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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`Petitioner,
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`v.
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`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
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`Case No. IPR2016-01101
`Patent No. RE 38,551
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`PATENT OWNER ABBREVIATED PRELIMINARY RESPONSE AND
`OPPOSITION TO PETITIONER’S MOTION FOR JOINDER
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`Patent No. RE 38,551
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`Case No. IPR2016-01101
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`Patent Owner Research Corporation Technologies, Inc. (“Patent Owner”)
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`provides the following abbreviated preliminary response to the petition filed by
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`Mylan Pharmaceuticals Inc. (“Petitioner” or “Mylan”) on May 25, 2016, and
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`opposition to Mylan’s accompanying motion requesting joinder to Grounds 3A and
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`3B of IPR2016-00204 (“the Argentum proceeding”).
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`The Federal Circuit’s decision in Magnum Oil—issued after the decision to
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`institute the Argentum proceeding—coupled with the also recent Federal Circuit
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`Intelligent Bio-Systems decision, make clear that a petitioner must present its
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`evidence in its petition, and that the failures of a petition cannot be cured through a
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`reply paper. Here, Mylan’s Petition is a “practical copy” of the Argentum petition,
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`and in any event, Mylan, if joined, would be limited to the evidence and arguments
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`presented in the Argentum petition. See Sections I and IV, infra. This evidence
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`fails to show the unpatentability of any claim of the ’551 patent. Because such
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`deficiencies cannot be cured, the Board should deny Mylan’s Petition and
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`accompanying Motion for Joinder. See 35 U.S.C. § 315(c).
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`1
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`Patent No. RE 38,551
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`Case No. IPR2016-01101
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`I.
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`The Petition Should Be Denied as to Grounds 1A, 1B, 2A, 2B, 4A, and
`4B
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`Patent Owner hereby
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`incorporates by reference1
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`its Patent Owner
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`Preliminary Response in IPR2016-00204, which addressed the failure of the
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`petition in that proceeding to establish a reasonable likelihood that any claim of the
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`’551 patent is unpatentable, under any of the enumerated Grounds. See IPR2016-
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`00204, Paper 9. In a decision instituting inter partes review as to Grounds 3A and
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`3B, the Board found that Argentum’s petition had not established a reasonable
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`likelihood that any claim of the ’551 patent was unpatentable under Grounds 1A,
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`1B, 2A, 2B, 4A or 4B. See IPR2016-00204, Paper 19 at 22–23. Mylan’s Petition is
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`a “practical copy” of Argentum’s petition in IPR2016-00204 (see Pet. (Paper 2) at
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`1), which the Board has already found deficient as to Grounds 1A, 1B, 2A, 2B, 4A
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`1 As explained in the Board’s August 11, 2016 Order (Paper 7), the Board has
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`authorized Patent Owner to incorporate by reference arguments and information in
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`its Patent Owner Preliminary Response and in the Board’s Decision on Institution
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`from the Argentum proceeding (i.e., Papers 9 and 19 in IPR2016-00204). See
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`Paper 7 at 4; Ex. 2001 at 33:9–15.
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`2
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`and 4B (see IPR2016-00204, Paper 19 at 8–12, 22–23; Paper 3 at 1).2 For the same
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`reasons why the Board denied Argentum’s petition as to Grounds 1A, 1B, 2A, 2B,
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`4A and 4B, Mylan’s Petition should be denied here as to those same grounds. See
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`IPR2016-00204, Paper 19 at 8–12, 22–23.
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`II. The Petition Fails to Establish a Reasonable Likelihood that the Claims
`Are Unpatentable Under Grounds 3A or 3B
`A.
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`Intervening Case Law Clarifies Petitioner’s Burden to
`Present Evidence of Unpatentability in Its Petition
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`Subsequent to the Board’s May 23, 2016 decision to institute the Argentum
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`proceeding, the Federal Circuit clarified that “it is inappropriate to shift the burden
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`to the patentee after institution to prove that the patent is patentable,” and that “the
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`petitioner continues to bear the burden of proving unpatentability after institution.”
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`In Re: Magnum Oil Tools Int’l, Ltd., __ F.3d __, 2016 WL 3974202, at *7 (Fed.
