`
`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 B2
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`IPR2017-01446
`
`Table of Contents
`INTRODUCTION ........................................................................................... 1
`
`LEGAL STANDARDS ................................................................................... 1
`
`I.
`
`II.
`
`III. ARGUMENT ................................................................................................... 2
`
`
`
`
`
`
`
`
`A.
`
`B.
`
`C.
`
`D.
`
`Exhibits 2006, 2015, and 2016 Are Not Inadmissible Hearsay ............ 2
`
`Exhibit 2008 Has Been Properly Authenticated, Is Relevant, and Is
`Not Inadmissible Hearsay ..................................................................... 4
`
`Exhibit 2010 Is Relevant ....................................................................... 6
`
`
`IV. CONCLUSION .............................................................................................. 10
`
`
`Exhibit 2014 Has Been Properly Authenticated And Is Not
`Inadmissible Hearsay ............................................................................ 8
`
`
`
`
`
`i
`
`
`
`
`
`Table of Authorities
`
`Page(s)
`
`
`Cases
`
`Nestle Healthcare Nutrition, Inc. v. Steuben Foods, Inc.,
`IPR2015-00249, Paper 77 (PTAB June 2, 2016) ............................................ 3
`
`
`Nichia Corp. v. Emcore Corp.,
`IPR2012-00005, Paper 68 (PTAB Feb. 11, 2014) .......................................... 1
`
`
`In re Paoli RR Yard PCB Litigation,
`35 F. 3d 717 (3d Cir. 1994) ........................................................................... 10
`
`
`Sipnet EU S.R.O. v. Straight Path IP Group, Inc.,
`IPR2013-00246, Paper 63 (PTAB Oct. 9, 2014) ..................................... 1, 6, 8
`
`
`United States v. Turner,
`718 F.3d 226 (3d Cir. 2013) ............................................................................ 4
`
`
`In re Wilson,
`311 F.2d 266 (CCPA 1962) ............................................................................. 2
`
`
`Statutes & Regulations
`
`37 C.F.R. § 42.20(c) ........................................................................................... 1, 6, 8
`
`37 C.F.R. § 42.62 ................................................................................................... 1, 3
`
`77 Fed. Reg. 48,756-48,773 (Aug. 14, 2012) ............................................................ 8
`
`83 Fed. Reg. 21,221-21,226 (May 9, 2018) ............................................................... 7
`
`Rules
`
`FRE 401 ................................................................................................................. 6, 7
`
`FRE 402 ................................................................................................................. 6, 7
`
`FRE 403 ................................................................................................................. 7, 8
`
`
`
`
`ii
`
`
`
`
`
`FRE 702 ..................................................................................................................... 9
`
`FRE 703 ........................................................................................................... 3, 4, 10
`
`FRE 801 ..................................................................................................................... 5
`
`FRE 802 ..................................................................................................................... 6
`
`FRE 803 ..................................................................................................................... 6
`
`FRE 901 ............................................................................................................. 4, 5, 9
`
`Other Materials
`
`Manual of Patent Examining Procedure, § 2124 ....................................................... 2
`
`
`
`
`iii
`
`
`
`IPR2017-01446
`
`I.
`
`INTRODUCTION
`Petitioner Taro Pharmaceuticals U.S.A., Inc.’s (“Taro”) attempt to exclude
`
`Patent Owner Apotex Technologies Inc.’s (“Apotex”) relevant evidence of
`
`patentability should be denied. Specifically, the Board should reject Taro’s
`
`attempts to exclude Exhibits 2006, 2008, 2010, 2014, 2015, and 2016 because each
`
`of these Exhibits is relevant to the proceeding at hand and because none of these
`
`Exhibits are inadmissible for lack of authentication or hearsay.
`
`II. LEGAL STANDARDS
`“The party moving to exclude evidence bears the burden of proof to
`
`establish that it is entitled to the relied requested—namely, that the material sought
`
`to be excluded is inadmissible under the Federal Rules of Evidence.” Sipnet EU
`
`S.R.O. v. Straight Path IP Group, Inc., IPR2013-00246, Paper 63 at 2 (PTAB Oct.
