throbber
Trials@uspto.gov
`571-272-7822
`
`. Paper No. 12
`Entered: December 19, 20 14
`
`UNITED STATES·PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.,.
`Petitioner,
`
`v.
`
`RB PHARMACEUTICALS LIMITED,
`Patent Owner.
`
`Case IPR20 14-00998
`Patent 8,475,832 B2
`
`Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`and Dismissing Motion for Joinder
`37 C.FR. §§ 42.108, 42.122
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`IPR20 14-00998
`Patent 8,475,832 B2
`
`INTRODUCTION
`
`BioDelivery Sciences International, Inc. ("Petitioner") petitioned for
`
`an inter partes review of claims 15-19 of U.S. Patent No. 8,475,832 B2
`
`(Ex. 1001, ''the '832 patent"). Paper 2 ("Pet."). Petitioner also sought to
`
`join this proceeding with IPR2014-00325, an inter partes review of the same
`
`challenged claims currently pending before the Board. Paper 6. RB
`
`Pharmaceuticals Limited ("Patent Owner") timely filed a Preliminary
`
`Response. Paper 9 ("Prelim. Resp."). In addition, Patent Owner filed an
`
`Opposition to Petitioner's Motion for Joinder. Paper 10. We have
`
`jurisdiction under 35 U.S.C. § 314.
`
`For the reasons provided below, we exercise our discretion and deny
`
`the Petition under 35 U.S,C. § 325(d). Because we do not institute an inter
`
`partes review, we dismiss as moot the Motion for Joinder under 35 U.S.C.
`
`§ 315(c).
`
`Related Proceedings
`
`Parties state that Patent Owner previously asserted the '832 patent
`
`against Petitioner in Reckitt Benckiser Pharmaceuticals, Inc., v. BioDelfvery
`
`Sciences International, Inc., No. 5: 13-cv-760 (E.D.N.C.). See Pet. 3; Paper
`
`5, 3. The case was later dismissed without prejudice as premature on
`
`procedural grounds. See Pet. 3; Paper 5, 3.
`
`According to Patent Owner, Petitioner filed BioDelivery Sciences
`
`International, Inc. v. Reckitt Benckiser Pharmaceuticals, Inc., No. 14-cv-529
`
`2
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`IPR20 14-00998
`Patent 8,475,832 B2
`
`(E.D.N.C.), seeking a declaratory judgment of invalidity of the '832 patent
`claims. 1 Prelim. Resp. 1-2.
`
`Petitioner previously petitioned for review of, and the Board instituted
`
`trial on, the same challenged claims ofthe '832 patent in IPR2014-00325
`
`("the '325 IPR"), currently pending before the Board.
`
`The '832 Patent
`
`The '832 patent relates to compositions and methods for treating
`
`narcotic dependence using an orally dissolvable film comprising
`
`buprenorphine and naloxone, where the film provides a bioequivalent effect
`
`to Suboxone®. Ex. 1001, 4:55-58.
`
`Suboxone® is an orally dissolvable tablet ofbuprenorphine and
`
`naloxone. !d. at 4:51-55. Buprenorphine provides an effect of satisfYing the
`
`body's urge for narcotics, but not the "high" associated with misuse. !d. at
`
`1 :36-40. Naloxone reduces the effect and, thus, decreases the likelihood of
`
`diversion and abuse ofbuprenorphine. !d. at 1:46-52. The tablet form,
`
`however, still has the potential for abuse because it can be removed easily
`
`from the mouth for later extraction and injection ofbuprenorphine. !d. at
`
`1:55-62. The film ofthe '832 patent "provides buccal adhesion while it is in
`
`the user's mouth, rendering it difficult to remove after placement." !d. at
`
`4:58-60.
`
`1 Patent Owner does not specify when Petitioner filed the declaratory
`judgment action in the district court. We observe that, despite pointing to
`the district court case, Patent Owner does not challenge Petitioner's standing
`in this proceeding as barred under 35 U.S.C. § 315(a)(1).
