Paper No. 15
`Filed: April 30, 2014
`
`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
`____________________
`
`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.107
`
`
`
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`
`
`Filed: April 30, 2014
`
`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
`____________________
`
`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.107
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`TABLE OF CONTENTS
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`Page
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`2.
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`C.
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`D.
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`INTRODUCTION AND BACKGROUND .................................................. 1
`I.
`THE ʼ832 PATENT ....................................................................................... 6
`II.
`III. CLAIM CONSTRUCTION ........................................................................... 9
`IV. PETITIONER HAS NOT DEMONSTRATED A REASONABLE
`LIKELIHOOD OF PREVAILING ON ANY OF THE PROPOSED
`GROUNDS FOR UNPATENTABILITY ................................................... 20
`A.
`The Reitman Declaration Should Be Disregarded ............................ 20
`B.
`The Purported Anticipatory References Fail Because None
`Disclose A Specific Embodiment Within The Scope Of Claim
`15 ....................................................................................................... 22
`The Suboxone Tablet Label Does Not Disclose A Film
`1.
`And Therefore Cannot Anticipate (Ground 1) ........................ 24
`Neither Euro-Celtique Nor Labtec Disclose A Specific
`Embodiment Within The Scope Of Claim 15 ......................... 25
`a.
`Euro-Celtique Does Not Anticipate (Ground 9) ........... 26
`b.
`Labtec Does Not Anticipate (Ground 5) ....................... 30
`BDSI’s Petition Fails To Provide Sufficient Evidence To Meet
`The Threshold To Institute IPR On Any Obviousness Ground ........ 33
`Petitioner’s Reliance On Yang And Birch As Supporting
`Certain Obviousness Grounds Is Equally Insufficient ...................... 41
`1.
`Yang ........................................................................................ 42
`2.
`Birch ........................................................................................ 43
`CONCLUSION ............................................................................................ 47
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`V.
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`-i-
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`TABLE OF AUTHORITIES
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`Page(s)
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`CASES
`Allergan, Inc. v. Barr Labs., Inc.,
`501 F. Appx. 965 (Fed. Cir. 2013) ..................................................................... 35
`
`Alza Corp. v. Mylan Labs., Inc.
`464 F.3d 1286 (Fed. Cir. 2006).......................................................................... 35
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010)(en banc) .......................................................... 30
`
`In re Arkley,
`455 F.2d 586 (CCPA 1972) ................................................................... 22, 25, 30
`
`Blackberry Corp. v. MobileMedia Ideas LLC, IPR2013-00016, Paper 32
`(PTAB Feb. 25, 2014) .................................................................................. 34, 36
`
`Conopco, Inc. v. Procter & Gamble Co., IPR2013-00509, Paper 10 (PTAB
`Feb. 12, 2014), ........................................................................... 22, 23, 25, 29, 32
`
`Elcommerce.com, Inc. v. SAP AG,
`No. 2011-1369, 2014 U.S. App. LEXIS 3357 (Fed. Cir. Feb. 24, 2014) .......... 34
`
`Eli Lilly and Co. v. Sicor Pharms., Inc.,
`705 F. Supp. 2d 971 (S.D. Ind. 2010) ................................................................ 26
`
`Epistar v. Trustees of Boston Univ., IPR2013-00298, Paper 18 (PTAB Nov.
