Trials@uspto.gov
`571-272-7822
`
`Paper 14
`Date: March 1, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Patent Owner’s Request
`on Rehearing of Decision on Institution
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 14
`Date: March 1, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Patent Owner’s Request
`on Rehearing of Decision on Institution
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`
`INTRODUCTION
`
`Liquidia Technologies, Inc. (“Petitioner”) filed a Petition (Paper 1
`
`(“Pet.”)), seeking an inter partes review of claims 1–9 of U.S. Patent No.
`
`9,604,901 B2 (Ex. 1001, “the ’901 patent”). We granted the Petition and
`
`instituted inter partes review on all challenges to all claims. Paper 7
`
`(“Decision” or “Dec.”). United Therapeutics Corporation (“Patent Owner”)
`
`filed a Request for Rehearing of the Decision. Paper 9 (“Req. Reh’g”).
`
`For the reasons expressed below, the Request for Rehearing is denied.
`
`As a result, inter partes review shall continue on all grounds challenging all
`
`claims addressed in the Petition.
`
`STANDARD OF REVIEW
`
`The party challenging a decision in a request for rehearing bears the
`
`burden of showing the decision should be modified. 37 C.F.R. § 42.71(d)
`
`(2019). A request for rehearing “must specifically identify all matters the
`
`party believes the Board misapprehended or overlooked, and the place where
`
`each matter was previously addressed.” Id. When rehearing a decision on
`
`institution, the Board reviews the decision for an abuse of discretion. 37
`
`C.F.R. § 42.71(c). It is not an abuse of discretion to have made an analysis
`
`or conclusion with which a party disagrees. Instead, an abuse of discretion
`
`occurs if a decision is based on an erroneous interpretation of law, if a
`
`factual finding is not supported by substantial evidence, or if the decision
`
`represents an unreasonable judgment in weighing relevant factors. Arnold
`
`P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004).
`
`ANALYSIS
`
`In our Decision, we determined that Petitioner demonstrated a
`
`reasonable likelihood of success in showing that the challenged claims
`
`2
`
`
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`would have been obvious over the asserted combination of Moriarty and
`
`Phares. See Dec. 22–28. In its Request for Rehearing, Patent Owner
`
`contends that our determination to institute inter partes review is improper
`
`for three reasons. First, Patent Owner argues that we misapprehended the
`
`differences between the prior art and the claims at issue. Reh’g Req. 2–5.
`
`Second, Patent Owner argues that we misapprehended the standard for
`
`inherency. Id. at 5–7. Third, Patent Owner argues that we overlooked
`
`objective indicia of nonobviousness. Id. at 7–10.
`
`Because we did not expressly address Patent Owner’s arguments with
`
`respect to objective indicia of nonobviousness (see Paper 6 (“Prelim. Resp.”)
`
`69–71), we address those arguments now. For the reasons explained below,
`
`however, we deny the Request for Rehearing because none of Patent
`
`Owner’s arguments persuade us of an abuse of discretion in instituting
`
`review in this proceeding.
`
`Differences between the Prior Art and Claim 1
`
`Patent Owner contends that “the Decision mistakenly finds that ‘the
`
`combination of Moriarty and Phares teaches the same process steps as
`
`challenged claim 1.’” Reh’g Req. 4 (citing Dec. 27). Patent Owner contends
`
`that claim 1’s recited steps do not involve isolating the treprostinil
`
`intermediate. Id. at 2–3. Patent Owner contends that claim 1 differs from
`
`Phares and Moriarty because each reference separately describes isolating
`
`the treprostinil intermediate. Id. at 3. Patent Owner contends that Petitioner
`
`relies on the ordinarily skilled artisan being motivated to modify the prior art
`
`by removing the isolating step from the Moriarty and Phares processes. Id. at
`
`2–3. Because of this modification, Patent Owner contends that “Moriarty
`
`3
`
`
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`and Phares do not teach the same process steps” resulting in the claimed
`
`product. See id. at 4. We are not persuaded by Patent Owner’s argument.
`
`As an initial matter, to the extent that Patent Owner attacks the
`
`references individually, we emphasize that we consider the combination of
`
`the prior art as a whole. See In re Merck & Co., Inc., 800 F.2d 1091, 1097
`
`(Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking
`
`references individually where the [challenge] is based upon the teachings of
`
`a combination of references.”).
`
`In the Decision, we explained that Phares explicitly describes the
`
`Moriarty process in teaching the synthesis of (-)-treprostinil, the enantiomer
`
`of (+)-treprostinil. Dec. 25 (citing Ex. 1008, 40). Thus, on the record before
`
`us at that time, we “agree[d] with Petitioner that an ordinarily skilled artisan
`
`would have combined the process of Moriarty with the step of adding
`
`diethanolamine to treprostinil as taught by Phares.” Id. The resulting
`
`combination of Moriarty and Phares would not involve isolating the
`
`treprostinil intermediate and accordingly, teaches the same process steps as
`
`challenged claim 1. Having reconsidered the pre-institution record, we
`
`continue to find persuasive Petitioner’s argument that a skilled artisan would
`
`have found it obvious to add diethanolamine to a treprostinil solution
`
`without isolating treprostinil when combining Moriarty with Phares. See Pet.
