Trials@uspto.gov
`571-272-7822
`
`
`
` Paper No. 71
` Entered: March 27, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN PHARMACEUTICIALS INC. and
`DR. REDDY’S LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATIVED ACTIVITY COMPANY,
`Patent Owners.
`_______________
`
`Case IPR2017-019951
`Patent 9,220,698 B2
`_______________
`
`Before TONI R. SCHEINER, MICHELLE N. ANKENBRAND, and
`DEBRA L. DENNETT, Administrative Patent Judges.
`
`DENNETT, Administrative Patent Judge.
`
`DECISION AND ORDER
`Vacating Institution and Terminating Proceeding
`37 C.F.R. §§ 42.71(a), 42.72
`
`
`
`
`
`1 Petitioner Dr. Reddy’s Laboratories, Inc., from IPR2018-00894, has been
`joined as a Petitioner to this proceeding.
`
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`IPR2017-01995
`Patent 9,220,698 B2
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`
` On January 25, 2019, we authorized the parties to file simultaneous
`briefs discussing the effect of the Federal Circuit’s decision in Click-to-Call
`Technologies, LP v. Ingenio, Inc., 899 F.3d 1321 (Fed. Cir. 2018) (“Click-to-
`Call”) on this proceeding. Paper 60, 3–4. Having considered that briefing,
`and for the reasons stated below, we vacate our Institution Decision and
`terminate this proceeding.
`BACKGROUND
`I.
`Petitioner Mylan Pharmaceuticals Inc. (“Mylan”) filed a Petition for
`inter partes review of U.S. Patent 9,200,698 (“the ’698 patent”) on August
`24, 2017. Paper 2. Then-Patent Owners (Pozen Inc. (“Pozen”) and Horizon
`Pharma USA, Inc. (“Horizon”))2 filed a Preliminary Response on December
`12, 2017, arguing, inter alia, that 35 U.S.C. § 315 barred institution. Patent
`Owners contended that § 315(a) barred the Petition because Mylan, in an
`earlier and previously unrelated district court litigation, filed an Answer to
`Patent Owners’ Amended Complaint that included a counterclaim for
`declaratory judgment of non-infringement and invalidity of the ’698 patent.
`Paper 10, 5–7. Patent Owners also argued that § 315(b) barred institution
`because Mylan filed its Petition more than one year after the date on which
`Patent Owners asserted in a counterclaim that Mylan infringes the ’698
`patent. Id. at 10–12. To clarify, Patent Owners had not, at the time of
`Mylan’s above-referenced Answer, served Mylan with a complaint alleging
`infringement of the ’698 patent. Id. at 6. Rather, it was Mylan who first
`brought the ’698 patent into the litigation through its counterclaim. In Patent
`
`
`2 As explained infra, Horizon’s interests were subsequently transferred to
`Nuvo Pharmaceuticals (Ireland) Designated Activity Company and Nuvo
`Pharmaceuticals Inc. (collectively, “the Nuvo entities”).
`2
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`IPR2017-01995
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`Owners’ Answer to Mylan’s counterclaims, Patent Owners did “not contest
`that there is a case or controversy between [Patent Owners] and Mylan as to
`Mylan’s infringement of the patents-in-suit,” but denied Mylan’s remaining
`allegations. Ex. 2006, 6.
`We authorized, and Mylan filed, a Reply to Patent Owners’
`Preliminary Response, disputing the applicability of § 315(a) due to the
`parties’ stipulation in the district court litigation to dismiss without prejudice
`Mylan’s counterclaims related to the ’698 patent. Paper 16; Ex. 1047.
`We instituted an inter partes review of the ’698 patent on March 8,
`2018. Paper 18. Regarding § 315(a), we determined that then-existing
`precedent required us to treat the district court invalidity claim dismissed
`without prejudice as if the claim had never been filed. Id. at 13–14.
`Because we found that the voluntary dismissal placed the parties in a
`position as if the district court declaratory judgment action on the ’698
`patent had never been filed, we did not decide in the Institution Decision
`whether Mylan’s invalidity counterclaim against the ’698 patent triggered
`the time bar in § 315(a), or whether Patent Owners’ Answer to Mylan’s non-
`infringement counterclaim against the ’698 patent triggered the time bar in
`§ 315(b). Id. at 14–15. Patent Owners requested rehearing on the § 315
`issues (Paper 24), which we denied (Paper 34) because Patent Owners failed
`to demonstrate we abused our discretion in finding that Mylan was not time
`barred under §§ 315(a) and (b) based on the dismissal without prejudice of
`Mylan’s counterclaims related to the ’698 patent.
`On April 6, 2018, Dr. Reddy’s Laboratories Inc. (“Dr. Reddy’s”) filed
`a Petition requesting an inter partes review of the ’698 patent (IPR2018–
`00894 (the “894 IPR”)) and moved to join IPR2017–01995 as a petitioner.
