Paper No. _______
`
`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 No. IPR2014-00325
`Patent 8,475,832
`_______________
`
`
`
`PETITIONER’S REPLY
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`
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`
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`I.
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`II.
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`III.
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`
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`Table of Contents
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`Page
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`Introduction ...................................................................................................... 1
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`RB does not deny that each and every limitation recited in the
`challenged claims is disclosed in Labtec. ........................................................ 1
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`Instead of construing a specific claim term, RB argues the
`claims should be read “as reciting…oral transmucosal
`absorption” ....................................................................................................... 1
`
`A. Under the broadest reasonable interpretation,
`limitations that have no express basis in the claim
`are not read in. ....................................................................................... 2
`
`B.
`
`C.
`
`RB is attempting to amend its claims without
`meeting its burden to demonstrate the claims are
`patentable over the prior art. ................................................................. 3
`
`RB’s arguments that the ‘832 patent “solely
`concerns oral transmucosal absorption” lack merit .............................. 4
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`IV. RB argues that Labtec’s anticipating disclosure of oral
`transmucosal absorption should be ignored .................................................... 5
`
`A.
`
`B.
`
`C.
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`Labtec is not limited to “peroral GI-absorbed
`dosages.” ................................................................................................ 5
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`Teaching away is not relevant to anticipation. ...................................... 6
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`Labtec discloses the claimed film formulation,
`arranged as recited in the claims. .......................................................... 6
`
`D.
`
`Labtec is enabled. .................................................................................. 7
`
`1.
`
`2.
`
`3.
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`Labtec’s alleged mistake is irrelevant. ........................................ 7
`
`RB’s evidence refutes its theory that
`Labtec’s film is “inoperable.” ..................................................... 8
`
`RB’s evidence refutes its theory that
`Labtec’s film could not accomplish
`therapeutically acceptable effects ............................................. 10
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`Table of Contents
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`4.
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`RB’s evidence does not support its argument
`about claim 19 ........................................................................... 11
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`Page
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`V.
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`RB does not refute the obviousness of the challenged claims
`based on the references as applied by the Board to the recited
`limitations. ..................................................................................................... 12
`
`A.
`
`B.
`
`C.
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`RB’s non-obviousness arguments are based on
`distinctions that do not exist or teachings for which
`the references were not applied. .......................................................... 12
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`There is no evidence of “undue experimentation.” ............................. 13
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`RB provides no probative evidence of commercial
`success or nexus .................................................................................. 14
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`Case IPR2014-00325
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`I.
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`
`
`INTRODUCTION
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`RB does not dispute that every recited element of the challenged claims, as
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`arranged in the claims, is disclosed in Labtec. Instead, RB asks the Board to read
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`in a new limitation—oral transmucosal absorption (“OTA”)—not by interpretation
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`of any specific claim language, but because the ‘832 patent “solely concerns”
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`OTA. RB then asks the Board to ignore the disclosure of OTA in Labtec.
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`
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`But RB’s reasons for reading in OTA from the specification, and ignoring its
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`disclosure in Labtec—based on a theory that Labtec and the ‘832 patent have
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`mutually exclusive disclosures—did not bear up to cross-examination.
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`
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`RB’s non-enablement arguments fail because even RB cannot tell us what is
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`not enabled. RB similarly cannot tell us why its claims are not obvious. And while
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`RB argues commercial success, it provides no evidence of it.
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`II.
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`RB DOES NOT DENY THAT EACH AND EVERY LIMITATION RECITED IN THE
`CHALLENGED CLAIMS IS DISCLOSED IN LABTEC.
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`
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`RB does not refute that Labtec (Ex. 1017) discloses the recited elements of
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`the challenged claims, as arranged in the claims. For example, when asked, RB’s
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`expert could not identify any recited element of claim 15 that was not disclosed in
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`Labtec. Ex. 1028, 108:24-109:20, 126:19-127:19.
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`III.
