`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`SLAYBACK PHARMA LLC,
`
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`__________________
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
`
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`Table of Contents
`
`I.
`II.
`
`Page
`EX-2023, ¶ 7 and Portions of Exhibit 1052 Should Not Be Excluded ........... 1
`EX-2156 and EX-2023, ¶ 14-18 Should Not Be Excluded ............................. 4
`EX-2156 Is Admissible ......................................................................... 4
`EX-2023, ¶¶ 14-18 Are Admissible ...................................................... 9
`III. Exhibits 2152-2155 and EX-2023, ¶ 6 Should Not Be Excluded .................10
`IV. Conclusion .....................................................................................................11
`
`
`
`
`
`
`
`i
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Air Land Forwarders, Inc. v. United States,
`172 F. 3d 1338 (Fed. Cir. 1999) ........................................................................... 7
`Bianco v. Globus Med., Inc.,
`No. 2:12-CV-00147-WCB, 2014 WL 119284 (E.D. Tex. Jan. 12,
`2014) ..................................................................................................................... 6
`Boehringer Ingelheim Animal Health USA Inc. v. Kansas State Univ.
`Rsch. Found.,
`PGR2020-00076, Paper 42 (P.T.A.B. Jan. 31, 2022) ........................................... 3
`Fambrough v. Walmart Stores, Inc.,
`611 Fed. App’x 322 (6th Cir. 2015) ................................................................. 7, 8
`FLIR Sys., Inc. v. Leak Surveys, Inc.,
`IPR2014-00411, Paper 113 (P.T.A.B. Sept. 3, 2015)........................................... 1
`In re Lyman Good Dietary Supplements Litig.,
`No. 17-CV-8047 (VEC), 2020 WL 3414927 (S.D.N.Y. June 22,
`2022) ..................................................................................................................... 8
`Mgmt., Inc. v. Incredible Pizza Co.,
`No. CV 08-04310 MMM, 2009 WL 8591607 (C.D. Cal. July 14,
`2009) ..................................................................................................................... 6
`Purdue Pharma L.P. v. DepoMed, Inc.,
`IPR2014-00379, Paper 72 (P.T.A.B. July 8, 2015) ............................................ 10
`Puzhen Life USA, LLC v. ESIP Series 2, LLC,
`IPR2017-02197, Paper 24 (P.T.A.B. Feb. 27, 2019) ............................................ 3
`Sanofi-Aventis U.S. LLC v. Immunex Corp.,
`IPR2017-01879, Paper 88 (P.T.A.B. Feb. 14, 2019) .......................................... 10
`Smith & Nephew Inc. v. ConforMIS, Inc.,
`IPR2017-00115, Paper 33 (P.T.A.B. Apr. 19, 2018) ........................................... 1
`
`ii
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`Telebrands Corp. v. Tinnus Enters., LLC,
`PGR2016-00030, Paper 91 (P.T.A.B. Feb. 7, 2018) ........................................ 5, 6
`Rules
`Fed. R. Evid. 602 ....................................................................................................... 2
`Fed. R. Evid. 701 ................................................................................................... 2, 3
`Fed. R. Evid. 702 ............................................................................................. 3, 9, 10
`Fed. R. Evid. 703 ................................................................................................... 3, 4
`Fed. R. Evid. 803 ........................................................................................... 5, 6, 7, 9
`Fed. R. Evid. 1006 ................................................................................................. 2, 4
`Regulations
`37 C.F.R. § 42.20 ....................................................................................................... 1
`37 C.F.R. § 42.64 ....................................................................................................... 3
`
`
`iii
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`Patent Owner respectfully requests the Board deny Petitioner’s motion to
`
`exclude (Paper 57, “Mot.”)1 because Petitioner failed to timely preserve its
`
`objections and show that the exhibits requested to be excluded are inadmissible
`
`under the Federal Rules of Evidence. See 37 C.F.R. § 42.20(c); Smith & Nephew
`
`Inc. v. ConforMIS, Inc., IPR2017-00115, Paper 33 at 67 (P.T.A.B. Apr. 19, 2018)
`
`(“As movant, Patent Owner has the burden of showing that an exhibit is not
`
`admissible.”); FLIR Sys., Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113 at
`
`5 (P.T.A.B. Sept. 3, 2015) (“In our proceedings it is the opponent [of the
`
`challenged evidence] who bears the burden of establishing inadmissibility of an
`
`exhibit.”).
