UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Taro Pharmaceuticals U.S.A., Inc.
`Petitioner,
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`v.
`
`Apotex Technologies, Inc.
`Patent Owner
`
`
`Case No.: IPR2017-01446
`Patent No. 7,049,328
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE
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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
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`Taro Pharmaceuticals U.S.A., Inc.
`Petitioner,
`
`v.
`
`Apotex Technologies, Inc.
`Patent Owner
`
`
`Case No.: IPR2017-01446
`Patent No. 7,049,328
`
`
`
`
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE
`
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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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`A. Dr. Mehta Is Qualified To Provide the Opinions Set Forth in
`Paragraphs 63-85 of Exhibit 1002 and Paragraphs 19-50 of Exhibit 1060
`
`Patent Owner asserts that Dr. Mehta is not qualified to offer the opinions
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`provided in paragraphs 63-85 of his opening declaration (Ex. 1002) and in
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`paragraphs 19-50 of his reply declaration (Ex. 1060) because “he lacks the relevant
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`expertise.” (PO Motion to Exclude at 2 and 10.) Patent Owner’s assertions are
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`baseless. Dr. Mehta’s training and experience fits within either party’s definition
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`of the person of ordinary skill in the art. (Ex. 2020 at ¶ 2; Ex. 1068 at ¶ 2.) As the
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`Board found in its Institution Decision, a person of ordinary skill in the art
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`“includes M.D.’s with clinical experience with iron chelators in treatment of
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`transfusion patients with iron overload.” (Paper 7 at n. 8.) Dr. Mehta earned his
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`M.D. from Bombay University in 1990, and he has extensive experience with iron
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`chelators, including deferiprone, in the treatment of transfusion patients with iron
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`overload. (Ex. 1003 at 1.)
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`As Dr. Mehta testified in his opening declaration, he was directly involved
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`with the care of several transfusion-dependent patients who received deferiprone
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`while practicing in India from 1989-1991. (Ex. 1002 at ¶ 8.) And even after he
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`left India, he continued to be involved in the treatment of these patients through at
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`least 1995. (Id.) Since 1995, he has treated many patients with iron chelators, and
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`continued to follow the literature describing treatment of blood transfusion-
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`dependent patients with deferiprone. (Id.)
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`During Dr. Mehta’s second deposition, he agreed with counsel for Patent
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`Owner that “Dr. Olivieri was one of the foremost researchers in the 1990s in the
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`treatment of thalassemia major.” (Ex. 2040 at 65:20-24.) Counsel then asked Dr.
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`Mehta whether it was “fair to say” that “as of the mid 1990s, Dr. Olivieri had more
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`experience than just about anybody else in the field in terms of administering
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`deferiprone in an attempt to treat thalassemia major patients.” (Id. at 65:25-66:4.)
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`Dr. Mehta testified as follows: “I would say she probably had more experience
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`than most, but there are exceptions…And I think it’s fair to say that, purely the
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`experience with managing patients who are on deferiprone goes, I think there was
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`a time when I was more experienced than Nancy Olivieri.” (Id. at 66:5-14.)
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`In contrast to Dr. Mehta’s experience treating thalassemia patients with
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`deferiprone, Patent Owner’s expert Dr. Pennell admitted that he has never
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`administered an iron chelator to a thalasemmia patient. (Ex. 1059 at 33:21-34:1;
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`see also id. at 15:9-12 (testimony that Dr. Pennell’s only involvement with
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`thalassemia patients was in performing heart scans).) And, in contrast to Dr.
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`Mehta’s use of deferiprone in the 1990s, i.e., prior to the filing date of the ’328
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`patent, Patent Owner’s other expert, Dr. Coates, testified that he did not use
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`deferiprone until after 2000. (Ex. 1058 at 24:9-11.) Thus, of all the experts
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`involved in this proceeding, Dr. Mehta has the most hands-on experience as of the
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`June 30, 2000 priority date.
