UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS, INC.
`Petitioner,
`
`v.
`
`BAYER INTELLECTUAL PROPERTY, GMBH,
`Patent Owner.
`
`Case No. IPR2018-01143
`Patent No. 9,539,218
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`

`

`TABLE OF CONTENTS
`
`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`
`TABLE OF CONTENTS .......................................................................................... ii
`
`TABLE OF AUTHORITIES ................................................................................... iii
`
`I.
`
`INTRODUCTION ............................................................................................... 1
`
`II. THE PERSON OF ORDINARY SKILL IN THE ART ..................................... 4
`
`III. CLAIM CONSTRUCTION ............................................................................. 5
`
`A. “Rapid-Release Tablet” .................................................................................... 5
`
`1. The Phrase “Rapid-Release Tablet” Should Be Construed According to the
`Express Definition in the ’218 Patent .................................................................. 5
`
`2. The Petition’s Proposal to Adopt a Different Construction of “Rapid-
`Release Tablet” Should Be Rejected. ................................................................ 10
`
`B. Other Claim Construction Issues .................................................................... 17
`
`IV. ARGUMENT .................................................................................................. 17
`
`A. Trial Should Not Be Instituted Pursuant to Section 325(d) ........................... 19
`
`1. The Board Should Decline to Institute Based on Ground 1 ........................ 20
`
`2. The Board Should Decline to Institute Based on Ground 2 ........................ 21
`
`B. Trial Should Not Be Instituted Because the Petition Fails to State the
`Asserted Grounds with Particularity ..................................................................... 25
`
`V. CONCLUSION .................................................................................................. 32
`
`ii
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`
`TABLE OF AUTHORITIES
`
`CASES
`
`AIA Eng’g Ltd., et al. v. Magotteaux Int’l S/A, et al.,
`657 F.3d 1264, 1279 (Fed. Cir. 2011) ................................................................ 14
`
`Becton, Dickenson and Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB, Dec. 15, 2017) (informative) ........................ 20
`
`Core Wireless Licensing S.A.R.L. v. LG Elecs., Inc.,
`880 F.3d 1356 (Fed. Cir. 2018) .......................................................................... 14
`
`Dorco Co., Ltd. v. The Gillette Co., LLC,
`IPR2017-00500, Paper 7 (PTAB June 21, 2017) ................................... 19, 20, 25
`
`Dynamic Drinkware LLC v. Nat’l Graphics, Inc.,
`IPR2013-00131, Paper 16 (PTAB Oct. 28, 2013) .............................................. 27
`
`Enovate Medical LLC v. Intermetro Industries Corp.,
`IPR2015-00300, Paper 12 (PTAB May 20, 2015) ............................................. 28
`
`Ford Motor Co. v. Paice LLC,
`IPR2015-00800, Paper 12 (PTAB Oct. 27, 2015) .............................................. 28
`
`Gea Process Eng’g, Inc. v. Steuben Foods, Inc.,
`IPR2014-00054, Paper 11 (PTAB Mar. 10, 2014) ............................................. 27
`
`Google Inc. v. Zuili,
`CBM2016-00021, Paper 11 (PTAB June 1, 2016) ....................................... 28, 29
`
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) .......................................................................... 19
`
`Hologic, Inc. v. bioMerieux, Inc.,
`IPR2018-00568, Paper 9 (PTAB Aug. 7, 2018) ........................................... 17, 20
`
`Hopkins Mfg. Corp., et al. v. Cequent Performance Prods., Inc.,
`IPR2015-00609, Paper 9 (PTAB Aug. 14, 2015) ............................................... 30
`
`In re Power Integrations, Inc.,
`884 F.3d 1370 (Fed. Cir. 2018) ............................................................................ 8
`
`iii
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`
`In re Smith International, Inc.,
`871 F. 3d 1375 (Fed. Cir. 2017) ........................................................................... 8
`
`Kayak Software Corp. et al. v. Int’l Business Machines Corp.