`
`I.
`
`EX-2023, ¶ 7 and Portions of Exhibit 1052 Should Not Be Excluded
`Exhibit 2023 is a declaration of Mr. John Ferris, Senior Vice President,
`
`Global Consumer within the Bausch + Lomb family of companies (“Bausch”). EX-
`
`2023, ¶ 3. Paragraph 7 of his declaration discusses the market success of Lumify—
`
`a commercial embodiment of the ’742 patent—based on a third-party study
`
`
`1 Patent Owner will not be filing a motion to seal the portions of Petitioner’s
`motion to exclude and Patent Owner’s opposition thereto despite the fact that these
`papers address confidential exhibits and deposition testimony because these papers
`discuss such information at a sufficiently high level that the details of those
`confidential materials is not revealed.
`
`1
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`commissioned by Bausch. See EX-2023, ¶ 7; EX-1051, 17:19-20:6. Exhibit 1052 is
`
`the deposition transcript of Mr. John Jarosz, Patent Owner’s economics expert who
`
`opined on commercial success of Lumify. The portions Petitioner objected to relate
`
`to, inter alia, reliability of IQVIA data and how “virtually every pharmaceutical
`
`firm relies upon” it as “the gold standard data on shipments and prescriptions and
`
`volumes and revenues and prices for a variety of therapies.” EX-1052, 105:10-
`
`107:16.
`
`Petitioner argues that the exhibits should be excluded because they
`
`constitute improper expert testimony from Mr. Ferris, who was never introduced as
`
`an expert in this case, opining on “specific statistics about the use of Lumify.”
`
`Mot., 2. This is irrelevant. Paragraph 7 is admissible as a summary to prove
`
`content of voluminous IQVIA data that cannot be conveniently examined in court.
`
`Fed. R. Evid. 1006. Contrary to Petitioner’s complaint that it “had no ability to
`
`challenge the basis for these data,” (Mot., 3), Petitioner already deposed Mr. Ferris
`
`on the underlying IQVIA data, which Patent Owner’s counsel offered to produce.
`
`See EX-1051, 17:16-20:6. But Petitioner never asked for it.
`
`Also, Mr. Ferris is a lay fact witness who can provide opinion testimony
`
`based on his review of the IQVIA data, which is routinely collected at Bausch for
`
`market research purposes. Fed. R. Evid. 701; EX-1051, 18:6-19:8. Thus, Paragraph
`
`7 is proper opinion testimony by Mr. Ferris as a lay witness that is rationally based
`
`2
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`on Mr. Ferris’s perception of the IQVIA data, and it is helpful to clearly
`
`understanding the witness’s testimony and to determining facts relating to
`
`objective indicia of non-obviousness, including commercial success and industry
`
`praise. See Fed. R. Evid. 701, 602. And stating what he saw in the IQVIA data
`
`does not require any scientific, technical, or other specialized knowledge within the
`
`scope of Rule 702. See Fed. R. Evid. 701.
`
`Petitioner next argues that EX-1052, 105:5-107:17 should be excluded
`
`because it relies on EX-2023, ¶ 7, and “is unsupported by any facts or data that are
`
`in the record of this proceeding.” Mot., 4. As a threshold matter, Petitioner’s
`
`motion should be denied for failing to properly preserve its objections. There is no
`
`objection in EX-1052, 105:5106:4. See 37 C.F.R. § 42.64(a); Puzhen Life USA,
`
`LLC v. ESIP Series 2, LLC, IPR2017-02197, Paper 24, 52-61 (P.T.A.B. Feb. 27,
`
`2019). As for the remaining portions, Petitioner only lodged a “beyond the scope”
`
`objection, and thus, it waived any other objections Petitioner raised in the motion.
`
`Id., 106:8-107:17. Boehringer Ingelheim Animal Health USA Inc. v. Kansas State
`
`Univ. Rsch. Found., PGR2020-00076, Paper 42, 45 (P.T.A.B. Jan. 31, 2022)
`
`(denying a motion to exclude portions of a deposition transcript as hearsay because
`
`no hearsay objection was preserved during the deposition).
`
`Furthermore, as explained above, Mr. Jarosz relied on the IQVIA data in Mr.
`
`Ferris’s declaration. See EX-2023, ¶ 7; EX-1051, 17:16-19:18. As an expert, Mr.