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`2
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`Because Patent Owner’s objections to Dr. Mehta are unfounded, and
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`because Dr. Mehta is qualified to testify from the perspective of a POSA, the
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`Board should deny Patent Owner’s motion to exclude these paragraphs of Exhibit
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`1002 and Exhibit 1060.
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`B. Dr. Mehta’s Opinions in Paragraphs 26-28, 30, 33, 34, 36, 37, 40, 55, 56,
`60, 64, 66, 67, 72, 74-76, 80, and 82-85 of Exhibit 1002 and Paragraphs
`5, 14-16, 18, 20, 21-23, 36, 38-41, and 45-46 of Exhibit 1060 Are Well
`Supported and Reliable
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`Patent Owner objected to the listed paragraphs of Dr. Mehta’s declarations
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`as “not based on sufficient facts or data, the product of reliable principles and
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`methods, and/or reliable application of the principles of methods and facts lack
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`merit.” (PO Motion to Exclude at 3, 10.) Patent Owner is wrong.
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`As examples of the facts in Exhibit 1002 that supposedly lack any basis,
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`Patent Owner recited “background information on thalassemia and red blood
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`cells,” “iron overload as a result of treating thalassemia,” “the side effects of
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`subcutaneous infusions of desferrioxamine,” and “that most therapeutic agents for
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`most diseases are given in combination with excipients.” (PO Motion to Exclude
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`at 3-4.) None of these facts are contested in this proceeding, and the background
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`section of the ’328 patent itself describes these facts. (See Ex. 1001 at, e.g., cols.
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`1-2.) And, Patent Owner’s expert Dr. Coates described these same facts in his
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`opening declaration, without citing to a single reference aside for the patent itself.
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`(See Ex. 2001 at ¶¶ 16-23.)
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`3
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`
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`In response to Patent Owner’s original objections, Petitioner served Patent
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`Owner with supplemental declarations in which Dr. Mehta clarified that these
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`paragraphs contain (1) statements from the cited references and the ’328 patent, (2)
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`information that would have been understood by a person of ordinary skill in the
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`art based on a review of the cited references and the ’328 patent, (3) facts
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`regarding thalassemia, blood transfusions, iron overload, desferrioxamine or
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`deferiprone that were common knowledge to a person of ordinary skill in the art as
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`of June 30, 2000, (4) statements of his own knowledge as of June 30, 2000, or (5)
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`statements of his own opinion, from the perspective of a person of ordinary skill in
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`the art as of June 30, 2000. (Ex. 2020 at ¶ 3; Ex. 1068 at ¶ 3.) Dr. Mehta also
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`pointed out that Dr. Coates made “points similar or even identical to” points that
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`Dr. Mehta made. (Compare Ex. 2001 at ¶¶ 16-20 to Ex. 1002 at ¶¶ 26-28, 30; Ex.
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`2001 at ¶¶ 21-23 to Ex. 1002 at ¶ 33; Ex. 2001 at ¶ 24 to Ex. 1002 at ¶ 34.)
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`Moreover, with respect to paragraph 36 of Exhibit 1060, Dr. Mehta
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`explained his reasoning that a person of ordinary skill in the art would have known
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`that Olivieri 1995 discloses the treatment of blood transfusion-dependent patients
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`who had an iron overload condition of the heart as follows: “The serial serum
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`ferritin and liver iron concentration measurements are the same measurements as
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`those used in the ’328 patent to measure iron overload. The patients with serum
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`ferritin and liver iron concentrations higher than the given thresholds had iron
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`4
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`overload in the range which indicate complications of iron overload, such as
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`cardiac iron overload and cardiac disease.” (Ex. 1060 at ¶ 36.) With respect to
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`paragraph 38, Dr. Mehta’s statement regarding the patient’s expected life span was
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`based on the LVEF reported for these patients and on Dr. Mehta’s experience
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`treating iron overload patients.
