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`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
`
`PETITIONER’S OPPOSITION TO PATENT
`OWNER’S MOTION TO EXCLUDE
`
`Patent Trial and Appeal Board
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1
`
`
`
`Patent Owner moves to exclude six exhibits downloaded from FDA’s website,
`
`which FDA maintains to provide the public with FDA communications, reports and
`
`package inserts with respect to FDA approved drug products.1 Patent Owner has
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`previously submitted similar exhibits in this case, also downloaded from FDA’s or Patent
`
`Owner’s websites. (e.g., EX2003, EX2004, EX2005.)
`
`Nevertheless, Patent Owner moves to exclude all six exhibits as hearsay evidence,
`
`and three exhibits (1054-1056) as irrelevant to invalidity since they were dated after the
`
`priority date of the patent at issue in this IPR.
`
`I.
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`Patent Owner’s Hearsay Objections
`
`All the challenged exhibits are subject to the public record exception, F.R.E, Rule
`
`803(8), which provides that a record of a public office is not hearsay if:
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` (A) it sets out:
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`(i) the office’s activities;
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`(ii) a matter observed while under a legal duty to report, but not including, in a
`criminal case, a matter observed by law-enforcement personnel; or
`
`(iii) in a civil case or against the government in a criminal case, factual findings
`from a legally authorized investigation; and
`
`
`1 Patent Owner also objected to (but has not moved to exclude) the Declaration of James
`McCracken, dated February 7, 2019 (EX.1045), because it did not include a proper oath.
`Pursuant to 37 CFR 42.64(b)(2), Petitioner served a Corrected Declaration of James
`McCracken on February 26, 2019, which is submitted herewith (EX.1058).
`
`
`
`2
`
`
`
` (B) the opponent does not show that the source of
`information or other circumstances indicate a lack of trustworthiness.
`
`
`
`Here, all the exhibits are FDA records available on the FDA website, and each sets
`
`out (i) FDA’s activities respecting its approval of certain drug products, including
`
`Adderall XR and Mydayis, (ii) matters FDA observed based on Patent Owner’s
`
`applications to FDA for approval of Adderall XR and Mydayis, and (iii) factual findings
`
`by FDA in its review of those applications. (See Exhibit 1060, Declaration of Steven
`
`Roth ¶¶ 2-5, 7-9; EX1047, EX1049, EX1051, EX1054-56.)2 Moreover, Patent Owner
`
`has not and cannot show that the FDA website is an unreliable source. Numerous cases
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`have held that FDA letters, filings and reports are not hearsay under the public records
`
`exception. See, e.g., Sabel v. Mead Johnson & Co., 737 F. Supp. 135, 140-144 (D. Mass.
`
`1990); Fujisawa Pharm. Co., Ltd. v. Kapoor, 1999 WL 543166 ** 1-2 (N.D. Ill, July 21,
`
`1999); Novartis Pharm. Corp. v. Teva Pharm. USA, Inc., 2009 WL 3754170 **10-11
`
`(D.N.J., Nov. 5, 2009). In addition, all the challenged exhibits, even if hearsay, are
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`admissible under the Residual Exception, F.R.E, Rule 807.
`
`At least two of the Exhibits are not even hearsay as they were not introduced for
`
`
`2 Petitioner served the Declaration of Steven Roth as supplemental evidence, pursuant to
`37 C.F.R. 42.64(b)(2), within 10 business days of Patent Owner’s Objection to these
`exhibits (Paper No. 32).
`
`
`
`3
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`
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`the truth of the matter asserted, but for Patent Owner’s intent (Exhibits 1047 and 1051).
`
`Exhibit 1047 is an FDA pharmacology report in the Mydayis NDA file available to the
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`public. It is referenced in Petitioner’ Reply brief (Paper 31, at p. 2) as additional evidence
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`(which is undisputed) that Patent Owner’s intent in developing the three-bead product
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`was to extend ADHD treatment. Exhibit 1051 is FDA’s Summary Review of Mydayis,
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`also available on the FDA website in the Mydayis file, and it is cited in Petitioner’s Reply
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`(at p. 15) to show that Patent Owner advised FDA that it abandoned the FDA application
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`for 9 years because of “business reason,” which is inconsistent with Patent Owner’s
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`current claim of long felt need. Thus, both exhibits are relevant to show Patent Owner’s
`
`intent.
