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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS, LLC
`Petitioner
`
`v.
`
`SUPERNUS PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`CASE IPR2013-00368
`Patent 8,206,740
`_____________________
`
`AMNEAL PHARMACEUTICALS’ MOTION
`TO EXCLUDE EVIDENCE UNDER 37 C.F.R. § 42.64(c)
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`Petitioner Amneal Pharmaceuticals files this motion pursuant to 37 C.F.R. §
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`42.64(c) and in accordance with Due Date 4 of the Scheduling Order (Paper 9).
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`The Board should exclude Patent Owner Supernus Pharmaceuticals' Exhibits 2028,
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`2029, 2032-2034, 2039, 2049, 2050, 2147, 2149-2154, and 2156 because these
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`documents are unauthenticated, contain hearsay, or both. Amneal timely objected
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`to these exhibits on March 18, 2014, and Supernus failed to cure Amneal's
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`objections.
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`I. OVERVIEW
`Supernus has
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`introduced dozens of unauthenticated documents
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`in
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`contravention of the rule against hearsay in order to support its patentability
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`arguments. It appears that Supernus intends to argue that all of these documents
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`fall within the business records exception to the hearsay rule. But it has failed to
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`introduce competent evidence to establish that any hearsay exception applies.
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`The Federal Rules of Evidence, which govern admissibility of evidence in
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`this proceeding, serve important gatekeeping functions in this proceeding. The
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`authentication rule ensures that documents that are put before the Board are what
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`they purport to be. Where a party such as Supernus seeks to rely on documents that
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`are not self-authenticating, it must produce sufficient evidence to confirm the
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`authenticity of those documents. Fed. R. Evid. 901(a).
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`The Board should also be particularly wary of permitting the introduction of
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`hearsay to support the patentability of Supernus's patent. For example, here
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`Supernus points to documents that purport to show that another company
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`(Faulding) tried and failed to develop a once-daily doxycycline formulation. (See,
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`e.g., Exhibits 2032 & 2049.) But absent from the record is any evidence as to who
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`authored these documents or any other circumstances surrounding their creation.
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`Consequently, Amneal has had no opportunity to cross-examine any witness who
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`claims to have personal knowledge of the factual statements contained therein.
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`Likewise, Supernus relies upon a number of emails to support its efforts to
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`antedate the prior art, including emails written by a named inventor. (See Exhibits
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`2028, 2029, 2151, 2152, 2153, 2154, and 2156.) Such unsworn statements should
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`not be permitted to prove prior invention.
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`II. ARGUMENT
`The exhibits at issue in this motion share two common infirmities. The first
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`is that each is indisputably hearsay because Supernus seeks to rely upon these
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`documents to prove the truth of the information contained therein. Fed. R. Evid.
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`802. The second common infirmity is that Supernus has not proffered sufficient
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`evidence that each document is authentic—meaning that it is what it purports to be.
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`See Fed. R. Evid. 901(a).
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`It appears that Supernus will seek to avoid the hearsay rule by arguing that
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`each of the following documents is a business record. But qualifying as a business
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`record requires more than a showing that Supernus located the document among its
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`files. Rather, the business records exception requires proof of the following:
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`(A) the record was made at or near the time by — or
`from information transmitted by — someone with
`knowledge;
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`(B) the record was kept in the course of a regularly
`conducted
`activity of
`a business, organization,
`occupation, or calling, whether or not for profit;
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`(C) making the record was a regular practice of that
`activity;
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`(D) all these conditions are shown by the testimony of
`the custodian or another qualified witness, or by a
`certification that complies with Rule 902(11) or (12) or
`with a statute permitting certification; and
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`(E) neither the source of information nor the method or
`circumstances of preparation
`indicate a
`lack of
`trustworthiness.
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`Fed. R. Evid.803(6). As set forth in more detail below, Supernus cannot qualify
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`each of these documents as business records as it has offered no evidence that the
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`documents were made by someone with personal knowledge and/or that the
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`documents were made and kept in the course of a regular business activity.