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`Cir. 2016). Prior to Magnum Oil, it was unclear whether the burden of production
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`may shift to the patent owner post-institution, to come forward with evidence of
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`patentability. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375,
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`1379 (Fed. Cir. 2015) (noting that the burden of production may shift from the
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`2 In any event, if Mylan—an otherwise time-barred party (Ex. 2001, 7:18–8:5)—is
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`joined to the Argentum proceeding, Mylan will be limited to the evidence and
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`arguments in the Argentum petition. See Section IV, infra.
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`3
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`patent challenger to the patentee, in the context of establishing conception and
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`reduction to practice). Magnum Oil resolved this question, rejecting the notion
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`“that the burden of production shifts to the patentee upon the Board’s conclusion in
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`an institution decision that ‘there is a reasonable likelihood that the petitioner
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`would prevail.’” Magnum Oil, 2016 WL 3974202, at *6. Thus, both the burdens of
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`persuasion and production to show unpatentability remain with the petitioner and
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`do not shift to the patent owner at any time. See id. at *6–*8.
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`This un-shifting burden of proof—a burden that remains with the petitioner
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`throughout the proceeding—is particularly significant in light of additional recent
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`Federal Circuit law, holding that “the expedited nature of IPRs bring[s] with it an
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`obligation for petitioners to make their case in their petition to institute,” which
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`must “identify ‘with particularity’ the ‘evidence that supports the grounds for the
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`challenge to each claim.’” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
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`821 F.3d 1359, 1369 (Fed. Cir. 2016) (emphases added); see also id. at 1369–70
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`(concluding petitioner’s reply brief and accompanying declaration were improper
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`under 37 C.F.R. § 42.23(b) because petitioner “relied on an entirely new rationale”
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`in its reply to explain motivation to combine). Thus, because a petitioner must both
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`provide its evidence and make its case in its petition,3 and because the burdens of
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`production and persuasion never shift to the patent owner, a petitioner’s failure to
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`include key evidence in its petition is irremediable and cannot be cured through a
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`reply paper.
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`For example, as explained further below, the prior art on which Petitioner
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`relies in Grounds 3A and 3B fails to disclose a “therapeutic composition” as
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`construed by the Board, and as required by claim 10 of the ’551 patent. Because
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`the burden of production never shifts from the Petitioner, as the Federal Circuit has
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`now made clear (Magnum Oil, 2016 WL 3974202, at *6–*8), and because
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`Petitioner cannot cure its failure of proof in its Reply (Intelligent Bio-Systems, 821
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`3 The Federal Circuit’s decision in Genzyme is not to the contrary. While the
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`Federal Circuit in Genzyme observed that “the introduction of new evidence in the
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`course of the trial is to be expected in inter partes review trial proceedings,” the
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`“new evidence” cited in the reply in Genzyme had been cited in the petition and
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`was already part of the record. See Genzyme Therapeutic Products Ltd.
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`Partnership v. Biomarin Pharm. Inc., __ F.3d __ (Fed. Cir. 2016), 2016 WL
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`3254734, at *5. In addition, the Board did not rely on that evidence to establish any
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`claim limitations, or to fill in any gaps in the petition. See id. at *6.
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`5
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`F.3d at 1369), it is clear at this stage that Petitioner has not—and cannot—meet its
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`burden of proving unpatentability of the claims.
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`B.
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`Petitioner Fails to Present Evidence Showing that the
`Claims Are Unpatentable
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`Petitioner fails to present evidence to meet its burden of showing
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`unpatentability of claims 1–9 over Kohn 1991 and Silverman. In the first instance,
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`Petitioner fails to provide evidence showing that a POSA4 would have selected any
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`functionalized amino acid (“FAA”) as a lead compound, much less selected
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`Compound 3l in Kohn 1991 over other FAAs, including similarly potent FAAs,5
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`given Compound 3l’s “synthetic and stability issues.” See Pet. at 41; IPR2016-
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`00204, Paper 9 at 27–31 (discussing lead compound selection), 46 (discussing the
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`problems with Compound 3l). Petitioner further fails to provide evidence showing
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`that a POSA would have been motivated to modify Compound 3l in the way
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`Petitioner suggests, given that a POSA would have known that similar
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`modifications in FAAs resulted in a reduction in activity; Petitioner similarly fails
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`4 Patent Owner incorporates by reference its description of the level of ordinary
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`skill in the art from its Preliminary Response in the Argentum proceeding. See
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`IPR2016-00204, Paper 9 at 9. However, regardless of the definition, the
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`conclusions regarding insufficient evidence remain the same.
