UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed: March 5, 2021
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN INSTITUTIONAL LLC and PFIZER INC.,
`Petitioners,
`
`v.
`
`NOVO NORDISK A/S,
`
`Patent Owner.
`
`Case No. IPR2020-003241
`U.S. Patent No. 8,114,833
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`
`REDACTED VERSION
`
`1
`
`IPR2020-01252 has been joined with this proceeding.
`
`
`
`Filed: March 5, 2021
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN INSTITUTIONAL LLC and PFIZER INC.,
`Petitioners,
`
`v.
`
`NOVO NORDISK A/S,
`
`Patent Owner.
`
`Case No. IPR2020-003241
`U.S. Patent No. 8,114,833
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`
`REDACTED VERSION
`
`1
`
`IPR2020-01252 has been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`FACTUAL BACKGROUND .......................................................................... 1
`PORTIONS OF INVENTOR TESTIMONY BY DORTHE
`KOT ENGELUND, AND ANY RELIANCE THEREON,
`SHOULD BE EXCLUDED ............................................................................ 2
`PORTIONS OF THE TESTIMONY OF NOVO’S EXPERT,
`DR. TESSIER, AND ANY RELIANCE THEREON, SHOULD
`BE EXCLUDED .............................................................................................. 6
`EXHIBITS 2013, 2014, 2020, 2021, 2049, AND 2061, AND
`ANY RELIANCE ON THEM, SHOULD BE EXCLUDED ....................... 11
`A.
`The Exhibits Lack Authentication and Relevance .............................. 12
`B.
`The Exhibits Constitute Improper Hearsay ......................................... 14
`EXHIBITS 2018-2019 SHOULD BE EXCLUDED ..................................... 15
`
`I.
`II.
`
`III.
`
`IV.
`
`V.
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`Air Turbine Tech., Inc. v. Atlas Copco AB,
`410 F.3d 701 (Fed. Cir. 2005) .............................................................................. 5
`
`Black & Decker v. Bosch Tools,
`No. 04 C 7955, 2006 WL 5156873 (N.D. Ill. Sept. 8, 2006) ............................... 7
`Fail–Safe, L.L.C. v. A.O. Smith Corp.,
`744 F. Supp. 2d 870 (E.D. Wis. 2010) ................................................................. 7
`Forest Labs., LLC v. Sigmapharm Labs., LLC,
`918 F.3d 928 (Fed. Cir. 2019) .............................................................................. 2
`
`Frontier Therapeutics, LLC v. Medac Gesellschaft Für Klinische
`Spezialpräparate MBH,
`IPR2016-00649, Paper 10 (P.T.A.B. Sept. 1, 2016) ........................................... 14
`In re Soni,
`54 F.3d 746 (Fed. Cir. 1995) ................................................................................ 2
`Info-Hold, Inc. v. Muzak LLC,
`No. 11-cv-283, 2013 WL 4482442 (S.D. Ohio Aug. 20, 2013) aff’d
`in relevant part, 783 F.3d 1365 (Fed. Cir. 2015) ........................................... 6, 11
`MGM Well Services, Inc. v. Mega Lift Sys., LLC,
`No. H-05-1634, 2007 WL 150606 (S.D. Tex. Jan. 16, 2007) aff’d
`without op., 264 F. App’x 900 (Fed. Cir. 2008) ............................................. 6, 11
`Mylan Pharm.Inc. v. Boehringer Ingelheim Int’l GmbH,
`IPR2016-01566, Paper 15 (P.T.A.B. Feb. 3, 2017) ............................................ 14
`Pfizer, Inc. v. Biogen, Inc.,
`IPR2017-01166, Paper 9 (P.T.A.B. Nov. 13, 2017) ........................................... 14
`Standard Oil Co. v. Am. Cyanamid Co.,
`774 F. 2d 448 (Fed. Cir. 1985) ......................................................................... 2, 4
`
`State Farm Fire & Casualty Co. v. Electrolux Home Prods., Inc.,
`980 F. Supp. 2d 1031 (N.D. Ind. 2013) ................................................................ 7
`
`ii
`
`
`
`Xactware Sols., Inc. v. Pictometry Int’l Corp.,
`IPR2016-00594, Paper 46 (P.T.A.B. Aug. 24, 2017) ......................................... 13
`OTHER AUTHORITIES
