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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`and PFIZER, INC,
`Petitioners,
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`v.
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`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
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`Case IPR2018-01675
`Patent No. 8,603,044
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`PETITONER MOTION TO EXCLUDE
`37 CFR §42.64(c)
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`Case IPR2018-01675
`Patent No. 8,603,044
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`The petitioner (Mylan) seeks exclusion of patent owner (Sanofi) exhibits
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`2001-2023, 2100-2107, 2111-2153, 2158-2201, 2203-2212, 2214-2218, and 2223-
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`2225, and the redirect testimony in Mylan exhibit 1054. Except as otherwise noted,
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`the objections appear in Papers 30, 40 and 66.
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`I.
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`ARGUMENT
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`Petitioner (“Mylan”) submits the following objections:
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`A. EX2001-EX2003 – Press Releases (PR Newswire)
`EX2001-EX2003 should be excluded under Federal Rules of Evidence
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`(FRE) 402-403. They are offered to show Mylan’s clinical development and
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`commercialization of a follow-on insulin glargine product. Paper 23, 6. That
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`Mylan is developing such a product is not relevant to any contested issue in this
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`proceeding. Thus, EX2001-EX2003 lack relevance and risk confusing the issues.
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`B.
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`EX2004, EX2005, EX2007 – Sanofi Complaints, (D. Del.),
`(D.N.J.)
`EX2004, EX2005 and EX2007 should be excluded under FRE 402-403.
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`EX2004 and EX2005 are offered to show Sanofi asserted the ’044 patent against
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`other competitors. Paper 13, 6. EX2007 is offered to show that Sanofi asserted the
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`’044 patent in collateral litigation. Paper 13, 10. Whether the ’044 patent has been
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`Case IPR2018-01675
`Patent No. 8,603,044
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`asserted is not relevant to any contested issue in this proceeding. Thus, these
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`exhibits lack relevance and risk confusing the issues.
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`C. EX2006 – Stipulation and Proposed Order, (D.N.J.)
`EX2006 should be excluded under FRE 402-403. EX2006 is offered to show
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`a joint request for a trial date in collateral litigation. Paper 19, 2; Paper 23, 8. This
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`request is not relevant to any contested issue in this proceeding. Thus, EX2005
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`lacks relevance and risks confusing the issues.
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`D. EX2007-EX2010 – Mylan Invalidity Contentions, (D.N.J.)
`EX2007-EX2010 should be excluded under FRE 402-403. These exhibits
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`are offered to show that Mylan has referenced overlapping prior art as a basis for
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`invalidity in the co-pending district court case. Paper 23, 7 n.2, 10, and 11. That
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`Mylan has referenced overlapping prior art in its invalidity contentions in the
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`district court case is not relevant to any contested issue in this proceeding. Thus,
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`they lack relevance and risk confusing the issues.
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`E.
`EX2011 –Service of Sanofi’s Responses (D.N.J.)
`EX2011 should be excluded under FRE 402-403. EX2011 is offered to show
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`the date on which Sanofi served its response to Mylan’s amended invalidity
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`contentions, Paper 23, 15-16, which is not relevant to any contested issue in this
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`proceeding. Thus, EX2011 lacks relevance and risks confusing the issues.
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`Case IPR2018-01675
`Patent No. 8,603,044
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`F.
`EX2012 – MP4 file of Sanofi’s Patented Pen animation
`EX2012 should be excluded under FRE 801-804. EX2012 is offered to show
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`an animated operation of an embodiment of the injection pen described in the ’486
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`patent. Paper 23, 19. The animation is hearsay because it is offered for the truth of
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`its content without satisfying any of the hearsay exceptions.
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`G. EX2013, EX2014, EX2015 – Dictionary Excerpts
`EX2013-EX2015 should be excluded under FRE 801-804. These exhibits
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`are offered to define “helical.” Paper 23, 26-28. The definition is offered for the
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`truth of its content without satisfying any of the hearsay exceptions.
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`H. EX2016-EX2020 – Papers, (N.D. W. Va.), (D.N.J.)
`EX2016-EX2020 should be excluded under FRE 402-403. These exhibits
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`are offered to show party statements regarding the timelines of collateral litigation.
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`Paper 19, 1-4. These statements are not relevant to the issues in this proceeding.
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`These exhibits lack relevance and risk confusing the issues.
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`I.
`EX2021, EX2022 –Transcript Excerpts, (D.N.J.)