`
`3
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`Jarosz “may base an opinion on facts or data in the case that the expert has been
`
`made aware of or personally observed.” Fed. R. Evid. 703. And Mr. Jarosz
`
`confirmed in his deposition that such IQVIA data are routinely collected and relied
`
`upon by pharmaceutical companies. See EX-1052, 105:5-107:17. Thus, EX-2023,
`
`¶ 7 and EX-1052, 105:5-107:17 are the type of facts and data that an expert like
`
`Mr. Jarosz would reasonably rely on in forming an opinion on objective indicia of
`
`non-obviousness, which “need not be admissible for the opinion to be admitted.”
`
`Fed. R. Evid. 703.
`
`II. EX-2156 and EX-2023, ¶ 14-18 Should Not Be Excluded
` EX-2156 Is Admissible
`EX-2156 is entitled “Lumify ECP A&U Report,” which is a report of a
`
`survey conducted by a third-party Ipsos Healthcare (“Ipsos”) on behalf of Bausch
`
`for market research purposes. EX-2023, ¶ 14. Ipsos is “a known, reputable
`
`service,” whose surveys “would be generally accepted and relied upon in the
`
`industry.” EX-2023, ¶ 14. In his declaration, Mr. Ferris summarized, based on his
`
`review of the report, the protocols that Ipsos used and the results of the survey. See
`
`EX-2023, ¶¶ 14-18.
`
`Petitioner argues that EX-2156 is inadmissible hearsay, arguing that “Patent
`
`Owner has not presented any evidence that establishes Exhibit 2156 as falling into
`
`an exclusion or exception to the rule against hearsay.” Mot., 5. This is incorrect.
`
`4
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`EX-2156 is admissible as a summary report to prove the content of voluminous
`
`Ipsos survey results that cannot be conveniently examined in court. Fed. R. Evid.
`
`1006. EX-2156 is the original report from Ipsos, which contains the underlying
`
`data. See EX-2156. Patent Owner submitted several pieces of evidence
`
`demonstrating that EX-2156 qualifies for the market reports and similar
`
`commercial publications exception under Rule 803(17), and the business records
`
`exception under Rule 803(6).
`
`EX-2156 qualifies as a market report or a similar commercial publication
`
`that is “generally relied on by the public or by persons in particular occupations.”
`
`Fed. R. Evid. 803(17). First, Mr. Ferris confirmed—as the SVP of Global
`
`Consumer with more than 15 years of experience in marketing, sales, and
`
`commercial leadership positions—that Ipsos surveys, including EX-2156, are
`
`generally accepted and routinely relied upon in the industry. EX-2023, ¶ 14.
`
`Second, Patent Owner produced a declaration from Mr. Robert Gorman Jr., Senior
`
`Vice President, Assistant General Counsel, Global Intellectual Property within
`
`Bausch, confirming that “this type of survey is routinely conducted and relied upon
`
`in the industry,” including Bausch. EX-2215, ¶ 8. Petitioner conspicuously failed
`
`to address any of this.
`
`Petitioner argues that the Rule 803(17) exception does not apply because it
`
`applies only to “compilations of data, not to narrative and potentially subjective
`
`5
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`assessments,” citing Telebrands Corp. v. Tinnus Enters., LLC, PGR2016-00030,
`
`Paper 91, 58-59 (P.T.A.B. Feb. 7, 2018). As an initial matter, the cited paper from
`
`Telebrands has been expunged from the record, making it impossible to verify
`
`whether the facts of that case are applicable here. Petitioner’s motion states that the
`
`panel in Telebrands quoted Bianco v. Globus Med., Inc., No. 2:12-CV-00147-
`
`WCB, 2014 WL 119284, at *1 (E.D. Tex. Jan. 12, 2014)), which is inapplicable
`
`here. There, the Texas court held that “stock analysist reports” do not qualify for
`
`the exception under Rule 803(17) because “they contain a substantial amount of
`
`subjective analysis of Globus, its prospects, and its position in the market for
`
`medical devices.” Id. at *2. Unlike the stock analyst reports in Bianco, which are
`
`mostly based on subjective and speculative analysis of a company’s position in the
`
`market, EX-2156 was generated based on actual data collected from a survey
`
`conducted based on Ipsos’s protocols and statistical analysis. See EX-2023, ¶¶ 14-
`
`18; EX-2156, 3-7. Petitioner’s reliance on Mgmt., Inc. v. Incredible Pizza Co., No.