`
`In addition, three of the exhibits (Exhibits 1054-1056) are admissible under F.R.E,
`
`Rule 703, even if they are hearsay and not subject to any exception, as they were relied
`
`on by Petitioner’s expert, Dr. McCracken (Exhibit 1045 ¶¶101-102), and their probative
`
`value outweighs their prejudicial effect. These three exhibits are FDA approved package
`
`inserts for extended release amphetamine drug products. The probative value of these
`
`exhibits, as discussed more fully below, is that they demonstrate that the absence of a
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`“food effect” is an inherent property of amphetamine extended release formulations,
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`regardless of the formulation. Id. There is no prejudicial effect of admitting these
`
`exhibits.
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`
`4
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`
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`II.
`
`Patent Owner’s Relevance Objections (Exhibits 1054-1056)
`
`Patent Owner objects to Exhibits 1054-1056 as irrelevant evidence as they post-
`
`date the priority date of the patents at issue. These exhibits are package inserts for various
`
`extended release amphetamine drug products, and are relevant to show that the
`
`compositions of claim 1, if obvious, inherently possesses the “no food effect” element of
`
`dependent claim 19. Evidence that an obvious product has an inherent feature is relevant,
`
`regardless of when the evidence was published.
`
`Monsanto Tech. LLC v. E.I. DuPont de Nemours 878 F.3d 1336 (Fed. Cir. 2018)
`
`is on point. The case concerned the validity of a patent on a soybean plant obtained by
`
`(a) crossing two parent plant lines and (b) obtaining a progeny having certain properties.
`
`The Federal Circuit affirmed the PTAB’s finding the patent anticipated and obvious over
`
`a single prior art reference (“Booth”) teaching step (a) above, combined with non-prior
`
`art declarations (“the Kinney Declarations”) demonstrating that the properties in step (b)
`
`were inherent. The Federal Circuit held that the “evidence [of inherency] need not
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`antedate the critical date of the patent at issue.” Id. at 1345. That’s because the evidence
`
`is only showing what is necessarily present in an obvious product. And although the
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`statement above was made in the context of anticipation, the Federal Circuit applied the
`
`same analysis in finding the claims obvious, including reliance on the non-prior art
`
`declarations to show that step (b) is inherent in the otherwise obvious plant progeny. See,
`
`
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`5
`
`
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`Id. at 1347. In footnote 13, the Court explicitly stated that the same analysis applies (“our
`
`finding that the PTAB properly looked at the Kinney Declarations [to find step (b)
`
`inherent] in its anticipation analysis equally applies to the PTAB’s obviousness
`
`findings.”)
`
`In re Kao, 639 F.3d 1057, 1070 (Fed. Cir. 2009) is also on point. The Federal
`
`Circuit affirmed the BPAI’s finding that a patent on an extended release formulation is
`
`obvious, and that the food effect limitation is inherent in the obvious formulation.
`
`Rejecting the same argument Patent Owner is making here, the Federal Circuit held that
`
`the evidence of inherency properly came from the specification of the patent at issue,
`
`which is obviously not prior art. See, also, In re Kubin, 561 F.3d 1351, 1357 (Fed. Cir.
`
`2009) (also found inherency from the specification of the patent at issue).
`
`Patent Owner reads too much into Honeywell Int. Inc. v. Mexichem Amanco
`
`Holdings S.A., 865 F.3d 1348 (Fed. Cir. 2017). Again the facts are instructive. The patent
`
`at issue claims a composition comprising a certain refrigerant (“HFO”) combined with a
`
`certain lubricant (“HFA”). Patentee argued that the combination is not obvious because
`
`the prior art suggested that the combination would be unstable, but Patentee found,
`
`unexpectedly, that the combination was stable. The PTAB found the combination
`
`obvious because stability was an inherent property. The Federal Circuit reversed because
`
`“the Board erred in relying on inherency to dismiss evidence showing unpredictability
`
`in the art . . .” Id. at 1354.
`
`
`
`6
`
`
`
`The point in the Honeywell case is that evidence of unpredictability must be found
`
`in the prior art. This proposition is true by definition. The evidence of what is expected
`
`(or unexpected) before the invention at issue must, ipso facto, be known before the
`
`invention at issue. An expected event takes place after the expectation, and the evidence
`
`of what is expected must be known before the event expected.
`
`But that is a far cry from the issue of whether a property of an obvious composition
`
`is necessarily present in the composition. Thus, Honeywell only held that while the
`
`evidence of obviousness, such as motivation to combine and expected results must be
`
`known in the prior art, the evidence of whether a property is necessarily present in an
`
`obvious product need not be known in the prior art. The case of Pernix v. Alvogen Malta
`
`Op. Ltd., 323 F.Supp.3d 566 (D. Del. 2018) made this precise distinction over
`
`Honeywell, holding that the unknown pharmacokinetic properties of a claimed drug
`
`product were inherent in that product, and stating that Honeywell is inapposite “because
`
`that case involved using an unknown but inherent property as a teaching in an
`
`obviousness analysis; it did not involve a limitation that recites an inherent property.” Id.