`3
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`IPR20 14-00998
`Patent 8,475,832 B2
`
`The '832. patent teaches controlling the local pH to maximize the
`
`absorption of the buprenorphine while simultaneously minimizing the
`
`absorption of the naloxone. !d. at 11:28-30. According to the '832 patent,
`
`"it has been surprisingly discovered" that, at a local pH level from about 2 to
`
`about 4, and most desirably from 3 to 4, the film composition of the
`
`invention achieves bioequivalence to the Suboxone® tablet. !d. at 11 :50-61.
`
`The '832 patent defines bioequivalent as "obtaining 80% to 125% of
`
`the Cmax and AUC values for a given C).ctive in a different product." !d. at
`
`3:48-:50. According to the '832 patent, ~~cmax refers to the mean maximum
`
`plasma concentration after administration of the composition to a human
`
`subject;" and "AUC refers to the mean area under the plasma concentration(cid:173)
`
`time curve value after administration of the compositions." !d. at 3:9-14.
`
`The '832 patent discloses:
`
`[T]o be considered bioequivalent to the Suboxone® tablet, the
`Cmax of buprenorphine is between about 0.624 and 5.638, and
`the AUC of buprertorphine is between about 5.431 to about
`56.238. Similarly, to be considered bioequivalent to
`the
`Suboxone® tablet, the Cmax of naloxone is between about
`41.04 to about 323.75, and the AUC of naloxone is between
`about 102.88 to about 812.00.
`!d. at 17:41-47.
`
`Illustrative Claim
`
`Among the challenged claims, claim 15 is the sole independent claim.
`
`It reads:
`
`formulation compnsmg
`film
`15. An orally dissolving
`buprenorphine and naloxone, wherein said formulation provides
`an in vivo plasma profile having a Cmax of between about
`
`4
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`IPR20 14-00998
`Patent 8,475,832 B2
`
`0.624 ng/ml and about 5.638 ng/ml for buprenorphine and an in
`vivo plasma profile having a Cmax of between about 41.04
`pg/ml to about 323.75 pg/ml for naloxone.
`
`Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds, each of which challenges the
`
`patentability of claims 15-19:
`
`Under 35 U.S.C. § 325(d),
`
`ANALYSIS
`
`In determining whether to institute or order a proceeding under
`... chapter 31, the 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.
`Patent Owner asks us to exercise our discretion under 35 U.S.C.
`
`§ 325(d) and deny this Petition. Prelim. Resp. 20-33. Patent Owner argues
`
`2 Oksche et al., Int'l Pub. No. WO 2008/025791 A1, published on March 6,
`2008 (Ex. 10 18) ("Euro-Celtique").
`3 European Medicines Agency (EMEA) Study Report on Suboxone®
`Tablets, 2006 (Ex. 10 15) ("EMEA Study Report").
`4 Fuisz et. al., Int'l Pub. No. WO 03/030883 A1, published on April 17, 2003
`(Ex. 1031) ("the '883 Application").
`5 Yang et al., U.S. Patent No. 7,357,891 B2, issued on April15, 2008
`(Ex. 10 16) ("Yang").
`
`5
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`IPR20 14-00998
`Patent 8,475,832 B2
`
`that the Petition is redundant "because it substantially repeats the same
`
`arguments and relies substantially on the same prior art that the same
`
`Petitioner relied upon in its earlier ('325 IPR] Petition regarding the same
`
`claims of the same patent." !d. at 1. We agree.
`
`In the '325 IPR, Petitioner challenged claims 15-19 ofthe '832 patent
`
`on numerous grounds, including, among others, (1) grounds based on
`Labtec6 as the primary reference (for example, anticipation by Labtec, and
`obviousness over the combination ofLabtec, Birch,7 and Yang); and (2)
`
`grounds based on Euro-Celtique as the primary reference (including
`
`anticipation by Euro-Celtique, and obviousness over Euro-Celtique, either
`
`alone or in combination with Birch, or with Birc~ and Yang). See the '325
`
`IPR, Paper 8 ("the '325 IPR Pet."). We instituted a trial to review whether
`
`the challenged claims are anticipated by Labtec and/or rendered obvious
`
`over the combination ofLabtec, Birch, and Yang. See the '325 IPR, Paper
`
`17.
