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 IPR2018-016761
`Patent No. 8,603,044
`_____________________________
`
`PETITIONERS’ OBSERVATIONS REGARDING THE
`TESTIMONY OF ALEXANDER SLOCUM, Ph.D.
`
`1 To maintain uniformity and to simplify the Board’s review of Petitioners’
`
`observations across nine related IPRs, all nine papers present the same set of
`
`observations.
`
`
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MYLAN PHARMACEUTICALS INC.
`and PFIZER INC.,
`Petitioners,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`_____________________________
`
`Case IPR2018-016761
`Patent No. 8,603,044
`_____________________________
`
`PETITIONERS’ OBSERVATIONS REGARDING THE
`TESTIMONY OF ALEXANDER SLOCUM, Ph.D.
`
`1 To maintain uniformity and to simplify the Board’s review of Petitioners’
`
`observations across nine related IPRs, all nine papers present the same set of
`
`observations.
`
`
`
`Case IPR2018-01676
`Patent No. 8,603,044
`
`1.
`
`Dr. Slocum testified that he had no personal experience designing injector
`
`pens as of March 2003 (EX1115, 518:17-23), which is relevant to Petitioners’
`
`position that his testimony should be excluded or at least given little to no weight.
`
`Paper 64 (“Motion to Exclude”), 5-8. It is also relevant to Petitioners’ position that
`
`a person of ordinary skill in the art (“POSA”) would have been motivated to
`
`modify the injector-pen references, because it shows that Dr. Slocum, who disputes
`
`that motivation, lacks familiarity with the relevant aspects of injector-pen design.
`
`Paper 2 (“Petition”), 40-42, 76-79; Paper 46 (“Reply”), 11-18.
`
`2.
`
`Dr. Slocum testified that he had no evidence to support his assertion that
`
`Steenfeldt-Jensen’s express suggestion to provide a threaded driver tube was added
`
`by lawyers rather than the inventors. EX1115, 526:6-12. This is relevant to
`
`Petitioners’ position that a POSA would have been motivated to modify Steenfeldt-
`
`Jensen as proposed within the reference itself, and would have had no reason to
`
`ignore the reference’s express suggestion, because it shows that Dr. Slocum’s
`
`justification that this suggestion was merely a “lawyer add-on” is not supported by
`
`any evidence. Petition, 40-42; Reply, 9-10.
`
`3.
`
`Dr. Slocum testified that Steenfeldt-Jensen expressly proposes an
`
`embodiment where the driver tube has an internal thread instead of a slot, and wall
`
`4 has a slot instead of a thread, and that a POSA would have been able to
`
`accomplish this modification. EX1115, 526:6-12. This is relevant to Petitioners’
`
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`Case IPR2018-01676
`Patent No. 8,603,044
`
`position that a POSA would have been motivated to modify the reference as
`
`proposed with a reasonable expectation of success. Petition, 40-42; Reply, 2-8.
`
`4.
`
`Dr. Slocum testified that Steenfeldt-Jensen’s first and fifth embodiments
`
`have very similar drive mechanisms and force chains for injection. EX1115,
`
`531:12-22. This is relevant to Petitioners’ position that Steenfeldt-Jensen’s
`
`suggestion of alternative embodiments (with a threaded driver tube and a wall with
`
`flats) equally applies to the fifth embodiment, because it shows that the aspects of
`
`the drive mechanism implicated by the proposed modification are the same in the
`
`first and fifth embodiments. Petition, 40-42; Reply, 2-8.
`
`5.
`
`Dr. Slocum testified that Steenfeldt-Jensen includes a claim describing a
`
`threaded driver tube that rotates relative to a threaded piston rod to drive the piston
`
`rod distally during injection. EX1115, 534:16-542:21. This is relevant to
`
`Petitioners’ position that Steenfeldt-Jensen does suggest a threaded driver tube
`
`satisfying the recited drive sleeve. Petition, 40-42; Reply, 2-3.
`
`6.
`
`Dr. Slocum testified that Robert Veasey, an inventor of the challenged
`
`patent, provided key bases for Dr. Slocum’s opinions. EX1115, 546:18-552:23.
`
`This is relevant to Petitioners’ position that Dr. Slocum’s testimony should be
`
`excluded or at least given little to no weight. Reply, 11-14; Motion to Exclude, 5-8.
`
`It is relevant because it shows that Dr. Slocum lacked the relevant knowledge of
`
`the field and instead relied on an interested party to provide numerous, critical
`
`- 2 -
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`Case IPR2018-01676
`Patent No. 8,603,044
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`bases for his opinions.
`
`7.
`
`Dr. Slocum testified that, despite knowing that lubricious plastics could have
`
`coefficients of friction of 0.08 or lower, he followed Mr. Veasey’s instructions to
`
`use 0.1 because of Dr. Slocum’s own lack of experience with pen injectors.
`
`EX1115, 552:24-555:12. This is relevant to Petitioners’ position that Dr. Slocum is
`
`not qualified as an expert in this proceeding and that the underlying bases for his
`
`testimony were not his own. Motion to Exclude, 5-8. It is also relevant to
`
`Petitioners’ position that Dr. Slocum’s assessment of Steenfeldt-Jensen is
`
`unreliable, because it shows that a key variable for the injection-force calculation
`
`was controlled by an inventor of the challenged patent. Reply, 11-14.