`
`at 606-607 (emphasis added).
`
`The issue is thus whether the evidence demonstrates a basis for the obviousness
`
`analysis (e.g., motivation to combine, expectation of success, teaching away) which must
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`be known in the prior art, or whether the evidence demonstrates whether a feature is
`
`necessarily present in an otherwise obvious invention. In the latter case, the evidence of
`
`
`
`7
`
`
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`the inherent feature need not be known in the prior art.
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`In the present case, Petitioner contends that the “no food effect” limitation in claim
`
`19 is an inherent property of the obvious formulations covered by claim 1, from which
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`claim 19 depends. Petitioner’s expert is using Exhibits 1054-1056 as evidence to show
`
`that amphetamine extended release formulations have no food effect (AUC and Cmax)
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`regardless of the formulation, because numerous amphetamine extended release products
`
`with different formulations have no food effect. He is not using it in the obviousness
`
`analysis of the formulation itself, but only to show what is inherent in an otherwise
`
`obvious formulation. Accordingly, there should be no requirement that the evidence of
`
`this inherent property be known in the prior art. If “no food effect” is necessarily present
`
`in the claim 1 formulations, it doesn’t become less so, regardless of when the proof is
`
`established. See, Santarus, Inc. v. Par Pharm., Inc. 694 F.3d 1344, 1354 (Fed. Cir. 2012)
`
`(“an obvious formulation cannot become non-obvious simply by administering it to a
`
`patient and claiming the resulting serum concentrations.”)
`
`Petitioner also introduced the Dexedrine (dextroamphetamine) package insert
`
`(2007) (EX1054) to show that while Dexedrine IR has a Tmax of 3 hours, Dexedrine SR
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`has a Tmax of 8 hours. (Petitioner’s Reply, Paper 31, pp. 7-8.) After Patent Owner’s
`
`Objections on February 14, 2019 (Paper No. 32), Petitioner, on February 26, 2019,
`
`provided supplemental evidence to this exhibit, pursuant to 37 C.F.R. 42.64(b)(2), in the
`
`form of the Dexedrine package insert found in the 2005 Physician Desk Reference
`
`
`
`8
`
`
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`(“PDR”) which has the same information regarding Tmax as the Dexedrine label from
`
`the FDA website.3 (See EX.1060, Declaration of Steven Roth, ¶10.) Both Dexedrine
`
`package inserts were shown to Dr. McCracken at this deposition and he testified that
`
`they describe the same product characetrisitcs (EX.2082, p. 175). And Patent Owner filed
`
`the 2005 Dexedrine Package Insert from the PDR with its Sur-Reply in this case as
`
`Exhibit 2084.
`
`The 2005 PDR is prior art to the patent at issue here, and is covered by the public
`
`records exception (F.R.E. 803(8)) and Learned Treatises exception (F.R.E. 803(18)) to
`
`the hearsay rule, as it was called to the attention of Dr. McCracken in his deposition and
`
`is well known as a reliable compilation of FDA approved drug package inserts, which
`
`the Board may take judicial notice of, pursuant F.R.E. 803(18).
`
`Dated: March 15, 2019
`
`
`
`Respectfully submitted,
`
`/s/Steven Roth/
`Steven Roth, PTO Reg. No. 47,039
`Lucas & Mercanti, LLP
`
`
`3 Dexedrine package inserts prior to 2006 are not available on the FDA website.
`
`
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`9
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that, pursuant to 37 C.F.R. §§ 42.6(e) the
`
`foregoing PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION
`
`TO EXCLUDE was served electronically via email on March 15, 2019, the
`
`Corrected Declaration of James McCracken (EX.1058) was served electronically
`
`via email on February 26, 2019, and the Declaration of Steven Roth (Ex.1060) was
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`served electronically via email on February 28, 2019 on the following:
`
`Joseph R. Robinson
`Troutman Sanders LLP
`875 Third Avenue
`New York, NY 10022
`joseph.robinson@troutmansanders.com
`
`Dustin B. Weeks
`Troutman Sanders LLP
`Bank of America Plaza
`600 Peachtree Street NE, Suite 5200
`Atlanta, GA 30308-2231
`dustin.weeks@troutmansanders.com
`
`Robert Schaffer
`Troutman Sanders LLP
`875 Third Avenue New
`York, NY 10022
`robert.schaffer@troutmansanders.com
`Patent Owner has consented to electronic service.
`
`Date: March 15, 2019
`
`
`
`By:
`
`
`
`/Steven Roth/
`Steven Roth
`Reg. No. 47,039
`
`10
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`
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