Trials@uspto.gov
`571-272-7822
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`Paper 17
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`Entered: July 29, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
`Petitioner,
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`v.
`
`RB PHARMACEUTICALS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2014-00325
`Patent 8,475,832 B2
`____________
`
`
`Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
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`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`571-272-7822
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`Paper 17
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`Entered: July 29, 2014
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`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 IPR2014-00325
`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
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`INTRODUCTION
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`BioDelivery Sciences International, Inc. (“Petitioner”) petitioned for
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`an inter partes review of claims 15-19 of U.S. Patent No. 8,475,832 B2
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`(Ex. 1001, “the ’832 patent”). Paper 8 (“Pet.”). RB Pharmaceuticals
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`Limited (“Patent Owner”) timely filed a Preliminary Response. Paper 15
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`(“Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314.
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`For the reasons provided below, we determine that Petitioner has
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`satisfied the threshold requirement set forth in 35 U.S.C. § 314(a) and
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`established a reasonable likelihood that it would prevail in showing the
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`unpatentability of the challenged claims. Therefore, we institute an inter
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`partes review of claims 15-19 of the ’832 patent.
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`The ’832 Patent
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`The ’832 patent relates to compositions and methods for treating
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`narcotic dependence using an orally dissolvable film comprising
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`buprenorphine and naloxone, where the film provides a bioequivalent effect
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`to Suboxone®. Ex. 1001, 4:55-58.
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`Suboxone® is an orally dissolvable tablet of buprenorphine and
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`naloxone. Id. at 4:51-55. Buprenorphine provides an effect of satisfying the
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`body’s urge for the narcotics, but not the “high” associated with misuse. Id.
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`at 1:36-40. Naloxone reduces the effect and, thus, decreases the likelihood
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`of diversion and abuse of buprenorphine. Id. at 1:46-52. The tablet form,
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`however, still has the potential for abuse because it can be removed easily
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`from the mouth for later extraction and injection of buprenorphine. Id. at
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`1:55-62. The film of the ’832 patent “provides buccal adhesion while it is in
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`the user’s mouth, rendering it difficult to remove after placement.” Id. at
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`4:58-60.
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`The ’832 patent teaches controlling the local pH to maximize the
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`absorption of the buprenorphine while simultaneously minimizing the
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`absorption of the naloxone. Id. at 11:28-30. According to the ’832 patent,
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`“it has been surprisingly discovered” that, at a local pH level from about 2 to
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`about 4, and most desirably from 3 to 4, the film composition of the
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`invention achieves bioequivalence to the Suboxone® tablet. Id. at 11:50-61.
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`The ’832 patent defines bioequivalent as “obtaining 80% to 125% of
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`the Cmax and AUC values for a given active in a different product.” Id. at
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`3:48-50. According to the ’832 patent, “Cmax refers to the mean maximum
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`plasma concentration after administration of the composition to a human
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`subject;” and “AUC refers to the mean area under the plasma concentration-
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`time curve value after administration of the compositions . . . .” Ex. 1001,
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`3:9-14. The ’832 patent discloses:
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`[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.
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`Id. at 17:41-47.
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`Illustrative Claim
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`Among the challenged claims, claim 15 is the sole independent claim.
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`It reads:
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`3
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`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.
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`Asserted Grounds of Unpatentability
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`Petitioner asserts the following grounds, each of which challenges the
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`patentability of claims 15-19:
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`Basis
`§ 102(b)
`§ 103
`§ 103
`§ 103
`§ 102(b)
`§ 103
`§ 103
`§ 103
`§ 102(b)
`§ 103
`§ 103
`§ 103
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`Reference(s)1
`Suboxone Tablet Label
`Suboxone Tablet Label
`Suboxone Tablet Label and Yang
`Suboxone Tablet Label, Yang, and Birch
`Labtec
`Labtec
`Labtec and Birch
`Labtec, Birch, and Yang
`Euro-Celtique
`Euro-Celtique
`Euro-Celtique and Birch
`Euro-Celtique, Birch, and Yang
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`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. 1017) (“Labtec”); Oksche et al., Int’l Pub.
`No. WO 2008/025791 A1 (Ex. 1018) (“Euro-Celtique”); Birch et al., U.S.
`Patent Publication No. 2005/0085440 A1 (Ex. 1019) (“Birch”).