`EX2021 and EX2022 should be excluded under FRE 402-403. These
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`exhibits are offered to show comments of the district court judge and magistrate
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`judge, respectively, in collateral litigation. Paper 19, 2-3. These comments are not
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`Case IPR2018-01675
`Patent No. 8,603,044
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`relevant to any contested issues in this proceeding. Thus, these exhibits lack
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`relevance and risk confusing the issues.
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`J.
`EX2023 –Local Patent Rules, Explanatory Notes
`EX2023 should be excluded under FRE 402-403. EX2023 is offered to
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`establish the patent rules specific to the United States Court for the District of New
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`Jersey. Paper 19, 3. These rules are irrelevant to the issues in this proceeding.
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`Thus, EX20123 lacks relevance and risks confusing the issues.
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`K. EX1054 – Professor Slocum Redirect (pp. 391-406)
`Objection preserved at page 391 of the exhibit. The redirect should be
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`excluded under FRE 702(a). Professor Slocum may be an esteemed professor of
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`mechanical engineering, but that does not automatically qualify him as an expert in
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`injection pens. Indeed, he conceded that he “didn't have personal knowledge of the
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`industry at the time of the invention, so I wanted to talk to [inventor Robert
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`Veasey] who was clearly in the thick of it at the time.” Sanofi did not offer Mr.
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`Veasey as its expert on what a person of ordinary skill in the art would have known
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`or done at the relevant time; instead, it relied on Professor Slocum, who bases his
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`testimony on what Mr. Veasey told him off the record.
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`Triers of fact must exercise a gatekeeping function, “ensuring that an
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`expert's testimony both rests on a reliable foundation and is relevant to the task at
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`Patent No. 8,603,044
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`hand.” Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 580 (1993). Here,
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`Professor Slocum is used simply to launder the off-record testimony of Robert
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`Veasey, the lead inventor of the challenged patents, as well as data and a test rig
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`that Professor Slocum unquestioningly accepted from Mr. Veasey. EX1053, 30:23-
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`33:13; 37:21-38:3; 40:20-42:13; 46:23-47:2; 47:25-51:13; 54:2-22; 75:8-21; 203:2-
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`5; 209:15-213:5; EX1054, 316:22-323:18; 329:13-331:11; 332:23-333:25.
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`Professor Slocum’s lack of curiosity about the bases of his own testimony and
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`willingness to outsource his qualifications to an inventor is the most salient feature
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`of his testimony as an expert in this case. Yet the case law is clear that inventor
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`testimony must be viewed with skepticism precisely because inventors are
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`presumed to be motivated to protect their patents. E.g., Allergan, Inc. v. Apotex
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`Inc., 754 F.3d 952, 968 (Fed. Cir. 2014). Use of any testimony infected by the
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`inventor’s off-record, unexamined influence would undermine the integrity of this
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`proceeding.
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`Here, Sanofi not only fails to corroborate its inventor’s factual assertions, it
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`actively shields its inventor from cross examination by passing the inventor’s
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`untested assertions through Professor Slocum and refusing to produce Mr. Veasey
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`for cross examination on his substantial and off-the-record shaping of Dr.
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`Case IPR2018-01675
`Patent No. 8,603,044
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`Slocum’s testimony. By his own admission, Professor Slocum was not
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`knowledgeable about the relevant art at the relevant time (instead relying on an
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`inventor for his information) or about the equipment or parameters needed for his
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`ex parte testing (instead docilely accepting of any data and equipment the inventor
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`provided). Professor Slocum’s testimony in this case thus lacks the reliable
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`foundation required of expert testimony.
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`L.
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`EX2100-EX2102, EX2104-EX2106, EX2111-EX2153,
`EX2158-EX2201, EX2203-EX2212, EX2214-EX2218
`and EX2225 – exhibits not cited
`EX2100-EX2102, EX2104-EX2106, EX2111-EX2153, EX2158-EX2201,
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`EX2203-EX2212, EX2214-EX2218 and EX2225 should be excluded under FRE
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`402 and 403 because they were not discussed in the response, cannot be relevant to
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`it, and consequently serve only to confuse and create prejudice through belated
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`surprise.
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`M. EX2103 - Leinsing Deposition Exhibit 2103: Annotations of
`Figures 6-15 of Burroughs
`EX2103 should be excluded under FRE 402-403. The exhibit, hand-drawn
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`annotations made during the deposition of Mylan’s expert, is offered to establish
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`an actual modification purported to be embodied by the annotations. Sanofi’s use
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`Case IPR2018-01675
`Patent No. 8,603,044
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`of EX2103 lacks relevance, risks confusing the issues, is misleading, and is
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`prejudicial.