`37 C.F.R. § 42.61 ....................................................................................................... 1
`37 C.F.R. § 42.62 ....................................................................................................... 1
`37 C.F.R. § 42.64 ....................................................................................................... 1
`37 C.F.R. § 42.65 ................................................................................................. 7, 11
`Fed. R. Evid. 402 ............................................................................................. 3, 7, 13
`Fed. R. Evid. 403 ................................................................................................... 3, 7
`Fed. R. Evid. 701 ................................................................................................... 3, 6
`Fed. R. Evid. 702 ..................................................................................... 3, 5, 6, 7, 11
`Fed. R. Evid. 703 ....................................................................................................... 7
`Fed. R. Evid. 801 ..................................................................................................... 14
`Fed. R. Evid. 802 ..................................................................................................... 15
`Fed. R. Evid. 901 ............................................................................................... 12, 13
`
`iii
`
`
`
`Pursuant to 37 C.F.R. §§ 42.61(a), 42.62, and 42.64(c), Petitioners move to
`
`exclude the following:
`
`(1) Paragraphs 13, 16-33, 35-43, 45-48, 50-52, and 54-64 of Exhibit 2023
`
`(Engelund Declaration), and Novo’s citations to, and reliance on, those
`
`paragraphs;
`
`(2) Paragraphs 51, 62-63, 87, 89-103, 105-107, 124, 127, 207-209, 265-267,
`
`270, 272-273, 277, and 280 of Exhibit 2022 (Tessier Declaration), and
`
`Novo’s citations to, and reliance on, those paragraphs;
`
`(3) Exhibits 2018 and 2019, and Novo’s citations to, and reliance on, those
`
`exhibits; and
`
`(4) Exhibits 2013, 2014, 2041, 2049, and 2061, and Novo’s citations to, and
`
`reliance on, those exhibits.
`
`I.
`
`FACTUAL BACKGROUND
`This proceeding involves a challenge to U.S. Patent No. 8,114,833 (“the
`
`’833 patent”), which claims GLP-1 agonist formulations and methods related
`
`thereto. Following institution on June 23, 2020, Petitioners filed objections to
`
`evidence submitted by Novo with its Preliminary Response on July 7, 2020. Paper
`
`18. On September 18, 2020, Novo filed its Response, including Exhibits 2022-
`
`2082. See Papers 20, 25. On September 25, 2020, Petitioners timely filed
`
`objections. Paper 23. For the reasons explained more fully below, Petitioners now
`
`1
`
`
`
`move to exclude several exhibits.
`
`II.
`
`PORTIONS OF INVENTOR TESTIMONY BY DORTHE KOT
`ENGELUND, AND ANY RELIANCE THEREON, SHOULD BE
`EXCLUDED
`Unexpected results are often used to support the patentability of challenged
`
`claims. However, to inform the obviousness analysis, the determination as to
`
`whether a result is expected or unexpected must be made from the perspective of a
`
`person of ordinary skill in the art (“POSA”). Forest Labs., LLC v. Sigmapharm
`
`Labs., LLC, 918 F.3d 928, 937 (Fed. Cir. 2019) (“In considering unexpected
`
`results, courts ask whether ‘the claimed invention exhibits some superior property
`
`or advantage that a person of ordinary skill in the relevant art would have found
`
`surprising or unexpected.’” (emphasis added) (citation omitted)); In re Soni, 54
`
`F.3d 746, 750 (Fed. Cir. 1995) (same). Thus, under Federal Circuit case law, the
`
`obviousness inquiry does not include the inventors’ own subjective beliefs,
`
`including what they would or would not have expected. See Standard Oil Co. v.
