Trials@uspto.gov Paper No. 12
`Entered: April 12, 2016
`571-272-7822
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS IRELAND LTD. and
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00002
`Patent 8,772,306
`____________
`
`
`
`Before ERICA A. FRANKLIN, BRIAN P. MURPHY, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
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`IPR2016-00002
`Patent 8,772,306
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`I.
`
`INTRODUCTION
`Par Pharmaceutical, Inc. (“Petitioner”) filed a Petition (Paper 3,
`“Pet.”), requesting institution of an inter partes review of claims 1–34 of
`U.S. Patent No 8,772,306 (Ex. 1001, “the ’306 patent”). Jazz
`Pharmaceuticals Ireland Ltd. and Jazz Pharmaceuticals, Inc. (collectively,
`“Patent Owner”) timely filed a Preliminary Response (Paper 10,
`“Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314, which
`provides that an inter partes review may not be instituted “unless . . . there is
`a reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.”
`Upon consideration of the Petition and the Preliminary Response, and
`for the reasons explained below, we determine Petitioner has not shown a
`reasonable likelihood that it would prevail with respect to any of the
`challenged claims. We, therefore, decline to institute an inter partes review
`of claims 1–34 of the ’306 patent.
`
`A. Related Proceedings
`Petitioner has identified a related litigation proceeding in the District
`of New Jersey: Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc., C.A.
`No. 14-6150 (D.N.J.). Pet. 1. Patent Owner has further identified the
`following related litigation proceedings involving the ’306 patent: Jazz
`Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC, 2:13-cv-391
`(consolidated) (D.N.J.); Jazz Pharmaceuticals, Inc. v. Roxane Laboratories,
`Inc., 2:15-cv-1360 (D.N.J.); Jazz Pharmaceuticals, Inc. v. Wockhardt Bio
`AG, 2:15-cv-5619 (D.N.J.); and Jazz Pharmaceuticals, Inc. v. Lupin Ltd.,
`2:15-cv-6548 (D.N.J.). Paper 8, 1–2. Patent Owner also identified two
`other cases, Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC,
`
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`2:15-cv-6562 (D.N.J.) and Jazz Pharmaceuticals, Inc. v. Par
`Pharmaceutical, Inc., 2:15-cv-7580 (D.N.J.), concerning a patent related to
`the ’306 patent. Id. at 2.
`In addition, Ranbaxy Inc. and Amneal Pharmaceuticals each filed
`separate petitions for inter partes review of the ’306 patent. See IPR2016-
`00024; IPR2016-00546.
`B.
`The ’306 Patent (Ex. 1001)
`The ’306 patent issued on July 8, 2014, and claims a priority date as
`early as March 1, 2013. See Ex. 1001, Title Page. It names Mark Eller as
`the sole inventor. Id.
`The ’306 patent relates generally to methods for improving the safety
`and efficacy of the administration of gamma-hydroxybutyrate (“GHB”) or a
`salt thereof to a patient. Id., Abstract. More specifically, the ’306 patent is
`concerned with treating patients suffering from certain disorders such as
`cataplexy or narcolepsy, who are concomitantly receiving treatment with
`valproate, with a reduced dose of GHB. Id. at 1:15–36. The specification
`states that valproate can increase or prolong the effects of GHB, resulting in
`unsafe conditions such as excessive daytime sleepiness. Id. at 15:19–16:21
`. In certain embodiments, the reduced amount of GHB ranges from 1% to
`50% of the effective dose normally given to the patient. Id. at 1:32–36.
`C. Illustrative Claims
`Petitioner challenges claims 1–34 of the ’306 patent. All of the
`challenged claims are directed to methods of treating certain sleep disorders
`by orally administering a reduced dosage of GHB to patients who are
`concomitantly receiving valproate.
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`
`Claims 1, 11, 19, 30, and 33 are independent. Independent claim 1 is
`illustrative, and reproduced below:
`
`1. A method for treating a patient who is suffering from
`excessive daytime sleepiness, cataplexy, sleep paralysis, apnea,
`narcolepsy, sleep time disturbances, hypnagogic hallucinations,
`sleep arousal, insomnia, or nocturnal myoclonus with gamma-
`hydroxybutyrate (GHB) or a salt thereof, said method
`comprising:
`orally administering to the patient in need of treatment at
`least 5% decrease in an effective dosage amount of the
`GHB or salt thereof when the patient is receiving a
`concomitant administration of valproate, an acid, salt, or
`mixture thereof.