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`INSTEAD OF CONSTRUING A SPECIFIC CLAIM TERM, RB ARGUES THE CLAIMS
`SHOULD BE READ “AS RECITING…ORAL TRANSMUCOSAL ABSORPTION”
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`
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`In the Institution Decision, the Board declined to read mucosal absorption
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`into the claims. Decision, 15 (“In, addition, [RB] does not propose that we
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`construe ‘film formulation’1 to require … mucosal absorption of buprenorphine,
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`and we decline to read those unrecited features into the challenged claims.”). RB
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`now asks the Board to read OTA into the claims from the specification, contrary to
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`the broadest reasonable interpretation standard applied in inter partes review
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`proceedings. Patent Owner Corrected Response (“POCR”), 20.
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` A. Under the broadest reasonable interpretation, limitations that have no
`express basis in the claim are not read in.
`
`
`
`In asking the Board to read a limitation into the claims from the
`
`specification, RB cites a Federal Circuit case not based on the broadest reasonable
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`interpretation. POCR, 20. When reviewing Board decisions under the broadest
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`reasonable interpretation standard, the Federal Circuit has found that, because the
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`applicant has the opportunity to amend the claims during prosecution, giving a
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`claim its broadest reasonable interpretation reduces the possibility that the claim,
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`once issued, will be interpreted more broadly than is justified. In re Yamamoto,
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`740 F.2d 1569, 1571 (Fed. Cir. 1984); In re Prater, 415 F.2d 1393, 1404-05
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`(CCPA 1969). Because RB had the opportunity to amend the claims, the policy
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`1 BDSI’s proposed construction of “film formulation” does not read out the word
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`“film”—it explicitly requires that it be “capable of being used to prepare a single
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`film.” Petition, 22.
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`that supports the broadest reasonable interpretation during prosecution also applies
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`here. The appeals court in Prater explained that “‘reading a claim in the light of
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`the specification,’ to thereby interpret limitations explicitly recited in the claim, is
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`a quite different thing from ‘reading limitations of the specification into a claim,’
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`to thereby narrow the scope of the claim by implicitly adding disclosed limitations
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`which have no express basis in the claim.” Id., at 1404; see also In re Morris,
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`127 F.3d 1048, 1054-55 (Fed. Cir. 1997). RB has not moved to amend the claims,
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`and now instead asks the Board not to apply the broadest reasonable interpretation.
`
` B. RB is attempting to amend its claims without meeting its burden to
`demonstrate the claims are patentable over the prior art.
`
`
`
`In a motion to amend, the patent owner bears the burden “to show patentable
`
`distinction over the prior art of record.” IPR2012-00027, Decision on Motion to
`
`Amend, Paper 26, 7. RB effectively seeks to amend the claims while avoiding its
`
`burden to patentably distinguish, e.g., over Euro-Celtique (Ex. 1018). RB knows it
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`could not meet its burden. See Petition, IPR2014-00325, 46-56 (Grounds 9-12
`
`applying Euro-Celtique); see also Ex. 1033, IPR2014-00998, Petition for Inter
`
`Partes Review of the ‘832 Patent, 41 (noting Euro-Celtique discloses film that
`
`delivers active through the mucosa); Ex. 1034, IPR2014-00998, Institution
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`Decision, 6, 9 fn. 8 (denying institution as a discretionary matter). Indeed, RB is
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`aware that the Patent Office has finally rejected claims that are narrower than the
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`challenged claims, over Euro-Celtique. Ex. 1035, IPR2014-00998, Motion for
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`Joinder, 4-5 (comparing rejected and challenged claims); see also Ex. 1036,
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`Publication of USSN 13/964,975; Ex. 1037, Non-final Rejection; Ex. 1038,
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`Amendment and Response; Ex. 1039, Final Rejection. RB should not be allowed
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`to amend without meeting its burden.
`
` C. RB’s arguments that the ‘832 patent “solely concerns oral transmucosal
`absorption” lack merit
`
`
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`RB presents two reasons that the ‘832 patent “solely concerns [OTA].”
