Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`Paper 49
` Entered: February 11, 2021
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`GALDERMA S.A.; GALDERMA LABORATORIES, INC.; GALDERMA
`LABORATORIES LP; GALDERMA RESEARCH & DEVELOPMENT
`SNC; NESTLÉ SKIN HEALTH, INC.; NESTLÉ SKIN HEALTH S.A.; and
`NESTLÉ S.A.,
`Petitioner,
`v.
`MEDY-TOX, INC.,
`Patent Owner.
`
`PGR2019-00062
`Patent 10,143,728 B2
`
`
`
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`PAULRAJ, Administrative Patent Judge.
`
`
`
`
`ORDER
`Granting Patent Owner’s Motion to Disqualify Andrew M. Pickett as Patent
`Owner’s Expert Witness
`37 C.F.R. §§ 42.5, 42.20
`
`
`Tel: 571-272-7822
`
`
`
`Paper 49
` Entered: February 11, 2021
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`GALDERMA S.A.; GALDERMA LABORATORIES, INC.; GALDERMA
`LABORATORIES LP; GALDERMA RESEARCH & DEVELOPMENT
`SNC; NESTLÉ SKIN HEALTH, INC.; NESTLÉ SKIN HEALTH S.A.; and
`NESTLÉ S.A.,
`Petitioner,
`v.
`MEDY-TOX, INC.,
`Patent Owner.
`
`PGR2019-00062
`Patent 10,143,728 B2
`
`
`
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`PAULRAJ, Administrative Patent Judge.
`
`
`
`
`ORDER
`Granting Patent Owner’s Motion to Disqualify Andrew M. Pickett as Patent
`Owner’s Expert Witness
`37 C.F.R. §§ 42.5, 42.20
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`
`
`INTRODUCTION
`I.
`Pursuant to our Order dated January 13, 2021 (Paper 35), Petitioner
`Galderma S.A., et al., (“Petitioner”) filed a Motion to Disqualify Dr. Andrew
`M. Pickett as an expert witness for Patent Owner Medy-Tox, Inc., (“Patent
`Owner”). Paper 7. Dr. Pickett submitted an expert declaration in support of
`Patent Owner’s revised Motion to Amend. Ex. 2031. We also authorized
`Petitioner to submit no more than 10 documents for in camera review in
`support of its Motion. Paper 35. Patent Owner filed an Opposition to
`Petitioner’s Motion to Disqualify. Paper 42 (unredacted version); Paper 43
`(redacted version).
`For the reasons stated below, Petitioner’s Motion is granted.
`FACTUAL BACKGROUND
`II.
`The following statement of facts are largely undisputed, and are based
`primarily on declarations submitted in support of the Motion by Petititoner’s
`lead outside counsel Joseph A. Mahoney (Ex. 1082), Petitioner’s Head of
`Aesthetic Programs Leader Xiaoming Lin (Ex. 1086), as well as a second
`declaration submitted by Dr. Pickett in opposition to the Motion (Ex. 2053).
`We have also taken into account the in camera documents (Exs. 1061–1069)
`and other exhibits submitted by the parties with respect to the Motion.
`Dr. Pickett was employed by Petitioner as the Head of Development,
`and then Senior Program Leader & Scientific Expert, Neurotoxins from
`2011 to 2017. Ex. 2050; Ex. 2053 ¶ 5. Pursuant to his employment
`agreement and employment termination agreement, Dr. Pickett was subject
`to a non-competition clause for a term of 6 months after he left Petitioner’s
`employment and a continuing confidentiality obligation. Ex. 2053 ¶¶ 7–10;
`Ex. 1070 ¶¶ 17, 18.1; Ex. 1071 ¶¶ 3.1, 3.2, 7.1, 7.2, 8.1.
