`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-007221
`U.S. Patent No. 7,041,786
`__________________
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
`
`
`
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`

`

`
`
`
`I.
`
`II.
`
`
`TABLE OF CONTENTS
`
`Case IPR2022-00722
`Patent No. 7,041,786
`
`i
`
`Exhibits 2024 and 2025 (Davies and Waldman Declarations) Are
`Admissible ....................................................................................................... 1
`A. Drs. Davies’ and Waldman’s Lead Compound Arguments Are
`Legally Proper ....................................................................................... 2
`Dr. Davies Applied the Correct Standard for Reasonable
`Expectation of Success .......................................................................... 4
`Drs. Davies and Waldman Correctly Understood Li (Ex. 1006) .......... 5
`C.
`D. Dr. Davies’ Opinions Concerning pKa Values Are Proper and
`Should be Considered ............................................................................ 6
`Drs. Davies and Waldman Provide Reliable Testimony
`Regarding Human Uroguanylin’s Topoisomeric Instability ................. 7
`Exhibits 2027 and 2028 (Preclinical Study Report Nos. SP-PH-001
`and SP-PH-004) Are Admissible ..................................................................... 9
`A.
`The Preclinical Study Reports Satisfied the Authenticating /
`Identifying Requirements Under FRE 901 ........................................... 9
`The Contents of Exhibits 2027 and 2028 Are Records of a
`Regularly Conducted Activity Under FRE 803(6) .............................10
`The Probative Value of the Preclinical Study Reports Is Not
`Outweighed by a Danger of Unfair Prejudice Under FRE 403 ..........11
`III. Exhibit 2040 (Pennington Letter) Is Admissible ...........................................12
`A.
`The Letter Satisfies the Authenticating / Identifying
`Requirements Under FRE 901 ............................................................12
`The Letter Constitutes a Record of a Regularly Conducted
`Activity Under FRE 803(6) .................................................................13
`The Probative Value of the Letter Is Not Outweighed by a
`Danger of Unfair Prejudice Under FRE 403 .......................................15
`IV. Conclusion .....................................................................................................15
`
`B.
`
`E.
`
`B.
`
`C.
`
`B.
`
`C.
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`

`

`
`
`
`TABLE OF AUTHORITIES
`
`Case IPR2022-00722
`Patent No. 7,041,786
`
` Page(s)
`
`Federal Cases
`Altana Pharma AG. v. Teva Pharms.,
`566 F.3d 999 (Fed. Cir. 2009) .............................................................................. 2
`Apator Miitors ApS v. Kamstrup A/S,
`887 F.3d 1293 (Fed. Cir. 2018) ...................................................................... 9, 10
`eBay Inc. v. MoneyCat Ltd.,
`CBM2014-00092, Paper 49 (PTAB Sept. 23, 2015) ............................................ 1
`Gainer v. Wal-Mart Stores East, L.P.,
`933 F. Supp. 2d 920 (E.D. Mich. 2013) ............................................................. 10
`Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc.,
`655 F.3d 1291 (Fed. Cir. 2011) ............................................................................ 5
`Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ............................................................................ 4
`Intelligent Bio-Systems v. Illumina Cambridge,
`821 F.3d 1359 (Fed. Cir. 2016) ............................................................................ 2
`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co.,
`CBM2012-00002, Paper 66 (PTAB Jan. 23, 2014) ........................................ 1, 15
`In re Omeprazole Patent Litig.,
`536 F.3d 1361 (Fed. Cir. 2008) ............................................................................ 4
`In re Papesch,
`315 F.2d 381 (C.C.P.A. 1963) .............................................................................. 4
`Sanofi-Synthelabo v. Apotex, Inc.,
`550 F.3d 1075 (Fed. Cir. 2008) ............................................................................ 4
`SK Hynix Inc. v. Netlist, Inc.,
`IPR2017-00562, Paper 36 (PTAB July 5, 2018) .......................................... 11, 15
`U.S. Gypsum Co. v. Lafarge N. Am. Inc.,
`670 F. Supp. 2d 737 (N.D. Ill. 2009) .................................................................... 3
