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.
`Petitioner,
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`v.
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`Apotex Technologies, Inc.
`Patent Owner
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`Case No.: IPR2017-01446
`Patent No. 7,049,328
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`PETITIONER’S REPLY IN SUPPORT OF 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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`IPR2017-01446
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`
`
`Taro Pharmaceuticals U.S.A., Inc.
`Petitioner,
`
`v.
`
`Apotex Technologies, Inc.
`Patent Owner
`
`
`Case No.: IPR2017-01446
`Patent No. 7,049,328
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`
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`PETITIONER’S REPLY IN SUPPORT OF 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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`IPR2017-01446
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`A. Exhibits 2006, 2015, and 2016 Should Be Excluded
`Patent Owner relies on the alleged facts discussed in these non-prior art
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`references for claim construction purposes, as part of its attempt to import a
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`limitation of measuring cardiac iron by MRI T2* into the claims. (See Patent
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`Owner Response, Paper 17 at, e.g., 32 (“It was not until 2000 that cardiac MRI
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`T2* was capable of quantitatively assessing cardiac iron levels. Thus, at the time
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`of the invention, a POSA would not have viewed [other data] as demonstrating that
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`the patients in that study were experiencing an iron overload condition of the
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`heart.”).) But, references that are not prior art cannot be included in the claim
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`construction inquiry. See, e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1313 (“A
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`court construing a patent claim seeks to accord a claim the meaning it would have
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`had to a [POSA] at the time of the invention.”) (emphasis added). The alleged
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`facts reported in these Exhibits were not part of the knowledge of a POSA as of
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`June 30, 2000, and therefore may not be considered for claim construction.
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`Patent Owner’s citation of MPEP § 2124 is inapposite. MPEP § 2124 provides
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`limited situations when later-arising facts may be considered, but none are
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`analogous to claim construction. The MPEP explicitly prohibits the use of post art
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`to inform an analysis of the claims at the time of the invention. For example, the
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`MPEP makes clear that “it is impermissible to use a later factual reference to
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`determine whether the application is enabled,” which must be judged as of the
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`IPR2017-01446
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`priority date. Id. See MPEP § 2164.05(a); see also Hybritech Inc. v. Monoclonal
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`Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986). Thus, MPEP § 2124 does
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`not provide a basis for the Board to consider this post art to construe the claims.
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`Patent Owner admits that it relies on Exhibits 2006, 2015, and 2016 for the
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`truth of the matters reported in those exhibits, making them hearsay. Patent Owner
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`argues that Exhibits 2006, 2015, and 2016 qualify as an exception to the rule
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`against hearsay “under FRE 703,” but, FRE 703 does not present exceptions to the
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`rule against hearsay. Rule 703 allows an expert to rely on “facts or data” even if
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`those facts or data are not admissible. Fed. R. Evid. 703. Here, the exhibits are
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`inadmissible hearsay, and Patent Owner’s experts have not established that the
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`facts or data are those upon which “experts in the particular field would reasonably
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`rely,” as required by FRE 703. Further, Exhibits 2006, 2015, and 2016 cannot be
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`properly considered for claim construction, and thus, the prejudicial effect of their
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`admission substantially outweighs any probative value of these Exhibits.
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`The proposed use of these exhibits is not permitted by MPEP § 2124 (or any
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`other section of the MPEP), and the exhibits are not within any recognized hearsay
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`exception. The Board should therefore exclude and not consider these exhibits.
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`B. Exhibit 2008 Should Be Excluded
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`Patent Owner has not provided any information on the source of Exhibit 2008.
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`Patent Owner relies on alleged “hallmarks of authenticity under FRE 901(b)(4)”
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`IPR2017-01446
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`(Paper 53 at 5), but Patent owner merely lists the information in the document
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`without explaining how these features support authenticity. “[T]he mere recitation
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`of the contents of documents does not authenticate them or provide for their
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`admissibility.” Mathin v. Kerry, 782 F.3d 804, 812 (7th Cir. 2015). Exhibit 2008
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`is therefore not authenticated and should be excluded and not considered.
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`Exhibit 2008, discussing the FDA approval of Ferriprox®, is also not relevant to
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`the instant proceeding, which concerns only the unpatentability of the ’328 patent.