`
`9, 2014) (citing 37 C.F.R. §§ 42.20(c), 42.62(a)). Motions to exclude are
`
`disfavored by the Board, since “[t]here is a strong public policy for making all
`
`information filed in a non-jury, quasi-judicial administrative proceeding available
`
`to the public, especially in an inter partes review which determines the
`
`patentability of claims in an issued patent. It is better to have a complete record of
`
`the evidence submitted by the parties than to exclude particular pieces.” Nichia
`
`Corp. v. Emcore Corp., IPR2012-00005, Paper 68 at 59 (PTAB Feb. 11, 2014).
`
`
`
`
`
`
`
`III. ARGUMENT
`A. Exhibits 2006, 2015, and 2016 Are Not Inadmissible Hearsay
`Taro moves to exclude Exhibits 2006, 2015, and 2016 as hearsay based
`
`largely on these scientific publications not being prior art to the ’328 patent. (See
`
`Paper 48 at 1, 5-6.) However, Taro’s motion ignores long-standing precedent that
`
`“references cited to show a universal fact need not be available as prior art before
`
`applicant’s filing date.” See Manual of Patent Examining Procedure § 2124 (citing
`
`In re Wilson, 311 F.2d 266, 268 (CCPA 1962). “Such facts include the
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`characteristics and properties of a material or a scientific truism.” Id. Apotex cites
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`Ex. 2006 in Paper 6 as an exemplary publication that explains the scientific fact
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`that the liver and heart take in and release iron by different mechanisms. (See
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`Paper 6 at 2.) Similarly, Exs. 2015 and 2016 are cited by Dr. Pennell for the fact
`
`that myocardial T2* measurements prove that there was no correlation between
`
`myocardial iron and the parameters of liver iron and serum ferritin. (See Paper 48
`
`at 5-6 (citing Ex. 2003 at ¶ 26).) Moreover, as in Wilson, “Appellants [i.e., Taro]
`
`have made no effort to refute the fact for which it [Exs. 2006, 2015, and 2016] was
`
`cited, contenting themselves with the contention that we [i.e., the Board] cannot
`
`rely on the publication for any reason.” Wilson, 311 F.2d at 268-69. Thus, it is
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`wholly proper for the Board to consider Exhibits 2006, 2015, and 2016 as evidence
`
`of the facts asserted.
`
`
`
`2
`
`
`
`
`
`Further, Exhibits 2006, 2015, and 2016 qualify as an exception to the rule
`
`against hearsay under FRE 703. For example, Ex. 2006, titled “Longitudinal
`
`analysis of heart and liver iron in thalassemia,” was published in BLOOD, Ex.
`
`2015, titled “Cardiovascular T2-star (T2*) magnetic resonance for the early
`
`detection of myocardial iron overload,” was published in EUROPEAN HEART
`
`JOURNAL, and Ex. 2016, titled “Comparison of the effects of oral deferiprone and
`
`subcutaneous desferrioxamine on myocardial iron concentrations and ventricular
`
`function in beta-thalassemia,” was published in THE LANCET—each of which are
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`publications routinely reviewed by those in the field (i.e., cardiologists and
`
`hematologists who treat iron overload in patients requiring chronic blood
`
`transfusions). Nor does Taro’s motion allege that Exhibits 2006, 2015, and 2016
`
`are not evidence that an expert would reasonably rely upon. (See Paper 48 at 1, 5-
`
`6.) Accordingly, Exhibits 2006, 2015, and 2016 are admissible under FRE 7031 as
`
`industry publications, relied upon by experts in the field. See, e.g., Nestle
`
`Healthcare Nutrition, Inc. v. Steuben Foods, Inc., IPR2015-00249, Paper 77 at 13,
`
`2016 WL 4366980, at *7-9 (PTAB June 2, 2016) (allowing a hearsay exhibit
`
`
`1 FRE 703 includes the caveat that if the underlying facts are inadmissible, those
`facts may only be disclosed to the finder of fact if their probative value in helping
`evaluate the opinion substantially outweighs their prejudicial effect. However,
`since the determination in an IPR is made by the Board and not a jury, this caveat
`does not apply. See 37 C.F.R. § 42.62(b) (portions of the Federal Rules of
`Evidence relating to juries do not apply).
