IPR2017-01446
`
`
`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.
`________________
`
`Case No. IPR2017-01446
`
`U.S. Patent No. 7,049,328 B2
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION
`TO COMPEL ROUTINE DISCOVERY OR, IN THE ALTERNATIVE,
`FOR ADDITIONAL DISCOVERY
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`
`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.
`________________
`
`Case No. IPR2017-01446
`
`U.S. Patent No. 7,049,328 B2
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION
`TO COMPEL ROUTINE DISCOVERY OR, IN THE ALTERNATIVE,
`FOR ADDITIONAL DISCOVERY
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`IPR2017-01446
`
`I.
`
`INTRODUCTION
`
`Patent Owner, Apotex Technologies, Inc. (“Apotex”), opposes Taro
`
`Pharmaceuticals U.S.A., Inc.’s (“Taro”) Motion to Compel Routine Discovery or,
`
`in the Alternative, for Additional Discovery (“Taro’s Motion”). Taro has not
`
`shown that it is entitled to Routine or Additional Discovery. The requested
`
`documents do not contain inconsistent information, and their production would not
`
`be in the interest of justice. Accordingly, Taro’s Motion should be denied.
`
`II. TARO’S MOTION FOR DISCOVERY FAILS
`
`A. Taro Has Not Met Its Burden On Routine Discovery
`
`“Routine discovery under 37 C.F.R. 41.51(b)(1)(iii) is narrowly directed to
`
`specific information known to the responding party to be inconsistent with a
`
`position advanced by that party in the proceeding, and not broadly directed to any
`
`subject in general within which the requesting party hopes to discover such
`
`inconsistent information.” Garmin Int’l et al., v. Cuozzo Speed Techs. LLC,
`
`IPR2012-00001, Paper 26 at 4 (Mar. 5, 2013). Taro bears the burden to obtain
`
`routine discovery, see 37 C.F.R. § 42.20, a burden that it has not met.
`
`Taro’s Motion alleges that Apotex “made statements in its Patent Owner
`
`Response [“POR”] . . . that are inconsistent with facts discovered by Petitioner . . .
`
`during the parallel district court case concerning [U.S. Patent No. 7,049, 328 (“the
`
`’328 patent)].” (See Paper 24 at 1.) Taro identifies 12 documents (Exhibits 1037-
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`IPR2017-01446
`
`1045 and 1047-1049) as allegedly “inconsistent” under § 42.51(b)(1)(iii) with
`
`Apotex’s positions concerning: (i) the Olivieri publications; (ii) the cardiac disease
`
`of patients treated with deferiprone in the prior art; and (iii) the inherent result of
`
`treatment with 75 mg/kg/day of deferiprone. (See id. at 2-6.)
`
`Taro’s Motion for routine discovery should be denied because no statements
`
`in the requested documents are inconsistent with Apotex’s positions on any of the
`
`above issues.
`
`1.
`
`The requested documents are not inconsistent with Apotex’s
`position on the Olivieri Publications
`
`Apotex’s POR stated that the “Olivieri Publications” caused “significant
`
`disagreement in the scientific community” (POR at 5) and taught away from the
`
`use of deferiprone (id. at 44-45, 53, 53-54). Far from being inconsistent with these
`
`statements, Exs. 1037-1045 fully support Apotex’s position that there was a
`
`significant dispute/disagreement in the industry concerning Dr. Olivieri’s research
`
`on deferiprone.
`
`For example,
`
`PROTECTIVE ORDER MATERIAL
`
`2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-01446
`
`
`
`
`
`
`
`
`
`
`
` Thus,
`
`far from contradicting the POR, Ex. 1037 supports Apotex’s position that the
`
`“Olivieri Publications” caused “significant disagreement in the scientific
`
`community.”
`
`Exhibits 1038-1045 further show that Dr. Olivieri’s results with deferiprone
`
`led to a “significant disagreement in the scientific community.”
`
`
`
`
`
`
`
`
`
`
`
`
`
` The other exhibits Taro seeks to have admitted similarly corroborate Apotex’s
`
`position that Dr. Olivieri’s findings with deferiprone were disputed in the scientific
`
`community. (See Ex. 1039 at 2; Ex. 1041 at 2; Ex. 1042 at 122:16-19, 125:18-22,
`
`129:21-24; Ex. 1043 at 175:11-176:8, Ex. 1044 at 40; Ex. 1045 at 55.)
`
`
`1 All emphases throughout are supplied unless specified otherwise.
`
`PROTECTIVE ORDER MATERIAL
`
`3
`
`
`
`IPR2017-01446
`
`Moreover, Taro’s own prior art cites the Olivieri Publications as showing the
`
`scientific community disagreed about the efficacy and safety of deferiprone. (See
`
`Ex. 1026 at 302.) Accordingly, Exs. 1037-1045 are not inconsistent with Apotex’s
`
`position that the “Olivieri Publications” caused “significant disagreement in the
`
`scientific community” (POR at 5) and taught away from the use of deferiprone,
`
`and thus are not “routine discovery” under § 42.51(b)(1).
`
`2.
`
`The requested documents are not inconsistent with Apotex’s
`position regarding the cardiac disease of patients treated
`with deferiprone in the prior art
`
`Taro is correct that “Apotex contends that the Primary References ‘do not
`
`explicitly or inherently disclose administering deferiprone to blood transfusion-
`
`dependent patients having iron induced cardiac disease.’” (See Paper 24 at 3.)
