`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS, INC.1
`Patent Owner
`
`
`
`Patent No. 9,339,507
`Issue Date: July 13, 2017
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
`
`Inter Partes Review No. 2017-01622
`____________________________________________________________
`
`REQUEST FOR REHEARING OF DECISION AUTHORIZING
`PETITIONER’S REPLY TO PATENT OWNER’S PRELIMINARY
`RESPONSE UNDER 37 C.F.R. § 42.71
`
`
`
`
`
`
`1 The caption identifies Patent Owner as “United Therapeutics, Inc.,”
`whereas the assignment and the patent identify Patent Owner as “United
`Therapeutics Corporation.” Ex. 1001, 1(73). Accordingly, appropriate correction
`of this caption is suggested.
`
`4836-6432-6483.1
`
`

`

`IPR2017-01622
`
`I.
`
`INTRODUCTION
`
`
`
`Request for Rehearing of Decision
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.71(d), Patent Owner United Therapeutics
`Corporation (“Patent Owner”) respectfully requests rehearing of the decision dated
`November 2, 2017 authorizing Petitioner to file a reply to Patent Owner’s
`Preliminary Response. In its entirety, the November 2nd decision (issued by email
`from the Board’s Supervisory Paralegal) reads as follows (Ex. 2031):
`In IPR2017-01621 and IPR2017-01622, Petitioner is authorized to file a
`Reply to Patent Owner’s Preliminary Response to address Patent Owner’s
`argument relating to 35 U.S.C. § 315(b) and its assertion that Ghofrani is not
`prior art by another. The Reply is limited to 5 pages and shall be filed no
`later than November 9, 2017. A conference call is not necessary at this time.
`
`The parties did not brief the issue beyond Petitioner’s email request for permission
`to file a reply and Patent Owner’s statement of opposition. Ex. 2031.
`II. ARGUMENT
`A. The Board Should Not Permit a Reply Because the Board Cannot
`Consider a Reply in Its Institution Decision
`
`The Board should not permit Petitioner to file a reply because the Board
`cannot consider any reply or accompanying evidence in making its institution
`decision under 35 U.S.C. § 314. Section 314(a) prohibits the Board from
`instituting trial “unless the Director determines that the information presented in
`the petition filed under section 311 and any response filed under section 313 shows
`that there is a reasonable likelihood that the petitioner would prevail with respect to
`at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (emphasis
`added). Thus, the statute makes clear that the Board may look to only two sources
`in making its institution decision: (1) the petition under § 311; and (2) patent
`owner’s preliminary response under § 313. Id.; see also Leatherman v. Tarrant
`1
`
`4836-6432-6483.1
`
`

`

`IPR2017-01622
`
`
`
`Request for Rehearing of Decision
`
`Cty. Narcotics Intelligence and Coordination Unit, 507 U.S. 163, 168 (1993)
`(holding that Rule 9(b)’s enumeration of two specific causes of action excludes
`others); Cook v. Principi, 318 F.3d 1334, 1339 (Fed. Cir. 2003) (“[a]pplying the
`familiar canon of expressio unius est exclusio alterius” to conclude that Congress
`did not intend exceptions beyond those specifically enumerated). Although the
`statute does not expressly forbid a reply, § 314(a) prohibits the Board from relying
`on anything in a Petitioner’s reply in making its institution decision. Thus,
`Petitioner should not be permitted to submit a reply.
`B.
`Patent Owner’s Preliminary Response Presented No Evidence
`Relating to the 35 U.S.C. § 315(b) Issue That Would Have Been
`Unavailable to Petitioner at the Time It Filed Its Petition
`
`The facts presented by Patent Owner on the § 315(b) issue in its Preliminary
`Response were available to Petitioner at the time it filed its petition. Indeed,
`Petitioner specifically addressed timeliness under § 315(b) in its Petition. Pet. at 5.
`The Board has refused to permit a petitioner’s reply in other cases. For example,
`in ARM, Ltd. v. Godo Kaisha IP Bridge 1, IPR2016-00825, Paper 11 (PTAB Sept.
`29, 2016), the petitioner sought authorization to reply to the patent owner’s
`argument of priority entitlement. The panel denied the petitioner’s request,
`explaining that “[p]etitioner had notice and opportunity to raise this issue” as
`demonstrated by the fact that the petition “makes clear that [p]etitioner at least
`contemplated the possibility” that the patent owner would rely on foreign priority.
`Id. at 3. Here too, Petitioner should not be permitted to present evidence and
`arguments in a reply that it should have included in its Petition.
`
`4836-6432-6483.1
`
`2
`
`