`15, 2013) ...............................................................................................................5
`
`Ex Parte Cima Labs Inc.,
`No. 2009-3071, 2009 Pat. App. LEXIS 7228 (BPAI Sept. 28, 2009) ............... 18
`
`Ferring B.V. v. Watson Labs., Inc.,
`No. 3:11cv481, 2013 U.S. Dist. LEXIS 17536 (D. Nev. Feb. 6, 2013) ............ 17
`
`Garmin Int’l, Inc. v. Cuozzo Speed Tech., LLC,
`IPR2012-00001, Paper 15 (PTAB Jan. 9, 2013) ............................................... 14
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................... 34, 37, 40
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`TABLE OF AUTHORITIES
`(continued)
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`Page(s)
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`
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`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................... 34, 37, 40
`
`Monsanto Co. v. Pioneer Hi-Bred Int’l., Inc., IPR2013-00022, Paper 43
`(PTAB April 11, 2013) ...................................................................................... 21
`
`Monsanto Co. v. Pioneer Hi-Bred Int’l, Inc., IPR2013-00023, Paper 32
`(PTAB April 11, 2013) ...................................................................................... 36
`
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008).......................................................................... 25
`
`Norman Noble, Inc. v. NUTech Ventures, IPR2013-00101, Paper 14 (PTAB
`June 20, 2013) .................................................................................................... 40
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ......................................................... 14
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`550 F.3d 1075 (Fed. Cir. 2008).......................................................................... 22
`
`Structural Rubber Prods. Co. v. Park Rubber Co.,
`749 F.2d 707 (Fed. Cir. 1984) ............................................................................ 26
`
`Therasense, Inc. v. Becton Dickinson & Co.,
`593 F.3d 1325 (Fed. Cir. 2010).......................................................................... 27
`
`Valeant Int'l (Barbados) SRL v. Watson Pharms., Inc.,
`No. 10-20526, 2011 U.S. Dist. LEXIS 128742 (S.D. Fl. November 7,
`2011) .................................................................................................................. 25
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ............................................................................ 14
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010).......................................................................... 35
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`TABLE OF AUTHORITIES
`(continued)
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`Page(s)
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`STATUTES
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`35 U.S.C. § 103(a) ................................................................................................... 33
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`35 U.S.C. § 311(b) .............................................................................................. 5, 21
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`35 U.S.C. § 312(a)(3) .............................................................................................. 33
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`35 U.S.C. § 313 ..........................................................................................................1
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`35 U.S.C. § 314(a) ................................................................................................... 47
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`OTHER AUTHORITIES
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`37 C.F.R. § 42.65(a) ................................................................................................ 21
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`37 C.F.R. § 42.65(b) ................................................................................................ 22
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`37 C.F.R. § 42.100(b) .............................................................................................. 14
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`37 C.F.R. § 42.104(b)(2) ......................................................................................... 21
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`37 C.F.R. § 42.107 .....................................................................................................1
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`77 Fed. Reg. 48756 (Aug. 14, 2012) ................................................................... 4, 34
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`Case IPR2014-00325
`Patent No. 8,475,832
`Patent Owner RB Pharmaceuticals Limited respectfully submits this
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`Preliminary Response to the Petition (“Pet.”) seeking inter partes review (IPR) of
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`claims 15-19 of U.S. Patent 8,475,832 (“the ʼ832 patent”). This Preliminary
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`Response is timely under 35 U.S.C. § 313 and 37 C.F.R. § 42.107 because it is
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`filed within three months of the January 30, 2014 Notice of Filing Date. Paper 9 at
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`1.
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`I.
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`INTRODUCTION AND BACKGROUND
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`Patent Owner shares the same parent company as real party-in-interest
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`Reckitt Benckiser Pharmaceuticals Inc. (“RBP”), which is the exclusive licensee of
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`the ʼ832 patent. RBP has been the pioneer in developing pharmaceutical
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`formulations to treat opioid addiction. The ʼ832 patent is listed in the Food and
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`Drug Administration’s (FDA) Orange Book as covering RBP’s commercial
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`product Suboxone® sublingual film, which was launched in 2010 and is the
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`leading opioid addiction treatment in the U.S. The predecessor product to
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`Suboxone® film was Suboxone® tablets, which were approved by FDA in 2002.
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`The active ingredients in both Suboxone® film and Suboxone® tablets are
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`buprenorphine (a partial opioid agonist that is used to effect the addiction
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`dependence treatment) and naloxone (an opioid antagonist that is included to deter
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`abuse). As explained in the ʼ832 patent, when used for these purposes in these
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`products, the objective is to obtain the desired level of absorption of the
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`buprenorphine through the oral mucosa upon dissolution while inhibiting the
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`absorption of naloxone (so that the patient is not put into withdrawal).
