throbber
Paper No. 8
`Filed: August 18, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`Patent No. 8,017,150
`Issue Date: September 13, 2011
`Title: POLYETHYLENE OXIDE-BASED FILMS AND DRUG DELIVERY
`SYSTEMS MADE THEREFROM
`Inter Partes Review No. IPR2016-01112
`
`
`
`
`
`
`
`
`PETITIONER’S OPPOSITION TO PATENT OWNER MONOSOL RX,
`LLC’S MOTION FOR ADDITIONAL DISCOVERY1
`
`
`
`1 Corresponding opposition briefs are being filed in IPR2016-01111 and IPR2016-
`
`01113.
`
`

`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`PATENT OWNER POINTS TO NO EVIDENCE OF
`PRIVITY BETWEEN PETITIONER AND TEVA ........................................ 1
`A.
`There Is No Evidence Of Any Kind That Privity Existed
`Between Petitioner And Teva On December 3, 2014 ........................... 2
`Patent Owner Offers No Evidence That Privity Existed
`Between Petitioner And Teva On May 31, 2016 .................................. 4
`THE PATENT OWNER’S MOTION IS BASED ON AN
`ERRONEOUS THEORY OF PRIVITY ......................................................... 7
`A.
`Successive Ownership Of The Same Allegedly Infringing
`Property Does Not Create Privity ......................................................... 7
`III. THE DISCOVERY REQUESTED IS NOT “NECESSARY IN
`THE INTEREST OF JUSTICE” ...................................................................12
`A.
`Patent Owner’s Requested Discovery Will Not Yield
`“Useful Information” ...........................................................................13
`Patent Owner Has The Ability To Seek Equivalent
`Information By Other Means ..............................................................13
`The Requests Are Overly Burdensome ...............................................14
`C.
`IV. CONCLUSION ..............................................................................................15
`
`B.
`
`B.
`
`
`
` i
`
`
`
`
`
`
`
`
`

`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Aruze Gaming Macau, Ltd. V. Gaming, Inc.,
`IPR2014-01288, Paper 13 (PTAB Feb. 20, 2015) ............................... 2, 3, 10
`Garmin Int’l v. Cuozzo Speed Tech.,
`IPR2012-00001, Paper 26 (PTAB Jan. 9, 2013) .......................................1, 14
`Hewlett-Packard Company v. MCM Portfolio, LLC,
`IPR2013-00217, Paper 10 (PTAB Sept. 1, 2013) ........................................... 9
`Nestle USA, Inc. v. Steuben Foods, Inc.,
`IPR2014-01235, Paper 12 (PTAB Dec. 22, 2014) .......................................... 9
`Synopsys, Inc. v. Mentor Graphics Corp.,
`814 F.3d 1309 (Fed. Cir. 2016) ....................................................................... 2
`Synopsys, Inc. v. Mentor Graphics Corp.,
`IPR2012-00042, Paper 16 (PTAB Feb. 22, 2013) ................................ passim
`Synopsys, Inc. v. Mentor Graphics Corp.,
`IPR2012-00042, Paper 23 (PTAB Feb. 22, 2013) ....................................7, 11
`Synopsys, Inc. v. Mentor Graphics Corp.,
`IPR2012-00042, Paper 24 (PTAB Feb. 22, 2013) ......................... 2, 7, 11, 12
`Synopsys, Inc. v. Mentor Graphics Corp.,
`IPR2012-00042, Paper 60 (PTAB Feb. 22, 2013) ........................... 3, 4, 7, 12
`Taylor v. Sturgell,
`553 U.S. 880 (2008)...................................................................................9, 10
`Statutes
`35 U.S.C. § 315(b) ........................................................................................... passim
`Other Authorities
`37 CFR 42.51(b)(2)(i) ................................................................................................ 1
`
`ii
`
`
`

`
`Rules
`Fed.R.Civ.P. 26(b)(1) ...............................................................................................14
`
`
`
`iii
`
`
`