`Independent claims 11, 19, 30, and 33 also require either administering or
`recommending a reduced dose of GHB to a patient who is taking valproate.
`Petitioner treats all claims similarly under each ground asserted in the
`Petition. Therefore, we treat all the claims similarly for purposes of our
`analysis in this Decision.
`
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of the claims of the ’306 patent
`on the following grounds:
`
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`
`References
`Xyrem 2005 Label,1 Depakote
`2011 Label,2 Cagnin,3
`Waszkielewicz,4 and
`the FDA Guidance5
`Xyrem 2005 Label, Depakote
`2011 Label, Cagnin,
`Waszkielewicz, Weiss,6 and
`the FDA Guidance
`
`Basis
`§ 103(a)
`
`Claims challenged
`1–34
`
`§ 103(a)
`
`1–34
`
`
`II. DISCUSSION
`A. Claim Construction
`We interpret claims using the “broadest reasonable construction in
`light of the specification of the patent in which [they] appear[].” 37 C.F.R.
`§ 42.100(b); see also In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–
`
`
`1 Jazz Pharmaceuticals, Inc., Prescribing Information and Medication Guide
`for XYREM® (sodium oxybate) (Nov. 18, 2005) (Ex. 1006).
`2 Abbvie, Inc., Prescribing Information and Medication Guide for
`DEPAKOTE (divalproex sodium) (Oct. 7, 2011) (Ex. 1007).
`3 Cagnin, A. et al., γ-Hydroxybutyric Acid-Induced Psychosis and Seizures,
`21(2) Epilepsy Behav. 203–05 (2011) (Ex. 1008).
`4 Waszkielewicz, A. et al., γ-Hydrobutyric Acid (GHB) and Its Chemical
`Modifications: A Review of the GHBergic System, 56(1) Pol. J. Pharmacol.
`43–49 (2004) (Ex. 1009).
`5 FDA’s Center for Drug Evaluation and Research, Guidance for Industry:
`Drug Interaction Studies—Study Design, Data Analysis, Implications for
`Dosing, and Labeling Recommendations (Feb. 2012) (Ex. 1011).
`6 Weiss, T. et al., Gamma-Hydroxybutyrate (GHB) and Topiramate—
`Clinically Relevant Drug Interaction Suggested by a Case of Coma and
`Increased Plasma GHB Concentration, 69(5) Eur. J. Clin. Pharmacol. 1193–
`94 (2013) (Ex. 1010).
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`79 (Fed. Cir. 2015) (“Congress implicitly approved the broadest reasonable
`interpretation standard in enacting the AIA,” 7 and “the standard was
`properly adopted by PTO regulation.”), cert. granted, sub nom. Cuozzo
`Speed Techs. LLC v. Lee, 136 S. Ct. 890 (mem.) (2016). Under the broadest
`reasonable construction standard, claim terms are given their ordinary and
`customary meaning, as would be understood by one 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). “Absent claim language carrying a narrow meaning,
`the PTO should only limit the claim based on the specification . . . when [it]
`expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320,
`1325 (Fed Cir. 2004). “Although an inventor is indeed free to define the
`specific terms used to describe his or her invention, this must be done with
`reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994).
`We determine that no explicit construction of any claim term is
`necessary to determine whether to institute a trial in this case. See, e.g.,
`Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)
`(“[C]laim terms need only be construed ‘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)).
`
`B. Prior Art Relied Upon
`Petitioners rely upon the following prior art in its challenges.
`
`
`
`7 The Leahy-Smith America Invents Act, Pub. L. No. 11229, 125 Stat. 284
`(2011) (“AIA”).
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`1. Xyrem 2005 Label (Ex. 1006).
`The Xyrem 2005 Label discloses the prescribing information for an
`oral administration of sodium oxybate (i.e., a GHB salt), a central nervous
`system depressant for treating excessive daytime sleepiness and cataplexy.
