`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
` AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`
`___________________
`
`Case IPR2018-00608
`U.S. Patent No. 9,161,926 B2
`___________________
`
`PETITIONERS’ OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE PETITIONER’S EVIDENCE UNDER 37 C.F.R. §42.64
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Case IPR2018-00608
`Patent No. 9,161,926 B2
`
`INTRODUCTION
`
`Seeking to distance itself from Dr. Julie Harper’s deep and long-standing
`
`consulting relationship with Allergan—Patent Owner Almirall’s predecessor-in-
`
`interest in the ’926 patent at issue here—Almirall moves to exclude Exhibits
`
`AMN1041-1048 as allegedly “unauthentic” and “irrelevant.” Exhibits AMN1041-
`
`47 are annual financial reports showing that Dr. Harper received at least
`
`$213,344.70 to $232,342.70 from Allergan between 2011 to 20171 for, among
`
`other things, promoting2 ACZONE 5% Gel (which is highly relevant prior art to
`
`1 This amount does not even include payments to Dr. Harper for her promotional
`
`work relating to the AZCONE 5% Gel from its FDA approval in 2008 to July of
`
`2011 (which is the first data available under the Sunshine Act). AMN1049, 8:26:3-
`
`9:30:14. As Dr. Harper was fond of saying at her deposition, she is “always
`
`compensated” for her time, so it is likely that she was compensated for these
`
`activities too. AMN1049, 10:34:5-7, 12:42:1-6, 42:163:1-19.
`
`2 To the extent that Almirall may try to draw some distinction between
`
`“promoting” a drug and “educating” physicians on the drug, see, e.g., Sur-Reply,
`
`2-3, Dr. Harper testified that she has “done promotional speaking,” which she
`
`defined as “educating [the audience] on the drug,” and that she is “always
`
`compensated” for such activities. AMN1049, 9:31:2-10:34:7. With respect to the
`
`prior art ACZONE 5% Gel, she testified that she has “spoken promotionally for
`
`- 1 -
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`the 7.5% dapsone formulation claimed in the ’926 patent). Exhibit AMN1048
`
`reflects the amount of money Dr. Harper took from 2013 to 2017 from Allergan
`
`specifically for to her work related to ACZONE. During that period, she brought in
`
`the fourth-highest ACZONE-related earnings of all doctors who promoted the
`
`product. AMN1048, 1. Almirall’s motion fails on both procedural and substantive
`
`grounds and, therefore, should be denied.
`
`Procedurally, Almirall’s objections to AMN1041-48 were not timely. These
`
`exhibits were first entered into evidence at the March 11, 2019 deposition of Dr.
`
`Harper. Almirall’s counsel did not object at that time, or even within five business
`
`days of service pursuant to 37 C.F.R. § 42.64(b)(1). Almirall objected two weeks
`
`after being served, on March 25, 2019. See Paper 32. Any objection to these
`
`exhibits has thus been waived.
`
`Substantively, AMN1041-48 are both authentic and relevant. First, as shown
`
`below, AMN1041-48 are self-authenticating “official publications” under FRE
`
`902(5) as they report payments from drug companies (e.g., Allergan) to doctors
`
`(e.g., Dr. Harper) as required by the federal Sunshine Act. The payment amounts
`
`disclosed in these exhibits were also authenticated by Dr. Harper herself during her
`
`deposition.
`
`Aczone 5 Percent” beginning with its release in 2008 through the time when the
`
`7.5% product launched in 2016. Id., 10:35:7-11:38:15.
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`Next, these documents are also relevant to reveal Dr. Harper’s potential bias
`
`in Almirall’s/Allergan’s favor, which the Board should consider in assessing her
`
`credibility as an expert witnesses. For example, AMN1041-48 reveal that Dr.
`
`Harper received more than $200,000 from Allergan from 2011 to 2017, and nearly
`
`$100,000 specifically related to ACZONE from 2013 to 2017. Additionally, given
`
`that AMN1041-48 reflect the considerable sums Dr. Harper received from
`
`Allergan for promoting the use of ACZONE 5% Gel, these documents are relevant
`
`in exposing Dr. Harper’s inconsistent testimony in this proceeding where she
`
`appears to disparage the prior-art ACZONE 5% Gel (also disclosed in Amneal’s
`
`primary reference, Garrett, AMN1004) and discount its usefulness as a
`
`monotherapy. Exhibits AMN1041-48 should not be excluded.
`
`ARGUMENT
`
`I.
`
`Almirall waived its objections to Exhibits AMN1041-48 by failing to
`timely object.