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`Thus, because Patent Owner’s objections are unfounded, and the challenged
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`paragraphs providing background facts are consistent with the knowledge of the
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`person of ordinary skill as of June 30, 2000, as well as the background section of
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`the ’328 patent, the Board should deny Patent Owner’s motion to exclude these
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`paragraphs of Dr. Mehta’s declarations.
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`C. Paragraphs 30, 31, 37-40, 63-65, 68-71, and 80-81 of Exhibit 1002;
`Paragraphs 14, 25, 28, and 44-45 of Exhibit 1060; footnotes 1, 3, and 8
`of Exhibit 1060; and Exhibits 1028, 1029, 1031, 1033-1035, and 1063-
`1066 Are Relevant and Helpful
`
`The listed paragraphs of Ex. 1002, the listed paragraphs and footnotes of Ex.
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`1060, and the listed exhibits, were not directly cited in the Petition or Reply1 but
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`these paragraphs, footnotes, and exhibits are evidence and relevant to this
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`proceeding. As Dr. Mehta explained in his supplemental declarations that
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`Petitioner served in response to Patent’s Owner original objections, “these
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`paragraphs and Exhibits offer background information that is required to
`
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`1 Exhibits 1028, 1029, 1031, 1033-1035, and 1063-1066 were cited in Dr. Mehta’s
`declarations. (See Ex. 1002 at ¶¶ 8, 9, and 30 and Ex. 1060 at ¶¶ 14, 25, and 28.)
`5
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`understand the facts and opinions presented” in Dr. Mehta’s declarations. (Ex.
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`2020 at ¶ 6; Ex. 1068 at ¶ 6.) Some of the paragraphs and exhibits were “included
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`for ease of understanding and organizational purposes.” (Ex. 2020 at ¶ 6; Ex. 1068
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`at ¶ 6.)
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`The Board has recognized that the purpose of an expert declaration is to
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`provide more information and elaboration on the positions presented in the
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`Petition. (See, e.g., Infobionic, Inc. v. Braemer Manufacturing, LLC, IPR2015-
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`01704, Paper 11 at 6 (PTAB Feb. 16, 2016) (“We do not find the testimony of
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`Petitioner’s expert to be persuasive or helpful as it repeats the Petitioner’s
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`arguments and offers little or no elaboration as to how one of ordinary skill in the
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`art” would understand the contested term.).)
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`Dr. Metha’s declarations properly elaborate on and further explain the
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`positions described in the Petition and Reply, including in the paragraphs,
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`footnotes, and exhibits that are not cited in the Petition or Reply. Because such
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`elaboration is relevant and helpful, the Board should deny Patent Owner’s motion
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`to exclude these materials.
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`D. Exhibits 1005, 1006, 1022, 1024, 1026, and 1030 Are Relevant To Show
`the Knowledge of a Person of Ordinary Skill in the Art
`
`Patent Owner objects to these exhibits as irrelevant even though they were
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`included in Taro’s Petition and Dr. Mehta’s declaration. These exhibits, however,
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`are relevant to the obviousness analysis presented in the Petition, which states that
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`6
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`obviousness is based on “each of the Primary References in view of the knowledge
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`of a person of ordinary skill in the art.” (Petition at 43-44.) These exhibits are
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`discussed in Dr. Mehta’s declaration (Ex. 1002) at paragraph 83, and support his
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`discussion of the knowledge of a person of ordinary skill in the art. (See Ex. 1002
`
`at ¶ 83; Ex. 2020 at ¶ 10.) Accordingly, the Board should deny Patent Owner’s
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`motion to exclude these relevant and helpful exhibits.