`
`In the '325 IPR, Petitioner did not explain any meaningful advantage
`
`of the Euro-Celtique-based grounds over the Labtec-based grounds. To the
`
`contrary, according to Petitioner, the Labtec-based grounds are not
`
`cumulative to the Euro-Celtique-based grounds "at least because [Labtec]
`
`explicitly 'identifies and understands the criticality of pH' to modify
`
`absorption"-a teaching that, according to Petitioner; Patent Owner "stated
`
`6 Leichs et al., Int'l Pub. No. WO 2008/040534 A2, published on April 10,
`2008 (Ex. 10 17) ("Labtec").
`7 Birch et al., U.S. Patent Pub. No. 2005/0085440 AI, published on April21,
`2005 (Ex. 10 19) ("Birch").
`
`6
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`IPR20 14-00998
`Patent 8,475,832 B2
`
`was lacking in Euro-Celtique" during the prosecution of the '832 patent.
`
`The '325 IPR Pet., 39. As a result, Vole exercised our discretion and declined
`
`to institute an inter partes review on all Euro-Celtique-based grounds. See
`
`the '325 IPR, Paper 17, 20.
`
`Nearly two months after Patent Owner filed its Preliminary Response
`
`in the '325 IPR, Petitioner filed this second Petition, challenging claims 15-
`
`19 of the '832 patent based on four grounds: obviousness over (1) Euro(cid:173)
`
`Celtique alone, (2) the combination ofEuro-Celtique and the EMEA Study
`
`. Report, (3) the combination ofEuro-Celtique, the EMEA Study Report, and
`
`the '883 Application, or (4) the combination ofEuro-Celtique, the EMEA
`
`Study Report, and Yang. Pet. 34-54. Petitioner acknowledges:
`
`This petition is directed to the same five claims of the same
`This -petition
`patent as the IPR2014-00325 proceedings;
`involves the same parties as the IPR20 14-00325 proceedings.
`The grounds in this petition are substantially based on a subset
`of the references cited in the IPR2014-00325 proceedings.
`While grounds in this petition cite two references that were not
`cited in IPR2014-00325, these two references are related to a
`reference cited in IPR2014-00325.
`Id. at 2-3.
`
`The two references allegedly not cited in the '325 IPR are the EMEA
`
`Study Report and the '883 Application. Petitioner, however, did present the
`
`EMEA Study Report in the '325 IPR Petition. See the '325 IPR Pet., iii
`
`(showing the EMEA Study Report as Ex. 1015 in the Exhibit list). In
`
`a.ddition, Petitioner specifically cited the EMEA Study Report for disclosing
`
`the Cmax and AUC values of naloxone. !d. at 28, see also id. at 40-41 ·
`
`(citing the EMEA Study Report in claim chart for unpatentability grounds
`7
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`IPR20 14-00998
`Patent 8,475,832 B2
`
`based on Labtec ), 49 (citing the EMEA Study Report in claim chart for
`
`unpatentability grounds based on Euro-Celtique). Noting Petitioner's
`
`argument, we cited the EMEA Study Report in our decision to institute the
`
`'325 IPR. See the '325 IPR, Paper 17, 14 (acknowledging Petitioner's
`
`reliance on page 12 of the EMEA Study Report). In the present case,
`
`Petitioner cites the same page of the EMEA Study Report (page 12) for the
`
`same disclosure, i.e., for disclosing "mean Cmax and AUC values for
`
`buprenorphine and naloxone following administration of Suboxone tablets
`
`that fall within the ranges recited in claims 15-17." Pet. 45.
`
`Petitioner did not cite the '883 Application in the '325 IPR petition.
`
`But, according to Petitioner, Euro-Celtique, "a primary reference in both this
`
`petition and the IPR2014-00325 petition ... repeatedly cites" the '883
`
`Application. !d. at 3; see also id. at 49 (stating that Euro-Celtique identifi.es
`
`the '883 Application as "describing 'standard technology' for preparing
`
`films"). Petitioner explains that the '883 Application is part of a family of
`
`patent applications that resulted in Yang, a U.S. patent that Petitioner relied
`
`on in the '325 IPR. !d. at 49. In its Motion for Joinder, Petitioner further
`
`states that the '883 Application "is cited for the same relevant disclosure as a
`
`related family member cited in the ['325 IPR] Petition (i.e., Yang)." Paper
`
`6, 9.