`
`PETITIONER’S EXHIBIT LIST
`
`Exhibit No.
`1050
`
`1051
`
`Reference
`Federal Trade Commission Press Release entitled, “FTC Requires
`Teva to Divest Over 75 Generic Drugs to Settle Competition
`Concerns Related to its Acquisition of Allergan’s Generic
`Business,” dated July 27, 2016
`Dr. Reddy’s Laboratories Ltd. Press Release entitled, “Dr. Reddy’s
`completes acquisition of product portfolio from TEVA,” dated
`August 3, 2016
`
`
`
`iv
`
`
`

`
`Pursuant to the Board’s Order (Paper 6), Petitioners Dr. Reddy’s
`
`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (“Petitioner”) respectfully
`
`submit this Opposition to MonoSol Rx, LLC’s (“Patent Owner”) Motion for
`
`Additional Discovery (“Motion”). Further, pursuant to the Board’s instruction that
`
`Petitioner identify specifically whether and to what extent it opposes Patent
`
`Owner’s discovery requests, a specific response to each of Patent Owner’s four
`
`requests is provided in the attached Appendix.
`
`Patent Owner’s Motion should be denied. The burden of demonstrating that
`
`the requested discovery is in the interest of justice falls squarely on the Patent
`
`Owner. 37 CFR 42.51(b)(2)(i). Despite all its rhetoric about “gamesmanship” and
`
`“abuse of the IPR process,” Patent Owner utterly fails to satisfy its burden.
`
`I.
`
`PATENT OWNER POINTS TO NO EVIDENCE OF PRIVITY
`BETWEEN PETITIONER AND TEVA
`
`To establish that additional discovery is “necessary in the interest of justice,”
`
`the moving party must present evidence – not vague allegations and speculative
`
`attorney argument – that shows discovery has a likelihood of producing of useful
`
`evidence. See Garmin Int’l v. Cuozzo Speed Tech., IPR2012-00001, Paper 26 at 7
`
`(PTAB Jan. 9, 2013). Indeed, a party seeking discovery should already possess
`
`evidence “tending to show beyond speculation that . . . something useful will be
`
`uncovered.” Id. Patent Owner points to no evidence of privity between Petitioner
`
`and Teva, either at the time Patent Owner filed its complaint against Teva on
`1
`
`
`

`
`December 3, 2014, or at the time Petitioner filed its Petition for IPR on May 31,
`
`2016. Therefore, Patent Owner’s Motion must be denied.
`
`A. There Is No Evidence Of Any Kind That Privity Existed Between
`Petitioner And Teva On December 3, 2014
`
`Patent Owner filed its complaint against Teva on December 3, 2014. See
`
`
`
`Motion at 3-4. Yet Patent Owner has not even suggested, much less pointed to any
`
`evidence, that privity existed between Petitioner and Teva at that time. See e.g.,
`
`Synopsys, Inc. v. Mentor Graphics Corp., IPR2012-00042, Paper 24 at 5 (PTAB
`
`Feb. 22, 2013) (denying motion for discovery because, inter alia, “Mentor
`
`Graphics has not directed us to evidence that would tend to show, for example, that
`
`in 2006 EVE had any relationship with Synopsis (Sic.) at all.”)
`
`Patent Owner glosses over the importance of privity at the time the
`
`complaint was filed with vague and misleading citations to Aruze2 and Synopsys3.
`
`However, those cases teach that the relationship between the parties during the
`
`underlying lawsuit is critical to the privity analysis. See Aruze at 14 (“the focus of
`
`
`2 Aruze Gaming Macau, Ltd. V. Gaming, Inc., IPR2014-01288, Paper 13 (PTAB
`
`Feb. 20, 2015) (“Aruze”).
`
`3 Synopsys, Inc. v. Mentor Graphics Corp., 814 F.3d 1309 (Fed. Cir. 2016)
`
`(“Synopsys”).
`
`2
`
`
`