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`E. Exhibits 1052-1054 and 1056 Are Relevant
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`Patent Owner objects to these exhibits as irrelevant because they were not
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`cited in either Petitioner’s Reply or in Dr. Mehta’s reply declaration. (PO Motion
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`to Exclude at 9.) Exhibits 1052-53 were introduced during Dr. Coates’s deposition
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`in this matter to show the state of the art. (Ex. 1058 at 58 and 99.) Exhibits 1054
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`and 1056 are relevant to Patent Owner’s position that MRI T2 is not a reliable
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`method of measuring cardiac iron. (See, e.g., Paper 17 at 4.) For example, Exhibit
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`1054 is an article coauthored by Dr. Coates stating that MRI T2 can reliably
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`measure cardiac iron. (Ex. 1054 at 5 (“Although traditionally estimated by biopsy
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`or SQIBD, liver iron level can now be accurately estimated using MRI. Iron
`
`shortens the MRI relation parameters T2 and T2* (and lengthens R2 and R2 *) in a
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`predictable and reproducible manner. These MRI techniques can be used to assess
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`iron levels in the heart as well.”).) Because these exhibits relate to the state of the
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`7
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`art and to the credibility of Patent Owner’s expert Dr. Coates, they are relevant to
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`this proceeding and should not be excluded.
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`F. Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 Are Documents
`Produced by Patent Owner or Documents Generated during the
`Parallel District Court Litigation; They Are Relevant, Do Not
`Constitute Hearsay, and Are Authenticated
`
`The listed exhibits were produced by Patent Owner following the Board’s
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`Order to produce them as Additional Discovery. (See Paper 33.) These exhibits
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`are relevant to this proceeding, are not hearsay, and are authenticated. The Board
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`should therefore deny Patent Owner’s motion to exclude these exhibits.
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`1. These Exhibits Are Relevant
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`Patent Owner asserts that these documents are not relevant to this IPR
`
`because “none of these documents contain inconsistent statements” with arguments
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`that Patent Owner has made in this proceeding, but that is not the standard for
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`admissibility under FRE 401-403. (PO Motion to Exclude at 6.) This Board has
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`already found these exhibits to be relevant when it granted Petitioner’s Motion for
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`Additional Discovery. (See Paper 33 at, e.g., at 5-6 (“We do not find Patent
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`Owner’s argument that the evidence does not directly address the Primary
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`References to be persuasive, because the evidence is relevant to Patent Owner’s
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`underlying argument that the Primary References do not inherently anticipate the
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`claims of the ’328 patent.”); id. at 7 (“After weighing Petitioner and Patent
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`Owner’s arguments, we are persuaded that the information sought will have value
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`8
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`
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`in informing the analysis of Patent Owner’s positions relative to the Primary
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`References”).)
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`Moreover, contrary to Patent Owner’s assertions, the Board has already
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`found that these exhibits contain inconsistent statements. (See Paper 33 at, e.g., n.
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`1 (“Exhibits 1037-1040 and 1042 provide evidence supporting Petitioner’s position
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`of inconsistent statements.”); id. at 5 (“The statements of Dr. Spino and Dr. Pennell
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`that patients undergoing transfusion have iron overload of the heart that results in
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`heart disease are therefore reasonably understood as inconsistent with Patent
`
`Owner’s position…”); id. at 7 (“We are again persuaded that the production of
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`evidence by Patent Owner related to whether an ‘inherent result must inevitably
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`result,’…that is inconsistent with Patent Owner’s position is in the interests of
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`justice.”).)
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`Finally, none of the statements on which Petitioner relies implicate the
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`different claim constructions entered by the district court and the Board. For
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`example, many of these statements were made by Patent Owner or its
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`representative well in advance of litigation. (See Exhibits 1038, 1040, 1041.)
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`Other statements regarding deferiprone and its action in the human body (Exhibits
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`1042, 1043, 1045) are facts that are not impacted by how the claims are construed.
`
`Therefore, there is no potential for confusion or prejudice and no basis to exclude
`
`these exhibits.
