Paper No. ___
`Date Filed: October 28, 2015
`
`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. IPR2014-005501
`U.S. Patent 6,335,031 B1
`
`NOVARTIS AG and LTS LOHMANN THERAPIE SYSTEME AG’s
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d)
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`
`Date Filed: October 28, 2015
`
`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. IPR2014-005501
`U.S. Patent 6,335,031 B1
`
`NOVARTIS AG and LTS LOHMANN THERAPIE SYSTEME AG’s
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d)
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .................................................................................... ii
`
`I.
`
`II.
`
`INTRODUCTION ...........................................................................................1
`
`STATEMENT OF PRECISE RELIEF REQUESTED ...................................1
`
`III.
`
`THE RELIEF REQUESTED SHOULD BE GRANTED...............................2
`
`A.
`
`Petitioner Failed To Meet Its Burden Of Proof That
`Claims 1-3, 7, 15-16 And 18 Of The ’031 Patent Are
`Unpatentable Over Enz, The Handbook, Rosin, Ebert
`and/or Elmalem .....................................................................................2
`
`1.
`
`2.
`
`3.
`
`The Board Misapprehended Or Overlooked The
`Federal Circuit’s Recognition That Elmalem Did
`Not Teach That Rivastigmine Is “Susceptible” To
`Oxidative Degradation................................................................4
`
`The Board Misapprehended Or Overlooked
`Evidence That Neither Elmalem Nor Knowledge
`In The Art Teaches That Rivastigmine Is
`“Susceptible” To Oxidative Degradation ...................................7
`
`The Board Misapprehended Or Overlooked The
`Federal Circuit’s Recognition, As Well As
`Evidence, That A Person Of Ordinary Skill Would
`Not Have Added An Antioxidant To A
`Rivastigmine Transdermal Device Unless One
`Was Needed ................................................................................9
`
`B.
`
`Petitioner Failed To Meet Its Burden Of Proof That
`Claims 1-3, 7, 15-16 And 18 Of The ’031 Patent Are
`Unpatentable Over Enz and Sasaki.....................................................13
`
`IV. CONCLUSION..............................................................................................15
`
`- i -
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Celsis In Vitro, Inc. v. CellzDirect, Inc.,
`664 F.3d 922 (Fed. Cir. 2012) .........................................................................6
`
`In re Baxter International, Inc.,
`678 F.3d 1357 (Fed. Cir. 2012) .......................................................... 1, 2, 3, 9
`
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) .....................................................................15
`
`Novartis Pharmaceuticals Corp. v. Watson Laboratories, Inc.,
`611 F. App’x 988 (Fed. Cir. 2015)....................... 1, 2, 3, 4, 5, 6, 9, 11, 12, 14
`
`Novartis Pharms. Corp. v. Noven Pharms., Inc.,
`C.A. No. 13-527, slip op. (D. Del. Aug. 31, 2015) .............................. 5, 6, 10
`
`Novartis Pharms. Corp. v. Par Pharm., Inc.,
`48 F. Supp. 3d 733 (D. Del. 2014) ................................................... 4, 6, 9, 12
`
`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`135 S. Ct. 831(2015)........................................................................................6
`
`Rules
`
`37 C.F.R. § 42.71(d) ..................................................................................................1
`
`- ii -
`
`
`
`I.
`
`INTRODUCTION
`
`Patent Owner respectfully requests rehearing under 37 C.F.R. § 42.71(d) of
`
`the Patent Trial and Appeal Board’s September 28, 2015 Final Written Decision
`
`(Paper 69) (“Final Decision”) as to claims 1-3, 7, 15-16 and 18 of U.S. Patent No.
`
`6,335,031 B1 (“the ’031 patent”). The Board found those claims unpatentable as
`
`obvious over Enz, The Handbook, Rosin, Ebert and/or Elmalem or alternatively,
`
`over Enz and Sasaki.2 Patent Owner respectfully requests that the Board revisit
`
`Patent Owner’s arguments that were misapprehended or overlooked, and conclude
`
`that the ’031 patent claims at issue would not have been obvious. In particular, the
`
`Board overlooked 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) (“Watson”) affirming the
`
`nonobviousness of the ’031 patent.