`
`our privity inquiry is on the relationship between the parties during the prior
`
`lawsuit.”) (emphasis in original).4
`
`As the Aruze panel explained, this inquiry is critical because the petitioner
`
`must have a “full and fair opportunity” to litigate the validity of the patent at issue.
`
`See, id. (“In other words, we ask whether the instant petitioner and the prior
`
`litigant’s relationship – as it relates to the lawsuit – is sufficiently close that it can
`
`be fairly said that the petitioner has a full and fair opportunity to litigate the
`
`validity of the patent in the lawsuit.”)
`
`The Board provided a similar analysis in Synopsys, Inc. v. Mentor Graphics
`
`Corp., IPR2012-00042, Paper 60 at 13 (PTAB Feb. 22, 2013) (“Synopsys 60”):
`
`Mentor Graphics has not alleged that Synopsys was a privy of EVE in
`2006 when EVE was served with a complaint alleging infringement of
`the ’376 patent. Thus, there is no contention that Synopsys had any
`control of this previous suit or even had notice of it, along with an
`opportunity to participate while it was still pending. … Thus, this lack
`of relationship between Synopsys and EVE in the 2006 litigation is
`another reason to conclude that there was no privity relationship
`between Synopsys and EVE sufficient to trigger § 315(b)’s
`prohibitions.
`
`
`
`4 In Aruze the Board found no privity between commonly-owned, sister companies
`
`having common legal representation.
`
`3
`
`
`

`
`[Emphasis added]. The analysis in Synopsys 60 applies squarely to the present
`
`case. Petitioner had no control or participation in the Teva lawsuit at any time prior
`
`to the filing of its petition, and Patent Owner has offered no evidence otherwise.
`
`Its Motion should therefore be denied.
`
`B.
`
`Patent Owner Offers No Evidence That Privity Existed Between
`Petitioner And Teva On May 31, 2016
`
`
`As the Board clearly stated in Synopsys 60, “it is only privity relationships
`
`up until the time a petition is filed that matter; any later-acquired privies are
`
`irrelevant.” IPR2012-00042, Paper 60 at 12. The purported evidence relied on by
`
`Patent Owner establishes that Petitioner’s acquisition of the ANDAs from Teva
`
`occurred after the petition was filed on May 31, 2016. Any suggestion by Patent
`
`Owner to the contrary is based on nothing but pure speculation.
`
`First, the June 11, 2016 press release (EX. 2004) shows that Petitioner’s
`
`acquisition of the ANDAs was not complete even as of that date. Rather, the press
`
`release states that “The acquisition of these ANDAs is also contingent on the
`
`closing of the Teva/Allergan generics transaction and approval by the U.S. Federal
`
`Trade Commission of Dr. Reddy’s as a buyer.” See EX. 2004.
`
`Next, the FTC’s press release of July 27, 2016 (EX. 1050) shows that the
`
`acquisition was not even finalized as of that date, but rather that “Teva and
`
`Allergan must divest the drug products no later than 10 days after the acquisition is
`
`4
`
`
`

`
`complete.” See EX. 1050 at 2. (Patent Owner neglected to include the July 27,
`
`2016 press release with its motion papers).
`
`It was not until August 3, 2016 that Dr. Reddy’s issued a press release
`
`announcing “that it successfully completed the previously announced acquisition of
`
`eight Abbreviated New Drug Applications (ANDAs) in the U.S. from Teva.” See
`
`EX. 1051, Press Release dated August 3, 2016 (Patent Owner neglected to include
`
`the August 3, 2016 press release with its motion papers).
`
`In the face of this evidence, Patent Owner only offers speculation and
`
`innuendo that privity between Petitioner and Teva somehow arose prior to May 31,
`
`2016. For example, Patent Owner argues that Petitioner’s petitions are “virtually
`
`identical” to the petitions previously filed by Teva, and that they “seek review of
`
`the same claims of the same patents, rely on the same arguments and prior art,
`
`contain substantially identical text,” etc. Motion at 4.5 Patent Owner offers no
`
`authority for the premise that similarity between IPR petitions can give rise to
`
`privity. Moreover, Teva’s IPR petitions are publicly available documents, and
`
`similarities between the petitions is not indicative of any relationship between Teva
`
`and Petitioner. Patent Owner’s insinuation is based on nothing but idle speculation.
`
`5 Patent Owner also states that Petitioner’s expert declarations are “substantially
`
`identical” to Teva’s publicly available expert declarations, but fails to point out
`
`that Petitioner retained a different expert than Teva.
`
`5
`
`
`

