Paper No. __
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`MICRO LABS LIMITED AND MICRO LABS USA INC.
`Petitioners,
`
`v.
`
`SANTEN PHARMACEUTICAL CO., LTD. AND ASAHI GLASS CO., LTD.
`Patent Owners.
`_____________
`
`Inter Partes Review No. IPR2017-01434
`U.S. Patent No. 5,886,035
`
`_____________
`
`
`PETITIONERS’ REPLY IN SUPPORT OF THEIR MOTION TO
`EXCLUDE EVIDENCE
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`MICRO LABS LIMITED AND MICRO LABS USA INC.
`Petitioners,
`
`v.
`
`SANTEN PHARMACEUTICAL CO., LTD. AND ASAHI GLASS CO., LTD.
`Patent Owners.
`_____________
`
`Inter Partes Review No. IPR2017-01434
`U.S. Patent No. 5,886,035
`
`_____________
`
`
`PETITIONERS’ REPLY IN SUPPORT OF THEIR MOTION TO
`EXCLUDE EVIDENCE
`
`
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`
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`
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`
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` Case IPR2017-01434
`Patent 5,886,033
`
`I.
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`EXHIBIT 2027 SHOULD BE EXCLUDED
`Patent Owners’ arguments demonstrate exactly why the Board should grant
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`Petitioners’ motion to exclude the Canadian court decision (Ex. 2027). It is
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`irrelevant and confuses the issues. The issue facing the Board is “what a POSA
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`would have chosen to select as a lead compound and modify [in view of Kishi or
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`any other prior art]… in December 1996.” (Ex. 1031, ¶ 74) (emphasis added). But
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`the issue before the Canadian court was: whether a POSA in August 1993, would
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`have considered compound C as a therapeutic agent for direct “human testing”
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`(and whether the compound would accordingly anticipate the claims of the
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`Canadian patent at issue in that case). (Id. at ¶ 72; Ex. 2027 at ¶¶ 9–11, 337.) The
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`Canadian decision has been taken out of context and Patent Owners’ reliance on
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`cherry-picked, paraphrased, and incomplete portions of Dr. deLong’s alleged
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`opinions from the Canadian case is unfairly prejudicial.
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`In any event, there is no contradiction between Dr. deLong’s opinions in the
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`Canadian case and his opinions in this case. A compound that causes moderate
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`hyperemia may not be considered as having an acceptable therapeutic profile for
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`direct use as a therapeutic drug, but it may be the best candidate for a lead
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`compound if further modification is expected to reduce the side effects. (Ex. 1031,
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`¶¶ 73–74.) Dr. deLong, however, was not asked in the Canadian proceeding to
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`consider what compound would be selected as a lead compound and what
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`1
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` Case IPR2017-01434
`Patent 5,886,033
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`modification to make to the compound in view of the prior art. Indeed, neither
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`Kishi nor the ’856 publication was ever referenced in the Canadian proceeding, nor
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`was there any reason to because in the Canadian case the issue was not
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`modification of compound C in view of any prior art reference, including Kishi,
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`but direct human testing of compound C. Also, Dr. deLong’s opinion regarding 16-
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`phenoxy PGF2α analogs in the Canadian case was based on “the prior art
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`information available” in August 1993, which would have excluded Klimko.
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`The rule of completeness and fundamental fairness warrants exclusion of the
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`Canadian opinion because it gives a “misleading impression created by taking
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`matters out of context.” FRE 106 Adv. Comm. note; Echo Acceptance Corp. v.
