throbber
Trials@uspto.gov
`571.272.7822
`
`
`
`
` Paper No. 23
` Entered: October 4, 2018
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INDIVIOR INC.,
`Petitioner,
`
`v.
`
`RHODES PHARMACEUTICALS L.P.,
`Patent Owner.
`____________
`
`Case IPR2018-00795
`Patent 9,370,512 B2
`____________
`
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`

`

`IPR2018-00795
`Patent 9,370,512 B2
`
`
`
`I. INTRODUCTION
`Indivior Inc. (“Petitioner”) filed a Petition requesting an inter partes
`review of claims 1–24 of U.S. Patent No. 9,370,512 B2 (Ex. 1001, “the ’512
`patent”). Paper 1 (“Pet.”). Rhodes Pharmaceuticals L.P. (“Patent Owner”)
`filed a Preliminary Response to the Petition. Paper 17 (“Prelim. Resp.”).
`With our authorization, Petitioner filed a Reply to the Preliminary Response
`(Paper 20), and Patent Owner filed a Surreply (“Surreply,” Paper 22).
`We have authority 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.” 35 U.S.C. § 314(a). Upon considering
`the arguments and evidence, we determine that it is appropriate to exercise
`our discretion to deny institution under 35 U.S.C. § 325(d). Accordingly, we
`decline to institute an inter partes review of the challenged claims of
`the ’512 patent.
`
`Related Proceedings
`A.
`Patent Owner has asserted the ’512 patent against Petitioner in a
`pending lawsuit, Rhodes Pharmaceuticals L.P. v. Indivior Inc., Case No. 1-
`16-cv-01308 (D. Del.). Pet. 3; Paper 4, 2.
`Patent Owner has also identified several patents and applications that
`are related by priority to the ’512 patent, but “does not concede that any of
`the above-identified patents or applications would affect, or be affected by, a
`decision” in this proceeding. Paper 4, 1.
`The ’512 Patent
`B.
`The ’512 patent relates to oral pharmaceutical dosage forms
`comprising buprenorphine that release buprenorphine instantly upon oral
`application of the dosage form. Ex. 1001, 1:4–7. Buprenorphine
`
`1
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`preparations are administered in drug substitution programs to treat
`opioid addiction. Id. at 1:61–63. According to the specification,
`buprenorphine is administered in the form of a tablet for sublingual
`administration. Id. Drug addicts, however, sometimes attempt to divert
`the tablets by removing them from the mouth when the supervising
`healthcare professional is not looking. Id. at 2:4–7. The tablets may then
`be sold or the buprenorphine may be extracted to administer it
`parenterally. Id. at 2:7–9.
`The ’512 patent specification notes the drug Suboxone, which is
`approved in the United States, is also aimed at preventing the possibility
`of abuse. Id. at 2:10–12. Suboxone comprises buprenorphine and the
`opioid antagonist naloxone. Id. at 2:13–15. The naloxone is intended to
`prevent parenteral abuse of buprenorphine, as naloxone causes serious
`withdrawal symptoms when co-administered parenterally with
`buprenorphine. Id. at 2:15–18.
`Accordingly, the specification states it is an object of the invention
`to provide an oral dosage form of buprenorphine “that is less prone to
`diversion and/or abuse in drug substitution therapy.” Id. at 2:31–34.
`Thus, in one embodiment, the invention relates to a dosage form that
`releases buprenorphine instantly upon oral, preferably sublingual,
`application of the dosage form. Id. at 2:38–43.
`Illustrative Claim
`C.
