IPR2017-01446
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF MOTION TO EXCLUDE
`PETITIONER’S EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF MOTION TO EXCLUDE
`PETITIONER’S EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(c)
`
`
`
`
`
`Table of Contents
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`IPR2017-01446
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`I.
`
`II.
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`Dr. Mehta Lacked the Requisite Training and Experience in the
`Relevant Timeframe ........................................................................................ 1
`The Paragraphs of Dr. Mehta’s Declarations and the Exhibits
`That Are Not Cited in the Petition or Petitioner’s Reply Are Not
`Relevant to the Proceeding .............................................................................. 2
`Petitioner Fails to Provide Sufficient Evidence That Exhibits 1037,
`1038, 1040-1043, and 1047-1049 Are Authentic Under FRE 901
`or 902 ............................................................................................................... 4
`IV. Conclusion ....................................................................................................... 5
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`
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`III.
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`
`
`i
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`
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`TABLE OF AUTHORITIES
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`IPR2017-01446
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`
` Page(s)
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`Cases
`Oxford Nanopore Techs. Ltd. v. Univ. of Wash. & UAB Research
`Found.,
`IPR2014-00512, 2014 WL 4644357 (Sept. 15, 2014) .......................................... 3
`Other Authorities
`FRE 402 ..................................................................................................................... 3
`FRE 702 ..................................................................................................................... 2
`FRE 703 ..................................................................................................................... 2
`FRE 901 ................................................................................................................. 1, 5
`FRE 902 ................................................................................................................. 1, 5
`
`
`
`ii
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`
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`IPR2017-01446
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`Petitioner’s arguments in opposition to Patent Owner’s Motion to Exclude
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`are unavailing for at least the following reasons: (1) Dr. Mehta lacked the requisite
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`training and experience in the relevant subject matter as of the filing date of the
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`’328 patent; (2) the paragraphs of Dr. Mehta’s declarations and the exhibits that are
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`not cited in the Petition or Petitioner’s Reply are not relevant to the proceeding;
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`and (3) Petitioner failed to provide sufficient evidence to establish that Exhibits
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`1037, 1038, 1040-1043, and 1047-1049 are authentic under Federal Rules of
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`Evidence (FRE) 901 or 902. Because Petitioner’s arguments are flawed, the Board
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`should grant Patent Owner’s Motion to Exclude.
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`I.
`
`Dr. Mehta Lacked the Requisite Training and Experience in the
`Relevant Timeframe
`Despite Petitioner’s assertions that Patent Owner’s arguments are baseless,
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`Petitioner cannot establish that Dr. Mehta had the requisite training and experience
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`of a person of ordinary skill in the art as of the of the filing date of the ’328 patent.
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`Indeed, as Dr. Mehta and Petitioner readily admit, Dr. Mehta stopped prescribing
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`deferiprone in 1993 and was peripherally involved in treatment with deferiprone
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`until 1995. But as both Petitioner’s and Patent Owner’s papers in this proceeding
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`have detailed, much of the relevant publications to the ’328 patent and this
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`proceeding are post-1995. What is more, even though the challenged claims of the
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`’328 patent relate to treating an iron overload condition of the heart and iron-
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`induced heart disease, Dr. Mehta readily admitted that he would have consulted a
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`1
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`IPR2017-01446
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`cardiologist to assess those conditions. (Ex. 2024 at 49:12 – 50:4; 53:16 – 54:2;
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`64:14 – 65:4; 108:3-21; 130:2-10.) For example, in both his opening and reply
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`declarations, Dr. Mehta opines about the T2 relaxation times (“TRT”) as measured
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`by MRI disclosed in the Olivieri 1995 Abstract (see, e.g., Ex. 1002 at ¶ 75; Ex.
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`1060 at ¶¶ 21-28), but conceded at deposition that these tests are run and
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`understood by a cardiologist, not a hematologist like Dr. Mehta. (Ex. 2024 at
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`53:16 – 54:2; 130:2-10.) Because he is unqualified, Dr. Mehta’s opinions
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`expressed in ¶¶ 63-85 of Exhibit 1002 and ¶¶ 19-50 of Exhibit 1060 should be
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`excluded under FRE 702 and 703.
`
`II. The Paragraphs of Dr. Mehta’s Declarations and the Exhibits That Are
`Not Cited in the Petition or Petitioner’s Reply Are Not Relevant to the
`Proceeding
`Petitioner admits that the following paragraphs of Dr. Mehta’s opening and
`
`reply declarations and exhibits are not cited in the Petition or Petitioner’s Reply:
`
`- Paragraphs 30, 31, 37-40, 63-65, 68-71, and 80-81 of Exhibit 1002;
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`- Paragraphs 14, 25, 28, 44, and 45 and footnotes 1, 3, and 8 of Exhibit
`
`1060; and
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`- Exhibits 1005, 1006, 1022, 1024, 1026, 1028, 1030, 1031, 1033-1035,
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`1060, and 1063-1066.
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`(Paper 56 at 5.) Despite this, Petitioner argues that these paragraphs of Dr.