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`POCR, 20-21. First, RB argues that a person of skill would understand the “oral
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`transmucosal nature of the claimed film” from (i) the desire to mimic Suboxone
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`tablet absorption, (ii) the desired dissolution time, and (iii) the desire to select a pH
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`that achieves its goals. POCR, 22-23. But these desired (and unclaimed) attributes
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`are no different from those disclosed in Labtec. Ex. 1017, 3:15-18, Table A
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`(disclosing a film that mimics Suboxone tablets); Ex. 1028, 137:13-138:4, 140:20-
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`141:17 (RB’s expert discussing overlap between preferred dissolution times of
`
`Labtec and the ‘832 patent); 127:25-128:3 (RB’s expert admitting Labtec discloses
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`controlling pH to adjust drug absorption).
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`
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`Second, RB argues the ‘832 patent is “solely concerned” with OTA because
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`“all of the pharmacokinetic data and ranges in the specification and the claims
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`represent the results of [OTA].” POCR, 21. But RB’s expert opined that
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`buprenorphine could be absorbed in the gut “if some is unintentionally swallowed”
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`(Ex. 2003, ¶ 72, fn. 11), and then later admitted that the solution resulting from an
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`orally-dissolving film “has to be swallowed” (Ex. 1028, 236:25-237:18). As Dr.
`
`Feigal explains, “the bioavailability of buprenorphine from an orally-dissolving
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`dosage form results from absorption in both the mouth and the GI tract.” Ex. 1029,
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`¶ 31, see also ¶ 30. In short, the ‘832 patent is not “solely concerned” with OTA.
`
`IV. RB ARGUES THAT LABTEC’S ANTICIPATING DISCLOSURE OF ORAL
`TRANSMUCOSAL ABSORPTION SHOULD BE IGNORED
`
`
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`There is no dispute that Labtec states its “invention provides an orally
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`disintegrating film comprising: (a) an active pharmaceutical agent that is
`
`absorbable through the oral mucosa when dissolved; and (b) means for retarding
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`absorption of said active pharmaceutical ingredient through the oral mucosa.” Ex.
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`1017, 15. Thus Labtec specifically discloses OTA. Labtec also discloses retarding
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`absorption with pH adjusting agents to achieve bioequivalence. Ex. 1017, 15-16.
`
`This is the allegedly surprising discovery of the ‘832 patent. Ex. 1001, 23:1-7.
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`
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`RB argues that Labtec does not anticipate based on its theories of how
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`Labtec’s films function and how Labtec allegedly teaches away.
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` A. Labtec is not limited to “peroral GI-absorbed dosages.”
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`
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`RB presents an elaborate argument that Labtec’s films are designed to mimic
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`“peroral GI-absorbed dosages.” POCR, 27-29. But Labtec actually discloses film
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`products that follow the same absorption “pathways” as target products. Ex. 1017,
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`3:15-18. Because Labtec refers to a plurality of absorption “pathways,” it is
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`clearly not limited to a single absorption pathway. And again, Labtec discloses
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`OTA. Id., 15:27; Ex. 1029, ¶¶ 39-40. Labtec discloses that, in some embodiments,
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`as little as about 60% of the active ingredient is delivered to the GI tract. Ex. 1017,
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`15:30-32. Thus, as much as about 40% is OTA absorbed. Ex. 1029, ¶ 40.
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` B. Teaching away is not relevant to anticipation.
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`
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`Rather than addressing Labtec’s actual disclosure, RB argues that Labtec
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`does not anticipate because it teaches away. However, as already recognized by
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`the Board, teaching away is legally irrelevant to anticipation. Decision, 15. And
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`even with a teaching away, “a reference may be read for all that it teaches,
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`including uses beyond its primary purpose.” In re Mouttet, 686 F.3d 1322, 1331
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`(Fed. Cir. 2012). And Labtec teaches everything recited in the challenged claims.
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`Finally, even if OTA were claimed, Labtec discloses OTA.
`
` C. Labtec discloses the claimed film formulation, arranged as recited in
`the claims.