`
`Next, Patent Owner argues that the June 11, 2016 press release was issued a
`
`“mere eleven days after filing the petitions,” and does not specify when
`
`negotiations began or when the agreement was reached. Motion at 5. Patent Owner
`
`is apparently insinuating that an agreement must have been reached prior to May
`
`31, 2016 because only eleven days had passed. Again, this is based on nothing
`
`more than speculation, particularly in light of the press releases of July 27, 2016
`
`(EX. 1050) and August 3, 2016 (EX. 1051), which show that the acquisition of the
`
`ANDAs was not final until well after May 31, 2016. And, in any event, the Board
`
`has found that negotiations leading to an agreement do not give rise to privity. See
`
`Synopsys, Inc. v. Mentor Graphics Corp., IPR2012-00042 Paper 16 at 16 (PTAB
`
`Feb. 22, 2013) (“Although there is evidence that on September 27, 2012, Synopsis
`
`and EVE entered into an ‘agreement to acquire,’ there is no evidence that such an
`
`agreement created privity between the two entities.”)
`
`Patent Owner also points to a press report dated May 5, 2016 (EX. 2008) but
`
`– aside from the questionable reliability of the report, which cites only “a source
`
`familiar with the matter” – the press report states that Teva “expected the
`
`transaction to be completed by June.” See EX. 2008 (emphasis added). Again, all
`
`the purported evidence relied on by Patent Owner (along with the August 3, 2016
`
`press release (EX. 1051)), indicates that the acquisition of the ANDAs occurred
`
`after May 31, 2016. There is nothing but speculation to suggest otherwise.
`
`6
`
`
`

`
`II. THE PATENT OWNER’S MOTION IS BASED ON AN ERRONEOUS
`THEORY OF PRIVITY
`
`Patent Owner’s Motion should be denied for the additional reason that it is
`
`
`
`based on a flawed theory of privity. Indeed, Patent Owner acknowledges that its
`
`theory of privity is contrary to the law (see Motion at 13, arguing that the Board
`
`“wrongly decided several legal issues” in the Synopsys IPR decisions6). Patent
`
`Owner now seeks to create an entirely new legal standard of privity in order to
`
`stave off an imagined threat of “enabl[ing] any accused infringer to circumvent the
`
`statutory time limit in § 315(b) after failing to timely file an IPR petition by selling
`
`its accused asset to a third party, which would then be able to take over the
`
`infringement litigation and file an otherwise time-barred IPR petition.” Motion at 2
`
`(emphasis in original). This conspiratorial argument is pure bluster. As the Patent
`
`Owner itself acknowledges, “Teva has agreed to divest various ANDAs in order to
`
`receive FTC approval of its acquisition of Allergan Plc.” (see Motion at n.2), not to
`
`circumvent 35 U.S.C. § 315(b).
`
`A.
`
`Successive Ownership Of The Same Allegedly Infringing Property
`Does Not Create Privity
`
`
`
`
`6 Synopsys, Inc. v. Mentor Graphics Corp., IPR2012-00042, Papers 16, 23, 24 and
`
`60.
`
`
`
`7
`
`
`

