UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`Taro Pharmaceuticals U.S.A., Inc.,
`v.
`Apotex Technologies, Inc.
`Patent No. 7,049,328 B2
`
`Title: USE FOR DEFERIPRONE
`
`
`
`
`
`SUPPLEMENTAL DECLARATION OF JAYESH MEHTA, M.D.
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`1 of 6
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1068
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`Taro Pharmaceuticals U.S.A., Inc.,
`v.
`Apotex Technologies, Inc.
`Patent No. 7,049,328 B2
`
`Title: USE FOR DEFERIPRONE
`
`
`
`
`
`SUPPLEMENTAL DECLARATION OF JAYESH MEHTA, M.D.
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`1 of 6
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1068
`
`
`
`I, Jayesh Mehta, M.D., declare as follows:
`1.
`I am the same Jayesh Mehta who submitted a declaration dated May
`
`14, 2017, in support of Taro Pharmaceuticals U.S.A., Inc.’s Petition for inter
`
`partes review of U.S. Patent No. 7,049,328 (“the ’328 patent), and a declaration
`
`dated June 13, 2018, in support of Taro Pharmaceuticals U.S.A., Inc.’s Reply In
`
`Support of its Petition for inter partes review. I submit this supplemental
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`declaration to respond to objections that Patent Owner submitted on June 20, 2018,
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`regarding my June 13, 2018, declaration. I reserve the right to further respond to
`
`those objections and to further supplement this declaration.
`
`2.
`
`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
`
`the definition of that term that I proposed in my May 14, 2017, declaration at
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`paragraph 17 or on the definition of that term proposed by Dr. Coates in his
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`September 8, 2017, declaration at paragraph 27. All of the statements of my
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`opinion set forth in my declarations are presented from the perspective of the
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`hypothetical person of ordinary skill of the art, and I am qualified to opine from
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`this perspective due to my extensive training in blood disorders, including my
`
`administration of deferiprone to blood transfusion dependent patients prior to June
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`30, 2000, my years of experience treating patients with blood disorders, my
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`2 of 6
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`Taro Pharmaceuticals, Ltd.
`Exhibit 1068
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`research into blood disorders, and my investigation and analysis of the cited prior
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`art.
`
`3.
`
`Patent Owner objected to paragraphs 5, 14-16, 18, 20, 21-23, 36, 38-
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`41, 45-46 of my June 13, 2018, declaration as “not based on sufficient facts or
`
`data, the product of reliable principles and methods, and/or reliable application of
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`the principles of methods and facts.” (Paper 43 at 2.) I disagree because these
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`paragraphs contain (1) statements from the ’328 patent, (2) statements from the
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`cited references, (3) information that would have been understood by a person of
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`ordinary skill in the art based on a review of the ’328 patent and the cited
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`references, (4) facts regarding thalassemia, blood transfusions, iron overload,
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`serum ferritin, liver iron concentration, and iron-induced cardiac disease that were
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`common knowledge to a person of ordinary skill in the art as of June 30, 2000, (5)
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`statements of my own knowledge as of June 30, 2000, or (6) statements of my own
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`opinion, from the perspective of a person of ordinary skill in the art as of June 30,
`
`2000.
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`4.
`
`In paragraph 5, I discuss the meaning of the claims based on the
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`meaning of the included term “prevention.” The dictionary definition of
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`“prevention” is “the act of preventing or impeding.” (See Exhibit 1067 at 3.)
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`“Prevent,” in turn, is defined as “to keep from happening.” (Id.) In this context,
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`“prevention,” means to keep from developing iron-induced cardiac disease.
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`3
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`3 of 6
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`Taro Pharmaceuticals, Ltd.