`
`ii
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`

`

`Case IPR2022-00722
`Patent No. 7,041,786
`
`
`
`
`Rules
`FRE 402 ..................................................................................................................... 1
`FRE 403 ............................................................................................................... 1, 11
`FRE 603 ..................................................................................................................... 1
`FRE 702 ..................................................................................................................... 1
`FRE 703 ..................................................................................................................... 8
`FRE 802 ..................................................................................................................... 1
`FRE 803 ................................................................................................. 10, 13, 14, 15
`FRE 901 ............................................................................................... 1, 9, 10, 12, 13
`Regulations
`37 C.F.R. § 42.20 ................................................................................................. 1, 15
`77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012) ........................................................... 1
`
`
`iii
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`

`

`
`
`Case IPR2022-00722
`Patent No. 7,041,786
`
`Patent Owner respectfully submits this Opposition to Petitioner Mylan
`
`Pharmaceuticals Inc.’s Motion to Exclude (Paper 54, “Mot.”). Petitioner’s Motion
`
`improperly argues the weight of the evidence, rather than its admissibility, and is
`
`further deficient because Petitioner mischaracterizes the relevance of the challenged
`
`Exhibits and manufactures reliability concerns where none exist. Because Petitioner
`
`has not met its burden to establish that Exhibits 2024, 2025, 2027, 2028, and 2040
`
`are inadmissible, it cannot contravene the strong public policy favoring admission
`
`of reliable evidence. 37 C.F.R. § 42.20(c); Liberty Mut. Ins. Co. v. Progressive Cas.
`
`Ins. Co., CBM2012-00002, Paper 66 at 60-61 (PTAB Jan. 23, 2014).
`
`I.
`
`Exhibits 2024 and 2025 (Davies and Waldman Declarations) Are
`Admissible
`Petitioner states that it timely objected to Exhibits 2024 and 2025 under FRE
`
`402, 403, 603, 702, 802, and 901. Mot., 1 (citing Paper 30, 1-2). But in its Motion,
`
`Petitioner baldly asserts that Exhibits 2024 and 2025 should be excluded because
`
`Dr. Davies’ and Waldman’s testimony is not reliable. Rather than assert a cognizable
`
`evidentiary ground, Petitioner improperly uses its Motion to respond to Patent
`
`Owner’s Sur-Reply. Petitioner contravenes the Board’s unambiguous rules: “A
`
`motion to exclude is not a vehicle for addressing the weight to be given evidence—
`
`arguments regarding weight should appear only in the merits documents.”
`
`Consolidated Trial Practice Guide, November 2019 (“TPG”) at 79; 77 Fed. Reg.
`
`48,756, 48,767 (Aug. 14, 2012); eBay Inc. v. MoneyCat Ltd., CBM2014-00092,
`
`1
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`

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`Case IPR2022-00722
`Patent No. 7,041,786
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`Paper 49 at 69 (PTAB Sept. 23, 2015). Not even attempting to disguise its
`
`impermissible arguments, Petitioner cites, inter alia, Altana Pharma AG. v. Teva
`
`Pharms., 566 F.3d 999, 1007-08 (Fed. Cir. 2009), regarding the lead compound
`
`analysis and Intelligent Bio-Systems v. Illumina Cambridge, 821 F.3d 1359, 1367
`
`(Fed. Cir. 2016), regarding reasonable expectation of success. Mot., 2, 4. Petitioner’s
`
`improper obviousness arguments—submitted under the guise of a motion to
`
`exclude—should be rejected in their entirely.
`
`A. Drs. Davies’ and Waldman’s Lead Compound Arguments Are
`Legally Proper
`Petitioner incorrectly asserts that Drs. Davies and Waldman “erroneously
`
`requir[e] a single lead compound” and that their testimony should thus be excluded.
`
`Mot., 2-3. As an initial matter, Petitioner mischaracterizes the Board’s Institution
`
`Decision, which stated that Patent Owner will have the opportunity to address the
`
`lead compound issue more fully at trial and suggested further development of the
`
`topoisomerism issue. Paper 16, 22.