`
`Patent Owner bases its privity argument solely on the assertion that
`
`Petitioner and Teva are successive owners of the same allegedly infringing
`
`property. However, the Board has consistently rejected this theory of privity
`
`because “[p]atentability, not infringement, is the issue before the Board in an inter
`
`partes review.” Synopsys IPR, Paper 16 at 17.
`
`Notwithstanding Patent Owner’s strained arguments to the contrary,
`
`Synopsys IPR is squarely on point. In Synopsys IPR, the patent owner, Mentor
`
`Graphics Corp. (“Mentor”), contended that Synopsys’s IPR petition was time-
`
`barred under § 315(b) because Synopsys had acquired an entity (EVE-USA, Inc.
`
`(“EVE”)) who Mentor sued for infringement of the subject patent several years
`
`earlier in 2006. Id. at 15. Mentor asserted that because Synopsys was a successor-
`
`in-interest of EVE, the petition was time-barred. Id. at 16. More particularly,
`
`Mentor argued “that it is the property interest in EVE’s products…that were
`
`accused of infringement in 2006, that leads to the alleged bar of inter partes review
`
`by § 315(b).” Id. at 17.
`
`The Board soundly rejected Mentor’s argument because “that particular
`
`property interest [i.e., successive ownership of allegedly infringing product] is
`
`irrelevant” in an IPR. Id. As the Board explained, “[a]ny potentially infringing
`
`products are irrelevant to the issues raised in the Petition, all of which involve
`
`8
`
`
`

`
`patentability. … Thus, any privity created by successive interest in EVE’s products
`
`does not apply here.” Id. (citation omitted).
`
`Like Mentor, Patent Owner now argues that Petitioner’s successive
`
`ownership of allegedly infringing product (i.e., the ANDAs for buprenorphine
`
`HCL/naloxone HCL oral film) gives rise to privity under § 315(b). But the Board
`
`has found, plainly, unequivocally and on numerous occasions (in addition to
`
`Synopsys IPR), that this theory of privity has no merit. See, e.g., Hewlett-Packard
`
`Company v. MCM Portfolio, LLC, IPR2013-00217, Paper 10 at 8 (PTAB Sept. 1,
`
`2013) (“MCM bases its privity argument solely on its assertion that HP and
`
`Pandigital are successive owners of the same allegedly infringing property. … We
`
`are not persuaded that this allegation alone is enough to confer privity for purposes
`
`of § 315(b). … Under Synopsys ‘any potentially infringing products are irrelevant
`
`to the issues raised in the Petition, all of which involve patentability.’”); see also
`
`Nestle USA, Inc. v. Steuben Foods, Inc., IPR2014-01235, Paper 12 at 9 (PTAB
`
`Dec. 22, 2014) (“Petitioner’s and [third-party] GEA’s respective property interests
`
`are not persuasive in our privity analysis on the current record because
`
`patentability, not infringement, is the issue before the Board in an inter partes
`
`review.”)7
`
`7 Patent Owner cites Taylor v. Sturgell, 553 U.S. 880, 892-93 (2008) for the
`
`premise that legal relationships such as those between “preceding and succeeding
`
`9
`
`
`

`
`Realizing that its position is contrary to the law, Patent Owner engages in a
`
`strained attempt to distinguish this case from Synopsys IPR, and even to discredit
`
`the Board’s sound reasoning set forth in Synopsys IPR. Motion at 12-13. Patent
`
`Owner contends that Synopsys IPR is “wholly distinguishable” from the present
`
`case because “there was no already-pending litigation, no substitution of litigants,
`
`and no previous failed IPR attempt.” Id. at 12. Patent Owner offers no authority as
`
`
`owners of property” can support nonparty preclusion due to privity. Motion at 2, 8.
`
`However, Taylor is completely inapplicable to the present case. Taylor involved a
`
`question of nonparty preclusion in a FOIA matter, and the Court included
`
`“preceding and succeeding owners of property” among a list of six categories that
`
`may lead to nonparty preclusion depending on the circumstances. See Taylor, 553
`
`U.S. at 893-894. Taylor has no bearing on the particular property interests at issue
`
`in an IPR, and it in no way contradicts the clear rulings of Synopsys IPR and the
`
`similar IPR decisions cited above. Patent Owner compounds its error by implying
`
`that Aruze relies on Taylor for the same premise. Motion at 8. Rather, Aruze
`
`mentioned the “preceding and succeeding owners of property” language in dicta
`
`while citing the entire list of six categories in a broad discussion of Taylor. See
`
`IPR2014-01288 at 8-9. Aruze did not involve successive ownership of allegedly
`
`infringing product and, like Taylor, does not contradict Synopsys IPR in any way.
`
`
`
`10
`
`
`