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`PGR2019-00062
`Patent 10,143,728 B2
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`During his employment with Petitioner, Dr. Pickett was in charge of
`the development of QM1114, an animal-free botulinum neurotoxin
`formulation that Petitioner alleges will compete with Patent Owner’s
`MT10109L product that is discussed in the challenged patent, US
`10,143,728 (“the ’728 patent,” Ex. 1001). Ex. 1086 ¶¶ 2, 5–8. Additionally,
`while he was Petitioner’s employee, Dr. Pickett communicated with
`Petitioner’s in-house and outside counsel, including Mr. Mahoney and others
`at the firm of Mayer Brown LLP, regarding the patentability of U.S. Patent
`9,480,731 (“the ’731 patent,” Ex. 1002). Ex. 1082 ¶¶ 2–5; Exs. 1061–1069
`(in camera). The challenged ’728 patent issued from a continuation
`application of the ’731 patent and shares the same specification with similar
`claims directed to a method of treating certain conditions with a
`therapeutically effective amount of an animal-protein-free botulinum toxin
`composition. Ex. 1002. Indeed, the claims of the ’731 patent were similar
`enough to the claims of the ’728 patent that an obviousness-type double
`patenting rejection was made by the Examiner, and a terminal disclaimer
`was required (and filed by Patent Owner) during prosecution. Ex. 1003,
`106, 121.
`The documents we have reviewed support Mr. Mahoney’s declaration
`statement that:
`Starting in June of 2017 and continuing over the next
`several months, Mayer Brown lawyers worked directly with Dr.
`Pickett, who had agreed to act as an expert in relation to the
`unpatentability of the ’731 patent. As such, Dr. Pickett was a
`key participant in the development of Galderma’s early legal
`strategy relating to the ’731 patent family.
`Ex. 1082 ¶ 5. Mr. Mahoney asserts that the following topics were discussed
`with Dr. Pickett during this time: (a) noninterchangeability of unit doses of
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`PGR2019-00062
`Patent 10,143,728 B2
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`neurotoxin products generally and as disclosed in the ’731 patent; (b)
`meaning, scope, and validity of “period of longer time” and “dosed at the
`same amount” as claimed in the ’731 patent; (c) Galderma’s QM11114
`product; (d) duration and efficacy of animal-free neurotoxins versus ones
`with animal proteins; (e) potency, LD50 assays and activity units; (f)
`deficiencies in the description of the LD50 assay disclosed in the prior art
`Jung I reference; (g) comparing doses in terms of units versus amount; (h)
`breadth of the claims of the ’731 patent; (i) the clinical data in Examples 1–2
`of the ’731 patent; and (j) the prior art. Id.
`We recognize that Dr. Pickett asserts in his second declaration:
`I do not remember ever reviewing the ’731 patent (prior
`to involvement in this disqualification motion), or having any
`communications related to it, including any conversations with
`Mayer Brown counsel, including Joseph Mahoney and Chandra
`Critchelow, or in-house counsel at Galderma, including Eric
`Terranova and Stephanie Flijane. I also do not remember
`reviewing any declarations or being provided with (or
`participating in) any legal strategy during that time frame.
`Ex. 2053 ¶ 15. However, we do not find this assertion to be credible in view
`of the nature and extent of the communications between Dr. Pickett and
`Petitioner’s counsel that were submitted for in camera review. Dr. Pickett’s
`memory aside, the documents submitted by Petitioner persuade us that
`communications between at least Dr. Pickett and Mr. Mahoney of a
`confidential, strategy-based, and work-product/privileged nature relevant to
`the subject matter of the challenged patent did occur. For instance, without
`getting into the specifics of any privileged communications, it is apparent
`that, over a period of months, Dr. Pickett
`
` (Ex. 1061), agreed to serve as an expert
`for such a challenge (Ex. 1064), and discussed several technical issues
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`PGR2019-00062
`Patent 10,143,728 B2
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`relevant to such a challenge, such as the LD50 assay, how units of activity
`are calculated for botulinum toxin formulations, and what was known in the
`prior art, including the “Jung I” patent (Exs. 1066–1068).