`
`Almirall says that it “timely objected to Exhibits 1041-48” “[f]ollowing
`
`service of Amneal’s Reply.” See Paper 36 at 1. Almirall is wrong. In compliance
`
`with 37 C.F.R. § 42.53(f)(3), AMN1041-48 were marked and served at the March
`
`11, 2019 deposition of Dr. Julie Harper. See AMN1049, 2:5:11-22, 39:152:15-19,
`
`40:155:10-12, 40:156:14-19, 40:157:19-25, 41:158:18-21, 41:159:14-19,
`
`41:160:23-161:4, 41:161:24-25; see also 37 C.F.R. § 42.53(f)(3) (All exhibits used
`
`during the deposition “must, if not previously served, be served at the
`
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`deposition.”). Indeed, at the beginning of Amneal’s questioning of Dr. Harper on
`
`AMN1041, Almirall’s counsel even acknowledged that these exhibits were being
`
`newly served. AMN1049, 39:152:20-153:3.
`
`Notably, Almirall’s counsel conducted re-direct using several of these
`
`exhibits—AMN1041, 1042, and 1048 (see AMN1049, 43:167:1-169:5)—but
`
`failed to make any objection to these documents at any time during the deposition,
`
`as it was required to do under Rule 42.64(a). See generally AMN1049, 39:152:15-
`
`43:166:20; see also 37 C.F.R. § 42.64(a) (“An objection to the admissibility of
`
`deposition evidence must be made during the deposition.”). Even under a more
`
`generous reading of the rules, Almirall would have been required to object to
`
`AMN1041-48 within five business days of service, i.e., by March 18, 2019. 37
`
`C.F.R. § 42.64(b)(1) (“Once a trial has been instituted, any objection must be filed
`
`within five business days of service of evidence to which the objection is
`
`directed.”). But Almirall waited an additional seven days after that deadline (until
`
`March 25, 2019) to object. See Paper 32, 3-7, 9; Paper 36, 1.
`
`By not timely objecting to AMN1041-48, Almirall has waived any
`
`evidentiary objection to these exhibits, and the Board should deny Almirall’s
`
`motion on this basis alone.3 Sanofi-Aventis U.S. LLC et al. v. Immunex Corp.,
`
`3 For the same reason, Almirall’s statement that Amneal failed to serve curative
`
`evidence is irrelevant.
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`IPR2017-01884, Paper 96, 27 (PTAB Feb. 14, 2019) (ruling that an untimely
`
`objection is waived).
`
`II. Exhibits AMN1041-48 are authentic because they are (1) self-
`authenticating government documents or are based on self-
`authenticating government documents, and (2) were corroborated by
`Dr. Julie Harper.
`
`Exhibits AMN1041-48 are authentic under FRE 902 for at least two reasons.
`
`First, AMN1041-48 are self-authenticating or are based on self-
`
`authenticating documents. Pursuant to FRE 902(5), a “publication purporting to be
`
`issued by a public authority” is self-authenticating. The face of each of AMN1043-
`
`1047 shows that the information is published at “openpaymentsdata.cms.gov.”
`
`AMN1043, 1; AMN1044, 1; AMN1045, 1; AMN1046, 1; AMN1047, 1. The
`
`website openpaymentsdata.cms.gov. is “a federal government website managed by
`
`Centers for Medicare & Medicaid Services.” See
`
`https://openpaymentsdata.cms.gov/.
`
`CMS is legally required to collect and disclose payments (and other transfers
`
`of value) so that the public can see any financial relationships between the health
`
`care industry (i.e. drug and device companies) and providers (i.e. physicians and
`
`teaching hospitals). See https://openpaymentsdata.cms.gov/about,
`
`https://www.cms.gov/OpenPayments/About/How-Open-Payments-Works.html;
`
`https://www.propublica.org/article/about-the-dollars-for-docs-data. As CMS is
`
`undeniably a “public authority” within the meaning of FRE 902, its publications
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`- 5 -
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`are self-authenticating.
`
`Relatedly, AMN1041-42 and AMN1048 were obtained from the website
`
`“Dollars for Docs.” See https://projects.propublica.org/docdollars/. The Dollars for
`
`Docs website obtains the payment data from CMS, and compiles it into a single,
`
`comprehensive database. See https://www.propublica.org/article/about-the-dollars-
`
`for-docs-data/. Indeed, AMN1048 says on its face that it displays data obtained
`
`from CMS. AMN1048, 1.4 That is, AMN1041-42 and AMN1048 are no less
`
`authentic than AMN1043-47.