`

`IPR2017-01622
`
`
`
`Request for Rehearing of Decision
`
`C. The Board’s Decision Provides No Reasoning and Was Made
`Without Hearing Arguments from Patent Owner
`
`Patent Owner was denied an opportunity to be heard. Also, other Board
`decisions have provided reasoning for authorizing a Petitioner’s Reply and
`analyzed whether Petitioner’s request satisfied the “good cause” standard. For
`example, in Xactware Solutions Inc. v. Pictometry Int’l Corp., IPR2016-00593
`and-00594, Papers 11 and 12 (PTAB July 1, 2016), a panel denied the petitioner’s
`request for authorization to file a reply, explaining:
`Good cause may exist in certain situations such as where new
`evidence comes to light after the filing of a petition or a legal argument of
`first impression is made by the Patent Owner, we are not persuaded that
`sufficient good cause exists in this case. To the extent that Petitioner seeks to
`identify new citations or bolster arguments in the Petition, we are not
`required to allow Petitioner to do so. Additionally, identifying and
`evaluating statements or misstatements of the facts and law are well within
`the purview of the Panel of Judges assigned to these proceedings. It may
`always be the case that a Petitioner is unhappy with how Patent Owner
`characterizes the facts and law presented in the Petition. Our rules, however,
`provide for a Petitioner Reply only when good cause exists. Petitioner has
`not established good cause and as such, we do not authorize the filing of any
`Replies.
`
`
`Here too, Petitioner has not shown good cause. Also, the Board’s decision
`
`suffers from the same problems noted in Ultratec, Inc. v. CaptionCall, LLC, 872
`F.3d 1267 (Fed. Cir. 2017). Namely, the Board’s procedure allowed it to render its
`decision without providing an explanation or reasoned basis, thus impeding
`“meaningful appellate review of the agency decision-making.” Id. at 1274.
`
`III. CONCLUSION
`Patent Owner respectfully requests rehearing of the decision to authorize a
`reply by Petitioner to Patent Owner’s Preliminary Response.
`3
`
`4836-6432-6483.1
`
`

`

`IPR2017-01622
`
`
`
`Request for Rehearing of Decision
`
`Date: November 3, 2017
`
`Respectfully submitted,
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`
`George E. Quillin
`Registration No. 32,792
`
`Foley & Lardner LLP
`3000 K Street, N.W.
`Suite 600
`Washington, D.C. 20007
`
`Shaun R. Snader
`Registration No. 59,987
`United Therapeutics Corporation
`1735 Connecticut Avenue, N.W.
`Second Floor
`Washington, DC 20009
`
`Counsel for Patent Owner
`
`4836-6432-6483.1
`
`4
`
`

`

`IPR2017-01622
`
`
`
`Request for Rehearing of Decision
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing REQUEST FOR
`REHEARING OF DECISION AUTHORIZING PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE UNDER 37 C.F.R. § 42.71
`and accompanying exhibit is being served on November 3, 2017, by filing this document
`through the PTAB E2E System as well as delivering copies via email to the following counsel
`
`for the Petitioner:
`Michael K. Nutter (Reg. No. 44,979)
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: mnutter@winston.com
`
`Andrew R. Sommer (Reg. No. 53,932)
`WINSTON & STRAWN LLP
`1700 K Street, N.W.
`Washington, DC 20006-3817
`Email: asommer@winston.com
`
`Kurt A. Mathas
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: kmathas@winston.com
`
`/Stephen B. Maebius/
`
`Stephen B. Maebius
`Registration No. 35,264
`
`George E. Quillin
`Registration No. 32,792
`
`Shaun R. Snader
`Registration No. 59,987
`
`Counsel for Patent Owner
`
`4836-6432-6483.1
`
`