`
`Petitioner contends that Drs. Davies and Waldman rejected human
`
`uroguanylin as a lead compound simply because STs were “more attractive.” Mot.,
`
`3. Contrary to Petitioner’s characterization, Drs. Davies and Waldman did not opine
`
`that human uroguanylin and STs were both promising compounds and that STs were
`
`simply more attractive. Instead, Drs. Davies and Waldman opined that human
`
`uroguanylin was not a promising compound because of its disadvantageous
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`2
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`Case IPR2022-00722
`Patent No. 7,041,786
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`properties, including its topoisomeric instability and mediocre potency. See, e.g., Ex.
`
`2024 ¶¶ 49, 69, 124, 130; Ex. 2025 ¶ 53. Indeed, Drs. Davies and Waldman did not
`
`treat “uroguanylin and STs as mutually-exclusive alternatives such that the
`
`availability of one must necessarily have dissuaded modification of the other.” Mot.,
`
`3; see, e.g., Ex. 2024 ¶¶49, 69, 124, 130; Ex. 2025 ¶53.
`
`Further, and contrary to Petitioner’s assertion, Drs. Davies and Waldman did
`
`not use Currie’s selection of an ST to conclude that human uroguanylin would not
`
`have been a lead compound. Mot., 3. Drs. Davies and Waldman acknowledged that
`
`Currie, the inventor of Petitioner’s primary reference (Ex. 1005), selected an ST as
`
`a lead compound for further development and opined that this evidence corroborates
`
`their opinion that STs would have been considered as lead compounds because of
`
`their superior properties. See e.g., Ex. 2024 ¶ 141; Ex.2025 ¶¶ 68-69.
`
`Petitioner’s cited case, U.S. Gypsum Co. v. Lafarge N. Am. Inc., 670 F. Supp.
`
`2d 737, 745 (N.D. Ill. 2009), is distinguishable. Mot., 2. In U.S. Gypsum, the
`
`plaintiff’s economic expert failed to consider a necessary fact and made an
`
`inappropriate assumption in arriving at her damages determination. U.S. Gypsum,
`
`670 F. Supp. 2d at 745. Here, Drs. Davies and Waldman neither failed to consider
`
`any necessary fact nor made any inappropriate assumption in reaching their
`
`conclusions that human uroguanylin would not have been a suitable lead compound.
`
`Concluding that a POSA would not have selected human uroguanylin as a lead
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`3
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`compound does not render Dr. Davies’ or Waldman’s testimony legally erroneous.
`
`B. Dr. Davies Applied the Correct Standard for Reasonable
`Expectation of Success
`Petitioner argues that Dr. Davies applied a “legally erroneous standard” for
`
`reasonable expectation of success because Dr. Davies considered not only the
`
`claimed compound but also its properties. Mot., 3-5. Petitioner argues that because
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`“a POSA could make [Glu3]-human uroguanylin easily using known methods,” it
`
`has established a reasonable expectation of success. Id., 4 (emphasis added). Not so.
`
`Reasonable expectation is tied to the proposed motivation. Institut Pasteur &
`
`Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1346 (Fed. Cir. 2013).
`
`It is not a question of whether one could make the claimed compound, as Petitioner
`
`incorrectly argues, but whether one would have done so based on some proposed
`
`motivation and reasonably expected it to succeed for the proposed objective. In re
`
`Omeprazole Patent Litig., 536 F.3d 1361, 1379-81 (Fed. Cir. 2008). Here, the
`
`relevant art pertains to constipation, and a POSA seeking to make a better anti-
`
`constipation drug would have considered the properties of various prior-art
`
`compounds and would not have ignored human uroguanylin’s stability, potency, or
`
`binding affinity in selecting a lead compound. POR, 28-37, 58-64. Indeed, “[f]rom
`
`the standpoint of patent law, a compound and all of its properties are inseparable;
`
`they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (C.C.P.A. 1963);
`
`see also Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1086 (Fed. Cir. 2008).
