`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner
`
`
`
`U.S. Patent No. 7,049,328 B2
`
`
`Case No.: IPR2017-01446
`
`
`PETITIONER’S MOTION TO COMPEL ROUTINE
`DISCOVERY OR, IN THE ALTERNATIVE, FOR
`ADDITIONAL DISCOVERY
`
`
`
`
`
`
`
`Introduction
`
`I.
`Patent Owner Apotex Technologies, Inc. (“Apotex”) made statements in its
`
`Patent Owner Response (Paper 17, “POR”) that are inconsistent with facts
`
`discovered by Petitioner Taro Pharmaceuticals USA, Inc. (“Taro”) during the parallel
`
`district court case concerning the ’328 patent. These inconsistencies are central to
`
`the issues here, including (1) whether the prior art teaches away from the claimed
`
`method, as Apotex now contends; (2) whether the patients in the instituted prior art
`
`references necessarily had iron induced heart disease, as Taro contends and Apotex
`
`denies; and (3) whether the dosage disclosed in the prior art was inherently an
`
`effective dose, as Taro contends and Apotex denies.
`
`The relevant documents, attached as Exhibits 1037-1045 and 1047-1049, were
`
`either served or generated during discovery in the ongoing litigation, and therefore,
`
`Taro is aware of their contents. However, because Apotex has designated the
`
`documents Highly Confidential, the protective order entered in the district court case
`
`prevents Taro from relying on them in this proceeding. Therefore, pursuant to the
`
`Board’s Order (Paper 18), Taro moves the Board to compel Apotex to produce the
`
`documents and a stipulation attesting to their authenticity in line with Apotex’s
`
`routine discovery obligations (37 CFR § 42.51(b)(1)), or, in the alternative, as
`
`additional discovery under 37 CFR § 42.51(b)(2).
`
`
`
`1
`
`
`
`
`
`II. The Requested Documents Are Relevant to and Inconsistent with
`Positions Advanced by Apotex in the POR and Should Have Been
`Produced as Routine Discovery
`
`The rule on routine discovery obligates Patent Owner to produce the documents
`
`listed below because they contain statements inconsistent with those made in this
`
`proceeding. 37 CFR § 42.51(b)(1); see also Becton, Dickinson and Co. v. B. Braun
`
`Melsungen AG, IPR2017-01586, Paper 20 at 4 (PTAB Feb. 28, 2018) (“Statements
`
`made by a party or by the party’s expert that are inconsistent with a position taken
`
`during this trial should be produced and become part of the record.”) (discussing
`
`Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d 1267, 1275 (Fed. Cir. 2017)).
`
`A. Documents Inconsistent with Apotex’s Position on the Olivieri Publications
`
`Here, Apotex describes publications by Dr. Olivieri that questioned the safety and
`
`efficacy of deferiprone as causing “significant disagreement in the scientific
`
`community” (POR at 5) and “teaching away” from the use of deferirpone (id. at 44-
`
`45, 53-54).
`
`
`
`2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`B. Documents Inconsistent with Apotex’s Position Regarding the Cardiac
`Disease of Patients Treated with Deferiprone in the Prior Art
`
`Apotex now contends that the Primary References “do not explicitly or inherently
`
`disclose administering deferiprone to blood-transfusion dependent patients having
`
`iron-induced cardiac disease” (POR at 26) because those patients’ cardiac disease
`
`may have had a different cause. (Id. at 26, 30.)
`
`
`
`3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Specifically with respect to Hoffbrand 1998, Apotex contends that it does not
`
`disclose patients with iron induced cardiac disease (POR at 26),
`
`
`
`4
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`C. Documents Inconsistent with Apotex’s Position on the Inherent Result of
`Treatment with 75 mg/kg/day of Deferiprone
`
`Apotex takes the position that the 75/mg/kg/day dose of deferiprone disclosed in
`
`the prior art is not necessarily an effective dose of deferiprone to reduce cardiac iron
`
`levels. (POR at 37, 41-42.)
`
`
`
`5
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Last, Apotex’s position in the IPR that “there was no evidence that [as of 2000]
`
`deferiprone provided any cardio-protective benefit to TM patients” (POR at 5) is
`
`
`
`
`
`
`
`
`
`III. The Garmin Factors Favor Granting Additional Discovery
`In the alternative, Petitioner seeks production of these documents as additional
`
`discovery. (37 CFR § 42.51(b)(2).) Each of the Garmin factors weigh in favor of
`
`the Board granting additional discovery. See Garmin Int’l, Inc. v. Cuozzo Speed
`
`Techs., LLC, IPR2012-00001, 2013 WL 11311697, at *3 (PTAB Mar. 5, 2013).
`
`First, there is more than a possibility and mere allegation that the identified
`
`documents have relevant and useful information, indeed, the documents, as described
`
`above and filed as Exhibits 1037-1045 and 1047-104949, contain statements
`
`inconsistent with positions taken by Apotex during the IPR. Second, Petitioner does
`
`not seek litigation positions or their underlying basis; indeed, Petitioner is already in
`
`possession of the Patent Owner Response which lays out Patent Owner’s litigation
`
`positions. Third, due to the district court’s protective order, Taro is unable to
`6
`
`
`
`
`
`
`
`generate these documents or their equivalent by means other than the Board’s order
`
`to Apotex to produce the documents in this proceeding. Fourth, the instructions to
`
`produce thirteen specifically identified documents are easily understandable. Last,
`
`the documents “are already in possession of Petitioner” and Petitioner is merely
`
`requesting “permission to use those documents” in this proceeding, which is not
`
`overly burdensome. See Baker Hughes, Inc. v. LiquidPower Specialty Prods., Inc.,
`
`IPR2016-01901, Paper 29, at 6 (PTAB Sept. 18, 2017).
`
`Respectfully submitted,
`
`
`
`Date: April 16, 2018
`
`
`
`By:
`/Huiya Wu/
`Huiya Wu (Reg. No. 44,411)
`Sarah Fink (Reg. No. 64,886)
`
`Counsel for Petitioner
`
`GOODWIN PROCTER, LLP
`The New York Times Building
`620 Eighth Avenue
`New York NY 10018
`hwu@goodwinlaw.com
`
`7
`
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that, on April 16, 2018, I caused a true and correct copy of
`
`the foregoing materials: PETITIONER’S MOTION TO COMPEL ROUTINE
`
`DISCOVERY OR, IN THE ALTERNATIVE, FOR ADDITIONAL
`
`DISCOVERY, and Exhibits 1036-1045 and 1047-1049 to be served via electronic
`
`mail on the following attorneys of record:
`
`
`
`
`
`
`
`By:
`/Sarah Fink/
`Sarah Fink (Reg. No. 64,886)
`
`
`
`W. Blake Coblentz
`Aaron S. Lukas
`Barry Golob
`
`Email:
`wcoblentz@cozen.com
`alukas@cozen.com
`bgolob@cozen.com
`
`
`
`
`
`
`
`
`
`ACTIVE/94983246.2
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