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`Further, it is apparent from the face of many of the documents that they were
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`not created by Supernus. Where a party attempts to invoke the business records
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`exception over documents that it did not create, it must show that it "incorporated
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`the records of another entity into its own, relied upon those records in its day-to-
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`day operations," and it must show "where there are other strong indicia of
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`reliability." Air Land Forwarders, Inc. v. United States, 172 F.3d 1338, 1344 (Fed.
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`Cir. 1999). Here, Supernus’s evidence is also lacking.
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`1. Exhibits 2028 and 2029. Exhibits 2028 and 2029 each purport to be
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`email communications from within Shire Laboratories. These exhibits are not
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`directly cited in the Patent Owner’s Response. However, Dr. Rudnic relies upon
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`Exhibit 2028 and 2029 to support his opinion that doxycycline has a narrow
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`absorption window. (Exhibit 2016, ¶ 51.) Amneal objected to each of these
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`exhibits on the basis of, among other things, authenticity and hearsay. (Ex. 1116, at
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`Nos. 10 &11.)
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`In an attempt to overcome Amneal's evidentiary objections, Supernus may
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`argue that Exhibits 2028 and 2029 are admissible under the business records
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`exception. But the mere fact that email communications may be a regular activity
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`at Supernus "is simply insufficient on that basis alone to establish a foundation for
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`admission under Rule 803(6)(B)." United States v. Cone, 714 F.3d 197, 220 (4th
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`Cir. 2013). Put simply, "there is no across-the-board rule that all emails are
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`admissible as business records." In re Oil Spill by the Oil Rig DEEPWATER
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`HORIZON in the Gulf of Mexico, 2012 WL 85447, 3 (E.D. La. 2012). Rather, to
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`qualify an email as a business record, a party “must show that the employer
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`imposed a business duty to make and maintain such a record.” Schaghticoke Tribal
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`Nation v. Kempthorne, 587 F. Supp.2d 389, 397 (D. Conn. 2008). Importantly,
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`email "is typically a more casual form of communication than other records usually
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`kept in the course of business, such that it may not be appropriate to assume the
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`same degree of accuracy and reliability." Cone, 714 F.3d at 219-200 (quoting It's
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`My Party, Inc. v. Live Nation, Inc., No. JFM–09–547, 2012 WL 3655470 at *5 (D.
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`Md. 2012). Absent a showing that each of these emails was generated under a
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`business duty to create and maintain these communications, they do not qualify
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`under any exception to the hearsay rule. Supernus has not endeavored to make
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`such a showing here and these documents should be excluded.
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`2. Exhibit 2032. Exhibit 2032
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`is a document entitled "Status-
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`Manufacturing" and shows a date of May 2001. Exhibit 2032 is unsigned and bears
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`no indication as to the identity of the author or the author’s personal knowledge
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`concerning any of the statements contained therein. Exhibits 2032 is cited in the
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`Patent Owner's Response as evidence of failure of others (Paper 39 at 47-48) and is
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`similarly relied upon by Dr. Rudnic. (Ex. 2016, ¶¶ 67, 68 130, 192, 194, and 197.)
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`Amneal objected to Exhibit 2032 on the basis of, among other things, authenticity
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`and hearsay. (Ex. 1116, at No. 12.)
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`Supernus may argue that Exhibit 2032 is from Galderma's files and,
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`therefore, is a business record. But the business records exception requires more
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`than proof that the document is from the files of a business and that the business
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`maintains files. It requires proof that the author had personal knowledge of the
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`information in the document and that the author had a business duty to prepare the
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`document. Here, Supernus has offered no explanation as to who prepared the
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`document or any of the circumstances surrounding its preparation. It also has not
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`shown that Exhibit 2032 is a document that Supernus, Galderma, or anyone else
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`relied on as part of its day-to-day business operations. Consequently, Exhibit 2032
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`should be excluded as hearsay.