`Ex. 1006 at 1, 7. According to the Xyrem 2005 Label, the “dose of Xyrem
`should be titrated to effect.” Id. at 22. The Xyrem 2005 Label recommends
`a starting dose of sodium oxybate of 4.5 g/night, divided into two equal
`doses of 2.25 g. Id. at 22–23. The Xyrem 2005 Label also recommends
`increasing the dosage to a maximum of 9 g/night in increments of 1.5
`g/night (0.75 g per dose), and further discloses that the effective dose range
`is 6 to 9 g/night. Id. at 23.
`The Xyrem 2005 Label includes a black box warning on the first page
`that the drug “[s]hould not be used with alcohol or other CNS depressants.”
`Id. at 1. Additionally, the Xyrem 2005 Label indicates that “[s]odium
`oxybate is contraindicated in patients with succinic semialdehyde
`dehydrogenase [SSADH] deficiency.” Id. at 8.
`2. Depakote 2011 Label (Ex. 1007).
`The Depakote 2011 Label discloses the prescribing information for an
`oral administration of divalproex sodium (valproate), an anti-epileptic drug
`for treating seizures, migraine headaches, and bipolar disorder. Ex. 1007, 1.
`The Depakote 2011 Label warns that “[s]ince valproate products may
`produce CNS depression, especially when combined with another CNS
`depressant (e.g., alcohol), patients should be advised not to engage in
`hazardous activities . . . .” Id. at 48.
`
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`3. Cagnin (Ex. 1008).
`Cagnin is a case report describing a patient affected with bipolar
`disorder and alcohol dependence who experienced seizures after co-
`administration of valproate and GHB. Ex. 1008, 203. The patient had been
`receiving a 500 mg dose of valproate, twice daily, as mood-stabilizing
`treatment. Id. The patient also began receiving a dose of 3500 mg/day of
`GHB for treatment of alcohol dependence. Id. Subsequently, the patient
`developed psychotic behavior and experienced seizures. Id. at 203–204.
`Cagnin states that “[o]nly GHB discontinuation restored the neurotransmitter
`balance and caused seizures to cease.” Id. at 205.
`Cagnin suggests that an interaction between valproate and GHB may
`have triggered the seizures. Id. In particular, Cagnin states that valproate is
`a potent in vitro inhibitor of SSADH, which “catalyzes the production of
`succinate from succinic semialdehyde [SSA], an intermediate product in the
`metabolic pathway transforming GHB into GABA and vice versa.” Id.
`Cagnin also discloses that “[a]n inherited deficiency of SSADH activity
`leads to accumulation of [SSA] and, consequently, a 30-fold increase in
`GHB level and a 2- to 4-fold increase in GABA in the brains of affected
`rats,” resulting in tonic-clonic seizures and convulsive status epilepticus. Id.
`4. Waszkielewicz (Ex. 1009).
`Waszkielewicz provides a review of the “GHBergic system,” and
`aims to present the “mechanisms of [GHB] action from pharmacological
`point of view, which may help to properly treat intoxication and other
`pathological states caused by GHB ingestion.” Ex. 1009, 43. According to
`Waszkielewicz, “GHB originates from GABA which is metabolized by a
`transaminase to succinic semialdehyde and then by a dehydrogenase to
`
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`GHB.” Id. at 44. Waszkielewicz further observes that GHB dehydrogenase
`inhibitors, including valproate, can intensify the effects observed after
`administration of GHB. Id. at 48. Waszkielewicz states that “[t]he effect is
`observed due to inhibited GHB metabolism.” Id.
`5. The FDA Guidance (Ex. 1011).
`The FDA Guidance “provides recommendations for sponsors of new
`drug applications (NDAs) and biologics license applications (BLAs) for
`therapeutic biologics regulated by CDER regarding in vitro and in vivo
`studies of drug metabolism, drug transport, and drug-drug or drug-
`therapeutic protein interactions.” Ex. 1011, 1. The FDA Guidance
`recommends that “[i]nteractions between an investigational new drug and
`other drugs should be defined during drug development, as part of an
`adequate assessment of the drug’s safety and effectiveness.” Id. at 2. The
`FDA Guidance indicates that drug-drug interactions should be studied to
`determine “the need for dosage adjustments, additional therapeutic
`monitoring, a contraindication to concomitant use, or other measures to
`mitigate risk.” Id.