`Petitioner challenges claims 1–24 of the ’512 patent, of which claims
`1 and 19 are the only independent claims. Claim 1 is representative and is
`reproduced below:
`1. A method of opioid substitution therapy for
`treating opioid addiction, the method comprising
`contacting the sublingual mucosa of a patient in need
`
`2
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`thereof with a sublingual film dosage form
`comprising:
`a) approximately 0.1 mg to approximately 16 mg
`buprenorphine, or an equivalent amount of a
`pharmaceutically acceptable salt thereof;
`b) naloxone or a pharmaceutically acceptable salt
`thereof; and
`c) at least one non-gelatin polymeric film-forming
`material in which the buprenorphine or the
`equivalent amount of the pharmaceutically
`acceptable salt thereof and the naloxone or the
`pharmaceutically acceptable salt thereof, are
`dissolved or homogeneously dispersed;
`the buprenorphine or the equivalent amount of the
`pharmaceutically acceptable salt thereof and the
`naloxone or the pharmaceutically acceptable salt
`thereof being present in the sublingual film dosage
`form in a weight ratio of from 1:1 to 10:1;
`such that within less than 5 minutes after contacting
`the sublingual mucosa of the patient with the
`sublingual film dosage form, the buprenorphine or
`the pharmaceutically acceptable salt thereof and
`approximately substantially all of the naloxone or
`the pharmaceutically acceptable salt thereof
`contact the sublingual mucosa, and wherein said
`contacting achieves:
`(i) an average buprenorphine AUC0-48 from
`approximately 10 to approximately 15
`(hrs*ng)/ml when the sublingual film dosage
`form includes 4 mg buprenorphine or an
`equivalent amount of a pharmaceutically
`acceptable salt thereof;
`(ii) an average buprenorphine AUC0-48 from
`approximately 15 to approximately 25
`(hrs*ng)/ml when the sublingual film dosage
`
`3
`
`

`

`
`
`Claim(s) challenged
`1–5 and 7–24
`
`IPR2018-00795
`Patent 9,370,512 B2
`form includes 8 mg buprenorphine or an
`equivalent amount of a pharmaceutically
`acceptable salt thereof, or
`(iii) an average buprenorphine AUC0-48 from
`approximately 25 to approximately 40
`(hrs*ng)/ml when the sublingual film dosage
`form includes 16 mg buprenorphine or an
`equivalent amount of a pharmaceutically
`acceptable salt thereof.
`Ex. 1001, 11:39–12:14.
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–24 of the ’512
`patent on the following grounds:
`References
`Cremer1 and Suboxone PDR2
`in view of Fuisz3 and/or
`Rademacher4
`Cremer, Suboxone PDR, and
`McAleer5 in view of Fuisz
`and/or Rademacher
`
`
`Basis
`§ 103
`
`§ 103
`
`6
`
`
`1 Cremer et al., AU 741362, published July 15, 1998 (“Cremer,” Ex. 1004).
`2 Entry for Suboxone in PHYSICIANS’ DESK REFERENCE 2866–69 (58th ed.,
`2004) (“Suboxone PDR,” Ex. 1005).
`3 Fuisz et al., WO 03/030883 A1, published Apr. 17, 2003 (“Fuisz,”
`Ex. 1007).
`4 Rademacher et al., US 2005/0163830 A1, published July 28, 2005
`(“Rademacher,” Ex. 1009).
`5 McAleer et al., Pharmacokinetics of High-Dose Buprenorphine Following
`Single Administration of Sublingual Tablet Formulations in Opioid Naïve
`Healthy Male Volunteers Under a Naltrexone Block, 72 DRUG AND
`ALCOHOL DEPENDENCE 75–83 (2003) (“McAleer,” Ex. 1013).
`4
`
`

`

`IPR2018-00795
`Patent 9,370,512 B2
`Petitioner also relies on the Declaration of Rodolfo Pinal, Ph.D.
`Ex. 1006.
`
`
`
`II. ANALYSIS
`Institution of inter partes review is discretionary. See Harmonic Inc.
`v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (explaining “the
`PTO is permitted, but never compelled, to institute an IPR proceeding”). In
`particular, § 325(d) states “[i]n determining whether to institute or order a
`proceeding under this chapter . . . [t]he Director may take into account
`whether, and reject the petition or request because, the same or substantially
`the same prior art or arguments previously were presented to the Office.”
`In evaluating whether the same or substantially the same prior art or
`arguments were previously presented to the Office under § 325(d), the Board
`has considered a number of non-exclusive factors, including, for example:
`(a) the similarities and material differences between the asserted
`art and the prior art involved during examination;
`(b) the cumulative nature of the asserted art and the prior art
`evaluated during examination;
`(c) the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis
`for rejection;
`(d) the extent of the overlap between the arguments made
`during examination and the manner in which Petitioner
`relies on the prior art or Patent Owner distinguished the
`prior art;
`(e) whether Petitioner has pointed out sufficiently how the
`Examiner erred in its consideration of the asserted prior art;
`and
`(f) the extent to which additional evidence and facts presented
`in the Petition warrant reconsideration of the asserted prior
`art or arguments.
