my
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`first declaration are presented from the perspective of the hypothetical person of
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`ordinary skill of the art, and I am qualified to opine from this perspective due to
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`my extensive training in blood disorders, my years of experience treating patients
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`with blood disorders, my research into blood disorders, and my investigation and
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`analysis of the cited prior art.
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`3.
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`Patent Owner objected to paragraphs 26, 27, 28, 30, 33, 34, 36, 37, 40,
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`55, 56, 60, 64, 66, 67, 72, 74, 75, 76, 80, 82, 83, 84, and 85 of my first declaration
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`as “not based on sufficient facts or data, the product of reliable principles and
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`Apotex Tech.
`Ex. 2020
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`methods, and/or reliable application of the principles of methods and facts.”
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`(Patent Owner’s Objections to Evidence at 1.) I disagree because these paragraphs
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`contain (1) statements from the cited references, (2) information that would have
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`been understood by a person of ordinary skill in the art based on a review of the
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`cited references, (3) facts regarding thalassemia, blood transfusions, iron overload,
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`desferrioxamine or deferiprone that were common knowledge to a person of
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`ordinary skill in the art as of June 30, 2000, (4) statements of my own knowledge
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`as of June 30, 2000, or (5) statements of my own opinion, from the perspective of a
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`person of ordinary skill in the art as of June 30, 2000.
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`4.
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`I note that Patent Owner’s own expert, Dr. Coates, included
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`statements in his September 8, 2017, declaration that make points similar or even
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`identical to those I made in certain paragraphs in my first declaration to which
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`Patent Owner objected. (Compare Coates Declaration (Ex. 2001) at ¶¶ 16-20 to
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`my first declaration at ¶¶ 26-28 and 30; Coates Declaration at ¶¶ 21-23 to my first
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`declaration at ¶ 33; Coates Declaration at ¶ 24 to my first declaration at ¶ 34.)
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`5.
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`Patent Owner objected to paragraphs 31, 34, 37-40, 63-65, 68-71, and
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`80-81 of my first declaration as “irrelevant,” because they “are not directly cited in
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`the Petition and the relevance of the paragraphs is not apparent.” (Patent Owner’s
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`Objections to Evidence at 1.) Patent Owner also objected to paragraph 30 of my
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`first declaration as “irrelevant because it contains a cite to Exhibit 1028, which is
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`3
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`Apotex Tech.
`Ex. 2020
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`not cited in the Petition.” (Id.) Patent Owner further objected to Exhibits 1028,
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`1029, 1031, and 1033-1035 because they are not cited in the Petition. (Id. at 2.) I
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`do not agree that any of the statements made in these paragraphs or any of these
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`Exhibits are irrelevant to the facts and opinions presented in my first declaration.
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`6.
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`These paragraphs and Exhibits offer background information that is
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`required to understand the facts and opinions presented in my first declaration.
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`Some these paragraphs and Exhibits are included for ease of understanding and
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`organizational purposes. The fact that the paragraphs and Exhibits are not cited in
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`the Petition that is supported by my declaration does not render the paragraphs
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`“irrelevant”; I drafted my first declaration to be a stand-alone document that
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`contains the relevant facts and my opinions, presented from the perspective of a
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`person of ordinary skill in the art.
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`7.
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`Patent Owner objected to paragraphs 63-85 of my first declaration as
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`“testimony provided on a topic which the declarant is not qualified to opine.”
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`(Patent Owner’s Objections to Evidence at 1.) These paragraphs present my
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`opinions on anticipation and obviousness, and also include my understanding of
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`the cited prior art. I am qualified to opine on these matters due to my
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`qualifications, which render me at least a person of ordinary skill in the art.
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`8.
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`As I explained in my first declaration, counsel explained the standards
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`for anticipation and obviousness to me before I arrived at my opinions, and my
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`Apotex Tech.
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`opinions are based on those standards and presented from the perspective of a
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`person of ordinary skill in the art. Dr. Coates, similarly, stated that he relied on
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`counsel for his understanding of the relevant legal concepts, and presented his
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`opinions, purportedly from the perspective of a person of ordinary skill in the art.
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`(See Declaration of Dr. Coates at ¶¶ 8-15.)
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`9.
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`Patent Owner also objected to my first declaration because it does not
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`disclose my compensation. (Patent Owner’s Objections to Evidence at 1.) I have
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`already publicly stated that Petitioner is compensating me at the rate of $800 per
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`hour for my work related to the ’328 patent in a document that I understand was
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`served on Patent Owner. (See Declaration of Jayesh Mehta M.D. in Support of
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`Defendant’s Responsive Claim Construction Brief, ApoPharma, Inc. v. Taro
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`Pharmaceutical Industries, Ltd., No. 16-00528 (E.D.Texas) (D.I. 59-14) (Apr. 5,
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`2017) at 12.)
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`10. Patent Owner objected to “the relevance of Exhibits 1005, 1006,
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`1022, 1024, 1026, and 1030 in the obviousness section” of my first declaration
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`(specifically citing ¶ 83) because “the Petition failed to identify any combination of
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`references in the obviousness analysis.” (Patent Owner’s Objection to Evidence at
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`2.) Patent Owner is incorrect: the Petition states that the obviousness analysis is
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`based on each of the “Primary References” in view of the knowledge of a person of
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`ordinary skill in the art. (See Petition at 43-44 (“these claims are rendered obvious
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`Apotex Tech.
`Ex. 2020
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`by each of the Primary References in view of the knowledge of a person of
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`ordinary skill in the art.”).) The objected-to Exhibits are cited in my first
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`declaration in paragraph 83 as part of my discussion of the knowledge of a person
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`of ordinary skill in the art and are representative of the knowledge of a person of
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`ordinary skill in the art.
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`*
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`*
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`*
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`*
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`*
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`I understand that willful false statements and the like are punishable by fine
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`or imprisonment, or both. All statements made of my own knowledge are true and
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`all statements made on information and belief are believed to be true. I declare
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`under penalty of perjury that the foregoing is true and correct.
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`Date: December 27, 2017
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`Jayesh Mehta, M.D.
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`6
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`Apotex Tech.
`Ex. 2020
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