`
`Having considered the papers filed in this proceeding, as well as the
`
`papers filed in' the '325 IPR, we agree with Patent Owner that Petitioner has
`
`recycled previous art and arguments. See Prelim. Resp. 24-32. Petitioner
`
`does not provide any persuasive reasoning as to why we should institute
`
`8
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`IPR20 14-00998
`Patent 8,475,832 B2
`
`another inter partes review of the same challenged claims over "the same or
`
`substantially the same prior art or arguments" that were presented in the
`'325 IPR.8 Based on the totality of the facts before us, we exercise our
`
`discretion and deny the Petition under 35 U.S.C. § 325(d). We dismiss as
`
`moot Petitioner's Motion for Joinder with the '325 IPR.
`
`Accordingly, it is
`
`ORDER
`
`ORDERED that Petitioner's request for an inter partes review of
`
`claims 15-19 ofthe '832 patent is denied; and
`
`FURTHER ORDERED that the Motion for Joinder with Case
`
`IPR2013-00325 is dismissed.
`
`8 Petitioner contends that "[i]n addition to the recited limitations, Euro(cid:173)
`Celtique discloses features that are disclosed in the '832 patent but not
`required by the claims 15-19," such as a mucoadhesive film and a film that
`delivers active through the mucosa. Pet. 41. This argument was not
`presented in the '325 IPR. Petitioner does not, however, explain why these
`features matter to our patentability analysis, if they are not required by the
`challenged claims.
`
`9
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`IPR20 14-00998
`Patent 8,475,832 B2
`
`For PETITIONER:
`
`Danielle L. Herritt
`McCarter & English, LLP
`dherritt@mccarter.com
`
`Kia L. Freeman
`McCarter & English, LLP
`kfreeman@mccarter.com
`
`For PATENT OWNER:
`
`James M. Bollinger
`Troutman Sanders LLP
`james. bollinger@troutinansanders.com
`
`Daniel A. Ladow
`Troutman Sanders LLP
`daniel.Jadow@troutmansanders.com
`
`10
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`AO 120l_Rev. 08/101
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`Eastern District of North Carolina
`filed in the U.S. District Court
`on the following
`D Trademarks or
`IllY Patents.
`( D the patent action involves 35 U.S.C. § 292.):
`
`DOCKET NO.
`5: 14-cv-529-H
`PLAINTIFF
`
`DATE FILED
`9/20/2014
`
`U.S. DISTRICT COURT
`Eastern District of North Carolina
`DEFENDANT
`
`BioDelivery Sciences International, Inc.
`
`Reckitt Benckiser Pharmaceuticals, Inc. et al
`
`PATENTOR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`SEE ATTACHED COPY OF COMPLAINT
`
`In the above-entitled case, the following patent(s)/ trademark(s) have been included:
`
`INCLUDED BY
`
`D Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`D Answer
`
`D Cross Bill
`
`D Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`I
`
`i, 'i"7.f,g3:2_
`2 1,1111 oro
`3 a,65:1,37K
`4 7,r;).Y sf;(
`5 7;'3S7 1 gel}
`
`DATE INCLUDED
`
`PATENTOR
`TRADEMARK NO.
`71 "/.).SIJ.q~
`
`I
`
`2
`
`3
`
`4
`
`5
`
`In the above-entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`JULIE A. RICHARDS
`
`(BY) DEPUTY CLERK
`Is/ Jade Felder
`
`DATE
`
`9/22/2014
`
`Copy 1-Upon initiation of action, mail this copy to Director Copy 3-Upon termination of action, mail this copy to Director
`Copy 2-Upon filing document adding patent(s), mail this copy to Director Copy 4-Case file copy
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`Case3:14-cv-04240-JCS Document7 Filed09/19/14 Pagel of 1
`
`~ AO 120 (Rev 2/99)
`
`TO: Mail Stop 8
`Director of the U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`tl Trademarks:
`D Patents or
`filed in the U.S. District Court Northern District California on the
`
`DOCKET NO.