`
`
`
`3
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`894 IPR Papers 1 and 3. Patent Owners opposed joinder, arguing that
`35 U.S.C. § 315(b) barred Dr. Reddy’s from filing an inter partes review
`because Patent Owners sued Dr. Reddy’s for infringement of the ’698 patent
`in August, 2016, some 19 months before Dr. Reddy’s filed the Petition.
`894 IPR Paper 8, 1. Dr. Reddy’s replied by withdrawing its own expert
`declarations, stating that Mylan had agreed to share its experts with
`Dr. Reddy’s, and agreeing to take a “backseat” position to Mylan if joinder
`was granted. 894 IPR Paper 9. Dr. Reddy’s also noted that the joinder
`motion was timely under 35 U.S.C. § 315(c). Id. at 2–3.
`We instituted an inter partes review in the 894 IPR and granted
`Dr. Reddy’s motion to join this proceeding on August 14, 2018. Paper 47.3
`Two weeks thereafter, Pozen filed a Suggestion of Bankruptcy. Paper 50.
`On August 31, 2018, we suspended all deadlines in the case pursuant to 11
`U.S.C. § 362, which operates to stay all proceedings against a debtor. Paper
`51.
`
`No further action took place in the case until the U.S. Bankruptcy
`Court for the Southern District of New York entered, in January, 2019, an
`order that lifted the automatic stay (Ex. 1052, 28) and an asset purchase
`agreement (Ex. 1052) that documented assignment of Pozen’s patent rights
`to Nuvo Pharmaceuticals (Ireland) Limited (Ex. D to Ex. 1052). Patent
`Owners then updated their mandatory notices to disclose the Nuvo entities as
`real parties-in-interest. Paper 54, 1.
`
`
`3 In our Institution Decision in the 894 IPR, we terminated that proceeding
`under 37 C.F.R. § 42.72 and ordered all further filings to be made in this
`proceeding. Paper 47, 8.
`
`
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`
`II. WHETHER CLICK-TO-CALL APPLIES TO § 315(a)
`Between the time of our decision instituting an inter partes review of
`the ’698 patent and the bankruptcy court’s lifting of the stay, the Federal
`Circuit issued its decision in Click-to-Call, holding that the statutory time
`bar of 35 U.S.C. § 315(b) applies to bar institution of an inter partes review
`proceeding, even if the litigation triggering the bar was voluntarily dismissed
`without prejudice. Click-to-Call, 899 F.3d at 1329. As we note above, we
`determined that the Federal Circuit’s decision warranted additional briefing
`on the applicability of §§ 315(a) and (b) to the facts in this proceeding, as we
`had not addressed those issues on the merits in the Institution Decision. See
`Paper 60, 3–4. On February 8, 2019, the parties submitted briefs addressing
`the impact, if any, that the Click-to-Call decision has on this proceeding.
`Papers 63 and 65.
`In their Click-to-Call briefing, Patent Owners acknowledge that we
`did not reach the issue of whether Mylan’s Petition is barred under
`§ 315(a)(1) and/or § 315(b) because we treated Mylan’s dismissed
`counterclaims as if they had never been brought. Paper 63, 1. Patent
`Owners argue Click-to-Call clarifies that earlier claims trigger the statutory
`bars of § 315, even if those claims subsequently are dismissed without
`prejudice. Id. at 2 (citing Click-to-Call, 899 F.3d at 1328, n.3). Patent
`Owners further note that the Federal Circuit expressly rejected that
`Bonneville Associates, Ltd. Partnership v. Barram, 165 F.3d 1360, 1364
`(Fed. Cir. 1999) and Graves v. Principi, 294 F.3d 1350, 1356–57 (Fed. Cir.
`2002) apply to § 315. Id. at 2–3 (citing Click-to-Call, 899 F.3d at 1334–35).
`We expressly relied on Bonneville Associates and Graves in declining to
`
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`IPR2017-01995
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`reach the merits of Patent Owners’ § 315 arguments in our Institution
`Decision. See Paper 18, 13–15.
`In particular, the Federal Circuit held that Bonneville Associates and
`Graves “concern whether an appellant’s filing of a notice of appeal and
`subsequent dismissal of that appeal ‘tolls’ the jurisdictional deadline to
`appeal from the decision below.” Click-to-Call, 899 F.3d at 1334. The
`court continued: “by contrast, the appropriate question in Click-to-Call is
`whether the voluntary, without prejudice dismissal of a civil action in which
`a complaint had been served nullifies an administrative time bar that is
`triggered by service of that complaint. It does not.” Id. at 1335. Although
`the Click-to-Call decision directly addresses § 315(b), for the reasons below,
`we find that the court’s reasoning in the decision applies equally to § 315(a).
`
`“Section 315 governs the relationship between IPRs and other
`proceedings conducted outside the IPR proceeding.” Applications in
`Internet Time, LLC v. RPX Corp., 897 F.3d 1336, 1346 (Fed. Cir. 2018).