`
`4
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`

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`Petitioner also rehashes its arguments regarding the scope of claim 1, alleging
`
`that Dr. Davies did not “demonstrate that all topoisomers falling within the scope of
`
`the claims . . . have the stability, potency, heat stability, or binding affinity that Dr.
`
`Davies relies upon for his ‘reasonable expectation of success’ argument.” Mot., 5.
`
`Petitioner cites no case law in support of its argument, which conflates the legal
`
`requirements for reasonable expectation of success and unexpected results. Genetics
`
`Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291, 1308 (Fed.
`
`Cir. 2011) (“absolute identity of scope” not required). And Patent Owner’s evidence
`
`of unexpected results is plainly commensurate with the scope of the challenged
`
`claims. As such, it is Petitioner, and not Dr. Davies, that misunderstood the
`
`applicable legal standard for reasonable expectation of success.
`
`C. Drs. Davies and Waldman Correctly Understood Li (Ex. 1006)
`Petitioner argues that Drs. Davies’ and Waldman’s testimony should be
`
`excluded because their interpretation of Li’s Figure 3 is allegedly inconsistent with
`
`Li and the teachings of another article, Hamra 1993. Mot., 5-6. Petitioner is incorrect.
`
`Regarding Li, Petitioner asserts that “Li expressed the expectation that rat
`
`uroguanylin’s potency would be shown in future dose-response experiments to be
`
`‘comparable to that of opossum or human uroguanylin.’” Mot., 5 (quoting Ex. 1006,
`
`54). With this, Petitioner implies that Li’s Figure 3, which shows that rat uroguanylin
`
`is far less potent than opossum uroguanylin, cannot be used to compare the peptides’
`
`5
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`

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`Case IPR2022-00722
`Patent No. 7,041,786
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`potency. But Li actually states that it expects rat uroguanylin’s “affinity to be
`
`comparable to that of opossum or human uroguanylin.” Ex. 1006, 54. Indeed, the
`
`cited paragraph concerns rat uroguanylin’s expected affinity, not its potency, which
`
`is set forth in Figure 3.
`
`Regarding Hamra 1993, Petitioner ignores that Li and Hamra 1993 compared
`
`different peptides. Li evaluated opossum uroguanylin, which has fifteen amino
`
`acids. Ex. 1006 at Fig. 6. Hamra 1993 in contrast evaluated a truncated opossum
`
`uroguanylin peptide having fourteen amino acids. Ex. 2012, 10464; see also Ex.
`
`2069, 86:9-13. As such, neither Dr. Davies nor Dr. Waldman misunderstood Li.
`
`D. Dr. Davies’ Opinions Concerning pKa Values Are Proper and
`Should be Considered
`Dr. Davies opined that pKa values of amino acids vary unpredictably when
`
`those amino acids are incorporated into a peptide chain. Ex. 2024 ¶ 178-79.
`
`Petitioner argues that Dr. Davies’ opinions are relevant to only “buried” acid residues
`
`and should be excluded because Marx’s figure allegedly indicates that Asp3 of
`
`human uroguanylin is “not buried.” Mot., 6. Petitioner again is wrong.
`
`Indeed, Petitioner wholly ignores that Marx does not depict, inter alia, intra-
`
`chain hydrogen bonding, which Dr. Peterson agrees can affect pKa values of the
`
`involved amino acids. Ex. 2069, 96:19-97:2, 97:19-98:22. Indeed, Asp3 contains an
`
`ionizable carboxylic acid side chain, which was known to be involved in intra-chain
`
`hydrogen bonding due its ability to ionize. See, e.g., Reply, 14 (noting “an ionizable
`
`6
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`Case IPR2022-00722
`Patent No. 7,041,786
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`sidechain modification at position 3”); see also Ex. 2010, 236. Substituting Asp3
`
`with Glu3 would have affected this intra-chain hydrogen bonding and, consequently,
`
`the involved amino acids’ pKa values, including in unpredictable ways. Ex. 2069,
`
`90:16-22 (acknowledging that any “prediction as to the pKa of the carboxylic acid
`
`on the side chain . . . would require accounting for the environment in which these
`
`residues are found when incorporated into a peptide chain”). And Harms’ systematic
`
`study shows that the pKa values can vary unpredictably when incorporated into a
`
`peptide chain and that Asp can even have a higher pKa value than Glu. Ex. 2045,
`
`37, Table 1. Therefore, Petitioner’s request to exclude Dr. Davies’ opinion based its
`
`incorrect classification of human uroguanylin’s residues either as “buried” or
`
`“exposed,” without considering the effects of intra-chain hydrogen bonding, is
`
`improper and should be rejected.
