Paper 8
`Trials@uspto.gov
`Entered: February 6, 2018
`Tel: 571-272-7822
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`KVK-TECH, INC.
`FLAT LINE CAPITAL, LLC,
`Petitioner,
`
`v.
`
`SILVERGATE PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case PGR2017-00039
`Patent 9,463,183
`___________
`
`
`Before GRACE KARAFFA OBERMANN, RAMA G. ELLURU,
`and MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
` DECISION
`Instituting Post Grant Review of Claims 1–13
`35 U.S.C. § 324; 37 C.F.R. § 42.208
`
`
`
`
`
`Trials@uspto.gov
`Entered: February 6, 2018
`Tel: 571-272-7822
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`KVK-TECH, INC.
`FLAT LINE CAPITAL, LLC,
`Petitioner,
`
`v.
`
`SILVERGATE PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case PGR2017-00039
`Patent 9,463,183
`___________
`
`
`Before GRACE KARAFFA OBERMANN, RAMA G. ELLURU,
`and MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
` DECISION
`Instituting Post Grant Review of Claims 1–13
`35 U.S.C. § 324; 37 C.F.R. § 42.208
`
`
`
`
`
`
`PGR2017-00039
`Patent 9,463,183
`
`
`I. INTRODUCTION
`Petitioner filed a Petition for post grant review of claims 1–13 of U.S.
`Patent No. 9,463,183 B1 (Ex. 1001, “the ’183 patent”). Paper 1 (“Pet.”).
`Patent Owner filed a Preliminary Response. Paper 7 (“Prelim. Resp.”).
`Applying the standard set forth in 35 U.S.C. § 324(a), which requires
`demonstration that it is more likely than not that at least one challenged
`claim is unpatentable, we institute post grant review of the challenged claims
`based on a single ground of unpatentability identified in the Order below.
`The following preliminary findings of fact and conclusions of law are
`made for the sole purpose of determining whether Petitioner meets the
`threshold for initiating review. Any final decision shall be based on the full
`trial record, including any response timely filed by Patent Owner.
`Arguments not raised by Patent Owner in a timely-filed response shall be
`deemed waived, even if they were presented in the Preliminary Response.
`Taking account of the information presented in the Petition and
`Preliminary Response, we determine that the Petition shows sufficiently the
`following facts for the purposes of trial institution.
`A. Related Proceedings
`“Petitioner is unaware of any potentially related matters” and Patent
`Owner identifies none. Pet. 3; Paper 4.
`B. The ’183 Patent (Ex. 1001)
`The ’183 patent is titled “Lisinopril Formulations.” Ex. 1001, [54].
`The ’183 patent specification describes lisinopril as an “antihypertensive”
`drug useful for treating “high blood pressure,” as well as “heart failure and
`acute myocardial infarction.” Id. at 1:5–56. The specification further
`discloses that “[l]isinopril is currently administered in the form of oral
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`Patent 9,463,183
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`tablets,” identifying two commercially-available tablet forms of the drug.
`Id. at 1:52–53. The specification explains that some people, including
`“children and the elderly,” may experience difficulty swallowing lisinopril
`in tablet form. Id. at 4:37. That circumstance may result in “non-
`compliance with the recommended medical therapy” or even “choking.” Id.
`at 4:34–35, 38. A prior art practice of compounding the lisinopril tablets
`(that is, pulverizing or crushing the tablets into powder and reconstituting
`the powder in liquid) may lead to undesirable consequences, including
`inaccurate dosing and rapid instability of the drug. Id. at 39–56.
`The invention addresses those problems by providing a “lisinopril oral
`liquid formulation” that is “stable in various storage conditions” and tastes
`sweet. Id. at 6:41, 14:36, 14:67. The claimed invention is directed to an oral
`liquid formulation of lisinopril (or its pharmaceutically acceptable salts or
`solvates), a sweetener that is xylitol, a buffer comprising citric acid and
`sodium citrate, a preservative that is sodium benzoate, and water. Id.
`at 38:27–40 (claim 1). The formulation includes the ingredients in specified
`weight-to-volume amounts and, further, specifies a pH range for the
`formulation of about 4 to about 5. Id.
