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 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 MOTION TO EXCLUDE
`EXHIBITS 1047, 1049, 1051, & 1054-1056
`
`
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`IPR2018-00293
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`Pursuant to 37 C.F.R. 42.64(c), Patent Owner Shire LLC (“Shire”) submits
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`this motion to exclude Exhibits 1047, 1049, 1051, and 1054-1056 filed by Petitioner
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`in support of the Petitioner’s Reply (Paper 31). 1
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`I. INTRODUCTION
`With its Reply, Petitioner submitted six documents it says are published on
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`the FDA’s website: EX1047—Clinical Pharmacology/Biopharmaceutics Review
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`for NDA No. 22-063 (Mydayis®); EX1049—Chemistry Review for NDA No. 21-
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`303 (Adderall XR®); EX1051—FDA Summary Review for NDA 22-063
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`(Mydayis®); Ex. 1054—Dexedrine® Spansule® Sustained Release product label;
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`EX1055—Dyanavel XR® product label; and EX1056—Adzenys ER® product
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`1 In response to Patent Owner’s Objections (Paper 32), Petitioner served an
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`additional document—EX1059 (Physicians’ Desk Reference 2005)—on February
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`26, 2019. Petitioner alleged EX1059 to be “supplemental evidence.” The following
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`day at the Deposition of Dr. McCracken, Patent Owner objected to this exhibit as
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`untimely. Petitioner has not relied on EX1059 in any paper filed in this case. To the
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`extent Petitioner attempts to rely on this document, however, Patent Owner reserves
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`the right to move to exclude EX1059 as untimely. Patent Owner also notes that
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`EX1059 is an entirely new document that does not respond to objection raised by
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`Patent Owner.
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`1
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`IPR2018-00293
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`label. As discussed in below, each of these documents is offered by Petitioner to
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`prove the truth of various statements contained therein. Accordingly, they are
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`hearsay under Fed. R. Evid. 801(c). These documents furthermore are not excluded
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`from the definition of hearsay under Fed. R. Evid. 801(d), do not fall into any hearsay
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`exception under Fed. R. Evid. 803, and are inadmissible under Fed. R. Evid. 802.
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`Moreover, each of the product labels submitted by Petitioner are dated after
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`the filing date of the challenged patent. The ’100 patent has a priority date of at least
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`May 12, 2006. But EX1054 is dated 2007, and EX1055 and EX1056 are dated 2017.
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`Accordingly, these documents are irrelevant to the validity of the ’100 patent and
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`should be excluded under Fed. R. Evid. 402.
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`II. LEGAL STANDARD FOR MOTION TO EXCLUDE
`“A party wishing to challenge the admissibility of evidence must object timely
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`to the evidence at the point it is offered and then preserve the objection by filing a
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`motion to exclude the evidence.” Trial Practice Guide, 77 Fed. Reg. 48765, 48767
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`(Aug. 14, 2012) (citing 37 C.F.R. § 42.64). “A motion to exclude evidence must: (a)
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`Identify where in the record the objection originally was made; (b) Identify where
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`in the record the evidence sought to be excluded was relied upon by an opponent;
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`(c) Address objections to exhibits in numerical order; and (d) Explain each
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`objection.” Id.
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`2
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`IPR2018-00293
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`“Admissibility of evidence [in an IPR] is generally governed by the Federal
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`Rules of Evidence.” 77 Fed. Reg. 157, at 48758. “Irrelevant evidence is not
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`admissible” under Rules 401 and 402, when the evidence does not tend “to make a
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`fact more or less probable than it would be without the evidence” or the fact is not
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`of “consequence in determining the action.” Fed. R. Evid. 401 and 402; see also
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`Daubert, 509 U.S. at 587 (1993); Magnivision, Inc. v. Bonneau Co., 115 F.3d 956,
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`961 (Fed. Cir. 1997).
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`Hearsay evidence is inadmissible under Fed. R. Evid. 801 and 802, when a
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`statement, other than one made by the declarant, is offered in evidence “to prove the
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`truth of the matter asserted.” Air Land Forwarders, Inc. v. US, 172 F. 3d 1338, 1342
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`(Fed. Cir. 1999).
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`The proponent of the evidence, in this case Petitioner, has the burden of
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`establishing admissibility by a preponderance of the evidence. See Fed. R. Evid.
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`104(a); Bourjaily v. United States, 483 U.S. 171 (1987).
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`III. ARGUMENT
`A.
`Identify Where in the Record the Objection Originally was Made
`Patent Owner originally objected to Exhibits 1047, 1049, 1051, and 1054-
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`1056 on February 14, 2019, which was within five business days of the February 7,
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`2019 Petitioner Reply. See Paper 32.
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`3
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`IPR2018-00293
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`B.
