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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`KOIOS PHARMACEUTICALS LLC
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`Petitioner
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`v.
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`MEDAC GESELLSCHAFT FUER KLINISCHE SPEZIALPRÄPARATE MBH
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`Patent Owner
`____________
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`IPR2016-01370
`Patent No. 8,664,231
`Title: Concentrated Methotrexate Solutions
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`PETITIONER’S RESPONSE TO
`PATENT OWNER’S MOTION TO EXCLUDE
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`Response to Motion to Exclude
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`Table of Contents
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`INTRODUCTION...................................................................................................... 1
`I.
`II. EXHIBITS 1041-45 ................................................................................................. 1
`A. Exhibit 1041 .................................................................................................. 1
`B. Exhibit 1042 .................................................................................................. 2
`C. Exhibit 1043 .................................................................................................. 3
`D. Exhibits 1044 and 1045 ................................................................................. 4
`III. MS. SHOEMAKER’S TESTIMONY ............................................................................ 4
`IV. CONCLUSION. ........................................................................................................ 6
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`i
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`Response to Motion to Amend
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`I.
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`INTRODUCTION
`Medac’s objections misstate the nature of the challenged evidence and the
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`purposes for which it was introduced. None of the exhibits or testimony Medac
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`challenges is irrelevant, and none constitutes hearsay.
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`II. EXHIBITS 1041-45
`A. Exhibit 1041
`Exhibit 1041 details the correspondence between counsel for Koios and
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`Medac in which Koios invited Medac to take the depositions of its experts, and
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`Medac refused to do so. The exhibit is simply offered to show the Board that
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`exchange. It is not offered as evidence of why Medac refused to take the
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`depositions. The assertion that Medac refused to do so because it felt it could not
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`successfully challenge Dr. Schiff and Dr. Miller’s opinions through cross-
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`examination is an inference that the Board may draw from Medac’s decision—and
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`an argument that Koios has made—but Koios has not offered Exhibit 1041 as
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`direct evidence of that point.
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`Moreover, Exhibit 1041 is not offered to simply show that Medac did not
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`ultimately take depositions in this proceeding. Rather, it is submitted to show that
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`Koios proactively invited Medac to take its experts’ depositions, and Medac
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`refused. That reality is relevant in evaluating the weight and credibility of Medac’s
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`repeated assertions that Koios’s experts are not credible or that their testimony is
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`Response to Motion to Amend
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`not reliable.
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`B. Exhibit 1042
`Exhibit 1042 is self-authenticating as it is a judicial decision from the UK
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`High Court. Like other self-authenticating documents, the Board and Medac may
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`readily seek out and find the decision independently and verify its authenticity.
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`The second sentence of the first paragraph of Ex. 1042 makes clear that the
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`patent at issue there “claims the use of a formulation of methotrexate with a
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`concentration of about 50 mg/ml for the treatment of individuals with
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`inflammatory autoimmune diseases by subcutaneous injection.” Ex. 1042 at ¶ 1.
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`The Board can readily compare that claim language to claim 1 of the ’231 patent,
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`which recites: “A method for the treatment of inflammatory autoimmune diseases
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`in a patient in need thereof, comprising subcutaneously administering to said
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`patient a medicament comprising methotrexate in a pharmaceutically acceptable
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`solvent at a concentration of more than 30 mg/ml.”
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`Exhibit 1042 is offered for the truth of the matter that the UK High Court
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`found the claims of EP (UK) 2 046 332 as invalid for obviousness. Ex. 1042 ¶ 132.
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`Judicial decisions are not hearsay when offered for the truth of what those
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`decisions concluded, as Koios does here. Medac repeatedly argues that it was a
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`novel idea, as of July 2006, to administer MTX subcutaneously in concentrations
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`above 30 mg/ml for the treatment of inflammatory autoimmune diseases. The UK
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`Response to Motion to Amend
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`High Court’s decision supports Koios’s assertion that: “Two European courts and
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`the U.S. Patent and Trademark Office have recently concluded otherwise.”
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`C. Exhibit 1043
`Exhibit 1043 demonstrates that The Hague has also found the European
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`equivalent to the ’231 patent, EP 2 046 332, invalid as obvious.
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`In response to Medac’s objections, Koios timely served Ex. 1046 as
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`supplementary evidence, see 37 C.F.R. § 42.64(b)(2), and filed it in response to
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`Medac’s Motion to Exclude, see Handi Quilter, Inc. v. Bernina Int’l AG, IPR2013-
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`00364, Paper 30 (June 12, 2014) (explaining that “supplemental evidence [is]
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`served in response to an evidentiary objection and filed in response to a motion to
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`exclude”). Ex. 1046 shows the claims at issue in The Hague’s decision. See Ex.