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`The manufacture, use and sale of self-supporting pharmaceutical films,
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`where the film is not a coating on a drug carrying vehicle (such as a film on the
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`exterior of a tablet formulation), but rather itself carries the drug to be delivered,
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`such that the film itself is the drug delivery vehicle, is a relatively new area of
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`pharmaceutical formulation that has only emerged over the last decade or so and
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`has only seen the introduction of FDA approved products in the last several years.
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`The generally well-established technology used to produce compressed
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`pharmaceutical tablets is very different from and involves very different challenges
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`and types and ratios of excipients as compared to the newly emerging area of
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`orally dissolvable, mucoadhesive pharmaceutical films. The pioneering company
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`in this technology space has been MonoSol Rx Ltd (“MonoSol”).
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`The first two lingual and sublingual pharmaceutical films approved by FDA
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`(in 2010) were developed by MonoSol, one of which was Suboxone® film, of
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`which MonoSol is the exclusive manufacturer for RBP. The named inventors on
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`the ʼ832 patent were, at the time, employees of MonoSol. When RBP sought to
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`replace Suboxone® tablets with a more advantageous product and one that would
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`be safer and less subject to potential abuse, RBP turned to MonoSol to develop
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`what became Suboxone® film, which is the subject matter of the ʼ832 patent. The
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`Patent No. 8,475,832
`filing of the ʼ832 patent in August 2009 marked the first disclosure of an actual
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`embodiment of, and the first specific teaching how to make, a pharmaceutical film
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`containing buprenorphine and naloxone, and therefore was the first disclosure of
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`an actual embodiment of, and the first teaching how to make, an orally dissolvable,
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`mucoadhesive pharmaceutical film containing those ingredients that is
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`bioequivalent to Suboxone® tablets.1
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`Patent Owner submits that IPR should not be instituted in this matter
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`because Petitioner has failed to demonstrate that it has a reasonable likelihood of
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`prevailing with respect to any of the challenged claims of the ʼ832 patent.
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`Specifically, the Petition fails for at least three fundamental reasons.
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`First, Petitioner’s contention (Ground 1) that the claimed pharmaceutical
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`film product is anticipated by the label of the predecessor tablet product relies on
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`an insupportable claim construction that baselessly reads tablet formulations into
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`claims that are limited to film formulations.
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`Second, Petitioner cannot carry its burden of establishing a prima facie case
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`of anticipation or obviousness (as to any asserted Ground) in regard to this
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`complex subject matter where:
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`1 As explained in the ʼ832 patent, the Cmax ranges recited in the sole challenged
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`independent claim, claim 15, are based on the Cmax ranges of Suboxone® tablets.
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`See, e.g., Ex. 1001, 17:18-48, including Table 3.
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`Patent No. 8,475,832
` i) none of the references on which Petitioner relies discloses anything more
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`than the goal of obtaining the product that is actually disclosed and claimed in the
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`ʼ832 patent, e.g., none of those references disclose a specific embodiment (whether
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`as a working or paper example) of such a product or contain any specific teaching
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`as to how to make the product claimed in the ʼ832 patent; and
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`ii) Petitioner’s anticipation and obviousness contentions rely entirely on
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`attorney argument; Petitioner has presented no objective evidence, such as expert
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`evidence, that supports the elements necessary to establish those contentions, even
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`as a prima facie matter. For example, Petitioner has presented no objective
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`evidence as to: a) the level of skill in the art; b) why one of ordinary skill at the
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`time would have been motivated to take certain approaches or combine certain
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`references in an effort to achieve the claimed subject matter; or c) how or why
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`references that state no more than a goal would allow the skilled person to make
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`the claimed subject matter without more than routine experimentation.
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`Since patented subject matter is often technologically complex, the “Board
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`expects that most petitions and motions will rely upon affidavits of experts.”
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48763 (Aug. 14, 2012).
