IPR2017-00412
`Patent No. 6,943,166
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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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`MONOSOL RX, LLC
`Petitioner
`v.
`ICOS CORPORATION
`Patent Owner
`______________________
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`IPR2017-00412
`Patent No. 6,943,166
`______________________
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S REQUEST FOR
`REHEARING
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`Patent No. 6,943,166
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MONOSOL RX, LLC
`Petitioner
`v.
`ICOS CORPORATION
`Patent Owner
`______________________
`
`IPR2017-00412
`Patent No. 6,943,166
`______________________
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S REQUEST FOR
`REHEARING
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`IPR2017-00412
`Patent No. 6,943,166
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`TABLE OF CONTENTS
`Mere Disagreement with the Outcome is Insufficient .................................. 1
`I.
`The Board Did Not Overlook Dr. Williams’s Declaration............................ 1
`II.
`III. The Board Did Not Overlook the FDA Petition or Admitted Prior Art ........ 4
`IV. The Board Could Not Have Overlooked A Ground Never Raised................ 5
`V.
`Conclusion ................................................................................................... 5
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`i
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`TABLE OF AUTHORITIES
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`IPR2017-00412
`Patent No. 6,943,166
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`Page(s)
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`Federal Cases
`Hoffmann-LA Roche Inc. v. Apotex Inc.,
`748 F.3d 1326 (Fed. Cir. 2014) .......................................................................... 4
`In re Magnum Oil Tools International, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .......................................................................... 5
`Velander v. Garner,
`348 F.3d 1359 (Fed. Cir. 2003) .......................................................................... 1
`Patent Trial and Appeal Board Cases
`Daicel Corp. v. Celanese Int’l Corp.,
`IPR2014-01514, Paper 15 (PTAB June 26, 2015) .............................................. 1
`Sophos, Inc. v. Finjan, Inc.,
`IPR2015-01022, Paper 9 (PTAB Jan. 28, 2016) ................................................. 1
`Federal Statutes
`35 U.S.C. § 312 ...................................................................................................... 5
`Regulations
`37 C.F.R. § 42.71(d) ........................................................................................... 2, 4
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`ii
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`IPR2017-00412
`Patent No. 6,943,166
`I. Mere Disagreement with the Outcome is Insufficient
`Petitioner’s Request for Rehearing (“Request”) is premised on disagreement
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`with the Board’s finding that the Petition improperly rests on general guidance and
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`alleged “common sense.” (See Req. at 4; Dec. at 9.) The Request necessarily fails
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`because “it is not an abuse of discretion to have performed an analysis or reached a
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`conclusion with which Petitioner disagrees.” Sophos, Inc. v. Finjan, Inc., IPR2015-
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`01022, Paper 9 at 3-4 (PTAB Jan. 28, 2016). Even if the Request was not so
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`flawed, denial would still be appropriate based on the numerous reasons in Patent
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`Owner’s preliminary response (Paper 9) and the Board’s decision (Dec. at 8-11).
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`The deficiencies are in the Petition, not in the Board’s understanding or analysis.
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`II. The Board Did Not Overlook Dr. Williams’s Declaration
`Monosol falsely asserts that the Board “failed to address [Dr. Williams’s
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`(Ex. 1010)] declaration entirely in its analysis.” (Req. at 3, 4.) Not only did the
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`Decision expressly cite Ex. 1010, the Decision cites the Petition where it relied on
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`Ex. 1010. (See e.g., Dec. at 4 (citing Ex. 1010), 8 (citing Pet. at 15, 22, 27, and
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`38).) Nor would it have been an abuse of discretion to give more weight to the
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`prior art than to the conclusory Williams Declaration. See Velander v. Garner, 348
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`F.3d 1359, 1371 (Fed. Cir. 2003) (no abuse of discretion in giving little weight to
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`broad conclusory expert statements); Daicel Corp. v. Celanese Int’l Corp.,
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`IPR2014-01514, Paper 15 at 8 (PTAB June 26, 2015) (persuasiveness of expert
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`1
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`IPR2017-00412
`Patent No. 6,943,166
`testimony assessed in light of other factual evidence); (Paper 9 at 17, 25, 33).
