UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC
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`Petitioners
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`v.
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`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
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`Patent Owner
`
`Case IPR2015-00643 (Patent 8,232,250 B2)
`Case IPR2015-00644 (Patent 8,399,413 B2)
`Case IPR2015-00830 (Patent 8,969,302 B2)1,2
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`PATENT OWNER’S REPLY IN SUPPORT OF ITS MOTION TO
`EXCLUDE EVIDENCE
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`1 The word-for-word identical paper is filed in each proceeding identified in the
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`caption.
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`2 Cases IPR2015-01976, IPR2015-01980, and IPR2015-01981 have been joined
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`with IPR2015-00643, IPR2015-00644, and IPR2015-00830, respectively.
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC
`
`Petitioners
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
`
`Patent Owner
`
`Case IPR2015-00643 (Patent 8,232,250 B2)
`Case IPR2015-00644 (Patent 8,399,413 B2)
`Case IPR2015-00830 (Patent 8,969,302 B2)1,2
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS MOTION TO
`EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
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`1 The word-for-word identical paper is filed in each proceeding identified in the
`
`caption.
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`2 Cases IPR2015-01976, IPR2015-01980, and IPR2015-01981 have been joined
`
`with IPR2015-00643, IPR2015-00644, and IPR2015-00830, respectively.
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`I.
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`Khan 2009 (Exs. 1068 And 1089) Is Not Prior Art And Should Be
`Excluded
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`Petitioners admit the Khan 2009 abstracts (Exs. 1068 And 1089) are not
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`prior art. As such, they cannot be relied upon to show the state of the art as of the
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`priority date as Petitioners suggest. Petitioners have made no showing that any of
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`the information contained in the Khan 2009 abstracts would have been available to
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`a POSA before the priority date. Therefore, the abstracts are irrelevant to the
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`obviousness inquiry in this case as they are neither prior art nor evidence of the
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`“state of the art” available to a POSA in 2009.
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`Petitioners’ reliance on Syntex (U.S.A.) LLC v. Apotex, Inc. is misplaced. In
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`Syntex, the inventors authored a Pharmaceutical Report, published five days after
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`the priority date, that clearly states that octoxynol 40 was a well-known ingredient
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`in pharmaceutical products. 407 F.3d 1371, 1379 (Fed. Cir. 2005). The Federal
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`Circuit determined that the District Court erred by concluding that octoxynol 40
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`was not used in pharmaceuticals prior to its use in the patented invention. Id.
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`Syntex is distinguishable for at least 2 reasons. Here, unlike the Pharmaceutical
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`Report in Syntex, the Khan 2009 abstracts were not authored by the inventors and
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`make no statements about what was “well-known” in the art prior to the filing of
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`the patent. In fact, the Khan 2009 abstracts describe a clinical trial that had yet to
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`be presented to the field, and the Khan 2009 abstracts make no comments about the
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`1
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`state of the art before the priority date. Therefore, the Board should exclude the
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`Khan 2009 abstracts (Exs. 1068 And 1089).
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`II. The Board Should Exclude Teva’s Shared Solutions Website (Ex. 1086)
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`Once again, Petitioners’ admission that the Shared Solutions website is dated
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`after the priority date should end the inquiry as the website is not prior art. See
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`Paper 75 [Petitioners’ Opposition] at p. 6. Instead, Petitioners state that the Board
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`should consider the website because it “corroborate[s] Dr. Green’s testimony.” Id.
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`Yet Petitioners do not even attempt to explain how information from 2016 can
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`legitimately corroborate Dr. Green’s opinion about the state of the art in 2009.
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`Instead, Petitioners argue that the Board can rely on this after-the-fact information
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`by claiming it is Yeda’s burden to show that no “intervening clinical trial changed
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`the known state of the art” between 2009 and 2016. Id. at p. 6, n. 4. This kind of
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`post-hoc evidence is exactly the type of evidence the Board typically excludes in
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`order to prevent the type of hindsight analysis the Petitioners have offered. It is
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`Petitioners’ burden, not Yeda’s, to establish the state of the art as of the priority
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`date with information available to a POSA at the time of the priority date.
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`Therefore, the Board should exclude the Shared Solutions website.
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`III. The Board Should Exclude The Lebano Article (Ex. 1098)
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`Petitioners also improperly rely on the post-priority date 2012 Lebano
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`Article as purported evidence of the state of the prior art in 2009. Petitioners
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`2
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`incorrectly point to a passage in the Lebano Article which states “gray matter
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`lesions are still difficult to measure and not discernable using traditional MRI” in
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`order to argue that detecting gray matter lesions with MRI was “expensive and
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`difficult to deploy in a multicenter clinical trial” as of the priority date. Id. at p. 7-
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`8. But there is nothing in this statement pertinent to the state of the art in 2009
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`and, in fact, that gray matter lesions were “difficult” to measure is irrelevant to
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`whether or not a POSA would expect the claimed invention to reduce gray matter
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`lesions. Therefore, the Lebano Article is irrelevant and should be excluded.
