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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
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`V.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
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`
`_______________
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`Case IPR2020-00770
`Patent 9,604,901
`_______________
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`PATENT OWNER’S REQUEST FOR REHEARING
`UNDER 37 C.F.R. § 42.71
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`Case IPR2020-00770
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`Patent Owner’s Rehearing Request
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`TABLE OF CONTENTS
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`B.
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`INTRODUCTION ........................................................................................... 1
`LEGAL STANDARD ..................................................................................... 2
` ARGUMENT ................................................................................................... 2
`A.
`The Decision Misapprehended the Differences Between Claim
`1’s Pharmaceutical Batch and the Combination of Moriarty and
`Phares .................................................................................................... 2
`The Decision Misapprehended or Overlooked the Standard for
`Inherency ............................................................................................... 5
`The Decision Overlooked Objective Indicia of Nonobviousness
`Indicating Why a POSA Would Not Have Made or Expected
`To Make a “Pharmaceutical Batch” Using Phares Form B .................. 7
`D. Ground 1 Is Not Sufficient for Institution ........................................... 10
` CONCLUSION .............................................................................................. 11
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`C.
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`TABLE OF AUTHORITIES
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`Cases
`Crown Operations Intern., Ltd. v. Solutia Inc., 289 F.3d 1367 (Fed. Cir. 2002) .... 12
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`Honeywell Int’l v. Mexichem Amanco Holding S.A., 865 F.3d 1348 (Fed. Cir.
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`2017) .................................................................................................................... 11
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`In re Best, 562 F.2d 1252 (CCPA 1977) .................................................................. 12
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`In re Cyclobenzaprine Hydrochloride, 676 F.3d 1063 (Fed. Cir. 2012) ................... 8
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`Nike, Inc. v. Adidas, AG, 812 F. 3d 1326 (Fed. Cir. 2016) ........................................ 8
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`Par Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186 (Fed. Cir. 2014) .................. 6
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`Board Decisions
`Ferrum Ferro Capital, LLC v. Allergan Sales, LLC, IPR2015-00858, Paper 10,
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`(PTAB Sept. 21, 2015) ........................................................................................... 5
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`Lower Drug Prices for Consumers, LLC v. Forest Laboratories Holdings Ltd.,
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`IPR2016-00379, Paper 14 (PTAB July 1, 2016) ................................................. 11
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`Semiconductor Component Indus., LLC v. Power Integrations, Inc., IPR2016-
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`01588, Paper 15 (PTAB Feb. 17, 2017) ................................................................ 8
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`Tietex International, Ltd. v. Precision Fabrics Group, Inc., IPR2014-01248,
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`Paper 39 (PTAB Jan. 27, 2016) ........................................................................... 12
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`Rules
`37 C.F.R. § 42.71(d) ..............................................................................................1, 2
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`ii
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`INTRODUCTION
`In response to the decision (Paper No. 7, “Decision” or “Dec.”) instituting
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`inter partes review of U.S. Patent No. 9,604,901 (“the ’901 patent”), United
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`Therapeutics Corporation (“Patent Owner”) respectfully seeks rehearing of
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`institution under 37 C.F.R. § 42.71(d), and requests that the Patent Trial and
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`Appeal Board (“Board”) reconsider and deny institution.
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`There are three reasons that the Decision improperly instituted trial, each of
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`which is independently sufficient to modify the Decision to deny review. First, the
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`Decision critically rests for both grounds on an inherency finding that lacks
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`substantial evidence. Specifically, the Decision misapprehended the second ground
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`in finding that “Moriarty and Phares teaches the same process steps as challenged
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`claim 1.” Dec., 27. Yet the steps are not the same as the Petition itself
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`acknowledges (Pet., 61), and the obviousness ground requires removing a step. Id.
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`Second, based on this unsupported finding, the Decision finds that “the product
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`from these steps would include the same resulting impurities.” Dec., 27. Yet using
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`inherency at the point of modification is improper in an obviousness analysis.
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`Third, the Decision overlooks the objective indicia of nonobviousness described in
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`the ’901 patent and file history, but ignored in the Petition, and in the POPR.
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`POPR, 71. The first ground suffers at least the same deficiencies. Dec., 31.
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`1
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` LEGAL STANDARD
`A rehearing “request must specifically identify all matters the party believes
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`the Board misapprehended or overlooked, and the place where each matter was
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`previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d).
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` ARGUMENT
`A. The Decision Misapprehended the Differences Between Claim 1’s
`Pharmaceutical Batch and the Combination of Moriarty and
`Phares
`A linchpin factual determination in the Board’s decision is that Moriarty and
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`Phares teach the same steps as claim 1: “we are persuaded by Petitioner’s evidence
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`and arguments that because the combination of Moriarty and Phares teaches the
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`same process steps as challenged claim 1, the product from these steps would
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`include the same resulting impurities. See Pet., 56.” Dec., 27. Yet this finding is
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`not supported by substantial evidence and, in fact, goes beyond what even
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`Petitioner argued.