`
`Am. Cyanamid Co., 774 F. 2d 448, 454 (Fed. Cir. 1985) (“[O]ne should not go
`
`about determining obviousness under § 103 by inquiring into what patentees (i.e.,
`
`inventors) would have known or would likely have done, faced with the revelations
`
`of references.”). Ms. Engelund’s Declaration presents nothing more and thus
`
`cannot be probative of patent validity.2
`
`2 Petitioner objected to the Engelund Declaration on several grounds including,
`
`2
`
`
`
`
`
`Novo offers Ms. Engelund’s Declaration to purportedly “show that
`
`propylene glycol unexpectedly and surprisingly reduced clogging and deposits
`
`compared to mannitol.” Ex. 2023 ¶8. According to the Declaration, Novo tested
`
`several candidate isotonicity agents, including propylene glycol (“PG”), in
`
`preliminary screening assays, along with several other agents. See, e.g., Exs. 2052,
`
`2053, 2057, 2058, 2059, 2060, 2063, 2064, 2065, 2068, 2071, 2072. Notably, PG
`
`was readily identified by the inventors as an isotonic agent known in the art. Ex.
`
`2023 ¶25. Ms. Engelund describes these initial studies (Ex. 2023 ¶¶23-53) as well
`
`as more recent tests (Ex. 2023 ¶¶60 -63), and opin es as to PG’s perform ance as
`
`compared to the other agents. Ex. 2023 ¶¶57, 64. She concludes by opining that
`
`Novo’s conventional excipient screening assays yielded a result she did not expect,
`
`namely, that PG was so mehow superior to other agents. Ex. 2023 ¶¶57-64. But
`
`even if true, Ms. Engelund’s alleged surprise is not evidence of nonobviousness for
`
`at least two reasons.
`
`First, Ms. Engelund offers the opinion of an inventor, not of a POSA. As
`
`described above, in order for evidence of unexpected results to support
`
`nonobviousness, a patentee must demonstrate what would have been unexpected to
`
`a POSA, not the subjective beliefs of the inventors. Yet not only did Ms. Engelund
`
`fail to offer any evidence directed to this objective inquiry, she admitted at
`
`inter alia, under Fed. R. Evid. 402, 403, 701, and 702. Paper 23, 3, 10-12.
`
`3
`
`
`
`deposition that she was not even aware that this is the appropriate standard. Ex.
`
`1078, 211:7-213:19. In fact, when asked if she was familiar with the concept of a
`
`POSA, Ms. Engelund confirmed she was not:
`
`So the term unexpected results has a particular legal meaning when it
`Q.
`comes to patents, and that legal meaning is viewed objectively from the
`perspective of what’s known as what [sic] a person of skill in the art. Are
`you familiar with that concept?
`A.
`No.
`Ex. 1078, 211:21-212:6 (objections omitted). Instead, Ms. Engelund confirmed
`
`that her opinions on unexpected results set forth in her Declaration were simply
`
`based on her own subjective experience, not that of a POSA:
`
`Okay. So the statements that you’ve made in your declaration and
`Q.
`your testimony today are from your subjective personal perspective of what
`unexpected results means, and not from the perspective of one skilled in the
`art; is that right?
`A. What’s stated here regarding unexpected results, that is based on the
`observations, based on all of the studies that we have made.
`Q.
`Okay. And that’s your personal perspective, and not from the more
`objective point of view from a person of skill in the art; is that right?
`A.
`That is based on all the results we have obtained in all these tests.
`Q.
`Right. And it’s from your perspective personally, correct?
`A.
`Yes. That is based on all the studies we have made regarding the
`different excipients we have tested to replace mannitol.
`Ex. 1078, 212:8-213:11 (objections omitted and emphasis added).
`
`Because her opinion is merely her own, divorced from the proper legal
`
`standard, Ms. Engelund’s testimony regarding unexpected results is irrelevant to
`
`the issue of unexpected results and to obviousness. Standard Oil, 774 F.2d at 454.
