Paper No. _
`Date Filed: May 15, 2017
`
`Filed on behalf of: Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS ON CROSS-
`EXAMINATION OF MR. ROBERT MCSORLEY
`
`PUBLIC VERSION
`
`
`Date Filed: May 15, 2017
`
`Filed on behalf of: Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS ON CROSS-
`EXAMINATION OF MR. ROBERT MCSORLEY
`
`PUBLIC VERSION
`
`
`
`Pursuant to the April 6, 2017 Second Joint Stipulation to Modify the
`
`Scheduling Order (Paper 49), Patent Owner Aventis Pharma S.A. (“Aventis”)
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`respectfully submits this motion for observations on the cross-examination of Mr.
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`Robert McSorley, deposed on April 19, 2017. The deposition was taken following
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`Petitioner’s Reply (Paper 42, “Reply”), and the transcript was filed as Exhibit
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`2261. The parties have agreed that one motion is permitted for each reply witness.
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`1.
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`At page 37, line 24 to page 38, line 15, Mr. McSorley admitted “from
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`a US dollar basis, US sales of Jevtana increased from
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`in 2013 to
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`in 2014 and to
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`in 2015” and that in 2016 would increase
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`“when you look at a full year.” At page 106, line 19 to page 107, line 7, Mr.
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`McSorley confirmed that according to his purported IMS data, Jevtana® sales
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`increased from 2013 to 2016. This testimony is relevant because it contradicts his
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`opinion that Jevtana® sales
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`at ¶¶81-82).
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`(Exh. 1044
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`2.
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`At page 56, line 6 to page 57, line 14, Mr. McSorley admitted that he
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`does not know whether the other Jevtana® patents listed in the Orange Book would
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`prevent pharmaceutical companies from performing research and development for
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`an FDA submission. This testimony is relevant because it undercuts his assertion
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`that these patents were “independent barriers” to research and development of
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`“drug products that practice” the claimed methods. (Exh. 1044 at ¶¶126-30).
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`PUBLIC VERSION
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`3.
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`At page 66, line 20 to page 67, line 13, Mr. McSorley agreed that
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`prior to the launch of Jevtana®, “in 2008, the expiration date [for U.S. Patent No.
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`5,847,170] that a person of ordinary skill in the art would have had in mind was the
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`2016 date” so that after 2016, the ’170 patent would not have prevented a
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`pharmaceutical company from bringing a product to market. This testimony is
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`relevant because it undercuts his assertion that this patent was an “independent
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`barrier[]” to research and development of “drug products that practice” the claimed
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`methods. (Exh. 1044 at ¶¶126-30).
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`4.
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`At page 61, line 23 to page 62, line 6, Mr. McSorley confirmed that
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`the “average time . . . to develop a drug” is “around 10 to 12 years.” This
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`testimony is relevant because it undercuts his assertion that the Orange Book
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`patents with expiration dates of 2016 or earlier were a barrier to research and
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`development in the 2008 timeframe. (Exh. 1044 at ¶¶126-30).
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`5.
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`At page 196, line 12 to page 197, line 20, Mr. McSorley admitted that
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`his declaration does not include an analysis of the quantity of economic
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`disincentive allegedly created by the existence of other Orange Book patents. This
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`testimony is relevant because it renders his assertion that Orange Book patents
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`were “economic disincentives” to research and development of “drug products that
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`practice” the claimed methods unhelpful with regard to how much of a disincentive
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`there actually was, if any. (Exh. 1044 at ¶¶126-30).
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`2
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`PUBLIC VERSION
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`6.
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`At page 81, line 10 to page 82, line 10, Mr. McSorley testified
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`regarding Exhibits 1089-1090 that “I don’t recall anyone telling me that it came
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`from IMS Health. It was an assumption I made given the format of the
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`information.” He also testified that he does not recall whether his understanding
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`came from “an e-mail that I received with the . . . files” or “the file said in the
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`name of the file IMS Health prescription and sales data.” This testimony is
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`relevant because it calls into question the authenticity of the data in Exhibits 1089-
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`1090 and therefore the reliability of Mr. McSorley’s analysis in Attachments 6-8.