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`The Petition acknowledges that claim 1’s recited steps differ from Phares
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`and Moriarty because they do not involve isolation of treprostinil intermediate.
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`Specifically, Petitioner argues that a POSA would be motivated to modify the prior
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`art steps and not isolate treprostinil (Pet., 37-38, 61) in order to remove a step from
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`the Moriarty and Phares processes.1 This modification would not be required if the
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`prior art disclosed the “same process steps.”
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`The POPR also explains that the steps are not the same. The claimed
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`pharmaceutical batches are an improvement over Moriarty and Phares in part
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`because they form a salt without prior isolation of the intermediate treprostinil.
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`POPR, 5, 33, 36, 44-45, and 71. Thus, claim 1 states that the recited impurities
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`must be those specific impurities that result from a process in which the salt is
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`formed without isolation of treprostinil intermediate after alkylation and hydrolysis
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`(step (b) of claim 1 forms “a solution comprising treprostinil” which is the starting
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`solution of the directly following step). This difference in claim 1 was highlighted
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`in red in the Table found in the POPR, 44-45.
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`Portions of the Decision also reflect this distinction noting that Phares teaches
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`“dissolving treprostinil” and then adding diethanolamine, demonstrating that the
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`intermediate treprostinil was isolated and in a solid form before being dissolved.
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`Dec., 23. Moriarty also teaches isolating a solid form of treprostinil in its final step.
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`Ex. 1009, 1902, right column.
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`1 “[N]ot isolating the treprostinil before contacting it with a base is obvious based
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`on what is taught by Phares.” Pet., 37.
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`Nonetheless, the Decision mistakenly finds that “the combination of
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`Moriarty and Phares teaches the same process steps as challenged claim 1.” Yet it
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`is uncontested that Moriarty and Phares do not teach the same process steps, and
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`thus, this finding is based on a misapprehension of the references, the claims, and
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`the Petition. This factual misapprehension leads to the further mistaken finding that
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`“the product from these steps would include the same resulting impurities. See Pet.,
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`56.” This resultant legal error is addressed below in Section III(B).
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`The Decision relies on the Petition at page 56 (Dec., 23, 27), but this portion
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`of the Petition is inapposite. Although the Petition asserts that the “combination of
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`Moriarty and Phares discloses the same process steps…” (Pet., 56), the context is
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`important. This portion of the Petition addresses whether the combination teaches
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`one element of claim 1: “A pharmaceutical batch consisting of treprostinil or a salt
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`thereof and impurities resulting from [the recited steps].” See Pet., 53-56. The
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`focus is on the product, including impurities. Id. In addressing the relevant process
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`steps, Petitioner repeatedly acknowledged the different process steps as discussed
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`above. Indeed, in this same section Petitioner acknowledges that Phares teaches
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`isolation of treprostinil prior to addition of the base (diethanolamine). Id. at 54.
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`Petitioner expands on this distinction and makes an obviousness argument based
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`on this distinction in addressing a relevant claim element, “claim element 1[d].”
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`Id. at 60-61 (acknowledging that “the treprostinil acid [of Phares was] isolated
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`before addition of the base” but arguing that “not isolating the treprostinil before
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`contacting it with a base is obvious….”). Thus, read in context, it is clear that even
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`Petitioner does not contend that Moriarty and Phares disclose the same process
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`steps as recited in the claims. Petitioner’s other arguments and, more importantly,
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`Moriarty and Phares themselves belie this claim.
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`B. The Decision Misapprehended or Overlooked the Standard for
`Inherency
`The Decision misapprehended or overlooked the standard for inherent
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`disclosure. Although the Board institutes based on a reasonable likelihood the
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`petitioner will prevail on at least one claim, this does not diminish the requirement
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`that a limitation undisclosed in the art must be established as a necessary result
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`prior to the point of institution. Ferrum Ferro Capital, LLC v. Allergan Sales, LLC,
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`IPR2015-00858, Paper 10, 10 (PTAB Sept. 21, 2015). Because the recited steps are
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`different from those disclosed in Moriarty and Phares (no isolation of treprostinil
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`after alkylation and hydrolysis steps before forming a salt), then the resulting
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`products cannot be assumed to be the same.
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`Inherency requires identity of steps before inherency can be inferred;
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`otherwise, the challenger must prove that the putative inherency will necessarily
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`result. POPR, 31-32 (citing Par Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186,
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`1195 (Fed. Cir. 2014)). Inherency is not proven by probabilities or possibilities.