`CBM2016-00075, Paper 16 (PTAB Dec. 15, 2016) (informative) .......... 3, 18, 25
`
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009) ............................................................................ 6
`
`Microsoft Corp. v. Proxyconn Inc.,
`789 F.3d 1292 (Fed. Cir. 2015) ............................................................................ 9
`
`Multiform Desiccants, Inc. v. Medzam, Ltd.,
`133 F.3d 1473 (Fed. Cir. 1998) ............................................................................ 5
`
`Neil Ziegman, N.P.Z., Inc. v. Stephens,
`IPR2015-01860, Paper 11 (PTAB Feb. 24, 2016) .............................................. 20
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .......................................................................... 14
`
`Profectus Technology v. Huawei Techs. Co.,
`823 F.3d 1375 (Fed. Cir. 2016) .......................................................................... 14
`
`Sinorgchem Co., Shandong v. Int’l Trade Comm’n,
`511 F.3d 1132 (Fed. Cir. 2007) ...................................................................... 5, 14
`
`Telebrands Corp. v. Tinnus Enterprises, LLC,
`PGR2017-00015, Paper 16 (PTAB Oct. 11, 2017) ............................................ 21
`
`Thorner, et al. v. Sony Comput. Entm’t Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) .......................................................................... 12
`
`TI Grp. Auto. Sys. Inc. v. VDO, L.L.C.,
`375 F.3d 1126 (Fed. Cir. 2004) .......................................................................... 15
`
`TRW Auto. US LLC v. Magna Elecs., Inc.,
`IPR2014-00293, Paper 21 (PTAB Aug. 28, 2014) ............................................. 31
`
`Unified Patents Inc. v. Berman,
`IPR2016-01571, Paper 10 (PTAB Dec. 14, 2016) (informative) ................... 3, 21
`
`iv
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`
`Wi-Lan, Inc. v. Apple, Inc.,
`811 F.3d 455 (Fed. Cir. 2016) ............................................................................ 14
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.104(b)(2), (4)-(5) ............................................................................. 26
`
`35 U.S.C. § 103 ........................................................................................................ 26
`
`35 U.S.C. § 312(a)(3) ..................................................................................... 4, 19, 25
`
`35 U.S.C. § 325(d) ............................................................................................passim
`
`H.R. Rep. No. 112-98, pt. 1 (2011).......................................................................... 20
`
`v
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`
`I.
`
`INTRODUCTION
`
`This proceeding involves a challenge to a patent protecting the once-daily
`
`administration of rivaroxaban in a rapid-release tablet for the treatment and/or
`
`prevention of life-threatening thromboembolic disorders. Ex. 1001 (’218 patent) at
`
`col. 1, ll. 37-44; see also Ex. 2001 (XARELTO® Prescribing Information) at 1.
`
`Rivaroxaban inhibits an enzyme involved in blood clot formation called factor Xa,
`
`and is the active ingredient in XARELTO®. See, e.g., Ex. 1001 at col. 2, ll. 19-32,
`
`col. 3, ll. 18-32; Ex. 2001 at 1. XARELTO® was the first orally-available, direct
`
`factor Xa inhibitor to receive FDA-approval for clinical use, in particular to treat
`
`and/or prevent stroke, pulmonary embolisms, and deep venous thromboses. See
`
`Ex. 2001 at 1. Administering XARELTO® in a once-daily regimen provides
`
`important advantages from a compliance and patient convenience perspective. See
`
`Ex. 1001 at col. 2, ll. 35-39.
`
`Patent Owner’s position on the merits is that the claims of U.S. Patent No.
`
`9,539,218 (the “’218 patent”) are nonobvious and should be upheld as patentable—
`
`a position that is consistent with and supported by a previous decision of the Patent
`
`Trial and Appeal Board during the prosecution of the ’218 patent. If this case were
`
`to proceed to trial, Patent Owner Bayer Intellectual Property GmbH (“Bayer”)
`
`stands prepared to offer further evidence in support of this position. However, it is
`
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`respectfully submitted that there will be no need for Bayer to do so, as the
`
`Petition’s two grounds should be denied outright for two independent reasons.