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`Identify Where in the Record the Evidence Sought to be Excluded
`was Relied Upon by an Opponent
`Petitioner relied on Exhibits 1047, 1049, 1051, and 1054-1056 in its Reply.
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`See Paper 31, pp. 2 (Ex. 1047), 7-8 (Ex. 1054), 15 (Ex. 1051), 16-17 (Exs. 1054-56),
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`and 25 (Ex. 1049).
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`Address Objections to Exhibits in Numerical Order
`C.
`Patent Owner objections to Exhibits 1047, 1049, 1051, and 1054-56 are
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`addressed below in numerical order.
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`D.
`
`Explain Each Objection
`1. EX1047 is Inadmissible Under Fed. R. Evid. 802
`EX1047 is inadmissible as hearsay. Petitioner cites EX1047 in support of its
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`allegation that “[p]rior to 2006, doctors often prescribed a morning dose of Adderall
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`XR followed by a booster of Adderall IR taken 8-10 hours later.” Paper 31, p. 2.
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`Specifically, Petitioner quotes the following sentence from EX1047: “[t]he rationale
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`for the development of SPD465 (Long Acting Adderall XR) is to enable primary
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`adult and adolescent ADHD patients to benefit from ADHD symptom control
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`throughout the entire day and extend those benefits into the early evening hours.”
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`Thus, this statement is hearsay under Fed. R. Evid. 801 because Petitioner is offering
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`this statement from EX1047 to prove the truthfulness of the statement contained
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`therein, i.e., the specific rationale for the development of Mydayis. Further, this
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`statement in EX1047 is not excluded from the definition of hearsay in Fed. R. Evid.
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`IPR2018-00293
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`801(d), nor does it fall into any exception to the rule against hearsay under Fed. R.
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`Evid. 803. For these reasons, EX1047 should be excluded from this proceeding.
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`2. EX1049 is Inadmissible Under Fed. R. Evid. 802
`EX1049 is inadmissible as hearsay. Petitioner cites EX1049 in support of its
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`allegation that “[t]he first DR bead in SPD465 (EX. 1001, Example 3) uses the same
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`Eudragit coating in approximately the same amount as the DR bead in Burnside,
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`Example 2, which is also the same Eudragit coating used in the DR bead in Adderall
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`XR. (EX. 1049, p. 11).” Paper 31, p. 25. Petitioner alleges Ex. 1049 is a Chemistry
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`Review for NDA No. 21-303 (Adderall XR), and page 11 of EX1049 is a table
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`entitled “Theoretical Milligram/Capsule of components in SLI 381 Capsules, 10 mg,
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`20 mg, and 30 mg.” Included in that table is an entry for “Eudragit L30D-55.” Thus,
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`Ex. 1049 is hearsay under Fed. R. Evid. 801 because Petitioner offers it to prove the
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`truthfulness of statements therein, i.e., that Adderall XR contains Eudragit L30D-55.
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`Further, this portion of EX1049 is not excluded from the definition of hearsay in
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`Fed. R. Evid. 801(d), nor does it fall into any exception to the rule against hearsay
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`under Fed. R. Evid. 803. For these reasons, EX1049 should be excluded from this
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`proceeding.
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`3. EX1051 is Inadmissible Under Fed. R. Evid. 802
`EX1051 is inadmissible as hearsay. Petitioner cites EX1051 in support of its
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`allegation that “Shire told FDA that the nine-year hiatus was for ‘business reasons,’
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`5
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`IPR2018-00293
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`which is incongruous with its present claim of long felt need. (EX1051, pp. 1-2).”
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`Paper 31, p. 15. The statement in EX1051 quoted by Petitioner is as follows: “[t]he
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`Applicant notified the Agency in 2007 that they intended to file an amendment to
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`support approval; however, they later decided not to pursue further development of
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`SHP465 for business reasons.” EX1051, pp. 1-2. Thus, EX1051 is hearsay under
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`Fed. R. Evid. 801 because Petitioner offers it to prove the truthfulness of statements
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`therein, i.e., that the reason for not filing the amendment was for business reasons.
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`Further, this portion of EX1051 is not excluded from the definition of hearsay in
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`Fed. R. Evid. 801(d), nor does it fall into any exception to the rule against hearsay
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`under Fed. R. Evid. 803. For these reasons, EX1051 should be excluded from this
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`proceeding.
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`4. EX1054 is Inadmissible Under Fed. R. Evid. 402 and 802
`EX1054 is inadmissible as hearsay. Petitioner cites EX1054 in support of its
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`allegation that “Moreover, while Dexedrine IR (dextroamphetamine) has a Tmax of
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`3 hours and efficacy 3-6 hours, Dexedrine SR has a Tmax of 8 hours and efficacy
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`for at least 9-12 hours.” Paper 31, 7 (citing Ex. 1054). The statement in EX1054
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`relied on by Petitioner is as follows: “[f]ollowing administration of one 15-mg
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`sustained-release capsule, maximal dextroamphetamine plasma concentrations were
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`obtained approximately 8 hours after dosing.” EX1054, p. 2.