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`3. Exhibit 2033. Exhibit 2033 is a document entitled "Doxycycline
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`Bioavailability Study No. CM4899, 1. Study Summary." Exhibit 2033 is unsigned
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`and bears no indication as to the identity of the declarant or the declarant's personal
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`knowledge concerning any of the statements contained therein. Exhibit 2033.
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`Although Exhibit 2033 is not directly cited in the Patent Owner's Response, it is
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`cited in the declaration of Dr. Rudnic as purported evidence of failure of others to
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`develop a sustained release doxycycline formulation. (Ex. 2016, ¶ 67.) Amneal
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`objected to Exhibit 2033 on the basis of, among other things, authenticity and
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`hearsay. (Ex. 1116, at No. 13.)
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`Supernus may argue that Exhibit 2033 is from Galderma's files and,
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`therefore, is a business record. However, Supernus has offered no evidence to
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`show that Exhibit 2033 meets all the conditions of a business record within the
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`meaning of Rule 803(6). For example, it has not offered evidence of who authored
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`Exhibit 2033 or the author's personal knowledge of statements made in the
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`document relating to the bioavailability of the Faulding formulations. Supernus has
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`also failed to present evidence that Exhibit 2033 was prepared by someone under a
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`business duty to do so or that it relied on it as part of its day-to-day business
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`operations. Consequently, Exhibit 2033 should be excluded as hearsay.
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`4. Exhibit 2034. Exhibit 2034 purports to be a 25-page fax sent by Stefan
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`Lukas to Chris Phillips on February 3, 2000. The document provides no indication
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`as to whether the author is qualified to make any of the statements attributed to him
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`or whether such statements were made in the course of a regularly-conduted
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`business activity. In addition, it is unclear whether each of the pages is part of the
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`original document. Among other things, the pages bearing the Bates Numbers
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`GLD0227794-798 do not have a fax transmission header while the pages bearing
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`the Bates Numbers GLD0227799-818 do bear a fax transmission header. Further,
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`the date listed in the fax transmission header is January 28, 2000, whereas the date
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`listed on cover page is February 3, 2000. In addition, the fax header that begins on
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`page 6 of the document (GLD0227799) indicates that it is page 2 of the fax
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`transmission. Therefore, it appears that Exhibit 2034 is comprised of pages from
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`different original documents. Exhibit 2034 is cited in the Patent Owner's Response
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`as evidence of failure of others (Paper 39 at 47) and is similarly relied upon by Dr.
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`Rudnic. (Ex. 2016, ¶¶ 67, 192, 194, Fn. 47-48.) Amneal objected to Exhibit 2034
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`on the basis of, among other things, authenticity and hearsay. (Ex. 1116, at No.
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`14.)
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`Supernus may argue that Exhibit 2034 is from Galderma's files and,
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`therefore, is a business record. But these bare assertions do not cure the evidentiary
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`infirmities of Exhibit 2034. Although the author of Exhibit 2034 is identified as
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`Stefan Lukas, there is no indication as to whether Mr. Lukas has personal
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`knowledge of the statements and opinions set forth in Exhibit 2034 relating to
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`bioavailability of the Faulding formulations. There is also no indication as to
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`whether Mr. Lukas prepared Exhibit 2034 under a business duty to do so or that
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`Supernus or anyone else relied on Exhibit 2034 as part of its day-to-day business
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`operations. Consequently, Exhibit 2033 should be excluded as hearsay.
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`5. Exhibit 2039. Exhibit 2039 purports to be memoranda on Shire stationery
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`and prepared for CollaGenex Pharmaceuticals on December 9, 2002. It is neither
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`signed nor does it identify the author or authors. It also bears significant redactions,
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`which Supernus claims are due to the presence of privileged information. Exhibit
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`2039 is not directly cited in Supernus's Patent Owner's Response. However, Dr.
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`Rudnic relies upon Exhibit 2039 for the assertion that Shire conducted in silico
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`modeling in late 2002 to "assess options for continued development of an IR/DR
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`combination formulation," for the assertion that Shire recommended a 75:25
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`(IR/DR) formulation for clinical testing, and for the assertion that the inventors
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`selected the 75:25 ratio based on in silico modeling. (Ex. 2016, ¶ 70, Fn. 40.)