`
`First, the Board should decline to institute trial under 35 U.S.C. § 325(d) in
`
`light of the prior decision of the Board referenced above. With respect to Ground
`
`1, the Petition does not purport to base its arguments on a substantively different
`
`obviousness position from the one previously considered by the Office. Rather,
`
`the arguments are fundamentally premised on the Board adopting a different claim
`
`construction from the one it previously adopted. Specifically, the Petition alleges
`
`that the Board construed the claim term “rapid-release tablet” too narrowly during
`
`prosecution, and therefore that it should accept a broader construction here. That is
`
`a hard row to hoe. As the Board previously found, “rapid-release tablet” is
`
`expressly defined in the specification of the ’218 patent, and the Board construed
`
`the term according to that lexicography. The definition has not changed and there
`
`is no reason for a different outcome here. That warrants denial of institution under
`
`35 U.S.C. § 325(d). Indeed, the Petition does not even suggest that Ground 1
`
`could survive a Section 325(d) challenge if the Board’s prior (and correct) claim
`
`construction were maintained.
`
`Ground 2 of the Petition fares no better. In Ground 2, the Petition employs
`
`the construction of rapid-release tablet previously adopted by the Board, and then
`
`adds an additional reference to Ground 1 (Forsman) that the Petition alleges
`
`2
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`Patent No. 9,539,218(cid:3)
`discloses a rapid-release tablet according to the Board’s prior construction
`
`(although the reference does not discuss factor Xa inhibitors or rivaroxaban).
`
`However, the question for the Board and the Examiner during prosecution was not
`
`whether a “rapid-release tablet” as defined in the specification was a known
`
`concept. To the contrary, both the Board and the Examiner would have understood
`
`from the ’218 patent specification itself that such tablets existed, as the definition
`
`of rapid-release tablet requires a particular release profile according to a known
`
`United States Pharmacopeia dissolution test. Ex. 1001 at col. 8, ll. 21-24. Instead,
`
`the issue during prosecution was whether the art before the Board and the
`
`Examiner concerning the pharmacokinetics of rivaroxaban rendered obvious the
`
`use of a rapid-release tablet containing rivaroxaban in a once-daily dosing
`
`regimen. The Petition does not even attempt to characterize Forsman as addressing
`
`that issue, and the reference is indeed irrelevant to that question. Accordingly,
`
`even with the addition of Forsman, Ground 2 does not raise any issues beyond
`
`what the Office has already considered and rejected. See Kayak Software Corp. et
`
`al. v. Int’l Business Machines Corp. CBM2016-00075, Paper 16 at 7-12 (PTAB
`
`Dec. 15, 2016) (informative) (denying institution under Section 325(d) where
`
`additional reference did not add to the issues analyzed by the Examiner during
`
`prosecution); see also Unified Patents Inc. v. Berman, IPR2016-01571, Paper 10 at
`
`12 (PTAB Dec. 14, 2016) (informative) (denying, in relevant part, institution under
`
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`Section 325(d), even though one asserted reference was not considered during
`
`prosecution). That failure warrants denial under Section 325(d).
`
`Second, and independently, both grounds are deficient because they assert,
`
`as a single reference, a series of three separate abstracts—the “Kubitza
`
`Abstracts”—reflecting three different studies with three different analyses and
`
`three different sets of conclusions. By treating these three references as a group,
`
`the Petition fails to specify which obviousness combinations are actually being
`
`asserted, let alone which particular aspects of the three abstracts are being relied
`
`upon for each of those combinations. The Petition therefore runs afoul of the legal
`
`requirement that a petition lay out the asserted grounds of unpatentability with
`
`particularity. See 35 U.S.C. § 312(a)(3). That deficiency likewise warrants denial
`
`of the Petition.
`
`For these reasons, Patent Owner submits that trial should not be instituted.
`
`II.
`
`THE PERSON OF ORDINARY SKILL IN THE ART
`
`For purposes of this Preliminary Response only, Bayer will not contest the
`
`definition of the person of ordinary skill in the art set forth in the Petition, but
`
`reserves the right to do so if trial is instituted. See Pet. at 7.
`
`4
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
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`III. CLAIM CONSTRUCTION
`
`A.
`
`“Rapid-Release Tablet”
`
`The Board should construe the phrase “rapid-release tablet” to mean “a
`
`tablet which, according to the USP release method using apparatus 2 (paddle), has
`
`a Q value (30 minutes) of 75%.” That is exactly how the phrase is defined in the
`
`specification, and exactly how the Board previously construed the term. See Ex.