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`IV. The Wolinsky Transcript (Ex. 1140) is Irrelevant And Should Be
`Excluded
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`The Wolinsky Transcript was never cited in any of Petitioners’ filings in this
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`proceeding or cited by any of Petitioners’ experts and, therefore, is not of record.
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`Petitioners’ attempt to introduce the exhibit through improper re-direct
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`examination of its own witness during the reply round of depositions is in flagrant
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`disregard of the Board’s rules regarding the supplementation of evidence. 3 See 37
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`3 Petitioners’ argument that Yeda waived its objections under 37 CFR § 42.123 is
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`baseless. Counsel for Yeda specifically states that “I want to object to this
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`document being offered. It's not part of the record in this proceeding. So I just
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`object to any testimony on the document.” This objection clearly includes an
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`objection under 37 CFR § 42.123.
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`3
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`CFR § 42.123(b). Rather than seek leave to move to supplement the record, as was
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`required4, Petitioners attempted to have Dr. Green ostensibly read portions of the
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`Wolinsky Transcript into the record at his deposition despite objections made by
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`Yeda’s counsel that it was improper to do so.5 Dr. Green even admitted that he had
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`not seen the Wolinsky Transcript until the week before his deposition and that it
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`played no part in the opinions that he set forth in this IPR. (Ex. 1142, 404:10-12,
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`404: 22-24). The Wolinsky Transcript is also irrelevant to these proceedings
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`because it is not prior art and therefore cannot be the basis of any finding by the
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`Board. The prescribing practices and rationales of a single physician are irrelevant
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`if those practices were not known and available to a POSA as of the priority date.
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`4 Petitioners’ argument that Yeda improperly maintained confidentiality over the
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`Wolinsky Transcript is similarly baseless. In district court litigation, it is regular
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`practice, as Petitioners’ themselves have done, to mark an entire deposition
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`transcript confidential to protect client confidential information, and there was no
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`undue delay in addressing Petitioners’ request in the district court litigation.
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`5 Yeda objected to the Wolinsky Transcript at Dr. Green’s deposition as improper
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`IPR evidence and as outside the scope of Dr. Green’s direct examination. (Ex.
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`1142, 396:3-10, 397:1-10, 398:3-4, 398:10, 399:5-8, 398:22-23).
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`4
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`As Petitioners have not made any showing on this issue, the Wolinsky Transcript,
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`which is not of record, is irrelevant and should be excluded.
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`V.
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`Patent Owner Did Not Neglect Its Duty Of Candor To The Board
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`Petitioners allege that Yeda violated its duty of candor by not disclosing the
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`Wolinsky Transcript to the Board. This allegation is baseless. A party has an
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`obligation to serve “relevant information that is inconsistent with a position
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`advanced by the party during the proceeding.” 37 C.F.R § 42.51(b)(1)(iii). First,
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`as discussed above, the Wolinsky Transcript is irrelevant to the current
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`proceedings. Second, Dr. Wolinsky’s testimony is not inconsistent with positions
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`taken by Yeda in this proceeding. Yeda has consistently maintained that a POSA
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`would not have been motivated to develop a 40 mg, three times per week dosing
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`regimen for GA based on the teaching of the prior art as a whole—including prior
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`art studies using 20 mg GA every other day. None of Dr. Wolinsky’s fact
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`testimony about his own private prescribing practices with 20 mg GA is relevant or
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`inconsistent with these arguments.
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`Dated: April 28, 2016
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`Respectfully submitted,
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`/Elizabeth J. Holland/
`Elizabeth J. Holland
`Registration No. 47,657
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10019-1405
`Tel: 212-813-8800
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`5
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that I caused PATENT OWNER’S
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`REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE EVIDENCE to be
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`served electronically via e-mail on April 28, 2016 on the following:
`
`Jeffrey W. Guise
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`jguise@wsgr.com
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`Brandon M. White
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`BMWhite@perkinscoie.com
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`Shannon Bloodworth
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`sbloodworth@perkinscoie.com
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`David Anstaett
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`DAnstaett@perkinscoie.com
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`Richard Torczon
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`rtorczon@wsgr.com
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`Vince Capuano
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`vcapuano@duanemorris.com
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`Christopher Kroon
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`CSKroon@duanemorris.com
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`/Brian T. Drummond/
`Brian T. Drummond
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`Dated:
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`April 28, 2016
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