IPR2018-00293
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`KVK-Tech, Inc.,
`Petitioner,
`
`v.
`
`Shire LLC,
`Patent Owner.
`____________
`
`Case IPR2018-00293
`Patent 9,173,857
`____________
`
`PATENT OWNER’S REPLY TO
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
`EXHIBITS 1047, 1049, 1051, & 1054-1056
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`KVK-Tech, Inc.,
`Petitioner,
`
`v.
`
`Shire LLC,
`Patent Owner.
`____________
`
`Case IPR2018-00293
`Patent 9,173,857
`____________
`
`PATENT OWNER’S REPLY TO
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
`EXHIBITS 1047, 1049, 1051, & 1054-1056
`
`
`
`IPR2018-00293
`
`Patent Owner Shire LLC submits this Reply to Petitioner’s Opposition to
`
`Patent Owner’s Motion to Exclude Exhibits 1047, 1049, 1051, and 1054-1056.
`
`I.
`
`Exhibits 1047, 1049, 1051, and 1054-1056 Are Inadmissible Hearsay
`
`First, Petitioner fails to show that the offered evidence falls into any exception
`
`to the rule against hearsay under Fed. R. Evid. 803. The burden is on Petitioner to
`
`establish admissibility by a preponderance of the evidence. See Fed. R. Evid. 104(a);
`
`Bourjaily v. United States, 483 U.S. 171 (1987). Petitioner fails to carry its burden.
`
`In its Opposition, Petitioner merely restates Fed. R. Evid. 803(8) in its entirety
`
`without specifying what, if any, portion of the Rule applies in the present case. Paper
`
`47, 2-3. Petitioner does nothing to show how the offered Exhibits embody “factual
`
`findings from a legally authorized investigation” and are a final product of the FDA’s
`
`own legally mandated investigative efforts. See Fed. R. Evid. 803(8)(iii). Petitioner
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`similarly fails to identify any legal duty or show how the Exhibits embody “a matter
`
`observed while under a legal duty to report.” See Fed. R. Evid. 803(8)(ii).
`
`Second, Petitioner’s argument that EX1047 and EX1051 are excluded from
`
`the definition of hearsay is without merit. Petitioner introduces EX1047 to prove the
`
`truthfulness of a statement contained therein, i.e., the rationale for developing of
`
`MYDAYIS. Similarly, Petitioner introduces the statement from EX1051 that “[t]he
`
`Applicant notified the Agency in 2007 that they intended to file an amendment to
`
`support approval; however, they later decided not to pursue further development of
`
`1
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`IPR2018-00293
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`SHP465 for business reasons,” for the truthfulness of that statement, i.e., not filing
`
`the amendment was for business reasons. Contrary to Petitioner’s bald assertion,
`
`neither EX1047 nor EX1051 establish Patent Owner’s intent. See Paper 47, 4.
`
`Petitioner also asserts, even if inadmissible as hearsay, EX1054-1056 are
`
`admissible under Fed. R. of Evid. 703, because Petitioner’s expert relied on them.
`
`Petitioner cites no case law to support this proposition. Rule 703 does not address
`
`the admissibility of evidence; it sets forth the proper basis for an expert opinion. Id.
`
`While Rule 703 provides that an expert opinion may in some circumstances be
`
`admissible if based on otherwise inadmissible facts or data, the Rule allows only the
`
`opponent of the opinion—in this case the Patent Owner—to disclose otherwise
`
`inadmissible evidence and “only if [its] probative value in helping the jury evaluate
`
`the opinion substantially outweighs [its] prejudicial effect.” Id. (emphasis added).
`
`Nothing in Rule 703 allows Petitioner to introduce otherwise inadmissible evidence,
`
`simply because an expert relies on it. Furthermore, Rule 703 does not place
`
`Petitioner’s expert in any position to assert the truth of hearsay statements involving
`
`FDA’s practices or Patent Owner’s intentions for MYDAYIS.
`
`Exhibits 1047, 1049, 1051, and 1054-1056 all fall squarely within the
`
`definition of hearsay under Fed. R. Evid. 801. Petitioner failed to show that any
`
`exception to the rule against hearsay applies under Fed. R. Evid. 803. Therefore, the
`
`offered Exhibits should be excluded from this proceeding.
`
`2
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`
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`IPR2018-00293
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`II.
`
`Exhibits 1054-1056 Are Inadmissible as Irrelevant
`
`Petitioner cites no law to support its broad proposition that “[e]vidence that
`
`an obvious product has an inherent feature is relevant,” let alone that such evidence
`
`is relevant “regardless of when the evidence was published.” Paper 47, 5. Inherent
`
`obviousness is not inherent anticipation; it requires operative knowledge by a POSA
`
`before the invention. Honeywell Int’l Inc. v. Mexichem Amanco Holding S.A., 865
`
`F.3d 1348, 1354-55 (Fed. Cir. 2017). Regardless of how Petitioner now characterizes
`
`its argument or reframes the issue, Petitioner introduced evidence that post-dates the
`
`claimed invention to establish the challenged claims are obvious. Paper 31, 16-17.
