IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DR. REDDY’S LABORATORIES, LTD. AND
`DR. REDDY’S LABORATORIES, INC.,
`Petitioners,
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`v.
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`MONOSOL RX, LLC
`Patent Owner.
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`Case No. IPR2016-01111
`Patent No. 8,603,514
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`PATENT OWNER’S REQUEST FOR REHEARING
`UNDER 37 C.F.R. § 42.71(d)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DR. REDDY’S LABORATORIES, LTD. AND
`DR. REDDY’S LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`MONOSOL RX, LLC
`Patent Owner.
`
`Case No. IPR2016-01111
`Patent No. 8,603,514
`
`PATENT OWNER’S REQUEST FOR REHEARING
`UNDER 37 C.F.R. § 42.71(d)
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`IPR2016-01111
`U.S. Patent No. 8,603,514
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`I. INTRODUCTION
`Patent Owner, MonoSol Rx, LLC, respectfully requests rehearing under 37
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`C.F.R. § 42.71(d) for reconsideration of the Decision Denying Patent Owner’s
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`Motion for Additional Discovery (“Decision Denying Discovery”; Paper No. 9) with
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`respect to Patent Owner’s second Request for Production. The Board stated that
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`“authorizing the second . . . Request[] would be unproductive” because “Petitioner
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`represents that no responsive documents exist. Opp. 18” Paper 9, p. 8.
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`Patent Owner respectfully submits that the Board misapprehended Petitioner’s
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`carefully crafted response to the second Request for Production (“Second Request”).
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`Petitioner’s Opposition (Paper 8) at page 18 does not state that no responsive
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`documents exist, but rather, addresses only correspondence or communications
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`related to selected items, i.e., term sheets, letters of intent, common interest
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`agreements, or other agreements related to the “‘definitive agreement’ referenced in
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`Petitioner’s June 11, 2016 press release (the ‘Agreement’).” Paper 8, pp. 17-18.
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`Notably absent from Petitioner’s response is correspondence or communications
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`related to the Agreement itself, or drafts of the Agreement, all of which fall within
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`the scope of the Second Request and would have come into existence in the months
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`leading up to the August 3, 2016 press release (Ex. 1042) announcing the successful
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`acquisition of Teva’s ANDAs. Correspondence or communications related to the
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`Agreement, or to drafts of the Agreement, dated prior to the filing of the present
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`IPR2016-01111
`U.S. Patent No. 8,603,514
`petition, would be indicia that privity existed between Teva and Petitioner at that
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`time, but Petitioner has made no representations whether these documents exist. Ex.
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`2001, 24:14-26:23; Paper 8, pp. 17-18. Accordingly, Patent Owner requests the
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`Board to authorize the Second Request with respect to correspondence or
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`communications related to the Agreement or drafts of the Agreement.
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`Patent Owner submits that the present request is timely filed, within fourteen
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`days of the Decision Denying Discovery in accordance with 37 C.F.R. § 42.71(d)(1).
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`II.
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`STATEMENT OF RELIEF REQUESTED
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`Patent Owner requests that the Board reconsider the Decision Denying
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`Discovery, and authorize the Second Request with respect to correspondence or
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`communications related to the Agreement or drafts of the Agreement.
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`III. STANDARD OF REVIEW
`A request for rehearing “must specifically identify all matters the party
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`believes the Board misapprehended or overlooked, and the place where each matter
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`was previously addressed . . . .” 37 C.F.R. § 42.71(d). “When rehearing a decision
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`on petition, the panel will review the decision for an abuse of discretion.” 37 C.F.R.
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`§ 42.71(c). An abuse of discretion occurs when a “decision was based on an
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`erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error
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`of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co. Inc., 840 F.2d
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`1565, 1567 (Fed. Cir. 1988) (citations omitted).
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`IPR2016-01111
`U.S. Patent No. 8,603,514
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`IV. ARGUMENT
`A.