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`Instead of specifying what was allegedly overlooked, the Request rehashes
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`the flawed Williams declaration without identifying where the arguments were
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`previously raised in the Petition. This failure is sufficient reason alone to deny the
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`Request. 37 C.F.R. §42.71(d). Nevertheless, nothing was overlooked:
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`1. Petitioner’s argument regarding “market pressure . . . and the design need to
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`avoid side effects,” (Req. at 3, citing Pet. at 10) was addressed in the Decision on
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`pages 8 and 9, citing the Petition, including page 10. These conclusory arguments
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`are also not specific guidance overlooked that would cause one of ordinary skill to
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`limit the tadalafil dose to 20 mg per day. (Paper 9 at 25-26.)
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`2. The Request quotes Dr. Williams’s declaration at ¶¶166 and 167 regarding
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`“obvious to try” and further asserts that the Decision “does not address the obvious
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`to try argument at all.” (Req. at 4, 12.) This is false. The Board specifically
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`addressed this argument (“Petitioner argues that the claimed range would have
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`been obvious to try”), considered Dr. William’s assertions regarding “reasonable,
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`response guided titration steps” and “finite number of identified, predictable
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`solutions,” and found it all unpersuasive. (Dec. at 8-9.) The Decision even quotes
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`In re O’Farrell, an “obvious to try” case. (Id.) Regardless, the Request does not
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`cure the Petition’s failure to address expectation of success. (Paper 9 at 30.)
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`3. The Request argues that the Board’s finding of a lack of specific, persuasive
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`IPR2017-00412
`Patent No. 6,943,166
`evidence was “not accurate,” pointing to 80 paragraphs from Dr. Williams’s
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`declaration. (Req. at 4-5.) This fails to articulate what was specifically overlooked
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`and is an improper incorporation by reference. (Paper 9 at 25-26).
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`4. The Request mentions “Cutler,” without specifying an exhibit number. (Req.
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`at 5). Nevertheless, the Board addressed the maximum tolerated dose concept in
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`Cutler (Ex. 1016) when discussing a “dose beyond which titration should not
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`ordinarily be attempted because of a lack of further benefit” (Dec. at 8). The
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`Request does not identify any tadalafil-related information overlooked in Cutler.
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`5. The Request mentions alleged facts regarding tadalafil’s effectiveness, route
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`of administration, mechanism of action, and IC50 values. (Req. at 5.) The Request
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`then repeats its “common sense” argument based on the comparability of Viagra®
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`to Cialis® doses. (Id.) This repetition does not overcome
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`the Board’s
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`determination that Petitioner’s reliance on common sense was insufficient. (Dec. at
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`9.) The argument is also based entirely on non-prior art (Ex. 1018) and unmitigated
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`hindsight reliance on the non-prior art Cialis® product that resulted from the
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`claimed invention. (Id. at 10; Ex. 1010 at ¶¶ 183-185.)
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`6. Footnote 4 states that Dr. Williams opined that a POSA could have
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`requested Exs. 1018 and 1019. Not so. Dr. Williams’s stated that he (a former FDA
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`employee) read such documents, not a POSA. (Ex. 1010 at ¶ 176; Paper 9 at 34.)
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`Petitioner also does not rebut the Board’s determination that “neither Exhibit 1018
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`3
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`IPR2017-00412
`Patent No. 6,943,166
`nor Exhibit 1019 appears to be in existence before the priority date.” (Dec. at 10.)