`
`1001 at col. 8, ll. 21-24; Ex. 1004 at 0111, 0116. By contrast, the construction
`
`proposed in the Petition is contrary to the definition in the specification, was not
`
`adopted by the Board, and was even rejected by a federal district court in parallel
`
`litigation involving the ’218 patent.
`
`1.
`
`The Phrase “Rapid-Release Tablet” Should Be Construed
`According to the Express Definition in the ’218 Patent
`
`Under Federal Circuit precedent, when a claim term or phrase is defined in
`
`the specification, that ends the inquiry into its meaning, and the Board need look
`
`no further to construe it. See, e.g., Sinorgchem Co., Shandong v. Int’l Trade
`
`Comm’n, 511 F.3d 1132, 1138 (Fed. Cir. 2007) (“‘When the specification explains
`
`and defines a term used in the claims, without ambiguity or incompleteness, there
`
`is no need to search further for the meaning of the term.’”) (quoting Multiform
`
`Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998));
`
`5
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir. 2009)
`
`(“When a patentee explicitly defines a claim term in the patent specification, the
`
`patentee’s definition controls.”). That is precisely the case here with respect to the
`
`phrase “rapid-release tablet.” The ’218 patent provides as follows:
`
`Tablets are preferred, in particular tablets rapidly releasing the active
`compound. In the context of the present invention, rapid-release
`tablets are in particular those which, according to the USP release
`method using apparatus 2 (paddle), have a Q value (30 minutes) of
`75%.
`
`Ex. 1001 at col. 8, ll. 20-24 (emphasis added). Under Federal Circuit precedent,
`
`that express definition governs the claim construction inquiry, and there is no need
`
`for the Board to search further for the meaning of the phrase.
`
`
`
`As noted in the Petition, Pet. at 15-16, the Board itself has already concluded
`
`that “rapid-release tablet” should be construed according to this express definition
`
`in the specification. During prosecution, the Board heard an appeal from the
`
`Examiner’s final rejection of the pending claims. See Ex. 1004 at 0109-17. In
`
`deciding the appeal, the Board made a series of factual findings, one of which—
`
`“FF4”—was that the specification “defines ‘rapid-release tablets’ as ‘those which,
`
`according to the USP release method using apparatus 2 (paddle), have a Q value
`
`(30 minutes) of 75 %.’” Id. at 0111 (emphasis added) (citing Ex. 1004 at 5022,
`
`specification at 10, ll. 7-9). Later in its opinion, the Board referred back to this
`
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`factual finding, and reiterated its conclusion that the specification sets forth an
`
`“express definition” of “rapid-release tablet”:
`
`Appealed claim 5 recites a “rapid-release tablet,” which we interpret
`in view of the express definition thereof provided in the Specification,
`which is “those [tablets] which, according to the USP release method
`using apparatus 2 (paddle), have a Q value (30 minutes) of 75 %.”
`
`Id. at 0116 (citing “FF4”) (alteration in Board opinion). The Board proceeded to
`
`reverse the Examiner’s rejection in light of that construction, id. at 0117, and on
`
`remand the “rapid-release tablet” limitation was incorporated into every claim of
`
`the ’218 patent, id. at 0053-54. The Examiner then allowed the now-issued claims,
`
`relying in part on the Board’s finding that the specification provides an “express
`
`definition” of “rapid-release tablet” in her Notice of Allowance:
`
`In the Patent Board Decision filed on 6/3/2016, the Board states that
`the “rapid-release tablet” is interpreted in view of the express
`definition in the Specification which is “those [tablets] which,
`according to USP release apparatus 2 (paddle), have a Q value of (30
`minutes) 75%.”
`
`Id. at 0055 (alteration in original).
`
`Nothing has changed. The ’218 patent still defines the term “rapid-release
`
`tablet” as set forth above, a fact recognized by the Board and relied upon by the
`
`Examiner in allowing the claims to issue. The Board should not depart from its
`
`7
`
`earlier reasoning here.