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`Amneal objected to this exhibit on the basis of, among other things, authenticity
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`and hearsay. (Ex. 1116, at No. 17.)
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`In an effort to overcome Amneal's evidentiary objections, Supernus may
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`argue that Exhibit 2039 is from Supernus's files and, therefore, constitutes a
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`business record. But there is no evidence of who authored Exhibit 2039, whether
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`the author had personal knowledge of the factual statements and opinions
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`contained therein, whether Exhibit 2039 is a final version or mere draft, or whether
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`Supernus relied upon the accuracy of this document as part of its day-to-day
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`operations. Consequently, Exhibit 2039 should be excluded as hearsay.
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`6. Exhibit 2049. Exhibit 2049 is entitled "Status-Manufacturing" and shows
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`a date of August 24, 2000. Exhibit 2049 is unsigned and bears no indication as to
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`the identity of the author or the author’s personal knowledge concerning any of the
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`statements contained therein. Exhibit 2049 is not directly cited in the Patent
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`Owner's Response, but is relied upon by Dr. Rudnic as purported evidence of
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`failure of others. (Ex. 2016, ¶¶ 192, 194.) Amneal objected to Exhibit 2049 on the
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`basis of, among other things, authenticity and hearsay. (Ex. 1116, at No. 25.)
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`Exhibit 2049 contains similar hearsay statements relating to the Faulding
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`formulations as Exhibit 2032.
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`Supernus may argue that Exhibit 2049 is from Galderma's files and,
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`therefore, is a business record. For the same reasons that Exhibit 2032 should be
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`excluded as hearsay, Exhibit 2049 should also be excluded.
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`7. Exhibit 2050. Exhibit 2050 purports to be a 7-page fax sent by Stefan
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`Lukas to Chris Phillips on December 3, 1999. Like Exhibit 2034, there is no
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`indication as to whether the author is qualified to make any of the statements
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`attributed to him or whether such statements were made in the course of a regularly
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`conducted business activity. Exhibit 2050 is not directly cited in the Patent Owner's
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`Response. However, Dr. Rudnic relies upon Exhibit 2050 as evidence of failure of
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`others. (Ex. 2016, ¶ 192.) Amneal objected to Exhibit 2050 on the basis of, among
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`other things, authenticity and hearsay. (Ex. 1116, at No. 26.)
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`Supernus may argue that Exhibit 2050 was located in the files of Galderma
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`and, therefore, is a business record. However, it has offered no evidence that cures
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`the evidentiary infirmities of Exhibit 2050. For example, it has offered no evidence
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`of who the author is or the author’s personal knowledge. Supernus has also failed
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`to present evidence that Exhibit 2050 was prepared by someone under a business
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`duty to do so or that it relied on Exhibit 2050 as part of its day-to-day business
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`operations. Supernus has also failed to even provide evidence that Exhibit 2050 is
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`a true and correct copy of what it purports to be.
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`8. Exhibits 2147, 2149, and 2150. Exhibit 2147 is entitled "Periostat XR
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`Project – Draft." Exhibit 2147 is unsigned and bears no indication as to the identity
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`of the author or the author's personal knowledge concerning any of the statements
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`contained therein. Exhibit 2149 is a document entitled "Clinical Study Report,
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`Sponsor Reference: 5732:11 QD." Exhibit 2150 is a document entitled "Shire Labs
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`Monthly Project Report: October 2002." Supernus relies on Exhibit 2147 to
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`demonstrate purported diligence toward an actual reduction to practice. (Paper 39,
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`at 58-59.) It relies on Exhibit 2149 and 2150 to show that it had purportedly
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`reduced to practice "as much of the claimed invention" as the prior art disclosed.
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`(Paper 39, at 57-58.) Amneal objected to the admissibility of each these exhibits on
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`the basis of, among other things, authenticity and hearsay. (Ex. 1116, at Nos. 73,
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`75 & 76.)
