Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`
` Paper No. 27
`
`
` Entered: May 12, 2016
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`STEADYMED LTD.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00006
`Patent 8,497,393 B2
`____________
`
`
`
`Before LORA M. GREEN, JONI Y. CHANG, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`
`ORDER
`Joint Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
` Paper No. 27
`
`
` Entered: May 12, 2016
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`STEADYMED LTD.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00006
`Patent 8,497,393 B2
`____________
`
`
`
`Before LORA M. GREEN, JONI Y. CHANG, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`
`ORDER
`Joint Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`
`
`
`
`IPR2016-00006
`Patent 8,497,393 B2
`
`
`
`Patent Owner’s Unredacted Preliminary Response (Paper 10), as well
`as Exhibits 2003, 2004, 2005, and 2006, were filed under seal. Patent
`Owner concurrently submitted a Motion to File under Seal (Paper 7).
`Because we declined to rule on Patent Owner’s Motion to File under Seal
`when we issued our Decision to Institute (Paper 12), that Decision was
`sealed, pending submission by the parties of agreed redactions to the
`Decision. Patent Owner’s Unredacted Preliminary Response (Paper 10), and
`Exhibits 2003, 2004, 2005, and 2006 likewise remain provisionally sealed.
`Pursuant to our Order on the Conduct of the Proceeding (Paper 16),
`the parties filed a Joint Written Statement (Paper 17), identifying the
`portions of the Decision to Institute that should remain under seal. The
`parties concurrently filed a Joint Motion to Seal those portions of the
`Decision to Institute (Paper 18). For the reasons set forth below, we grant-
`in-part the parties’ Motion and enter a Redacted Decision to Institute
`(Paper 28) including some, but not all, of the redactions proposed by the
`parties.
`There is a strong public policy in favor of making information filed in
`a post-grant review open to the public. Generally, the record of a post-grant
`review proceeding shall be made available to the public. 35 U.S.C.
`§ 326(a)(1); 37 C.F.R. § 42.14. Our rules, however, “aim to strike a balance
`between the public’s interest in maintaining a complete and understandable
`file history and the parties’ interest in protecting truly sensitive information.”
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760 (Aug. 14,
`2012).
`
`2
`
`
`
`IPR2016-00006
`Patent 8,497,393 B2
`
`
`
`Thus, the parties may move to seal certain information (37 C.F.R.
`§ 42.14), but only “confidential information” is protected from disclosure
`(35 U.S.C. § 326(a)(7)). Confidential information means trade secret or
`other confidential research, development, or commercial information.
`37 C.F.R. § 42.2. The standard for granting a motion to seal is “for good
`cause.” 37 C.F.R. § 42.54(a). Sufficient facts must, therefore, be presented
`to demonstrate that the materials proposed for sealing are in fact
`confidential. See Corning Optical Commc’ns RF, LLC v. PPC Broadband,
`Inc., Case IPR2014-00736, Paper 37, slip op. at 2–3 (PTAB Apr. 6, 2015).
`As an initial matter, we observe that certain of the proposed redactions
`to the Decision to Institute (Paper 12) would redact information made public
`in UTC’s prior filings. For example, the following appears in UTC’s
`Redacted Preliminary Response (Paper 8):
`The percent yield and purity levels of the final treprostinil
`product are compared to the former process in a chart on
`Ex. 2005, at p. 3, further demonstrating the differences that result
`in the final treprostinil product when all of steps (a)-(d) of claims
`1 and 101 of the ’393 patent are performed.
`*
`*
`*
`Finally, Ex. 2006, at pp. 3–4 states that, when the new
`process was implemented, “it was observed that the purity of the
`treprostinil improved close to 100%” . . . .
`
`
`1 Issued claim 9 of the ’393 patent is identified as claim 10 in documents in
`the prosecution history for the ’393 patent, and the Preliminary Response
`itself occasionally refers to claim 10, rather than claim 9, when discussing
`pre-issuance documents.