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`7.
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`At page 94, lines 2-5 and 14-19, Mr. McSorley confirmed that he did
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`not know who obtained Exhibits 1089-1090 from their original source; he believed
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`“it was someone in Wilson Sonsini’s office that received it either indirectly
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`through Mylan or from IMS Health.” At page 92, lines 9-22, Mr. McSorley
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`admitted that “I’m not sure they [counsel] requested from IMS Health. It might
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`have been requested from Mylan.” This testimony is relevant because it calls into
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`question the authenticity of the data in Exhibits 1089-1090 and therefore the
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`reliability of Mr. McSorley’s analysis in Attachments 6-8.
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`8.
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`At page 186, lines 2-16, Mr. McSorley, using the sales and
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`prescription data that allegedly came from IMS, calculated that Jevtana®’s price
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`per prescription would be
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`, which he confirmed was “obviously not
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`correct.” At page 187, line 9 to page 188, line 5, Mr. McSorley testified that he
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`3
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`PUBLIC VERSION
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`believed that the calculation was too high because the number of prescriptions was
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`too low, stating that “I would concede that the Jevtana prescriptions as reflected in
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`my Figure H and Attachment 8 appear to be understated.” This testimony is
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`relevant because it demonstrates that Mr. McSorley’s purported IMS data is
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`inaccurate, and any opinions based on it are also inaccurate and unreliable. (Exh.
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`1044 at ¶¶24-27, 53, 57-58, 74, 78-80, 83-84).
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`9.
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`At page 188, line 24 to page 189, line 11, Mr. McSorley admitted that
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`he did not know by how much the purported IMS data was understated. This
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`testimony is relevant because it demonstrates that Mr. McSorley’s purported IMS
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`data is inaccurate to an unknown degree, and any opinions based on it are also
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`inaccurate and unreliable. (Exh. 1044 at ¶¶24-27, 53, 57-58, 74, 78-80, 83-84).
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`10. At page 105, lines 7-17, Mr. McSorley confirmed that the purported
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`IMS data that he relied on did not differentiate which of the prescriptions were
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`“on-label for prostate cancer or off-label for a different type of cancer.” This
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`testimony is relevant because it shows that the purported IMS data does not take
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`into account the FDA-approved indication for Jevtana® or any other drugs, and
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`therefore does not reflect market share for any relevant market.
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`11. At page 71, line 24 to page 77, line 14, Mr. McSorley admitted that he
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`did not undertake any analysis to determine what the off-label uses were for the
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`products listed in his purported IMS data. This testimony is relevant because it
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`4
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`PUBLIC VERSION
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`demonstrates that Mr. McSorley’s purported IMS data does not reflect market
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`share for any relevant market.
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`12. At page 200, line 13 to page 201, line 24, Mr. McSorley admitted that
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`Mr. Tate relies on documents that “expressly exclude[] off-label use” and the data
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`represents “patients that are prescribed Jevtana and other prostate cancer drugs
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`who have been previously treated with docetaxel.” This testimony is relevant
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`because in combination with Observations 8-11, it demonstrates that Mr. Tate’s
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`market share analysis is more reliable for the post-docetaxel market than Mr.
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`McSorley’s analysis of IMS data.
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`13. At page 116, line 17 to page 117, line 2, Mr. McSorley testified that
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`he believed
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`At page 118,
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`line 17 to page 119, line 17, Mr. McSorley agreed that
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`and that he “can’t point to any particular document” in support
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`of his understanding. This testimony is relevant because it undercuts Mr.
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`McSorley’s opinions on off-label use as Mr. McSorley’s interpretation of
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`has no basis in the record evidence. (See also Exh. 1071 at
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`SA_JEV_1041143-145 (
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`14. At page 114, line 6 to page 116, line 16, Mr. McSorley testified that
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`)).