`
`II.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Patent Owner respectfully requests that the Board reconsider its Final
`
`Decision and hold that Petitioner has failed to establish by a preponderance of the
`
`2 Patent Owner’s Request for Rehearing uses the same abbreviations and
`
`shorthand references used in the Final Decision (Paper 69).
`
`- 1 -
`
`
`
`evidence that claims 1-3, 7, 15-16 and 18 of the ’031 patent are unpatentable.
`
`III. THE RELIEF REQUESTED SHOULD BE GRANTED
`
`A.
`
`Petitioner Failed To Meet Its Burden Of Proof That Claims
`1-3, 7, 15-16 And 18 Of The ’031 Patent Are Unpatentable
`Over Enz, The Handbook, Rosin, Ebert and/or Elmalem
`
`The Board held the ’031 patent claims at issue obvious over Enz, the
`
`Handbook, Rosin, Ebert and/or Elmalem. Specifically, the Board found that either
`
`Elmalem or knowledge in the art taught that rivastigmine was “susceptible” to
`
`oxidative degradation and that this alleged “susceptibility” would have motivated a
`
`person of ordinary skill in the art to combine rivastigmine with an antioxidant in a
`
`transdermal device. (Paper 69 at 28-38.)
`
`While the Board is correct that Petitioner presented additional prior art that
`
`was not before the federal courts in Watson (id. at 4), the Board incorrectly
`
`overlooked the Federal Circuit’s Watson decision affirming the nonobviousness of
`
`the ’031 patent with respect to the prior art and arguments that were before the
`
`Watson Court. See Baxter, 678 F.3d at 1365 (“[E]ven with the more lenient
`
`standard of proof” that applies in reexamination, “the PTO ideally should not
`
`arrive at a different conclusion” than a district court finding of nonobviousness
`
`- 2 -
`
`
`
`affirmed on appeal, and based on “the same presentation and arguments.”).3
`
`(Paper 62 at 1; Paper 67 at 38:1-8, 39:8-40:3.)
`
`In particular, the Board ignored the Federal Circuit’s holding in Watson that
`
`Elmalem does not disclose that oxidative degradation was a known problem with
`
`rivastigmine. 611 F. App’x at 996-97. And the Board overlooked Patent Owner’s
`
`evidence in this inter partes review demonstrating that neither Elmalem nor the art
`
`taught that rivastigmine was “susceptible” to oxidative degradation. (Paper 25 at
`
`13-20, 28-36; Paper 44 at 1-10.) The Board also ignored the Federal Circuit’s
`
`holding in Watson, as well as undisputed evidence in the instant proceeding, that a
`
`person of ordinary skill in the art would not have been motivated to add an
`
`3 In Baxter, there was evidence adduced in reexamination that was not before the
`
`Baxter district court, whose nonobviousness decision was affirmed on appeal. The
`
`Federal Circuit in Baxter nonetheless explained that PTO and federal court
`
`outcomes based on the same evidence “ideally” should be the same, “[l]est it be
`
`feared we are erroneously elevating a decision by the PTO over a decision by a
`
`federal district court, which decision has been affirmed by this court.” 678 F.3d at
`
`1365. In the instant rehearing request, Patent Owner challenges only Board
`
`findings that contradict the Federal Circuit’s conclusions in Watson concerning
`
`prior art or arguments that were fully considered by that court.
`
`- 3 -
`
`
`
`antioxidant to rivastigmine in a transdermal device absent evidence of oxidative
`
`degradation. 611 F. App’x at 996. (Paper 25 at 3, 10-12; Paper 31 at 15.)
`
`1.
`
`The Board Misapprehended Or Overlooked The Federal
`Circuit’s Recognition That Elmalem Did Not Teach That
`Rivastigmine Is “Susceptible” To Oxidative Degradation
`
`The Board incorrectly found “no persuasive reason why a person of ordinary
`
`skill in the art would not understand Elmalem’s disclosure of including an
`
`antioxidant in each drug sample, including the RA7 sample, ‘to prevent oxidation’
`
`to mean anything other than just that.” (Paper 69 at 35.) This finding contradicts,
`
`and thus overlooks, the Federal Circuit’s Watson decision concerning Elmalem.