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`
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`RB argues that Labtec does not disclose the “claimed composition …
`
`‘without any need for picking, choosing, and combining various disclosures.’”
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`POCR, 31. But again, Labtec specifically discloses the claimed film formulation
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`in one embodiment with all the claim limitations, as arranged in the claims. Ex.
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`1017, 21, 23. RB also argues Labtec fails to disclose examples of films
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`“bioequivalent to Suboxone tablets.” POCR, 31. Even if that were claimed,
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`Labtec discloses such a film.
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`
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`RB’s “§ 112 analysis” is not applicable to Labtec’s anticipation. POCR, 31.
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`Anticipation does not require actual performance of the teachings of the
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`reference—only that the disclosure is enabled. In re Gleave, 560 F.3d 1331, 1334
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`(Fed. Cir. 2009) (“no ‘actual creation or reduction to practice’ is required”).
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` D. Labtec is enabled.
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`
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`RB’s expert could point to no element recited in the challenged claims that
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`was not disclosed in Labtec. Ex. 1028, 126:19-127:19; Ex. 1029, ¶ 50 (Dr. Feigal
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`agreeing), ¶¶ 51-52. And, RB’s expert admits Labtec discloses controlling the pH
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`to adjust drug absorption. Ex. 1028, 127:20-128:3. This is the only
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`experimentation suggested in the ‘832 patent (which “surprisingly” discovered a
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`film with the same pH as the tablet it was copying). Ex. 1001, 18:25-22:67 (in vivo
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`study), 23:1-7 (“surprising” result); Ex. 1028, 146:8-13 (RB’s expert admitting
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`Suboxone film has the same pH as Suboxone tablets). RB’s expert admitted that
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`Labtec’s films are administered to the oral cavity and dissolved in the mouth. Ex.
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`1028, 104:2-10. And RB’s expert admitted that Labtec discloses longer dissolution
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`times than that preferred in the ‘832 patent. Id., 136:16-141:17.
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`
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`Unable to identify what Labtec does not enable, RB instead argues non-
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`enablement of unclaimed features, contradicting RB’s own clinical data.
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`1. Labtec’s alleged mistake is irrelevant.
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`
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`RB admits that Labtec is directed to an “orally dissolving film that is meant
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`to follow the same metabolic route and to use the same dosage amounts as the
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`brand name products listed in Labtec.” POCR, 3. RB also admits that Labtec
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`discloses a film product that follows the same absorption “pathways” as the brand
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`name product. Id., 32. RB admits that Labtec discloses Suboxone tablets and that
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`they are “not peroral drugs for GI absorption.” Id., 33. But then RB argues that
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`Labtec’s disclosure should be limited to “swallowable GI-absorbed dosage forms.”
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`Id. By RB’s own admissions, Labtec is not so limited. In his review of the
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`relevant material, Dr. Feigal has “seen no evidence that the disclosure of
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`Suboxone…is a mistake.” Ex. 1029, ¶ 33, ¶¶ 34-41. And any alleged mistake
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`does not circumvent Labtec’s actual disclosure of Suboxone and Subutex tablets.
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`2. RB’s evidence refutes its theory that Labtec’s film is “inoperable.”
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`
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`RB argues that Labtec is inoperable based on its theory that Labtec’s orally-
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`dissolving film would not produce pharmacokinetic values “similar” to Suboxone
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`orally-dissolving tablets. POCR, 34-5; Ex. 1028, 6:7-9 (RB’s expert agreeing that
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`Suboxone tablets are orally-dissolving tablets). This argument is based on the
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`theory that the “peroral administration for GI absorption” of Labtec’s film, as
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`compared to administration of Suboxone tablets, results in (i) “much lower
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`bioavailability” and (ii) more variability. POCR, 34.
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`
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`As a preliminary matter, RB’s expert defines “peroral” as “a dosage form
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`[that] is swallowed for subsequent absorption in the gastrointestinal tract.” Ex.