`
`4
`
`
`
`
`
`Thus, her testimony does not belong in this proceeding for any purpose, and it
`
`should be excluded or given no weight.
`
`Second, Ms. Engelund is not offered as an expert. In addition to improperly
`
`opining on unexpected results, Ms. Engelund’s Declaration also purports to
`
`interpret Exhibits 2073 -2075, which are Novo internal scientific studies and
`
`protocols in which she did not participate and had no personal familiarity with. Ex.
`
`2023 ¶¶60-64; Ex. 1078, 221:10-12 (Q. Are you familiar with the protocol that was
`
`performed in this case [discussing Ex. 2073]? A. No.); Ex. 1078, 223:20-224:13
`
`(as to Ex. 2074, Ms. Engelund “did not participate in performing the study, and . . .
`
`did not participate in writing the report or concluding on the results; but at a certain
`
`time point . . . received a copy of the report” and that her testimony was based on
`
`“reading the conclusions of this particular document”); id. at 22 7:2-9 (similar
`
`testimony on Ex. 2075). As a lay witness, Ms. Engelund is permitted only to testify
`
`based on her own personal experience or perception – not as to testing and analysis
`
`she did not perform; because Novo has not offered her as an expert witness, she is
`
`precluded from opining as
`
`to “scientific,
`
`technical, or other specialized
`
`knowledge” that falls within the scope of Fed. R. Evid. 702. Air Turbine Tech., Inc.
`
`v. Atlas Copco AB, 410 F.3d 701, 714 (Fed. Cir. 2005) (affirming district court
`
`conclusion that inventor’s opinion “amounted to improper expert testimony”). Ms.
`
`Engelund’s improper expert testimony on Exhibits 2073-2075 should be excluded
`
`5
`
`
`
`
`
`or given no weight.
`
`Accordingly, the Board should exclude paragraphs 13, 16-33, 35-43, 45-48,
`
`50-52, and 54-64 of Exhibit 2023, or give them no weight, because they constitute
`
`improper expert testimony by a lay witness under Fed. R. Evid. 701. The Board
`
`should also strike or give no weight to material that relies on those paragraphs, at
`
`least on page 48 of Patent Owner’s Response (Paper 25) and in paragraphs 63, 98,
`
`103, 105, 270, 272-273, and 277 of the Tessier Declaration (Ex. 2022).
`
`III.
`
`PORTIONS OF THE TESTIMONY OF NOVO’S EXPERT, DR.
`TESSIER, AND ANY RELIANCE THEREON, SHOULD BE
`EXCLUDED
`An expert’s opinion must be based on “reliable principles and methods” and
`
`must “reliably appl[y] the principles and methods to the facts of the case.” Fed. R.
`
`Evid. 702. To satisfy the standards for reliability under Rule 702, “an expert’s
`
`testimony must be based on independent analysis and objective proof.” Info-Hold,
`
`Inc. v. Muzak LLC, No. 11-cv-283, 2013 WL 4482442, at *5 (S.D. Ohio Aug. 20,
`
`2013) aff’d in relevant part, 783 F.3d 1365 (Fed. Cir. 2015). Under this standard,
`
`“[o]pinions are excludable if they are supported only by the ipse dixit of the
`
`expert.” MGM Well Services, Inc. v. Mega Lift Sys., LLC, No. H-05-1634, 2007
`
`WL 150606, at *4 (S.D. Tex. Jan. 16, 2007) aff’d without op., 264 F. App’x 900
`
`(Fed. Cir. 2008) (nonprecedential). As explained in State Farm Fire & Casualty
`
`Co. v. Electrolux Home Prods., Inc., “‘[w]hen an expert bases her opinion on
`
`6
`
`
`
`
`
`information supplied by another,’ particularly a party, ‘the Court[ ] must focus on
`
`the reliability of the expert’s foundation.’” 980 F. Supp. 2d 1031, 1049 (N.D. Ind.