`
`CV 08-04310 MMM (PLAx), 2009 WL 8591607, at *24 (C.D. Cal. July 14, 2009)
`
`is also misplaced. There, the court held it cannot determine whether the reports at
`
`issue qualify for the Rule 803(17) exception because they have been redacted of
`
`“all substantive content” and “neither party has produced unredacted copies of
`
`reports.” Id.
`
`6
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`EX-2156 also qualifies for the business records exception under Rule 803(6)
`
`because Mr. Ferris established that EX-2156 was made by Ipsos at Bausch’s
`
`request, Bausch kept the survey report in the course of regularly conducted market
`
`research activities of Bausch, and making the survey report was a regular practice
`
`of Bausch’s sales and marketing activities. EX-2023, ¶ 14; EX-1051, 22:19-23:7,
`
`23:15-27:16. And Petitioner failed to show that the source of information or the
`
`method or circumstances of preparation indicate a lack of trustworthiness. Fed. R.
`
`Evid. 803(17). In fact, uncontroverted evidence shows that Ipsos is well known in
`
`the pharmaceutical industry “for completing surveys such as this and for high-
`
`quality research and data.” EX-1051, 23:22-24:3.
`
`Petitioner argues EX-2156 does not qualify for the business records
`
`exception because “Patent Owner has supplied no foundational testimony from the
`
`third party to establish how the document was generated” and Mr. Ferris “has
`
`never been employed by Ipsos and has no knowledge of how they create or retain
`
`their documents.” Mot., 6. Petitioner misses the mark. As explained above, Patent
`
`Owner provided the foundational testimony from Mr. Ferris to establish the
`
`business records exception. And Mr. Ferris need not have been an Ipsos employee
`
`or have personal knowledge of how Ipsos generates its documents. See Fambrough
`
`v. Walmart Stores, Inc., 611 Fed. App’x 322, 329 (6th Cir. 2015) (“Courts have
`
`generally agreed that ‘Rule 803(6) does not require that the document actually be
`
`7
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`prepared by the business entity proffering the document … [and] would allow an
`
`incorporated document to be admitted based upon the foundation testimony of a
`
`witness with first-hand knowledge of the record keeping procedures of the
`
`incorporating business, even though the business did not actually prepare the
`
`document.” (quoting Air Land Forwarders, Inc. v. United States, 172 F. 3d 1338,
`
`1343 (Fed. Cir. 1999) (collecting cases)). As Mr. Ferris repeatedly testified, EX-
`
`2156 was generated by Ipsos at Bausch’s request, and Petitioner does not, and
`
`cannot, challenge that Mr. Ferris has personal knowledge about how Bausch
`
`commissions market research studies and its record keeping procedures. See EX-
`
`1051, 9:17-10:12, 22:17-23:7, 24:5-25:4, 25:12-27:4, 29:10-17, 30:6-20, 32:10-
`
`33:11.
`
`Petitioner relies on two cases, both of which are unavailing. It cites
`
`Fambrough, where the Sixth Circuit held that the records at issue do not qualify for
`
`the business records exception because there was no evidence showing that two of
`
`the requirements of the business records exception are met. 611 Fed. App’x at 326-
`
`27. In this proceeding, Patent Owner provided evidence showing that all
`
`requirements are met. In re Lyman Good Dietary Supplements Litig., No. 17-CV-
`
`8047 (VEC), 2020 WL 3414927, at *3–6 (S.D.N.Y. June 22, 2022) is also
`
`inapposite because the records at issue were lab reports generated in anticipation of
`
`litigation, and there was no witness to lay appropriate foundation or provide a
`
`8
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`certification that the requirements of the business records exception are met. Id. at
`
`*3. In contrast, here, Patent Owner submitted two declarations and deposition
`
`testimony from Bausch employees who have personal knowledge of EX-2156 and
`
`how these survey reports are generated and maintained at Bausch.
`
`EX-2023, ¶¶ 14-18 Are Admissible
`
`Petitioner argues that paragraphs 14-18 of Mr. Ferris’s declaration should be
`
`excluded as inappropriate expert testimony and inadmissible hearsay for relying on
`
`EX-2156. Mot., 7-8. These arguments fall flat. As explained above, as a lay fact
`
`witness, Mr. Ferris is entitled to provide opinion testimony under Rule 701.