`
`E. Drs. Davies and Waldman Provide Reliable Testimony Regarding
`Human Uroguanylin’s Topoisomeric Instability
`Petitioner asserts that Drs. Davies’ and Waldman’s testimony regarding
`
`topoisomeric instability should be excluded as unreliable because Patent Owner
`
`presented no evidence to rebut Petitioner’s argument that a POSA would have
`
`expected only a small amount of interconversion. Mot., 8. Petitioner is wrong.
`
`As an initial matter, Petitioner first made this argument in its Reply, precluding
`
`Patent Owner from offering any new evidence in response. Moreover, it is
`
`undisputed that human uroguanylin suffered from topoisomeric instability. Mot., 7-
`
`7
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`Case IPR2022-00722
`Patent No. 7,041,786
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`8; Reply, 7-11. Yet Petitioner contends that a POSA would have ignored this
`
`instability because “uroguanylin was known to be stable and effective in vivo after
`
`oral administration.” Mot., 8. Petitioner bases its contention on gastrointestinal pHs
`
`and transit times in healthy patients, not constipated patients. Id.; Ex. 2070, 45:18-
`
`47:7 (conceding transit times would be longer in constipated patients), 38:6-22.
`
`Further, Petitioner cites no literature to support its suggestion that a POSA
`
`would have ignored human uroguanylin’s topoisomeric instability. This is especially
`
`problematic given the literature’s recognition that biological properties of human
`
`uroguanylin’s inactive topoisomer were “completely unknown.” Ex. 2020, 229; Ex.
`
`2069, 106:9-19. Indeed, Drs. Epstein and Peterson recognized that any compound,
`
`including those produced in the human body, can be toxic if administered at high
`
`doses. Ex. 2070, 35:19-36:13. Thus, contrary to Petitioner’s assertions, Patent
`
`Owner rebutted Petitioner’s arguments in this regard, and Petitioner’s request to
`
`exclude Dr. Davies’ and Dr. Waldman’s testimony is unfounded.
`
`Petitioner argues that Drs. Davies’ and Waldman’s testimony relying on
`
`Exhibits 2027, 2028, and 2040 should be excluded because those Exhibits are
`
`inadmissible. Petitioner is wrong for the reasons set forth below, and in any event,
`
`Drs. Davies and Waldman may rely on inadmissible evidence. FRE 703. While
`
`Petitioner asserts that Drs. Davies and Waldman never testified that experts in this
`
`field would reasonably rely on such Exhibits, Drs. Davies’ and Waldman’s
`
`8
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`

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`Case IPR2022-00722
`Patent No. 7,041,786
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`declarations and CVs plainly show that experts in this field like themselves routinely
`
`rely on T84 cell cGMP data, EC50 data, and HPLC data (Exs. 2027 and 2028) as well
`
`as manufacturing efficiency information (Ex. 2040) in forming their opinions. See,
`
`e.g., Ex. 2024 ¶¶ 9, 14; Ex. 2025 ¶¶ 11, 17-19, 42; Ex. 2029; Ex. 2030.
`
`II. Exhibits 2027 and 2028 (Preclinical Study Report Nos. SP-PH-001 and
`SP-PH-004) Are Admissible
`Bausch’s Preclinical Study Report Nos. SP-PH-001 (Ex. 2027) and SP-PH-
`
`004 (Ex. 2028) are a part of the NDA submitted to the FDA for Trulance®.