`
`
`
`3
`
`
`
`
`
`because Rule 703 permits an expert to base his opinion on facts or data that an
`
`expert in the field would have reasonably relied upon.); FRE 703. For these
`
`reasons, Taro’s motion to exclude Exhibits 2006, 2015, and 2016 should be denied.
`
`B.
`
`Exhibit 2008 Has Been Properly Authenticated, Is Relevant, and
`Is Not Inadmissible Hearsay
`The Board should deny Taro’s motion to exclude Ex. 2008 because it has
`
`been properly authenticated, is relevant to this proceeding, and is not inadmissible
`
`hearsay.
`
`First, Ex. 2008, which is a publication titled “FDA Approves Ferriprox to
`
`Treat Patients with Excess Iron in the Body,” has been properly authenticated.
`
`Under the Federal Rules of Evidence, Ex. 2008 is authenticated by “evidence
`
`sufficient to support a finding that the item is what the [Patent Owner] claims it is.”
`
`See FRE 901(a). Further, the standard for admissibility under FRE 901(a) is
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`“slight.” See United States v. Turner, 718 F.3d 226, 232 (3d Cir. 2013) (“The
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`standard for authenticating evidence is ‘slight’ . . . .”).
`
`Here, Ex. 2008 bears the “appearance, contents, substance, internal patterns,
`
`or other distinctive characteristics of the item, taken together with the
`
`circumstances” for the Board to find that this exhibit is what Apotex purports it to
`
`be. (FRE 901(b)(4).) Specifically, Ex. 2008 includes: the FDA’s logo, links to
`
`FDA’s websites (e.g., http://www.fda.gov/), as well as contact information for
`
`individuals at FDA responsible for media and consumer inquiries (e.g.,
`
`
`
`4
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`
`
`
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`erica.jefferson@fda.hhs.gov and 888-INFO-FDA, respectively). (See Ex. 2008.)
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`Further, Ex. 2008 states “Source U.S. Food and Drug Administration,” and
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`includes a valid URL address. (Id.) Therefore, because Exhibit 2008 bears the
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`hallmarks of authenticity under FRE 901(b)(4), it is admissible and should not be
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`excluded.
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`Second, Ex. 2008 is relevant to this proceeding. Apotex cites Ex. 2008 for
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`the fact that FDA approved Ferriprox® (deferiprone) in 2011 after an accelerated
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`review. (Paper 6 at 9.) What is more, contrary to Taro’s assertions (see Paper 48
`
`at 2-3), Ferriprox® is relevant because its FDA-approved use is embodied by the
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`claims of the ’328 patent. Indeed, as Apotex explained in its Preliminary
`
`Response, “[t]he ’328 patent is listed in the FDA’s publication ‘Orange Book:
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`Approved Drug Product with Therapeutic Equivalence Evaluations,’ as covering
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`the FDA-approved method of administering Ferriprox® for ‘the treatment of
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`patients with transfusional iron overload due to thalassemia syndromes when
`
`current chelation therapy is inadequate.’” (Paper 6 at 9.) Thus, Exhibit 2008 is
`
`relevant to this proceeding and Taro has not met its burden to establish otherwise.
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`Third, Exhibit 2008 is not inadmissible hearsay. Hearsay is an out-of-court
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`statement offered to prove the truth of the matter asserted in the statement. (FRE
`
`801.) In its Motion to Exclude, Taro fails to identify a specific “statement” from
`
`Exhibit 2008 that Apotex offers to prove the truth of the matter asserted in such
`
`
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`5
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`
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`statement. Instead, Taro argues, generically, that “Patent Owner relied on Exhibit
`
`2008 for the truth of the matter stated therein.” (Paper 48 at 3 (emphasis added).)
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`Thus, because Taro has not identified a specific out-court-statement from Exhibit
`
`2008 that Apotex relies upon to prove the truth of the matter asserted therein, Taro
`
`has not met its burden to establish that Exhibit 2008 is inadmissible under FRE 802
`
`and 803. See, e.g., Sipnet, IPR2013-00246, Paper 63 at 2; see also 37 C.F.R.
