Public Version
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS OF
`PRODUCING THE SAME
`
`Inv. No. 337-TA-1120
`
`ORDER NO. 32: GRANTING-IN-PART COMPLAINANT GLYCOSYN LLC'S
`OMNIBUS MOTION IN LIMINE
`
`(May 2, 2019)
`
`On April 15, 2019, complainant Glycosyn LLC ("Glycosyn") filed an omnibus motion in
`
`limine (1120-026) with four subparts. On April 29, 2019 respondent Jennewein Biotechnologie
`
`GmbH ("Jennewein") and the Commission Investigative Staff ("Staff') responded to the motion.
`
`For the reasons detailed below, Glycosyn's motion (1120-026) is granted-in-part.
`
`Glycosyn's Motion in Limine No. 1
`
`Glycosyn's Motion in Limine No. 1 seeks "to preclude Respondent from providing testimony
`
`inconsistent with its representations to the FDA;" in particular, those representations included in
`
`Jennewein's "Generally Regarded as Safe (`GRAS')" submission and regarding the processes by
`
`which the accused products are manufactured. (See Mot. Mem. at 1-2.) Glycosyn argues:
`
`Where an accused infringer makes representations to the Food and
`Drug Administration ("FDA") in a manner that directly addresses the
`issue of patent infringement, the submission to the FDA will control
`the infringement inquiry. See Abbott Labs. v. TorPharm, Inc., 300 F.3d
`1367, 1373 (Fed. Cir. 2002) ("[A]n [FDA] specification defining a
`proposed generic drug in a manner that directly addresses the issue of
`infringement will control the infringement inquiry."); see also Bayer
`AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1249, 2000 U.S.
`App. LEXIS 9878, *21 (Fed. Cir. 2000) ("[T]he specification in
`[accused infringer's FDA submission] defines its product in a way that
`directly addresses the question of infringement . . . . [Accused infringer]
`is bound by this specification."). While these cases are generally in the
`context of submissions to the FDA to support Abbreviated New Drug
`1
`
`

`

`Public Version
`
`Applications ("ANDA"), they are relevant to submissions to the FDA
`to support Generally Regarded As Safe ("GRAS") status as well.
`Simply put, there are severe repercussions for submitting false or
`misleading statements to the FDA, and thus their evidentiary weight
`and indicia of reliability are deemed high. See Bayer AG, 212 F.3d at
`1249- 50 (listing various penalties for false or misleading statements to
`the FDA inside and outside the context of ANDA).
`
`(Id.) Glycosyn then identifies four such representations it wishes to hold Jennewein to. (See id. at 2-
`
`8.) Glycosyn adds that an agreement between third-party Abbott and Jennewein "prohibits Jennewein
`
`from making any changes to its manufacturing process without prior written approval from Abbott"
`
`and thus, in the absence of any agreements signaling a change, "Jennewein is thus bound to the
`
`disclosures in its FDA GRAS submission." (See id. at 7-8.)
`
`Jennewein opposes the motion and describes it as "light on legal support but heavy on
`
`inflammatory rhetoric." (Opp. at 1.) More specifically, Jennewein contends: the law cited by
`
`Glycosyn is specific to ANDA litigation and thus not relevant to a GRAS notice (id. at 2-4); GRAS
`
`notices "certify the safety of a product and don not require any specific process used to make that
`
`product" (id. at 1, 4-9); and there is no legal basis for the Abbott-Jennewein agreement to exclude
`
`argument and evidence in this investigation (id. at 1, 9-10).
`
`The Staff also opposes the motion and describes it as "utterly baseless." (Staff Resp. at 2.)
`
`According to the Staff, "Where is no support in those [cases cited by Glycosyn] for Glycosyn's
`
`overbroad statement that in all cases, 'where an accused infringer makes representations to the Food
`
`and Drug Administration (`FDA') in a manner that directly addresses the issue of patent infringement,
`
`the submission to the FDA will control the infringement inquiry.' (Id.) The Staff adds, "[e]ven if a
`
`valid parallel could be drawn between ANDA and GRAS notification procedures, the cases cited do
`
`not support Glycosyn's overbroad characterization of ANDA law" because they held that "there will
`
`almost never be a genuine dispute of material fact that the claim is infringed with respect to that
`
`2
`
`