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`The United States District Court for the District of Delaware (“District
`
`Court”) reached the identical conclusion in parallel litigation involving the ’218
`
`patent, finding that the specification defined “rapid-release tablet” to mean “a
`
`tablet which, according to the USP release method using apparatus 2 (paddle), has
`
`a Q value (30 minutes) of 75%.”1 Ex. 2002 (District Court Markman Order) at 2.
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`(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)
`1 While the Board construes a term according to its “broadest reasonable
`
`interpretation,” which may differ from the Phillips standard applied by a federal
`
`district court, both standards are in alignment when it comes to applying an express
`
`definition set forth in the specification. See In re Power Integrations, Inc., 884
`
`F.3d 1370, 1377 (Fed. Cir. 2018) (“The correct inquiry in giving a claim term its
`
`broadest reasonable interpretation in light of the specification is not whether the
`
`specification proscribes or precludes some broad reading of the claim term adopted
`
`by the examiner. Instead, a proper claim construction analysis endeavors to assign
`
`a meaning to a disputed claim term that corresponds with . . . how the inventor
`
`describes his invention in the specification.” (citation and internal quotation marks
`
`omitted, alteration in original)); In re Smith International, Inc., 871 F. 3d 1375,
`
`1382 (Fed. Cir. 2017) (“[T]he protocol of giving claims their broadest reasonable
`
`interpretation . . . does not include giving claims a legally incorrect interpretation
`
`divorced from the specification and the record evidence.” (internal quotation marks
`
`8
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`The District Court noted that the ’218 patent has a definitions section, which
`
`begins where the specification states: “For the purpose of the present invention as
`
`disclosed and described herein, the following terms and abbreviations are defined
`
`as follows.” Ex. 2002 at 2 (citing Ex. 1001 at col. 7, ll. 22-24). The District Court
`
`further concluded that “[i]n between the definitions of ‘oral dosage forms’ and
`
`‘once daily,’ the specification states, in part, ‘Tablets are preferred, in particular
`
`tablets rapidly releasing the active compound. In the context of the present
`
`invention, rapid-release tablets are in particular those which, according to the USP
`
`release method using apparatus 2 (paddle), have a Q value (30 Minutes) of 75%.’”
`
`Id. at 1-2 (citing Ex. 1001 at col. 8, ll. 20-24). “Thus,” the District Court
`
`concluded, “in the lexicography section of the patent, ‘[i]n the context of the
`
`present invention,’ the patentees give a very precise explanation of what they mean
`
`by a ‘rapid-release tablet.’” Id. at 2 (alteration in original). The District Court
`
`construed the term accordingly, thereby seconding the Board’s earlier construction
`
`of the term.
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`(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)
`omitted) (quoting Microsoft Corp. v. Proxyconn Inc., 789 F.3d 1292, 1298 (Fed.
`
`9
`
`Cir. 2015)).
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`The Petition’s Proposal to Adopt a Different Construction of
`“Rapid-Release Tablet” Should Be Rejected.
`
`2.
`
`The Petition invites the Board to depart from the clear lexicography in the
`
`specification and instead construe “rapid-release tablet” “broadly” to “refer[] to
`
`conventional tablets that have not been formulated to release the active compound
`
`in a modified manner, such as through delayed or extended release.” Pet. at 22.
`
`That construction is unsupported and should be rejected.
`
`First, although the Petition points to other portions of the specification to try
`
`to glean a different meaning of “rapid-release tablet,” those arguments are
`
`unavailing. The Petition provides the following block quotation from the
`
`specification:
`
`Pet. at 22. However, the way in which this quotation is broken up paints an
`
`inaccurate picture of the ’218 patent specification. Specifically, it omits a
`
`paragraph break between two sentences, and likewise omits the sentences both
`
`preceding and following this text. The specification actually reads as follows:
`
`10
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`
`Ex. 1001 at col. 8, ll. 13-24. This more fulsome excerpt—showing the actual
`
`paragraph breaks, and including the sentences both before and after the excerpt in
`
`the Petition—reflects two points. One point is that the phrase that the Petition
`
`relies upon—“tablets releasing the active compound rapidly or in a modified
`
`manner”—is part of the definition of “oral dosage forms.” It is not—contrary to
`
`the suggestion in the Petition—tethered to the discussion in the separate,
`
`subsequent paragraph regarding “rapid-release tablets.” A second point is that the
`
`context shows that the specification does not—as the Petition suggests—somehow
`
`implicitly define a rapid-release tablet to mean a tablet that is not a modified
`
`release tablet. Instead, the specification contains its own explicit discussion of
`
`“rapid-release tablets” and defines the term to mean tablets “which, according to
`
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`the USP release method using apparatus 2 (paddle), have a Q value (30 minutes) of
`
`75%.” Ex. 1001 at col. 8, ll. 21-24.