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`1028, 3:23-25. But then RB’s expert admits that he “can’t think of any films that
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`are actually swallowed for subsequent absorption in the gastrointestinal tract.” Id.,
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`30:16-18. In fact, he states “you can’t take a film and swallow it.” Id., 93:12-13.
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`Finally, he admits that Labtec’s film is not simply swallowed—but rather dissolved
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`in saliva and the drug/saliva solution is subsequently swallowed. Id., 104:2-10.
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`Any difference suggested by the use of the word “peroral” to characterize
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`administration and/or absorption of Labtec’s film is, at best, unclear. Ex. 1029,
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`¶ 46 (“I find [RB’s expert’s] use of the word ‘peroral’ to distinguish the
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`administration and/or absorption described in Labtec from that described in the
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`‘832 patent to be unhelpful and misleading.”), ¶¶ 43-49.
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`
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`Both Labtec’s film and a Suboxone tablet are orally dissolving dosage
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`forms, which are dissolved in the mouth before swallowing. And, RB’s expert
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`admitted that “in an orally dissolving dosage form, buprenorphine would be
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`absorbed in the oral cavity.” Id., 96:7-9. Accordingly, buprenorphine from both
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`Labtec film and Suboxone tablets would be absorbed in the oral cavity.
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`
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`And in any event, contrary to the opinion of RB’s expert, as compared to
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`buprenorphine administered in Suboxone tablets, orally-administered
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`buprenorphine results in (i) overlapping bioavailability and (ii) less variability. In
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`the opinion of RB’s expert, the approximate mean absolute oral bioavailability of
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`buprenorphine is 5-14%. Ex. 1028, 76:8-14. Although RB’s expert disputes it, RB
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`reports that its own Suboxone tablets have a mean absolute bioavailability for
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`buprenorphine of 13.6% (range 5.1-24.9%). Ex. 2007, 2; see also Ex. 1028, 77:12-
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`23; Ex. 1029, ¶¶ 54-60 (explaining why RB’s expert’s dispute lacks merit). RB
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`also reports “[t]here was a wide inter-patient variability in the sublingual
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`absorption of buprenorphine…from SUBOXONE tablets.” Ex. 2007, 2; Ex. 1029,
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`¶ 65 (pointing out that RB’s expert does not explain why wide variability would be
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`acceptable in one dosage form, but not in another). Thus, RB’s evidence proves its
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`theory is wrong.
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`
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`Similarly, contrary to the opinion of RB’s expert, as compared to naloxone
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`administered in Suboxone tablets, orally-administered naloxone results in (i)
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`similar bioavailability and (ii) similarly “wide” variability. In the opinion of RB’s
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`expert, the approximate mean absolute oral bioavailability of naloxone is
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`“somewhere between one and two percent.” Ex. 1028, 37:24-38:23. RB reports
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`that its Suboxone tablets have a mean absolute bioavailability for naloxone of 3%.
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`Ex. 2007, 2. RB also reports “[t]here was a wide inter-patient variability in the
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`sublingual absorption of …naloxone from SUBOXONE tablets.” Id. Thus, RB’s
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`evidence again proves its theory—that Labtec’s film would be inoperable—wrong.
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`3. RB’s evidence refutes its theory that Labtec’s film could not
`accomplish therapeutically acceptable effects.
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`
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`RB then argues that Labtec’s film could not accomplish therapeutically
`
`acceptable effects because “peroral administration of buprenorphine …result[s in]
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`poor bioavailability and expected increased inter- and intra-patient variability.”
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`POCR, 36. As discussed directly above, RB’s evidence proves its theory wrong—
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`compared to buprenorphine administered in Suboxone tablets, orally-administered
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`buprenorphine results in (i) overlapping bioavailability and (ii) less variability.
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`And RB admits “that the inclusion of naloxone does not alter the pharmacokinetics
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`of buprenorphine.” Ex. 1028, 51:10-19; see also Ex. 2007, 2. Finally, there is no
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`“therapeutic effect” of naloxone, which is only included in Suboxone to deter IV
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`abuse. Ex. 1028, 61:24-62:23; see also Ex 2007, 1-2.