`4
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`ANALYSIS
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`Preliminary Matters
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`Reitman Declaration
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`In support of the Petition, Petitioner submits a declaration by
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`Dr. Maureen Reitman, who testifies that the pH of Suboxone® tablets “was
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`measured to be 3.5.” Ex. 1004 ¶ 5. Patent Owner asks us to disregard the
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`Reitman Declaration because (1) Suboxone® tablets do not constitute prior
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`art for an inter partes review; and (2) the Reitman Declaration fails to
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`provide sufficient and reliable evidence. Prelim. Resp. 20-22.
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`Patent Owner’s argument is moot because we do not need to rely on
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`Reitman Declaration at this stage of the proceeding. Petitioner, in discussing
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`several asserted grounds, refers to pH 3-3.5 allegedly emphasized in the ’832
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`patent. See, e.g., Pet. 36 (asserting that “[t]o the extent the pH range of
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`about 3 to about 3.5 is read into the challenged claims, the use of that pH
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`range was already described and obvious in view of Birch”). As Patent
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`Owner points out, however, “pH is not recited in the challenged claims.”
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`Prelim. Resp. 5. Thus, for purposes of this Decision, we do not address
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`Petitioner’s argument or the Reitman Declaration discussing the pH of
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`Suboxone® tablets.
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`Lack of expert testimony on claim construction
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`Patent Owner faults Petitioner for presenting no expert testimony on
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`how one of ordinary skill in the art would understand the term “film
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`formulation.” Prelim. Resp. 12. As explained below, in this case,
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`disclosures in the Specification provide sufficient guidance for claim
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`construction. Thus, given the record before us, the absence of expert
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`testimony on claim construction is inconsequential. Patent Owner also
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`criticizes Petitioner for only relying on attorney argument. Prelim. Resp. 12.
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`We, however, are satisfied that evidence of record, as supplied by both
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`parties, is sufficient to allow us to construe claim terms for purposes of this
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`Decision.
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`Lack of expert testimony on anticipation and obviousness
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`To support the Petition, Petitioner submits two expert declarations:
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`Reitman Declaration addressing the pH of Suboxone® tablets (Ex. 1004),
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`and a declaration by Dr. Philip T. Lavin discussing certain data in the ’832
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`patent (Ex. 1005). Patent Owner urges us to deny the Petition for the sole
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`reason that neither declaration presents direct analysis on anticipation or
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`obviousness. Prelim. Resp. 4-5; see also id. at 33-37. We decline to do so.
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`Patent Owner is correct that “[t]he Board expects that most petitions
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`and motions will rely upon affidavits of experts.” Prelim. Resp. 4 (quoting
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,763 (Aug. 14,
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`2012)). Especially in complex cases where obviousness is asserted as a
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`ground of unpatentability, “expert testimony may be critical, for example, to
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`establish the existence of certain features in the prior art or the existence (or
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`lack thereof) of a motivation to combine references.” Wyers v. Master Lock
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`Co., 616 F.3d 1231, 1240 n.5 (Fed. Cir. 2010) (citations omitted). But
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`expert testimony is not a per se requirement—where the technology is
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`simple, where the references are easily understandable without the need for
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`expert explanatory testimony, or where the factual inquiries underlying the
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`obviousness determination are not in material dispute, expert testimony,
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`though it might be helpful, may not be indispensable. Allergan, Inc. v. Barr
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`Labs., Inc., 501 F. App’x 965, 972 (Fed. Cir. 2013). In addition, a reason to
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`combine prior art teachings may exist “in the content of the public prior art,
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`in the nature of the problem addressed by the invention, or even in the
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`knowledge of one of ordinary skill in the art.” Princeton Biochemicals Inc.
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`v. Beckman Coulter Inc., 411 F.3d 1332, 1338-39 (Fed. Cir. 2005). And in
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`some cases, “the legal determination of obviousness may include recourse to
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`logic, judgment, and common sense, in lieu of expert testimony.” Wyers,
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`616 F.3d at 1239. Therefore, we reject a bright-line rule requiring expert
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`testimony analyzing unpatentability for all petitions for inter partes review.
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`At this stage of the proceedings, Petitioner has provided sufficient
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`evidence and we understand the prior art disclosures and a possible
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`reasoning to modify or combine the references without guidance of an
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`expert.