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`Par Pharm., 773 F.3d at 1196. Yet Petitioner provided neither argument nor
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`evidence to demonstrate this different combination of steps would necessarily
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`result in claim 1’s impurities from Phares’ working example relied upon in the
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`Decision. Rather, the Decision relies on page 56 of the Petition.
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`This portion of the Petition addresses only purity level—not impurity type.
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`Pet., 56 (“[T]hese references would disclose a purity of at least equal purity to that
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`claimed in the ’901 patent”). Indeed, Petitioner repeatedly makes arguments about
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`relative purity, e.g., “Form A should be more pure than the starting batch and Form
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`B more pure than Form A” and “purity of treprostinil may be as low as 90.0%.” Id.
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`This argument is not accidental. Petitioner must make this argument because it
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`cannot argue identical impurities, which are what is required by the claim, given
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`the different process steps. POPR, 9, 33, 39, 44-45, 58-59 (discussing why the
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`claims require specific impurities rather than a generic impurity level). Moreover,
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`Petitioner’s own arguments effectively conceded that the resulting impurities may
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`not necessarily be the same as recited in the claims. Pet., 56 (“A POSA would
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`understand that this transformation, similar to that described in the ’901 patent,
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`typically removes impurities. (Id.) As such, Form A should be more pure than the
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`starting batch and Form B more pure than Form A.” (emphasis added)). Because
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`Petitioner cannot retroactively add this required proof to its Petition, its theory of
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`unpatentability is doomed.
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`The Decision mistakenly relied on an out-of-context statement claiming
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`identical processes, which is a clear misapprehension. Supra Section III(A). Given
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`different processes and no evidence or argument from Petitioner showing that the
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`resulting impurities are necessarily the same as those recited in the claims, the
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`Decision lacked proper basis for provisionally finding inherency.
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`C. The Decision Overlooked Objective Indicia of Nonobviousness
`Indicating Why a POSA Would Not Have Made or Expected To
`Make a “Pharmaceutical Batch” Using Phares Form B
`The Board overlooked evidence of objective indicia of nonobviousness, as
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`set forth in the ’901 patent specification and prosecution history and outlined by
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`Patent Owner. Objective indicia of nonobviousness, when present, must always be
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`considered. In re Cyclobenzaprine Hydrochloride, 676 F.3d 1063, 1076 (Fed. Cir.
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`2012); POPR, 69; see also Semiconductor Component Indus., LLC v. Power
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`Integrations, Inc., IPR2016-01588, Paper 15, 28-29 (PTAB Feb. 17, 2017)
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`(denying institution for failure to address known objective indicia of
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`nonobviousness). “[W]hen secondary considerations are present ... it is error not to
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`consider them.” Nike, Inc. v. Adidas, AG, 812 F. 3d 1326, 1339 (Fed. Cir. 2016)
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`(citing In re Kao, 639 F.3d 1057, 1067 (Fed. Cir. 2011)).
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`As the POPR explained, the Petition did not address the objective indicia of
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`nonobviousness except to assert that they did not exist. POPR, 69 (citing Pet., 71).
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`Because the Petition failed to address a required element for obviousness apparent
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`from the patent disclosure and original prosecution, it cannot have shown a
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`reasonable likelihood of obviousness. Rather, the Petition was facially deficient
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`and cannot be cured retroactively and should have been denied. The Decision
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`overlooks this facial deficiency of the Petition when it too fails to address the
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`objective indicia of nonobviousness in the ’901 patent and original prosecution.
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`Those nonobviousness indicia show that a POSA would not have made or
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`expected to make a “pharmaceutical batch” as construed in this proceeding2 using
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`Phares Form B. POPR, 69-71 (relying on data to show improvement over the
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`2 Patent Owner’s claim construction for “pharmaceutical batch,” which the
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`Decision accepts, specifically states “This pharmaceutical batch is defined, in part,
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`as ‘consisting of . . . impurities’ resulting from the process by which it is made, and
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`may be stored and then processed into the pharmaceutical products of claims 6 and
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`7. Id.; Ex. 2002, ¶¶ 54-56.” POPR, 8. Thus, “pharmaceutical batch” in claim 1
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`requires storage stability, while dependent claims 6 and 7 specifically relate to
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`storage stability at ambient temperature.