`
`(Paper 62 at 1; Paper 67 at 38:1-8; see also Paper 25 at 28-36.)
`
`In Watson, the District Court agreed with Patent Owner that a person of
`
`ordinary skill in the art would understand that Elmalem “reports the findings of a
`
`well-controlled experiment, i.e., one in which any variability that can be eliminated
`
`is eliminated.” Novartis Pharms. Corp. v. Par Pharm., Inc., 48 F. Supp. 3d 733,
`
`756-57 (D. Del. 2014) (“Watson”). (See also Paper 25 at 32-34.) The District
`
`Court in Watson further found that “[w]hen read in this context, the statement, ‘All
`
`drugs were made up freshly in sterile saline, which included an equal weight of
`
`sodium metabisulphite, to prevent oxidation,’ is better understood as a measure to
`
`reduce the variability than a teaching that RA7 is subject to oxidative degradation.”
`
`48 F. Supp. at 756-57. (See also Paper 25 at 32-34.)
`
`- 4 -
`
`
`
`The Federal Circuit agreed with the District Court, holding that “the
`
`experimental procedure in the Elmalem article could reasonably be understood to
`
`add an antioxidant to the other test formulations for the purpose of negating an
`
`additional variable in the experiment.” Watson, 611 F. App’x at 996-97. (See also
`
`Paper 25 at 32-34.) For this reason, the Federal Circuit in Watson affirmed the
`
`District Court’s finding that “the Elmalem article does not disclose that oxidative
`
`degradation was a known problem with rivastigmine.” Id. at 997 (emphasis
`
`added). (See also Paper 25 at 32-34.) And the Federal Circuit rejected the
`
`argument that “the Elmalem article expressly provides [a] motivation [to combine
`
`rivastigmine with an antioxidant] by teaching that oxidative degradation was a
`
`known problem for rivastigmine.” Id. at 995. (See also Paper 25 at 35.)
`
`Consistent with the Federal Circuit’s holding, the District Court in the Noven
`
`case which proceeded parallel to this proceeding held that a person of ordinary
`
`skill would have understood that the Elmalem antioxidant was added to
`
`physostigmine to prevent oxidation of a hydrolytic degradant and was added to the
`
`other drugs as a control to keep the number of variables constant. Novartis
`
`Pharms. Corp. v. Noven Pharms., Inc., C.A. No. 13-527, slip op. at 14-15 (D. Del.
`
`Aug. 31, 2015) (“Noven”). (Paper 68 at 1; see also Paper 25 at 32-34.) Thus, a
`
`person of ordinary skill would not have understood that an antioxidant was added
`
`to each drug in Elmalem to prevent it from oxidizing. Id. (Paper 25 at 32-34.)
`
`- 5 -
`
`
`
`Moreover, in the Watson case, the District Court found Dr. Klibanov’s
`
`explanation of how a person of ordinary skill in the art would understand Elmalem
`
`to be credible and to better comport with the District Court’s understanding. 48 F.
`
`Supp. 3d at 757. The Federal Circuit found no clear error in these findings.
`
`Watson, 611 F. App’x at 996-97. Likewise, in the Noven case, the District Court,
`
`having heard both the direct testimony and cross-examination of Drs. Klibanov and
`
`Kydonieus—the same two experts who offered the same opinions on Elmalem in
`
`the instant proceeding—found “Dr. Klibanov’s testimony regarding Elmalem to be
`
`more credible than that of [Petitioner’s] expert,” Dr. Kydonieus. Noven, slip op. at
`
`15. (See also Paper 25 at 30 n.6, 33-34; Paper 42 at 8-11.)
`
`In contrast to the District Court and Federal Circuit, however, the Board did
`
`not find Dr. Klibanov’s explanation persuasive. (Paper 69 at 34. Contra Paper 25
`
`at 30 n.6, 33-34; Paper 42 at 8-11.) The Board thus overlooked that district court
`
`expert credibility determinations should be accorded great deference “because the
`
`court saw the witnesses and heard their testimony.” See Celsis In Vitro, Inc. v.