`Exhibit 1068
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`Indeed, Patent Owner confirmed this meaning of “prevention” during prosecution
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`of the application that issued as the ’328 patent. In a response to an Office Action,
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`the Patent Owner (then the “Applicant”) stated: “To clarify Applicant’s meaning
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`with respect to the term “prevention” it is intended that the iron loading on the
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`heart of a transfusion dependent patient would ultimately affect the function of the
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`heart to a level beyond that which is normal. It is submitted that the use of
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`deferiprone will prevent abnormal functioning of the heart because of the removal
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`of the iron stores therein.” (See Exhibit 1004 at 380 of 435 (Response to Office
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`Action dated Sep. 29, 2005 at 12).) My conclusion regarding the meaning of “iron
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`overload condition of the heart,” which includes patients who are at risk for but do
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`not already have iron-induced heart disease, is thus supported by this definition.
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`5.
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`Patent Owner also objected to paragraphs 44-45, footnote 1, portions
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`of paragraph 14, footnote 3, portions of paragraph 25, footnote 8, and portions of
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`paragraph 28 of my June 13, 2018, declaration as “irrelevant,” because they “are
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`not directly cited in the Reply,” or because they cite to exhibits that are not cited in
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`Petitioner’s Reply. (Paper 43 at 2.) Patent Owner further objected to Exhibits
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`1063-1066 because they are not cited in the Reply. (Id.) I do not agree that any of
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`the statements made in these paragraphs, footnotes, or any of these Exhibits are
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`irrelevant to the facts and opinions presented in my June 13, 2018 declaration.
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`4
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`4 of 6
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`Taro Pharmaceuticals, Ltd.
`Exhibit 1068
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`6.
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`These paragraphs, footnotes, and Exhibits offer background
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`information that is required to understand the facts and opinions presented in my
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`June 13, 2018, declaration. Some these paragraphs, footnotes, and Exhibits are
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`included for ease of understanding and organizational purposes. The fact that the
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`paragraphs, footnotes, and Exhibits are not cited in the Reply that is supported by
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`my declaration does not render the paragraphs, footnotes, or Exhibits “irrelevant”;
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`I drafted my June 13, 2018, declaration to be a stand-alone document that contains
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`the relevant facts and my opinions, presented from the perspective of a person of
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`ordinary skill in the art as of June 30, 2000.
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`7.
`
`Patent Owner objected to Exhibit 1065 as irrelevant and because it is
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`allegedly not a printed publication. (Paper 43 at 3.) I did not rely on Exhibit 1065
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`as evidence that MRI TRT (T2) and MRI T2* are related. My reliance on Exhibit
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`1065 was to support my independent knowledge of the relationship between MRI
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`TRT and MRI T2*. Thus, Exhibit 1065 corroborates my opinion about MRI TRT
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`(T2) and MRI T2*.
`
`8.
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`Patent Owner objected to Exhibit 1065 as not authenticated. As I
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`explained in my Declaration dated June 13, 2018, in footnote 3, paragraph 25, I
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`downloaded Exhibit 1065 from http://mriquestions.com/t2-vs-t2.html (a webpage
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`entitled “Questions and Answers on MRI: T2 vs T2*, What is the difference
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`between T2 and T2*?”) on June 13, 2018.
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`5
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`5 of 6
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`Taro Pharmaceuticals, Ltd.
`Exhibit 1068
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`9.
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`Patent Owner objected to paragraphs 19-50 of my June 13, 2018,
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`declaration as “testimony provided on a topic which the declarant is not qualified
`
`to opine.” (Paper 43 at 2.) These paragraphs present my understanding of the
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`cited prior art and my opinions on anticipation and obviousness. I am qualified to
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`opine on these matters due to my qualifications, which, as previously described,
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`render me capable of opinion on these matters from the perspective of a person of
`
`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: July 5, 2018
`
`Digitally signed by Jayesh
`Mehta
`DN: cn=Jayesh Mehta, o,
`ou, email=jmehta@nm.org,
`c=US
`Date: 2018.07.05 18:52:12
`
`-05'00'
`Jayesh Mehta, M.D.
`
`
`
`
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`6
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`6 of 6
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`Taro Pharmaceuticals, Ltd.
`Exhibit 1068
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