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`4. RB’s evidence does not support its argument about claim 19.
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`
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`RB argues that “it is not technically possible to meet claim 19 through
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`peroral administration of naloxone.” POCR, 37-38. But RB’s expert admits that,
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`like Suboxone tablets, the films of Labtec are dissolved in the mouth and then
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`swallowed. Ex. 1028, 104:2-10. And Labtec discloses an orally dissolving film
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`designed to mimic a Suboxone orally-dissolving tablet, like the ‘832 patent. Ex.
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`1017, 3:15-18.
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`
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`RB’s expert also admits that the Cmax for 1 mg naloxone administered in a
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`Suboxone tablet is approximately 3 times the lower limit of the naloxone Cmax
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`range recited in claim 15. Ex. 1028, 54:23-55:7. So, in other words, a Suboxone
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`tablet including 1 mg naloxone, the lowest dose recited in claim 19, produces a
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`Cmax three times the lower limit of the naloxone Cmax range recited in claim 15.
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`Accordingly, Labtec’s orally-dissolving film would produce a Cmax within the
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`naloxone range recited in claim 15 for dosages recited in claim 19.
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`And even if Labtec’s film were swallowed, RB’s expert reluctantly admitted
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`that the mean absolute bioavailability of oral naloxone is “one-third” that of a
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`Suboxone tablet. Ex. 1028, 45:7-20. RB’s expert opined that the Cmax for
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`naloxone increases for doses from 1 mg to 4 mg, the range recited in claim 19. Id.,
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`51:20-52:4. Thus, even if Labtec’s film were swallowed, it would produce a
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`naloxone Cmax in the range recited in claim 15 from 1 mg of naloxone (the lowest
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`dose recited in claim 19). Even if it did not, Labtec’s film—containing a larger
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`naloxone dose within the range recited in claim 19—would.
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`V. RB DOES NOT REFUTE THE OBVIOUSNESS OF THE CHALLENGED CLAIMS BASED
`ON THE REFERENCES AS APPLIED BY THE BOARD TO THE RECITED LIMITATIONS.
`
` A. RB’s non-obviousness arguments are based on distinctions that do not
`exist or teachings for which the references were not applied.
`
`
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`RB does not refute the obviousness ground as to the recited limitations of the
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`claims. POCR, 39-47. RB’s arguments regarding Labtec are based on disproven
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`theories that (i) the challenged claims somehow exclude GI absorption, (ii)
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`Labtec’s films somehow excludes OTA, and/or (iii) Labtec’s films are swallowed
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`whole. Again, RB’s arguments based on these non-existent distinctions fail.
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`
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`RB admits Yang discloses the teaching for which it was applied by the
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`Board. POCR, 42 (“Yang…discloses methods of making pharmaceutical films”).
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`RB instead argues that Yang does not teach “how to ensure the resulting film
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`provides a bioequivalent effect of a specific tablet.” POCR, 43. That is not
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`claimed. And, in any event, it is disclosed in Labtec. Finally, whether Birch
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`teaches pharmaceutical films is not relevant. Birch was not applied by the Board
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`for this or any other teaching. Decision, 17-18.
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` B. There is no evidence of “undue experimentation.”
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`
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`BDSI has established both motivation to combine and a reasonable
`
`expectation of success to achieve the claimed film formulations. See e.g., Petition,
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`4-14, 26-56. And RB’s expert states a person of skill in the art “would need to
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`have a good understanding of at least: i) orally dissolving pharmaceutical films; ii)
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`the pharmacokinetics of buprenorphine and naloxone….” Ex. 2003, ¶ 23.
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`
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`Notably, when asked, RB’s expert admitted he has no practical experience in
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`orally dissolving pharmaceutical films. Ex. 1028, 258:24-259:5. And he disputed
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`RB’s description of the pharmacokinetics of buprenorphine and naloxone of RB’s
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`own products. Ex. 1028, 77:12-23 (buprenorphine bioavailability); 64:18-65:18
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`(naloxone first pass effects); see also Ex. 1029, ¶¶ 53-70 (Dr. Feigal pointing out
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`inconsistencies between the opinions of RB’s expert and the evidence he cites).