`
`to why these purported distinctions should matter to the privity analysis. Of course,
`
`there is no such authority because these distinctions are not material to the question
`
`of whether privity exists between Petitioner and Teva.
`
`Patent Owner also mischaracterizes the Synopsys IPR panel’s various
`
`decisions addressing privity as each having a “different rational.” Motion at 13.
`
`But this is simply untrue. The Synopsys IPR panel first addressed privity in its
`
`Decision on Institution of IPR review, IPR2012-00042, Paper 16. The Board found
`
`that “Patent Owner has not persuasively shown that Petitioner was a privy of EVE
`
`in 2006 when EVE was served with a complaint alleging infringement of the ‘376
`
`patent.” Id. at 16. As discussed above, the Board also rejected Mentor’s contention
`
`that privity stemmed from Synopsys’s “property interest in EVE’s products…that
`
`were accused of infringement in 2006.” Id. at 17.
`
`Next, the Synopsys IPR panel addressed privity in its Decision on Request
`
`for Rehearing, Synopsys, Inc. v. Mentor Graphics Corp., IPR2012-00042, Paper 23
`
`(PTAB Feb. 22, 2013). Consistent with its earlier decision, the Board rejected
`
`Mentor’s contention that Synopsys’s petition was barred under § 315(b) “because
`
`Petitioner is a successor-in-interest of the allegedly infringing products of EVE.”
`
`Id. at 4.
`
`Next, the Synopsys panel rejected Mentor’s privity argument in its Decision
`
`denying Mentor’s motion for additional discovery, IPR2012-00042, Paper 24.
`
`11
`
`
`

`
`Again, there is nothing in Paper 24 to suggest that the Board relied on a “different
`
`rationale” than in its prior decisions. Rather, the Board found, inter alia, that
`
`Mentor failed to articulate the relevance of its requested discovery to “[t]he legal
`
`standard adopted by the Board … that § 315(b) requires a privity relationship in
`
`2006 when EVE was served with a complaint alleging infringement of the ‘376
`
`patent.” IPR2012-00042, Paper 24, at 3.
`
`Lastly, in its Final Written Decision, IPR2012-00042, Paper 60 at 13, the
`
`Board found, inter alia, that “Mentor Graphics has not alleged that Synopsys was a
`
`privy of EVE in 2006 when EVE was served with a complaint alleging
`
`infringement of the ‘376 patent.” Once again, there is no “different rational”
`
`between the Board’s Final Written Decision and its previous decisions.
`
`Because the Board’s decisions in Synopsys IPR fall so squarely against
`
`Patent Owner’s theory of privity, and thus its request for additional discovery,
`
`Patent Owner has resorted to attacking those decisions by suggesting they are
`
`somehow erratic and disparate. Patent Owner then states that it “requests the
`
`opportunity to brief those issues after pertinent discovery has been taken.” Motion
`
`at 13. It is difficult to imagine a more speculative grounds for discovery, and
`
`Patent Owner’s Motion should therefore be denied.
`
`III. THE DISCOVERY REQUESTED IS NOT “NECESSARY IN THE
`INTEREST OF JUSTICE”
`
`
`12
`
`
`