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`5 See, e.g., Compound 3n in Kohn 1991 (Ex. 1012), Table 1.
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`6
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`to provide evidence to show that a POSA would have had a reasonable expectation
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`of success in making such modification. See Pet. at 41–43; IPR2016-00204, Paper
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`9 at 47–49. Petitioner cannot cure any of these failures in its reply paper. Thus
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`Petitioner has not—and cannot—meet its burden with respect to claims 1–9.6
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`With respect to claim 10, the only basis appearing for Petitioner’s Ground
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`3B assertion that claim 10 is obvious over Kohn 1991, Silverman, and the ’729
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`patent, is the “rationales and prior art disclosures discussed in Ground 1B,” where
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`6 Importantly, a recent judicial opinion confirmed the non-obviousness of
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`lacosamide (the compound of claim 8) over Kohn 1991 Compound 3l. See UCB,
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`Inc. et al. v. Accord Healthcare, Inc. et al., 1:13-cv-01206-LPS, Dkt. 313 (D. Del.)
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`(Ex. 2003). The district court found that (1) “a POSA would not have selected any
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`FAA as a lead compound,” and (2) “[e]ven if, contrary to the evidence, a POSA
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`would have selected a nonaromatic FAA as a lead compound, such a person would
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`not have selected compound 3l.” Id. at 84–88 (emphasis in original). The Court
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`also found that (3) a POSA would not “have been motivated to change the
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`NHOC[H]3 of compound 3l to the CH2OCH3 of lacosamide,” and (4) “a POSA
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`would not have had a reasonable expectation of success from substituting an amine
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`for a methylene in compound 3l.” Id. at 88–89; see Pet. at 41–43 (discussing
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`modifying the NHOCH3 of compound 3l to the CH2OCH3 of lacosamide).
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`Ground 1B concerns patentability over the LeGall Thesis together with the ’729
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`patent. See Pet. at 44. Petitioner’s Ground 1B arguments are therefore directed to a
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`different reference that is not at issue here.7 In any event, Petitioner fails to show
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`that claim 10—which claims a “therapeutic composition”—is unpatentable.
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`Critically, Petitioner fails to show any disclosure of a “therapeutic
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`composition” in the ’729 patent or in any other prior art reference. In the Argentum
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`proceeding, the Board found “therapeutic composition” to be a limitation of claim
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`10 and construed this term as a composition “suitable for use as a treatment
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`regimen over an extended period of time (chronic administration).” IPR2016-
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`00204, Paper 19 at 7–8. This construction is also the construction adopted by the
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`district court in the consolidated Delaware litigation, in which Petitioner was a
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`named defendant. UCB, Inc., et al. v. Accord Healthcare, Inc., et al., No. 13-1206
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`(LPS), Dkt. 240 (D. Del.).
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`7 The Argentum petition failed to establish that the LeGall Thesis is a printed
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`publication. See IPR2016-00204, Paper 19 at 8–12. Because the Petition here is a
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`“practical copy” of Argentum’s petition in IPR2016-00204 (see Pet. at 1), and
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`because, in any event, Petitioner is limited to solely those arguments and evidence
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`in the Argentum petition (see Section IV, infra), Petitioner likewise fails to meet its
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`burden to establish that the LeGall Thesis is a printed publication.
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`Petitioner was fully aware of the consistent construction of this claim term
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`by both the Board and the district court when it filed its Petition. Indeed, in its
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`Petition, Petitioner repeatedly refers to the district court’s construction and argues
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`against it. See Pet. at 8–10; see also Ex. 1007 (Petitioner’s exhibit providing the
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`district court’s claim construction order). Nonetheless, Petitioner fails to provide
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`any evidence that Kohn 1991, Silverman, and the ’729 patent teach or suggest a
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`“therapeutic composition” as construed. Petitioner fails to provide any evidence
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`because no such evidence existed in the prior art.