`
`CellzDirect, Inc., 664 F.3d 922, 929 (Fed. Cir. 2012) (quoting Federal Circuit
`
`precedent); see also Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 838-
`
`39 (2015) (recognizing that “practical considerations” favoring deferential review
`
`of district court fact findings include that district court judges have “listened to”
`
`the proceedings and can “question[ ] the experts”).
`
`- 6 -
`
`
`
`In sum, the Board erred in overlooking the Federal Circuit’s holding in
`
`Watson that Elmalem would not have taught a person of ordinary skill in the art
`
`that rivastigmine is oxidatively unstable or required an antioxidant. Because a
`
`person of ordinary skill would not have been motivated to add an antioxidant to try
`
`to solve an unknown stability problem, it should have followed that claims 1-3, 7,
`
`15-16 and 18 of the ’031 patent are nonobvious over Enz, the Handbook, Rosin,
`
`Ebert and/or Elmalem. (Paper 25 at 3, 10-12; Ex. 2012 ¶¶ 38-45, 56.)
`
`2.
`
`The Board Misapprehended Or Overlooked Evidence That
`Neither Elmalem Nor Knowledge In The Art Teaches That
`Rivastigmine Is “Susceptible” To Oxidative Degradation
`
`In reaching its conclusion on Elmalem, the Board further overlooked Patent
`
`Owner’s evidence in the instant inter partes review that the Elmalem authors did
`
`not believe or reasonably expect rivastigmine to be oxidatively unstable or require
`
`an antioxidant. (Paper 25 at 36; Paper 42 at 1; Paper 67 at 64:22-65:18; Ex. 2012
`
`¶ 74.) As Patent Owner explained, Elmalem is contemporaneous with Enz 1991
`
`and post-dated by Weinstock 1994, a paper written by two of the Elmalem authors.
`
`(Paper 25 at 36; Ex. 2012 ¶ 74.) Neither Enz 1991 nor Weinstock 1994 report
`
`adding an antioxidant to rivastigmine or teach that rivastigmine requires an
`
`antioxidant in any pharmaceutical formulation. (Paper 25 at 36; Ex. 2012 ¶¶ 47,
`
`74; Ex. 2026; Ex. 2027.) That the Elmalem authors did not add an antioxidant to
`
`rivastigmine in their later Weinstock 1994 paper demonstrates that they did not
`
`- 7 -
`
`
`
`believe or reasonably expect rivastigmine to be oxidatively unstable or require an
`
`antioxidant. (Paper 25 at 36; Paper 42 at 1; Paper 67 at 64:22-65:18; Ex. 2012
`
`¶ 74.) Significantly, Petitioner never challenged or even addressed this argument
`
`in the instant inter partes review. And the Board incorrectly overlooked it.
`
`Furthermore, in reaching its conclusion on the knowledge in the art, the
`
`Board overlooked Patent Owner’s evidence of multiple compounds with the same
`
`structural features as rivastigmine that were not reported in the prior art to be
`
`oxidatively unstable or to contain an antioxidant in their commercial formulations.
`
`(Paper 25 at 18; Paper 44 at 14; Ex. 2012 ¶¶ 133-137.) In contrast, Petitioner
`
`produced only a single example of a compound with (at best) similar structural
`
`features as rivastigmine, i.e., nicotine. (Paper 44 at 6; Paper 67 at 52:6-11.) The
`
`Board offered no reason why a person of ordinary skill in the art would ignore
`
`Patent Owner’s multiple exemplary compounds and focus exclusively on nicotine,
`
`and the Board did not even mention Patent Owner’s compounds in its Final
`
`Decision.
`
`In sum, the Board incorrectly overlooked Patent Owner’s evidence that
`
`neither Elmalem nor knowledge in the art teaches that rivastigmine is “susceptible”
`
`to oxidative degradation. And, because a person of ordinary skill in the art would
`
`not have been motivated to add an antioxidant to try to solve an unknown stability
`
`problem, it should have followed that claims 1-3, 7, 15-16 and 18 of the ’031
`
`- 8 -
`
`
`
`patent are nonobvious over Enz, the Handbook, Rosin, Ebert and/or Elmalem.