`Even after Dr. Pickett left Petitioner’s employment in December
`2017, Petitioner discussed a potential engagement with Dr. Pickett in 2018
`relating to this proceeding. Ex. 1082 ¶ 18; Ex. 2053 ¶ 13; see also Exs.
`1072–1073. Dr. Pickett, however, ultimately did not agree to the terms of
`such an engagement and was not retained by Petitioner for this proceeding.
`III. ANALYSIS
`In order to decide whether Dr. Pickett must be disqualified, the parties
`agree that we apply a two-prong test to determine (1) whether it is
`objectively reasonable for Petitioner to believe that it had a confidential
`relationship with Dr. Pickett; and (2) whether Petitioner disclosed
`confidential information to Dr. Pickett that is relevant to the current
`proceeding. See Mot. 5; Opp. 5; Wang Labs., Inc. v. Toshiba Corp., 762 F.
`Supp. 1246, 1248 (E.D. Va. 1991); FujiFilm Corp. v. Sony Corp., IPR2017-
`01267 (“FujiFilm”), Paper 9 at 6 (PTAB July 10, 2017). Affirmative
`answers to both inquiries compel disqualification. Id. As the party seeking
`disqualification, Petitioner bears the burden of establishing that both prongs
`of the test are met. See 37 C.F.R. § 42.20(c).
`With respect to the first prong, we find that Petitioner had a
`confidential relationship with Dr. Pickett at least with respect to the scope of
`his employment. This is reflected, for example, by the confidentiality
`provision in his employment agreement. Ex. 1070 § 17. Notably, that same
`agreement states that the confidentiality obligation shall remain in full force
`and effect following termination of his employment. Id. § 21.3. This
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`PGR2019-00062
`Patent 10,143,728 B2
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`confidentiality obligation was also reiterated in the employment termination
`agreement that Dr. Pickett signed in November 2017. Ex. 1071 § 7.1. And
`when Dr. Pickett negotiated with Petitioner’s counsel about the terms of a
`potential engagement concerning this proceeding, he acknowledged his
`continuing confidentiality obligation resulting from his prior employment
`termination agreement. Ex. 1073, 1 (“I have checked about confidentiality
`and I am completely covered by my final agreement that was signed in
`November 2017.”). Moreover, even though no explicit confidentiality
`agreement specific to this proceeding was ever formally executed, we
`conclude that it is objectively reasonable for Petitioner to believe that a
`confidential relationship existed with Dr. Pickett. We discuss this further
`below.
`In its Opposition, Patent Owner argues that Dr. Pickett did not have a
`confidential relationship with Petitioner at the time of this proceeding. Opp.
`5. Patent Owner notes that Dr. Pickett is a former employee who is free to
`work with other companies, and that his prior employment agreements
`limited his non-competition period only until June 2018. Id. at 5–6. Patent
`Owner also contends that Dr. Pickett has not “switched sides” insofar as he
`has never been retained as an expert witness in any matter. Id. at 7–8. We
`find these arguments unpersuasive. Contrary to Patent Owner’s arguments,
`a former employee may nonetheless continue to have a confidential
`relationship with his prior employer. Dr. Pickett acknowledges he was privy
`to confidential information during his employment by Petitioner. Ex. 2053 ¶
`10. Moreover, there is no genuine dispute that Dr. Pickett is under a
`continuing obligation to maintain the confidentiality of that information.
`And further, at least some of the documents and communications exchanged
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`PGR2019-00062
`Patent 10,143,728 B2
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`between Mr. Mahoney, other in-house representatives of Petitioner, and Dr.
`Pickett, which detail Dr. Pickett’s assistance on technical matters and
`Petitioner’s potential legal claims and defenses, are marked expressly
`“**Privileged & Confidential**”. See generally Ex. 1062; see also Ex.
`1069 (“DRAFT PRIVILEGED/CONFIDENTIAL” Pickett Declaration).
`This is enough for us to conclude that it was objectively reasonable for
`Petitioner to believe that it had a confidential relationship with Dr. Pickett.