`
`A.
`
`Patent Owner’s Requested Discovery Will Not Yield “Useful
`Information”
`
`None of the items of requested discovery could lead to useful information
`
`
`
`because Patent Owner’s theory of privity is utterly baseless. Each of Patent
`
`Owner’s discovery requests is addressed in turn below:
`
`Request (1). On its face, the June 11, 2016 press release (EX. 2004) shows
`
`that Petitioner’s acquisition of Teva’s ANDAs was not complete even as of that
`
`date. Rather, the press release states that the acquisition of the ANDAs is
`
`contingent on, inter alia, FTC approval. See EX. 2004. Any suggestion that the
`
`requested documents would show otherwise is only speculation.
`
`Request (2). The press releases (EXs. 2004, 1050, 1051) indicate that the
`
`acquisition of the ANDAs was not finalized until August 3, 2016. Any suggestion
`
`otherwise is speculation.
`
`Request (3). See Appendix.
`
`Request (4). Patent Holder does not provide any rationale as to how the
`
`initiation of discussions is pertinent to the issue of privity. Merely initiating
`
`discussions does not give rise to privity.
`
`B.
`
`Patent Owner Has The Ability To Seek Equivalent Information
`By Other Means
`
`Patent Owner has made little or no effort to obtain the requested discovery
`
`
`
`through the Teva litigation. See Motion at 14. Discovery in federal court is broad
`
`13
`
`
`

`
`and permissive. Fed.R.Civ.P. 26(b)(1) provides that “[p]arties may obtain
`
`discovery regarding any nonprivileged matter that is relevant to any party's claim
`
`or defense.” Patent Owner should first seek the requested information using the
`
`broad discovery tools available in the federal litigation.
`
`Patent Owner suggests that it cannot seek the discovery in the litigation
`
`because Teva has reported that it will soon cease to be a party to the litigation.
`
`Motion at 14. This excuse does not pass muster. Patent Owner has known about
`
`the issues it raises in its Motion since at least June 27, 2016, when it first contacted
`
`Petitioner’s counsel to request a meet and confer. Motion at 5. Patent Owner could
`
`have taken steps to seek the discovery from Teva then. Patent Owner’s lack of
`
`diligence ought not result in unreasonable burdens on Petitioner and the Board.
`
`Patent Owner also speculates that the district court may not grant the
`
`discovery request because fact discovery is closed. Id. As the Board is likely
`
`aware, motions for discovery after the close of the formal fact discovery period are
`
`fairly routine in federal litigation. Patent Owner should at least file a motion for
`
`discovery in the litigation before seeking it here.
`
`
`
`C. The Requests Are Overly Burdensome
`
`Patent Owner’s requests are overly burdensome given the expedited nature
`
`of the inter partes review. See IPR2012-00001, Paper 26 at 7. “[T]he burden
`
`includes financial burden, burden on human resources, and burden on meeting the
`
`14
`
`
`

`
`time schedule of Inter Partes Review.” Id. Patent Owner’s requests would require
`
`a significant expenditure of time, along with human and financial resources. For
`
`example, Patent Owner’s second request seeks “[c]orrespondence or
`
`communications related to (a) the agreements or term sheets identified in category
`
`(1) above or (b) the Suboxone® Film-related ANDAs.” See Motion, Appendix.
`
`This request is overly broad and seeks a classic “fishing expedition” into
`
`Petitioner’s email system. The request potentially covers all communications, both
`
`internal and external, relating in any way to Suboxone® Film-related ANDAs,
`
`including technical evaluations and the like. The request would potentially force
`
`Petitioner to engage in a large scale e-discovery operation at multiple facilities that
`
`would likely costs tens of thousands of dollars, and would require untold hours of
`
`work by Petitioner’s executives, employees, inside counsel and outside counsel.
`
`Potentially thousands of pages of documents would need to be reviewed for
`
`responsiveness, confidentiality and privilege issues. Clearly, the breadth of Patent
`
`Owner’s request defies the clear congressional intent that discovery in IPRs be
`
`limited.
`
`IV. CONCLUSION
`
`
`The discovery Patent Owner seeks is unwarranted and unjustified. Patent
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`Owner’s Motion should be denied.
`
`
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`15
`
`
`