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`Claim Construction
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`In an inter partes review, the Board interprets a claim term in an
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`unexpired patent according to its broadest reasonable construction in light of
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`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b).
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`Under that standard, we assign claim terms their ordinary and customary
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`meaning, as understood by a person of ordinary skill in the art, in the context
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`of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
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`1257 (Fed. Cir. 2007).
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`Petitioner asks us to construe the terms “film formulation” and
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`“provides an in vivo plasma profile” recited in independent claim 15. The
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`parties propose the following constructions:
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`Prelim. Resp. 11; see also Pet. 22.
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`We address each term in turn.
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`“Film formulation”
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`Both parties argue that the Specification and prosecution history of the
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`’832 patent, as well as dictionary definitions support their respective
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`proposed claim constructions. Pet. 15-19; Prelim. Resp. 10-19.
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`According to Petitioner, during the prosecution of the ’832 patent,
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`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.”
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`Pet. 16 (citations omitted, emphasis added by Petitioner). Based on this,
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`Petitioner concludes that “Applicant distinguished a film formulation from a
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`resulting film product that provides a release profile.” Id. In other words,
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`Petitioner contends that “film formulation” does not require a film, but
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`broadly encompasses a combination of components that are capable of
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`forming a single film, even if such components are not in the form of a film.
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`Id. at 15, 22.
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`Patent Owner points out that Petitioner emphasizes and relies on
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`misquoted language from the prosecution history. Prelim. Resp. 12-13.
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`Patent Owner contends that it explained the invention as directed to the
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`“formation of a suitable film product.” Id. at 13 (quoting Ex. 1007, 7
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`(emphasis added)). Patent Owner persuades us that the quotes from the
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`prosecution history do not support Petitioner’s position.
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`In addition, Petitioner, citing two sentences from two U.S. patents
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`incorporated into the ’832 patent by reference, asserts that “the specification
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`[of the ’832 patent] distinguishes a film formulation from a resulting film
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`product.” Pet. 16-17. The ’832 patent incorporates the two U.S. patents by
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`reference, however, to exemplify suitable processes to form the film
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`compositions. Ex. 1001, 15:29-32. An isolated sentence from each of those
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`two patents does not persuade us to read “film” out of the term “film
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`formulation,” as Petitioner suggests.
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`Nor do we find the rest of the Specification to support Petitioner’s
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`construction. Petitioner directs our attention to Table 5 of the ’832 patent,
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`entitled “Formulations of Test Films . . . .” Pet. 17 (citing Ex. 1001, 18:44-
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`67). According to Petitioner, each of the three formulations listed in Table 5
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`“consists of a combination of components used in the preparation of a test
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`film.” Id. Petitioner contends that this table, together with excerpts
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`referencing information in this table, provides the context to support its
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`construction. Id.
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`We disagree. First, we construe the term “film formulation,” not
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`“formulation.” In the context of the Specification, the use of the word
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`“formulation” alone does not inform the meaning of “film formulation.”
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`More importantly, the two paragraphs preceding Table 5 support Patent
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`Owner’s position that the term “film formulation” is synonymous with “film
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`product, film composition, or film dosage.” Prelim. Resp. 10. Indeed, the
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`Specification explains:
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`Film dosages were prepared for use in an in vivo study to
`determine the bioavailability of buprenorphine/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.
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`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.
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`Ex. 1001, 18:30-42 (emphases added). Other passages in the Specification
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`provide additional examples:
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`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.
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`Id. at 23:49-55 (emphases added). The juxtaposition of “tablets” and “film
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`formulations,” the comparison of “film,” “film formulation,” and “film
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`product” with “tablet formulation,” as well as the reference to the first of the
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`“three film formulations” as “film,” all indicate that “film formulation”
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`refers to a film product, not merely components capable of being used to
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`prepare a film.
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`Petitioner also contends that Patent Owner could have claimed a
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`“film,” but “instead chose to claim a ‘film formulation’ in the challenged
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`claims.” Pet. 19. We find this argument unpersuasive because Petitioner
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`does not point adequately to where a distinction appears in the ’832 patent
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`between the usage of “film formulation” and “film dosage, film product,
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`film composition, film strip, and film,” or otherwise suggests that a “film
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`formulation” is not necessarily in the form of a film.
