Paper No. _______
`Date Filed: December 20, 2016
`
`
`Filed On Behalf Of:
`Novartis AG
`
`
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`PAR PHARMACEUTICAL, INC.,
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`AND ROXANE LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`
`
`
`
`Case IPR2016-000841
`Patent No. 5,665,772
`
`
`
`PATENT OWNER’S REQUEST FOR ORAL
`ARGUMENT PURSUANT TO 37 C.F.R. § 42.70(a)
`
`
`
`
` 1
`
` Breckenridge Pharmaceutical, Inc. was joined as a party to this proceeding via a
`Motion for Joinder in IPR2016-01023; Roxane Laboratories, Inc. was joined as a
`party via a Motion for Joinder in IPR2016-01102.
`
`
`
`
`
`
`Date Filed: December 20, 2016
`
`
`Filed On Behalf Of:
`Novartis AG
`
`
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`PAR PHARMACEUTICAL, INC.,
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`AND ROXANE LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`
`
`
`
`Case IPR2016-000841
`Patent No. 5,665,772
`
`
`
`PATENT OWNER’S REQUEST FOR ORAL
`ARGUMENT PURSUANT TO 37 C.F.R. § 42.70(a)
`
`
`
`
` 1
`
` Breckenridge Pharmaceutical, Inc. was joined as a party to this proceeding via a
`Motion for Joinder in IPR2016-01023; Roxane Laboratories, Inc. was joined as a
`party via a Motion for Joinder in IPR2016-01102.
`
`
`
`
`
`
`
`
`
`Pursuant to the April 29, 2016 Scheduling Order (Paper 9) in this
`
`proceeding, as modified by the Order dated December 2, 2016 (Paper 45), and 37
`
`C.F.R. § 42.70(a), Patent Owner Novartis AG requests that the Patent Trial and
`
`Appeal Board hear oral argument on the issues below. As set forth in the
`
`December 2, 2016 Order, and the Board’s email of the same date, oral argument is
`
`scheduled for February 2, 2017, and the Board has confirmed the availability of
`
`Hearing Room A on the morning of February 2, 2017.
`
`Patent Owner respectfully requests 60 minutes of argument time.
`
`Pursuant to 37 C.F.R. § 42.70(a), Patent Owner specifies the following
`
`issues to be argued, without intent to waive consideration of any issue not
`
`requested:
`
`(1) Petitioners’ failure to meet their burden of establishing obviousness of
`
`challenged claims 1-3 and 8-10 under either of the instituted Grounds, particularly
`
`where:
`
`(a) Neither Lemke nor Yalkowsky, alone or in combination, provides a
`
`motivation to replace rapamycin’s C40 hydroxyl (-OH) group with a
`
`different hydroxyl-containing group that additionally has an ether oxygen
`
`and two methylenes (-OCH2CH2OH), with a reasonable expectation that the
`
`modification will increase water solubility, because, inter alia:
`
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`
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`1
`
`
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`
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`(i) Lemke teaches that the addition of an ether oxygen (-O-) and two
`
`methylene groups (-CH2CH2-), i.e., the groups present in everolimus
`
`but not rapamycin, will have a net zero impact on water solubility;
`
`(ii) Petitioners’ declarant Dr. Jorgensen admitted that Yalkowsky is
`
`not analogous art;
`
`(iii) Yalkowsky’s teachings about the ideal solubility of long-chain
`
`derivatives of rigid molecules of intermediate size are not applicable
`
`to the non-ideal solubility of rapamycin or everolimus in water; and
`
`(iv) Yalkowsky’s entropy teachings (i.e., adding long flexible side
`
`chains increases the change in entropy, which may increase ideal
`
`solubility) cannot predict solubility in non-ideal solutions, as
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`solubility in non-ideal solutions requires consideration of how a given
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`modification impacts both entropy and enthalpy.
`
`(b) A POSA seeking to increase rapamycin’s water solubility while
`
`maintaining immunosuppressive activity would have pursued approaches
`
`likely to meaningfully impact water solubility, such as formulation,
`
`prodrugs, and water-soluble salts—not chemical synthesis of everolimus.
`
`(c) The prior art contradicts Petitioners’ unsupported suggestion that a
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`POSA would consider only three specific compounds with “small” groups.
`
`2
`
`
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`
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`(d) Petitioners failed to apply the proper legal analysis and consider the art
`
`as a whole prior to selecting a lead compound.
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`(e) The prior art fails to establish that rapamycin’s water solubility for
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`immunosuppressive use was a known problem that a POSA would have tried
`
`to solve.
`
`(f) The prior art fails to establish that a POSA would have reasonably
`
`expected everolimus to have increased water solubility, similar
`
`immunosuppressive activity as rapamycin, and/or its unique combination of
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`immunosuppressive and anti-tumor properties.
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`(g) Compelling objective indicia of non-obviousness concerning both
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`everolimus’s immunosuppressive and anti-tumor properties further support a
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`finding of non-obviousness.
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`(h) Concerning Ground 2, Hughes fails to provide a reasonable expectation
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`that everolimus’s methods of treatment would have been obvious.
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`(2) Petitioners’ reliance on evidence that fails to comply with the Federal
`
`Rules of Evidence and/or 37 C.F.R. § 42, as set forth in Patent Owner’s Motion to
`
`Exclude.
`
`(3) Petitioners’ improper attempts to raise new arguments and cite new
`
`evidence in their Reply (Paper 46) and accompanying declarations (Exhibits 1118
`
`and 1119), that should have been included in the Petition.
`
`
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`
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`3
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`
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`(4) Petitioners’ mischaracterization in their Reply (Paper 46) of many of the
`
`arguments set forth in Patent Owner’s Response (Paper 27).
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`(5) Any other issues raised by Petitioners in a request for oral argument,
`
`motion to exclude, or any other paper filed by Petitioners before oral argument.
`
`(6) Any other issues that the Board deems necessary.
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`Patent Owner requests the ability to use audio-visual equipment to display
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`demonstrative exhibits, including the use of a projector and screen for PowerPoint
`
`display.
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`
`
`Dated: December 20, 2016
`
`
`
`
`
`
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`
`
`
`
`4
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`
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`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing PATENT OWNER’S REQUEST FOR
`
`ORAL ARGUMENT PURSUANT TO 37 C.F.R. § 42.70(a) was served on
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`December 20, 2016 by causing it to be sent by email to counsel for Petitioners at
`
`the following email addresses:
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`
`Daniel G. Brown (dan.brown@lw.com)
`
`Robert Steinberg (bob.steinberg@lw.com)
`
`Brenda L. Danek (Brenda.danek@lw.com)
`
`
`
`Jonathan M. Strang (jonathan.strang@lw.com)
`
`Matthew L. Fedowitz (mfedowitz@merchantgould.com)
`
`B. Jefferson Boggs (jboggs@merchantgould.com)
`
`Daniel R. Evans (devans@merchantgould.com)
`
`Keith A. Zullow (kzullow@goodwinlaw.com)
`
`Marta Delsignore (mdelsignore@goodwinprocter.com)
`
`
`
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`Dated: December 20, 2016
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`1
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`
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`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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