`

`Public Version
`
`limitation" (id at 3 (citing Abbott Labs., 300 F. 3d at 1373)) as opposed to "never a valid dispute
`
`concerning infringement" (id.).
`
`Upon review, Glycosyn's Motion in Limine No. 1 is hereby denied. The central premise of
`
`the motion—that any time "an accused infringer makes representations to the Food and Drug
`
`Administration ('FDA') in a manner that directly addresses the issue of patent infringement, the
`
`submission to the FDA will control the infringement inquiry" (Mot. Mem. at 1)—is not supported by
`
`the cited authority. The holdings of both Abbott Labs. and Bayer AG relied on ANDA submissions
`
`to guide the infringement inquiry because of the fact that no accused product actually existed yet—a
`
`circumstance specific to ANDA litigation—while also acknowledging that evidence beyond that
`
`submission must still be taken into account. As stated in Abbott Labs.:
`
`An infringement inquiry provoked by an ANDA filing under 35 U.S.C.
`§ 271(e)(2)(A) is focused on the product that is likely to be sold
`following FDA approval. Glaxo, Inc. v. Novopharm, Ltd, 110 F.3d
`1562, 1568, 42 USPQ2d 1257, 1262 (Fed.Cir.1997). This
`determination is based on consideration of all the relevant evidence,
`including the ANDA filing, other materials submitted by the accused
`infringer to the FDA, and other evidence provided by the
`parties. Id at 1570, 42 USPQ2d at 1263-64. Because drug
`manufacturers are bound by strict statutory provisions to sell only
`those products that comport with the ANDA 's description of the drug,
`an ANDA specification defining a proposed generic drug in a manner
`that directly addresses the issue of infringement will control the
`infringement inquiry. Bayer, 212 F.3d at 1249-50,54 USPQ2d at 1717.
`Thus, in Bayer, we held that summary judgment of no literal
`infringement was properly granted where the ANDA specification
`required the proposed drug to have a specific surface area outside the
`range claimed by the patent in suit. Id. at 1250, 54 USPQ2d at 1717.
`
`300 F. 3d at 1373 (emphasis added). The Bayer AG court similarly held:
`
`The focus, under § 271(e)(2)(A), is on "what the ANDA applicant will
`likely market if its application is approved, an act that has not yet
`occurred." Glaxo, 110 F.3d at 1569, 42 USPQ2d at 1263. "[This
`hypothetical inquiry is properly grounded in the ANDA application
`and the extensive materials typically submitted in its
`support." Id Therefore, it is proper for the court to consider the ANDA
`itself, materials submitted by the ANDA applicant in support of the
`ANDA, and any other relevant evidence submitted by the applicant or
`3
`
`

`

`Public Version
`
`patent holder. See id. at 1570, 110 F.3d 1562, 42 USPQ2d at 1263.
`However, if the ANDA "is to sell [a] well-defined compound," then the
`"ultimate question of infringement is usually straightforward." Id. at
`1569, 110 F.3d 1562, 42 USPQ2d at 1263.
`
`212 F. 3d at 1249 (emphasis added).
`
`In contrast, a GRAS submission is voluntary and Glycosyn cites no authority for the
`
`proposition that such a submission binds the manufacturer "to sell only those products that comport
`
`with the [GRAS submission's] description" of the product. Abbott Labs., 300 F. 3d at 1373. Thus,
`
`Glycosyn's editorial replacements of [ANDA] with [FDA] in its quotation of Abbot Labs. and [Elan's
`
`ANDA] with [accused infringer's FDA submission] in its quotation of Bayer AG (see Mot. Mem. at
`
`1) are unpersuasive. Further, as noted by Jennewein (see Opp. at 2), Glycosyn cites no legal authority
`
`for the proposition that Jennewein's agreement with non-party Abbott also controls the infringement
`
`inquiry (see Mot. Mem. at 6-7).
`
`Glycosyn's Motion in Limine No. 2
`
`Glycosyn's Motion in Limine No. 2 seeks "to preclude Respondent from relying on 29 foreign
`
`language exhibits, which were served without any translation into English, certified or unofficial, in
`
`violation of Ground Rule 9.5.5. (Mot. Mem. at 8.) Glycosyn notes "[o]n April 15, 2019, counsel for
`
`Jennewein, in response to our meet and confer, confirmed that it will not be relying upon any of these
`
`29 exhibits" but adds "[i]n the event that Jennewein withdraws all 29 of these exhibits, this motion
`
`will become moot." (Id.)
`
`In its response, Jennewein states the exhibits "have already been withdrawn" (Opp. at 10),
`
`and thus the issues is moot. The Staff took an identical position. (Staff Resp. at 5.)
`
`Based upon Jennewein's representation, Glycosyn's motion is denied as moot.
`
`Glycosyn's Motion in Limine No. 3
`
`Glycosyn's Motion in Limine No. 3 seeks to preclude "Respondent's expert from offering
`
`new enablement, non-infringement, and technical prong of domestic industry opinions advanced for
`4
`
`