`
`2013) (alterations in original) (quoting Black & Decker v. Bosch Tools, No. 04 C
`
`7955, 2006 WL 5156873, at *1 (N.D. Ill. Sept. 8, 2006)). Thus, in State Farm, the
`
`court excluded an expert’s analysis and opinions where that analysis was based on
`
`data supplied from a party that the expert did nothing to independently verify. 980
`
`F. Supp. 2d at 1049; see also Fail–Safe, L.L.C. v. A.O. Smith Corp., 744 F. Supp.
`
`2d 870, 888 (E.D. Wis. 2010) (holding defendant’s expert’s reliance on
`
`defendant’s own data, which he did not independently verify, rendered his opinion
`
`unreliable).
`
`The same is true of the analysis of Novo’s expert, Dr. Peter M. Tessier,
`
`Ph.D. Ex. 2022.3 Several paragraphs of the Tessier Declaration are based entirely
`
`on information provided by Novo, parrot information in the Engelund Declaration,
`
`and accept assumptions stated in internal Novo documents absent any independent
`
`analysis. This fails to meet the threshold for reliability under Fed. R. Evid. 702.
`
`As one example, Novo’s unexpected results argument is predicated on
`
`screening assays
`
`that Novo employees conducted analyzing formulations
`
`3 Petitioner objected to the Tessier Declaration on several grounds including, inter
`
`alia, under Fed. R. Evid. 402, 403, 702, and 703; and 37 C.F.R. § 42.65(a). Paper
`
`23, 3, 10-12.
`
`7
`
`
`
`
`
`containing different isotonicity agents, e.g., mannitol and PG. See, e.g., Ex. 2023
`
`¶¶24-34, 57; see also Exs. 205 3, 2057, 2058, 2059, 2065, 2072. H owever, the
`
`formulations included in these tests did not contain active ingredient; as Dr. Tessier
`
`acknowledged during his deposition that placebo formulations (i.e., “media”)
`
`lacking a GLP-1 agonist were used to test alternative isotonic agents. Ex. 1077,
`
`62:22-63:19; Ex. 2053. But the claims at issue require that the formulations contain
`
`a GLP-1 agonist. Absent this claim element, there can be no nexus between the
`
`claims and the results in Novo’s internal studies.
`
`In an attempt to remedy this lack of nexus, Dr. Tessier relies on an internal
`
`Novo study that conveniently concluded (with no analysis) that tests using placebo
`
`formulations yielded the same results as tests conducted with active ingredients.
`
`Ex. 1077, 62:22 -63:19; Ex. 2053. But Dr . Tessier never perform ed any
`
`independent analysis to verify whether that conclusion was true—or even whether
`
`the “active ingredient” tests were conducted at all. Instead, Dr. Tessier blindly
`
`adopted the conclusion at face value without question. Ex. 1077, 63:14 -19 (“So it
`
`does look like these are placebo - placebo formulations that are being used. But it
`
`also looks like the inventors are claiming that they get similar results. And so they
`
`have a justification for doing that, and I would have no reason to doubt that.”
`
`(emphasis added)). Dr. Tessier’s unquestioning acceptance of Novo emp loyees’
`
`conclusions is not expert opinion. Novo cannot use Dr. Tessier as a conduit to
`
`8
`
`
`
`
`
`cloak inadmissible hearsay in the guise of expert opinion.
`
`The record is replete with other instances where Dr. Tessier simply parrots
`
`the views of others with no independent analysis:
`
`Unexpected Results: In paragraphs 265-267, 270, 272, 273, and 277 of his
`
`Declaration, Dr. Tessier offer “opinions” related to unexpected results that simply
`
`parrot Ms. Engelund’s improper opinions. As discussed above, Ms. Engelund, an
`
`interested party, offers testimony based solely on her personal perspective. Ex.
`
`1078, 212:8-213:19; supra at 5. Dr. Tessier, in turn, relies almost exclusively on
`
`Ms. Engelund’s Declaration in opining on unexpected results. The shortcomings of
`
`the Engelund Declaration cannot be remedied by restating Ms. Englund’s opinions
`
`in Dr. Tessier’s words. As expert testimony, Dr. Tessier’s testimony fails because
`
`it does not consider obviousness from the perspective of a POSA. Indeed, Dr.