`CV 14-04240 JCS
`PLAINTIFF
`JACKSON FAMILY WINES, ET AL
`
`DATE FILED
`9/19/14
`
`U.S. DISTRICT COURT
`450 Golden Gate A venue l61h Floor San Francisco CA 94102
`DEFENDANT
`CONSTELLATION BRANDS, ET AL
`
`PATENTOR
`
`DATE OF PATENT
`
`HOLDER OF PATENT OR TRADEMARK
`
`1 -L, '3'f 3,.S""l3
`
`***see Attach Complaint***
`
`2
`
`3
`
`4
`
`5
`
`In the above-entitled case, the following patent(s) have been included:
`DATE INCLUDED
`INCLUDED BY
`
`D Answer
`
`D Cross Bill
`
`D Other Pleading
`
`0 Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`PATENT OR
`TRADEMARK NO.
`
`I
`
`2
`
`3
`
`4
`
`5
`
`HOLDER OF PATENT OR TRADEMARK
`
`In the above-entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Richard W. Wieking
`
`Gina Agustine
`
`September 19, 2014
`
`Copy 1-Upon initiation of action, mail this copy to Commissioner Copy 3-Upon termination of action, mail this copy to Commissioner
`Copy 2--Upon filing document adding patent(s), mail this copy to Commissioner Copy 4-Case file copy
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`Trials@uspto.gov
`571-272-7822
`
`Paper 17
`Entered: July 29, 2014
`
`UNITED STATES PATENT AND TRADEMARI<. OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
`Petitioner,
`
`v.
`
`RB PHARMACEUTICALS LIMITED,
`Patent Owner.
`
`Case IPR20 14-00325
`Patent 8,475,832 B2
`
`Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
`ZHENYU YANG, Administrative Patent Judges .
`
`. YANG, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`INTRODUCTION
`
`BioDelivery Sciences International, Inc. ("Petitioner") petitioned for
`
`an inter partes review of claims 15-19 of U.S. Patent No. 8,475,832 B2
`
`(Ex. 1001, "the '832 patent"). Paper 8 ("Pet."). RB Pharmaceuticals
`
`Limited ("Patent Owner") timely filed a Preliminary Response. Paper 15
`
`("Prelim. Resp."). We have jurisdiction under 35 U.S.C. § 314.
`
`For the reasons provided below, we determine that Petitioner has
`
`satisfied the threshold requirement set forth in 35 U.S.C. § 314(a) and
`
`established a reasonable likelihood that it would prevail in showing the
`
`unpatentability of the challenged claims. Therefore, we institute an inter
`
`partes review of claims 15-19 ofthe '832 patent.
`
`The '832 Patent
`
`The '832 patent relates to compositions and methods for treating
`
`narcotic dependence using an orally dissolvable film comprising
`
`buprenorphine and naloxone, where the film provides a bioequivalent effect
`
`to Suboxone®. Ex. 1001, 4:55-58.
`
`Suboxone® is an orally dissolvable tablet of buprenorphine and
`
`naloxone. Jd. at 4:51-55. Buprenorphine provides an effect of satisfying the
`
`body's urge for the narcotics, but not the "high" associated with misuse. Jd.
`
`at 1:36-40. Naloxone reduces the effect and, thus, decreases the likelihood
`
`of diversion and abuse ofbuprenorphine. Jd. at 1:46-52. The tablet form,
`
`however, still has the potential for abuse because it can be removed easily
`
`from the mouth for later extraction and injection ofbuprenorphine. Jd. at
`
`1:55-62. The film of the '832 patent "provides buccal adhesion while it is in
`
`2
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`the user's mouth, rendering it difficult to remove after placement." !d. at
`
`4:58-60.
`
`The '832 patent teaches controlling the local pH to maximize the
`
`absorption of the buprenorphine while simultaneously minimizing the
`
`absorption of the naloxone. !d. at 11:28-30. According to the '832 patent,
`
`"it has been surprisingly discovered" that, at a local pH level from about 2 to
`
`about 4, and most desirably from 3 to 4, the film composition of the
`
`invention achieves bioequivalence to the Suboxone® tablet. !d. at 11 :50-61.