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`5
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`PUBLIC VERSION
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`he based his interpretation of a
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`on a single case he was involved in
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`regarding Gleevec®, a leukemia drug. This testimony is relevant because it
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`undercuts Mr. McSorley’s opinions on off-label use as Mr. McSorley’s
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`interpretation of
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`is based on information regarding a
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`different product for a different disease that he did not cite to in his declaration.
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`15. At page 127, lines 12-21, Mr. McSorley testified that he did not call
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`AlphaImpactRx to inquire about the meaning of
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`because “I didn’t feel I
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`needed to [given] my experience with that term and the documents that I was
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`reviewing.” This testimony is relevant because it undercuts Mr. McSorley’s
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`opinions on off-label use based on his interpretation of
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`and Mr.
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`McSorley’s criticism of Mr. Tate’s declaration for “fail[ing] to investigate the
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`integrity of
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`” (Exh. 1044 at ¶¶59-
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`61 (citing Exh. 1042 at 116:25-117:11, 149:24-150:10)).
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`16. At page 141, lines 13-24, Mr. McSorley testified that he did not know
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`if
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`This testimony is relevant because
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`it demonstrates that Mr. McSorley did not investigate the meaning of
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`in Exhibit 1065 and might be wrong in his interpretation.
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`17. At page 133, lines 11-24, Mr. McSorley admitted that a patient who
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`6
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`PUBLIC VERSION
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`“wait[s] six months between the time docetaxel is prescribed and cabazitaxel is
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`prescribed” is “basically a
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`.” This testimony is relevant because it means
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`that a
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`could include
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`, and therefore contradicts his opinion that
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`(Exh. 1044 at ¶39).
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`18. At page 146, line 23 to page 147, line 2, Mr. McSorley agreed that Dr.
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`Sartor’s testimony did not support his opinion that Jevtana® is often prescribed off-
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`label. This testimony is relevant because it contradicts Mr. McSorley’s reliance on
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`Dr. Sartor’s testimony as a basis for his opinion that there was “considerable off-
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`label use” of Jevtana®. (Exh. 1044 at ¶¶42, 45).
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`19. At page 147, line 3 to page 148, line 3, Mr. McSorley confirmed that
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`he relied on Exhibit 1067 for his “opinion that Jevtana is used off-label” and that
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`Exhibit 1067 is a draft document describing “the Veteran Administration’s . . .
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`formulary position on reimbursing cabazitaxel for its insureds.” At page 14, line
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`19 to page 16, line 5, Mr. McSorley confirmed that he has never worked at a
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`company that had a formulary, and that he was not “an expert in the field of getting
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`drugs onto formularies.” This testimony is relevant because it undermines Mr.
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`McSorley’s reliance on Exhibit 1067 as a basis for his opinion that Jevtana® is used
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`off-label because he is not competent to testify about the significance of inclusion
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`7
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`PUBLIC VERSION
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`
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`of language on the Veteran Administration’s National Drug Monograph.
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`20. At page 150, line 7 to page 151, line 7, Mr. McSorley confirmed that
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`he does not “read [Exhibit 1067] as promoting off-label uses” and Exhibit 1067
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`“doesn’t indicate what percentage, if any, of prescriptions written for Jevtana are
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`written for off-label uses . . . .” This testimony is relevant because it undermines
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`Mr. McSorley’s reliance on Exhibit 1067 as a basis for his opinion that there was
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`“considerable off-label use” of Jevtana®. (Exh. 1044 at ¶43).
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`21. At page 124, line 11 to page 125, line 23, Mr. McSorley testified that
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`he reviewed “two-dozen, three-dozen market type of reports for different time
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`periods,” but could not
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`At page 157, line 6 to page 159, line 2, Mr. McSorley testified
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`that while he “reviewed a lot of market studies,” he did not cite to studies other
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`than Exhibit 1065 for alleged off-label use of Jevtana®. This testimony is relevant
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`because it demonstrates that Mr. McSorley cherry-picked market share data to
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`determine first-line use of Jevtana® using his definition of
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`22. At page 171, lines 8-23, Mr. McSorley admitted that combination
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`therapy and supportive care agents “could explain” why
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`At page 177, line 19 to page 178, line 4, Mr.
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`McSorley admitted that
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`8
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`PUBLIC VERSION
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`This testimony is relevant because it undermines Mr. McSorley’s
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`conclusion that
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`(Exh. 1044 at ¶¶60-61).
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`23. At page 175, line 5 to page 177, line 15, Mr. McSorley testified that
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`he believed that the AlphaImpactRx
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`“was prepared for purposes of
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`this litigation. It was not prepared in the normal course of business.” He stated,
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`“maybe I reached the conclusion myself that it was prepared in response to Mr.
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`Tate’s request,” but that “I concluded that it was prepared for purposes of litigation
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`and Mr. Tate improperly relied on it.” This testimony is relevant because Mr.
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`McSorley’s incorrect and undisclosed assumption that Exhibits 2170 and 2179
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`were prepared for litigation is contradicted by the declaration of Mr. Art Lathers.
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`(Exh. 2231 at ¶¶3-4), indicating that Mr. McSorley did not understand the data he
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`was criticizing.
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`24. At page 181, line 12 to page 182, line 17, Mr. McSorley testified that
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`he remembered a court case ruling against his expert opinions because “[w]hile
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`VIIV’s internal launch plan showed an intention for the commercial embodiments
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`to compete within all anti-HIV drug classes, Mr. McSorley’s contention that
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`VIIV’s launch plan determines the market is not persuasive. VIIV’s internal
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`aspirations for market dominance are not evidence of how the drugs are prescribed
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`9
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`PUBLIC VERSION
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`in practice and are thus less probative when determining those markets.” This
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`testimony is relevant because it undermines Mr. McSorley’s argument that
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`aspirations of first-line Jevtana® approval demonstrate that Jevtana® competes in a
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`broader market than what Jevtana® is indicated for. (Exh. 1044 at ¶¶44-45). See
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`also ViiV Healthcare UK Ltd. v. Lupin Ltd., 6 F. Supp. 3d 461, 501 (D. Del. 2013).
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`25. At page 46, line 21 to page 47, line 2, Mr. McSorley confirmed that
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`“Federal Courts don’t define commercial success as requiring profitability.” At
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`page 190, lines 1-24, Mr. McSorley testified that he did not analyze and was not
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`offering an opinion on whether or not Jevtana® was profitable. This testimony is
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`relevant because neither economic expert analyzed Jevtana®’s profitability (Exh.
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`1042 at 160:19-22) making Mr. McSorley’s discussion of what Mr. Tate should
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`have included in a profit analysis irrelevant. (Exh. 1044 at ¶¶88-100).
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`26. At page 194, lines 15-20, Mr. McSorley testified that “the greater
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`majority” of branded pharmaceutical products are influenced by promotional
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`activity. At page 195, lines 8-12, Mr. McSorley testified that he did not compare
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`the amount of money Aventis spent to promote Jevtana® to the amount of money
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`other companies spent promoting their products. This testimony is relevant
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`because it undermines Mr. McSorley’s assertion that “Aventis incurred substantial
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`expenses to promote Jevtana” and that “Aventis’s efforts to promote Jevtana® have
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`been extensive.” (Exh. 1044 at ¶¶94-96, 120-23).
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`10
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`PUBLIC VERSION
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`Dated: May 15, 2017
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Attorney for Patent Owner,
`Aventis Pharma S.A.
`
`11
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`PUBLIC VERSION
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`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS ON CROSS-
`
`EXAMINATION OF MR. ROBERT MCSORLEY was served on May 15, 2017
`
`by causing it to be sent by email to counsel for Petitioner at the following email
`
`addresses:
`
`sparmelee@wsgr.com
`
`mrosato@wsgr.com
`
`jmills@wsgr.com
`
`mreed@wsgr.com
`
`namjadi@wsgr.com
`
`wdevine@wsgr.com
`
`May 15, 2017
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`PUBLIC VERSION
`
`
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