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`Petitioner’s allegation that “Claim 10 is obvious because a POSA knew to
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`use an effective amount of the active agent and also to use a pharmaceutical
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`carrier” (Pet. at 27 (Ground 1B)) is insufficient and beside the point—nowhere
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`does the Petition explain how the combination of Kohn 1991, Silverman, and the
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`’729 patent meet the therapeutic composition limitation of claim 10 as construed.
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`Petitioner fails to address this key limitation of claim 10—which requires that the
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`composition be “suitable for use as a treatment regimen over an extended period of
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`time (chronic administration)”—and thus its patentability challenge should be
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`rejected.
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`Petitioner’s patentability challenge should be rejected for the separate reason
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`that Petitioner has not shown that a POSA would have reasonably expected to
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`achieve a therapeutic composition—i.e., a composition “suitable for use as a
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`treatment regimen over an extended period of time (chronic administration)”—of
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`any of the compounds of claims 1–9, or of any FAA. A finding of obviousness
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`requires “not only the existence of a motivation to combine elements from
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`different prior art references, but also that a skilled artisan would have perceived a
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`reasonable expectation of success in making the invention via that combination.”
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`Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (emphasis
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`added). No liver toxicity data, which would indicate to a POSA whether a
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`composition is suitable for chronic administration, appeared in the prior art for any
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`FAA, let alone any of the compounds of claims 1–9. See Ex. 2002, 178:4–9.8 Thus,
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`a POSA would not have had any data on which to base an expectation regarding
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`suitability for chronic administration as to FAAs generally, or the compounds of
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`claims 1–9 specifically. Indeed, liver toxicity data for lacosamide (the compound
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`of claim 8, also known as (R)-N-benzyl-2-acetamido-3-methoxypropionamide, and
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`referred to in the ’551 patent as “BAMP” (see Ex. 1001, 24:56–58)) was disclosed
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`for the first time in the ’551 patent.9 See Ex. 1001, 25:44–29:36; Ex. 2002, 178:4–9
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`8 See IPR2016-00204, Paper 9 at 2–3 n.2.
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`9 With respect to “therapeutic composition,” the district court (see note 6, supra)
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`noted that its construction of this claim term—the same construction adopted by
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`the Board in the Argentum proceeding—“presupposes that the compound will not
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`(Dr. Heathcock’s testimony that no liver toxicity data for any FAA was disclosed
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`in any prior art to the ’551 patent).
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`In sum, Petitioner has failed to provide any evidence whatsoever in its
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`Petition of a “therapeutic composition”—which is required by claim 10—in the
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`prior art. In addition, as explained in the Patent Owner Preliminary Response (see,
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`e.g., IPR2016-00204, Paper 9 at 46–50), Petitioner has also failed to provide any
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`evidence that a POSA would have reasonably expected to achieve the compounds
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`of claims 1–9, much less a “therapeutic composition” of any of these compounds.
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`Petitioner has likewise failed to provide any evidence that a POSA would have
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`reasonably expected to achieve a method of treating using these compounds, as
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`recited in claims 11–13. Each of these failures shows that Petitioner has not met its
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`initial burden to show a reasonable likelihood of unpatentability of the claims of
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`the ’551 patent, and that Petitioner cannot meet its ultimate burden to show
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`unpatentability by a preponderance of the evidence. See Intelligent Bio-Systems,
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`821 F.3d at 1369–70 (new theory of invalidity supported by new evidence not
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`present in the petition cannot be presented for the first time in reply). Accordingly,
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`the Board should deny the present Petition.
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`result in liver toxicity.” Ex. 2003 at 64 n.19. “A medicine is not suitable for
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`chronic administration if it will be toxic to the liver.” Id.
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`III. Petitioner’s Motion for Joinder Should Be Denied
`Joinder requires, “as an initial matter, a determination that the petition
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`accompanying the joinder motion warrants institution of review.” Lupin Ltd., et al.
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`v. Senju Pharmaceutical Co., Ltd., IPR2015-01871, Paper 13 at 2 (P.T.A.B. Jan.