`
`§ 42.20(c). For these reasons, Taro’s motion to exclude Ex. 2008 should be
`
`denied.
`
`C. Exhibit 2010 Is Relevant
`Taro moves to exclude Ex. 2010, the Claim Construction Opinion and Order
`
`issued in the co-pending district court litigation (Case No. 2:16-cv-00528 (E.D.
`
`Tex.)) solely on the basis of relevance. (See Paper 48 at 3-4.) However, Ex. 2010
`
`is relevant and admissible under both FRE 401 and 402, as well as this tribunal’s
`
`evolving jurisprudence concerning the proper claim construction standard in IPR
`
`proceedings.
`
`Apotex cites Ex. 2010 to support its argument that the “result-oriented”
`
`claim terms are limitations of the claims and not merely intended results that can
`
`be ignored. (Paper 6 at 10.) As explained in its Preliminary Response, “Apotex’s
`
`position is consistent with the ‘broadest reasonable interpretation’ of the
`
`challenged claims . . . and as held by the district court, is supported by the words of
`
`
`
`6
`
`
`
`
`
`the claims themselves, the specification of the ’328 patent, and the prosecution
`
`history.” (Paper 6 at 12 (citing Ex. 2010) (emphasis added).) Because the Board
`
`has not yet finally decided the proper constructions for the challenged claims, Ex.
`
`2010 is relevant under FRE 401 as evidence of the fact that a district court has
`
`construed the disputed claim terms as limitations that are relevant to patentability.
`
`Moreover, a recent proposed rulemaking by the PTO “proposes to replace the
`
`broadest reasonable interpretation (“BRI”) standard for construing unexpired
`
`patent claims and proposed claims in these trial proceedings with a standard that is
`
`the same as the standard applied in federal district courts . . . .” (83 Fed. Reg.
`
`21,221 at 21,222 (May 9, 2018).) Further, “[t]his proposed rule also would amend
`
`the rules to add that the Office will consider any prior claim construction
`
`determination concerning a term of the involved claim in a civil action, or an ITC
`
`proceeding, that is timely made of record in an IPR, PGR, or CBM proceeding.”
`
`Here, Ex. 2010 was timely submitted and the Board can assign Ex. 2010 its proper
`
`weight, but there is no basis to exclude this document at this point in the
`
`proceedings.
`
`Taro further argues that “[t]he Board should therefore exclude and not
`
`consider Exhibit 2010 under FRE 402, or under FRE 403 because any probative
`
`value is substantially outweighed by the danger of unfair prejudice or confusing
`
`the issues.” (Paper 48 at 4 (emphasis added).) However, Taro fails to sufficiently
`
`
`
`7
`
`
`
`
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`explain what the unfair prejudice would be or how Ex. 2010 would confuse the
`
`Board. Thus, Taro has not met its burden to establish that Ex. 2010 is inadmissible
`
`under FRE 403. See, e.g., Sipnet, IPR2013-00246, Paper 63 at 2; see also 37
`
`C.F.R. § 42.20(c).
`
`Finally, Taro’s motion to exclude Ex. 2010 fails to comply with Federal
`
`Regulations. Specifically, “[a] motion to exclude evidence must: (a) [i]dentify
`
`where in the record the objection was originally made; (b) [i]dentify where in the
`
`record the evidence sought to be excluded was relied upon by an opponent; (c)
`
`[a]ddress objections to exhibits in numerical order; and (d) explain each
`
`objection.” Office Patent Trial Guide, 77 Fed. Reg. 48767 (Aug. 14, 2012). Taro
`
`failed to identify where in the record Ex. 2010 is relied upon by Apotex. (See
`
`generally Paper 48.) For each of these reasons, Taro’s motion to exclude Ex. 2010
`
`should be denied.
`
`D. Exhibit 2014 Has Been Properly Authenticated And Is Not
`Inadmissible Hearsay
`Taro moves to exclude Ex. 2014 for lack of authentication and as hearsay.