`
`8.
`
`Dr. Slocum testified that, in his spreadsheet purporting to calculate injection
`
`force in Steenfeldt-Jensen’s fifth embodiment, using a lower coefficient of friction
`
`or a smaller collar diameter would lower the injection force. EX1115, 555:13-
`
`557:19, 559:24-561:14. This is relevant to Petitioners’ position that Dr. Slocum’s
`
`assessment of Steenfeldt-Jensen is flawed, because it shows why the flawed
`
`assumptions of the model provided by Mr. Veasey skew the results. Reply, 15-16.
`
`9.
`
`Dr. Slocum testified that he disagreed that 0.05 was a reasonable coefficient
`
`of friction for his calculations. EX1114, 463:13-16. Yet he also testified that in an
`
`earlier book, he wrote that sliding contact bearings (the type of interface addressed
`
`in his “collar friction” testimony) have coefficients of friction between 0.05 and
`
`- 3 -
`
`
`
`Case IPR2018-01676
`Patent No. 8,603,044
`
`0.1 (EX1115, 557:22-559:19) and that he would have used 0.05 if Mr. Veasey had
`
`suggested it (Id., 555:5-12). This is relevant to Petitioners’ position that Dr.
`
`Slocum’s Steenfeldt-Jensen analysis is unreliable and flawed, because it shows that
`
`he chose the highest coefficient of friction from his previously published range,
`
`and because it shows that his present-day view regarding coefficients of friction
`
`contradicts his previously published views. Reply, 15-16. It is also relevant to
`
`Petitioners’ position that Dr. Slocum did not provide critical bases for his
`
`testimony, because it shows that he adopted Mr. Veasey’s suggestions over his
`
`own previously published views. Reply, 11-14; Motion to Exclude, 5-8.
`
`10. Dr. Slocum testified that his assertion of a 51% increase in injection force
`
`was based on calculations that only factored in points of added friction without
`
`considering points of reduced friction elsewhere in the mechanism. EX1115,
`
`561:19-563:6. This is relevant to Petitioners’ position that Dr. Slocum’s
`
`assessment is flawed, because it shows that his calculation skewed the result by
`
`omitting any points of reduced friction. Reply, 14.
`
`11. Dr. Slocum testified that the specification has only one embodiment
`
`(EX1115, 576:21-577:16), that this embodiment does not have an internally
`
`threaded piston rod (Id., 586:2-7), that none of the purported examples of internally
`
`threaded piston rods he identified were injector pens (Id., 586:8-587:1), and that he
`
`did not search injector-pen art to see whether internally-threaded piston rods were
`
`- 4 -
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`
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`Case IPR2018-01676
`Patent No. 8,603,044
`
`conventional in injector pens as of 2003 (Id., 587:2-8). This is relevant to
`
`Petitioners’ position in a related IPR that claims 21-30 of the ’844 patent are not
`
`entitled to the claimed priority date because the earlier applications do not support
`
`the claims’ full scope. IPR2018-01680, Paper 2, 15-18; IPR2018-01680, Paper 52,
`
`2-6.
`
`12. Dr. Slocum testified that he identified no pre-2003 documents showing
`
`injection force was the sole motivating factor in injector-pen design. EX1115,
`
`591:17-23. This is relevant to Petitioners’ position that Dr. Slocum’s analysis of
`
`the proposed modifications is flawed, because it shows that his opinion on what
`
`purportedly motivated injector-pen designers was based on statements made after
`
`the earliest claimed priority date. Reply, 10-11, 21-24, 26.
`
`13. Dr. Slocum testified that when SoloSTAR pen was released, another pen
`
`with low injection force and a similar number of components was available.
`
`EX1115, 591:35-592:21. This is relevant to Petitioners’ position that the touted
`
`benefits did not drive Lantus SoloSTAR’s sales, because it shows that alternative
`
`insulin pens with the same purported benefits (albeit with different insulin
`
`formulations) were available. IPR2018-01682, Paper 2 (-1682 Reply”), 22-27.
`
`Date: 20 December 2019
`
`Respectfully submitted,
`
`/Wesley E. Derryberry/
`Wesley E. Derryberry, Reg. No. 71,594
`
`- 5 -
`
`
`
`Case IPR2018-01676
`Patent No. 8,603,044
`
`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
`
`anish.desai@weil.com
`
`sundip.kundu@weil.com
`
`Kathryn M. Kantha
`
`kathryn.kantha@weil.com
`
`William S. Ansley
`
`Matthew D. Sieger
`
`Adrian C. Percer
`
`Brian C. Chang
`
`Robert T. Vlasis
`
`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:
`
`- 6 -
`
`
`
`Case IPR2018-01676
`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
`
`Respectfully submitted,
`
`Date: 20 December 2019
`
`
`/Wesley E. Derryberry/
`Wesley E. Derryberry, Reg. No. 71,594
`
`- 7 -
`
`
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