`6. Weiss (Ex. 1010).
`Weiss is a letter to the editor describing a 52-year old woman who
`was hospitalized for worsening chronic cluster headache. Ex. 1010, 1193.
`The patient had taken Xyrem® (sodium oxybate) at a dose of 4.5 grams
`twice-nightly for the previous six years. Id. A single dose of 25 mg of
`topiramate was added to the patient’s therapeutic regime, and the next
`morning, the patient developed confusion, as well as intermittent myoclonic
`jerks, miosis, and a rapid onset of coma. Id. Weiss observed that “the GHB
`concentration 5 h after the second daily dose of GHB was 2.8-fold higher
`
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`than without topiramate.” Id. Weiss suggests that “the coma was drug
`induced due to a pharmacokinetic interaction between GHB and
`topiramate.” Id. Weiss further notes that prior “[i]n vitro studies have
`demonstrated that GHB-dehydrogenase is inhibited by the antiepileptic
`drugs valprotate and ethosuximide . . ., but according to Xyrem®’s product
`information no interaction studies with antiepileptics have been performed in
`humans.” Id. Until the interactions between GHB and antiepileptic drugs
`are further evaluated, Weiss recommends “using such combinations only
`with great care.” Id.
`
`C. Analysis of Petitioner’s Patentability Challenges
`1. Obviousness of Claims 1–34 Based on the Xyrem 2005
`Label, Depakote 2011 Label, Cagnin, Waszkielewicz, and
`the FDA Guidance
`Petitioner contends that claims 1–34 are obvious based on the
`combination of the Xyrem 2005 Label, the Depakote 2011 Label, Cagnin,
`Waszkielewicz, and the FDA Guidance. Pet. 18–41. In addition to the
`teachings of the references, Petitioner relies upon the Declaration of John W.
`Winkelman, M.D., Ph.D. Ex. 1003.
`With respect to each of the challenged claims 1–34, Petitioner asserts
`that, based on the recognition of both potential pharmacodynamic
`interactions (by the Xyrem 2005 Label and the Depakote 2011 Label) and
`pharmacokinetic interactions (by Cagnin and Waszkielewicz), a skilled
`artisan would have been motivated to combine these references to arrive at
`the claimed invention. Pet. 22. According to Petitioner, the skilled artisan
`would subscribe to the principle of “start low and go slow,” reducing the
`dose beyond what was suggested in the Xyrem 2005 Label and re-titrating
`
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`the dose to effect. Id. at 25–27. Petitioner argues that the skilled artisan
`“would have found it obvious to try to reduce the dosage of GHB by at least
`5%—and likely more—when a patient is concomitantly receiving valproate
`with a reasonable expectation of success in avoiding toxicity from GHB due
`to an interaction with valproate.” Id. at 27.8
`Patent Owner argues that Petitioner fails to establish that the skilled
`artisan would have: (1) been motivated to combine the asserted references;
`(2) been motivated to administer reduced GHB doses even if the skilled
`artisan believed that valproate causes negative GHB-related side effects in
`humans; and (3) reasonably expected that the reduced GHB doses would be
`effective for treating the claimed sleep disorders. Prelim. Resp. 2. In
`particular, Patent Owner argues that the prior art would have taught the
`skilled artisan that the co-administration of GHB and valproate would result
`in unpredictable effects. Id. at 9–21. Patent Owner also argues that the prior
`art does not disclose or suggest reducing the GHB dose in a patient taking
`valproate. Id. at 21–22. Rather, according to Patent Owner, both the Xyrem
`2005 Label and Cagnin teach away from the claimed invention by warning
`against the co-administration of valproate or other CNS depressants with
`GHB due to potential side effects. Id. at 29–41.
`
`
`8 Petitioner defines the person of ordinary skill in the art (POSA) as someone
`“hav[ing] at least a Ph.D., Doctor of Pharmacy degree, or medical degree,
`and five years of experience of treating patients with neurologic disorders,
`including at least narcolepsy, cataplexy, and excessive daytime sleepiness in
`narcolepsy,” and further indicates that “a POSA may also include a clinical
`pharmacologist with at least three years of experience consulting with
`physicians on the dosing of drugs in light of potential drug-drug interactions,
`comorbid conditions, or other factors that could affect dosing.” Pet. 2; Ex.