`
`Tessier admitted that he could not answer whether he considered Ms. Engelund’s
`
`testimony to be presented from the perspective of a POSA “because [he] didn’t
`
`review her qualifications, in terms of her education, what degree she has. And so
`
`[he] did not review her background in enough detail to answer that question.” Ex.
`
`1077, 3 2:9-19. That incuriousness does not lay a foundation fo r reliable expert
`
`testimony.
`
`Engelund’s Work: Paragraphs 89-98 of the Tessier Declaration simply
`
`repeat Ms. Engelund’s summary of her work (compare with Ex. 2023 ¶¶24-27, 28-
`
`9
`
`
`
`
`
`29, 31-59 of the Engelund Declaration), adding nothing to Dr. Engelund’s own
`
`description.
`
`Novo Internal Studies: Paragraphs 99-103 of the Tessier Declaration merely
`
`restate Dr. Engelund’s summary (Ex. 2023 ¶¶60-64) of studies performed to test
`
`the stability of liraglutide formulations containing PG as compared to those
`
`containing glycerol.
`
`Invention and RTP: To prov e actual reduction to practice, the inventors
`
`must have produced an embodiment that meets every limitation of the claimed
`
`invention; and the inventors must have appreciated whether that embodiment
`
`worked for its intended purpose; here, reducing deposits and clogs in a GLP -1
`
`agonist formulation. Paragraphs 106-107 and 208-209 of the Tessier Declaration
`
`purport to opine on the date of invention and reduction to practice, but instead,
`
`they merely repeat Ms. Engelund’s testimony (Ex. 2023 ¶¶12, 37, and 54-56)
`
`related to these topics.
`
`It is undisputed that the inventors only tested placebo formulations—and
`
`never a formulation that included a GLP-1 agonist—in their drop, clogging , or
`
`simulated fill tests before ,
`
`the date the invention was purportedly
`
`reduced to practice. Although t hose tests form the core of Dr. Tessier’s opin ion
`
`that the inventions of the ’833 patent had been reduced to practice by that date (see
`
`Ex. 2022 ¶¶16, 84, 106-107, 203, 207-209, 280), his Declaration is silent as to how
`
`10
`
`
`
`
`
`they meet the standard for actual reduction to practice. As a result, Dr. Tessier’s
`
`opinions relating thereto are not only unreliable, but are in violation of 37 C.F.R.
`
`§ 42.65(a) for failing to identify the underlying facts or data on which his opinion
`
`is based.
`
`* * *
`
`It is improper for an expert to form opinions based solely on the facts and
`
`data from another without conducting his or her own investigation or independent
`
`verification. Info-Hold, 2013 WL 4482442, at *5; State Farm, 980 F. Supp. 2d at
`
`1049. That is what Dr. Tessier has done. As such, his opinions are “at best an effort
`
`to synthesize [Novo’s] positions and present them summarily as an expert
`
`opinion.” MGM Well Servs., 2007 WL 150606, at *4. For the aforementioned
`
`reasons, the Board should exclude paragraphs 89-103, 106-107, 207-209, 265-267,
`
`270, 272-273, 277, and 280 of Exhibit 2022, or give them no weight, as unreliable
`
`and unhelpful under Fed. R. Evid. 702 and in violation of 37 C.F.R. § 42.65(a).
`
`Further, the Board should strike material on pages 46-51 of the Patent Owner
`
`Response, which relies on those paragraphs of Exhibit 2023 as substantive
`
`evidence.
`
`IV.