`
`A. The Preclinical Study Reports Satisfied the Authenticating /
`Identifying Requirements Under FRE 901
`Petitioner complains that a co-signatory (Dr. Jacob) of these study reports has
`
`not provided testimony in this proceeding and that the reports were not signed under
`
`oath. Mot., 9. These complaints are immaterial to the admissibility of the reports. To
`
`the extent Petitioner is questioning the authenticity of the reports, Dr. Shailubhai—
`
`the first listed signatory and only listed author of both reports—provided testimony
`
`under oath in this proceeding that he has first-hand knowledge of Study Nos. SP-
`
`PH-001 and SP-PH-004, as required by FRE 901(b)(1). Ex. 2066 ¶ 34. These reports
`
`are also authenticated under FRE 901(b)(7) because they were filed with FDA as
`
`authorized by law. Moreover, Petitioner cites Apator Miitors ApS v. Kamstrup A/S,
`
`887 F.3d 1293, 1296-97 (Fed. Cir. 2018), and argues that an inventor corroborating
`
`his own corroborating documents is a “catch-22.” Mot., 9. But Apator does not
`
`9
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`

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`Case IPR2022-00722
`Patent No. 7,041,786
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`concern any evidentiary rule. In Apator, the court held that “unwitnessed emails and
`
`drawings, alone” cannot corroborate the inventor’s alleged conception date. Apator,
`
`887 F.3d at 1297. Petitioner confuses the admissibility of evidence with the weight
`
`it should be accorded. In any event, the study reports are not unwitnessed. They were
`
`reviewed and evaluated by the FDA. Exhibits 2027 and 2028 undoubtedly satisfy
`
`the authentication requirements of FRE 901.
`
`B.
`
`The Contents of Exhibits 2027 and 2028 Are Records of a Regularly
`Conducted Activity Under FRE 803(6)
`Petitioner incorrectly argues that the statements, including the data, contained
`
`in the study reports are hearsay without exception. But Dr. Shailubhai, the author
`
`and signatory of the reports, provided testimony under oath that he has first-hand
`
`knowledge of the data in Study Nos. SP-PH-001 and SP-PH-004. Ex. 2066 ¶ 30; see
`
`also Gainer v. Wal-Mart Stores East, L.P., 933 F. Supp. 2d 920, 928-929 (E.D. Mich.
`
`2013). Dr. Shailubhai further testified that each of the records for Study Nos. SP-
`
`PH-001 and SP-PH-004 (i.e., Ex. 2027 and Ex. 2028): (A) were made or obtained at
`
`or near the time of occurrence of the matters set forth in the records, by, or from
`
`information transmitted by, a person with personal knowledge of those matters; (B)
`
`were kept in the course of regularly conducted business activity; (C) were created or
`
`obtained as a regular business practice; and (D) are the types of information created,
`
`obtained, and used in the ordinary course of business. Ex. 2066 ¶¶ 31-33. Thus, the
`
`data in the study reports satisfy the hearsay exception under FRE 803(6) as records
`
`10
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`

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`of a regularly conducted activity.
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`
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`Case IPR2022-00722
`Patent No. 7,041,786
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`C. The Probative Value of the Preclinical Study Reports Is Not
`Outweighed by a Danger of Unfair Prejudice Under FRE 403
`The preclinical study reports support plecanatide’s unexpected superior
`
`results and discuss synthesis and testing of GCC receptor agonist peptides to
`
`examine their isomerization, biological activity, and heat stability. Ex. 2027; Ex.
`
`2028. Seeking to exclude plecanatide’s unexpected superior results from the record,
`
`Petitioner asserts that these reports are unduly prejudicial. Petitioner argues that the
`
`reports reflect undisclosed data obtained by Dr. Dheer. But the data themselves are
`
`disclosed within the reports, of which Dr. Shailubhai testified that he had firsthand
`
`knowledge. Further, Petitioner argues that the earlier version of the report touted an
`
`alleged 10-fold difference in potency between peptides that was retracted by the later
`
`version of the report. But this argument is inaccurate. The cGMP levels reported
`
`remained the same, and only the EC50 values, which were calculated using a
`
`nonlinear regression curve fit, were updated in view of more current software. Ex.
`
`2027, 20. Petitioner fails to balance any of its conclusory allegations of prejudice
`
`against the probative value of the preclinical study data, as required by FRE 403.