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`N. EX2107 – Slocum Declaration
`EX2107 should be excluded under FRE 702 for the reasons provided above
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`(in section K) for the redirect portion of EX1054.
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`Additionally, EX2107 should be excluded under FRE 702, 703 and 705
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`because it does not provide sufficient facts or data, is not the product of reliable
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`principles and methods, and has not applied the proper principles to the facts of
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`this proceeding. For example, Appendences A through F do not set forth the
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`principles used nor do they demonstrate the calculations used in generating the
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`spreadsheets. EX2107 appendix B indicates that Dr. Slocum received input values
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`from a named inventor (Veasey) but provides no independent justification for
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`relying on data about a third-party pen injector from one of the inventors. Other
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`contributions from Mr. Veasey go entirely unmentioned. As a matter of law, no
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`expert should accept uncorroborated data from an inventor as the bases for expert
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`testimony. Allergan, 754 F.3d at 968. At a minimum, the paragraphs relying on the
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`declarations—¶¶182-191, 233, 237-238, 242-255—should be excluded for failing
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`to disclose the underlying facts and data, and failing to set forth the bases of
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`Case IPR2018-01675
`Patent No. 8,603,044
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`Dr. Slocum’s opinions.
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`O. EX2117, EX2147-EX2152, EX2162, EX2167, EX2168,
`EX2206, EX2207, EX2211, EX2215-EX2218 – Animations
`EX2117, EX2147-EX2152, EX2162, EX2167, EX2168, EX2206, EX2207,
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`EX2211, and EX2215-EX2218 should be excluded under FRE 801-804. The
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`animations are offered to show animated operations of prior art and non-prior art
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`injection pens. The animations are hearsay because they are offered for the truth of
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`their contents without satisfying any of the hearsay exceptions.
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`P. EX2223 – DCA web page; EX2224 – tandfonline.com web page
`EX2223 and EX2224 should be excluded under FRE 403, 802, 901. These
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`exhibits are offered to show secondary considerations. They are hearsay without
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`exception, lack authentication, and are unreasonably prejudicial because they are
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`cited for a new purpose. EX2223 is just self-serving advertisement by an interested
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`entity.
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`Q. Limiting request
`To the extent that any exhibit or portion of an exhibit is not excluded, use of
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`the exhibit should be restricted to the use for which it was originally submitted.
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`FRE 105.
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`Case IPR2018-01675
`Patent No. 8,603,044
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`II. CONCLUSION
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`Exhibits 2001-2024, 2100-2107, 2111-2153, 2158-2201, 2203-2212, 2214-
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`2218, and 2223-2225, and the redirect testimony in Mylan exhibit 1054 should be
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`excluded.
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`Dated: 9 December 2019
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`Respectfully submitted,
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`/Wesley E. Derryberry/
`Wesley E. Derryberry,
`First Back-up Counsel
`Reg. No. 71,594
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`-9-
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`Case IPR2018-01675
`Patent No. 8,603,044
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`CERTIFICATE OF SERVICE
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`I certify that this paper was served today on the electronic service addresses
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`of Sanofi as follows:
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`Elizabeth Stotland Weiswasser
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`elizabeth.weiswasser@weil.com
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`Anish R. Desai
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`Sundip K. Kundu
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`anish.desai@weil.com
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`sundip.kundu@weil.com
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`Kathryn M. Kantha
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`kathryn.kantha@weil.com
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`William S. Ansley
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`Matthew D. Sieger
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`Adrian C. Percer
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`Brian C. Chang
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`Robert T. Vlasis
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`sutton.ansley@weil.com
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`matthew.sieger@weil.com
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`adrian.percer@weil.com
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`brian.chang@weil.com
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`robert.vlasis@weil.com
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`WEIL, GOTSHAL & MANGES LLP
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`Sanofi.IPR.Service@weil.com
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`John S. Goetz, Joshua A. Griswold,
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`PTABInbound@fr.com
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`Matthew S. Colvin, Kenneth W. Darby
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`and W. Karl Renner
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`and on joinder counsel as follows:
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`Case IPR2018-01675
`Patent No. 8,603,044
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`Jovial Wong
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`Charles B. Klein
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`Dan H. Hoang
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`jwong@winston.com
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`cklein@winston.com
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`dhoang@winston.com
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`WINSTON & STRAWN LLP
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`PfizerIPRs@winston.com
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`Dated: 9 December 2019
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`Respectfully submitted,
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`/Wesley E. Derryberry/
`Wesley E. Derryberry,
`First Back-up Counsel
`Reg. No. 71,594
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`-11-
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