`
`(See Paper 48 at 4.) The Board should deny Taro’s motion to exclude Exhibit
`
`2014 because Exhibit 2014 has been properly authenticated and is not inadmissible
`
`hearsay.
`
`First, Ex. 2014, which is a document titled “Canadian Scientists Honored
`
`for Role in Breakthrough Drug,” has been properly authenticated. Specifically,
`
`
`
`8
`
`
`
`
`
`Ex. 2014 includes: a date and time (Jun 08, 2017, 08:00 ET); a verifiable URL
`
`address (at the bottom of the document); the name, email address
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`(hackermann@thalassemia.org), and phone number of an individual to contact
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`“[f]or more information or to arrange an interview with Anthony Viola, Dr.
`
`Fernando Tricta or a patient with thalassemia”; as well as information concerning
`
`the publisher—Cooley’s Anemia Foundation (http://www.thalassemia.org). (See
`
`Ex. 2014.) Thus, there is evidence sufficient “to support a finding that the item is
`
`what the [Patent Owner] claims it is.” FRE 901(a). Further, Ex. 2014 bears the
`
`“appearance, contents, substance, internal patterns, or other distinctive
`
`characteristics of the item, taken together with the circumstances” for the Board to
`
`find that this exhibit is what Apotex purports it to be. (FRE 901(b)(4).)
`
`Second, expert witnesses are permitted to rely upon hearsay documents if (a)
`
`the expert’s scientific, technical, or other specialized knowledge will help the trier
`
`of fact to understand the evidence or to determine a fact in issue; (b) the testimony
`
`is based on sufficient facts or data; (c) the testimony is the product of reliable
`
`principles and methods; and (d) the expert has reliably applied the principles and
`
`methods to the facts of the case. (FRE 702.) Dr. Thomas Coates cites Ex. 2014 in
`
`support for his opinion that “the extensive amount of praise for the claimed
`
`invention established the non-obviousness of the ’328 patent.” (See Ex. 2001 at
`
`35.) Taro cross-examined Dr. Coates in these proceedings on the reliability of Ex.
`
`
`
`9
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`
`
`
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`2014 as evidence of industry praise for the inventions claimed in the ’328 patent.
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`(See Ex. 1058 at 56-57.) Dr. Coates testified that Cooley’s Anemia Foundation is
`
`primarily comprised of families and patients, as well as hematologists such as
`
`himself. (See id. at 56.) Further, Dr. Coates testified that he himself had no part in
`
`the decision to give Dr. Spino [and Dr. Tricta] a Humanitarian of the Year award,
`
`but that he was aware of what Dr. Spino and Dr. Tricta did. (See id.) Moreover,
`
`Taro makes no assertion that, in evaluating “industry praise” hematologists such as
`
`Dr. Coates would not reasonably rely upon Ex. 2014 for the fact that Cooley’s
`
`Anemia Foundation awarded Dr. Spino the Humanitarian of the Year award. See
`
`FRE 703; see also In re Paoli RR Yard PCB Litig., 35 F. 3d 717, 747 (3d Cir.
`
`1994) (“We have held that the district judge must make a factual finding as to what
`
`data experts find reliable, and that if an expert avers that his testimony is based on
`
`a type of data on which experts reasonably rely, that is generally enough to survive
`
`the Rule 703 inquiry.” (internal citations omitted).) Thus, Taro’s motion to
`
`exclude Ex. 2014 on the basis of hearsay should be denied because Taro has not
`
`alleged that Ex. 2014 is evidence that an expert would not reasonably rely upon.
`
`IV. CONCLUSION
`For the foregoing reasons, Apotex respectfully requests that the Board deny
`
`Taro’s Request to Exclude Evidence.
`
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`10
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`Date: July 12, 2018
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`Respectfully submitted,
`
`By: W. Blake Coblentz
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, D.C. 20036
`(202) 912-4837
`
`
`11
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`
`
`IPR2017-01446
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on July 12, 2018, I caused a true and correct copy of
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`Patent Owner’s Opposition to Petitioner’s Motion to Exclude Evidence to be
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`served via electronic mail on the 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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`Date: July 12, 2018
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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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