`
`Because Petitioner has failed to meet its burden to prove inadmissibility of the study
`
`reports, these reports should be admitted for the Board’s consideration. SK Hynix
`
`Inc. v. Netlist, Inc., IPR2017-00562, Paper 36 at 49 (PTAB July 5, 2018) (refusing
`
`to exclude and noting that “the Board, sitting as a non-jury tribunal with
`
`11
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`Case IPR2022-00722
`Patent No. 7,041,786
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`administrative expertise, is well positioned to determine and assign appropriate
`
`weight to evidence presented”).
`
`III. Exhibit 2040 (Pennington Letter) Is Admissible
`A. The Letter Satisfies the Authenticating / Identifying Requirements
`Under FRE 901
`Petitioner wrongly asserts that the recipient of the Pennington letter (Ex.
`
`2040), Dr. Shailubhai, did not provide any competent testimony regarding the letter.
`
`On the contrary, Dr. Shailubhai unambiguously testified that “Exhibit 2040 is a letter
`
`dated March 31, 2004, that I received from Michael Pennington, Ph.D., who was
`
`with BACHEM Bioscience Inc.” and that “I hereby certify that the document marked
`
`as Exhibit 2040 is a true and correct copy of the letter.” Ex. 2066 ¶¶ 35-36. This
`
`testimony alone satisfies the requirement of authenticating or identifying an item of
`
`evidence under the FRE 901(b)(1).
`
`In addition, the Pennington letter (Ex. 2040) is a part of the file history of EP
`
`02721604.3, which can be found in Petitioner’s own Exhibit 1067. Ex.1067, 128.
`
`Petitioner complains that no one verified the letter. Mot., 11. That is not true. Exhibit
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`1067 indicates that a European patent attorney, Peter David Rands, submitted the
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`letter to the European Patent Office on October 14, 2011, stating that:
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`It is notable that, as a result of the reduced interconversion between
`active and inactive conformations for SP-304, chemical synthesis and
`purification has been found to be much easier for SP-304 than for
`uroguanylin. We enclose a letter from the manufacturer of SP-304
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`Case IPR2022-00722
`Patent No. 7,041,786
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`which particularly notes these points. The author of the letter, Dr.
`Michael Pennington, is a very well-known peptide chemist, and he has
`been working with uroguanylin for the last twenty years. As is apparent
`from the letter, the cost of manufacturing SP-304 is about five times
`lower than the cost of manufacturing uroguanylin.
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`Ex.1067, 139. The European Patent Office admitted this letter and cited it in the
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`interlocutory decision dated March 29, 2012, stating that “[t]he P acknowledges that
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`the active isomer is difficult to purify and this assertion is supported by the fax from
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`Bachem submitted with the P’s letter of 14.10.2011.” Ex.1067, 52. The Pennington
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`letter is a part of the file history from the European Patent Office and a part of
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`Petitioner’s own Exhibit 1067. The letter satisfies the requirement of authenticating
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`or identifying an item of evidence under FRE 901(a) and FRE 901(b)(7) at least
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`based on the identification made by the European Patent Office and attorney Rands,
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`which are also found in Petitioner’s own exhibit. Ex.1067, 52, 128, 139.
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`B.
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`The Letter Constitutes a Record of a Regularly Conducted Activity
`Under FRE 803(6)
`Petitioner argues that the statements in the letter are hearsay without
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`exception. Petitioner is wrong and asserts in conclusory fashion that this letter does
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`not purport to be a record kept by Bachem in the course of its regularly conducted
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`activity as opposed to “something manufactured at the request of the patent owner
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`for the purposes of litigation.” Mot., 13. This speculation is not only unfounded but
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`also incorrect. This letter is dated and faxed on March 31, 2004, and submitted to
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`Case IPR2022-00722
`Patent No. 7,041,786
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`the European Patent Office on October 14, 2011, as evidenced by Petitioner’s own
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`exhibit. Trulance® was initially approved by the FDA in 2017, and this action and
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`the related district court actions were initiated much later than October 14, 2011.
