Case 1:14-cv-02758-PAC Document 130 Filed 01/18/17 Page 1 of 6
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`MADDOX ll? EDWARDS
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`1900 K STREET NW - SUITE 725
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`WASHINGTON. DC 20006
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`(202) 830 - 0707
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`January 17., 2017
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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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`Kan-a Company. Ltd. et a]. v. Amneal Pharmaceuticals LLC, et a]...
`Case Nos. 14-cv-2758 (PAC); l4-cv-5575 (PAC); 14-cv-7934 (PAC);
`and lS—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.
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`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 130 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. 901:. 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-l422 is especially troubling, because on November
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`16. 2016., 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-l332 that the
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`first replication did not produce Form A — while Plaintiflr ’ counsel withheldfrom the witness the
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`rest ofrhe record which definitiver proved when-vise.
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`(Roberts Dep. at 101 (“That tells you that
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`the crystalline 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-l332 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 130 Filed 01/18/17 Page 3 of 6
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`available for a deposition if Plaintiffs wished. (November 30. 2016 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 trio! began (November 16. 2016 email 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, until 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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`was 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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`I
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`If.
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`Steven A. Maddox
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`cc:
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`All counsel of record in CA. Nos:
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`14—cv-2753 (PAC);
`l4-cv-55'75 (PAC):
`l4-cv-7934 (PAC); and
`15-cv—3935 (PAC)
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`Case 1:14-cv-02758-PAC Document 130 Filed 01/18/17 Page 4 of 6
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`
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`Kowa Company, Ltd. et al...
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`Plaintiffs,
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`v.
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`Civil Action No. l4—CV-5575 (PAC)
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`Sawai USA. Inc. et a]...
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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 31..
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`Defendants.
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`Kowa C ompany. Ltd. et al...
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`Plaintiffs.
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`Lupin Ltd. et al...
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`Defendants.
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`Civil Action No. l4-cv-7934 (PAC)
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`Civil Action No. lS-CV-3935 (PAC)
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`SUPPLEMENTAL EXPERT REPORT OF
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`KEVIN J. ROBERTS, PH.D. REGARDING INVALIDITY
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`Case 1:14-cv-02758-PAC Document 130 Filed 01/18/17 Page 5 of 6
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`THIS ENTIRE REPORT AND ATTACHED EXHIBIT(S) ARE:
`HIGHLY CONFIDENTIAL — SUBJECT TO STIPULATION REGARDING
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`CONFIDENTIALITY AND PROTECTIVE ORDER
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`1. Kevin J. Roberts. Plt.D.. submit this sopplemental eXpert report in this matter.
`1.
`recently came to my attention that the record with respect to my discussion OfNissan’s internal
`documentation of attempts to reproduce Example 3 from European Publication NO. EP 0 520 406
`(“EP 406“) was incomplete. Within the past few days. I have for the first time become aware ofa
`translation ofa 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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`It
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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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`fi3.
`The newly—translated document is attached as Exhibit A to this report. The original
`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
`4.
`of Example 3 ofEP ‘406.
`(See Opening Report at 43.. ‘Il 104.) However. Exhibit 28 also refers to a
`previous replication ofthe 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 analysis.
`(See. cg. Ex. 28 at MYLAN(Pitav)O73197 (“{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."
`(1:13.)
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`The newly-obtained translation at Exhibit 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
`KN001753854 and MYLAN(Pitav)073199: Ex. A at KN001713738—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
`1." (Ex. A at KNOOI 713742.) Exhibit A states that the water content ofthe product was 5.72%.
`(Id)
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`Exhibit A reflects that Nissan used different drying parameters in its first
`6.
`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
`l0.5%. (Ex. 23 at KN001753851.)
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`This newly-acquired translation of a Nissan document is not the source of a new
`7.
`It was and remains my opinion that Nissan demonstrated and represented to the European
`opinion.
`patent authorities that Example 3 of the EP "406 patent produces Form A of the then-pending
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`1
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`Case 1:14-cv-02758-PAC Document 130 Filed 01/18/17 Page 6 of 6
`Case 1:14-cv-02758-PAC Document 130 Filed 01/18/17 Page 6 of 6
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`THIS ENTIRE REPORT AND ATTACHED ExHIBIT(s) ARE:
`HIGHLY CONFIDENTIAL —- SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`European C iba patent. and the claimed Form A of the “993 patent—in-suit. The new document
`completes the record of internal Nissan documentation of that work.
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`1 do not believe ansthing in the newly-discovered document Exhibit A is
`8.
`inconsistent Iwith Nissan‘s conclusion that it Obtained Form A —- both in the conclusion of Exhibit A
`itself. and as referenced in Exhibit 23. Although the poor quality ofthe image data hampers a high
`lex'el ofprecision. l previously Opined that the XRD plot Of Form A from the “993 patent and the
`XRD plot submitted by Nissan to the European Patent Office are substantially similar. (See
`Opening Report at 54..
`l38-——-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
`is substantially similar to Form A Of the ‘993 patent and the plot submitted by Nissan. This is
`consistent with Nissan's representations to the European Patent Office and Nissan’s conclusions in
`the FIE“ document and in Exhibit 28.
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`W K
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`evin J. Roberts
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`Dated: November 30.. 20] 6
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`IR.)
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