Paper No. ______
`Filed March 10, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
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`v.
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`RB PHARMACEUTICALS LIMITED
`Patent Owner
`____________
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`Case IPR2014-00325
`Patent 8,475,832
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`____________
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
`EXCLUDE EXHIBIT 2043
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`Filed March 10, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
`
`v.
`
`RB PHARMACEUTICALS LIMITED
`Patent Owner
`____________
`
`Case IPR2014-00325
`Patent 8,475,832
`
`
`____________
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
`EXCLUDE EXHIBIT 2043
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`IPR2014-00325
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`I.
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`Introduction
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`Patent Owner RB Pharmaceuticals Limited (“Patent Owner”) submits this
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`Opposition to Petitioner’s Motion (Paper 35) to Exclude Exhibit 2043. Patent
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`Owner submits that Ex. 2043 (1) is relevant under F.R.E. 401 and, therefore,
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`admissible under F.R.E. 402 and (2) should not be excluded under F.R.E. 403.
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`II. Background of Patent Owner’s Reliance on Ex. 2043
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`In support of Patent Owner’s position that Petitioner failed to meet its
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`burden of establishing that Claims 15-19 of the ‘832 patent were obvious over the
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`combination of Labtec, Birch, and Yang, Patent Owner’s Response asserted that
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`(1) the Petitioner failed to establish that a person skilled in the art would have had
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`a reasonable expectation of successfully combining those references to arrive at the
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`claimed invention, and (2) the proposed combination would have required undue
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`experimentation to arrive at the claimed invention. See generally Patent Owner’s
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`Corrected Response, Paper 25, 42-53. Specifically, Patent Owner provided
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`testimony from Dr. Johnston that because “designing pharmaceutical films is a
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`complex art,” “[i]t undoubtedly took extensive research and development . . . [to]
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`design[] the formulation to produce the claimed films.” Id. at 49 (citing Ex. 2003 at
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`¶¶ 110-111, 114-115). Further, Patent Owner submitted that:
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`As one skilled in the art understands, altering any component of a
`formulation may have a significant impact on the entire system
`because the interrelationship of the ingredients and desired
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`1
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`IPR2014-00325
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`characteristics is complicated.
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`Id.
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`To further support its position on the complexity of film design and the
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`sensitivity of desired characteristics, e.g., absorption (or inhibition of absorption)
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`of the active ingredients, to even small changes in the composition of the film
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`formulation, Patent Owner submitted Ex. 2043, which is a patent owner response
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`submitted by Petitioner in IPR2014-00376, to show that Petitioner itself (or at least
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`its admitted subsidiary) previously admitted in another proceeding that, indeed,
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`“tinkering with even one component may have a significant effect on the entire
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`system . . . the combination of ingredients and desired characteristics requires a
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`delicate balance” (Paper 25, 50 (quoting Ex. 2043 at 2)), and “even small changes
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`to the formulation may have drastic effects on the entire device” (id. (quoting Ex.
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`2043 at 35)).
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`Petitioner, however, chose not to substantively respond to the substance of
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`Patent Owner’s argument in its Reply (Paper 31). Rather, Petitioner now tries to
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`use motion practice to effectively introduce substantive arguments regarding the
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`weight that Ex. 2043 should be afforded – arguments that it did not introduce in its
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`Reply, which is the proper avenue for such arguments.1
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`1 The Board has indicated that a motion to exclude is not an opportunity for a party
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`to supplement the record with arguments regarding the sufficiency of the evidence
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`2
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`IPR2014-00325
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`Furthermore, Petitioner’s argument on relevance is without merit; the Board
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`should be aware that Petitioner is taking a position in an IPR where it is the patent
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`owner that contradicts its position that it takes here as Petitioner. Specifically, Ex.
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`2043 provides quotes taken straight from Petitioner that Patent Owner uses as
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`evidence of the complexity of designing films to achieve specific characteristics.
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`Petitioner argues that Ex. 2043 is somehow irrelevant to the factual inquiry of
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`whether the limited disclosure of Petitioner’s cited references regarding how a
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`person skilled in the art might manipulate certain ingredients to achieve the
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`claimed limitations is insufficient, such that the proposed combination fails to
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`provide a reasonable expectation of success and requires undue experimentation.
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`As discussed below, however, Ex. 2043 is both (1) relevant under F.R.E. 401 and,
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`therefore, admissible under F.R.E. 402, and (2) highly probative as to whether the
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`references provide a reasonable expectation of success or would require undue
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`experimentation with limited, if any, prejudicial effect or danger of confusion or
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`waste of time.
