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`Paper No._______
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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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 No. IPR2014-00325
`Patent 8,475,832
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`PETITIONER’S MOTION TO EXCLUDE
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`ME1 19784568v.2
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`Case IPR2014-000325
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`I.
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`INTRODUCTION
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`Exhibit 2043 is a Patent Owner Response from an unrelated IPR proceeding.
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`It is not relevant to the instant proceeding and RB’s use of it only serves to confuse
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`the issues and waste time.
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`Specifically, RB cites two quotes from Exhibit 2043 and characterizes them
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`as an “agreement” from BDSI about the complexity of making pharmaceutical film
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`generally. This is not the case. Instead, the quotes from Ex. 2043 concern the
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`difficulty of successfully manipulating seven recited limitations to practice a
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`specific claim in an unrelated patent. None of these seven limitations is recited the
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`claims challenged in the instant IPR. Finally, Exhibit 2043 is not only irrelevant
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`under FRE 401, but RB’s submission of it only serves to waste time and confuse
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`the issues, and is inadmissible under FRE 403.
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`II. BACKGROUND
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`BDSI timely objected to Exhibit 2043 on November 14, 2014 under Federal
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`Rules of Evidence 401-403. Ex. 1054, Nov. 14, 2014 Petitioner’s Objections, at 5.
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`Exhibit 2043 is a Patent Owner Response filed by a BDSI subsidiary in
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`unrelated IPR2014-00376. RB claims it is not involved in IPR2014-00376. RB
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`has not identified either IPR2014-00376, or the patent challenged in that
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`proceeding—US Patent No. 7,579,019 (“‘019 patent”)—as a related matter in the
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`ME1 19784568v.2
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`instant proceeding. Indeed, the ‘832 patent and the ‘019 patent are not related in
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`Case IPR2014-000325
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`any way by common disclosure, priority, or provenance. Compare Exhibit 1001
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`with Exhibit 1055. And, as illustrated by the sole independent claim of the ‘019
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`patent (reproduced below), the claims of the ‘019 and the claims challenged in the
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`instant proceeding share no common claim language, other than the words “film”
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`and “profile”:
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` 1. A method for the transmucosal delivery of a systemic
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`pharmaceutical for achieving a fast onset of activity in a subject or a
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`desired level of a systemic pharmaceutical in the blood of a subject,
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`comprising:
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`adhering a bioerodable device to an oral mucosa surface of a
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`subject such that there is minimal foreign body sensation;
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`and
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`directionally delivering an amount of a systemic
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`pharmaceutical from the bioerodable device to mucosal
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`tissue of the subject such that an effective amount of the
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`systemic pharmaceutical is delivered to the subject
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`achieving a fast onset of activity in the subject or a
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`desired level of the systemic pharmaceutical in the blood
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`of the subject within about 30 minutes,
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`wherein the bioerodable device has a residence time of less than
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`1 hour or about 1 hour, and the device comprises a thin and flexible
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`adherent and bioerodable polymeric film containing a systemic
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`pharmaceutical, and wherein the bioerodable device comprises soluble
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`ME1 19784568v.2
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`polymers selected based on dissolution rates to achieve the desired
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`Case IPR2014-000325
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`residence time and release profile.
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`Ex. 1055, ‘019 patent, at 24:47-67.
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`RB’s reference to Ex. 2043 is on page 50 of Patent Owner’s Corrected
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`Response. Paper No. 25 (“POCR”), at 50. RB relies on two partial sentences from
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`Ex. 2043 in an attempt to establish an “agreement” that does not exist:
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`Petitioner agrees, taking the position, in a proceeding in which it is
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`defending its own patent, that in designing pharmaceutical films for
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`systemic drug delivery, “tinkering with even one component may
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`have a significant effect on the entire system . . . the combination of
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`ingredients and desired characteristics requires a delicate balance.”
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`Ex. 2043, IPR2014-00376, Paper 22 (October 27, 2014) at 2. “[E]ven
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`small changes to the formulation may have drastic effects on the
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`entire device.” Id. at 35.
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`POCR at 50 (emphasis added). But the quotes from Ex. 2043 do not evidence an
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`agreement about “designing pharmaceutical films for systemic drug delivery.” On
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`the contrary, the quotes specifically refer to seven recited requirements of claims of
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`an unrelated patent challenged in an unrelated IPR. And, contrary to RB’s
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`suggestion, Ex. 2043 is not relevant to the alleged complexity of achieving a
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`combination of unspecified and unclaimed “desired characteristics” and “required
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`objectives.” See POCR at 49.
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`ME1 19784568v.2
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`Case IPR2014-000325
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`III. ARGUMENT
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`A.
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`Exhibit 2043 is Not Relevant.