`
`The issue remains whether a POSA had a motivation to combine and reasonable
`
`expectation of success in arriving at the claimed invention, which depends on what
`
`the POSA knew in 2006. Whether different products exhibited a food effect in 2007
`
`is of no consequence to this issue. Evidence that post-dates the invention is of no
`
`consequence to whether an inherent quality was unexpected. Petitioner concedes as
`
`much. Paper 47, 7 (“Honeywell only held that . . . evidence of obviousness, such as
`
`motivation to combine and expected results must be known in the prior art.”).
`
`Honeywell is directly on point. The Federal Circuit held the critical issue in
`
`the case of inherency in obviousness is what was known or expected to a POSA at
`
`the time of the invention. Honeywell, 865 F.3d at 1354-55 (“What is important
`
`regarding properties that may be inherent, but unknown, is whether they are
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`3
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`IPR2018-00293
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`unexpected.”). The Court reiterated, “the use of inherency in the context of
`
`obviousness must be carefully circumscribed because ‘[t]hat which may be inherent
`
`is not necessarily known’ and that which is unknown cannot be obvious.” Id.
`
`Petitioner asks the Board to ignore these considerations and admit irrelevant
`
`evidence. Furthermore, the Honeywell court explained that a property that may be
`
`inherent in a single component of a formulation cannot be used to demonstrate
`
`obvious inherency of that property in a formulation containing additional
`
`components. Id. at 1353-55 (known miscibility of a refrigerant does not establish a
`
`composition containing the refrigerant in combination with other components is
`
`inherently miscible). That is precisely the situation before the Board. Petitioner is
`
`contending that amphetamine per se inherently has no food effect. Therefore, any
`
`formulation with amphetamine must inherently have no food effect. The Honeywell
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`court held that is an improper application of inherent obviousness. The obviousness
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`inquiry cannot be short-circuited, as Petitioner would have the Board do.
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`The case law relied upon by Petitioner is inapposite. In Monsanto Tech. LLC
`
`v. E.I. DuPont De Nemours & Co., 878 F.3d 1336 (Fed. Cir. 2018), the Federal
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`Circuit affirmed the Board’s holding of anticipation by inherent disclosure, which is
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`not at issue here. Petitioner quotes the Federal Circuit out of context. Its statement
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`that extrinsic evidence “need not antedate the critical date of the patent at issue” is
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`limited to inherent anticipation, not inherent obviousness, as the Court’s analysis
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`4
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`IPR2018-00293
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`made clear. Id. at 1345 (citation omitted). To hold otherwise would obviate any
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`obviousness inquiry. As Monsanto emphasized, “[a]lthough anticipation can be
`
`proven inherently, proof of inherent anticipation is not the same as proof of
`
`obviousness.” Id. at 1346 (citation omitted).
`
`Petitioner’s reliance on In re Huai-Hung Kao, 639 F.3d 1057 (Fed. Cir. 2011)
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`is similarly misplaced. In Kao, the Federal Circuit looked to the specification of the
`
`patent at issue to confirm that an unstated limitation was inherent in the claimed
`
`invention. Kao, 639 F.3d at 1070. There is no such admission here. Petitioner instead
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`invites the Board to consider extrinsic evidence post-dating the claimed invention to
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`invalidate the challenged claims. Because EX1054-1056 are irrelevant to the validity
`
`of the challenged claims, the documents should be excluded.
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`Finally, Petitioner’s belated introduction of EX2084 as supplemental evidence
`
`following the filing of Patent Owner’s Objections does nothing to cure Patent
`
`Owner’s objection to the admissibility of EX1054. EX2084 is an entirely different
`
`document than EX1054 and was not relied on by Petitioner or its expert.
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`III. Conclusion
`
`For the foregoing reasons, Patent Owner respectfully requests that its Motion
`
`to Exclude Exhibits 1047, 1049, 1051, & 1054-56 be granted.
`
`Respectfully submitted,
`
`
`
`/Joseph R. Robinson/ March 21, 2019
`Joseph R. Robinson, PTO Reg. No. 33,448
`
`
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`5
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`
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`IPR2018-00293
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
`
`Reply to Petitioner’s Opposition to Patent Owner’s Motion to Exclude Exhibits
`
`1047, 1049, 1051, & 1054-56 has been served on attorneys for Petitioner via
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`electronic mail on March 21, 2019 on attorneys for Petitioner:
`
`sroth@lmiplaw.com
`
`tvetter@lmiplaw.com
`
`djg@lmiplaw.com
`
`Dated: March 21, 2019
`
`
`
`Respectfully submitted,
`
`/Dustin B. Weeks/
`Dustin B. Weeks, PTO Reg. No. 67,466
`
`6
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