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`9
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`2. None of the Statements from the Exhibits 1038, 1040-43, and 1045
`Constitute Hearsay Because They are Party Admissions
`
`The FRE explicitly excludes party admissions from hearsay. FRE
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`801(d)(2)(D). Each of the statements relied on by Petitioner are not hearsay
`
`because each was made by Patent Owner’s agent or employee on a matter within
`
`the scope of the relationship:
`
`• Exhibit 1038 is an email from Michael Spino to Fernando Tricta on
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`October 7, 1999. Exhibit 1040 is an email exchange between Michael
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`Spino and others in early 2000. Exhibit 1041 is an email exchange
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`between Michael Spino and others between Dec. 31, 1999, and Jan. 1,
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`2000. During this time frame, and until 2003/2004, Dr. Spino was Vice
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`President of Scientific Affairs. (Ex. 1042 at 11:17-14:8; see also Ex.
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`1038 at 45 (stating that Dr. Spino was the “Senior V.P., Scientific
`
`Affairs” at Apotex Inc.); Ex. 1041 at 2 (same).)
`
`• Exhibit 1042 is the transcript of the deposition of Michael Spino in the
`
`related district court litigation. Dr. Spino testified that, at the time of the
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`deposition, he was the President for ApoPharma Inc., one of the real
`
`parties in interest for Patent Owner in this case. (Ex. 1041 at 13:24-25;
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`see also Paper 3 at 2.).
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`• Exhibit 1043 is the transcript of the deposition of Fernando Tricta in the
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`related district court litigation. Dr. Tricta testified that, at the time of the
`10
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`
`
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`deposition, he was Vice President of Medical Affair at Apotex and
`
`ApoPharma. (Ex. 1043 at 10:13-17.)
`
`• Exhibit 1045 is the Expert Report of Dr. Pennell submitted in the district
`
`court litigation. In his report, Dr. Pennell says that he submits the report
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`“on behalf of Plaintiffs ApoPharma Inc., ApoPharma USA, Inc., and
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`Apotex Technologies Inc.” (Ex. 1045 at 3.)
`
`Courts have found that an employee acting within the scope of his employment is
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`an agent within FRE 801. See, e.g., Pappas v. Middle Earth Condo. Ass'n, 963
`
`F.2d 534, 538 (2d Cir.1992). Here, each of Drs. Spino, Tricta, and Pennell made
`
`statements within the scope of their employment or agency. Accordingly, because
`
`none of the statements on which Petitioner relies in the contested exhibits are
`
`hearsay under FRE 801(d)(2)(D),2 the Board should deny Patent Owner’s motion
`
`to exclude these exhibits containing Patent Owner’s admissions.
`
`3. These Exhibits are Authenticated3
`
`
`2 Even if these statements are considered hearsay, the exhibits qualify under the
`following categories of hearsay exceptions: (i) records of a regularly conducted
`activity under FRE 803(6); (ii) former testimony under 804(b)(1); (iii) statement
`against interest under 804(b)(3); and (iv) residual exception under FRE 807.
`
` The Board granted Petitioner’s motion for discovery. (Paper 33.) In that motion,
`Petitioner moved the Board “to compel Apotex to produce the documents and a
`stipulation attesting to their authenticity.” (Paper 22 at 1.) Patent Owner did not
`serve a stipulation attesting to the documents’ authenticity, but because it was
`supposed to, the authenticity of these exhibits should be presumed.
`11
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` 3
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`
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`Patent Owner has established the authenticity of the following exhibits in its
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`Second Motion to Seal (Paper 35):
`
`• With respect to Ex. 1037: “The redacted portions of this exhibit concern
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`Apotex’s confidential business information…” (Paper 35 at 2.)
`
`• With respect to Exs. 1038, 1040, and 1041: “These documents are
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`confidential internal email communications between Apotex
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`employees…” (Id. at 3.)
`
`• With respect to Exs. 1042 and 1043: “The Deposition Transcripts of Dr.
`
`Fernando Tricta (Nov. 7, 2017) and Dr. Michael Spino, the President of
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`ApoPharma, Inc. (Nov. 8, 2017)…” (Id. at 4.)