`With respect to the second prong, we base our analysis on the
`discussions that Petitioner’s in-house and outside counsel had with Dr.
`Pickett when discussing a legal strategy for challenging the ’731 patent. In
`particular, based on the documents we have reviewed (Exs. 1061–1069), we
`agree with Petitioner that Dr. Pickett was privy to attorney-client privileged
`communications and attorney work-product documents given his role as the
`technical liaison to Petitioner’s legal team that was tasked with developing a
`clearance strategy relating to the ’731 patent. Mot. 7. We also agree with
`Petitioner that the confidential information communicated to and from Dr.
`Pickett regarding the ’731 patent strategy during his prior employment is
`relevant to this proceeding. As noted above, the ’731 patent issued from a
`parent application to the ’728 patent, shares the same specification, and
`includes very similar claims to those at issue in this proceeding. We also
`find there is significant overlap between Petitioner’s legal strategies against
`the ’731 patent and those presented in its challenges against the ’728 patent
`in this proceeding. For instance, in his declaration submitted in support of
`Patent Owner’s revised Motion to Amend, Dr. Pickett states that “[t]he
`amount of toxin needed for the botulinum toxin of the claims is described in
`Jung I (Ex. 1006), which is incorporated by reference in the ’728 patent.”
`
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`PGR2019-00062
`Patent 10,143,728 B2
`
`Ex. 2031 ¶53. Dr. Pickett also attests that the LD50 assay discussed in the
`Jung I patent “is well known in the art and routinely conducted to determine
`potency units for botulinum toxin compositions,” and that “[a] POSA would
`routinely be able to compare botulinum toxin products and have done so for
`decades.” Id. ¶¶ 54–55.
`Without getting into the details of any privileged communications, we
`find that Dr. Pickett confidentially discussed related issues when formulating
`a legal strategy with Petitioner’s counsel to challenge the ’731 patent. Ex.
`1066. Although some of the information Dr. Pickett discussed may have
`been in the public domain, it is clear that both Petitioner’s counsel and Dr.
`Pickett considered the underlying strategies related to how that information
`could be used in support of a patentability challenge as confidential and
`privileged. Cf. Wang Labs., 762 F.Supp. at 1249 (“While the value of the
`disclosures is debatable, their essential work-product nature is not. No
`experienced litigator would freely disclose these materials to opposing
`counsel.”).
`Patent Owner argues that Petitioner has shown neither disclosure of
`nor reliance on any confidential information relevant to this matter. Opp. 9.
`We are unpersuaded by this contention in view of the documents we have
`reviewed. Although we have no basis to doubt Dr. Pickett’s assertion that he
`has not revealed any confidential information he may have learned from his
`prior employment with Petitioner (Ex. 2053 ¶¶ 3, 10), the second prong of
`the disqualification test does not require proof that the expert who is the
`subject of the disqualification motion must have actually disclosed or even
`relied upon the confidential information obtained from his prior employment
`during the scope of his new engagement. Rather, in assessing whether to
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`PGR2019-00062
`Patent 10,143,728 B2
`
`disqualify an expert under the second prong, we look at whether “any
`confidential or privileged information [was] disclosed by the first party to
`the consultant.” Wang Labs., 762 F.Supp. at 1248 (emphasis added). On
`that, based on the evidence before us, the answer is a resounding “yes.”
`Accordingly, we find that Petitioner disclosed confidential information to
`Dr. Pickett during his prior employment that is relevant to the current
`proceeding. Having met its burden on both prongs, the facts compel Dr.
`Pickett’s disqualification.
`IV. CONCLUSION AND REMEDY
`We recognize that “[d]isqualification of an expert witness is a drastic
`measure [that] we hesitate to impose except when absolutely necessary.”