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`closest prior art, including storage stability); see also 51-55 (distinguishing the
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`prior art on storage stability). For example, the ’901 file history contains evidence
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`and argument explaining that a POSA would not have expected certain differences
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`in the impurity profile resulting from salt formation, which are important for a
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`“pharmaceutical batch.” POPR, 24 (citing Ex. 2007, 3819-3825 for arguments
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`about nonobviousness, which led to allowance of the ’901 claims); see also POPR,
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`51-52 (stating that storage stability of claimed “batches” not suggested by Phares)
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`and Dec., 30 (“Petitioner and Dr. Winkler have not shown that Phares describes or
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`suggests Form B as reaching a stability sufficient for storage.”). The Board, like
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`Petitioner, did not address this evidence of objective indicia of nonobviousness,
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`including unexpected results in relation to claims 1-5, 8, and 9.
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`The consideration of nonobviousness indicia is especially important when
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`“substantially the same” arguments had been previously fully considered,
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`analyzed, and accepted during original prosecution in relation to the particular
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`claim limitation (“pharmaceutical batch”) at issue here. POPR 24 (citing Ex. 2007,
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`3819-3825 for arguments about nonobviousness of making claimed
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`“pharmaceutical batch” based on Phares Form B). Lower Drug Prices for
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`Consumers, LLC v. Forest Laboratories Holdings Ltd., IPR2016-00379, Paper 14
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`(PTAB July 1, 2016) (denying institution based on unexpected results established
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`during original prosecution). In addition, the Decision appears to improperly rely
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`on inherency in an obviousness context to address the “pharmaceutical batch”
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`limitation by citing Moriarty while ignoring the arguments that a storage stable
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`batch would not have been expected based on Phares (Dec. 26-27). See Honeywell
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`Int’l v. Mexichem Amanco Holding S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017)
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`(holding that the Board erred as a matter of law by dismissing properties of the
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`claimed invention as merely inherent, without further consideration as to
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`unpredictability and unexpectedness).
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`D. Ground 1 Is Not Sufficient for Institution
`Ground 1, which purports to demonstrate obviousness from Phares alone, is
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`all the more deficient because it lacks whatever value Moriarty purportedly adds,
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`which as explained above is not enough. The Decision nevertheless institutes on
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`Ground 1 because “[t]he parties’ [inherency] disputes involve fact intensive issues
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`[so] the parties [should] fully develop the record during trial before [the Board]
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`resolv[es] these disputes.” Dec., 31. Yet a petition must be facially complete and
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`the burden to demonstrate inherency lies with the petitioner. If the petitioner has
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`not already demonstrated inherency, nothing remains to be tried because the
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`petitioner may not bolster its case after institution. This is an issue that a petitioner
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`could have anticipated. Indeed, Petitioner offered conclusory arguments on
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`inherency. Pet., 37. Examiners have some latitude to shift the burden on inherency
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`to the patent applicant because examiners have no ability to test their inferences
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`from the record. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). In an inter partes
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`context, however, petitioners have no such latitude. Tietex International, Ltd. v.
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`Precision Fabrics Group, Inc., IPR2014-01248, Paper 39, 10-12 (PTAB Jan. 27,
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`2016) (explaining that the ex parte practice does not apply in inter partes
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`proceedings); accord Crown Operations Intern., Ltd. v. Solutia Inc., 289 F.3d
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`1367, 1377-78 (Fed. Cir. 2002) (“Instead, Crown offers only an assumption and its
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`own contentions”); id. at 1378 n.4 (noting the failure to provide “direct” proof of
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`inherency). Here, Petitioner has made no effort to justify its reliance on conclusory
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`statements rather than direct proof. This threshold failure cannot be cured at trial.
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`Just as Ground 2 does not justify trial, Ground 1 likewise offers no basis for trial.
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` CONCLUSION
`For the foregoing reasons, Patent Owner requests reconsideration of the
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`Decision and a denial of institution on all grounds presented in the Petition.
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`Date October 27, 2020
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`FOLEY & LARDNER LLP
`3000 K St. NW
`Washington Harbour
`Washington, DC 20007
`Telephone: (202) 672-5569
`Facsimile:
`(650) 856-3710
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`Patent Owner’s Rehearing Request
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` Respectfully submitted,
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`By /Stephen B. Maebius/
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`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent Owner
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`Request for Rehearing was served on counsel of record for Petitioner on October
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`27, 2020 by delivering a copy via email to the counsel of record for the Petitioner
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`at the following addresses:
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`zLiquidiaIPR@cooley.com
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`ielrifi@cooley.com
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`emilch@cooley.com
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`dkannappan@cooley.com
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`
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`
`
`Date October 27, 2020
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`FOLEY & LARDNER LLP
`3000 K St. NW
`Washington Harbour
`Washington, DC 20007
`Telephone: (202) 672-5569
`Facsimile:
`(650) 856-3710
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`
`
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`
`
`
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`By /Stephen B. Maebius/
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`
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`
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`Stephen B. Maebius
`Registration No. 35,264
`
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`4852-7036-8975.4
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`
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