`
`Mehta’s declarations and exhibits are relevant and helpful as background. (Id. at
`
`
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`2
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`IPR2017-01446
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`5-6.) However, this is exactly why these paragraphs of Dr. Mehta’s declarations
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`and exhibits should be excluded. Petitioner’s position on obviousness is based on
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`each of the Primary References in view of the knowledge of a person of ordinary
`
`skill in the art. (Id. at 6-7.) Petitioner cannot supplement its obviousness case
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`under the guise of “background information” if it chose not to include this
`
`information in its Petition or Reply. It was Petitioner’s choice not to include
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`combinations of references for its grounds of obviousness. See Oxford Nanopore
`
`Techs. Ltd. v. Univ. of Wash. & UAB Research Found., IPR2014-00512, 2014 WL
`
`4644357, at *9 (Sept. 15, 2014) (declining to “import the extensive discussion
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`regarding obviousness from the declarations of Petitioner’s experts into the
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`Petition . . . .”).
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`Moreover, Petitioner asserts that Exhibits 1052-1054 and 1056 are relevant
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`to the credibility of Patent Owner’s expert, Dr. Coates. (Paper 56 at 7-8.)
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`However, Petitioner admittedly did not attack Dr. Coates’ credibility in its Reply
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`using these exhibits. Thus, the Board should exclude these exhibits under FRE
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`402.
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`Further, in arguing that Exhibits 1037, 1038, 1040-1043, 1045, and 1047-
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`1049 are relevant, Petitioner simply relies on the Board’s decision regarding
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`Petitioner’s Motion for Additional Discovery. (Id. at 7-9.) However, Patent
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`Owner maintains its arguments in opposition to the Motion for Additional
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`3
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`IPR2017-01446
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`Discovery and its Motion to Exclude that these exhibits are not inconsistent with
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`Patent Owner’s arguments and are thus not relevant to the proceeding. Further,
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`new evidence since the Board’s decision support that these exhibits are not
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`inconsistent with Patent Owner’s arguments. To the extent these exhibits speak to
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`the biological activity of deferiprone, that is irrelevant, because the ’328 patent
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`does not claim a biological activity. Instead the claims of the ’328 patent are
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`generally drawn to methods of treating a transfusion-dependent patient, such as a
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`thalassemia patient, who has an iron overload condition of the heart, such as iron-
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`induced cardiac disease, by administering an amount of deferiprone that is
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`therapeutically effective to achieve certain therapeutic results. And Petitioner’s
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`expert, Dr. Mehta, agrees that the therapeutic results claimed in the ’328 patent are
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`not inherent. For instance, Dr. Mehta testified at deposition that 75 mg/kg/day
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`would not bind iron and reduce iron overload in each and every patient treated with
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`that dose and that the ability of deferiprone to bind iron and remove it from the
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`body depends on the dose. (Ex. 2040 at 11:1 – 12:7.) Moreover, Dr. Mehta agreed
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`that the asserted claims of the ’328 patent require a therapeutically amount to
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`achieve a specific outcome. (Id. at 10:15-25.) Thus, Exhibits 1037, 1038, 1040-
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`1043, 1045, and 1047-1049 are not relevant and should be excluded.
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`III. Petitioner Fails to Provide Sufficient Evidence That Exhibits 1037, 1038,
`1040-1043, and 1047-1049 Are Authentic Under FRE 901 or 902
`Petitioner merely cites to Patent Owner’s Second Motion to Seal as support
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`4
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`IPR2017-01446
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`for establishing the authenticity of Exhibits 1037, 1038, 1040-1043, and 1047-
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`1049. (Paper 56 at 11-13.) However, Petitioner does not address how these
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`documents are authentic under FRE 901 and 902. Indeed, Petitioner provides no
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`analysis whatsoever of how FRE 901 or 902 apply. Further, Petitioner asserts that
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`“Exhibit 1045 is authenticated due to its distinctive characteristics.” (Id. at 12
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`(citing FRE 901(4)(b)).) Yet, Petitioner fails to explain what these “distinctive
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`characteristics” are beyond simply noting that Exhibit 1045 is the Opening Expert
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`Report of Dr. Pennell that was served in the related district court proceeding. (Id.)
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`That is not sufficient “to support a finding that [Exhibit 1045] is what [Petitioner]
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`claims it is.” (FRE 901(a).) For the reasons stated in the Motion to Exclude
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`(Paper 44) and in view of Petitioner’s failure to adequately address FRE 901 and
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`902, the Board should exclude these exhibits.
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`IV. Conclusion
`For the foregoing reasons, Patent Owner respectfully asks the Board to grant
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`its Motion to Exclude.
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`
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`Respectfully submitted,
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`Date: July 19, 2018
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`By: /s/ W. Blake Coblentz
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`
`
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`
`
`W. Blake Coblentz
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`
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`
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` Reg. No. 57,104
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`COZEN O’CONNOR
` 1200 Nineteenth Street, N.W.
` Washington, D.C. 20036
` Tel. (202) 912-4837
`
`
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`5
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`CERTIFICATE OF SERVICE
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`IPR2017-01446
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`I hereby certify that on July 19, 2018, I caused a true and correct copy of
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`Patent Owner’s Reply in Support of its Motion to Exclude Petitioner’s
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`Evidence Pursuant to 37 C.F.R. § 42.64(c) to be served via electronic mail on the
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`following attorneys of record:
`
`Huiya Wu
`Sarah Fink
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`HWu@goodwin.law.com
`SFink@goodwinlaw.com
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`
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`Date: July 19, 2018
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`
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`
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`/s/ W. Blake Coblentz
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, DC 20036
`(202) 912-4837
`
`
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