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`Household Retail Servs., Inc., 267 F.3d 1068, 1089 (10th Cir. 2001) (“The rule of
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`completeness ... functions as a defensive shield against potentially misleading
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`evidence proffered by an opposing party.”). Patent Owners’ assertion that they “do
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`not rely on any analyses or conclusions in the Canadian court decision that
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`implicate Canadian law” is misleading. (Opp. at 5). All of Dr. deLong’s opinions
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`submitted in the Canadian proceeding were provided based on his understanding of
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`Canadian patent law and the issues in that proceeding. Patent Owners did not ever
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`attempt to introduce a full copy of his purported testimony into the record. Patent
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`Owners’ assertion that Dr. deLong “had every opportunity to provide testimony on
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`any pertinent aspects of his opinions in the Canadian proceeding” is simply wrong.
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`2
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` Case IPR2017-01434
`Patent 5,886,033
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`(Opp. at 9.) As Dr. deLong testified, he is not allowed to due to the obligations of
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`his confidentiality agreement. (Ex. 2025 at 17:4-5; 11:1–4.) Patent Owners’ intent
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`is clear: To not afford Petitioners the opportunity to examine the different legal
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`context at play in the Canadian case. (Cf., e.g., Ex. 1027, deLong Decl. at ¶¶ 19–28
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`(setting forth his understanding of the U.S. law of obviousness as a basis for his
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`opinions in this IPR proceeding).)
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`Patent Owners erroneously assert that Dr. deLong has “had every
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`opportunity to dispute whether he made those statements or the truth of those
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`statements.” (Opp. at 6). This is simply not true. Despite having taken two
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`depositions, Patent Owners did not once seek to cross-examine Dr. deLong about
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`the allegedly contradictory statements that he made in the Canadian court
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`proceeding, and in fact did not introduce Ex. 2027 during his cross-examination.
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`That Petitioners could have asked Dr. deLong questions to obtain evidence that is
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`more reliable than the hearsay testimony currently being offered means that the
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`residual exception is unavailing to Patent Owners. The Canadian court decision is
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`simply not more probative of Dr. deLong’s prior statement in the Canadian
`
`proceeding “than any other reasonably obtainable evidence.” (Opp. at 7; FRE
`
`807(a).)
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`Patent Owners’ reliance on Ex. 2027 is also undisputedly double hearsay
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`because the statements purportedly attributable to Dr. deLong come from a third
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`3
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` Case IPR2017-01434
`Patent 5,886,033
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`party, a foreign judge, in the form of an opinion allegedly written by that judge.
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`Statements allegedly made by Dr. deLong reported in the opinion is what is
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`ultimately being relied on by Patent Owners in this case. Because each level of
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`hearsay must fall within an exception to hearsay to be considered “not hearsay,”
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`FRE 801(d)(1)(A), which provides for an exception for prior inconsistent
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`statements, does not render the double hearsay not hearsay. FRE 805. None of the
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`hearsay exception rules are applicable here. Indeed, Dr. deLong was never cross-
`
`examined on any of his prior testimony in the Canadian proceeding. Ex. 2027
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`should be excluded in its entirety.
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`II.
`
`PARAGRAPHS 8–26 OF EXHIBIT 2028 SHOULD BE EXCLUDED
`Patent Owners do not dispute that Dr. Macdonald has zero publications or
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`patents in the area of prostaglandin analogs. Nor do Patent Owners dispute that Dr.
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`Macdonald lacks personal knowledge regarding the subject matter that he provides
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`expert opinions on. Patent Owners also do not refute that his expertise is only
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`“generally applicable to lipid signaling systems.” (Opp. at 9) (emphasis added).
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`There is no evidence that Dr. Macdonald’s alleged consulting experience relates to
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`use of prostaglandin analogs for the treatment of glaucoma and ocular
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`hypertension. Patent Owners’ only response to Dr. Macdonald’s lack of expertise
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`is that the Board should draw a negative inference regarding Petitioners’ decision
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`to not take his deposition. But Patent Owners submitted two declarations from Dr.
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`4
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` Case IPR2017-01434
`Patent 5,886,033
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`Macdonald that show he lacks the requisite expertise, and Patent Owners did not
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`establish his expertise in a manner sufficient to warrant cross-examination. (See,
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`e.g., Ex. 1031 at ¶¶ 29–38; Paper 24 at 11.) Ex. 2028, ¶¶ 8–26 should be excluded,
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`or accorded no weight.