`
`Petitioner made a similar argument before the District Court, but the District
`
`Court rejected it. Specifically, Petitioner2 cited the phrase “tablets releasing the
`
`active compound rapidly or in a modified manner” and asserted that this phrase
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`somehow provided an implicit definition of “rapid-release tablet” that treats it as
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`an alternative to a modified-release tablet. Ex. 2003 at 19-20, 35; see also Pet. at
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`21-22. However, the District Court correctly pointed out that the language
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`Petitioner relied upon then—which it relies upon again in its Petition here—does
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`not even contain the term “rapid-release tablet.” Ex. 2002 at 3. It therefore
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`rejected Petitioner’s effort to find an implicit definition of rapid-release tablet in a
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`paragraph that is in fact providing an explicit definition of a different phrase (oral
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`dosage form). Id.; see also Thorner, et al. v. Sony Comput. Entm’t Am. LLC, 669
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`F.3d 1362, 1368 (Fed. Cir. 2012) (“Simply referring to two terms as alternatives
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`. . . is not sufficient to redefine a claim term.”).
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`Second, the Petition asserts that the language previously relied upon by the
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`Board as definitional refers to only a particular embodiment or “species” of the
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`(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)
`2 Petitioner was joined by other defendants in the District Court in making this line
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`12
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`of argument.
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`(cid:3)(cid:3)
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`broader concept of a rapid-release tablet. Pet. at 24. The argument is undermined
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`by the specification itself. Where the ’218 patent identifies individual
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`embodiments of the invention, it does so explicitly, using phrases like “[i]n a
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`preferred embodiment,” “[i]n another preferred embodiment,” and “[t]he invention
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`is illustrated, but in no way limited, by the following example.” Ex. 1001 at col. 3,
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`l. 18; col. 4, l. 12; col. 4, l. 20; col. 6, l. 61; col. 8, ll. 43-45. However, the sentence
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`cited by the Board as providing an express definition of “rapid-release tablet”
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`contains no such language that limits it to a single embodiment or example.
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`Moreover, the patent’s disclosure of multiple dosage forms, in what
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`Petitioner characterizes as progressive levels of specificity, see Pet. at 24-25, does
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`not somehow suggest that tablets with Q values (30 mins) of 75% are merely a
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`subset of “rapid-release tablets.” That the specification contains a definition of
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`“oral dosage forms” in one paragraph does not undermine the notion that “rapid-
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`release tablet” is itself expressly defined elsewhere in the specification in a
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`separate paragraph. And while Petitioner is correct that the claims do not
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`specifically contain the language “a Q value (30 minutes) of 75%,” that does not
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`mean that “rapid-release tablet” is intended to have a broader meaning than the one
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`dictated by the specification. To the contrary, such language is not needed in the
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`claims, as it is already part of the express definition of the claim phrase “rapid-
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`13
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`release tablet.”
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`(cid:3)(cid:3)
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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`Third, the Petition relies upon what it describes as extrinsic evidence, in the
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`form of literature references and expert declarations, to support its construction.
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`See Pet. at 22-24. Those efforts are unavailing. A party cannot rely upon such
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`evidence to overcome an express definition of a claim term in the specification.
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`Profectus Technology v. Huawei Techs. Co., 823 F.3d 1375, 1379 (Fed. Cir. 2016)
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`(“Legal error arises when a court relies on extrinsic evidence that contradicts the
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`intrinsic record.”); see also Core Wireless Licensing S.A.R.L. v. LG Elecs., Inc.,
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`880 F.3d 1356, 1369 (Fed. Cir. 2018) (“Extrinsic evidence may not be used ‘to
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`contradict claim meaning that is unambiguous in light of the intrinsic evidence.’”