`FujiFilm, Paper 9 at 6. In this case, however, in view of our conclusion that
`(1) it was objectively reasonable for Petitioner to believe that it had a
`confidential relationship with Dr. Pickett; and (2) Petitioner disclosed
`confidential information to Dr. Pickett that is relevant to the current
`proceeding, we find that disqualification of Dr. Pickett as an expert for
`Patent Owner is required. We will hereby strike Dr. Pickett’s expert
`declaration (Ex. 2031) from the record. Dr. Pickett’s declaration will not be
`assessed further in addressing the merits of Patent Owner’s Revised Motion
`to Amend.
`To minimize the impact that this may have on Patent Owner, while
`keeping in mind that we are about one month from the oral hearing for this
`proceeding, we will allow Patent Owner to submit a substitute declaration by
`a new expert who is willing to adopt wholesale the opinions set forth by Dr.
`Pickett. During our prior conference calls (in late December 2020, and early
`January 2021) where Petitioner sought, and we ultimately gave, permission
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`PGR2019-00062
`Patent 10,143,728 B2
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`to file the present motion, we suggested to Patent Owner that they should
`consider securing a substitute declarant (either Patent Owner’s other expert,
`Dr. Ashwani Singh, or someone else altogether) that might offer Dr.
`Pickett’s opinions as their own—in the event the Board granted Petitioner’s
`motion, as we have now done. As such, in view of the pending
`disqualification motion, we expect Patent Owner would have already begun
`to reach out to potential substitute declarants. Any substitute declaration
`shall be filed no later than February 19, 2021, and Patent Owner shall make
`the substitute declarant available for a deposition on or before February 26,
`2021. To be clear, the substitute declaration shall not add to or otherwise
`modify any of the opinions set forth in Dr. Pickett’s declaration.
`This Order will be entered as “Board and Parties Only” in view of the
`possibility that confidential information is discussed herein. However, in the
`interest of maintaining a public record of this proceeding, the parties are
`directed to meet and confer and submit a joint redacted version of this Order,
`and also submit redacted versions of any confidential exhibits cited herein
`(including Exhibits 1061–1069), within 10 business days after entry of this
`Order. In this regard, we emphasize that 37 C.F.R. § 42.56 “balances the
`needs of the parties to submit confidential information with the public
`interest in maintaining a complete and understandable file history for public
`notice purposes,” and “[t]he rule encourages parties to redact sensitive
`information, where possible, rather than seeking to seal entire documents.”
`See PTAB Consolidated Trial Practice Guide (Nov. 2019) at 22, available at
`https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL=
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`PGR2019-00062
`Patent 10,143,728 B2
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`The parties shall contact the Board and schedule a conference call in
`case there are any concerns with the procedure set forth above regarding the
`confidentiality of documents.
`
`V. ORDER
`In consideration of the foregoing, it is
`ORDERED that Petitioner’s Motion to Disqualify Andrew M. Pickett
`as Patent Owner’s Expert Witness is granted;
`FURTHER ORDERED that the expert declaration of Dr. Pickett (Ex.
`2031) shall be stricken from the record;
`FURTHER ORDERED that Patent Owner may submit a substitute
`declaration in support of its revised Motion to Amend by no later than
`February 19, 2021, and shall make the substitute declarant available for a
`deposition on or before February 26, 2021; any substitute declaration shall
`not add to or otherwise modify any of the opinions set forth in Exhibit 2031;
`and
`
`FURTHER ORDERED that the parties shall submit a joint redacted
`version of this Order, as well as any confidential exhibits cited herein, within
`10 business days after entry of this Order.
`
`
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`11
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`PGR2019-00062
`Patent 10,143,728 B2
`
`For PETITIONER:
`
`Joseph Mahoney
`Amanda Bonner
`Erick Palmer
`MAYER BROWN LLP
`jmahoney@mayerbrown.com
`astreff@mayerbrown.com
`ejpalmer@mayerbrown.com
`
`For PATENT OWNER:
`
`Dominick Conde
`VENABLE LLP
`dconde@venable.com
`
`
`
`
`
`
`12
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`
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