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`We conclude that Petitioner’s proposed construction of “film
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`formulation” is unreasonably broad in view of the Specification. The
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`broadest-construction rubric does not allow an unfettered license to interpret
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`claims to embrace anything remotely related to the claimed invention. In re
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`Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010). Accordingly, we
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`conclude that “film formulation” encompasses film dosage, film
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`composition, or film, but not a formulation that is not in the form of a film.
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`“Provides an in vivo plasma profile”
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`Petitioner contends the term “provides an in vivo plasma profile”
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`means “results in an in vivo plasma profile after a resulting film is
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`administered to a human subject.” Pet. 20-22. Patent Owner argues that the
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`term, having “a plain and unambiguous meaning on its face and in the
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`context of the specification,” needs no construction. Prelim. Resp. 11, 19.
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`We agree with Patent Owner.
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`The challenged claims require the claimed “film formulation” to
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`provide the recited in vivo plasma profile. Ex. 1001, 24:56-58. Petitioner
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`correctly recognizes that it is the film product that provides the in vivo
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`plasma profile. Pet. 20-21. Because Petitioner insists that “film
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`formulation” means “combination of components capable of” forming a
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`film, and not a film product, however, it adds the “resulting film” language
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`into the construction of “provides an in vivo plasma profile.” In other
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`words, Petitioner would have us read “film” out of “film formulation” and
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`into “provides an in vivo plasma profile.” We decline to do so. Because a
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`“film formulation” is a film, it is unnecessary to include an additional
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`element of “resulting film” into “provides an in vivo plasma profile.” In
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`view of the plain and unambiguous meaning on its face and in the context of
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`the Specification, we see no need to construe the term “provides an in vivo
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`plasma profile” beyond its ordinary meaning.
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`Patentability Analysis
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`Anticipation
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`Anticipation by Suboxone Tablet Label (Ex. 1013)
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`Petitioner asserts that Suboxone Tablet Label anticipates claims 15-19
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`of the ’832 patent based on Petitioner’s proposed claim construction of “film
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`formulation.” See Pet. 27.
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`As discussed above, the term “film formulation,” as recited in
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`independent claim 15, requires a formulation in the form of a film. As
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`conceded by Petitioner, Suboxone Tablet Label does not disclose a
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`formulation in the form of a film. Pet. 39. Thus, Petitioner has not
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`established a reasonable likelihood that it would prevail in showing that
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`Suboxone Tablet Label anticipates the challenged claims. We deny this
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`ground.
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`Anticipation by Labtec (Ex. 1017)
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`Petitioner asserts that Labtec anticipates claims 15-19. Pet. 38-41.
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`Labtec describes “non-mucoadhesive orally disintegrating film dosage forms
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`that mimic the pharmacokinetic profile of orally administered drug products
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`such as tablets . . . .” Ex. 1017, 3.2 One such tablet is Suboxone®. Id. at 23.
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`According to Petitioner, Labtec describes a film formulation
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`comprising buprenorphine and naloxone that mimics the pharmacokinetics
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`(i.e., in vivo plasma profile including Cmax and mean AUC) of Suboxone®
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`in relation to both active ingredients. Pet. 38-40. Petitioner points us to
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`Table A of Labtec, which lists “[e]xamples of doses for specific
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`pharmaceutically active agents that can be delivered per one strip of rapidly
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`dissolving oral film . . . along with preferred dosing schedules and
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`pharmacokinetic parameters.” Ex. 1017, 21; Pet. 38-40. Petitioner
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`contends that one example in Table A includes the combination of
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`buprenorphine HCl/naloxone HCl dehydrate, the active ingredients of
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`Suboxone®, as the pharmaceutical active agents for the described film.
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`Pet. 39-40; Ex. 1017, 23. Petitioner points to the example describing a
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`2 We cite to exhibit page numbers of Ex. 1017, rather than page numbers of
`the published PCT application itself.
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`Cmax of 1.84 and 3.0 ng/ml for buprenorphine, which Petitioner contends
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`falls within “a Cmax of between about 0.624 ng/ml and about 5.638 ng/ml
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`for buprenorphine,” as recited in claim 15. Pet. 40 (citing Ex. 1017, 23).