`1003, ¶ 20. We apply that description in our analysis.
`
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`We determine that Petitioner has not demonstrated a reasonable
`likelihood of prevailing with respect to any of the challenged claims.
`Although the language in each of the independent claims differs somewhat,
`Petitioner has treated each of these claims as requiring the concomitant
`administration of GHB and valproate, and asserts that the claims would have
`been obvious for the same reasons. See Pet. 28 (“Claim 11 would have been
`obvious for the same reasons discussed above for claim 1); id. at 29 (“Claim
`19 would have been obvious for the same reasons discussed above for claim
`1 and 11.”); id. at 31 (“Claims 30 and 33 would have been obvious for the
`same reasons as discussed for claims 1, 11, and 19 above.”). We
`accordingly treat the independent claims together for our analysis.
`As an initial matter, Petitioner does not account for the prior art’s
`teaching away of the co-administration of GHB and valproate. A reference
`teaches away from a claimed invention if it “criticizes, discredits, or
`otherwise discourages” modifying the reference to arrive at the claimed
`invention. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004); see also KSR
`Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“[W]hen the prior art
`teaches away from combining certain known elements, discovery of a
`successful means of combining them is more likely to be nonobvious.”).
`Here, we find it particularly relevant that Petitioner does not address the
`explicit black box warning that GHB should not be taken with other CNS
`depressants, despite Petitioner’s acknowledgement that valproate is a CNS
`depressant. Ex. 1006, 1; Pet. 5. Nor does Petitioner address the Xyrem
`Label’s contraindication of GHB in patients with SSADH deficiency,
`despite Petitioner’s acknowledgement that valproate was known to inhibit
`SSADH activity. Ex. 1006, 8; Pet. 9–10. Likewise, although Petitioner
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`relies upon Cagnin’s suggestion that an interaction between valproate and
`GHB may have triggered seizures in a single patient who was not part of a
`clinical trial or other controlled study (Pet. 20), Petitioner fails to address the
`ultimate conclusion in Cagnin that “[o]nly GHB discontinuation restored the
`neurotransmitter balance and caused seizures to stop.” Ex. 1008, 205
`(emphasis added). Both the Xyrem 2005 Label and Cagnin therefore both
`teach away from the co-administration of any amount of GHB with
`valproate.
`Moreover, even if the prior art did not teach away from reducing the
`effective dosage of GHB by at least 5% when valproate is co-administered,
`Petitioner has not demonstrated sufficiently that a skilled artisan would have
`had a reasonable expectation of success in treating the claimed sleep
`disorders with such a reduced dosage of GHB. Petitioner relies upon an
`“obvious to try” rationale based on prior art studies showing that valproate
`can decrease GHB metabolism. Pet. 27. We recognize that the prior art
`may have suggested to a person of ordinary skill in the art that valproate can
`increase endogenous GHB levels in the brain, and thereby intensify the
`effect of GHB. See, e.g., Ex. 1014 (Hechler); Ex. 1015 (Kaufman). Patent
`Owner, however, points to evidence of record showing that GHB is
`eliminated from the body through alternate pathways that are not inhibited
`by valproate, and these alternate elimination pathways may actually decrease
`GHB levels. Prelim. Resp. 9–12. Petitioner does not account for these other
`pathways by which GHB may be eliminated. Petitioner, therefore, has not
`identified a sufficient basis on this record to conclude that any increased
`brain levels of endogenous GHB caused by valproate could have been
`predictably compensated for by a corresponding decrease of at least 5% in
`
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`the amount of GHB orally administered to patients. See In re
`Cyclobenzaprine Hydrochloride Extended–Release Capsule Patent
`Litigation, 676 F.3d 1063, 1073 (Fed. Cir. 2012) (“[W]here the prior art, at
`best gives only general guidance as to the particular form of the claimed
`invention or how to achieve it, relying on an obvious-to-try theory to support
`an obviousness finding is impermissible.”) (citations omitted).