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`III. Ex. 2043 Is Relevant Under F.R.E. 401
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`“Evidence is relevant if: (a) it has any tendency to make a fact more or less
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`probable than it would be without the evidence; and (b) the fact is of consequence
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`to prove a particular fact. Office Trial Practice Guide, 77 Fed. Reg. 48765, 48767
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`(Aug. 14, 2012).
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`IPR2014-00325
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`in determining the action.” F.R.E. 401. Here, Ex. 2043 is being used by Patent
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`Owner as evidence of the complexity, sensitivity, and unpredictability of designing
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`a pharmaceutical film with specific characteristics, which is a relevant inquiry in
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`addressing the factual issue of whether the Petitioner has established that a person
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`skilled in the art would have had a reasonable expectation of success in arriving at
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`the claimed invention without undue experimentation.
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`Ex. 2043 is a Patent Owner Response filed by an admitted subsidiary of
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`Petitioner in another inter partes review – IPR2014-00376. There, when defending
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`the validity of its own patent, Petitioner argued that its claimed invention was
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`“remarkable” because of the difficulty of determining the specific combination of
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`ingredients necessary to achieve all of the claimed features. Paper 35, 4 (citing Ex.
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`2043 at 1). This was because:
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`Each ingredient and performance characteristic affects the others such
`that tinkering with even one component may have a significant effect
`on the entire system. In other words, the combination of ingredients
`and desired characteristics requires a delicate balance.
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`Ex. 2043 at 2. Therefore, even though Petitioner was arguing for the patentability
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`of another claim in that proceeding, Petitioner still argued that persons skilled in
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`this art had to strike a “delicate balance” of specific ingredients (none of which
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`were actually recited in the claim at issue) to obtain the claimed film, and that
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`manipulating any one ingredient could significantly affect the claimed
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`IPR2014-00325
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`characteristics of the film.
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` Patent Owner makes a virtually identical argument here. Specifically, Patent
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`Owner argues that “altering any component of a formulation may have a
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`significant effect on the entire system because of the interrelationship of the
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`ingredients and the desired characteristics” – the desired characteristics including
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`the claimed absorption rates of buprenorphine and naloxone. Paper 25, 49. Because
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`of this, “[n]one of the three references in any combination would teach the skilled
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`artisan how to strike such a balance and meet the required objectives with a
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`reasonable expectation of success or without undue experimentation.” Id. (citing
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`Ex. 2003 at ¶¶ 110-111, 114-115. Because Ex. 2043 is evidence in the compelling
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`form of statements by Petitioner that are directly supportive of Patent Owner’s
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`argument, it is relevant under F.R.E. 401.
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`IV. Ex. 2043 Should NOT Be Excluded Under F.R.E. 403
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`Under F.R.E. 403, “[t]he court may exclude relevant evidence if its
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`probative value is substantially outweighed by a danger of one or more of the
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`following: unfair prejudice, confusing the issues, misleading the jury, undue delay,
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`wasting time, or needlessly presenting cumulative evidence.”
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`A. Ex. 2043 Is Highly Probative
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`As discussed above, Patent Owner argued that due to the complexity,
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`sensitivity, and unpredictability in designing pharmaceutical film formulations,
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`5
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`IPR2014-00325
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`coupled with the failure of the prior art to describe how to manipulate specific
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`ingredients to achieved the claimed features, Petitioner failed to establish that an
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`ordinarily skilled artisan would have had a reasonable expectation of successfully
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`obtaining the claimed invention without undue experimentation. As also discussed
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`above, Ex. 2043 includes statements directly supporting Patent Owner’s argument
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`regarding the complexity of designing film formulations. Further, these statements
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`constitute admissions by Petitioner. Thus, Ex. 2043 is highly probative of a
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`material issue of fact.
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`Additionally, Petitioner’s argument that Ex. 2043 is not probative of any
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`material issue of fact because the claims of the ‘019 patent (subject of the
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`proceedings in IPR2014-00376) and the claims of the ‘832 patent “have no
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`common language” is without merit. Claim 1 of the ‘019 patent is directed to a
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`“method for the transmucosal delivery of a systemic pharmaceutical for achieving
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`. . . a desired level of a systemic pharmaceutical in the blood of a subject” by
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`“adhering” a “film containing a systemic pharmaceutical” “to an oral mucosa
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`surface of a subject” and “delivering an amount of a systemic pharmaceutical from
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`the [film] to mucosal tissue of the subject.” See Ex. 1055 at Claim 1 (emphasis
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`added). Thus, just like the ‘832 patent, the ‘019 patent is directed to a film dosage
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`form providing a desired level of a pharmaceutical active to a subject via oral
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`transmucosal absorption; that the two patents might use different “language” does
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`IPR2014-00325
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`not change this fact.