`
`3
`
`
`
`IPR2016-00006
`Patent 8,497,393 B2
`
`
`Redacted Prelim. Resp. 37–38 (emphasis added). Nevertheless, the parties
`propose that the statement “‘the purity of the treprostinil improved close to
`100%’ for treprostinil prepared as described in claims 1 and 9 of the ’393
`patent as opposed to the prior process implemented by UTC” (Decision to
`Institute 17) be redacted from the publicly available version of Decision to
`Institute. Paper 18, 2; Paper 17, 22.
`Similarly, the Redacted Preliminary Response (Paper 8) states that:
`Ex. 2005 is a Process Optimization Report that provides
`results for batches resulting from step (d) of claims 1 and 10 in
`the ’393 patent, which was performed on specific batches of the
`diethanolamine salt intermediate produced by steps (a)-(c) . . . .
`The percent yield and purity levels of the final treprostinil
`product are compared to the former process in a chart on Ex.
`2005, at p. 3, further demonstrating the differences that result in
`the final treprostinil product when all of steps (a)-(d) of claims 1
`and 10 of the ’393 patent are performed.
`Redacted Prelim. Resp. 36–37 (emphasis added). However, the parties
`request redaction of the statement “Ex. 2005 is a Process Optimization
`Report that provides results for batches resulting from step (d) of claims 1
`and 10 in the ’393 patent, which was performed on specific batches of the
`diethanolamine salt intermediate produced by steps (a)-(c)” (Decision to
`Institute 19–20) from the publicly available version of the Decision to
`Institute. Paper 18, 2; Paper 17, 24–25. The parties likewise request
`redaction of the italicized portion of the sentence “[t]he Process
`Optimization Report discloses the impurity analyses for five batches of
`treprostinil identified by UTC as having been prepared using the process
`
`4
`
`
`
`IPR2016-00006
`Patent 8,497,393 B2
`
`
`recited in the ’393 patent” (Decision to Institute 19) in the publicly available
`version of the Decision to Institute.
`Because the above described information, appearing on page 17, lines
`21–23, page 19, lines 20–22, and page 20, lines 1–3 of the Decision to
`Institute (Paper 12) was made public in UTC’s Redacted Preliminary
`Response (Paper 8), we decline to redact that information from the public
`version of the Decision to Institute. We note, however, that certain
`information appearing on page 20 at line 3 of the Decision to Institute
`(Paper 12) has not been publicly disclosed in the parties’ filings, and is
`confidential information concerning the manufacture of Remodulin®; as
`such, we grant the parties’ request with respect to this information.
`Regarding the proposed redactions to page 20 at lines 4–17 and
`footnote 7, as well as the proposed redactions to page 21 at lines 1–3 and 6–
`9 of the Decision to Institute (Paper 12), we agree with the parties that the
`disclosed numerical amounts and ranges, identity of the impurities detected,
`and particulars of the FDA treprostinil purity standard is confidential
`information concerning the manufacturing process for Remodulin®,
`submitted and held in confidence to the FDA, and susceptible to misuse by
`competitors seeking commercial advantage. See Paper 18, 4–5.
`We observe, however, that certain of the proposed redactions are
`overbroad and encompass non-confidential information. For example, UTC
`states in its Redacted Preliminary Response (Paper 8) that:
`[T]he letter proposes that “the range of the specification for the
`HPLC assay for treprostinil be shifted from [redacted]% to
`[redacted]% [redacted].”
`
`5
`
`
`
`IPR2016-00006
`Patent 8,497,393 B2
`
`
`
`The FDA subsequently approved the Patent Owner’s
`proposed implementation of the ’393 process and the increased
`purity standard.
`Redacted Prelim. Resp. 38. Yet the parties propose redaction of the similar
`statement, “[w]e also observe that although UTC sought, and obtained from
`the FDA, modification of the specification for the HPLC assay for
`treprostinil to require a purity range of . . . rather than . . . .” (Decision to
`Institute 20), in the publicly available version of the Decision to Institute.
`We, therefore, grant-in-part the parties’ request, and redact the
`portions of pages 20 and 21 that set forth numerical amounts or ranges, the
`identity of the impurities detected, or the particulars of the treprostinil purity
`standard.
`The parties additionally propose redaction of statements appearing on
`pages 18 and 19 of the Decision to Institute relating to our conclusions and
`interpretation of the evidence. In particular, the parties request redaction of
`the italicized portion of the following statement from the Decision to
`Institute (Paper 12, 18–19):
`Furthermore, the evidence presently before us, including
`UTC’s own testing results, suggests that inter-batch variability
`in impurity profiles, experimental error in impurity measuring
`equipment, and variations in reagents, solvents, and reaction
`conditions, rather than the instantly recited process steps,
`account for any purported improvements in purity reported by
`UTC.
`Paper 18, 2; Paper 17, 23–24. Contrary to the parties’ suggestion, the
`statement in question does not discuss “proprietary purity information from
`multiple sources, including Exhibits 2003–2006” (Paper 18, 3). Rather, the
`6
`
`
`
`IPR2016-00006
`Patent 8,497,393 B2
`
`
`statement in question appears in a paragraph discussing our assessment of
`Dr. Walsh’s Declaration (Ex. 1002, 346–350), which is part of the
`prosecution history for the ’393 patent and, therefore, part of the public
`record. Decision to Institute 18–19. It neither cites to nor addresses any
`purportedly confidential exhibit, nor describes any aspect of UTC’s
`Remodulin® manufacturing or testing procedures. Id.
`Similarly, the statement in the Decision to Institute (Paper 12) that
`“[m]oreover, the Process Optimization Report (Ex. 2005) proffered by UTC
`supports the conclusion that the process steps recited in the ’393 patent do
`not produce a treprostinil product that differs, either structurally or
`functionally, from that produced using prior art methods” (Decision to
`Institute 19) does not describe “proprietary purity information from multiple
`sources, including Exhibits 2003–2006” (Paper 18, 3–4). It simply reflects
`our disagreement with UTC’s position, articulated in its Redacted
`Preliminary Response (Paper 8), that
`The percent yield and purity levels of the final treprostinil
`product are compared to the former process in a chart on
`Ex. 2005, at p. 3, further demonstrating the differences that result
`in the final treprostinil product when all of steps (a)-(d) of claims
`1 and 10 of the ’393 patent are performed.
`Redacted Prelim. Resp. 37. Indeed, UTC’s public description of
`Exhibit 2005 goes beyond the statement of a high-level conclusion as to
`what the document shows akin to what is included in the Decision to
`Institute (Paper 12), and additionally includes a discussion of the contents of
`that purportedly confidential document.
`
`7
`
`
`
`IPR2016-00006
`Patent 8,497,393 B2
`
`
`
`Accordingly, because statements described above simply set forth our
`conclusions regarding whether the process for producing treprostinil recited
`in the ’393 patent resulted in a product structurally or functionally different
`from that produced by prior art methods, and do not describe any
`confidential information, we decline the parties’ request to redact these
`statements in the publicly available version of the Decision to Institute.
`
`It is
`ORDERED that the parties’ Joint Motion to Seal is granted-in-part.
`FURTHER ORDERED that a Redacted Decision to Institute,
`reflecting the redactions authorized in this Order, shall be entered into the
`record and made publicly available.
`
`
`
`8
`
`
`
`IPR2016-00006
`Patent 8,497,393 B2
`
`
`PETITIONER:
`
`Stuart E. Pollack
`Lisa A. Haile
`DLA Piper LLP
`stuart.pollack@dlapiper.com
`lisa.haile@dlapiper.com
`steadymed-ipr@dlapiper.com
`
`PATENT OWNER:
`
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`smaebius@foley.com
`gquillin@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`bdelafield@wsgr.com
`
`9
`
`
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