`The claimed formulation also “is stable at about 25±5° C. for at least
`12 months.” Id. The specification defines the word “stable,” which appears
`in each independent claim of the ’183 patent. Id. at 15:1–7 (definition of
`“stable”); 38:28, 38:39, 38:49, 39:60, 39:5, 39:17 (for stability limitations of
`claims 1, 6, and 12). According to the specification, “[s]table as used herein
`refer[s] to lisinopril oral liquid formulations having about 95% or greater of
`the initial lisinopril amount and about 5% w/w or less total impurities or
`related substances at the end of a given storage period.” Id. at 15:1–7.
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`C. Illustrative Claim
`Of the challenged claims, only claims 1, 6, and 12 are in independent
`form. Claim 1 is illustrative and reproduced below:
`1. A stable oral liquid formulation, comprising:
`(i) about 1 mg/ml lisinopril or a pharmaceutically
`acceptable salt or solvate thereof;
`(ii) about 150 mg/ml of a sweetener that is xylitol;
`(iii) a buffer comprising about 0.86 mg/ml citric acid and
`about 1.44 mg/ml sodium citrate;
`(iv) about 0.8 mg/ml of a preservative that is sodium
`benzoate; and
`(v) water;
`wherein the pH of the formulation is between about 4 and
`about 5; and
`wherein the formulation is stable at about 25±5° C. for at
`least 12 months.
`Ex. 1001, 38:27–40.
`The other claims differ from claim 1 in ways that do not affect
`our decision on institution. See id. at 38:41–39:20 (claims 2–13).
`D. Evidence Relied Upon
`The Petition identifies the following references as prior art in the
`grounds of unpatentability:
`(1) Ben Beidel, et al., “Liquid dosage forms intended for pediatric
`use: Lisinopril & Meclizine,” Department of Pharmaceutical Sciences,
`School of Pharmacy, Wilkes University, Wilkes-Barre, PA, presented at
`2011 AAPS Annual Meeting and Exposition, October 26, 2011,
`Washington, DC (Ex. 1005, “Beidel”);
`(2) Ben Beidel, et al., “Lisinopril as a liquid dosage form intended for
`pediatric use,” Meeting Abstract, AAPS 2011 (Ex. 1006, “Beidel Two”);
`(3) Maneesh J. Nerurkar, et al., WO 98/14196, published April 9,
`1998 (Ex. 1009, “Nerurkar”); and
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`(4) Lloyd V. Allen, Jr., “Lisinopril 1-mg/mL, Sodium Citrate, and
`Citric Acid Oral Liquid,” Int’l J. of Pharma. Compounding, Vol. 10 No. 5
`(September/November 2006) (Ex. 1010, “Pharma Compounding”).
`The Petition is supported by the Declaration of Arthur Kibbe, Ph. D.
`Ex. 1002. For the purposes of this decision, we find that Dr. Kibbe is
`qualified to opine from the perspective of a person of ordinary skill in the art
`at the time of the invention. See id. ¶¶ 2–7 (Dr. Kibbe’s background and
`qualifications), Appendix A (Dr. Kibbe’s curriculum vitae).
`E. The Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability against
`claims 1–13 of the ’183 patent:
`(1) lack of enablement under 35 U.S.C. ¶ 112(a);
`(2) lack of written description support under 35 U.S.C. ¶ 112(a); and
`(3) obviousness over the combined disclosures of Beidel, Beidel
`Two, Nerurkar, and Pharma Compounding under 35 U.S.C. § 103. Pet. 4.
`II. ANALYSIS
`We organize our analysis into three sections. First, we address the
`
`level of ordinary skill in the art at the time of the invention. Second, we
`discuss claim construction. Third, taking account of the information
`presented, we consider whether the Petition meets the threshold showing for
`post grant review for each of the three asserted grounds, which are based on
`enablement, written description, and obviousness.
`Based on that analysis, we conclude that the Petition meets the
`threshold for review only with respect to the third asserted ground, based on
`obviousness over the prior art. Accordingly, as set forth in the Order below,
`we institute trial limited to resolving whether the subject matter of the
`challenged claims would have been obviousness over the asserted prior art.