`
`5
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586,
`slip op. 17–18 (PTAB Dec. 15, 2017) (Paper 8) (Informative) (“the Becton
`Dickinson factors”).
`Prosecution History of the ’512 Patent
`A.
`The ’512 patent issued from U.S. Patent Application No. 14/800,270
`(“the ’512 patent application”), which claims priority to U.S. Patent
`Application No. 12/439,410 (“the parent application”), which issued as U.S.
`Patent No. 9,101,625 (“the ’625 patent” or “the parent patent”). Examiner
`Craig D. Ricci was the primary examiner for both applications. Ex. 1002,
`80; Ex. 1003, 1.
`During prosecution of the parent application, the examiner rejected
`the claims as anticipated over the English-translated abstract of
`WO 1998/26780 (“Cremer PCT”). Ex. 1003, 142. The rest of the
`specification of Cremer PCT is published in German. See id. at 146–60. In
`response, the applicants noted that Cremer PCT “issued in Australia as
`Patent No. 741362.” Id. at 127. Australian Patent No. 741362 and Cremer,
`relied upon by Petitioner in this proceeding, are the same reference. Prelim.
`Resp. 7 n.1.
`The examiner maintained the § 102 rejection over Cremer PCT in a
`final office action. Id. at 117. On October 22, 2012, the applicants filed an
`amendment after final that further addressed the examiner’s rejection over
`Cremer PCT. Id. at 90–104. In the remarks, the applicants referred the
`examiner to “Canadian application CA 2 274 910” (“Cremer CA”), which
`was previously cited in an Information Disclosure Statement (“IDS”). Id. at
`98; Ex. 2008, 9. In that same IDS, the applicants also cited Fuisz as “FP19”
`and Rademacher as “US6.” Ex. 2008, 8.
`
`6
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`Relying on the disclosure of Cremer CA, the applicants argued that
`Cremer does not disclose “a pharmaceutical dosage form, which comprises a
`matrix, which is formed from at least one matrix-forming polymer, in which
`buprenorphine is dissolved or homogeneously dispersed.” Ex. 1003, 100.
`The applicants further asserted that the claims would not be obvious over
`Cremer. Id. at 101–03. On December 28, 2012, the examiner issued an
`Advisory Action, stating “THE REPLY FILED 22 October 2012 FAILS TO
`PLACE THIS APPLICATION IN CONDITION FOR ALLOWANCE.” Id.
`at 87. Accordingly, the applicants filed a request for continued examination
`(“RCE”) and a supplemental amendment that stated the examiner’s rejection
`over Cremer PCT was moot in light of the claim amendments. Id. at 75–84.
`The examiner then rejected the claims as anticipated by the Suboxone
`Package Insert. Id. at 68–71. The Suboxone Package Insert is substantively
`identical to Suboxone PDR, asserted by Petitioner in this proceeding.
`Compare Ex. 2003 with Ex. 1005. After the applicants’ response, the
`examiner entered a final rejection, rejecting the claims as obvious over the
`Suboxone Package Insert in view of certain other references. Ex. 1003, 46–
`54. The applicants then filed another RCE, amended the claims, and
`traversed the examiner’s rejections. Id. at 34–44. Following an examiner’s
`amendment, the examiner allowed the claims of the parent patent on June
`18, 2015. Id. at 6–9.
`The applicants filed the ’512 patent application on July 15, 2015. On
`August 19, 2015, the applicants filed an IDS, listing Cremer CA as “FP2”
`(Ex. 1002, 58), Cremer PCT as “FP52” (id. at 64), Fuisz as “FP34” (id. at
`62), and Rademacher as “US80” (id. at 57). The applicants also referred the
`examiner to the prosecution of the parent application and included several of
`the office actions in the IDS. Id. at 123–24. The examiner considered each
`
`7
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`of the references except Cremer PCT, which was not in English. Id. at 189–
`94. The examiner rejected the claims as obvious over Suboxone Package
`Insert and certain other references. Id. at 176–81. The applicants traversed
`the rejection and the examiner issued a notice of allowance on June 24,
`2016. Id. at 223–37, 270.
`Application of Our Discretion Under 35 U.S.C. § 325(d)
`B.
