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`Filed On Behalf Of:
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`Novartis AG and LTS Lohmann Therapie-Systeme AG
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`By:
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`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`
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`Paper No. ____
`Date Filed: February 18, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`
`
`Inter Partes Review No. 2015-00268
`
`
`U.S. Patent 6,335,031
`
`
`PRELIMINARY RESPONSE BY
`PATENT OWNERS PURSUANT TO 37 C.F.R. § 42.107
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`TABLE OF CONTENTS
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`The Board Should Deny Institution Of Grounds 1 And 2
`Because Mylan Does Not Seek Institution Of Those Grounds ....................... 1
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`The Board Should Deny Institution Of Ground 1
`Because Elmalem Does Not Anticipate Claim 15 ........................................... 2
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`I.
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`II.
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`i
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`Cases
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`TABLE OF AUTHORITIES
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`In re Roth, No. 92-2941,
` 1993 WL 13725366 (B.P.A.I. Mar. 16, 1993) ............................................... 3
`
`In re Williams,
` 171 F.2d 319 (C.C.P.A. 1948) ........................................................................ 3
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
` 267 F. Supp. 2d 533 (N.D. W. Va. 2003) ....................................................... 3
`
`Power Mosfet Techs., L.L.C. v. Siemens AG,
` 378 F.3d 1396 (Fed. Cir. 2004) ...................................................................... 4
`
`Sanofi-Synthelabo v. Apotex, Inc.,
` 550 F.3d 1075 (Fed. Cir 2008) ....................................................................... 3
`
`Spectrum Int’l, Inc. v. Sterlite Corp.,
` 164 F.3d 1372 (Fed. Cir. 1998) ...................................................................... 4
`
`Teva Neuroscience, Inc. v. Watson Labs., Inc., No. 10-cv-5078,
` 2013 WL 1595585 (D.N.J. Apr. 12, 2013) ..................................................... 4
`
`Texas Instruments Inc. v. U.S. Int’l Trade Comm’n,
` 988 F.2d 1165 (Fed. Cir 1993) ....................................................................... 4
`
`Statutes
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`35 U.S.C. 315(c) ........................................................................................................ 2
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`
`
`
`ii
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`Patent Owners Novartis AG and LTS Lohmann Therapie-Systeme AG
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`respectfully submit this Preliminary Response to the Petition of Mylan
`
`Pharmaceuticals Inc. seeking inter partes review of U.S. Patent No.
`
`6,335,031 (“’031 patent”).
`
`I.
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`
`
`The Board Should Deny Institution Of Grounds 1 And 2
`Because Mylan Does Not Seek Institution Of Those Grounds
`
`Mylan’s IPR petition asserts the following five grounds, which are
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`identical to the five grounds asserted by Noven Pharmaceuticals Inc. in the
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`petition for IPR2014-00550 (“Noven IPR”):
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`1. Claim 15 is anticipated by Elmalem;
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`2. Claims 16 and 18 are obvious over Elmalem and the Handbook;
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`3. Claims 1, 2, 7, 15 and 18 are obvious over Enz and the
`Handbook, optionally in view of Rosin and/or Elmalem and/or
`Ebert;
`
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`4. Claims 3 and 16 are obvious over Enz and the Handbook and/or
`Rosin and/or Ebert; and
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`5. Claims 1, 2, 3, 7, 15, 16 and 18 are obvious over Enz and
`Sasaki.
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`On October 14, 2014, the Board in the Noven IPR instituted grounds
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`
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`3-5 (IPR2014-00550, Paper 10 at 10-26), but denied grounds 1 and 2 in view
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`of the fact that grounds 3-5 provided sufficient alternatives for the petitioner
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`to challenge the patentability of claims 15, 16 and 18. (Id. at 26-27.)
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`1
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`On November 13, 2014, Mylan moved under 35 U.S.C. 315(c) (Paper
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`3) to join this IPR with the Noven IPR. Mylan in its joinder motion admits
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`that its IPR petition is identical to the Noven IPR petition. (Paper 3 at 1, 6).
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`Mylan also admits that “[a]lthough Mylan has submitted a verbatim copy of
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`the Noven petition, including the grounds not instituted by the Board [i.e.,
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`grounds 1 and 2], Mylan seeks institution only as to the three grounds of
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`invalidity already instituted by the Board in the Noven IPR [i.e., grounds 3-
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`5].” (Id. at 6, emphasis added; see also Paper 12 at 5.)
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`
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`In view of (i) Mylan’s express representation that it does not seek
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`institution of grounds 1 and 2, (ii) the Board’s mandate to ensure the
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`efficient resolution of these IPR proceedings, and (iii) the Board’s previous
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`October 14, 2014 decision in the Noven IPR denying grounds 1 and 2,
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`Patent Owners respectfully request that the Board deny grounds 1 and 2 in
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`this IPR.