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`A. Level of Ordinary Skill in the Art
`We consider the grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art at the time of the
`invention. Petitioner submits that an ordinary artisan typically would have
`been a pharmaceutical formulator with at least a master’s degree in
`pharmacy, pharmaceutics, pharmacokinetics, or a related discipline and,
`further, would have had at least four years of experience. Pet. 27–28.
`Petitioner’s definition, which is not challenged in the Preliminary
`Response, is comparable to the level of skill reflected in the asserted prior
`art references. On this record, we find that the prior art itself is sufficient to
`demonstrate the level of ordinary skill in the art at the time of the invention.
`See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior
`art itself can reflect the appropriate level of ordinary skill in the art). To the
`extent that a more specific definition is required, for purposes of this
`decision, we adopt the unopposed definition advanced by Petitioner.
`B. Claim Construction
`The Board interprets claims in an unexpired patent using the “broadest
`reasonable construction in light of the specification of the patent.” 37 C.F.R.
`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46
`(2016). Under that standard, claim terms are given their ordinary and
`customary meaning in view of the specification, as understood by a person
`of ordinary skill in the art at the time of the invention. In re Translogic
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). We resolve disputed
`claim terms only to the extent necessary to our decision. Nidec Motor Corp.
`v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed.
`Cir. 2017) (“we need only construe terms ‘that are in controversy, and only
`
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`to the extent necessary to resolve the controversy’” (quoting Vivid Techs.,
`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
`The Petition does not assert that any claim term requires express
`construction. See generally Pet. Patent Owner, however, contends that the
`Petition is based on an overly-broad definition of “stable” that is
`unsupported by the intrinsic evidence. Prelim. Resp. 10. We determine that
`the meaning of the word “stable,” which appears in each independent
`challenged claim, requires discussion for purposes of this decision.
`We agree with Patent Owner that the ’183 patent specification sets
`forth an explicit definition of “stable.” Id. at 9–10 (citing Ex. 1001,
`15:1–5). The specification defines “stable” to mean “lisinopril oral liquid
`formulations having about 95% or greater of the initial lisinopril amount and
`about 5% w/w or less total impurities or related substances at the end of a
`given storage period.” Ex. 1001, 15:1–7.
`We do not agree with Patent Owner, however, that the Petition is
`based on an overly-broad definition of “stable.” Prelim. Resp. 10 (citing
`Pet. 77). On that point, Patent Owner directs us to an assertion in the
`Petition that an ordinary artisan would have understood “that a formulation
`of lisinopril was considered stable if the percent remaining” after any given
`storage period “was greater than 90%.” Id. (citing Pet. 77). The Petition
`acknowledges the express definition of “stable” set forth in the specification,
`which requires a percent remaining of “about 95%.” Pet. 26, 29–30 (citing
`Ex. 1001, 15:1–7), 38. Fairly read, the part of the Petition that Patent Owner
`identifies represents an attempt, on Petitioner’s part, to establish, in the
`context of the specification’s explicit definition of “stable,” whether “the
`prior art disclosed liquid lisinopril formulations with very high stability.”
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`Pet. 77. We leave for trial the development and resolution of any genuinely
`disputed issue of material fact surrounding that factual issue. Id.
`C. The Asserted Grounds of Unpatentability
`In this section, we address in turn each ground of unpatentability
`advanced in the Petition: namely, (1) lack of enablement; (2) lack of written
`description support; and (3) obviousness over the asserted prior art. Pet. 4.
`(1) Ground Based on Lack of Enablement
`We first address whether the Petition shows sufficiently that the ’183
`
`patent fails to enable the claimed invention. We evaluate enablement by
`considering whether the patent disclosure, at the time of filing, would have
`enabled a person of ordinary skill in art to make and use the subject matter
`of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The
`touchstone of enablement is whether undue experimentation would have
`been required to practice the claimed invention. Id.
`
`The Petition fails to allege facts from which we can reasonably
`conclude that any experimentation, much less undue experimentation, would
`have been required to enable an ordinary artisan to make and use the claimed
`invention. Specifically, Patent Owner’s information persuades us that the
`working examples set forth in the ’183 patent would have enabled an
`ordinary artisan to make and use the claimed lisinopril formulation (which is
`embodied in Formulations F1 and F7 in Table F-1 of the specification).
`Prelim. Resp. 13–15 (and evidence cited therein).