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`Here, despite the complexity of the subject matter, for reasons best known to
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`Petitioner, Petitioner has presented no expert analysis of the anticipation and
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`obviousness issues it asserts. In fact, this was obviously a very deliberate strategic
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`Patent No. 8,475,832
`decision: Petitioner did choose to submit two expert declarations, but neither
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`presents an anticipation or obviousness analysis. One expert declaration (Ex.
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`1004, the Reitman Declaration) is presented solely for the purpose of presenting
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`pH testing of supposedly prior art Suboxone® tablets—even though pH is not
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`recited in the challenged claims and tablets cannot serve as prior art in an IPR (35
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`U.S.C. § 311(b)). The other expert declaration (Ex. 1005, the Lavin Declaration) is
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`limited to commenting on certain pharmacokinetic data in certain Examples and
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`Tables in the patent—an odd detour in the Petition that is not relied on to support
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`any asserted Ground of invalidity.
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`Thus, neither the Reitman nor the Lavin expert declaration provides any
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`expert analysis as to anticipation or obviousness and Petitioner presents none.
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`Petitioner’s failure to present any objective evidence to support its contentions thus
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`precludes a finding that there is a reasonable likelihood that Petitioner would
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`prevail at trial on any asserted Ground. Accordingly, the Petition should be denied
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`in its entirety for this reason alone. See, e.g., Epistar v. Trustees of Boston Univ.,
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`IPR2013-00298, Paper 18 (PTAB Nov. 15, 2013) (denying Petition in its entirety
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`where the subject matter was complex and Petitioner’s contentions were found to
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`be unsupported by objective evidence).
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`Third, the references relied on by Petitioner have further individual flaws or
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`deficiencies that render them incapable of supporting Petitioner’s contentions—a
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`Patent No. 8,475,832
`point only further underscored by the absence of objective evidence in the Petition
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`to the contrary. For example, certain of the prior art plainly teaches away from the
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`subject matter claimed in the ʼ832 patent and, while that means that the prior art
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`does not support an obviousness contention, that evidentiary insufficiency is
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`further heightened by Petitioner’s failure to present not only any objective
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`evidence to the contrary, but also any objective evidence in support of its
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`obviousness contention based on that particular piece of prior art as a whole.
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`II. THE ʼ832 PATENT
`As indicated on its face, the ʼ832 patent was filed on August 7, 2009 and
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`issued on July 2, 2013. The patent was originally assigned to MonoSol and is now
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`assigned to Patent Owner.
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`As indicated by its heading, “Sublingual and Buccal Film Compositions,”
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`the ʼ832 patent concerns certain specific pharmaceutical film dosages or
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`formulations. As set forth in the “Field of the Invention” section at the outset of
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`the patent:
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`The present invention relates to compositions, methods of manufacture,
`products and methods of use relating to films containing therapeutic actives.
`The invention more particularly relates to self-supporting film dosage forms
`which provide a therapeutically effective dosage, essentially matching that
`of currently-marketed tablets containing the same active.
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`Ex. 1001, 1:6-11 (emphasis added). Noting that “[o]ral administration of two
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`therapeutic actives in a single dosage form can be complex if the intention is to
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`have one active absorbed in the body and the other active remain substantially
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`unabsorbed” ( id. at 1:20-24), the specification references Suboxone® tablets (see,
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`e.g., id. at 1:53-54) and goes on to describe the need the invention of the patent is
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`meant to satisfy: “There is currently a need for an orally dissolvable film dosage
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`form that provides the desired absorption levels of the agonist and antagonist,
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`while providing an adhesive effect in the mouth, rendering it difficult to remove
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`once placed in the mouth, thereby making abuse of the agonist difficult” (id. at
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`1:65 to 2:2). More specifically, the “Detailed Description of the Preferred
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`Embodiments” section of the patent states that “the present invention provides a
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`method of treating narcotic dependence by providing an orally dissolvable film
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`dosage, which provides a bioequivalent effect to Suboxone®” tablets. Id. at 4:55-
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`58.