`
`(Paper 25 at 3, 10-12, 19-20; Ex. 2012 ¶¶ 38-45, 56.)
`
`3.
`
`The Board Misapprehended Or Overlooked The
`Federal Circuit’s Recognition, As Well As Evidence,
`That A Person Of Ordinary Skill Would Not Have
`Added An Antioxidant To A Rivastigmine
`Transdermal Device Unless One Was Needed
`
`The Board held that “a person of ordinary skill in the art would have
`
`predicted that the transdermal formulation disclosed by Enz is susceptible to
`
`oxidative degradation and would have been motivated to add an antioxidant.”
`
`(Paper 69 at 38 (emphasis added).) Again, this finding contradicts, and thus
`
`overlooks, the Federal Circuit’s decision in Watson. Baxter, 678 F.3d at 1365.
`
`(Paper 67 at 39:8-40:3.)
`
`In Watson, the District Court found that a person of ordinary skill in the art
`
`“would not have been motivated to include an antioxidant in any formulation
`
`unless there was evidence of oxidative degradation.” 48 F. Supp. 3d at 754
`
`(emphasis added). The Federal Court agreed. Watson, 611 F. App’x at 996
`
`(finding no clear error in the District Court’s finding that “one of skill in the art
`
`would not have been motivated to risk incompatibility by including an antioxidant
`
`in a formulation without evidence of its necessity” (emphasis added)). (Paper 67 at
`
`39:8-40:3.) The Federal Circuit thus held that “susceptibility” to oxidative
`
`degradation would not have motivated a person of ordinary skill in the art to add an
`
`- 9 -
`
`
`
`antioxidant to the transdermal formulation in Enz. (Id.) Rather, a person of
`
`ordinary skill would have added an antioxidant only if one was needed, that is, if
`
`there was evidence of oxidative degradation in the pharmaceutical composition.
`
`(Paper 25 at 10-12.) The District Court in Noven likewise recognized that a person
`
`of ordinary skill would only be motivated to use an antioxidant in a pharmaceutical
`
`composition if one was required. Slip op. at 16 (“[Rosin] does not suggest that
`
`RA7 requires an antioxidant or that it undergoes oxidative degradation.”
`
`(emphasis added).) (See also Paper 25 at 3, 10-12.)
`
`The Board’s finding that a person of ordinary skill would have been
`
`motivated to add an antioxidant based on theoretical “susceptibility” to oxidative
`
`degradation is contrary to the Federal Circuit’s Watson decision because it was
`
`undisputed that theoretical susceptibility to oxidation does not reasonably predict
`
`whether oxidative degradation will occur in a pharmaceutical composition. (Paper
`
`69 at 21 (“[W]e find that the testimony of Dr. Kydonieus and Dr. Schöneich relied
`
`upon by Patent Owner explains that . . . whether and to what extent . . . expected
`
`degradation actually occurs needs to be shown experimentally.”); see also Paper
`
`25 at 16; Paper 44 at 1; Ex. 1025 at 96:10-18, 232:6-13; Ex. 1031 ¶ 10 (“a POSA
`
`would conduct testing to confirm to what extent, if any, the drug in the formulation
`
`oxidatively degrades” (emphasis added).) That is because, even a compound that
`
`is “susceptible” to degradation, may not degrade at all under pharmaceutically
`
`- 10 -
`
`
`
`relevant conditions, let alone in a particular formulation. (Paper 25 at 13, 16-18;
`
`Paper 42 at 6; Ex. 2012 ¶ 124.)
`
`Patent Owner further adduced evidence that dextromethorphan, a compound
`
`that Dr. Schöneich asserted is “susceptible” to oxidative degradation was reported
`
`in the art to be “very stable,” “[s]table under all normal conditions of storage,” and
`
`to show “[e]xcellent stability” under pharmaceutically relevant conditions. (Paper
`
`44 at 2-3; Ex. 2012 ¶¶ 139-143.) Because mere theoretical susceptibility to
`
`oxidation does not predict whether oxidative degradation will occur in a
`
`pharmaceutical composition, it does not allow a person of ordinary skill in the art
`
`to predict whether an antioxidant would be needed and it cannot provide a
`
`motivation to add an antioxidant. (Paper 25 at 16-18.) Indeed, dextromethorphan
`
`was reportedly formulated without an antioxidant, thereby confirming that a person
`
`of ordinary skill in the art would not have added an antioxidant just because a drug
`
`was “susceptible” to degradation. (Paper 25 at 17; Ex. 2012 ¶ 142.)