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`• With respect to Exs. 1047-1049: “These documents are part of the closed
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`portions of Apotex’s confidential NDA No. 21-825 that was filed with
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`FDA…” (Id.)
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`Finally, Exhibit 1045 is authenticated due to its distinctive characteristics.
`
`FRE 901(b)(4). This exhibit is the Opening Expert Report of Dudley J. Pennell,
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`M.D., expert for Patent Owner in this proceeding, that was served on Petitioner in
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`the related district court litigation on Jan. 18, 2018. (See Pennell Declarations,
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`Exhibits 2003 and 2026.)
`
`12
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`
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`Because all of these documents produced by Patent Owner are what
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`Petitioner claims they are, the Board should deny Patent Owner’s motion to
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`exclude these authenticated exhibits.
`
`G. Exhibit 1065 and Paragraph 25 of Exhibit 1060 Are Relevant To
`Address Patent Owner’s Reliance on the Post-Art Technique of MRI
`T2*
`
`Dr. Mehta opined that MRI TRT is reliable, inter alia, because of its
`
`relationship with MRT T2*. (Ex. 1060 at ¶ 25.) As Dr. Mehta explains in his
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`supplemental declaration that Petitioner served in response to Patent Owner’s
`
`original objection (Ex. 1068), he did not rely on Ex. 1065 as evidence that MRI
`
`TRT and MRT T2* are related. (Ex. 1068 at ¶ 7.) Instead, he relied on that exhibit
`
`to support and corroborate his independent knowledge of the relationship between
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`MRI TRT and MRI T2*. (Id.) The testimony in paragraph 25 of Exhibit 1060,
`
`based on Dr. Mehta’s own knowledge, is therefore standalone evidence that is
`
`relevant to this proceeding and should not be excluded.
`
`Patent Owner asserts that, since Exhibit 1065 is dated 2018, it is not relevant
`
`to the state of the art as of June 2000, because it “has no bearing on how a POSA
`
`would view the accuracy of MRI TRT during the relevant time period.” (PO
`
`Motion to Exclude at 13.) As Petitioner explained in its Reply, the entire concept
`
`of measuring cardiac iron is not relevant to the claims. (Paper 40 at 9.) To the
`
`extent, however, that Patent Owner is permitted to raise MRI T2*, which was not
`
`13
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`
`
`
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`part of the public knowledge until December 2000 (Ex. 2003 at ¶ 26), then other
`
`references dated after the priority date such as Exhibit 1065 are relevant. Patent
`
`Owner also objected to Ex. 1065 as not authenticated, but Dr. Mehta authenticated
`
`this exhibit in both his reply declaration (Ex. 1060 at n. 3), and in his supplemental
`
`declaration (Ex. 1068 at ¶ 5.)
`
`Because Exhibit 1065 and paragraph 25 of Exhibit 1060 set forth the
`
`relationship between MRI TRT and MRI T2*, they are relevant to counter Patent
`
`Owner’s arguments regarding MRI T2*, and should not be excluded.
`
`Dated: July 12, 2018
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`
`
`/Huiya Wu/
`Huiya Wu (Reg. No. 44,411)
`Sarah Fink (Reg. No. 64,886)
`GOODWIN PROCTER LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 355-3333
`
`Counsel for Petitioner
`
`
`
`
`
`
`
`14
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`
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 12th day of July, 2018, I
`
`caused to be served a true and correct copy of the foregoing “PETITIONER’S
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`OPPOSITION TO PATENT OWNER’S MOTION TO EXCLUDE” via electronic
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`mail on the following attorneys of record:
`
`W. Blake Coblentz
`Aaron S. Lukas
`Barry Golob
`
`Email:
`wcoblentz@cozen.com
`alukas@cozen.com
`bgolob@cozen.com
`
`
`
`
`By: /Sarah Fink/
` Sarah Fink
`
`
`
`
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