`Patent Owner advances a claim chart that identifies specific
`disclosures and asserts that the disclosures would have enabled an ordinary
`artisan to make and use a formulation containing all the required ingredients
`in the claimed amounts. Prelim. Resp. 26–30 (and citations therein to
`
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`Ex. 1001). We agree with Patent Owner that those disclosures would have
`informed an ordinary artisan of “the exact ingredients, their concentrations,
`and step-by-step instructions” to prepare the claimed lisinopril formulation.
`Id. at 21; see id. at 13–15 (identifying information sufficient to show that
`Formulations F1 and F7 meet independent claims 1, 6, and 12).
`The Petition does not present information sufficient to show that
`Formulations F1 and F7 fall outside the scope of the challenged claims. In
`that regard, the Petition assumes that those two formulations “fall within the
`challenged claims,” but argues that the ’183 patent disclosure nevertheless is
`non-enabling for three reasons. Pet. 30. We address each in turn below.
`First, the Petition asserts that the stability data reported in the
`specification fails to provide “the amount of remaining lisinopril compared
`to the ‘initial lisinopril amount’ at the end of a given storage period.” Id.
`That circumstance does not detract from the enabling disclosure (including
`the step-by-step instructions in Example F) set forth in the ’183 patent for
`making a liquid formulation of lisinopril (including Formulations F1 and F7)
`that meets every limitation of the claims, including the specified stability
`profiles. Prelim. Resp. 13–15, 26–30 (and citations to the record therein).
`Dr. Mosher explains that Formulations F1 and F7 “show excellent
`stability with little or no increase in lisinopril” degradation. Ex. 1003, 183
`(¶ 16)1 (stability data for Formulations F1 and F7). Although the “stability
`
`1 Exhibit 1003 is the prosecution history of the ’183 patent, which includes
`the Declaration of Gerold Mosher under 37 C.F.R. § 1.132 (“Mosher
`Declaration”). We refer to page numbers the parties have added to the
`exhibits (including Exhibit 1003), not the original page numbers, unless the
`citation is to a page and line of text.
`
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`study” set forth in the specification “had not reached 52 weeks (12 months)
`at the time of the” filing of the patent application, Dr. Mosher states that,
`based on the data disclosed in the specification, an ordinary artisan would
`have “expected to have similar results based on extrapolating the prior time
`points which showed little variance in the degradant concentrations.” Id.
`Dr. Mosher indicates that “[t]hese results support and demonstrate that the
`lisinopril oral liquid formulation of the present claims are stable at 25±5° C.
`for at least 12 months.” Id. Significantly, Dr. Mosher’s opinions are
`supported by objective proof that Formulations F1 and F7 were stored
`for 728 days and 364 days, respectively, “with no loss of lisinopril content.”
`Id. at 185 (¶ 21); see id. at 184 (¶ 20) (chart, showing “% of initial” lisinopril
`content after storage for 728 days and 365 days). On this record, Petitioner
`does not show sufficiently that an ordinary artisan, equipped with the ’183
`patent disclosure, would have been unable to make or use the claimed
`formulation. Pet. 30–35.
`Second, the Petition asserts that, because the Mosher Declaration was
`submitted after the filing date of the ’183 patent application, it “cannot be
`used to cure a defect of enablement.” Pet. 35. But, as Patent Owner points
`out, there is no defect in enablement, because the specification itself
`explicitly discloses “the exact components of the claimed formulations and
`their amounts . . . along with instructions for their manufacture.” Prelim.
`Resp. 13. Against that backdrop, Petitioner directs us to two cases that are
`distinguishable on their facts. Pet. 35; see Janssen Pharmaceutica N.V. v.
`Teva Pharms. USA, Inc., 583 F.3d 1317, 1321 (Fed. Cir. 2009) (specification
`“was only just over one page in length, and [] provided no basis for its stated
`conclusion that it was possible to administer ‘an effective Alzheimer’s
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`disease cognitively-enhancing amount of galanthamine’”); Plant Genetic
`Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1338, 1341 (Fed. Cir.
`2003) (invention was not “enabled for monocots” where it “did not disclose
`any method of achieving [] monocots”).