`
`In Watson, the Federal Circuit did state that the “district court also found
`
`without an appreciation for rivastigmine’s susceptibility to oxidative degradation,
`
`one of skill in the art would not have been motivated to patch together the prior art
`
`to add an antioxidant to a rivastigmine formulation, much less to a transdermal
`
`rivastigmine formulation.” 611 F. App’x at 997. But it is clear that neither the
`
`Federal Circuit nor the District Court in Watson used “susceptibility” in the same
`
`- 11 -
`
`
`
`way as Petitioner and the Board did here, that is, to refer to a theoretical possibility
`
`of oxidative degradation. (Compare Paper 67 at 39:8-40:3 with Paper 69 at 22 (“It
`
`is this susceptibility, i.e., a predicted potential for oxidative degradation . . . .”
`
`(emphasis added).) Instead, both Watson Courts were concerned with whether a
`
`person of ordinary skill could have reasonably predicted that oxidative degradation
`
`would actually occur in a pharmaceutical composition. (Paper 67 at 39:8-40:3.)
`
`See, e.g., Watson, 611 F. App’x at 995-96 (“The district court also did not clearly
`
`err in finding that the prior art does not unambiguously identify oxidative
`
`degradation to be a known problem with rivastigmine, and that therefore one of
`
`skill would not have had a reason to add an antioxidant to the [Enz] transdermal
`
`formulation.”), id. at 996 (“Although the addition of an antioxidant would have
`
`been an obvious solution for a formulation with known oxidation problems . . .
`
`.”), id. (affirming the finding that “one of skill in the art would not have been
`
`motivated to risk incompatibility by including an antioxidant in a formulation
`
`without evidence of its necessity”) (emphasis added in all); Watson, 48 F. Supp. 3d
`
`at 754 (a person of ordinary skill in the art “would not have been motivated to
`
`include an antioxidant in any formulation unless there was evidence of oxidative
`
`degradation”), id. (a person of ordinary skill in the art “would only be motivated to
`
`address and correct known degradation problems”) (emphasis added in both).
`
`In reaching its conclusion that a person of ordinary skill would have been
`
`- 12 -
`
`
`
`motivated to add an antioxidant based on theoretical “susceptibility” to oxidative
`
`degradation, the Board also overlooked Patent Owner’s evidence that a person of
`
`ordinary skill in the art would not add an antioxidant unless one was needed.
`
`(Paper 25 at 10-12.) For example, the prior art guidelines from the EMEA, the
`
`European equivalent to the FDA, expressly state that “[a]ntioxidants should only
`
`be included in a formulation if it has been proved that their use cannot be
`
`avoided.” (Ex. 2019 at 3 (emphasis added); Paper 25 at 10-12.) Petitioner did not
`
`and could not dispute this evidence. (Paper 31 at 15 (“The EMEA Guidelines . . .,
`
`when viewed in total, suggests that antioxidant use should be justified . . . .”).)
`
`Had the Board properly considered the Federal Circuit’s holding and the
`
`undisputed evidence that theoretical “susceptibility” would not have motivated a
`
`person of ordinary skill in the art to include an antioxidant in any formulation, and
`
`that instead, evidence of oxidative degradation was required, it would have
`
`followed that claims 1-3, 7, 15-16 and 18 of the ’031 patent are nonobvious over
`
`Enz, the Handbook, Rosin, Ebert and/or Elmalem. (Paper 25 at 3, 10-12.)
`
`B.