`
`The fact that AMN1041-42 and AMN1048 come from Dollars for Docs
`
`instead of CMS is unremarkable: from August 2013 and December 2015 Dollars
`
`for Docs published the data gathered by CMS, and from 2015 onwards CMS itself
`
`published the data. See https://www.propublica.org/article/about-the-dollars-for-
`
`docs-data (explaining that the Dollars for Docs database contains payments made
`
`4 Because the exhibit stamp on AMN1048 obscures some of the wording relating
`
`the source for its data, the complete note states: “We have made some effort to
`
`normalize the data and eliminate duplicates, but data is primarily as it has been
`
`reported by the companies to the Centers for Medicare and Medicaid Services. To
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`purchase the normalized data, please visit the ProPublica Data Store. If you spot an
`
`error, please let us know at drugs@propublica.org.” See
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`https://projects.propublica.org/docdollars/products/drug-aczone.
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`between August 2013 and December 2015);
`
`https://www.cms.gov/OpenPayments/About/How-Open-Payments-Works.html
`
`(explaining that in 2014 CMS started publishing its payment data from the prior
`
`year).
`
`Second, Dr. Harper, who has actual knowledge about the payments she
`
`received from Allergan, corroborated the disclosures of AMN1041-48 during her
`
`deposition. See FRE 901(b)(1). Specifically, Dr. Harper testified that “[t]he amount
`
`I would have been paid [from Allergan and for work promoting the prior art
`
`ACZONE 5% Gel] is available through the Sunshine Act.” AMN1049, 9:33:16-
`
`10:34:17. When asked if she knew “where that data is stored,” Dr. Harper directed
`
`Amneal’s counsel to “CMS,” or the “Centers for Medicare Medicaid Services,”
`
`which she acknowledged is “part of the Federal government.” AMN1049,
`
`10:34:18-35:6.
`
`Next, presented with AMN1041-48, Dr. Harper was asked whether she had
`
`any reason to disagree that she received the amounts of money AMN1041-48 show
`
`that she received. AMN1049, 40:156:2-13, 40:157:13-18, 41:158:10-17, 41:159:7-
`
`13, 41:160:6-22, 41:161:15-23, 42:163:7-19. Dr. Harper did not disagree with the
`
`disclosures of AMN1041-48; and it’s no wonder why: CMS allows the physicians
`
`and teaching hospitals that are subject to CMS’s reporting requirements to review
`
`and dispute the information before it is published. See 42 U.S.C. § 1320a-7h(c)(ix)
`
`- 7 -
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`(providing “covered recipients,” i.e., doctors, an opportunity to review and correct
`
`submissions); https://www.cms.gov/OpenPayments/About/How-Open-Payments-
`
`Works.html. So, Dr. Harper knew this data existed and had the opportunity to
`
`confirm its accuracy. Additionally, CMS instructs the public to “speak directly to
`
`the healthcare provider” if there are questions about the data. See
`
`https://www.cms.gov/OpenPayments/About/Open-Payments-Data-in-
`
`Context.html. And as above, Amneal questioned Dr. Harper regarding the accuracy
`
`of the data and she testified that she had no disagreement with it.
`
`Accordingly, that AMN1041-48 are self-authenticating coupled with Dr.
`
`Harper’s own testimony establish that AMN1041-48 are “what [Amneal] says”
`
`they are—accurate reflections of the payments Dr. Harper received from working
`
`on behalf of Allergan before, around, and after the ’926 patent’s invention date for
`
`promotional activities related to ACZONE 5% Gel. 5
`
`
`5 On re-direct, Dr. Harper testified that she did not know where the data shown in
`
`AMN1041 and AMN1048 was sourced. AMN1049:43:158:17-169:3. This
`
`testimony is legally irrelevant and merely shows that Dr. Harper did not know the
`
`source of the data. This testimony does not show that the data is in any way
`
`inaccurate or unauthentic. As shown above, however, the source is CMS.
`
`- 8 -
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`
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`III. Exhibits AMN1041-48 are relevant to expose Dr. Harper’s potential
`bias in favor of Almirall.
`
`If a fact-finder “relies upon expert testimony, it should determine that the
`
`expert testimony is reliable. It would make little sense to say that a trial court in its
`
`fact-finding role should accord much if any weight to expert testimony, the
`
`reliability of which is not established.” Libas, Ltd. v. U.S., 193 F.3d 1361, 1366
`
`(Fed. Cir. 1999). “By the same token, even less weight should be accorded to
`
`expert testimony the reliability of which is controverted by the evidence in the
`
`record.” Id. Exhibits AMN1041-48 controvert the reliability of Dr. Harper’s
`
`testimony, and so are all relevant, for the reasons below.