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`III. EXHIBITS 2023, 2034, 2038–2041, AND 2047 ARE IRRELEVANT
`AND SHOULD BE EXCLUDED
`Nothing in Patent Owners’ opposition explains why these exhibits,
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`admittedly not prior art, are relevant. Patent Owners’ attempt to bootstrap Exs.
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`2023, 2034, and 2047 into the record, based on their claim that Exs. 2023, 2034,
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`and 2047 somehow “confirm” what other evidence in the record says, is improper.
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`(Opp. at 12–13.) For Exs. 2038–2041, Patent Owners offer only a cursory
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`statement as to their alleged relevance, based on the theory that they show that
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`tafluprost can be dosed once per day and has less hyperemia than some other FDA-
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`approved prostaglandins. (Opp. at 13.) But this is of no consequence because
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`reduced hyperemia is not even mentioned in the ’035 patent, and Patent Owners’
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`attempted reliance on non-prior art to support an uncontemplated and undisclosed
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`alleged advantage is improper.
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`5
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`Dated: August 16, 2018
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`
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` Case IPR2017-01434
`Patent 5,886,033
`
`By: /Cedric C.Y. Tan/
` Cedric C.Y. Tan (Reg. No. 56,082)
`H. Keeto Sabharwal
`(admitted pro hac vice)
`Yun Wei (Reg. No. 70,744)
`Alton L. Hare (Reg. No. 68,638)
`PILLSBURY WINTHROP
`SHAW PITTMAN LLP
`1200 Seventeenth Street, NW
`Washington, DC 20036
`Tel.: (202) 663-8000
`Fax.: (202) 663-8007
`Email: cedric.tan@pillsburylaw.com
`Email:keeto.sabharwal@pillsburylaw.com
`Email: sophie.wei@pillsburylaw.com
`Email: alton.hare@pillsburylaw.com
`
` Sean M. Weinman (Reg. No. 69,515)
`PILLSBURY WINTHROP
`SHAW PITTMAN LLP
`1650 Tysons Boulevard, 14th Floor
`McLean, VA 22102
`Tel.: (703) 770-7511
`Fax.: (703) 770-4856
`Email: sean.weinman@pillsburylaw.com
`
`Counsel for Petitioners Micro Labs Limited
`and Micro Labs USA Inc.
`
`6
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`
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that a copy of the
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`foregoing Petitioners’ Reply In Support of Their Motion to Exclude Evidence was
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`served on August 16, 2018, by delivering a copy via electronic mail on the below-
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`listed attorneys of record for the Patent Owners and, in view of the present
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`unavailability of the PTAB E2E system, the undersigned further certifies that once
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`the undersigned is aware that the PTAB E2E system is available a copy will be
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`delivered on the below-listed attorneys of record for Patent Owners by filing through
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`the PTAB End to End System:
`
`Arlene L. Chow (Reg. No. 47,489)
`arlene.chow@hoganlovells.com
`Eric J. Lobenfeld (pro hac vice)
`eric.lobenfeld@hoganlovells.com
`Ernest Yakob, Ph.D. (Reg. No. 45,893)
`ernest.yakob@hoganlovells.com
`HOGAN LOVELLS US LLP
`875 Third Avenue
`New York, NY 10022
`Tel: (212) 918-3000
`Fax: (212) 918-3100
`
`
`
` /Cedric C.Y. Tan/
` Cedric C.Y. Tan (Reg. No. 56,082)
`PILLSBURY WINTHROP
`SHAW PITTMAN LLP
`1200 Seventeenth Street, NW
`Washington, DC 20036
`Tel.: (202) 663-8000
`Fax.: (202) 663-8007
`Email: cedric.tan@pillsburylaw.com
`
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