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`7. Petitioner repeats its argument regarding adverse event profiles and
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`minimizing side effects (Req. at 6-7), all of which were addressed by the Board
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`(Dec. at 8-9 (stating that a POSA may strive to minimize side effects).) The
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`Request also suggests a similarity between sildenafil and tadalafil side effects, but
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`this argument is baseless (Paper 9 at 27), not supported by prior art (Ex. 1010 at ¶
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`120), and not specific evidence regarding tadalafil’s maximum dose (Dec. at 9).
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`8. The extended restatement of the Petition’s unexpected results arguments
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`(Req. at 7-9) does nothing to overcome the Board’s finding that the Petition failed
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`to establish a reasonable likelihood that the challenged claims would have been
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`obvious (Dec. at 10). Petitioner cannot flip the burden to Patent Owner to prove
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`non-obviousness and the Request cannot cure Petitioner’s failure to meet its burden
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`of persuasion. The Hoffman case (Req. at 8), is distinguished as there were several
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`prior art references suggesting the claimed dosage or indicating that it was obvious.
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`748 F.3d 1326 (Fed. Cir. 2014). Here, no equivalent facts were established.
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`III. The Board Did Not Overlook the FDA Petition or Admitted Prior Art
`The Request asserts that the Board overlooked admitted prior art, but does
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`not state where the Petition previously relied on it. (Req. at 10.) Indeed, none of the
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`grounds in the petition cited to “admitted prior art.” (E.g., Pet. at 6-7.) This new
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`argument could not have been overlooked. 37 C.F.R. § 42.71(d). The Request also
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`IPR2017-00412
`Patent No. 6,943,166
`asserts that the FDA Petition (Ex. 1015), in the context of the prior art, was
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`overlooked. (Req. at 10-11.) But the Board discussed the FDA Petition (Dec. at 6-
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`7); quoted Petitioner’s argument regarding market pressure, efficacy, and adverse
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`effects (id. at 8-9); and determined that the FDA Petition “merely addresses the
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`side effects of sildenafil” (id. at 11). The Request also does not establish the FDA
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`Petition as prior art (Paper 9 at 32-36); connect the FDA Petition to tadalafil (id. at
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`39-40); or rectify the Petition’s incomplete citation of this exhibit (id.).
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`IV. The Board Could Not Have Overlooked A Ground Never Raised
`The Request states that institution would be consistent with the Board’s prior
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`decision in IPR2017-00323, falsely representing that Petitioner relied on “the exact
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`same evidence.” (Req. at 12-13.) But the Board acknowledged the other
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`proceeding (Dec. at 2), which was based on a different ground of rejection and
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`different evidence. Indeed, while the sole ground in the Mylan Petition included
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`the SNDA (Ex. 1011), Petitioner here never cited it in the Petition outside of the
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`exhibit list, plainly failing to identify it with particularity. 35 U.S.C. §312. The
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`Board cannot have overlooked what was never articulated and is not “free to adopt
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`arguments . . . that could have been, but were not, raised by the petitioner.” In re
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`Magnum Oil Tools International, Ltd., 829 F.3d 1364 (Fed. Cir. 2016).
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`V. Conclusion
`The Board should deny Monosol’s request for rehearing.
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`5
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`Dated: August 9, 2017
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`IPR2017-00412
`Patent No. 6,943,166
`Respectfully submitted,
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`By:
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`/ Maureen D. Queler /
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`
`
`Mark J. Feldstein, Reg. No. 46,693
`Maureen D. Queler, Reg. No. 61,879
`Finnegan, Henderson, Farabow, Garrett
` & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner in
`IPR2017-00412
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
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`OWNER’S OPPOSITION TO PETITIONER’S REQUEST FOR
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`REHEARING was served on August 9, 2017, via electronic mail directed to
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`counsel of record for the Petitioner at the following:
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`Harold H. Fox (hfox@steptoe.com)
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`Gretchen P. Miller (gmiller@steptoe.com)
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`Petitioner has agreed to electronic service.
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`Dated: August 9, 2017
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`By: /John W. Kozikowski /
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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