`
`However, it was Taro’s expert, not Apotex, who admitted Hoffbrand 1998 does not
`
`explicitly disclose administering deferiprone to the claimed patient population.
`
`(See, e.g., Ex. 2024 at 105:2-8, 106:11-108:2.)
`
`Further,
`
`
`
`
`
`
`
`
`
`Likewise, Taro misapprehends Ex. 1045 at ¶ 65. There,
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`4
`
`
`
`IPR2017-01446
`
`
`
`
`
`
`
`
`
`
`
`.
`
` Thus, Ex. 1045 at ¶ 65 is not
`
`inconsistent with Apotex’s position concerning the Primary References.
`
`3.
`
`The requested documents are not inconsistent with Apotex’s
`position on the inherent result of treatment with
`75 mg/kg/day of deferiprone
`
`Nor does any document contradict Apotex’s position that the Primary
`
`References do no inherently disclose that 75 mg/kg/day is an effective dose to
`
`reduce cardiac iron levels. For example,
`
`
`
`
`
`
`
` and therefore cannot be inconsistent with Apotex’s position that that
`
`the Primary References do no inherently disclose that 75 mg/kg/day is an effective
`
`dose to reduce cardiac iron levels.
`
`
`
`
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`5
`
`
`
`IPR2017-01446
`
` Thus, it cannot be inconsistent with Apotex’s
`
`position that the Primary References do no inherently disclose that 75 mg/kg/day is
`
`an effective dose to reduce cardiac iron levels.
`
`Lastly,
`
`
`
`
`
`
`
` Thus, Ex. 1049 is not inconsistent with Apotex’s IPR position
`
`that “there was no evidence that deferiprone provided and cardio-protective benefit
`
`to TM patients.” (See Paper 24 at 6.)
`
`In sum, Taro’s Motion should be denied because Apotex has produced all
`
`information covered by routine discovery, and knows of no information in its
`
`possession that is inconsistent with positions advanced in this proceeding.
`
`B.
`
`Taro has not Met its Burden on Additional Discovery
`
`Taro’s Motion for Additional Discovery should similarly be denied. (See
`
`Paper 24 at 6-7.) Taro must prove that its requests meet the stringent five-factor
`
`“interest of justice” test set forth in Garmin. Garmin, Paper 26 at 6-7; 35 U.S.C.
`
`§ 316(a)(5); see also 37 C.F.R. § 42.51(b)(2). Taro fails to meet this burden, as at
`
`least factors one and three of Garmin are not satisfied.
`
`First, Exs. 1037-1045 and 1047-1049 are not relevant to this proceeding
`
`because, as described above, they are not inconsistent with Apotex’s positions.
`
`PROTECTIVE ORDER MATERIAL
`
`6
`
`
`
`IPR2017-01446
`
`Further, any alleged “inconsistencies” do not concern the Primary References.
`
`See, Arctic Cat, Inc. v. Polaris Indus. Inc., IPR2014-01427, Paper 33 at 4 (July 17,
`
`2015) (“[t]he burden is on the Petitioner, as the moving party, to show
`
`persuasively that the requested information would be use or relevance in this
`
`proceeding”). Thus, the requested discovery is not relevant to the issues at hand—
`
`namely what is taught by the prior art. See Google, Inc. v. Meiresonne, IPR2014-
`
`01188, Paper 22 at 5 (May 20, 2015) (denying request for discovery allegedly
`
`relating issue of objective indicia because “the evidence sought is not probative of
`
`the issue . . . .”). Accordingly, the first Garmin factor weighs against discovery.
`
`Second, Taro does not need the Board’s order to “generate these
`
`documents,” because as Taro admits, ‘the documents ‘are already in possession of
`
`Petitioner’. . . .” (See Paper 24 at 16.) Taro has not explained why it is incapable
`
`of advancing its own arguments regarding the teachings of the Primary References
`
`in the absence of Apotex’s highly confidential litigation documents. See, e.g.,
`
`Garmin, Paper 26 at 14 (“Cuozzo can rely on its own analysis of the state of the art
`
`or on the opinions of independent analysts.”). Thus, the third Garmin factor also
`
`weighs against discovery.
`
`In sum, Taro has not shown that any of the requested documents contain
`
`inconsistent statements or are of substantive value to this proceeding. Thus,
`
`Apotex respectfully requests that Taro’s Motion be denied.
`
`PROTECTIVE ORDER MATERIAL
`
`7
`
`
`
`IPR2017-01446
`
`
`
`
`
`
`
`
`
`Dated: April 23, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`/W. Blake Coblentz/
`W. Blake Coblentz
`Counsel for Patent Owners
`
`
`
`
`
`COZEN O’CONNOR PC
`1200 Nineteenth St. N.W.
`Washington, D.C. 20036
`202-912-4837
`wcoblentz@cozen.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`8
`
`
`
`IPR2017-01446
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that, on April 23, 2018, I caused a true and correct copy of
`
`the foregoing materials:
`
`- PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION
`TO COMPEL ROUTINE DISCOVERY OR, IN THE ALTERNATIVE,
`FOR ADDITIONAL DISCOVERY
`
`
`
`
`to be served via electronic mail on the following attorneys of record:
`
`Huiya Wu
`Sarah Fink
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`HWu@goodwin.law.com
`SFink@goodwinlaw.com
`
`
`
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`By: /s/ W. Blake Coblentz
`
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, DC 20036
`(202) 912-4837
`
`
`
`
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