`
`61–62 (citing Ex. 1008, 40; Ex. 1002 ¶¶ 177–178).
`
`Our analysis is consistent with the Board’s previous finding in a
`
`related proceeding involving U.S. Patent No. 8,497,393 (“the ’393 patent”),
`
`which is a parent of the ’901 patent. See Ex. 1001, code (63). The Board
`
`previously held that claims of the ’393 patent are unpatentable. Dec. 3
`
`(citing IPR2016-00006, Paper 82 (PTAB Mar. 31, 2017) (“the ’393
`
`4
`
`
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`Decision” or “the ’393 Dec.”)). In doing so, the Board found that “an
`
`ordinarily skilled artisan would have modified the process of Moriarty to
`
`incorporate the step of adding and dissolving diethanolamine to treprostinil
`
`as taught by Phares to eliminate the requirement for intermediate
`
`purification, thus, improving synthetic efficiency and reducing cost.” The
`
`’393 Dec. 47. The Federal Circuit has affirmed that decision. United
`
`Therapeutics Corp. v. SteadyMed Ltd., 702 F. App’x. 990 (Fed. Cir. 2017).
`
`As we did in the Decision, we continue to “encourage the parties here to
`
`discuss whether issue preclusion applies in this proceeding such that Patent
`
`Owner cannot reargue this point.” Dec. 25 n.7.
`
`In sum, we are not persuaded that we misapprehended the differences
`
`between the prior art and claim 1.
`
`Inherency of the Claimed Product
`
`Patent Owner contends that “[b]ecause the recited steps are different
`
`from those disclosed in Moriarty and Phares (no isolation of treprostinil after
`
`alkylation and hydrolysis steps before forming a salt), then the resulting
`
`products cannot be assumed to be the same.” Reh’g Req. 5. Patent Owner
`
`contends that given the different process steps, Petitioner cannot argue
`
`“identical impurities” and “effectively conceded that the resulting impurities
`
`may not necessarily be the same as recited in the claims.” Id. at 6. On the
`
`current record, we are not persuaded by Patent Owner’s argument.
`
`As discussed above, at this stage of the proceeding, we remain
`
`persuaded by Petitioner’s argument that the combination of Moriarty and
`
`Phares teaches the same process steps, including adding a base to treprostinil
`
`solution without isolating treprostinil. Accordingly, we remain persuaded
`
`5
`
`
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`that there is a reasonable likelihood that the product from these steps would
`
`include the same resulting impurities. See Dec. 27.
`
`Patent Owner also argues that “the Decision appears to improperly
`
`rely on inherency in an obviousness context to address the ‘pharmaceutical
`
`batch’ limitation by citing Moriarty while ignoring the arguments that a
`
`storage stable batch would not have been expected based on Phares.” Reh’g
`
`Req. 10 (citing Dec. 26–27). On the pre-institution record, we disagree with
`
`Patent Owner’s inherency argument because Patent Owner is attacking the
`
`references individually. See In re Merck & Co., Inc., 800 F.2d 1091, 1097
`
`(Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking
`
`references individually where the [challenge] is based upon the teachings of
`
`a combination of references.”). Moreover, claim 1 does not require “a
`
`storage stable batch.” And contrary to Patent Owner’s assertion (Reh’g Req.
`
`8 n.2), we did not construe the term “pharmaceutical batch” in claim 1 to
`
`require storage stability (see Dec. 15–16).
`
`In sum, we are not persuaded that we misapprehended the standard for
`
`inherency of a product resulting from process taught by the prior art.
`
`Objective Indicia of Nonobviousness
`
`Patent Owner contends that “[t]he Board overlooked evidence of
`
`objective indicia of nonobviousness, as set forth in the ’901 patent
`
`specification and prosecution history and outlined by Patent Owner.” Reh’g
`
`Req. 7. Patent Owner presents two arguments that we should have denied
`
`institution based on Patent Owner’s proffered evidence of objective indicia.
`
`See Req. Reh’g 7–10. First, Patent Owner argues that we should have denied
`
`institution because Petitioner did not address objective indicia of
`
`nonobviousness in the Petition, except to assert that it does not exist. Id.
`
`6
`
`
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`at 7–8 (citing Pet. 71). Second, Patent Owner contends that the evidence of
`
`objective indicia supports the patentability of the claims over the prior art.
`
`See id. at 8–10. Despite having considered Patent Owner’s evidence and
`
`argument related to objective indicia pre-institution, we did not expressly
`
`address them in our Decision. We do so now.
`
`As for Patent Owner’s first contention that the Petition should have
`
`been denied for failing to address objective indicial of nonobviousness, we
`
`are not persuaded. Patent Owner cites Semiconductor Components
`
`Industries, LLC v. Power Integrations, Inc., IPR2016-01588, Paper 15 at
`
`28–29 (PTAB Feb. 17, 2017) as authority for denying a petition for inter
`
`partes review due to Petitioner’s failure to address objective indicia of
`
`nonobviousness. Id. at 7. In Semiconductor Components, the Federal Circuit
`
`previously determined that the claims at issue were not obvious due to
`
`evidence of commercial success presented during extensive litigation.