`Petitioner Never Addresses Correspondence or Communications
`Related to the Agreement or Drafts of the Agreement
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`The Second Request seeks,
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`in relevant part, “[c]orrespondence or
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`communications related to (a) the agreements or term sheets identified in category (1)
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`above,” where category (1) is “[t]he ‘definitive agreement’ referenced in Petitioner’s
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`June 11, 2016 press release (the ‘Agreement’), any drafts of the Agreement, any term
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`sheets or letter of intent related to the Agreement, and any common interest or other
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`agreement related to the Agreement.” Paper 7, p. 17 (emphasis added). The Board
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`stated that “authorizing the second . . . Request[] would be unproductive” because
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`“Petitioner represents that no responsive documents exist. Opp. 18” Paper 9, p. 8.
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`However, Petitioner’s response to the Second Request omits any reference to the
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`Agreement or drafts of the Agreement, stating only that “no correspondence or
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`communications directed to terms sheets or letters of intent exist,” and that “[n]o
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`common interest agreements or other agreements related to the Agreement prior to
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`the execution of the ‘definitive agreement’ identified in category (1) exist.” Paper 8,
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`pp. 17-18. Nowhere does Petitioner’s response to the Second Request ever mention
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`correspondence or communications related to the Agreement or drafts of the
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`Agreement, much less represent that no such documents exist.
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`Patent Owner sought clarification from Petitioner regarding the response to the
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`Second Request in light of the Board’s understanding that “Petitioner represents that
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`IPR2016-01111
`U.S. Patent No. 8,603,514
`no responsive documents exist.” Paper 9, p. 8. In particular, Patent Owner requested
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`confirmation that Petitioner represents that no documents responsive to the Second
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`Request exist, and to confirm that no correspondence or communications related to
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`the Agreement or drafts of the Agreement exist. Ex. 2014 (email correspondence
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`between Patent Owner and Petitioner dated September 8-9, 2016). Petitioner
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`“decline[d] to comment” on the Board’s understanding that “Petitioner represents
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`that no responsive documents exist,” or provide any response regarding the existence
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`of correspondence or communications related to the Agreement or drafts of the
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`Agreement. Id.
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`B.
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`The Board Misapprehended the Response to the Second Request
`and Overlooked that the Documents Petitioner Fails to Address
`Would be Indicia of Privity Prior to the Filing of the Petition
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`Patent Owner respectfully submits that the Board misapprehended the
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`response to the Second Request when stating that “Petitioner represents that no
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`responsive documents exist.” Paper 9, p. 8. As explained above, nowhere does
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`Petitioner’s response to the Second Request ever mention correspondence or
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`communications related to the Agreement or drafts of the Agreement, much less
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`represent that no such documents exist. And Petitioner’s refusal to clarify the
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`accuracy of the Board’s understanding is telling. To this day, Petitioner has never
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`represented that no preliminary documents (e.g., drafts of the Agreement or
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`IPR2016-01111
`U.S. Patent No. 8,603,514
`communications related to such drafts or to the Agreement itself) exist. Ex. 2001,
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`24:14-26:23; Paper 7, p. 11.1
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`Correspondence or communications related to the Agreement itself, or drafts
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`of the Agreement, fall within the scope of the Second Request, and Petitioner has not
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`argued to the contrary. See Paper 8. Such documents would have come into
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`existence in the months leading up to the August 3, 2016 press release (Ex. 1042)
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`announcing the successful acquisition of Teva’s ANDAs. Correspondence or
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`communications related to the Agreement, or to drafts of the Agreement, dated prior
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`to the filing of the present petition, would be indicia that privity between Petitioner
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`and Teva existed at that time, and Petitioner has not represented that no such
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`documents exist.
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`In the Decision Denying Discovery, the Board states that “Patent owner has
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`not proffered persuasive evidence that indicia of privity existed at any time prior to
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`the filing of the present Petition.” Paper 9, p. 7. Correspondence or communications
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`related to the Agreement or to drafts of the Agreement are not public, and are
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`1 Notably, Petitioner’s Response to the first Request for Production does not address
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`“drafts thereof” with respect to the “definitive agreement.” See Paper 8, p. 17 (“No
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`‘definitive agreement,’ common interest agreements or drafts thereof or other
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`agreements related to the ‘definitive agreement’ or drafts thereof executed on or
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`before May 31, 2016 exist.”) (emphases added).