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`Exhibits 2147, 2149, and 2150 were introduced through the declaration of
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`Dr. Jones W. Bryan (Ex. 2146). In an effort to overcome Amneal's evidentiary
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`objections, Dr. Bryan submitted a supplemental declaration that sought to show
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`these documents are business records. However, his subsequent deposition in this
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`proceeding undermines his supplemental declaration. With respect to Exhibit 2147,
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`Dr. Bryan testifies that he had no knowledge of who prepared the document, when
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`- 11 -
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`it was prepared, or how he came to be in possession of Exhibit 2147. (Ex. 1053, at
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`62-63.) With respect to Exhibit 2149, Dr. Bryan testified that he had no knowledge
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`of who prepared the document or who designed and performed the experiments
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`reported therein. (Ex. 1053, at 101-109.) And with respect to Exhibit 2150, Dr.
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`Bryan admitted that he had no knowledge of who authored the document or even
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`when he had first seen the document. (Ex. 1053, at 127.) Consequently, Exhibits
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`2147, 2149, and 2150 should be excluded because Supernus has offered no
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`competent evidence of their authenticity nor their admissibility under any
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`exception to the hearsay rule.
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`9. Exhibits 2151, 2152, 2153, 2154, and 2156. Exhibits 2151, 2152, 2153,
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`2154 and 2156 each purport to be email communications from within Shire
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`Laboratories. Supernus cites Exhibit 2152 as evidence to support its assertion that
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`the inventors had "possession of significantly more of the claimed invention" than
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`what was disclosed in the art. (Paper 39, at 58.) None of the other email
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`communications are directly cited in the Patent Owner's Response. However, Dr.
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`Bryan relies upon Exhibits 2151, 2152, 2153, 2154, and 2156 in his declaration to
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`support his testimony concerning the alleged dates of conception and reduction to
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`practice of the '740 patent. (Ex. 2146, ¶¶ 24-29.) Supernus, in turn, relies upon Dr.
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`Bryan's testimony in support of its efforts to antedate the Ashley references and to
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`invoke the CREATE Act. (Paper 39, at 57-60.) Amneal objected to each of these
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`- 12 -
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`exhibits on the basis of, among other things, authenticity and hearsay. (Ex. 1116, at
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`Nos. 77, 78, 79, 80 and 82.) For the same reasons set forth above with respect to
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`Exhibits 2028 and 2029, Supernus has not shown that each of these emails was
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`generated under a business duty to create and maintain these communications.
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`Consequently, they do not qualify under any exception to the hearsay rule.
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`III. CONCLUSION
`Amneal timely objected to Supernus's improper exhibits. Amneal now asks
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`that the foregoing exhibits be excluded from this IPR proceeding. These exhibits
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`do not meet the threshold for admissibility and should be excluded from the record.
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`Respectfully submitted,
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`/Eldora L. Ellison/
`Eldora L. Ellison
`Registration No. 39,967
`Lead Attorney for Petitioner Amneal
`Pharmaceuticals, LLC
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`Date: June 30, 2014
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`1864119_2.DOCX
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`- 13 -
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`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e))
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`The undersigned hereby certifies that the above-captioned "Amneal
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`Pharmaceuticals' Motion to Exclude Evidence under 37 C.F.R. 42.64(c)," along
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`with Exhibit 1116, were served in their entirety on June 30, 2014, via email on the
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`following:
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`
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`smaebius@foley.com
`Stephen B. Maebius
`stalapatra@foley.com
`Sunit Talapatra
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`abaluch@foley.com
`Andrew S. Baluch
`Gerald J Flattmann, Jr. geraldflattmann@paulhastings.com
`Gregory Morris
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`gregorymorris@paulhastings.com
`Evan Diamond
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`evandiamond@paulhastings.com
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`
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`
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`Respectfully submitted,
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`/Eldora L. Ellison/
`Eldora L. Ellison, Ph.D.
`Reg. No. 39,967
`Lead Attorney for Petitioner Amneal
`Pharmaceuticals, LLC
`
`
`Date: June 30, 2014
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
`
`
`
`
`
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