Case 1:14-cv-02758-PAC Document 131 Filed 01/18/17 Page 1 of 6
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`MADDOX •A= EDWARDS
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`1 900 K STREET NW · SUITE 725
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`W ASHINGTON. D C 20006
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`(202) 830 · 0707
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`January 17, 20 17
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`Hon. Paul A. Crotty
`United States District Judge
`Daniel Patrick Moynihan United States Courthouse
`500 Pearl Street, Room 735
`New York, NY 10007
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`Re:
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`Kowa Company, Ltd. et al. v. Amneal Pharmaceuticals LLC, et al. ,
`Case Nos. 14-cv-2758 (PAC); 14-cv-5575 (PAC); 14-cv-7934 (PAC);
`and 15-cv-3935 (PAC);
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`Your Honor:
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`On behalf of Amneal and Apotex, we write to request a resolution of a dispute regarding
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`(a) the admissibility of a business record of Plaintiff Nissan, and (b) Plaintiffs' delay until the
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`night before trial to object to a supplemental expert report served more than a month and a half
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`ago.
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`The business record is DTX-1422. It is one of two Nissan business records reflecting
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`Nissan's first replication of Example 3 of EP '406, and Nissan's conclusion that it produced
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`Form A. The other Nissan business record is DTX-1332. DTX-1422 is necessary to have a
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`complete record of the first replication. DTX-1422 contains a more detailed record of the
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`science conducted by Nissan.
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`Only two days before trial, Plaintiff belatedly identified their primary objection to DTX-
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`1422 as being "Untimely." (January 15, 2017 email from K. Carr to Defendants.) We do not
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`believe that is a valid evidentiary objection, especially for a document that Plaintiff Nissan itself
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`Case 1:14-cv-02758-PAC Document 131 Filed 01/18/17 Page 2 of 6
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`created and has possessed ever since (and throughout this litigation). Nissan's objection to it
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`being a foreign language document is answered by the certified translation Defendants provided
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`back in November. And Nissan 's objection for lack of foundation as a business record is
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`contrary to the parties· stipulation in the pretrial order which provides: "Any document
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`produced from the files of Plaintiffs or Defendants shall be deemed: (i) to be authentic under
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`Fed. R. Evid. 90 1 ~ and (ii) to satisfy the records of a regularly conducted activity exception of
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`Fed. R. Evid. 803(6)(A)-(C).'' (Pre-Trial Order, Stipulated Facts at 8, paragraph 47.)
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`Plaintiffs· position regarding DTX-1422 is especially troubling, because on November
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`16. 201 6, before Defendants found the rest of Nissan 's business record, Plaintiffs' counsel
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`attempted to force Defendants' expert to speculate on the partial record of DTX-13 3 2 that the
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`first replication did not produce Form A - while Plaintiffs ' counsel withheld from the witness the
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`resr of the record which definitively proved otherwise. (Roberts Dep. at 101 ("That tells you that
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`the crystaJline form that they had obtained was not the target polymorph, correct?" followed by
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`"Why can ' t you reach that conclusion?").)
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`When Defendants found the rest of the record in DTX-1422 after the deposition, they
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`obtained a certified translation over the Thanksgiving holiday, and provided it to Plaintiffs as
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`quickly as possible (on November 30, 2016), even though Plaintiffs already had it. And because
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`only the partial record in DTX-1332 had been an exhibit to Dr. Roberts' report, Defendants also
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`provided a 1.5 page supplemental expert report, in which Dr. Roberts explained why DTX-1422
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`was the rest of Nissan's business record-pointing out the correspondence between the details
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`mentioned in DT-1332 and DTX-1422. A copy of the supplemental report is attached.
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`Even though Dr. Roberts did not offer any new opinion in introducing the document
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`needed to complete Nissan' s business record, Defendants nevertheless offered to make him
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`Case 1:14-cv-02758-PAC Document 131 Filed 01/18/17 Page 3 of 6
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`a\1lilable for a deposition if Plaintiffs wished. (November 30, 20 t 6 letter from S. Maddox to K.
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`Carr.) Plaintiffs never responded in any way - until emailing an objection to it at 8: 14 pm the
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`night before trial bega11. (November 16. 20 16 emai l from K . Carr to Defendants (referring to
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`.. Dr. Rogers· untimely report'").)
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`By "going quiet" for a month and a half, unti l the night before trial and foregoing the
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`offered deposition. Plaintiffs waived any objection to Dr. Robert's supplemental report and any
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`objection to being confronted with their own document. In any event, the supplemental report
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`\\"35 appropriate. because it was necessary to complete the record, and Dr. Roberts did no more
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`than identify a document that Plaintiffs had possessed from the outset.
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`Respectfully submitted,
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`Steven A. Maddox
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`cc:
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`All counsel of record in C.A. os.:
`14-cv-2758 (PAC);
`14-cv-5575 (PAC);
`14-cv-7934 (PAC): and
`15-cv-3935 (PAC)
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`Case 1:14-cv-02758-PAC Document 131 Filed 01/18/17 Page 4 of 6
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`Kowa Company, Ltd. et al.,
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`Plaintiffs,
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`V.
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`Sawai USA, Inc. et al.,
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`Defendants.
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`Kowa Company, Ltd. et al.,
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`Plaintiffs,
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`V.