`
`The '832 patent defines bioequivalent as "obtaining 80% to 125% of
`
`the Cmax and AUC values for a given active in a different product." !d. at
`
`3:48-50. According to the '832 patent, "Cmax refers to the mean maximum
`
`plasma concentration after administration of the composition to a human
`
`subject;" and "AUC refers to the mean area under the plasma concentration(cid:173)
`time curve value after administration of the compositions .... " .px. 1001,
`3:9-14. The '832 patent discloses:
`
`[T]o be considered bioequivalent to the Suboxone® tablet, the
`Cmax of buprenorphine is between about 0.624 and 5.638, and
`the AUC of buprenorphine is between about 5.431 to about
`56.238. Similarly, to be considered bioequivalent to
`the
`Suboxone® tablet, the Cmax of naloxone is between about
`41.04 to about 323.75, and the AUC of naloxone is between
`about 102.88 to about 812.00.
`!d. at 17:41-47.
`
`Illustrative Claim
`
`Among the challenged claims, claim 15 is the sole independent claim.
`
`It reads:
`
`3
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`formulation comprising
`film
`15. An orally dissolving
`buprenorphine and naloxone, wherein said formulation provides
`an in vivo plasma profile having a Cmax of between about
`0.624 ng/ml and about 5.638 ng/ml for buprenorphine and an in
`vivo plasma profile having a Cmax of between about 41.04
`pg/ml to about 323.75 pg/ml for naloxone.
`
`Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds, each of which challenges the
`
`patentability of claims 15-19:
`
`Suboxone Tablet
`
`Labtec
`
`1 Suboxone Tablet Label, Revised September 2006 (Ex. 1013); Yang et al.,
`U.S. Patent No. 7,357,891 B2 (Ex. 1016) ("Yang"); Leichs et al., Int'l Pub.
`No. WO 2008/040534 A2 (Ex. 10 17) ("Labtec"); Oksche et al., Int'l Pub.
`No. WO 2008/025791 AI (Ex. 1018) ("Euro-Celtique"); Birch et al., U.S.
`Patent Publication No. 2005/0085440 A1 (Ex. 1019) ("Birch").
`4
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`ANALYSIS
`
`Preliminary Matters
`
`Reitman Declaration
`
`In support of the Petition, Petitioner submits a declaration by
`
`Dr. Maureen Reitman, who testifies that the pH of Suboxone® tablets "was
`
`measured to be 3.5." Ex. 1004 ~ 5. Patent Owner asks us to disregard the
`
`Reitman Declaration because ( 1) Suboxone® tablets do not constitute prior
`
`art for an inter partes review; and (2) the Reitman Declaration fails to
`
`provide sufficient and reliable evidence. Prelim. Resp. 20-22.
`
`Patent Owner's argument is moot because we do not need to rely on
`
`Reitman Declaration at this stage of the proceeding. Petitioner, in discussing
`
`several asserted grounds, refers to pH 3-3.5 allegedly emphasized in the '832
`
`patent. See, e.g., Pet. 36 (asserting that "[t]o the extent the pH range of
`
`about 3 to about 3.5 is read into the challenged claims, the use of that pH
`
`range was already described and obvious in view of Birch"). As Patent
`
`Owner points out, however, "pH is not recited in the challenged claims."
`
`Prelim. Resp. 5. Thus, for purposes of this Decision, we do not address
`
`Petitioner's argument or the Reitman Declaration discussing the pH of
`
`Suboxone® tablets.
`
`Lack of expert testimony on claim construction
`
`,
`
`Patent Owner faults Petitioner for presenting no expert testimony on
`
`how one of ordinary skill in the art would understand the term "film
`
`formulation." Prelim. Resp. 12. As explained below, in this case,
`
`disclosures in the Specification provide sufficient guidance for claim
`
`5
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`construction: Thus, given the record before us, the absence of expert
`
`testimony on claim construction is inconsequential. Patent Owner also
`
`criticizes Petitioner for only relying on attorney argument. Prelim. Resp. 12.