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`(quoting Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005)); Wi-Lan,
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`Inc. v. Apple, Inc., 811 F.3d 455, 462 (Fed. Cir. 2016) (same); Sinorgchem, 511
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`F.3d at 1138 (noting that lexicography ends the claim construction inquiry).
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`Finally, although the Petition relies upon statements that Patent Owner made
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`in European Opposition Proceedings of a foreign counterpart, those arguments fail
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`to support Petitioner’s proposed construction.
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`As an initial matter, the European Opposition proceedings are not relevant to
`
`the present inquiry. The Federal Circuit has explained that “the varying legal and
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`procedural requirements for obtaining patent protection in foreign countries might
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`render consideration of certain types of representations inappropriate for
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`consideration in a claim construction analysis of a United States counterpart.” AIA
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`14
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`(cid:3)(cid:3)
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`

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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`Eng’g Ltd., et al. v. Magotteaux Int’l S/A, et al., 657 F.3d 1264, 1279 (Fed. Cir.
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`2011) (internal quotations omitted) (quoting TI Grp. Auto. Sys. Inc. v. VDO,
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`L.L.C., 375 F.3d 1126, 1136 (Fed. Cir. 2004)). The Petition makes no attempt to
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`explain why or how the European Opposition Proceedings are relevant to the
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`issues raised in the Petition. That alone is sufficient basis to reject Petitioner’s
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`argument.
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`Moreover, the substance of Bayer’s submission to the European Opposition
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`Division does not support the notion that Bayer somehow admitted that “rapid-
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`release tablet” should be construed as Petitioner proposes—to the contrary, it
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`undermines it. In the Opposition Proceedings, the thirteen parties opposing the
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`counterpart of the ’218 patent had proposed conflicting interpretations of the
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`phrase “rapid-release tablet” depending on the particulars of their invalidity
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`arguments. Bayer pointed out these conflicting assertions and stated that in order
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`to simplify matters for the European Patent Opposition Division—for purposes of
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`those proceedings only—it was willing to accept the understanding of “rapid-
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`release tablet” proposed by the majority of the opponents. Ex. 1015 at 28, 32.
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`Patent Owner’s statement—which is not set forth in the Petition—was as follows:
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`To simplify matters for the present proceedings, we will adopt for the
`purpose of the present proceedings the understanding proposed by the
`majority of the opponents that any tablet that is not a sustained- or
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`15
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`(cid:3)(cid:3)
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`

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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
`retarded-release tablet is a “rapid-release tablet” as recited in claim 1
`of the Opposed Patent.
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`Ex. 1015 at 28 (emphasis added); see also id. at 32 (reiterating this same point).
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`The quoted passage reflects that Bayer was attempting to streamline the foreign
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`proceedings by assuming the opponents’ construction for the sake of argument; the
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`notion that Bayer was agreeing to that construction as a matter of abstract principle
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`is contradicted by what Bayer actually said. Accordingly, Bayer’s statements
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`before the European Patent Opposition Division should not affect the claim
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`construction proceedings here. Indeed, Petitioner raised this same argument before
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`the District Court, but the District Court rejected it, stating that it “d[id] not ascribe
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`any weight to Bayer’s statement in the European Opposition Proceedings. The
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`statement appears to have been what Bayer says it is, a position taken to streamline
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`the European litigation. If it came from a domestic proceeding, I would accord it
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`no weight.” Ex. 2002 at 3.
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`In sum, the Board should once again construe “rapid-release tablet” exactly
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`as it is defined in the specification: “a tablet which, according to the USP release
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`method using apparatus 2 (paddle), has a Q value (30 minutes) of 75%.”
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`16
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`(cid:3)(cid:3)
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`

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`Case IPR2018-01143
`Patent No. 9,539,218(cid:3)
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`B.
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`Other Claim Construction Issues
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`The Petition also proposes a construction for the term “treatment,” and then
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`further elaborates on what that construction means. Pet. at 20. For purposes of
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`this preliminary response only, Bayer will not challenge those positions.3
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`IV. ARGUMENT
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`The Board should decline to institute trial under Section 325(d) because both
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`grounds present “the same or substantially