`

`Public Version
`
`the first time in his initial and rebuttal witness statements" under Ground Rules 10 and 14.7.6. (Mot.
`
`Mem. at 12, 14.)1 Glycosyn identifies Q179-183, Q192-195, RDX-007, RDX-008, RDX-012 from
`
`RX-0384C and Q97-100, Q146-147, Q152, Q197, Q216, Q327-328, Q349-350, RDX-013, and a
`
`portion of CX-0038C from RX-409C as the offending content. (See id.)
`
`Jennewein opposes the motion, argues "Dr. Stephanopoulos's testimony is supported by his
`
`expert reports or deposition testimony" (Opp. at 12), and identifies the alleged support in those reports
`
`and deposition transcript for each of the witness statement questions and answers challenged by
`
`Glycosyn (see id. at 12-20).
`
`The Staff supports Glycosyn's motion in part, finding no adequate support in Dr.
`
`Stephanopoulos's reports or deposition for Q179, RDX-007, Q195, and RDX-012 in RX-384C, and
`
`Q216 and Q349-350 in RX-409C. (Staff Resp. at 6.) The Staff finds adequate support for the
`
`remainder of the testimony and demonstratives challenged by Glycosyn.
`
`Upon review, Glycosyn's Motion in Limine No. 3 is hereby granted-in-part. With respect to
`
`RX-384C, the Stephanopoulos Direct Witness Statement, Jennewein has not pointed to adequate
`
`support for Q179 and RDX-007 in the expert's prior reports or deposition transcript. Moreover,
`
`Jennewein tacitly acknowledges the notes presented in RDX-007, and summarized in Q179, were
`
`belatedly produced. (Opp. at 13 ("Moreover, his notes were provided at the deposition in response
`
`to Glycosyn's request").) With respect to RX-409C, the Stephanopoulos Rebuttal Witness Statement,
`
`Q216 and Q349-350 are hereby struck. The paragraphs Jennewein cites as support for Q216 fail to
`
`do so. (See Opp. at 19 (citing Opp. Ex. 14 at If 91; Opp., Ex. 15 at ¶ [69]).) Further, Q349-350 involve
`
`an assertion that Glycosyn does not conduct its Miller unit testing in accordance with the Miller
`
`1 Here, Glycosyn erroneously refers to Ground Rule 14.7.6 from Order No. 2 (June 21, 2018)—a
`rule eliminated by Order No. 24 (Feb. 7, 2019). Nonetheless, current Ground Rule 11.5.5, as put
`into effect with Order No. 24, reflects the same limitation for expert testimony provided at trial.
`5
`
`

`

`Public Version
`
`reference for domestic industry purposes; but this assertion is entirely absent from the expert report
`
`paragraphs Jennewein cites for support. (See Opp. at 20 (citing Opp., Ex. 15 at Tit 101-104).)
`
`Glycosyn's Motion in Limine No. 4
`
`Glycosyn's Motion in Limine No. 4 seeks to strike "the improper opinion testimony of a
`
`Jennewein fact witness, Dr. Katja Parschat, regarding her opinions on the Miller assay. . . and her
`
`interpretations of Jennewein's own Miller testing. ." (Mot. Mem. at 17.) Jennewein opposes the
`
`motion on the basis that it violates the ten-page limit imposed by Ground Rule 9.4. (Opp. at 21.)
`
`Upon review, Glycosyn's Motion in Limine No. 4 is hereby denied. Ground Rule 9.4 states
`
`"[t]he parties are limited to ten pages per [motion in limine]." (Order No. 24 (Feb. 7. 2019).)
`
`Glycosyn's fourth motion in limine is at least thirteen pages in violation of the rule. (See Mot. Mem.
`
`at 17-30.)
`
`Within seven days of the date of this document, the parties shall submit to the Office of the
`
`Administrative Law Judges a joint statement as to whether or not they seek to have any portion of
`
`this document deleted from the public version. If the parties do seek to have portions of this document
`
`deleted from the public version, they must submit to this office a copy of this document with red
`
`brackets indicating the portion or portions asserted to contain confidential business information. The
`
`submission may be made by email and/or hard copy by the aforementioned date and need not be filed
`
`with the Commission Secretary.
`
`SO ORDERED.
`
`Cameron Elliot
`Administrative Law Judge
`
`6
`
`

`

`CERTAIN HUMAN MILK OLIGOSACCHARIDES AND
`METHODS OF PRODUCING THE SAME
`
`INV. NO. 337-TA-1120
`
`PUBLIC CERTIFICATE OF SERVICE
`
`I, Lisa R. Barton, hereby certify that the attached Order No. 32 has been served by hand upon
`the Commission In)01Atintive Attorney, Lisa Murray, Esq. and the following parties as
`indicated, on I 1 3 2019
`
`..._
`
`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street SW, Room 112A
`Washington, DC 20436
`
`FOR COMPLAINANT GLYCOSYN LLC
`
`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY
`AND POPEO PC
`One Financial Center
`Boston, MA 02111
`
`( ) Via Hand Delivery
`( ) Express Delivery
`(./) Via First Class Mail
`( ) Other:
`
`FOR RESPONDENT JENNEWEIN BIOTECHNOLOGIE GmbH
`
`Gary M. Hnath, Esq.
`MAYER BROWN, LLP
`1999 K Street, NW
`Washington, DC 20006
`
`( ) Via Hand Delivery
`( ) Express Delivery
`(v) Via First Class Mail
`( ) Other:
`
`