`Third, the Petition argues that claims 4, 5, 10, and 112 (which require
`a formulation that is stable for 18 or 24 months) are not enabled by the ’183
`patent specification. Pet. 40–41. Specifically, Petitioner argues that the data
`submitted in the declaration of Dr. Mosher, which establishes that
`Formulation F1 experienced “no loss of lisinopril content” after 728 days
`(Ex. 1003, 185 (¶ 21), is “insufficient” because it was submitted after the
`filing date of the ’183 patent application. Pet. 40. Here again, however, the
`record reflects that, based on the data disclosed in the specification, one
`would have “expected to have similar results based on extrapolating the
`prior time points which showed little variance in the degradant
`concentrations.” Ex. 1003, 183 (¶ 16). Our above reasoning with respect to
`claim 1 (which requires stability after at least 12 months of storage),
`therefore, applies with equal force to claims 4, 5, 10, and 11.
`Furthermore, an enabling disclosure need not disclose any working
`examples or demonstrate that the claimed invention was actually reduced to
`practice at the time of filing. Prelim. Resp. 25 (citing Alcon Research Ltd. v.
`Barr Labs, Inc., 745 F.3d 1180, 1190 (Fed. Cir. 2014)). Where there is no
`need for an actual reduction to practice, Petitioner’s position that the failure
`
`
`2 The Petition does not advance separate reasoning directed to any other
`dependent claims.
`
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`to include test data sufficient to confirm a property or characteristic of
`Formulations F1 or F7 lacks merit.
`The Alcon decision informs our decision in this case. In Alcon, the
`patent claim was directed to “[a] method of enhancing the chemical stability
`of an aqueous composition” of a drug. Alcon Research Ltd., 745 F.3d at
`1184. The patent at issue in Alcon provided “only three working examples”
`and no “data for chemical stability.” Id. at 1188. Applying the principles set
`forth in In re Wands, the Federal Circuit observed that those facts were
`insufficient to make out a “threshold showing that any experimentation is
`necessary to practice the claimed methods.” Id. at 1188–89. The court
`reasoned that “a patentee is not required to provide actual working
`examples” and, further, that “an invention may be patented before it is
`actually reduced to practice.” Id. at 1189.
`The ’183 patent specification provides working examples and, during
`patent prosecution, the applicants submitted test data (Ex. 1003, 180–186)
`demonstrating that the claimed stability profile “represents an inherent
`property of the claimed formulations,” when the step-by-step instructions set
`forth in the ’183 patent are carried out to prepare Formulations F1 and F7.
`Prelim. Resp. 17. We determine that the step-by-step instructions for
`preparing those formulations, contained within the four corners of the ’183
`patent application, would have enabled an ordinary artisan to make and use a
`formulation that exhibits the specified stability profile. See Ex. 1003, 35–48
`(patent application, paragraphs 152–175) (disclosing working examples,
`including instructions for preparing Formulations F1 and F7), 180–186
`(Mosher Declaration, evidencing that Formulations F1 and F7 meet the
`claimed stability profile).
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`We do not agree that enablement turns on whether an ordinary artisan
`would have known or recognized that Formulations F1 and F7 inherently
`possess the stability profile specified in the claims. In any event, the record
`includes persuasive evidence that an ordinary artisan would have had the
`means to confirm that profile without resorting to “undue experimentation.”
`Prelim. Resp. 16. In that regard, as Patent Owner points out, the Petition
`does not contend that a “testing methodology,” suitable for assessing
`whether any given formulation exhibited the specified stability profile,
`would have been outside the ken of an ordinary artisan—or that performing
`such tests on Formulation F1 or F7 would have amounted to “undue
`experimentation.” Id. On the contrary, the Petition acknowledges that
`conducting such tests would have fallen squarely within the level of ordinary
`skill in art. Pet. 14 (asserting that an ordinary artisan would have been
`“well-aware how to measure the stability of an oral liquid formulation”) (and
`evidence cited therein). Petitioner’s own witness directs us to prior art
`references that identify techniques for assessing the long-term stability of
`oral liquid lisinopril formulations. Ex. 1002 ¶ 39. Patent Owner, for its part,
`correctly observes that “a considerable amount of routine experimentation”
`is permitted without rising to the level of undue experimentation under a
`correct enablement analysis. Prelim. Resp. 22 (citing PPG Indus. v.
`Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996)).
`Accordingly, on this record, we determine that the Petition fails to
`demonstrate that any challenged claim is more likely than not unpatentable
`for lack of an enabling disclosure.
`
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`(2) Ground Based on Lack of Written Description Support
`The Petition also asserts that the claimed invention lacks written
`
`description support in the patent disclosure. Pet. 40–41. “[T]he hallmark of
`written description is disclosure.” Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A disclosure is sufficient if
`it “reasonably conveys to those skilled in the art that the inventor had
`possession of the claimed subject matter as of the filing date,” based on an
`“objective inquiry into the four corners of the specification.” Id.
`The Petition advances facts in support of this ground that are
`substantially the same as those raised in connection with the ground based
`on enablement. Specifically, the Petition argues that the ’183 patent is
`“invalid for lack of written description” because the inventors submitted
`“new data” (namely, the Mosher Declaration (Ex. 1003, 180–186)) during
`patent prosecution to confirm the stability profile of Formulations F1
`and F7. Pet. 41–42.
`
`Patent Owner responds that “the stability profiles represent inherent
`properties of the claimed formulations that need not be fully described” to
`establish written description support. Prelim. Resp. 25 (citing Allergan, Inc.
`v. Sandoz Inc., 796 F.3d 1293, 1309 (Fed. Cir. 2016) (“A claim that recites a
`property that is necessarily inherent in a formulation that is adequately
`described is not invalid as lacking written description merely because the
`property is not explicitly described.”). The Mosher Declaration (presented
`during prosecution after the filing of the patent application) confirms that the
`required stability profile is an inherent property of Formulations F1 and F7,
`which are adequately described in the step-by-step instructions set forth in
`the patent disclosure. Ex. 1003, 180–186. The ’183 patent disclosure, thus,
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`demonstrates that the inventors were in possession of formulations
`(including Formulations F1 and F7) meeting all of the requirements of the
`claims, including an inherent property or characteristic (that is, the claimed
`stability) required by the claims. Prelim. Resp. 26–30 (claim chart, linking
`each challenged claim to disclosure in the ’183 patent specification).
`In a nutshell, Petitioner faults the inventors for filing their patent
`application without waiting to complete the tests detailed in the Mosher
`Declaration, which confirmed that Formulation F1 and F7 would remain
`stable for at least 12 months. See Pet. 41–42; Ex. 1001, 33:1–21 (Table C-2,
`reflecting stability data up to 26 weeks). As explained in Alcon, however,
`the written description “is not about whether the patentee has proven to the
`skilled reader that the invention works,” but rather only requires that the
`“patent disclosures demonstrate that the inventors . . . conceived of and
`described their invention at the time the respective original patent
`applications were filed.” Alcon Research Ltd., 745 F.3d at 1191. The
`Petition fails to allege facts sufficient to show that the instructions set forth
`in the patent application for making the claimed formulation are inadequate
`to show that the inventors had possession of the claimed invention. Prelim.
`Resp. 26–30 (and citations to the record therein).
`Accordingly, we determine that the Petition does not show that any
`challenged claim is more likely than not unpatentable for lack of written
`description support.
`(3) Ground Based on Obviousness Over the Asserted Prior Art
`The information presented in the Petition and Preliminary Response
`
`shows sufficiently the following facts, which bear on whether the Petition
`demonstrates that it is more likely than not that at least one challenged claim
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`would have been obvious over the combined disclosures of Beidel, Beidel
`Two,3 Nerurkar, and Pharma Compounding. Pet. 4. Our findings are based
`on the current record. Any final findings shall be based on the full record
`developed during trial. We emphasize that Patent Owner may challenge
`these preliminary factual findings through discovery and in a timely-filed
`response to the Petition. We first address claim 1, then turn to claims 2–13.
`(a) Claim 1
`The Petition shows sufficiently that an ordinary artisan at the time of
`the invention would have been working “to develop a non-compounded
`liquid formulation for lisinopril.” Id. at 52 (citing Ex. 1002 ¶ 64; Ex. 1005,
`1 (purpose section)). Further, the Petition directs us to information sufficient
`to show that the asserted prior art references would have suggested a
`formulation containing each ingredient required by claim 1. Id. at 54–63
`(textual claim chart, explaining sufficiently where each ingredient is
`suggested in the asserted prior art references).