`
`Paragraphs 14-18 of his declaration are based on his review of the EX-2156, his
`
`opinion is helpful to clearly understanding his testimony about the facts supporting
`
`objective indicia of non-obviousness, including commercial success and industry
`
`praise. Because Mr. Ferris is reporting the results recorded in EX-2156, his opinion
`
`is not based on scientific, technical, or other specialized knowledge within the
`
`scope of Rule 702.
`
`Also, paragraphs 14-18 of EX-2023 are not hearsay for the same reasons
`
`EX-2156 is not hearsay, and Mr. Ferris’s declaration provides ample foundational
`
`testimony to establish the hearsay exceptions under Rule 803(6) and 803(17).
`
`9
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`III. Exhibits 2152-2155 and EX-2023, ¶ 6 Should Not Be Excluded
`Exhibits 2152-2155 are website printouts of news articles and magazines
`
`available on the Internet stating that Lumify won various awards. Petitioner argues
`
`that these are “impermissible hearsay” under Rule 802. Petitioner, however, fails to
`
`recognize that these documents qualify for the Rule 803(17) exception. EX-2152 is
`
`a news article published on PR Newswire, a distributor of press releases. Its press
`
`releases are generally relied on by the public and people in the pharmaceutical
`
`industry, including Petitioner. In fact, Petitioner itself submitted a press release
`
`printed from PR Newswire as an exhibit in this proceeding. See EX-1082. Exhibits
`
`2153-2155 are printouts of online magazines, which are generally relied on by the
`
`public. Notably, Petitioner does not argue, and fails to point to any evidence, that
`
`Exhibits 2153-2155 are not reliable.
`
`Petitioner repeats the same arguments for EX-2023, paragraph 6. As a lay
`
`witness, Mr. Ferris can provide opinion testimony regarding Exhibits 2153-2155
`
`based on his perception of the documents, which is helpful to clearly understanding
`
`his testimony and to determining the facts that support the objective indicia of non-
`
`obviousness, including commercial success and industry praise. And Mr. Ferris’s
`
`testimony is not based on scientific, technical, or other specialized knowledge
`
`within the scope of Rule 702, which Petitioner does not dispute.
`
`10
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`Lastly, Petitioner argues, without any supporting case law, that the Board
`
`should exclude the evidence even if it does not rely on it in its Final Written
`
`Decision. Mot., 1-2. As a threshold matter, the objected-to exhibits are admissible
`
`for the reasons explained above. And the Board routinely denies a motion to
`
`exclude when it does not rely on the objected-to exhibits in its decision. See
`
`Sanofi-Aventis U.S. LLC v. Immunex Corp., IPR2017-01879, Paper 88, 25
`
`(P.T.A.B. Feb. 14, 2019); Purdue Pharma L.P. v. DepoMed, Inc., IPR2014-00379,
`
`Paper 72, 32-33 (P.T.A.B. July 8, 2015). It need not waste its judicial resources
`
`adjudicating admissibility of evidence that it does not rely on merely because of
`
`the possibility that Patent Owner may rely on it on appeal.
`
`IV. Conclusion
`For at least the foregoing reasons, Petitioner’s motion to exclude should be
`
`denied.
`
`Date: February 13, 2023
`
`Respectfully submitted,
`
`
`
`
`
`
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Reg. No. 32,409
`Justin J. Hasford, Reg. No. 62,180
`Caitlin E. O’Connell, Reg. No. 73,934
`Christina Ji-Hye Yang, Reg. No. 79,103
`
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`
`11
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Opposition to
`
`
`
`Petitioner’s Motion to Exclude was served electronically via email on February
`
`13, 2023, in its entirety on the following:
`
`Linnea P. Cipriano
`Goodwin Proctor LLP
`620 Eight Avenue
`New York, NY 10018
`lcipriano@goodwinlaw.com
`
`Louis H. Weinstein
`Patrick G. Pollard
`Windels Marx Lane & Mittendorf, LLC
`1 Giralda Farms
`Madison, NJ 07940
`lweinstein@windelsmarx.com
`ppollard@windelsmarx.com
`
`Robert Frederickson III
`Goodwin Proctor LLP
`100 Northern Avenue
`Boston, MA 02210
`rfrederickson@goodwinlaw.com
`
`Petitioner has consented to service by electronic mail.
`
`
`
`
`
`
`
`
`
` /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
`
`Dated: February 13, 2023
`
`
`
`
`
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
