`
`On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG,
`Patent Owners
`
`By: Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`NOVEN PHARMACEUTICALS, INC.,
`and MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`NOVARTIS AG and LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owner.
`___________________
`
`Case No. IPR2014-005491
`U.S. Patent 6,316,023 B1
`
`NOVARTIS AG and LTS LOHMANN THERAPIE SYSTEME AG’s
`NOTICE OF APPEAL UNDER 37 C.F.R. § 90.2(a)
`
`1 Case IPR2015-00265 has been joined with this proceeding.
`
`
`
`Case No. IPR2014-00549
`U.S. Patent 6,316,023 B1
`Notice is hereby given, pursuant to 37 C.F.R. § 90.2(a) and 35 U.S.C. § 142,
`
`that Patent Owners Novartis AG and LTS Lohmann Therapie Systeme AG appeal
`
`to the United States Court of Appeals for the Federal Circuit from the Final
`
`Written Decision of the Patent Trial and Appeal Board (“Board”) in Case
`
`IPR2014-00549 entered on September 28, 2015 (Paper 69) (“Final Written
`
`Decision”) and from the Decision Denying Patent Owner’s Request for Rehearing
`
`entered on November 30, 2015 (Paper 77) (“Rehearing Request Denial”), and from
`
`all underlying orders, decisions, rulings and opinions, including without limitation
`
`the Decision Instituting Inter Partes Review entered on October 14, 2014 (Paper
`
`10) (“Institution Decision”).
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Patent Owners indicate that
`
`the issues on appeal include, but are not limited to: the Board’s failure to observe
`
`procedure required by law, including, but not limited to, 5 U.S.C. §§ 554 and 556,
`
`35 U.S.C. §§ 2, 311, 314 and 316, and 37 C.F.R. §§ 42.1, 42.20, and 42.104; the
`
`Board’s failure to abide by its burden under In re Baxter International, Inc., 678
`
`F.3d 1357, 1365 (Fed. Cir. 2012) to “ideally . . . not arrive at a different
`
`conclusion” from the Federal Circuit’s decision in Novartis Pharmaceuticals Corp.
`
`v. Watson Laboratories, Inc., 611 F. App’x 988 (Fed. Cir. 2015) affirming the
`
`nonobviousness of the U.S. Patent No. 6,316,023 (“’023 patent”); the Board’s
`
`impermissible shifting of the burden to Patent Owners to show patentability in
`
`- 1 -
`
`
`
`Case No. IPR2014-00549
`U.S. Patent 6,316,023 B1
`violation of 35 U.S.C. § 316(e), 5 U.S.C. § 556(d), and 37 C.F.R. § 42.20(c); the
`
`Board’s failure to consider only prior art consisting of patents or printed
`
`publications in contravention of 35 U.S.C. § 311; the Board’s determination that
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`the challenged claims of the ’023 patent are unpatentable under 35 U.S.C. § 103,
`
`which is factually incorrect, not supported by law or substantial evidence, is not
`
`based on consideration of the complete record, was not the result of a logical and
`
`rational process, and is incorrect as a matter of law; and any finding or
`
`determination supporting or related to these issues, as well as all other issues
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`decided adversely to Patent Owners in any orders, decisions, rulings and opinions,
`
`all of which, taken together or independently, caused prejudicial harm to Patent
`
`Owners.
`
`Simultaneous with this submission to the Director of the United States
`
`Patent and Trademark Office, a copy of this Notice of Appeal is being filed
`
`electronically with the Patent Trial and Appeal Board. In addition, a copy of this
`
`Notice of Appeal is being filed with the Clerk’s Office for the United States Court
`
`of Appeals for the Federal Circuit, along with the required docketing fee.
`
`Respectfully submitted,
`
`Patent Owners: Novartis AG and
`Lohmann Therapie-Systeme AG
`
`Dated: January 29, 2016
`
`/Raymond R. Mandra/
`
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`
`
`
`Case No. IPR2014-00549
`U.S. Patent 6,316,023 B1
`Raymond R. Mandra
`Registration No. 34,382
`Lead Counsel for Patent Owners
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, New York 10104-3800
`Tel. (212) 218-2235
`Fax. (212) 218-2200
`Email: rmandra@fchs.com
`ExelonPatchIPR@fchs.com
`
`- 3 -
`
`
`
`CERTIFICATE OF FILING
`
`Case No. IPR2014-00549
`U.S. Patent 6,316,023 B1
`
`I certify that the foregoing NOVARTIS AG and LTS LOHMANN
`
`THERAPIE SYSTEME AG’s NOTICE OF APPEAL UNDER 37 C.F.R. § 90.2(a)
`
`was filed electronically through the Board’s PRPS System, and the original version
`
`was served by priority mail express (Mail Label: EK 476560805 US) on this 29th
`
`day of January, 2016, with the Director of the United States Patent and Trademark
`
`Office, at the following address:
`
`United States Patent and Trademark Office
`c/o Office of the General Counsel
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`CERTIFICATE OF FILING
`
`I certify that a true and correct copy of the foregoing NOVARTIS AG and
`
`LTS LOHMANN THERAPIE SYSTEME AG’s NOTICE OF APPEAL UNDER
`
`37 C.F.R. § 90.2(a) was filed electronically through the CM/ECF System on this
`
`29th day of January, 2016, with the Clerk’s Office of the United States Court of
`
`Appeals for the Federal Circuit, at the following address:
`
`United States Court of Appeals for the Federal Circuit
`717 Madison Place NW, Suite 401
`Washington, DC 20005
`
`- 1 -
`
`
`
`Case No. IPR2014-00549
`U.S. Patent 6,316,023 B1
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing NOVARTIS AG and LTS LOHMANN
`
`THERAPIE SYSTEME AG’s NOTICE OF APPEAL UNDER 37 C.F.R. § 90.2(a)
`
`was served on 29th day of January, 2016, by causing it to be sent by email to
`
`counsel for Petitioners at the following email addresses:
`
`Steven J. Lee (slee@kenyon.com)
`
`Michael K. Levy (mlevy@kenyon.com)
`
`Chris Coulson (ccoulson@kenyon.com)
`
`Steven W. Parmelee (sparmelee@wsgr.com)
`
`Michael T. Rosato (mrosato@wsgr.com)
`
`Dated: January 29, 2016
`
`/Raymond R. Mandra/
`Raymond R. Mandra
`Registration No. 34,382
`Lead Counsel for Patent Owners
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, New York 10104-3800
`Tel. (212) 218-2235
`Fax. (212) 218-2200
`Email: rmandra@fchs.com
`ExelonPatchIPR@fchs.com
`
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