`
`EXHIBITS 2013, 2014, 2020, 2021, 2049, AND 2061, AND ANY
`RELIANCE ON THEM, SHOULD BE EXCLUDED
`Novo relies on the following documents, which they purport are drug labels,
`
`prescribing information, or package inserts, as well as a document purported to be
`
`11
`
`
`
`
`
`an FDA guidance document:4
`
`• Exhibit 2013 is identified by Novo as “Humira® Package Insert (revised
`01/2003)”;
`
`• Exhibit 2014 is identified by Novo as “Norditropin® Approved Labeling
`(revised 05/2000)”;
`
`• Exhibit 2020 is identified by Novo as “Omnitrope® Highlights of
`Prescribing Information (dated 06/2009)”;
`
`• Exhibit 2021 is identified by Novo as “U.S. Food & Drug Admin., New and
`Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision
`2), Guidance for Industry (Dec. 2018) (“FDA Draft Guidance”)”;
`
`identified by Novo as “Highlights of Prescribing
`is
`• Exhibit 2049
`Information, Revised 08/2020 (“Victoza® Prescribing Information”)”; and
`
`• Exhibit 2061 is identified as “Center for Drug Evaluation and Research
`‘Final Printed Labeling – Application Number 21-319: FORTEO’ (2002).”
`For the reasons set forth below, these exhibits should be excluded.
`
`The Exhibits Lack Authentication and Relevance
`A.
`To properly authenticate evidence, “the proponent must produce evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.” Fed.
`
`R. Evid. 901(a). On their face, Exhibits 2013, 2014, 2020, 2021, 2049, and 2061 do
`
`not contain any distinctive or authenticating characteristics. Nor does Novo submit
`
`4 Petitioner objected to Exhibits 2013, 2014, 2020, 2021, 2049, and 2061 on
`
`several grounds including, inter alia, hearsay, relevance, and for lacking
`
`authentication. Paper 18, 4-5; Paper 23, 6-7, 10-12. Novo did not serve any
`
`supplemental evidence in response to these objections to these Exhibits.
`
`12
`
`
`
`
`
`any testimonial evidence regarding where Exhibits 2013, 2014, and 2061 were
`
`obtained, when they were obtained, who created them, whether they are a true and
`
`correct copy of documents known to Novo, or when—or if—Exhibits 2013, 2014,
`
`2020, and 2061 were purportedly available to the public. Thus, Exhibits 2013,
`
`2014, and 2061 lack authentication and should be excluded under Fed. R. Evid.
`
`901.
`
`Exhibit 2013 also appears to be a printout from a website. To authenticate
`
`information on a webpage, as with any evidence, a proponent
`
` must present
`
`testimony from a witness with personal knowledge of the website at issue that the
`
`document is what it is claimed to be. Fed. R. Evid. 901; see also Xactware Sols. ,
`
`Inc. v. Pictometry Int’l Corp., IPR2016-00594, Paper 46, 12 (P.T.A.B. Aug. 24,
`
`2017) (excluding printouts from a website). But Novo failed to provide testimony
`
`from any witness with personal knowledge of the contents of Exhibit 2013.
`
`Moreover, even if those documents were properly authenticated, Novo has
`
`failed to establish when or if Exhibits 2013, 2014, 2020, 2021, 2049, and 2061
`
`were available to the public, much less whether those exhibits qualify as prior art
`
`to the ’833 patent. As such, those exhibits lack relevance to any issue in this
`
`proceeding under Fed. R. Evid. 402 and/or 403. In particular, as to Exhibits 2013,
`
`2014, and 2016, the Board has routinely determined that drug labels are not prior
`
`art absent a sufficient showing otherwise, including additional evidence to support
`
`13
`
`
`
`that the drug labels in question were actually available to the public prior to the
`
`priority date of the relevant patent. See, e.g., Pfizer, Inc. v. Biogen, Inc., IPR2017-
`
`01166, Paper 9, 14 (P.T.A.B. Nov. 13, 2017) (drug label not shown to be prior art);
`
`Mylan Pharm. Inc. v. Boehringer Ingelheim Int’l GmbH, IPR2016-01566, Paper 15
`
`(P.T.A.B. Feb. 3, 2017) (same); Frontier Therapeutics, LLC v. Medac Gesellschaft
`
`Für Klinische Spezialpräparate MBH, IPR2016-00649, Paper 10 (P.T.A.B. Sept. 1,
`
`2016) (same).