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`Petitioner also points to the example further describing that “[m]ean peak
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`naloxone levels range from 0.11 to 0.28 ng/ml in dose range of 1-4 mg,”
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`which Petitioner contends describes “a Cmax of between about 41.04 pg/ml
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`to about 323.75 pg/ml for naloxone,” also recited in claim 15. Id.
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`In addition, Petitioner points to where Labtec describes AUC0-48 of
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`12.52, 20.22, and 34.89 hr.ng/ml, for 4, 8, and 16 mg buprenorphine,
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`respectively, which Petitioner contends falls within the mean AUC range for
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`buprenorphine as recited in claim 16. Id. For claim 17, which recites “a
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`mean AUC of between about 102.88 hr.pg/ml to about 812.00 hr.pg/ml for
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`naloxone,” Petitioner contends that Labtec describes “film formulations that
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`provide the same or bioequivalent pharmacokinetic profile as Suboxone
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`tablets.” Id. (citing Ex. 1017, 3:15-23). Petitioner relies on other evidence,
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`including the ’832 patent itself (Ex 1001, 16:53-63) and a “Suboxone Tablet
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`Study Report” (Ex. 1015, 12), to establish that Suboxone tablets, and
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`therefore, films exhibiting the same pharmacokinetic profile, necessarily
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`exhibit mean AUC levels for naloxone that falls within the range recited in
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`claim 17. Id. at 40-41.
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`Petitioner further points to where Labtec describes 2.0/0.5 or 8.0/2.0
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`mg as the preferred dose for buprenorphine/naloxone in a film, and 12-16
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`mg/day as the preferred dosing schedule, which Petitioner contends meets
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`the elements recited in dependent claims 18 and 19. Id. at 41.
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`In its Preliminary Response, Patent Owner first argues that “the
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`purpose of the ʼ832 patent is to provide an orally dissolvable, mucoadhesive,
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`film dosage form containing buprenorphine and naloxone,” while Labtec, in
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`contrast, concerns “non-mucoadhesive” film dosages. Prelim. Resp. 30-31.
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`The challenged claims, however, only require a film formulation without
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`indicating whether it is mucoadhesive or non-mucoadhesive. Thus, we are
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`not persuaded that Petitioner’s challenge based on Labtec fails on this basis.
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`Patent Owner also asserts that Labtec teaches away because the
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`claimed invention provides a mucoadhesive film whereby buprenorphine is
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`absorbed through the oral mucosa, while Labtec only discloses a non-
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`mucoadhesive film whereby the active ingredients are absorbed
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`predominantly through the gastrointestinal tract. Prelim. Resp. 30-32.
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`Teaching away, however, is legally irrelevant to the question of anticipation.
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`Celeritas Technologies, Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361
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`(Fed. Cir. 1998). In addition, Patent Owner does not propose that we
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`construe “film formulation” to require muco-adhesiveness or mucosal
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`absorption of buprenorphine, and we decline to read those unrecited features
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`into the challenged claims.
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`Patent Owner argues that Labtec does not “direct the skilled artisan to
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`that [claimed] composition ‘without any need for picking, choosing, and
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`combining various disclosures.’” Prelim. Resp. 32. Petitioner points to one
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`row in Table A of Labtec, however, when asserting disclosure of recited
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`elements regarding in vivo plasma profiles of buprenorphine and naloxone.
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`Pet. 39-41 (citing Ex. 1017, 23).
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`15
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`Patent Owner further contends that “Labtec merely states the desired
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`goal of having films that are bioequivalent [to] Suboxone® tablets” without
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`“a single, specific embodiment of a film containing buprenorphine alone or
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`together with naloxone, let alone one tested to determine a pharmacokinetic
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`profile.” Prelim. Resp. 31-32. Specifically, according to Patent Owner, the
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`buprenorphine pharmacokinetic values referenced in Labtec “are simply
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`those provided in the Suboxone® tablet label, and do not reflect the
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`pharmacokinetics of any film disclosed in Labtec.” Id. at 32 n.13.
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`“[A]nticipation does not require actual performance of suggestions in
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`a disclosure. Rather, anticipation only requires that those suggestions be
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`enabled to one of skill in the art.” Novo Nordisk Pharm., Inc. v. Bio-Tech.
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`Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also Schering Corp.