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`Patent Owner contends that Ferriprox® is relevant because it allegedly embodies
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`the claims of the ’328 patent. (Paper 53 at 5.) But, whether the ’328 patent is
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`listed in the FDA’s Orange Book as covering Ferriprox® is irrelevant to the validity
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`of the patent, and the truth of this assertion is currently contested at the district
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`court in the parallel litigation.1 Exhibit 2008 is titled “FDA Approves Ferriprox to
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`Treat Patients with Excess Iron in the Body,” and does not mention cardiac iron.
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`The Board should therefore exclude Exhibit 2008.
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`Last, contrary to Patent Owner’s assertions, Petitioner identified the statement
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`in Exhibit 2008 on which Patent Owner relied in this proceeding. (See Paper 48 at
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`1 At the district court, Petitioner denies Patent Owner’s assertion that Petitioner’s
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`generic version of Ferriprox will infringe the ’328 patent because, inter alia, the
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`prescribing information for this product does not instruct the treatment of cardiac
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`iron.
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`3
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`IPR2017-01446
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`2.) Patent Owner has not identified a single hearsay exception that applies. The
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`Board should therefore exclude Exhibit 2008 as inadmissible hearsay.
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`C. Exhibit 1010 Should Be Excluded
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`Exhibit 1010, the claim construction order from the parallel district court
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`litigation, was decided under a different claim construction standard than applies
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`here.2 37 C.F.R. § 42.100(b). And, as the Supreme Court has explained while
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`upholding the PTAB’s use of the broadest reasonable interpretation standard for
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`claim construction, the different standards that apply in district court and at the
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`PTAB “mean that the possibility of inconsistent results is inherent to Congress’
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`regulatory design.” Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2146
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`(2016). Thus, neither the district court’s ultimate order, nor its reasoning that led
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`to the order, are relevant to this proceeding. The district court’s claim construction
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`order is irrelevant, and the Board should exclude Exhibit 1010 under FRE 402.
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`Further, Patent Owner admitted that statements regarding the district court’s
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`claim construction “have no probative value should the PTAB maintain its
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`preliminary construction adopted in instituting these proceedings.” (Paper 44 at 6.)
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`2 Petitioner recognizes that there may be changes to the standard for claim
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`construction used in IPRs, but this proposed rulemaking is pending and subject to
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`change, and therefore should not impact this proceeding.
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`4
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`The Board should therefore exclude Exhibit 2010 under FRE 403 because it has no
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`probative value when the Board applies the correct claim construction.
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`D. Exhibit 2014 Should Be Excluded
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`Patent Owner has not provided any information on the source of Exhibit 2014.
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`As explained above, the recitation of the contents of the exhibit is insufficient to
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`authenticate the document. Mathin, 782 F.3d at 812. Exhibit 2014 is therefore not
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`authenticated and should be excluded and not considered.
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`Patent Owner cites FRE 702 and 703 to support the admissibility of Exhibit
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`2014 over Petitioner’s hearsay objections. But, as discussed above, FRE 702 and
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`703 do not present exceptions to the rule against hearsay. Patent Owner’s experts
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`have not established that the facts or data are those upon which “experts in the
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`particular field would reasonably rely,” as required by FRE 703. Further, because
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`there is no information regarding the source of the information, the prejudicial
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`effect of the admission of Exhibit 2014 substantially outweighs any probative
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`value of this Exhibit. Because Exhibit 2014 is hearsay, not within any hearsay
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`exception, the Board should exclude this exhibit.
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`Dated: July 19, 2018
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`Respectfully submitted,
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`/Huiya Wu/
`Huiya Wu (Reg. No. 44,411)
`Sarah Fink (Reg. No. 64,886)
`GOODWIN PROCTER LLP
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`Counsel for Petitioner
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`5
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`IPR2017-01446
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 19th day of July, 2018, I
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`caused to be served a true and correct copy of the foregoing “PETITIONER’S
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`REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE” via electronic mail on
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`the following attorneys of record:
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`W. Blake Coblentz
`Aaron S. Lukas
`Barry Golob
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`Email:
`wcoblentz@cozen.com
`alukas@cozen.com
`bgolob@cozen.com
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`By: /Sarah Fink/
` Sarah Fink
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`IPR2017-01446
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