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`B.
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`Ex. 2043 Will Not Confuse the Issues or Waste Time
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`Petitioner asserts two reasons for not admitting Ex. 2043 into evidence: (1)
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`it will waste time; and (2) it confuses the issues. Paper 35, 5. Regarding wasting
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`time, Petitioner asserts “the Board will waste time reviewing Ex. 2043, the claims
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`of the two unrelated patents, and possibly papers filed in the two unrelated IPRs”
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`which “will only reveal that the ‘019 claims and the challenged claims . . . have no
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`common claim language . . . that the ‘832 and ‘019 patents have no common
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`ownership and no common inventors, and that there is no ‘agreement’ in Exhibit
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`2043 regarding the complexity of the field relevant to the ‘832 patent.” Id. at 6. For
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`the reasons discussed above, Petitioner’s argument that the claims of the two
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`patents “have no common claim language” is without merit. Further, the fact that
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`the two patents have no common ownership or inventors is irrelevant as to how Ex.
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`2043 is being used by Patent Owner. Finally, contrary to Petitioner’s assertion and
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`as discussed herein, Ex. 2043 establishes that Petitioner has “agreed” with Patent
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`Owner’s arguments regarding the complexity of pharmaceutical, orally dissolving
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`film formulation design, such that altering even one ingredient in a film
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`formulation can have significant effects on the ability to achieve desired
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`characteristics.
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`Regarding its allegation that Ex. 2043 will confuse the issues, Petitioner
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`IPR2014-00325
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`merely asserts this in conclusory fashion, and it does so, tellingly, without any
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`further explanation as to what specific issue will be confused or how such
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`confusion will occur. See Paper 35, 6 (“Similarly, RB’s citation to arguments made
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`in an unrelated IPR about an unrelated patent creates unnecessary confusion of the
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`issues in this case, i.e., whether the challenged claims are patentable over the
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`applied grounds.”).
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`Further, even if, in another forum, jurors might need the extra protection
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`Petitioner is seeking here, Patent Owner is confident (as Petitioner should be) that
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`this Board will be well aware of the specific issue before it, i.e., “whether the
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`challenged claims are patentable over the applied grounds.” Id.; see also Gnosis
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`S.P.A., et al. v. S. Alabama Medical Science Foundation, IPR2013-00118, Paper
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`64, 43 (June 20, 2014) (“the PTAB, sitting as a non-jury tribunal with
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`administrative expertise, is well-positioned to determine and assign appropriate
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`weight to evidence presented”); Toyota Motor Corp. v. Am. Vehicular Sciences
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`LLC, IPR2013-00419, Paper 25, 3 (Feb. 11, 2014) (“[A]n assertion of irrelevance
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`in a motion to exclude evidence is not likely to be successful except in a rare
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`situation, because the Board is capable of according the proper weight to the
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`evidence, including none, based on the pertinence of the evidence.”).
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`IPR2014-00325
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`V. Conclusion
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`For at least the reasons set forth herein, Patent Owner submits that Ex. 2043
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`should not be excluded from this proceeding.
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`Dated: March 10, 2015
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` Respectfully submitted,
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`/ James M. Bollinger /
`James M. Bollinger, Reg. No. 32,555
`Daniel A. Ladow, pro hac vice
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`9
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`IPR2014-00325
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`CERTIFICATE OF SERVICE UNDER 37 C.F.R § 42.6(e)
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`The undersigned hereby certifies that a copy of the foregoing PATENT
`OWNER’S OPPOSITION TO PETITIONER’S MOTION TO EXCLUDE EX.
`2043 was served electronically via email on March 10, 2015, on attorneys for
`Petitioner:
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`
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`Danielle L. Herritt
`Kia L. Freeman
`MCCARTER & ENGLISH, LLP
`265 Franklin Street
`Boston, MA 02110
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`dherritt@mccarter.com
`IPR832@mccarter.com
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`Dated: March 10, 2015
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`
` /James M. Bollinger/
`James M. Bollinger
`Reg. No. 32,555
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`10
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