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`25, 2016) (discussing 35 U.S.C. § 315(c)). The decision whether to grant joinder is
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`discretionary. 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. “The Board will determine
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`whether to grant joinder on a case-by-case basis, taking into account the particular
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`facts of each case, substantive and procedural issues, and other considerations.”
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`Macronix Int’l Co., Ltd. v. Spansion LLC, IPR2014-00898, Paper 15 at 3 (P.T.A.B.
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`Aug. 13, 2014). Here, because Petitioner has failed to establish in its Petition a
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`reasonable likelihood that the claims are unpatentable, joinder is improper, and
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`Petitioner’s motion to join the Argentum proceeding should be denied.
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`IV.
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`If the Board Grants Petitioner’s Motion for Joinder, Petitioner Is
`Limited to an Understudy Role, and Its Evidence Is Limited to the
`Evidence in the Argentum Petition
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`If the Board grants Petitioner’s motion to join the Argentum proceeding,
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`Petitioner is limited to an “understudy” role, and is limited to the evidence and
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`arguments presented in the Argentum petition. See Paper 7 at 2; Ex. 2001 at 10:4–
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`11:11 (Petitioner agreeing to take an understudy role, such that it would not take its
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`own depositions, be filing papers separate from Argentum, or making arguments
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`separate from Argentum), 15:6–16:13 (Petitioner agreeing to be “a true me-too”
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`petitioner), 17:16–18:7 (Board explaining that the joined petitioners, including
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`Petitioner Mylan, “will be relying on all evidence and arguments that were made in
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`[the Argentum] petition”). Petitioner may not seek “(a) additional briefing or
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`pages, (b) to submit new evidence, such as declaration testimony, (c) additional
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`time for cross-examination of witness or time during an oral hearing, or (d) to alter
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`the trial schedule” set out in the scheduling order or otherwise agreed to during
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`trial in the Argentum proceeding. Paper 7 at 2. In other words, Petitioner is limited
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`to the arguments and evidence that were presented in the Argentum petition, and
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`may not rely on any additional evidence or expert testimony, including any such
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`additional evidence or testimony presented in its Petition or Motion for Joinder.
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`Paper 7 at 3 (“[T]he later Petitioners, including Petitioner Mylan, agreed to assert
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`arguments and evidence of record in IPR2016-00204 only, and not [to] rely on any
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`additional evidence raised in Petitions or Motions for Joinder filed by the later
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`Petitioners.”); Ex. 2001 at 15:6–16:13, 17:16–18:7.
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`V. Conclusion
`For the reasons discussed above, Federal Circuit case law now makes clear
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`that the Petition’s deficiencies cannot be cured by a reply paper. Because Petitioner
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`Mylan’s Petition fails to provide evidence showing the unpatentability of any claim
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`of the ’551 patent, and because such deficiencies cannot be cured, Mylan’s Petition
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`and its accompanying Motion for Joinder should be denied. However, should the
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`Board grant Petitioner My1an’s Motion for J oinder, the parties and the Board have
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`agreed that Petitioner will be limited to an understudy role, and to only the
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`evidence and arguments presented in the Argentum petition.
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`Date: August 19, 2016
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`Respectfully submitted,
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`B
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`Andrea G. Reister
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`Registration No. 36,253
`Jennifer L. Robbins
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`Registration No. 61,163
`COVINGTON & BURLING LLP
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`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`Attorneys for Patent Owner
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`14
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 19th day of August
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`2016,
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`the foregoing Patent Owner Abbreviated Preliminary Response and
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`Opposition to Petitioner’s Motion for Joinder was served by electronic mail, by
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`agreement of the parties, on the following counsel of record for Petitioner.
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`Steven W. Parmelee (sparme1ee@wsgr.com)
`Michael T. Rosato (rnrosato@wsgr.com)
`Jad A. Mills (jmills@wsgr.com)
`Wilson Sonsini Goodrich & Rosati
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`701 Fifth Avenue, Suite 5100
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`Seattle, WA 98104-7036
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`Date: August 19, 2016
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`%[
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`Jennifer L. Robbins, Esq.
`Registration No.: 61,163