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`RB quotes the two partial sentences from Exhibit 2043 in an attempt to
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`manufacture an “agreement” between RB and BDSI about the field. However, the
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`quoted language does not concern “designing pharmaceutical films for systemic
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`drug delivery,” generally. Instead, the quoted language—and Exhibit 2043—
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`specifically concerns the claims of the ‘019 patent. See, e.g., Ex. 2043 at 1-2, 35.
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`RB has made no effort to argue that the claims of the ‘019 patent are in any way
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`relevant to the challenged claims of the ‘832 patent. See POCR at 49-50. And
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`they are not, as even a cursory review of the ‘019 claims demonstrates. See Ex.
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`1055, ‘019 patent, at 24:47-26:4.
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`The quotes instead relate to successfully manipulating seven recited
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`requirements of the ‘019 patent claims, none of which is recited in the challenged
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`‘832 claims:
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`[W]hat makes this combination so “remarkable” … is that combining
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`the disparate requirements of [1] thinness, [2] flexibility, [3] residence
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`time, [4] adhesion, [5] bioerosion, [6] fast onset/desired blood level
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`within about 30 minutes, and [7] directional delivery, was, before
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`Tapolsky, no easy feat.
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`Ex. 2043 at 1 (bracketed numbers added).
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`ME1 19784568v.2
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`In other words, the language from Exhibit 2043 quoted by RB concerns the
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`Case IPR2014-000325
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`difficulty of successfully manipulating these seven specifically recited claim
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`limitations, rather than any alleged difficulty in making pharmaceutical film
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`generally. See Ex. 2043, at 1-2, 35. RB has made no arguments in its Response
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`regarding the combination of these seven limitations—or any other combination of
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`recited variables. It is unclear why RB contends these quotes from Exhibit 2043
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`are relevant to the instant IPR or inform the Board in any way.
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`As the Federal Circuit has explained, “[a]s provided in Rules 401-403,
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`admissible evidence must be relevant in that it must tend to make a consequential
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`fact more or less probable.” Magnivision, Inc. v. Bonneau Co., 115 F.3d 956, 961
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`(Fed. Cir. 1997). Nothing in Exhibit 2043—including the phrases quoted by RB—
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`tends to make any consequential fact in this proceeding more or less probable.
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`Exhibit 2043 is not relevant and should be excluded.
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`B.
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`RB’s Use of Exhibit 2043 Confuses the Issues and Wastes Time.
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` Any marginal relevance of Exhibit 2043 is substantially outweighed by the
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`waste of time and confusion created by RB’s failure to explain the difference
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`between the patents, claims, and issues presented in the two unrelated IPRs. Per
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`Federal Rule of Evidence 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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`ME1 19784568v.2
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`following: unfair prejudice, confusing the issues, … undue delay, [or] wasting time
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`…”. FRE 403. Further, as the Federal Circuit has found, “if evidence of marginal
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`probative worth necessitates lengthy rebuttal, it imparts disproportionate weight to
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`the issue.” Magnivision, 115 F.3d at 961.
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`In order to evaluate RB’s suggestion that there is some relationship between
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`the two unrelated patents or the two unrelated IPRs, the Board will waste time
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`reviewing Exhibit 2043, the claims of the two unrelated patents, and possibly the
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`papers filed in the two unrelated IPRs. This exercise will only reveal that the ‘019
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`claims and the challenged claims in the instant proceeding have no common claim
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`language (other than the words “film” and “profile”), that the ‘832 and ‘019
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`patents have no common ownership and no common inventors, and that there is no
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`“agreement” in Exhibit 2043 regarding the complexity of the field relevant to the
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`‘832 patent. Similarly, RB’s citation to arguments made in an unrelated IPR about
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`an unrelated patent creates unnecessary confusion of the issues in this case, i.e.,
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`whether the challenged claims are patentable over the applied grounds.
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`Accordingly, any marginal relevance of Exhibit 2043 is substantially
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`outweighed by the danger of confusion of the issues, waste of time, and undue
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`prejudice and is therefore inadmissible under FRE 403.
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`ME1 19784568v.2
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`IV. CONCLUSION
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`Case IPR2014-000325
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`BDSI requests that Exhibit 2043 be excluded in light of its irrelevance and
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`RB’s mischaracterization of the evidence, which lacks merit and is a waste of the
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`Board’s time.
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`Dated: February 24, 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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`ME1 19784568v.2
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`Case IPR2014-000325
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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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`MOTION TO EXCLUDE, including this Certificate of Service, was electronically
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`served on February 24, 2015 by transmitting a copy to lead counsel James
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`Bollinger at james.bollinger@troutmansanders.com and to backup counsel Daniel
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`Ladow at daniel.ladow@troutmansanders.com in accordance with the consent set
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`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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`ME1 19784568v.2
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