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`- 5 -
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`IPR2016-01111
`U.S. Patent No. 8,603,514
`precisely the type of document that would be directly relevant to the highly factual
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`inquiry of the existence of a privity relationship between Teva and Petitioner leading
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`up to the time of the filing of the petition. Here, the size and timing of the transaction
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`demonstrate more than the mere possibility or allegation that correspondence or
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`communications related to the Agreement, or to drafts of the Agreement, dated prior
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`to May 31, 2016, the filing date of the present Petition, exist.
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`A mere eleven days after filing the Petition, Petitioner announced that it had
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`“entered into a definitive agreement” with Teva Pharmaceutical Industries Ltd.
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`Paper 7, p. 5 citing Ex. 2004 (June 11, 2016 Press Release). Specifically, Petitioner
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`announced that it had agreed “to acquire a portfolio of eight Abbreviated New Drug
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`Applications (ANDAs) in the U.S. for $350 million in cash at closing.” Id. In
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`addition, news reports state that Teva was “finalizing” its ANDA sales nearly one
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`month before Dr. Reddy’s filed its petitions. Id. at 9 citing Ex. 2008 (Reuters report
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`dated May 5, 2016). On these facts, it is beyond speculation that correspondence or
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`communications related to the Agreement or drafts of the Agreement for the $350
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`million dollar deal existed prior to May 31, 2016.
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`Patent Owner respectfully submits that the Board misapprehended Petitioner’s
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`carefully worded response to the Second Request, and overlooked the fact that
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`Petitioner has not represented that no correspondence or communications related to
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`the Agreement itself, or drafts of the Agreement, exist. Because such documents
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`IPR2016-01111
`U.S. Patent No. 8,603,514
`dated prior to the filing of the present petition would be indicia that privity existed at
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`that time, Patent Owner requests that the Board reconsider its denial of discovery
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`relating
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`to
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`the Second Request, and authorize discovery with respect
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`to
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`correspondence or communications related to the Agreement or drafts of the
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`Agreement.
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`V. CONCLUSION
`A careful review of Petitioner’s response to the Second Request makes clear
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`that Petitioner has not represented that “no responsive documents exist” as stated in
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`the Decision Denying Discovery. Paper 9, p. 8. Rather, Petitioner fails to address
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`correspondence or communications related to the Agreement, or to drafts of the
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`Agreement, which go right to the heart of privity between Petitioner and Teva.
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`Petitioner has refused to voluntarily represent that no such documents exist. For
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`these reasons, Patent Owner requests that the Board reconsider its denial of discovery
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`relating
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`to
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`the Second Request, and authorize discovery with respect
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`to
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`correspondence or communications related to the Agreement of drafts of the
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`Agreement.
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`IPR2016-01111
`U.S. Patent No. 8,603,514
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`Respectfully submitted,
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`/Harold H. Fox/
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`Harold H. Fox
`Reg. No. 41,498
`Counsel for MonoSol Rx, LLC
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`
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`Date: September 14, 2016
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`Steptoe & Johnson LLP
`1330 Connecticut Avenue, N.W.
`Washington, DC 20036-1795
`Telephone: (202) 429-3000
`Facsimile: (202) 429-3902
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`IPR2016-01111
`U.S. Patent No. 8,603,514
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 14th day of
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`September 2016,
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`the
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`foregoing PATENT OWNER’S REQUEST FOR
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`REHEARING UNDER 37 C.F.R. § 42.71(D) and EXHIBIT were served by filing
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`this document through the Patent Trial Appeal Board End To End system as well
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`as by delivering a copy via electronic mail, by agreement of the parties, on the
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`following counsel of record for Petitioner.
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`Jeffrey B. Arnold
`jarnold@cantorcolburn.com
`Peter R. Hagerty
`phagerty@cantorcolburn.com
`Leslie-Ann Maxwell, Ph.D.
`amaxwell@cantorcolburn.com
`Andrew C. Ryan
`ryan@cantorcolburn.com
`Cantor Colburn LLP
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`/Harold H. Fox/
`Harold H. Fox
`Reg. No. 41,498
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`Date: September 14, 2016
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