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`II. The Board Should Deny Institution Of Ground 1
`Because Elmalem Does Not Anticipate Claim 15
`
`
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`Independent of Mylan’s express representation that it does not seek
`
`institution of ground 1, Patent Owners respectfully request that the Board
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`deny ground 1 because Elmalem does not anticipate claim 15.
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`2
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`First, whereas Elmalem discloses only the racemate RA7 (N-ethyl, N-
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`methyl-3-[1-(dimethylamino)ethyl] phenyl carbamate HCl) (Ex. 1009 at 2),
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`claim 15 expressly recites the (S)-enantiomer Compound A ((S)-N-ethyl-3-
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`{(1-dimethylamino)ethyl}-N-methyl-phenyl-carbamate in free base or acid
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`addition salt form) (Ex. 1001, col. 9). A prior art reference that discloses a
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`racemate does not disclose, and thus does not anticipate, a claim directed to
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`an enantiomer of that racemate. E.g., In re Williams, 171 F.2d 319, 320
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`(C.C.P.A. 1948); Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1084
`
`(Fed. Cir 2008); see also In re Roth, No. 92-2941, 1993 WL 13725366, at *2
`
`(B.P.A.I. Mar. 16, 1993) (prior art reference disclosing racemate containing
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`R-trans and S-trans enantiomers in admixture did not anticipate claims to R-
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`trans enantiomer). Likewise, a claim directed expressly to a specific
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`enantiomer cannot be construed to encompass a racemate, regardless of
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`whether the claim also recites an optical purity limitation. E.g., Ortho-
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`McNeil Pharm., Inc. v. Mylan Labs., Inc., 267 F. Supp. 2d 533, 542-43
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`(N.D. W. Va. 2003) (denying defendant’s summary judgment motion that
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`patent claim reciting (S)-enantiomer was anticipated by prior art racemate,
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`despite lack of optical purity claim limitation); Teva Neuroscience, Inc. v.
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`Watson Labs., Inc., No. 10-cv-5078, 2013 WL 1595585, at *5-6 (D.N.J.
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`3
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`Apr. 12, 2013) (rejecting proposed construction of claim expressly requiring
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`“R(+)” enantiomer to cover compound resembling racemic mixture).1
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`Because Elmalem’s disclosure of the racemate RA7 does not constitute a
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`disclosure of the (S)-enantiomer Compound A, and because claim 15 does
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`not encompass the racemate RA7, Elmalem does not anticipate claim 15.
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`1 Further, contrary to Mylan’s suggestion (Paper 1 at 10), the claim transition
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`“comprising” cannot be used to read out an express limitation of the claim,
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`such as “(S)-” in claim 15. E.g., Spectrum Int’l, Inc. v. Sterlite Corp., 164
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`F.3d 1372, 1379-80 (Fed. Cir. 1998) (rejecting argument that “comprising”
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`permits addition of elements from the prior art to the elements set forth in
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`the claim that would abrogate claim limitations); Power Mosfet Techs.,
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`L.L.C. v. Siemens AG, 378 F.3d 1396, 1409 (Fed. Cir. 2004) (“‘Comprising,’
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`while permitting additional elements not required by a claim, does not
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`remove the limitations that are present.”). See also Texas Instruments Inc. v.
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`U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1171 (Fed. Cir 1993) (rejecting
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`construction that would “read an express limitation out of the claims”).
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`4
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`Second, Mylan’s proposed construction of the term “amount of anti-
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`oxidant effective to stabilize Compound A from degradation” in claim 15
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`requires an amount of antioxidant that reduces the oxidative degradation of
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`Compound A. Elmalem, however, does not disclose that RA7 or Compound
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`A undergoes any degree of oxidative degradation, or that any amount of
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`antioxidant reduced such oxidative degradation. The purpose of the study in
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`Elmalem was not to assess oxidative degradation of RA7, but rather to assess
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`the ability of RA7 and other drugs to antagonize the respiratory depressant
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`effect of morphine in rabbits. (Ex. 1009 at 1.)
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`
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`For these additional reasons, Patent Owners respectfully request that
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`the Board deny ground 1.
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`
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`Last, although Patent Owners at this time do not address the substance
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`of grounds 2-5, it is Patent Owners’ position (as it was in the Noven IPR)
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`that grounds 2-5 do not meet the threshold requirement necessary to institute
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`IPR.
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`5
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`Dated: February 18, 2015
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`Respectfully submitted,
`
`/Raymond R. Mandra/
`Raymond R. Mandra
`Registration No. 34,382
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA,
`HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
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`6
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`CERTIFICATE OF SERVICE
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`I certify that a copy of the foregoing Preliminary Response By Patent
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`Owners Pursuant To 37 C.F.R. § 42.107 was served on February 18, 2015
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`by causing it to be sent by email to counsel for Petitioner at the following
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`email addresses:
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`BoxMylan2@knobbe.com
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`Dated: February 18, 2015
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`/Raymond R. Mandra/
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA,
`HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`7
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`
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