`
`Respectfully submitted,
`
`
`
`
`
`/s/ Jeffery B. Arnold
`Jeffery B. Arnold
`USPTO Reg. No. 39,540
`Cantor Colburn LLP
`1180 Peachtree Street, Suite 2050
`Atlanta, Georgia 30309
`Telephone: (404) 607-9991
`Facsimile: (404) 607 9981
`jarnold@cantorcolburn.com
`
`Lead Counsel for Petitioners
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
`
`16
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`
`
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`
`
`
`
`
`
`Dated: August 18, 2016
`
`
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`
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`
`

`
`APPENDIX
`
`
`
`Petitioner offers the following specific responses to Patent Owner’s
`
`Requests for Production as follows:
`
`REQUEST (1): The “definitive agreement” referenced in Petitioner’s June 11,
`
`2016 press release (the “Agreement”), any drafts of the Agreement, any term
`
`sheets or letter of intent related to the Agreement, and any common interest or
`
`other agreement related to the Agreement.
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`RESPONSE: Petitioner objects to the use of “related to” in this request as vague.
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`Notwithstanding this objection, and subject to it, Petitioner responds as follows:
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`No “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. No terms sheets or drafts thereof exist. No letters of
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`intent or drafts thereof exist. Petitioner objects to the production of common
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`interest agreements or other agreements related to the “definitive agreement” or
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`drafts thereof executed subsequent to the execution of the “definitive agreement”
`
`in that Patent Owner has failed to show how such documents are relevant to show
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`privity on or before May 31, 2016.
`
`REQUEST (2): Correspondence or communications related to (a) the agreements
`
`or term sheets identified in category (1) above or (b) the Suboxone® Film-related
`
`ANDAs.
`
`17
`
`
`

`
`RESPONSE: Petitioner objects to the use of “related to” in this request as vague.
`
`Notwithstanding this objection and the objections of category (1), and subject to
`
`them, no correspondence or communications directed to terms sheets or letters of
`
`intent exist. No common interest agreements or other agreements related to the
`
`Agreement prior to the execution of the “definitive agreement” identified in
`
`category (1) exist. Petitioner also objects to this request as asserted in Section
`
`III.C. above.
`
`REQUEST (3): Correspondence or communications between Teva or its counsel
`
`and Petitioners or their counsel regarding either Teva’s or Petitioner’s IPR
`
`petitions.
`
`RESPONSE: As Petitioner previously represented to Patent Owner’s counsel (see
`
`EX. 2005), no correspondence or communications between Teva or its counsel and
`
`Petitioners or their counsel regarding either Teva’s or Petitioner’s IPR petitions
`
`exist.
`
`REQUEST (4): Documents sufficient to show the date on or about which Teva
`
`and Petitioner initiated discussions relating to the Suboxone®
`
`Film-related ANDAs.
`
`RESPONSE: Petitioner objects in that the date on which Teva and Petitioner
`
`initiated discussions are not relevant to the determination of privity.
`
`
`
`
`
`18
`
`
`

`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on August 18, 2016, a true and correct copy of
`
`the foregoing PETITIONER’S OPPOSITION TO PATENT OWNER MONOSOL
`
`RX, LLC’S MOTION FOR ADDITIONAL DISCOVERY, APPENDIX and
`
`EXHIBITS were served pursuant to 37 C.F.R. § 42.6(e) on attorneys of record for
`
`the Patent Owner by filing this document through the Patent Trial and Appeal
`
`Board End to End (PTAB E2E) system and delivering a copy via electronic mail as
`
`follows:
`
`Harold H. Fox
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington, DC 20036-1795
`hfox@steptoe.com
`150IPR@steptoe.com
`
`John L. Abramic
`STEPTOE & JOHNSON LLP
`115 South LaSalle Street, Suite 3100
`Chicago, IL 60603
`jabramic@steptoe.com
`
`Counsel for MonoSol Rx, LLC
`
`Dated: August 18, 2016
`
`
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`19
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`
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`/s/ Jeffery B. Arnold
`Jeffery B. Arnold
`USPTO Reg. No. 39,540
`
`Lead Counsel for Petitioners
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.

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