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`1046 at 4-6. Exhibit 1046 thus supports the relevance of Ex. 1043, i.e., it
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`establishes that The Hague decision discussed in Ex. 1043 was with respect to the
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`same European patent found invalid by the UK High Court in Ex. 1042—a patent
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`in which Medac claimed to have invented subcutaneous administration of
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`methotrexate in concentrations of about 50 mg/ml for treating inflammatory
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`autoimmune diseases.
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`The fact that Medac has purportedly appealed goes to the weight of Ex.
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`1043, not its admissibility. Surely if Medac had any decisions it could present to
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`the Board in which its claims had been found patentable, it would have done so.
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`Response to Motion to Amend
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`There is no reason Koios should not be able to present judicial decisions that have
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`held otherwise.
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`D. Exhibits 1044 and 1045
`These documents are self-authenticating as they are records filed with the
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`PTO and publicly available and verifiable.
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`Medac’s arguments again go to weight, not admissibility. It is highly
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`relevant that the same examiners who issued the ’231 patent are now refusing to
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`issue further claims covering essentially the same subject matter as claim 1 and its
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`dependents. The Board may compare the rejected claims at issue in Exhibit 1044 to
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`those issued in the ’231 patent for itself to determine the extent of the similarities.
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`And there is no unfair prejudice here. Surely the Board should be aware that
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`the PTO, the UK High Court, and The Hague have each considered claims
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`essentially identical to those at issue in this proceeding, and each has concluded the
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`claims are not novel as of July 2006. While the Board may determine what weight
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`to give that information, there is no reason to exclude the exhibits.
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`III. MS. SHOEMAKER’S TESTIMONY
`Petitioner correctly questioned Ms. Shoemaker as to the contents of her
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`declaration. The testimony at issue was specifically directed to establishing the
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`information that Ms. Shoemaker’s declaration did not contain even though that
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`information was known to her. Medac’s expert has asserted that there were no
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`Response to Motion to Amend
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`meaningful barriers to bringing a product like Rasuvo to market prior to July 2006.
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`See Ex. 2032 at ¶¶ 38-40 (a section of Dr. Nicholson’s declaration entitled “There
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`Were No Substantial Barriers To Entry In The United States Market For A
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`Methotrexate Product Using The Innovation”). Yet Medac’s CEO, Ms. Shoemaker,
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`did not offer any testimony in her declaration to support that assertion, as her
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`deposition testimony shows. That testimony is within the proper scope of the
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`deposition because it is tied to Ms. Shoemaker’s declaration—it demonstrates what
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`her declaration does not say.
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`At her deposition, Ms. Shoemaker in fact testified that developing and
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`commercializing a product like Rasuvo entails significant cost, risk, and barriers to
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`entry. That questioning and the subsequent testimony goes to Ms. Shoemaker’s
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`credibility under Fed. R. Evid. 611. It demonstrates that Ms. Shoemaker withheld
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`information within her knowledge that is material to the issues in this proceeding
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`and that contradicts the testimony of Medac’s paid expert, Dr. Nicholson. That
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`reality impeaches Ms. Shoemaker’s credibility as to the testimony she did offer,
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`particularly given that she is Medac’s CEO. The challenged testimony is therefore
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`both relevant and admissible.
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`IV. CONCLUSION.
`For the reasons above, the Board should not exclude Exhibits 1041-45 or the
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`Response to Motion to Amend
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`deposition testimony from Ms. Shoemaker.
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`Respectfully submitted,
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`/s/ Kayvan Noroozi
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`DeAnn F. Smith (Lead Counsel)
`Reg. No. 36,683
`FOLEY HOAG LLP
`155 Seaport West
`Boston, MA 02210
`dsmith@foleyhoag.com
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`William P. Rothwell (Back-Up Counsel)
`Reg. No. 72,522
`NOROOZI PC
`2245 Texas Drive, Suite 300
`Sugar Land, TX 77479
`william@noroozipc.com
`
`Kayvan B. Noroozi (Back-Up Counsel)
`Admitted Pro Hac Vice
`NOROOZI PC
`1299 Ocean Ave., Suite 450
`Santa Monica, CA 90401
`kayvan@noroozipc.com
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`Counsel for Petitioner
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`6
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`Date: October 16, 2017
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`Response to Motion to Amend
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing PETITIONER’S
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`RESPONSE TO PATENT OWNER’S MOTION TO EXCLUDE was served
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`electronically via e-mail on October 16, 2017, on the following counsel of record
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`for Patent Owner:
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`
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`James F. Haley (Lead Counsel)
`Brian Gummow (Back-up Counsel)
`Service E-mail address
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`james.haley@hglaw.com
`brian.gummow@hglaw.com
`IPR2016-01370_Medac@ropesgray.com
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`Date: October 16, 2017
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`Respectfully submitted,
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`/s/ William P. Rothwell
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`William P. Rothwell (Back-Up Counsel)
`Reg. No. 72,522
`NOROOZI PC
`2245 Texas Drive, Suite 300
`Sugar Land, TX 77479
`william@noroozipc.com
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`Counsel for Petitioner
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`7
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