`
`First, AMN1041-48 show that up to the start of this proceeding Dr. Harper
`
`had at least a seven-year (2011 to 2017) paid consulting relationship with Allergan
`
`(the developer and marketer of the prior art ACZONE 5% Gel), through which she
`
`received compensation to speak with and promote to her peers the uses of the prior
`
`art ACZONE 5% Gel. Over those seven years, Dr. Harper received at least
`
`$213,344.70 to $232,342.70 from Allergan. AMN1049, 39:153:11-19.
`
`Given the substantial sums of money Dr. Harper received as a paid speaker
`
`for Allergan and ACZONE 5% Gel, AMN1041-48 are relevant to evaluating
`
`whether Dr. Harper’s factual assertions—that (1) a POSA would not have
`
`considered dapsone as an anti-acne drug (see, e.g., EX2022, ¶¶14, 57-61, 132-140),
`
`(2) ACZONE 5% Gel was not an obvious anti-acne treatment (see, e.g., id.), and
`
`- 9 -
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`
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`(3) using ACZONE 5% Gel without adapalene would not have been obvious (see,
`
`e.g., id., ¶¶164-172)—are tainted in any respect by her relationship with Allergan
`
`and the ACZONE 5% product (and/or furthering her relationship with new patent
`
`owner and marketer of ACZONE 7.5% Gel, Almirall).
`
`Second, AMN1041-48 are relevant to showing inconsistencies with Dr.
`
`Harper’s testimony in this proceeding. For example, on the one hand, to help
`
`Almirall’s attempt to rebut obviousness here, Dr. Harper has testified that a POSA
`
`at the time of invention of ’926 patent (which claims a 7.5% dapsone topical
`
`formulation) would not have been motivated to use the prior art ACZONE 5% Gel
`
`(a 5% dapsone topical formulation) as an anti-acne agent because (1) other
`
`allegedly more preferred anti-acne agents existed and (2) ACZONE 5% was,
`
`according to Dr. Harper, “relegated to second line status and was perceived as
`
`being less effective than other agents.” See, e.g., EX2022, ¶¶14, 57-61, 132-140.
`
`But, on the other hand, AMN1041-48 show the substantial sums of money
`
`that Dr. Harper took from Allergan from 2011-2017 for, inter alia, promoting the
`
`use of ACZONE 5% Gel as part of Allergan’s promotional efforts.6 AMN1049,
`
`39:153:11-19. Allergan paid at least $96,145 to Dr. Harper across five years to
`
`help promote ACZONE 5% Gel, but now she has taken the opposite position that a
`
`POSA would have had reasons to be discouraged from using it. See, e.g., EX2022,
`
`6 The 7.5% product covered by the ’926 patent was not approved until 2016.
`
`- 10 -
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`¶¶14, 57-61, 132-140. Indeed, Dr. Harper testified that she worked with Allergan
`
`and accepted its money because she believed in the ACZONE 5% Gel product.7
`
`AMN1049, 30:115:18-31:116:14. Exhibits AMN1041-48 are thus relevant.
`
`CONCLUSION
`
`The Board should deny Almirall’s motion to exclude AMN1041-48 for at
`
`least the above reasons.
`
`
`
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`
`
`Date: May 8, 2019
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Lead Attorney for Petitioners
`
`10444915.1
`
`
`
`
`
`
`
`
`
`
`7 In fact, when questioned about her CV, Dr. Harper testified that Allergan asked
`
`her to write AMN1035 in 2012. AMN1049, 6:19:8-20:8; see also EX2023, 4;
`
`AMN1035, 1.
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`- 11 -
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`
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`I certify that the above-captioned PETITIONERS’ OPPOSITION TO
`
`PATENT OWNER’S MOTION TO EXCLUDE PETITIONER’S EVIDENCE
`
`UNDER 37 C.F.R. §42.64 was served in its entirety on May 8, 2019, upon the
`
`following parties via electronic mail:
`
`
`
`
`
`
`
`
`
`
`
`James Trainor
`Vanessa Park-Thompson
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`
`Telephone (212) 430-2600
`Facsimile (650)938-5200
`jtrainor@fenwick.com
`vpark-thompson@fenwick.com
`
`Jennifer R. Bush
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`Telephone (650) 988-8500
`Facsimile (650) 938-5200
`jbush@fenwick.com
`
`
`
`
`
`
`
`
`
`Elizabeth B. Hagen
`FENWICK & WEST LLP
`1191 Second Avenue, 10th Floor
`Seattle, WA 98101
`Telephone (206) 389-4510
`Facsimile (206)389-4511
`ehagan@fenwick.com
`
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`Dennies Varughese, Pharm.D.
`Date: May 8, 2019
`1100 New York Avenue, N.W. Registration No. 61,868
`Washington, D.C. 20005-3934
`Lead Attorney for Petitioners
`(202) 371-2600
`
`
`
`
`
`- 12 -
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`
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