`We address the Becton Dickinson factors to evaluate whether to
`exercise our discretion under § 325(d). Having considered the parties’
`respective arguments and evidence, we determine that exercising our
`discretion is appropriate under the facts and circumstances of this case.
`Factors (a)–(d)
`1.
`Becton Dickinson factors (a)–(d) relate to whether and to what extent
`the prior art asserted in the Petition was considered and relied upon by the
`examiner during prosecution. Petitioner asserts that claims 1–5 and 7–24 of
`the ’512 patent are unpatentable over Cremer in view of Suboxone PDR and
`Fuisz and/or Rademacher. Petitioner also asserts claim 6 is unpatentable
`over Cremer in view of Suboxone PDR, McAleer, and Fuisz and/or
`Rademacher.
`Having considered the prosecution history, we find the examiner was
`aware of each of these references, except McAleer, during prosecution of the
`’512 patent application or the parent application (which was cited during
`prosecution of the ’512 patent application). The applicants noted during
`prosecution of the parent application that Cremer PCT “issued in Australia
`as Patent No. 741362,” which is the same Cremer reference asserted by
`Petitioner in the Petition. Ex. 1003, 127. Moreover, as explained above,
`Suboxone PDR is substantively identical to the Suboxone Package Insert,
`which the examiner relied on during prosecution of both the ’512 patent
`
`8
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`application and the parent application. Compare Ex. 2003 with Ex. 1005.
`Finally, Fuisz and Rademacher were both submitted to the examiner in an
`IDS, and the examiner indicated he considered both references. See
`Ex. 1002, 189, 194. Fuisz is also cited in the ’512 patent specification.
`Ex. 1001, 7:5–7 (“The films are prepared according to standard technology
`and the active agents are displaced thereon and therein as described in WO
`03/030883 [Fuisz].”). Thus, the examiner was aware of each of the
`references asserted by Petitioner, except McAleer, which was not cited
`during prosecution.
`We are persuaded, however, that McAleer is cumulative of prior art
`that the examiner relied on during prosecution. As Patent Owner asserts,
`Petitioner relies on McAleer solely for the T max limitation of claim 6.
`Prelim. Resp. 27 (citing Pet. 66–67). During prosecution, the examiner
`relied on Karch’s6 disclosure that Suboxone sublingual tablets provided a
`“T max from 0.5 to 3 hours.” Ex. 1002, 114. Petitioner relies on McAleer as
`disclosing an average T max of 60 minutes for Suboxone tablets. Pet. 66.
`Thus, we find McAleer’s disclosure is cumulative of Karch, which was
`already considered and relied on by the examiner during prosecution.
`The two main references relied on by Petitioner are Cremer and
`Suboxone PDR.7 It is indisputable that the examiner relied heavily on
`Suboxone PDR (via the Suboxone Package Insert) to reject the claims
`repeatedly during prosecution of both the ’512 patent application and the
`
`
`6 Steven B. Karch, Karch’s Pathology of Drug Abuse (4th ed. 2009)
`(“Karch,” Ex. 2004).
`7 In fact, Cremer and Suboxone PDR may be the only references relied on by
`Petitioner, as Petitioner asserts Fuisz and/or Rademacher in the alternative to
`Cremer. Pet. 49, 51, 64, 65.
`
`9
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`parent application. See supra. Thus, it is clear the examiner was well aware
`of and substantively considered Suboxone PDR.
`Whether the examiner substantively considered Cremer, on the other
`hand, is less clear. After reviewing the prosecution history as a whole,
`however, we are persuaded that the examiner did. For example, the
`examiner expressly relied on the English abstract of Cremer PCT as the
`basis for various anticipation rejections of the parent application’s claims.
`See supra. In response, the applicants pointed the examiner to the
`Australian patent, which is the same Cremer reference that Petitioner relies
`on. Ex. 1003, 127. If the examiner did not consider Cremer at that time, it
`is reasonable to infer that he considered the Canadian counterpart of Cremer,
`which was cited (and considered) in an IDS (Ex. 2008, 9), and which was
`discussed in detail in the applicants’ October 22, 2012, response after final
`office action (Ex. 1003, 98–103). As Patent Owner notes, Cremer CA is
`substantially similar to Cremer. Prelim. Resp. 26 (citing Ex. 2005).