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`Apotex, Inc. et al.,
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`Defendants.
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`Kowa Company, Ltd. et al.,
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`Plaintiffs,
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`V.
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`Lupin Ltd. et al..
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`Defendants.
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`C ivil Action No. 14-CV-5575 (PAC)
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`Civil Action No. 14-cv-7934 (PAC)
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`Civil Action No. 15-CV-3935 (PAC)
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`SUPPLEMENT AL EXPERT REPORT OF
`KEVIN J. ROBERTS, PH.D. REGARDING INVALIDITY
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`Case 1:14-cv-02758-PAC Document 131 Filed 01/18/17 Page 5 of 6
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`TH IS ENTIRE REPORT AND ATTACHED EXHIBIT(S) ARE:
`HIGHLY CONFIDENTIAL- SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTI VE ORDER
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`I. Kevin J. Roberts. Ph.D .. submit this supplemental expert report in this matter. It
`I.
`recently came to my attention that the record with respect to my discussion of Nissan 's internal
`documentation of anempts to reproduce Example 3 from European Publication No. EP O 520 406
`( .. EP ·-rn6 .. ) , as incomplete. Within the past few days, I have for the first time become aware of a
`translation of a Japanese document. which I am told by counsel was produced by plaintiffs in this
`action but not translated until within the last week.
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`The document is necessary to complete the record with respect to my previously
`2.
`expressed opinion that Nissan obtained Form A of the claimed invention by its faithful
`reproduction of Example 3 from EP · 406.
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`The newly-translated document is attached as Exhibit A to this report. The original
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`Japanese version of the document is appended to the back of the translation.
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`On its face, the translation of Exhibit 28 to my opening report describes a replication
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`of Example 3 of EP '406. (See Opening Report at 43, ,i I 04.) However, Exhibit 28 also refers to a
`previous replication of the example by Nissan - one in which, according to Exhibit 28, Nissan
`obtained the same polymorphic Form A of the ·993 patent-in-suit, according to XRD peak analys is.
`(See, e.g .. Ex. 28 at MYLAN(Pitav)073 I 97 ( .. {The result of} the powder X-ray diffraction of the
`samples in this confirmatory test is significantly in agreement with Ciba patent disclosure data
`basically in the same as the previous test.").) Exhibit 28 also indicates that the polymorphic Form
`A produced by the previous replication had a water content of 5.72% "obtained by over-drying.•·
`(Id.)
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`The newly-obtained translation at Ex hibit A describes a replication of Example 3 of
`5.
`EP ·406. and concludes that the product is Form A, based on XRPD analysis. The water content of
`the product is reported as 5.72%. In addition. the substances tested in both Exhibit 28 and the new
`document Exhibit A have the same lot prefix - that is, "' Lot YT-01354-_ .'' (Ex. 28 at
`KNOO 1753854 and MYLAN(Pitav)073 I 99: Ex. A at KNOO 1713738-42.) Exhibit A concludes:
`··This re-examination of synthetic sample (Lot. YT-01354-019-A) gave the same powder X-ray
`diffraction data as that of Form A which is described in the Ciba patent implementation example
`I :· (Ex. A at KNOO I 713742.) Exhibit A states that the water content of the product was 5.72%.
`(Id.)
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`Exhibit A reflects that Nissan used different drying parameters in its first
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`reproduction as compared to its second reproduction in Exhibit 28. In the first reproduction in
`Exhibit A. the crystals were .. vacuum dried for 5 hours at 40° C" which produced a water content of
`5.72%. (Ex. A at KN001713738.) In the second reproduction in Exhibit 28, the crystals were
`"dried under reduced pressure for 50 minutes at 40 degrees C," which produced a water content of
`I 0.5%. (Ex. 28 at KNOO 1753851.)
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`This newly-acquired translation of a Nissan document is not the source of a new
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`opinion. It was and remains my opinion that Nissan demonstrated and represented to the European
`patent authorities that Example 3 of the EP '406 patent produces Form A of the then-pending
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`Case 1:14-cv-02758-PAC Document 131 Filed 01/18/17 Page 6 of 6
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`THIS ENTIRE REPORT AND A TT ACHED EXHIBIT(S) ARE:
`HIGHLY CONFIDENTIAL- SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`European Ciba patent. and the claimed Form A of the ·993 patent-in-suit. The new document
`completes the record of internal Nissan documentati on of that work.
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`I do not believe anything in the newly-discovered document Exhibit A is
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`inconsistent v, ith Nissan ·s conclusion that it obtained Form A - both in the conclusion of Exhibit A
`itself. and as referenced in Exhibit 28. Although the poor quality of the image data hampers a high
`le\'el of precision. I previously opined that the XRD plot of Form A from the ' 993 patent and the
`XR D plot submitted by Nissan to the European Patent Office are substantially similar. (See
`Opening Report at 54. 11 138- 39.) Subject to similar limitations on precision due to quality of
`data. it appears from the comparison of the XRD plot from the new document, Exhibit A, that it too
`i sub tantially similar to Form A of the ·993 patent and the plot submitted by Nissan. This is
`con istent with Nissan·s representations to the European Patent Office and Nissan's conclusions in
`the ne" document and in Ex hibit 28.
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`Dated:
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`ovember 30. 2016
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`Kev in J. Roberts
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`2
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