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`The ʼ832 patent repeatedly refers throughout to “films,” “film
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`compositions,” “film dosage compositions,” “film formulations,” “film dosages,”
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`“film products,” and “film strips,” using all of these terms interchangeably and
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`synonymously. See, e.g., id. at 2:7,15, 23-24, 43-44, 55-56, 64; 3:57-66; 4:57, 61;
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`5:4; 6:60; 13:11, 45; 15:29, 63-65; 17:51, 56; 18:30-50; 23:8, 50. Such “film
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`formulation[s]” stand in contrast to “tablet formulation[s]” (see, e.g., id. at 23:49-
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`55).
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`Patent No. 8,475,832
`The specification discloses nothing about preparing tablet formulations, but
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`is, instead, directed throughout to the preparation of a self-supporting film
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`formulation, specifically one that is orally dissolvable, is mucoadhesive, and has
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`the same active ingredients as and is bioequivalent to Suboxone® tablets. Thus,
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`the “Summary of the Invention” section describes the “present invention” as a
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`“film dosage composition” or “film formulation.” Id. at 2:6 to 3:2. The
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`“Definitions” subsection of the section headed “Detailed Description of the
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`Preferred Embodiments” makes clear that the term “film” includes “thin films and
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`sheets” in any desired shape or size and contains no suggestion that a film
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`formulation as that term is used in the patent somehow embraces a tablet
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`formulation.
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`Similarly, the specification makes clear that the subject dosage form
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`constitutes a self-supporting film composition: “The film may contain any desired
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`level of self-supporting film forming polymer, such that a self-supporting film
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`composition is provided.” Id. at 12:37-39. Not surprisingly, all of the “how to”
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`sections of the patent are directed to making a self-supporting film and then, more
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`specifically, how to make one that is orally dissolvable, mucoadhesive and
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`bioequivalent to Suboxone® tablets. See, e.g., cols. 5 to 15, as well as Table 1 (at
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`col. 16) setting forth the specific components of the film formulations tested, as
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`further described in the Examples at cols. 15 to 23.
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`This disclosure in Table 1 (at col. 16) is the first disclosure in the art of an
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`actual embodiment, including the specific ingredients, their amounts and ratios, of
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`a film dosage or formulation containing buprenorphine and naloxone, and more
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`specifically, of one that is orally dissolvable, mucoadhesive, and bioequivalent to
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`Suboxone® tablets. And, the entirety of the specification, including but not
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`limited to the specific ingredients, their amounts and ratios as disclosed in Table 1
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`and the inventors’ discovery that the oral mucosal absorption of buprenorphine
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`(and naloxone) is bioequivalent to Suboxone® tablets when the local pH of the
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`film (as it dissolves in the mouth, see, e.g., 3:35-38) is lowered to about 3.0 to 3.5
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`(see, e.g., 23:1-7 and 11:50-61) constitutes the first teaching in the art how to make
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`such a film formulation.
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`III. CLAIM CONSTRUCTION
`The Petition is directed to claims 15-19. Claim 15 is the sole challenged
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`independent claim and the remaining claims depend from it. Claim 15 recites:
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` An orally dissolving film formulation comprising 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.2
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`2 The Cmax values that appear in this claim concern Suboxone® tablets, ranging in
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`buprenorphine/naloxone dosages from 2 mg/0.5 mg to 16 mg/4 mg, and were taken
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`Claim construction here is entirely straightforward. “Orally dissolving,” as
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`the term is used in the claim and throughout the specification, means dissolving in
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`the mouth. See, e.g., id. at 4:1-24. The term “film formulation,” as explained
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`above, is, as demonstrated throughout the specification, synonymous with a film
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`product, film composition, or film dosage, i.e., a self-supporting pharmaceutical
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`film. The term “Cmax” is defined in the specification as “the mean maximum
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`plasma concentration after administration of the composition to a human subject.”
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`Id. at 3:9-11.3
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`The parties’ proposed claim constructions for purposes of this proceeding
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`are as follows:
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`from Table 3 (at col. 17) and were, in turn, as the text explains, based on the
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`extrapolated absorption data set forth in Table 2A (see, generally, 16:35 to 17:48).