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`Considering this timeline, the Pennington letter could not have been manufactured
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`for the purposes of this litigation.
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`Petitioner further states that the letter includes “strategically-selected
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`language,” but this allegation is also unfounded. Mot., 14. Providing a quotation for
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`1 g instead of 50 mg would not have provided Patent Owner with any strategic
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`advantage in litigation, and Petitioner does not argue otherwise. Such a letter offering
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`a quote for a scale-up manufacturing constitutes records of a regular business activity
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`under FRE 803(6). Indeed, this is the type of information created, obtained, and used
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`in the ordinary course of business. As evidenced by the testimony of Dr. Shailubhai,
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`the recipient of the Pennington letter (Ex. 2040), there is no reason to doubt that the
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`Pennington letter: (A) was made or obtained at or near the time of occurrence of the
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`matters set forth in the records, by, or from information transmitted by, a person with
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`personal knowledge of those matters; (B) was kept in the course of regularly
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`conducted business activity; (C) was created or obtained as a regular business
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`practice; and (D) is the type of information created, obtained, and used in the
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`ordinary course of business. Ex. 2066 ¶¶ 35-37. Further, Petitioner’s complaint that
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`Dr. Pennington’s testimony was not provided is misplaced because Dr. Shailubhai’s
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`Case IPR2022-00722
`Patent No. 7,041,786
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`testimony verifies the contents of the letter, which satisfies the evidentiary rule for
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`admissibility. Mot., 11. Thus, the contents of the letter satisfy the hearsay exception
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`under FRE 803(6) as records of a regularly conducted activity.
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`C. The Probative Value of the Letter Is Not Outweighed by a Danger
`of Unfair Prejudice Under FRE 403
`As determined by the European Patent Office, the Pennington letter supports
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`that chemical synthesis and purification was much easier for plecanatide than for
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`uroguanylin as a result of the reduced interconversion. As discussed above,
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`Petitioner’s concern that the letter could have been fabricated is unfounded. The
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`letter demonstrates the highly probative value and should be admitted for the Board’s
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`consideration. Because Petitioner has failed to meet its burden to prove
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`inadmissibility of the letter, it cannot contravene the strong public policy favoring
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`the admission of reliable evidence. 37 C.F.R. § 42.20(c); Liberty Mut, CBM2012-
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`00002, Paper 66 at 60-61; SK Hynix Inc, IPR2017-00562, Paper 36 at 49.
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`IV. Conclusion
`Patent Owner respectfully requests that Petitioner’s motion to exclude be
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`denied.
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`Respectfully submitted,
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`Date: May 31, 2023
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`
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`By: /Justin J. Hasford/
`Justin J. Hasford, Reg. No. 62,180
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`Counsel for the Patent Owner
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`CERTIFICATE OF SERVICE
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`Case IPR2022-00722
`Patent No. 7,041,786
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`The undersigned certifies that a copy of the foregoing Patent Owner’s
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`Opposition to Petitioner’s Motion to Exclude was served electronically via
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`email on May 31, 2023, to counsel of record for the Petitioner at the following:
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`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
`
`Richard Torczon
`Tasha M. Thomas
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`tthomas@wsgr.com
`
`
`Dennis D. Gregory
`Wilson Sonsini Goodrich & Rosati PC
`900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`dgregory@wsgr.com
`
`4863-5899-2145@mail.vault.netdocuments.com
`
`Andrew O. Larsen
`Merchant & Gould, P.C.
`500 Fifth Avenue, Suite 4100
`New York, NY 10110
`alarsen@merchantgould.com
`
`Melissa Hayworth
`Merchant & Gould, P.C.
`1900 Duke, Street, Suite 600
`Alexandria, VA 22314
`
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`Case IPR2022-00722
`Patent No. 7,041,786
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`mhayworth@merchantgould.com
`
`Christopher J. Sorenson
`Merchant & Gould, P.C.
`150 South Fifth Street, Suite 2200
`Minneapolis, MN 55402
`csorenson@merchantgould.com
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`plecanatidemerchant@merchantgould.com
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`
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`Date: May 31, 2023
`
`
`By: /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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