`
`We, however, are satisfied that evidence of record, as supplied by both
`
`parties, is sufficient to allow us to construe claim terms for purposes of this
`
`Decision.
`
`Lack of expert testimony on anticipation and obviousness
`
`To support the Petition, Petitioner submits. two expert declarations:
`
`Reitman Declaration addressing the pH of Suboxone® tablets (Ex. 1004 ),
`
`and a declaration by Dr. Philip T. Lavin discussing certain data in the '832
`
`patent (Ex. 1 005). Patent Owner urges us to deny the Petition for the sole
`
`reason that neither declaration presents direct analysis on anticipation or
`
`obviousness. Prelim. Resp. 4-5; see also id. at 33-37. We decline to do so.
`
`Patent Owner is correct· that "[t]he Board expects that most petitions
`
`and motions will rely upon affidavits of experts." Prelim. Resp. 4 (quoting
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,763 (Aug. 14,
`
`2012)). Especially in complex cases where obviousness is asserted as a
`
`ground ofunpatentability, "expert testimony may be critical, for example, to
`
`establish the existence of certain features in the prior art or the existence (or
`
`lack thereof) of a motivation to combine references." Wyers v. Master Lock
`
`Co., 616 F.3d 1231, 1240 n.5 (Fed. Cir. 2010) (citations omitted). But
`
`expert testimony is not a per se requirement-where the technology is
`
`simple, where the references are easily understandable without the need for
`
`expert explanatory testimony, or where the factual inquiries underlying the
`
`6
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`obviousness determination are not in material dispute, expert testimony,
`
`though it might be helpful, may not be indispensable. Allergan, Inc. v. Barr
`
`Labs., Inc., 501 F. App'x 965, 972 (Fed. Cir. 2013). In addition, a reason to
`
`combine prior art teachings may·exist "in the content of the public prior art,
`
`in the nature of the problem addressed by the invention, or even in the
`
`knowledge of one of ordinary skill in the art." Princeton Biochemicals Inc.
`
`v. Beckman Coulter Inc., 411 F.3d 1332, 1338M39 (Fed. Cir. 2005). And in
`
`some cases, "the legal determination of obviousness may include recourse to
`
`logic, judgment, and common sense, in lieu of expert testimony." Wyers,
`
`616 F.3d at 1239. Therefore, we reject a bright-line rule requiring expert
`
`test~mony analyzing unpatentability for all petitions for inter partes review.
`
`At this stage of the proceedings, Petitioner has provided sufficient
`
`evidence and we understand the prior art disclosures and a possible
`
`reasoning to modify or combine the references without guidance of an
`
`expert.
`
`Claim Construction
`
`In an inter partes review, t~e Board interprets a claim term in an
`
`unexpired patent according to its broadest reasonable construction in light of
`
`the specification ofthe patent in which it appears. 37 C.F.R. § 42.100(b).
`
`Under that standard, we assign claim terms their ordinary and customary
`
`meaning, as understood by a person of ordinary skill in the art, in the context
`
`of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
`
`1257 (Fed. Cir. 2007).
`
`7
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`Petitioner asks us to construe the terms "film formulation" and
`
`"provides an in vivo plasma profile" recited in independent claim 15. The
`
`parties propose the following constructions:
`
`~--~;~~~ --· J~ci~ --
`
`WI~'~
`t.
`combination of components
`film composition or dosage
`capable of being used to
`prepare a single film
`results in an in vivo plasma
`profile after a resulting film is
`administered to a human
`subject
`
`film formulation
`
`~ ~~...:!.. .. ~~--
`
`provides an in vivo No construction needed
`plasma profile
`
`Prelim. Resp. 11; see also Pet. 22.
`
`We address each term in turn.
`
`"Film formulation"
`Both parties argue that the Specification and prosecution history of the
`
`'832_ patent, as well as dictionary definitions support their respective
`
`proposed claim constructions. Pet. 15-19; Prelim. Resp. 10-19.