`
`Semiconductor Components, Paper 15 at 28. Accordingly, the panel
`
`concluded that “it was incumbent on Petitioner to address substantively such
`
`objective considerations in the context of its obviousness challenges.” Id.
`
`Unlike the patent in Semiconductor Components, the ’901 patent does
`
`not have an extensive litigation record of objective indicia supporting
`
`nonobviousness. Rather, similar claims in the parent ’393 patent were
`
`determined unpatentable by the Board in an inter partes review proceeding.
`
`See Dec. 3. In the ’393 Decision, the Board determined that evidence of
`
`objective indicia, including long-felt need, unexpected results, and process
`
`advantages, did not establish nonobviousness. The ’393 Dec. 56–67. In the
`
`Decision in the instant proceeding, we considered the expert testimony of
`
`“higher average purity” that Patent Owner submitted during the prosecution
`
`7
`
`
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`of the challenged ’901 patent, and determined, based on the pre-institution
`
`record, that “the examiner erred in relying on the applicant’s argument on
`
`the improved purity profile to allow the challenged claims.” Dec. 13–15. As
`
`we explained in the Decision, “higher average purity” is not a limitation in
`
`the challenged claims of the ’901 patent. Id. at 14.
`
`Because the asserted evidence of objective indicia in the of the ’901
`
`patent and in a prior proceeding involving its parent ’393 patent either does
`
`not apply to the claims at issue (which do not recite “higher average
`
`purity”), or was previously found unpersuasive of nonobviousness, we do
`
`not find the Petition “facially deficient” because it does not address that
`
`evidence. Reh’g Req. 8; see Dec. 14; The ’393 Dec. 56–67. Insofar as Patent
`
`Owner asserts additional evidence and arguments related to objective indicia
`
`of nonobviousness in the Preliminary Response, Petitioner has not had an
`
`opportunity to address that evidence and argument. As a result, arguments
`
`and evidence of objective indicia are better suited for resolution on a fuller
`
`record developed during trial.
`
`In any event, we considered Patent Owner’s evidence of
`
`nonobviousness at the institution stage, and we provide our analysis here. In
`
`the Preliminary Response, Patent Owner argued that the ’901 patent includes
`
`comparative data illustrating multiple advantages over a process that “is
`
`essentially the same as Liquidia’s Moriarty references.” Prelim. Resp. 70–71
`
`(citing Ex. 1001, 1:27–34, 15:25–16:64 (Example 6), 16:65–17:12; Ex. 2002
`
`¶ 134). In the Rehearing Request, Patent Owner contends that the
`
`’901 patent’s file history “contains evidence and argument” for objective
`
`indicia of nonobviousness. Reh’g Req. 9 (citing Ex. 2007, 3819–3825).
`
`8
`
`
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`Based on the pre-institution record, we are not persuaded by Patent Owner’s
`
`arguments and evidence on this issue.
`
`Patent Owner has made generalized arguments as to evidence of “less
`
`waste,” “higher purity,” “storage at ambient temperatures,” “better-quality
`
`final product,” and “significant savings in material and labor.” See Prelim.
`
`Resp. 70–71. At this stage of the proceeding, Patent Owner has not
`
`established that these are more than an expected improvement in properties
`
`given the skilled artisan’s desire to make a “faster, more efficient and more
`
`economical” process. See Ex. 1002 ¶ 178. Moreover, “unexpected results
`
`must be established by factual evidence. Mere argument or conclusory
`
`statements in the specification does not suffice.” In re Soni, 54 F.3d 746, 750
`
`(Fed. Cir. 1995). We find Patent Owner has not presented sufficient factual
`
`evidence to show unexpected results on the preliminary pre-institution
`
`record.
`
`Accordingly, based on the pre-institution record, we remain persuaded
`
`that Petitioner demonstrated a reasonable likelihood of showing that at least
`
`one claim is unpatentable based upon our consideration of the arguments and
`
`evidence in the Petition and Preliminary Response, including Patent
`
`Owner’s asserted arguments and evidence as to objective indicia.
`
`
`
`CONCLUSION
`
`For the foregoing reasons, the Request for Rehearing is denied.
`
`Accordingly, it is
`
`ORDER
`
`ORDERED that Patent Owner’s Request for Rehearing is denied.
`
`
`
`
`
`9
`
`
`
`IPR2020-00770
`Patent 9,604,901 B2
`
`FOR PETITIONER:
`
`Ivor R. Elrifi
`Erik B. Milch
`Cooley LLP
`ielrifi@cooley.com
`emilch@cooley.com
`
`
`
`FOR PATENT OWNER:
`
`Stephen B. Maebius
`George Quillin
`Daniel R. Shelton
`Foley & Lardner LLP
`smaebius@foley.com
`gquillin@foley.com
`dshelton@foley.com
`
`
`Shaun R. Snader
`United Therapeutics Corp.
`ssnader@unither.com
`
`Douglas Carsten
`Richard Torczon
`Wilson, Sonsini, Goodrich & Rosati
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`
`
`
`10
`
`
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