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`v. Geneva Pharm., Inc., 339 F.3d 1373, 1380 (Fed. Cir. 2003) (“A reference
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`may enable one of skill in the art to make and use a compound even if the
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`author or inventor did not actually make or reduce to practice that subject
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`matter.”).
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`As discussed above, Petitioner points us to where Labtec discloses a
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`rapidly dissolving oral film with buprenorphine and naloxone as its active
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`agents. Pet. 38-40 (citing Ex. 1017, 21, 23). Petitioner also points us to
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`where Labtec discloses the film can be formulated to include pharmaceutical
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`active agents, a film-forming agent, and other ingredients. Pet. 39 (citing
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`Ex. 1017, 14-15). In addition, Petitioner explains where Labtec describes
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`formulating a film to ensure bioequivalence between the film and an existing
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`product, such as the Suboxone® tablet. Pet. 40 (citing Ex. 1017, 4-5, 13).
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`Specifically, according to Petitioner, Labtec discloses the pharmacokinetic
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`16
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`values of the Suboxone® tablet as the preferred pharmacokinetic parameters
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`for a film. Pet. 39-40 (citing Ex. 1017, 23). As a result, according to
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`Petitioner, one of ordinary skill in the art reading Labtec would have known
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`how to prepare buprenorphine/naloxone films as described in Table A, i.e.,
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`the film formulations recited in challenged claims 15-19. Pet. 38-41 (citing,
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`for example, Ex. 1017, 16:13-15, 16:29-17:5).
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`Based on the foregoing and the record before us, we are persuaded
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`that Petitioner has shown a reasonable likelihood that it would prevail in
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`demonstrating that Labtec anticipates claims 15-19.
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`Anticipation by Euro-Celtique (Ex. 1018)
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`Petitioner contends that Euro-Celtique anticipates claims 15-19.
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`Pet. 46-50. We determine that this ground is redundant in light of our
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`decision to institute review of anticipation of the same claims based on
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`Labtec. Thus, we exercise our discretion not to institute on this ground. 37
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`C.F.R. § 42.108(a).
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`Obviousness
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`Obviousness over Labtec, Birch (Ex. 1019), and Yang (Ex. 1016)
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`Petitioner argues that the challenged claims would have been obvious
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`over the combination of Labtec, Birch, and Yang. Pet. 44-45. Petitioner
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`relies on Birch “[t]o the extent the pH range of about 3 to about 3.5 is read
`
`into the challenged claims.” Pet. 43. As noted above, pH levels are not
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`recited in the challenged claims. Thus, we do not rely on Birch in our
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`17
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`obviousness determination, except to note that Patent Owner has not asserted
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`that Birch teaches away from the claimed film formulations.
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`According to Petitioner, Labtec discloses components suitable for
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`making films that are bioequivalent to the Suboxone® tablets. Id. at 38, 45.
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`Petitioner contends that to the extent Labtec, together with the knowledge of
`
`one skilled in the art, insufficiently teaches how to make a film (and thus
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`fails to anticipate the challenged claims), Yang explicitly supplies such
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`teaching. Id. at 45. As noted by Petitioner, Yang is one of the two U.S.
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`patents incorporated by reference into the ’832 patent for the disclosure of
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`suitable processes to form the claimed film. Id. (citing Ex. 1001, 15:30-31).
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`Patent Owner argues that Petitioner fails to provide sufficient
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`evidence to meet the threshold for instituting a trial on any obviousness
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`ground. Prelim. Resp. 33. First, according to Patent Owner, Petitioner does
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`not provide expert testimony on, or otherwise explain, the level of ordinary
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`skill in the art. Patent Owner contends that we should deny all asserted
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`obviousness grounds “for this reason alone.” Id. at 36. We disagree.
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`The skill-level determination is an important guarantee of objectivity
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`in an obviousness analysis. Graham v. John Deere Co., 383 U.S. 1, 17
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`(1966). But where the prior art itself reflects an appropriate level, and a
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`need for testimony is not shown, a specific finding on the level of skill in the
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`art is not required. Litton Indus. Products, Inc. v. Solid State Sys. Corp., 755
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`F.2d 158, 163-64 (Fed. Cir. 1985); In re Gentile, 11 F.3d 1069 (Fed. Cir.
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`1993). Petitioner’s failure to explicitly state the level of skill in the art is not
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`fatal for purposes of this Decision because we are persuaded that prior art in
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`18
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`general, and Labtec and Yang specifically, reasonably reflect an appropriate
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`level of skill.