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`6
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`IPR2018-00293
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`Petitioner also cites EX1054 in support of its allegation that “‘[N]o food
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`effect’ is inherent in all amphetamine ADHD formulations, regardless of formulation
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`type (e.g., sustained or pulsed release) or characteristics.” Paper 31, pp. 16-17 (citing
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`EX1054, p. 2). The statement relied on by Petitioner in EX1054 is as follows: “[i]n
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`12 healthy subjects, the rate and extent of dextroamphetamine absorption were
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`similar following administration of the sustained-release capsule formulation in the
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`fed (58 to 75 gm fat) and fasted state.”
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`Thus, these portions of EX1054 are hearsay under Fed. R. Evid. 801 because
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`Petitioner offers EX1054 to prove the truthfulness of statements therein, i.e., that
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`Dexedrine SR has a Tmax of 8 hours and has no food effect. Further, these portions
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`of EX1054 are not excluded from the definition of hearsay in Fed. R. Evid. 801(d),
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`nor do they fall into any exception to the rule against hearsay under Fed. R. Evid.
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`803.
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`Further, EX1054 is inadmissible as irrelevant under Fed. R. Evid. 402. As
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`discussed above, Petitioner cites to EX1054 twice in its Reply: (1) as evidence of
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`the Tmax of Dexedrine in support of Petitioner’s reasonable expectation of success
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`argument (Paper 31, pp. 7-8); and (2) as evidence that Dexedrine does not exhibit a
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`food effect in support of its inherency obviousness argument (Paper 31, pp. 16-17).
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`Both arguments, however, turn on the knowledge of a POSA at the time of the
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`invention of the ’100 patent, i.e., at least as early as May 12, 2006. Specifically,
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`IPR2018-00293
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`whether a POSA would have had a reasonable expectation of success in arriving at
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`the invention of the ’100 patent depends on what the POSA knew in 2006. Similarly,
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`the Federal Circuit has held that in the case of inherency in obviousness, what is
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`important is what was known or expected to a POSA at the time of the invention.
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`See, e.g., Honeywell Int’l Inc. v. Mexichem Amanco Holding S.A., 865 F.3d 1348,
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`1354-55 (Fed. Cir. 2017) (“We have previously stated that the use of inherency in
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`the context of obviousness must be carefully circumscribed because ‘[t]hat which
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`may be inherent is not necessarily known’ and that which is unknown cannot be
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`obvious.”) (“What is important regarding properties that may be inherent, but
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`unknown, is whether they are unexpected.”) (citations omitted).
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`Here, EX1054 is dated March 2007 (EX1054, p. 11), but there is no evidence
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`as to when EX1054 became publicly available. Even if it is assumed that EX1054
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`was publicly available in 2007, that date is still after the filing date of the ’100 patent.
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`Thus, that a POSA might have known in 2007 that Dexedrine had a Tmax of 8 hours
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`or had no food effect is irrelevant as to whether a POSA would have (1) had a
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`reasonable expectation of success of arriving at the claimed invention, or (2) have
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`expected or known the claimed composition would not have produced a food effect,
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`in 2006 at the time the ’100 patent was filed.
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`For these reasons, EX1054 should be excluded from this proceeding.
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`IPR2018-00293
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`5. EX1055 is Inadmissible Under Fed. R. Evid. 402 and 802
`EX1055 is inadmissible as hearsay. Like Ex. 1054, Petitioner cites EX1055 in
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`support of its allegation that “‘[N]o food effect’ is inherent in all amphetamine
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`ADHD formulations, regardless of formulation type (e.g., sustained or pulsed
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`release) or characteristics.” Paper 31, pp. 16-17 (citing Ex. 1055, p. 10). The
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`statement relied on by Petitioner in EX1055 discusses bioavailability of the drug
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`Dyanavel XR in the fed and fasted states before concluding that “[t]hese changes are
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`not considered clinically significant.” Thus, this portion of EX1055 is hearsay under
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`Fed. R. Evid. 801 because Petitioner offers EX1054 to prove the truthfulness of
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`statements therein, i.e., that Dyanavel XR has no food effect. Further, this portion of
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`EX1055 is not excluded from the definition of hearsay in Fed. R. Evid. 801(d), nor
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`does it fall into any exception to the rule against hearsay under Fed. R. Evid. 803.