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` Two of the dependent claims in issue, claims 16 and 17, also use the term AUC,
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` 3
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`which is defined in the specification as meaning “the mean area under the plasma
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`concentration-time curve value after administration of the compositions formed
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`herein.” Id. at 3:11-14. (In Patent Owner’s view, all of these constructions are the
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`same whether one uses the broadest reasonable interpretation standard applied by
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`the Board in IPRs or the standard set forth in governing Federal Circuit case law
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`with respect to actions in district court.)
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`Patent No. 8,475,832
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`Petitioner’s Construction
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`combination of components
`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
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`
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`Term
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`film formulation
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`Patent Owner’s
`Construction
`film composition or dosage
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`provides an in vivo
`plasma profile
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`No construction needed
`
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`To begin with, it should be pointed out that the sole reason that Petitioner is
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`making the contrived assertion the claim term “film formulation” means something
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`other than a film dosage or composition is that Petitioner needs to effectively read
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`“film” out of that claim term and have that term mean components that are merely
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`“capable of being used to prepare” a film (among other dosage forms) in order to
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`be able to assert its Ground 1 anticipation argument. As further discussed below,
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`Petitioner’s Ground 1 argument is that the label for Suboxone® tablets, which
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`discloses the ingredients in the tablet dosage, somehow anticipates claim 15 (and
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`its dependent claims) on the basis that claim 15 is not limited to film dosage forms
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`and that the individual ingredients shown on the label for Suboxone® tablets are
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`included in the ʼ832 patent’s general disclosure of components that may be used in
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`making a pharmaceutical film. Pet. 27. Thus, Petitioner’s claim construction rests
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`on the unsupported assertion that: “Applicant distinguished a film formulation
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`Patent No. 8,475,832
`from a resulting film product that provides a release profile.” Id. at 16. And the
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`purpose of this assertion is for Petitioner to advance the remarkable contention
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`that: “the claims recite a ‘film formulation,’ which cannot be distinguished from
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`the formulation of Suboxone tablets.” Id. at 27.
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`In asserting that the term “film formulation” as used in the claims does not
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`mean a film dosage or composition and that “film formulation” “cannot be
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`distinguished” from the formulation of Suboxone® tablets, Petitioner once again
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`presents no expert testimony about how one of ordinary skill in the art would
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`understand that (or any other) claim term. Instead, Petitioner relies on non
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`sequitur attorney argument such as the following.
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`Petitioner points to a sentence in the file history where the Applicant
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`supposedly stated: “The present invention is directed to formulation of a suitable
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`film product that provides a certain release profile.” Id. at 16 (emphasis in
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`original). Even if one were to assume (incorrectly) that this was an accurate
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`quotation and the applicant had used the word formulation in this sentence, the
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`sentence would simply state in effect that the invention concerns a particular
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`formulation for a film product (which plainly means the same thing as saying a
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`particular film formulation) that provides a certain release profile. Therefore, even
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`if the quote were accurate, it is evident that Petitioner would have no objective
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`basis to conclude, as it does, based on this sentence (and against the entire weight
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`Case IPR2014-00325
`Patent No. 8,475,832
`of the specification): “Thus, Applicant distinguished a film formulation from a
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`resulting film product that provides a release profile.” Id. In fact, however,
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`Petitioner misquotes the file history and then goes so far as to rely on the very
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`word that it misquotes. What the Applicant actually said in its First Response was
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`that:
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`the formation of a suitable film
`The present invention is directed to
`product that provides a certain release profile . . . .
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`(Ex. 1007 at 7) (emphasis added). Evidently straining to try to find some support
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`for its tortured claim construction position, Petitioner misquotes the word
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`“formation” as “formulation” (Pet. 16), and then seeks to freight the misquoted
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`word with a significance that it would not have had in any event, as discussed
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`above.
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`In addition to Petitioner’s lack of any objective evidence, including expert
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`evidence, to support its position on claim construction and the hollowness of its
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`assertions (as discussed above), there are numerous reasons why that position is
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`clearly wrong.
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`First, nowhere in the claims, the specification or the file history is there any
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`statement to the effect, or which even suggests, that the Applicant meant to draw a
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`distinction between its use of the term film formulation and its use of the terms
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`film dosage, film product, film composition, film strip, and film.
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`Case IPR2014-00325
`Patent No. 8,475,832
`Second, as discussed above, in fact all of those terms have a plain and
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`unambiguous meaning and are used synonymously and interchangeably throughout
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`the specification.4 See, e.g., Ex. 1001 at 2:7,15, 23-24, 43-44, 55-56, 64; 3:57-66;
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`4:57, 61; 5:4; 6:60; 13:11, 45; 15:29, 63-65; 17:51, 56; 18:30-50; 23:8, 50. To take
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`a few illustrative examples:
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`Still other embodiments of the present invention provide an orally dissolving
`film formulation including buprenorphine and naloxone, where the
`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
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`4 When construing claims in inter partes review, the Board gives each claim “its
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`broadest reasonable construction in light of the specification of the patent in which
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`it appears.” 37 C.F.R. § 42.100(b). The specification “is always highly relevant to
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`the claim construction analysis. Usually, it is dispositive; it is the single best guide
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`to the meaning of a disputed term.” Phillips v. AWH Corp., 415 F.3d 1303, 1315
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`(Fed. Cir. 2005) (en banc) (internal citations and quotations omitted). “The
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`specification acts as a dictionary when it expressly defines terms used in the claims
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`or when it defines terms by implication.” Vitronics Corp. v. Conceptronic, Inc., 90
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`F.3d 1576, 1582 (Fed. Cir. 1996) (citation omitted). See also Garmin Int’l, Inc. v.
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`Cuozzo Speed Tech., LLC, IPR2012-00001, Paper 15 at 4 (PTAB Jan. 9, 2013).
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`Case IPR2014-00325
`Patent No. 8,475,832
`plasma profile having a Cmax of between about 41.04 pg/ml to about 323.75
`pg/ml for naloxone. [Id. at 2:63 to 3:2, emphasis added]
`***
`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. [Id. at 18:30-34,
`emphasis added]
`
`***
`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. [Id.
`at 23:49-55, emphasis added]
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`The first excerpt above from the specification corresponds to the subject
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`matter claimed in claim 15. The syntax of the passage makes it unmistakably clear
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`that the “orally dissolvable film formulation” is “the formulation” (meaning the
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`film product, dosage or composition) that provides a certain in-vivo plasma profile.
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`In claim 15 itself, the wording is slightly different (“wherein said formulation” as
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`opposed to “where the formulation” as in the passage quoted above), but clearly
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`has the same meaning: “said formulation” is the film dosage or composition. The
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`second excerpt shows the explicit, interchangeable use of the terms “film dosages,”
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`“film formulations,” and “films.” The third excerpt shows the explicit,
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`Case IPR2014-00325
`Patent No. 8,475,832
`interchangeable use of the terms “film formulation” and “film product” and
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`contrasts those with “tablet formulation.” Furthermore, each of the dependent
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`claims in issue (claims 16-19) begin by reciting “The formulation of claim 15,
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`wherein said formulation provides….” Thus, the structure of the dependent claims
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`also shows that the term “film formulation” in claim 15 refers to a film dosage,
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`composition or product. Therefore, the broadest reasonable construction (indeed,
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`the only reasonable construction) of the term “film formulation” in claim 15 is film
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`dosage or composition.
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`That this is the correct construction is further brought home by Petitioner’s
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`apparent recognition that one needs to have, in Petitioner’s phrase, a “resulting
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`film” in order to achieve the in-vivo plasma profile recited in claim 15. However,
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`what Petitioner does to make sure there is in fact a film dosage in the claim is,
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`bizarrely enough, to read the term “resulting film” into the otherwise perfectly
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`unambiguous claim term “provides an in-vivo plasma profile,” which Patent
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`Owner does not believe needs any construction. Thus, Petitioner’
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