`
`Petitioner Failed To Meet Its Burden Of Proof
`That Claims 1-3, 7, 15-16 And 18 Of The ’031
`Patent Are Unpatentable Over Enz and Sasaki
`
`The Board held the ’031 patent claims at issue unpatentable as obvious over
`
`Enz and Sasaki. Specifically, the Board held that “a person of ordinary skill in the
`
`art would have predicted that the transdermal formulation disclosed by Enz was
`
`- 13 -
`
`
`
`“susceptible” to oxidative degradation, based on an application of Sasaki’s
`
`teachings, and would have been motivated to add an antioxidant to the
`
`formulation.” (Paper 69 at 23 (emphasis added).) This conclusion is contrary to,
`
`and thus overlooks, the Federal Circuit’s Watson decision. (Paper 67 at 38:1-8.)
`
`As explained above, in Watson, the Federal Circuit held that a mere
`
`theoretical “susceptibility” to oxidative degradation would not have motivated a
`
`person of ordinary skill in the art to add an antioxidant to the transdermal
`
`formulation in Enz. 611 F. App’x at 996. (Paper 25 at 10-12, 16.) Instead, a
`
`person of ordinary skill would have added an antioxidant only if one was needed,
`
`i.e., there was evidence of oxidative degradation in the pharmaceutical
`
`composition. (Id. at 10-12.) And as the Board recognized, Petitioner’s own
`
`experts conceded that a compound that is theoretically “susceptible” to oxidation
`
`may not undergo any oxidative degradation in a pharmaceutical composition.
`
`(Paper 69 at 21-22; Ex. 1031 ¶ 10; Ex. 1025 at 96:13-18, 258:8-13.) For this
`
`reason, it was undisputed that a person of ordinary skill would not have reasonably
`
`predicted whether an antioxidant was needed in advance of testing.4 (Paper 25 at
`
`4 The Board’s finding that “in view of Sasaki’s teaching, a person of ordinary skill
`
`in the art would have been able to reasonably predict ‘in advance’ of testing” that
`
`rivastigmine would degrade when formulated with an acrylic adhesive (Paper 69 at
`
`- 14 -
`
`
`
`2, 13-14.) And it was undisputed that no such experiments were reported in the
`
`prior art. (Paper 25 at 2; Paper 42 at 5.) Where the discovery of the problem—the
`
`oxidative degradation of rivastigmine in a transdermal patch—requires testing, the
`
`invention is not obvious. (Paper 25 at 7-8.) See Leo Pharm. Prods., Ltd. v. Rea,
`
`726 F.3d 1346, 1353, 1356-57 (Fed. Cir. 2013).
`
`Had the Board properly considered the Federal Circuit’s holding and the
`
`undisputed evidence, it would have followed that the ’031 patent claims at issue
`
`are nonobvious over Enz and Sasaki.
`
`IV. CONCLUSION
`
`Patent Owner respectfully requests that the Board reconsider its Final
`
`Decision and find that Petitioner has failed to establish by a preponderance of the
`
`evidence that claims 1-3, 7, 15-16 and 18 of the ’031 patent are unpatentable.
`
`18-19) directly contradicts and overlooks the admissions of Petitioner’s experts to
`
`the contrary (Paper 25 at 13-14; Ex. 1031 ¶ 10; Ex. 1025 at 96:13-18, 283:14-
`
`284:19).
`
`- 15 -
`
`
`
`Dated: October 28, 2015
`
`Respectfully submitted,
`
`Patent Owner: Novartis AG and
`Lohmann Therapie-Systeme AG
`
`/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, New York 10104-3800
`Tel. (212) 218-2235
`Fax. (212) 218-2200
`Email: rmandra@fchs.com
`ExelonPatchIPR@fchs.com
`
`- 16 -
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing NOVARTIS AG and LTS LOHMANN
`
`THERAPIE SYSTEME AG’s REQUEST FOR REHEARING UNDER 37 C.F.R.
`
`§ 42.71(d) was served on October 28, 2015 by causing it to be sent by email to
`
`counsel for Petitioner at the following email addresses:
`
`Steven J. Lee (slee@kenyon.com)
`
`Michael K. Levy (mlevy@kenyon.com)
`
`Chris Coulson (ccoulson@kenyon.com)
`
`Joseph M. Reisman (BoxMylan2@knobbe.com)
`
`Jay R. Deshmukh (BoxMylan2@knobbe.com)
`
`William R. Zimmerman (BoxMylan@knobbe.com)
`
`Dated: October 28, 2015
`
`/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
`
`- 1 -
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