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`Further, EX1055 is inadmissible as irrelevant under Fed. R. Evid. 402. As
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`discussed above, Petitioner cites to EX1055 as evidence that Dyanavel XR does not
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`exhibit a food effect, which is in support of its inherency obviousness argument
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`(Paper 31, pp. 16-17). As discussed with regards to EX1054, however, this argument
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`turns on the knowledge of a POSA at the time of the invention of the ’100 patent,
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`i.e., at least as early as May 12, 2006. Specifically, the Federal Circuit has held that
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`in the case of inherency in obviousness, what is important is what was known or
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`expected to a POSA at the time of the invention. See Honeywell supra. Here, Ex.
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`9
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`IPR2018-00293
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`1055 is dated January 2017 (EX1055, p. 1 (“Revised 1/2017”)), but there is no
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`evidence as to when EX1055 became publicly available. Even if it is assumed that
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`EX1055 was publicly available in 2017, that date is still well after the filing date of
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`the ’100 patent. Thus, that a POSA might have known in 2017 that Dyanavel XR did
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`not exhibit a food effect is irrelevant as to whether a POSA would have expected or
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`known the claimed composition would not have produced a food effect in 2006 at
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`the time the ’100 patent was filed.
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`For these reasons, EX1055 should be excluded from this proceeding.
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`6. EX1056 is Inadmissible Under Fed. R. Evid. 402 and 802
`EX1056 is inadmissible as hearsay. Like EX1054 and EX1055, Petitioner
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`cites EX1056 in support of its allegation that “‘[N]o food effect’ is inherent in all
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`amphetamine ADHD formulations, regardless of formulation type (e.g., sustained or
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`pulsed release) or characteristics.” Paper 31, pp. 16-17 (citing EX1056, p. 18). The
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`statement relied on by Petitioner in EX1056 discusses bioavailability of the drug
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`Adzenys ER with and without food before concluding that “[t]his change is not
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`considered clinically significant.” Thus, this portion of EX1056 is hearsay under
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`Fed. R. Evid. 801 because Petitioner offers EX1056 to prove the truthfulness of
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`statements therein, i.e., that Adzenys ER has no food effect. Further, this portion of
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`EX1056 is not excluded from the definition of hearsay in Fed. R. Evid. 801(d), nor
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`does it fall into any exception to the rule against hearsay under Fed. R. Evid. 803.
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`10
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`IPR2018-00293
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`Further, EX1056 is inadmissible as irrelevant under Fed. R. Evid. 402. As
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`discussed above, Petitioner cites to EX1056 as evidence that Adzenys ER does not
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`exhibit a food effect, which is in support of its inherency obviousness argument
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`(Paper 31, pp. 16-17). As discussed above with regards to EX1054, however, this
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`argument turns on the knowledge of a POSA at the time of the invention of the ’100
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`patent, i.e., at least as early as May 12, 2006. Specifically, the Federal Circuit has
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`held that in the case of inherency in obviousness, what is important is what was
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`known or expected to a POSA at the time of the invention. See Honeywell supra.
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`Here, EX1056 is dated September 2017 (EX1056, p. 1 (“Revised 9/2017”)), but
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`there is no evidence as to when EX1056 became publicly available. Even if it is
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`assumed that EX1056 was publicly available in 2017, that date is still well after the
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`filing date of the ’100 patent. Thus, that a POSA might have known in 2017 that
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`Adzenys ER did not exhibit a food effect is irrelevant as to whether a POSA would
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`have expected or known the claimed composition would not have produced a food
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`effect in 2006 at the time the ’100 patent was filed.
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`For these reasons, EX1056 should be excluded from this proceeding.
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`11
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`IPR2018-00293
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`IV. CONCLUSION
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`For the foregoing reasons, Patent Owner respectfully requests that its Motion
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`to Exclude Exhibits 1047, 1049, 1051, & 1054-56 be granted.
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`Dated: March 7, 2019
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` Respectfully submitted,
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`/Joseph R. Robinson/
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`Joseph R. Robinson, PTO Reg. No. 33,448
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` Robert Schaffer, PTO Reg. No. 31,194
` Dustin B. Weeks, PTO Reg. No. 67,466
` Attorneys for Patent Owner
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`12
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`IPR2018-00293
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
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`Motion to Exclude Exhibits 1047, 1049, 1051, & 1054-56 has been served on
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`attorneys for Petitioner via electronic mail on March 7, 2019 on attorneys for
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`Petitioner:
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`Steven Roth
`sroth@lmiplaw.com
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`Thomas Vetter
`tvetter@lmiplaw.com
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` David Galluzzo
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`djg@lmiplaw.com
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`Dated: March 7, 2019
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` Respectfully submitted,
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`/Dustin B. Weeks/
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` Dustin B. Weeks, PTO Reg. No. 67,466
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