`
`Accordingly, the Board should exclude Exhibits 2013, 2014, 2020, 2021,
`
`2049, and 2061, or give them no weight. Further, the Board should strike or give
`
`no weight to the material that relies on those exhibits as substantive exhibits,
`
`specifically, pages 7, 47, 52, 54 n.3, and 57 of the Response (Paper 25) and
`
`paragraphs 51, 62, 87, 124, and 127 of the Tessier Declaration (Ex. 2022).
`
`The Exhibits Constitute Improper Hearsay
`B.
`Hearsay is “a statement that: (1) the declarant does not make while testifying
`
`at the current trial or hearing; and (2) a party offers in evidence to prove the truth
`
`of the matter asserted in the statement.” Fed. R. Evid. 801(c). Exhibits 2013, 2014,
`
`and 2016 plainly meet this definition, and do not fall within any hearsay exception.
`
`Novo offers these exhibits for the truth of its assertion that prior art products
`
`used mannitol to adjust tonicity and that mannitol was recommended as an
`
`isotonicity agent without any report of crystallization issues. Paper 25, 7, 47, 52;
`
`14
`
`
`
`Ex. 2022 ¶¶58, 69. Novo offers Exhibit 2020 for truth of its assertion regarding
`
`Sandoz’s product storage instructions and Sandoz’s alleged “choice” to use
`
`mannitol instead of PG. Ex. 2022 ¶¶124, 127; Paper 25, 54 n.3 . Novo offers
`
`Exhibit 2021 for truth of its assertion that the FDA sees GLP-1 and hGH as falling
`
`within distinct categories of molecules. Paper 25, 57. Novo offers Exhibit 2049 for
`
`truth of its assertion regarding storage conditions for Victoza. Ex. 2022 ¶¶51, 124.
`
`Accordingly, Exhibits 2013, 2014, 2020, 2021, 2049, and 2061 should be excluded
`
`or given no weight as hearsay under Fed. R. Evid. 802. Further, the Board should
`
`strike or give no weight to the material that relies on those exhibits as substantive
`
`exhibits, specifically, pages 7, 47, 52, 54 n.3, and 57 of the Response (Paper 25)
`
`and paragraphs 51, 62, 87, 124, and 127 of the Tessier Declaration (Ex. 2022).
`
`V.
`
`EXHIBITS 2018-2019 SHOULD BE EXCLUDED
`Exhibits 2018 and 2019 are articles that were cited in the Preliminary
`
`Response but were not cited in subsequent filings. As such, they are not cited in the
`
`Patent Owner Response, Sur-Reply, or in any Declaration. Exhibits 2018 and 2019
`
`should, therefore, be excluded as irrelevant to any outstanding issue in this
`
`proceeding.
`
`15
`
`
`
`Dated: March 5, 2021
`
`/s/ Lara J. Dueppen
`Lara J. Dueppen
`Reg. No. 65,002
`
`Counsel for Petitioner Mylan
`Institutional LLC
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing redacted version of Petitioners’ Motion to Exclude
`
`Evidence by email to the electronic service addresses for Patent Owner and
`
`Petitioner Pfizer Inc.:
`
`Jeffrey Oelke
`Laura T. Moran
`Ryan P. Johnson
`FENWICK & WEST LLP
`joelke@fenwick.com
`laura.moran@fenwick.com
`ryan.johnson@fenwick.com
`Novo833IPR@fenwick.com
`Counsel for Patent Owner
`
`Thomas J. Meloro
`Michael W. Johnson
`WILLKIE FARR & GALLAGHER LLP
`tmeloro@willkie.com
`mjohnson1@willkie.com
`Counsel for Petitioner Pfizer Inc.
`
`Dated: March 16, 2021
`
`/s/ Lara J. Dueppen
`Lara J. Dueppen
`Reg. No. 65,002
`
`Counsel for Petitioner Mylan
`Institutional LLC
`
`
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