`Because Petitioner has not demonstrated a reasonable likelihood of
`establishing the obviousness of any of the independent claims, we also
`determine that Petitioner has not made a sufficient showing with respect to
`the corresponding dependent claims. See In re Fine, 837 F.2d 1071, 1076
`(Fed. Cir. 1988) (“Dependent claims are nonobvious under section 103 if the
`independent claims from which they depend are nonobvious.”).
`We, therefore, decline to institute an inter partes review based on
`Petitioner’s first obviousness challenge for any of claims 1–34.
`
`2. Obviousness of Claims 1–34 Based on the Xyrem 2005
`Label, Depakote 2011 Label, Cagnin, Waszkielewicz, Weiss,
`and the FDA Guidance
`Petitioner contends that claims 1–34 are obvious based on the
`combination of the Xyrem 2005 Label, the Depakote 2011 Label, Cagnin,
`Waszkielewicz, Weiss, and the FDA Guidance. Pet. 41–54. Petitioner also
`relies upon Dr. Winkelman’s Declaration in support of this challenge. Ex.
`1003.
`
`For this challenge, Petitioner additionally relies upon the teachings of
`Weiss. Petitioner argues, based on Weiss’s warning that the combination of
`GHB with antiepileptic drugs should be used with “great care,” that the
`skilled artisan would have been motivated to lower the dose of GHB when
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`co-administering valproate. Pet. 43–44. Petitioner further argues that, in
`combination with Cagnin, Weiss would have created a pattern showing that
`serious adverse events may result from co-administration of GHB and
`antiepileptic agents such as valproate due to a pharmacokinetic interaction.
`Id. at 43. Based on Weiss’s suggestion that “possible interactions should be
`evaluated in formal pharmacokinetic studies,” Petitioner asserts that the
`skilled artisan would have looked to the FDA Guidance, which provides
`instructions on how to do so. Id.
`We agree with Patent Owner’s argument that Petitioner’s reliance
`upon Weiss for this challenge does not cure the deficiencies of the other
`references. Prelim. Resp. 45–50.
`Although Weiss cautions that combinations of GHB with antiepileptic
`drugs, such as topiramate and valproate, should be used “only with great
`care,” Weiss does not purport to predict the efficacy or safety of using such a
`combination, even at reduced dosage amounts, in patients being treated for
`sleep disorders. Ex. 10101, 1193. Weiss’s statement that “possible [drug-
`drug] interactions should be evaluated in formal pharmacokinetic studies” is,
`at best, an invitation to conduct further experiments to evaluate the co-
`administration of GHB with antiepileptic drugs. We find this insufficient to
`show a likelihood of obviousness of the claimed invention. See In re
`O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988) (obviousness not established
`where “what was ‘obvious to try’ was to explore a new technology or
`general approach that seemed to be a promising field of experimentation,
`where the prior art gave only general guidance as to the particular form of
`the claimed invention or how to achieve it”).
`
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`Weiss, moreover, only discloses discontinuing co-administration of
`GHB and topiramate, not reducing the GHB dose. Weiss also does not
`equate the effects of valproate and topiramate, or suggest a class effect that
`would teach one of ordinary skill in the art to equate the drug-to-drug
`interactions of valproate and topiramate. Petitioner does not provide
`sufficient evidence for us to draw the conclusion that the interaction of GHB
`and topirimate, as reported in Weiss, would suggest reducing effective GHB
`dosing when concomitantly administering valproate to a patient.
`We, therefore, decline to institute an inter partes review based on this
`obviousness challenge.
`
`III. CONCLUSION
`For the foregoing reasons, we determine that Petitioner has not
`demonstrated that the information presented shows that there is a reasonable
`likelihood that it would prevail in proving the unpatentability of claims 1–34
`of the ’306 patent.
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that, pursuant to 35 U.S.C. § 314(a), the Petition for inter
`partes review is denied as to all challenged claims of the ’306 patent.
`
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`PETITIONER:
`Aziz Burgy
`Bradford C. Frese
`ARENT FOX LLP
`Aziz.Burgy@arentfox.com
`Bradford.Frese@arentfox.com
`
`PATENT OWNER:
`F. Dominic Cerrito
`Evangeline Shih
`Frank C. Calvosa
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`nickcerrito@quinnemanuel.com
`evangelineshih@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`John V. Biernacki
`JONES DAY
`jvbiernacki@jonesday.com
`
`
`
`17
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`