`Petitioner suggests that the examiner did not consider the After Final
`amendment because the amendment was not entered. Reply 2. But we note
`that the Advisory Action entered by the examiner on December 28, 2012,
`states, “THE REPLY FILED 22 October 2012 FAILS TO PLACE THIS
`APPLICATION IN CONDITION FOR ALLOWANCE.” Ex. 1003, 87. In
`light of that statement, we infer that the examiner considered the applicants’
`response, including the extensive discussion of Cremer CA and whether it
`teaches a matrix of buprenorphine that is “dissolved or homogeneously
`dispersed.” Id. at 100. We also agree that it is telling that, after that
`response, the examiner did not rely on Cremer PCT or any other Cremer
`reference to reject the claims of either the parent application or the ’512
`
`10
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`patent application, despite the fact that the “dissolved or homogeneously
`dispersed” limitation appeared in the claims.
`Thus, we are persuaded that the examiner substantively considered
`and relied upon Cremer and Suboxone PDR—the main references Petitioner
`relies upon in the Petition—during prosecution of the ’512 patent application
`and its parent. We are also persuaded that the examiner was aware of the
`disclosure of McAleer, which was cumulative of Karch, and Fuisz, which is
`cited in the ’512 patent specification (see Ex. 1001, 7:5–7). Accordingly, we
`are persuaded that Becton Dickinson Factors (a) through (d) weigh in favor
`of exercising our discretion under § 325(d).
`Factors (e) and (f)
`2.
` Factors (e) and (f) look to the Petition and whether Petitioner has
`made a case for reconsidering the asserted prior art. We find that Petitioner
`has not.
`Petitioner asserts that the Petition “applies [the references] in a new
`light, through arguments not previously presented to the Patent Office, and
`with support of expert opinion from Dr. Rodolfo Pinal.” Pet. 43. Petitioner
`also claims Cremer PCT “was not presented to the Examiner in English but
`instead was submitted only as a German-language original, without
`translation, and as part of an IDS including over 200 references.” Id.
`Petitioner also asserts that the examiner’s rejections over Cremer PCT “were
`limited to a legal theory different from that presented here” (i.e.,
`anticipation). Pet. 44.
`We are not persuaded. Given the applicants’ disclosure of Cremer
`itself and Cremer CA during prosecution of the parent application, we
`question Petitioner’s argument that the examiner was not aware of the
`English language counterpart of Cremer PCT. Moreover, § 325(d) only
`
`11
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`requires that the “same or substantially the same prior art or arguments
`previously were presented to the Office.” Thus, that the examiner only
`relied on Cremer PCT for anticipation purposes does not preclude exercising
`our discretion under § 325(d). Regardless, we note the applicants addressed
`the obviousness of the claims over Cremer PCT and Cremer CA, even
`though the examiner did not reject the claims as such. Ex. 1003, 100–03.
`Although Petitioner has offered the testimony of Dr. Pinal, which was
`not considered by the examiner, we are not persuaded that that information
`is sufficient to reconsider substantially the same art that was before the
`examiner during prosecution, particularly in light of the other Becton
`Dickinson factors that weigh in favor of exercising our discretion.
`Thus, under the facts and circumstances of this case, we find that
`substantially the same prior art was previously presented to the Office and
`that exercising our discretion under § 325(d) to deny institution is
`appropriate.
`
`III. CONCLUSION
`For the foregoing reasons, we exercise our discretion under 35 U.S.C.
`§ 325(d) and decline to institute an inter partes review of the ’512 patent
`claims.
`
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’512 patent and no trial is instituted.
`
`
`12
`
`

`

`
`
`IPR2018-00795
`Patent 9,370,512 B2
`
`
`PETITIONER:
`Carol Pitzel Cruz
`Christie R.W. Matthaei
`William R. Zimmerman
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2CMP@knobbe.com
`2CRW@knobbe.com
`2WRZ@knobbe.com
`BoxIndivior@knobbe.com
`
`
`PATENT OWNER:
`Eldora L. Ellison
`Neil P. Shull
`Joshua G. McCoy
`Matthew S. Bodenstein
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`eellison-PTAB@sternekessler.com
`nshull-PTAB@sternekessler.com
`jmccoy-PTAB@sternekessler.com
`mbodenstein-PTAB@sternekessler.com
`
`
`13
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket