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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MYLAN PHARMACEUTICALS INC.
`and PFIZER INC.,
`Petitioners,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`_____________________________
`
`Case No. IPR2018-01675
`Patent No. 8,603,044
`_____________________________
`
`PETITIONERS’ RESPONSE TO PATENT OWNER’S OBSERVATIONS
`ON TESTIMONY OF MR. KARL LEINSING
`
`
`
`Case No. IPR2018-01675
`Patent No. 8,603,044
`
`During his December 3, 2019, testimony, Mr. Leinsing explained numerous
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`flaws in arguments presented by Patent Owner Sanofi-Aventis Deutschland Gmbh
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`(“PO”). PO’s Observations (Paper 75; “Obs.”) omit key portions of that testimony
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`and other relevant context in an attempt to resuscitate those arguments.
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`Observation no. 1 – PO inaccurately characterizes Mr. Leinsing’s statements
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`on injection force by omitting portions of his testimony. PO quotes Mr. Leinsing as
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`stating “I wouldn’t say there’s a lot of focus on [reducing injection force]” and that
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`“it is a factor, but it’s not an important factor.” Obs., 1 (citing EX2227, 336:25-
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`337:14). However, Mr. Leinsing noted that injection force was “one of many
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`considerations” and that “as we saw” (referencing evidence from PO’s own pen
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`designers) “it doesn't rank as high as some others, but it's definitely a
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`consideration.” EX2227, 336:25-337:5. Pressed again, he explained:
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`I wouldn't say there's a lot of focus on that one thing or that it's
`important because it didn't rank, even by Sanofi or the developers of
`the -- you know, of the device, that it was even ranked a three versus
`a five. So it's not a very important factor. It is a factor, but it's not an
`important factor.
`Id., 337:6-14 (emphasis added). His complete testimony thus makes clear that he
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`was making the unassailable point, backed up by documents from PO’s own pen
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`designers, that injection force was just one of many factors considered by pen
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`designers, including PO’s own engineers.
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`PO also incorrectly characterizes Mr. Leinsing’s testimony as contradictory
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`by again ignoring context. Obs., 1. In his allegedly contradictory IPR testimony,
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`Mr. Leinsing responded to questions specifically addressing the importance of
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`acceptable injection force for insulin pens, not the relative importance of injection
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`force compared to other factors. EX2163, 80:10-81. The importance of avoiding
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`excessive injection force is entirely consistent with his subsequent testimony that
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`injection force was one of many design considerations. Regardless, neither the
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`claims nor the applied references are limited to insulin injectors or a particular
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`injection force, and obviousness does not require proof that a modification
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`optimizes a single, cherry-picked design factor. PO’s first observation is thus
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`inaccurate and, in the context of a proper obviousness inquiry, irrelevant.
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`
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`Observation no. 2 – PO’s focus on the original FlexPen’s injection force is a
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`red herring. The FlexPen product is not a reference in any ground in this IPR, and
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`design flaws in the FlexPen’s button have nothing to do with the ability of a person
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`of ordinary skill in the art (“POSA”) to apply ordinary creativity—including
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`common-sense solutions like lubricant or adjusting collar size—to reduce friction
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`on a driver tube’s collar. PO thus continues to focus exclusively on injection force,
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`ignoring other design considerations, the reference’s express motivation, and its
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`own expert’s admissions regarding expectations of success. See EX1115, 526:6-12.
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`
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`Additionally, PO incorrectly characterizes Mr. Leinsing’s testimony as
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`contradictory. PO accuses Mr. Leinsing of contradicting himself by noting that a
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`POSA could use ordinary creativity to mitigate any added collar friction on the
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`driver tube. Obs., 2-3. However, in testimony omitted by PO, Mr. Leinsing
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`explained that FlexPen’s “huge” redesign involved the button, not the driver:
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`Q: …So they did, in fact, go through a huge design process, right?
`A. Yes. As I said, on the button. It wasn't on the whole device, it was
`just on the button.
`EX2227, 339:11-14 (emphasis added). Mr. Leinsing’s testimony is thus entirely
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`consistent with his IPR testimony, since the scope of Novo Nordisk’s efforts to
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`redesign the FlexPen’s button has nothing to do with a POSA’s ability to address
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`collar friction in the context of Steenfeldt-Jensen’s driver tube.
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`
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`Observation no. 3 – PO attacks Mr. Leinsing’s credibility by again omitting
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`portions of his testimony. PO quotes the first portion of Mr. Leinsing’s testimony
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`stating that he first encountered the original FlexPen in 2002. Obs., 3 (citing
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`EX2227, 328:25-329:9). PO then selectively quotes from his IPR testimony to
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`create the incorrect impression that Mr. Leinsing only became aware of the original
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`FlexPen about two years ago. Obs., 3 (citing EX2227, 329:6-330:18). To achieve
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`this, PO removes the portion of Mr. Leinsing’s testimony where he clarified that
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`the pen he was referencing from two years ago was the Next Generation FlexPen,
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`not the original:
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`That was my testimony, understanding what the difference was
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`- 3 -
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`between we were talking about original and Next Generation. So
`when you are asking me that question, I didn't understand what you
`were talking about original. And I didn't even know when I was
`looking at that pen back then whether that one was original or not
`with the name. So that's what I was talking about.
`EX2227, 330:6-12.
`
`Indeed, Mr. Leinsing had already clarified this misunderstanding during his
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`IPR testimony. See EX2163, 120:13-121:25. Following the portion of his IPR
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`testimony read in district court and quoted in Observation No. 3, Mr. Leinsing
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`immediately clarified that, in his project from two years ago, he was “just looking
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`at the new pen”. Id., 120:20-121:9. He then further clarified that he was already
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`aware of a previous Novo Nordisk pen as of 2003:
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`Q. [I]n 2003, at that time, what pen injectors were you aware of?
`A. I was mostly just aware of what Eli Lilly had. I believe Novo
`Nordisk. There might have been some other ones. That's all I can
`remember since 2003. It was a long time ago.
`Id., 121:17-25 (emphasis added). These clarifications make it clear that Mr.
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`Leinsing’s description of his work with old and new FlexPens has been consistent.
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`
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`Observation no. 4 – Contrary to PO’s suggestion, the Court did not confirm
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`that Mr. Leinsing was successfully impeached by the attacks now presented by PO
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`in observations nos. 1-3. The Court was addressing a dispute regarding whether
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`PO’s prior attempt to hire Mr. Leinsing as an expert witness was relevant to PO’s
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`- 4 -
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`impeachment attacks. EX2227, 354:13-355:25. In the portion quoted by PO, the
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`Court was explaining that it did not view PO’s attempts to hire Mr. Leinsing as
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`relevant because PO’s impeachment attacks were based on specific testimony, not
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`his qualifications generally. See EX2227, 356:2-11. The omitted portion shows that
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`the Court was simply noting that PO’s attempt to hire Mr. Leinsing was a “very
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`different” issue from PO’s “impeachment attacks”, not expressing an opinion on
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`the merits of those attacks. Id., 356:7-14.
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`Observation no. 5 –Mr. Leinsing’s explanation that the net change in
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`injection force would be “very close to a wash” is consistent with his description of
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`certain changes to Dr. Slocum’s spreadsheet reducing the increase from 51% to 25-
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`30%. EX2227, 341:6-342:22. PO conveniently omits Mr. Leinsing’s explanation
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`that adjustments to the coefficient of friction and collar diameter alone achieved
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`the 25-30% figure, and that use of a conventional thrust washer would decrease
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`friction even further, making it essentially a “wash”. EX2227, 342:2-17. PO also
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`ignores the spreadsheet’s exclusion of concomitant reductions elsewhere in the
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`mechanism (e.g., the elimination of friction at the pressure foot). EX1115, 561:19-
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`563:6 (admitting omission). PO also complains that Mr. Leinsing did not save the
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`spreadsheet, yet PO declined his offer to recreate the modified spreadsheet during
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`trial. EX2227, 342:18-22. PO thus again inaccurately characterizes Mr. Leinsing’s
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`testimony by omitting relevant portions of the transcript.
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`- 5 -
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`
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`Case No. IPR2018-01675
`Patent No. 8,603,044
`
`
`
`
`Date: 27 December 2019
`
`
`Respectfully submitted,
`
`/Wesley E. Derryberry/
`Wesley E. Derryberry, Reg. No. 71,594
`
`- 6 -
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`
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`Case No. IPR2018-01675
`Patent No. 8,603,044
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`CERTIFICATE OF SERVICE
`
` I
`
` certify that this paper was served today on the electronic service addresses
`
`of Sanofi as follows:
`
`Elizabeth Stotland Weiswasser
`
`elizabeth.weiswasser@weil.com
`
`Anish R. Desai
`
`Sundip K. Kundu
`
`Kathryn M. Kantha
`
`William S. Ansley
`
`Matthew D. Sieger
`
`Adrian C. Percer
`
`Brian C. Chang
`
`Robert T. Vlasis
`
`anish.desai@weil.com
`
`sundip.kundu@weil.com
`
`kathryn.kantha@weil.com
`
`sutton.ansley@weil.com
`
`matthew.sieger@weil.com
`
`adrian.percer@weil.com
`
`brian.chang@weil.com
`
`robert.vlasis@weil.com
`
`WEIL, GOTSHAL & MANGES LLP
`
`Sanofi.IPR.Service@weil.com
`
`John S. Goetz, Joshua A. Griswold,
`
`PTABInbound@fr.com
`
`Matthew S. Colvin, Kenneth W. Darby
`
`and W. Karl Renner
`
`and on joinder counsel as follows:
`
`
`
`
`
`- 7 -
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`
`
`Case No. IPR2018-01675
`Patent No. 8,603,044
`
`Jovial Wong
`
`Charles B. Klein
`
`Dan H. Hoang
`
`jwong@winston.com
`
`cklein@winston.com
`
`dhoang@winston.com
`
`WINSTON & STRAWN LLP
`
`PfizerIPRs@winston.com
`
`
`
`
`Date: 27 December 2019
`
`
`Respectfully submitted,
`
`
`/Wesley E. Derryberry/
`Wesley E. Derryberry, Reg. No. 71,594
`
`
`
`- 8 -
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`
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