`The Petition identifies adequate reasons why a person of ordinary skill
`in the art would have been led to select those ingredients for combination in
`an oral liquid formulation of lisinopril. Id. at 6–12, 51–54 (and evidence
`cited therein). In that regard, the Petition is supported by the testimony of
`Dr. Kibbe, who explains, with reference to specific disclosures in the prior
`art, why a person of ordinary skill in the art would have selected each
`claimed excipient for use in an aqueous formulation of lisinopril and how,
`
`
`3 “The disclosure of Beidel Two substantially mirrors that of Beidel” except
`that “Beidel Two also discloses” a goal “to prepare a palatable and stable
`lisinopril mixture with a shelf life buffer of 18–24 months.” Pet. 50
`(citing Ex. 1006, 1).
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`16
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`PGR2017-00039
`Patent 9,463,183
`
`through routine optimization, one would have been led to add them in the
`amounts specified in claim 1. Id. at 54–63 (and citations to the record
`therein); see id. at 56, 59 (for routine optimization argument).
`The Petition also directs us to information sufficient to show that an
`ordinary artisan would have been prompted to buffer the formulation to
`within the claimed pH range of about 4 to 5. Pet. 63–64 (and citations to
`record therein). The Petition identifies information (id. at 64–66) showing
`sufficiently that the optimized formulation would have inherently exhibited
`the stability profile required by claim 1; that is, the property of remaining
`“stable at about 25±5° C. for at least 12 months.” Ex. 1001, 38:39–40.
`Patent Owner responds that the Petition is defective for failure to
`identify “a lead or reference composition.” Prelim. Resp. 46. That
`argument does not support denial of review, where the Petition presents
`information that shows adequately, with specific citations to the prior art,
`why and how an ordinary artisan would have been led to the invention of
`claim 1. See id. at 46–47 (tying this “lead or reference composition”
`argument to an asserted inadequacy in the Petition’s “rationale supporting a
`[] motivation to modify” the prior art “to arrive at the patented
`formulation”); but see Pet. 6–12, 51–54 (addressing reasons to combine).
`Patent Owner also asserts that “Nerurkar is not analogous art to the
`claims and thus is unavailable as prior art to the ’183 patent claims.” Prelim.
`Resp. 47–48. Nerurkar relates to liquid formulations, not of lisinopril, but of
`a different drug—namely, alendronic acid. Id. at 48 (citing 1009, 1:12). On
`this record, however, we find that the ’183 patent and Nerurkar are within
`the same general field (liquid drug formulations). See Ex. 1009, 2:2
`(Nerurkar, pertaining to general field of liquid drug formulation). In the
`
`17
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`PGR2017-00039
`Patent 9,463,183
`
`alternative, the particular problem sought to be solved by Nerurkar “is
`reasonably pertinent to the particular problem” that the inventors of the ’183
`patent sought to solve. Prelim. Resp. 48; compare Ex. 1009, 5:25–28
`(Nerurkar, seeking to develop a liquid drug formulation for “elderly patients
`who may experience difficulty in swallowing tablets or capsules”), with
`Ex. 1001, 4:28–32 (the ’183 patent, seeking to develop a liquid drug
`formulation for “children and the elderly” who may “have difficulty
`ingesting and swallowing solid oral dosage forms such as tablets and
`capsules”).
`In addition, Patent Owner argues that we should deny the Petition for
`alleged violations of our trial practice rules. Prelim. Resp. 5–8. First, Patent
`Owner argues that we should deny the Petition for failure to set forth “[t]he
`specific statutory grounds . . . on which the challenge to the claims is based.”
`Prelim. Resp. 5 (quoting 37 C.F.R. § 42.204(b)(5)). On that point, Patent
`Owner objects to the Petition’s citations to prior art references that are not
`identified in the stated grounds of unpatentability. Id. at 6 (citing Pet. 4,
`identification of grounds). We decline to deny the Petition on that basis. To
`the extent that the Petition refers to background references that are not
`identified in the stated grounds (Pet. 4), the Petition provides adequate notice
`to Patent Owner regarding precisely how and why those references support
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