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`Second, Patent Owner argues that Petitioner does not provide any
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`objective evidence, such as expert testimony, to support Petitioner’s asserted
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`reason to combine teachings in the references. Prelim. Resp. 37. But
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`testimony of an expert, as we explained above, is not the only source for
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`such evidence. Indeed, the reason to combine references sometimes may be
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`explicit or implicit from the prior art. Alza Corp. v. Mylan Labs., Inc., 464
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`F.3d 1286, 1290-91 (Fed. Cir. 2006). Here, Petitioner contends that Labtec
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`teaches the buprenorphine and naloxone as active ingredients for an orally
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`dissolving film with a preferred pharmacokinetics profile. Pet. 38-40. If it
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`does not do so adequately by itself, Petitioner contends that Labtec would
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`have motivated one skilled in the art to look to Yang for the method of
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`making a film. Id. at 45. We are persuaded that Petitioner reasonably
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`establishes that it would prevail in showing that an ordinary artisan would
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`have had a reason to consider the methods disclosed in Yang when reading
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`Labtec.
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`Third, Patent Owner alleges that
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`Labtec clearly teaches away from the subject matter claimed in
`the ʼ832 patent (directed to mucoadhesive film that delivers its
`active through the oral mucosa), since Labtec is focused on a
`non-mucoadhesive film that delivers its active not through the
`oral mucosa (indeed, Labtec seeks to block oral absorption) but
`in the intestinal tract.
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`Prelim. Resp. 39. Teaching-away is a proper inquiry for determining
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`obviousness. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). We find
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`Patent Owner’s argument, however, unpersuasive. As noted above, the
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`19
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`challenged claims do not recite either the muco-adhesiveness or mucosal
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`absorption that Patent Owner emphasizes. We are persuaded Petitioner
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`reasonably establishes that Labtec’s teaching of a non-mucoadhesive film
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`that delivers its active in the gastrointestinal tract would not have
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`discouraged one skilled in the art from developing a film that meets all
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`limitations of the challenged claims.
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`Based on the record before us, we are persuaded that Petitioner has
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`shown a reasonable likelihood that it would prevail in demonstrating that the
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`combination of Labtec, Yang, and Birch renders claims 15-19 obvious.
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`Other obviousness grounds
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`Petitioner also asserts that claims 15-19 would have been obvious
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`over: (1) Suboxone Tablet Label; (2) Suboxone Tablet Label and Yang; (3)
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`Suboxone Tablet Label, Yang, and Birch; (4) Labtec; (5) Labtec and Birch;
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`(6) Euro-Celtique; (7) Euro-Celtique and Birch; (8) Euro-Celtique, Birch,
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`and Yang. We determine that these grounds are redundant in light of our
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`decision to institute review of obviousness of the same claims based on
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`Labtec, Yang, and Birch. Thus, we exercise our discretion not to institute on
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`these grounds. 37 C.F.R. § 42.108(a).
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`CONCLUSION
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`For the foregoing reasons, the information presented in the Petition
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`establishes a reasonable likelihood that Petitioner would prevail in showing
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`the unpatentability of claims 15-19 of the ’832 patent.
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`20
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`The Board has not made a final determination on the patentability of
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`any challenged claim.
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`Accordingly, it is
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`ORDER
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`ORDERED that the Petition is granted as to claims 15-19 of the ’832
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`patent with respect to the following alleged grounds:
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`1.
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`2.
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`Claims 15-19 under 35 U.S.C. § 102 as anticipated by Labtec;
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`Claims 15-19 under 35 U.S.C. § 103 as obvious over the
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`combination of Labtec, Yang, and Birch;
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`FURTHER ORDERED that no ground other than those specifically
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`granted above is authorized for the inter partes review as to claims 15-19;
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`and
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`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
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`partes review of the ’832 patent is hereby instituted commencing on the
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`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
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`§ 42.4, notice is hereby given of the institution of a trial.
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`21
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`For PETITIONER:
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`Danielle Herritt
`dherritt@mccarter.com
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`Kia Freeman
`kfreeman@mccarter.com
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`For PATENT OWNER:
`
`James M. Bollinger
`James.bollinger@troutmansanders.co
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