`
`According to Petitioner, during the prosecution of the '832 patent,
`
`Applicant admitted that "[ d]elivery of compounds such as
`buprenorphine and naloxone was previously known, however,
`the previously-accepted form of the delivery is in the form of a
`. tablet (e.g., a Suboxone® tablet)." Applicant explained: "The
`present invention is directed to formulation of a suitable film
`product that provides a certain release profile."
`Pet. 16 (citations omitted, emphasis added by Petitioner). Based on this,
`
`Petitioner concludes that "Applicant distinguished a film formulation from a
`
`resulting film product that provides a release profile." ld. In other words,
`
`8
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`Petitioner contends th.at "film formulation" does not require a film, but
`
`broadly encompasses a combination of components that are capable of
`
`forming a single film, even if such components are not in the form of a film.
`
`!d. at 15, 22.
`
`Patent Owner points out that Petitioner emphasizes and relies on
`
`misquoted language from-the prosecution history. Prelim. Resp. 12-13.
`
`Patent Owner contends that it explained the invention as directed to the
`
`"formation of a suitable film product." Id. at 13 (quoting Ex. 1007,7
`
`(emphasis added)). Patent Owner persuades us that the.quotes from the
`
`prosecution history do not support Petitioner's position.
`
`In addition, Petitioner, citing two sentences from two U.S. patents
`
`incorporated into the '832 patent by reference, asserts that "the specification
`
`[of the '832 patent] distinguishes a film formulation from a resulting film
`
`product." Pet. 16-17. The '83 2 patent incorporates the two U.S. patents by
`
`reference, however, to exemplify suitable processes to form the film
`
`compositions. Ex. 1001, 15:29-32. An isolated sentence from each of those
`
`two patents does not persuade us to read "film" out of the term "film
`
`formulation," as Petitioner suggests.
`
`Nor do we find the rest of the Specification to support Petitioner's
`
`construction. Petitioner directs our attention to Table 5 of the '832 patent,
`
`entitled "Formulations of Test Films .... " Pet. 17 (citing Ex. 1001, 18:44-
`
`67). According to Petitioner, each of the three formulations listed in Table 5
`
`"consists of a combination of components used in the preparation of a test
`
`film." Jd. Petitioner contends that thi's table, together with excerpts
`
`9
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`referencing information in this table, provides the context to .support its
`
`construction. Id.
`
`We disagree. First, we construe the term "film formulation," not
`
`"formulation." In the context of the Specification, the use of the word
`
`"formulation" alone does not inform the meaning of "film formulation."
`
`More importantly, the two paragraphs preceding Table 5 support Patent
`
`Owner's position that the term "film formulation" is synonymous with "film
`
`product, film composition, or film dosage." Prelim. Resp. 10. Indeed, the
`
`_ Specification explains:
`
`Film dosages were prepared for use in an in vivo study to
`determine the bioavailability ofbuprenorphine/naloxone tablets
`and film formulations. Specifically, the films were tested to
`determine whether ·the film provides a bioequivalent effect to
`that of a tablet formulation.
`Three film formulations including 8 mg buprenorphine and 2
`mg naloxone were prepared, each being buffered to a different
`pH. The first film did not include any buffer, providing a _local
`pH of about 6.5. The second was buffered to a local pH level of
`about 3-3.5. The third was buffered to a local pH value of about
`5-5.5. The formulations are set forth in Table 5 below.
`Ex. 1001, 18:30-42 (emphases added). Other passages in the Specification
`
`provide additional examples:
`
`This demonstrates that even less absorption of the naloxone
`occurs for the film formulation at a local pH of 3.5 than the
`tablet formulation. Given the goal of reducing the absorption
`of naloxone, it appears that the film product ... provides even
`better results than the Suboxone® tablet formulation.
`!d. at 23:49-55 (emphases added). The juxtaposition of "tablets" and "film
`
`formulations," the comparison of "film," "film formulation," and "film
`
`product" with "tablet formulation," as well as the reference to the first of the
`10
`
`TEVA EXHIBIT 1002
`TEVA PHARMACEUTICALS USA, INC. V. RB PHARMACEUTICALS LTD.
`
`

`
`"three film formulation

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