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`Although in a unique position to do so, RB did not provide any evidence of
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`experimentation beyond that in the ‘832 patent. RB instead relies on the
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`unsupported testimony of its expert, who again, was not involved in the film
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`development and has no practical experience in orally dissolving pharmaceutical
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`films. Ex. 1028, 185:10-13; 258:24-259:5. Thus, the only evidence of
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`experimentation in the record is in the ‘832 patent. And, as RB’s expert admits, in
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`the ‘832 patent, two of the three test film formulations with different pHs fell
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`within the challenged claims. Ex. 1028, 193:18-199:22. RB also argues that it
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`“undoubtedly took extensive research and development” to develop a film… “to
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`provide effects bioequivalent to Suboxone® tablets.” POCR, 49. But, the
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`challenged claims do not require the film to “provide effects bioequivalent to
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`Suboxone® tablets.” Ex. 1029, ¶ 22 (“The ranges in Claims 15-17…do not
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`represent ‘bioequivalent’ ranges, as the term ‘bioequivalent’ is understood in the
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`field or as it is defined in the ’832 patent.”).
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`Finally, RB’s expert opines that designing orally-dissolving transmucosal
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`pharmaceutical films is a complex art because of the interrelationship of the
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`ingredients. Ex. 2003, ¶¶ 110-111. But the challenged claims only require two
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`ingredients: buprenorphine and naloxone. And RB admits that naloxone has no
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`effect on the pharmacokinetic parameters of buprenorphine. Ex. 2007, 2; Ex.
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`1028, 51:10-19.
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` C. RB provides no probative evidence of commercial success or nexus
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`RB does not explain why it relies on BDSI statements rather than presenting
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`its own verifiable sales, prescription, and market share data. Ex. 1031, ¶¶ 14-18.
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`Particularly since, in the opinion of Dr. Meyer, “those quotations are consistent
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`with RB’s product conversion campaign, rather than concerning the subject matter
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`of the challenged claims.” Id., ¶ 15. Because RB fails to provide the necessary
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`data and analysis, the conclusion that Suboxone® film was a commercial success
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`is unfounded. Id., ¶19.
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`RB’s expert relies on Exhibit 2040 for his opinion that RB’s commercial
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`films were covered by the claims. Ex. 2003, ¶ 118. But he did not, and could not,
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`verify the exhibit actually describes RB’s commercially available Suboxone film.
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`Ex. 1028, 217:4-223:8; Ex. 1029, ¶¶ 68-70. He also admitted he did not
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`understand the scope of the claims. Ex. 1028, 203:13-16. In any event, it is not
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`sufficient that a product merely be within the scope of a claim. IPR2013-00274,
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`Paper No. 31, at 27-28, citing Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d
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`1364, 1376 (Fed. Cir. 2005). RB also fails to make any showing that the alleged
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`commercial success of the product was attributable to the claimed subject matter,
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`and not the prior art, which includes the known combinations of the active
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`ingredients in dissolvable tablet form. Ex. 1031, ¶¶ 20-30.
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`Dated: January 30, 2015
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`Respectfully submitted,
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`By: /Danielle L. Herritt/
`Danielle L. Herritt (Reg. No. 43,670)
`Kia L. Freeman (Reg. No. 47,577)
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PETITIONER’S
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`REPLY, including Exhibits 1028 through 1053 and this Certificate of Service,
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`were electronically served on January 30, 2015 by transmitting a copy to lead
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`counsel James Bollinger at james.bollinger@troutmansanders.com and to backup
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`counsel Daniel Ladow at daniel.ladow@troutmansanders.com in accordance with
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`the consent set forth in RB Third Amended Mandatory Notice Information.
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`By:
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`/Danielle L. Herritt/
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`Danielle L. Herritt
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`Registration No. 43,670
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`Attorney for the Petitioner
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