`Section 315(a)(1) states: “[a]n inter partes review may not be instituted if,
`before the date on which the petition for such a review is filed, the petitioner
`or real party in interest filed a civil action challenging the validity of a claim
`of the patent.” 35 U.S.C. § 315(a)(1). Section 315(b) states: [a]n inter
`partes review may not be instituted if the petition requesting the proceeding
`is filed more than 1 year after the date on which the petitioner, real party in
`interest, or privy of the petitioner is served with a complaint alleging
`infringement of the patent.” Id. at 315(b). While the actions of a patent
`owner (serving a complaint alleging infringement) trigger § 315(b), the
`actions of a potential petitioner (filing a civil action challenging validity)
`trigger § 315(a)(1).
`
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`
`The court in Click-to-Call found the language of § 315(b) plain and
`unambiguous, stating that the statute “does not contain any exceptions or
`exemptions for complaints served in civil actions that are subsequently
`dismissed, with or without prejudice,” “[n]or does it contain any indication
`that the application of § 315(b) is subject to any subsequent act or ruling.”
`Click-to-Call, 899 F.3d at 1330. Interpreting the statute otherwise “would
`impose additional conditions not present in the statute’s text.” Id. at 1331.
`The court observed that “the text of § 315(b) is agnostic as to the ‘effect’ of
`the service—i.e., what events transpired after the defendant was served.” Id.
`at 1333. The court concluded that the voluntary, without prejudice dismissal
`of a complaint for infringement does not nullify § 315(b)’s time bar. Id. at
`1335.
`
`As in § 315(b), the language in § 315(a)(1) is plain and unambiguous,
`and contains no exceptions or exemptions for filing civil actions alleging
`invalidity that are later dismissed. See 35 U.S.C. § 315(a)(1). Therefore, the
`difference in actors (patent owner in § 315(b) versus potential petitioner in
`§ 315(a)(1)) and actions (serving a complaint alleging infringement in
`§ 315(b) versus filing a civil action challenging validity in § 315(a)(1)) does
`not justify imposing radically different outcomes to voluntary dismissal of a
`civil action. We understand that a potential petitioner’s filing of civil action
`triggers § 315(a)(1)’s time bar—agnostic to the effect of the filing—
`consistent with other Board panels that have addressed the issue. See, e.g.,
`Cisco Sys., Inc. v. Chrimar Sys., Inc., Case IPR2018-01514, slip op. at 6–13
`(PTAB Feb. 4, 2019) (Paper 10) (denying institution of an inter partes
`review); Ruiz Food Prods., Inc. v. Macropoint LLC, Case IPR2017-02016,
`slip op. at 5–9 (PTAB Feb. 14, 2019) (Paper 22) (granting Patent Owner’s
`
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`motion to dismiss); Avigilon Corp. v. Canon Inc., Case IPR2018-01627, slip
`op. at 6–11 (PTAB Mar. 18, 2019) (Paper 11) (denying institution of an inter
`partes review).
`III. WHETHER MYLAN’S PETITION WAS
`TIME BARRED UNDER § 315
`Patent Owners argue that we should have denied institution under
`§ 315 because Mylan’s Petition was time barred based on two events that
`occurred in the litigation between the parties. First, Patent Owners argue
`that we should have denied institution under § 315(a) based on Mylan’s
`invalidity counterclaim, which first brought the ’698 patent into the litigation
`between the parties and which Mylan filed more than one year before filing
`its Petition. Paper 63, 4–5. Second, Patent Owners contend that service of
`their Answer to Mylan’s counterclaims for declaratory judgment of non-
`infringement invoked § 315(b) and that we, therefore, should not have
`instituted a review on the Petition because Mylan filed it after the one-year
`bar. Id. at 3–4. We address each of Patent Owners’ arguments below.
` Whether Mylan’s Invalidity Counterclaim on the ’698 Patent
`Triggered the § 315(a) Time Bar
`We turn first to Patent Owners’ assertion that § 315(a) barred us from
`instituting this inter partes review based on Mylan’s invalidity counterclaim.
`Paper 63, 4–5. Mylan argues that its “February 9, 2016 counterclaim does
`not constitute ‘fil[ing] a civil action challenging the validity of a claim of the
`patent’ under 35 U.S.C. § 315(a)(1).” Paper 65, 5. We find to the contrary.
`As discussed supra, filing a civil action challenging validity triggers the time
`bar of § 315(a)(1).
`There is no dispute here that Mylan first introduced the ’698 patent
`into litigation with Patent Owners. See Ex. 2005, 40–41, 45; Paper 63, 1;
`
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`Paper 65, 1; see also Ex. 2004, 3–6 (describing the asserted patents and
`related patents, none of which include the ’698 patent). In its Answer to
`Patent Owners’ infringement complaint asserting five patents other than the
`’698 patent, Mylan filed counterclaims for declaratory judgment of non-
`infringement and invalidity of the ’698 patent. Ex. 2005, 40–41, 45. Patent
`Owners had not previously sued Mylan for infringement of the ’698 patent.
`See Paper 63, 3. On these facts, Mylan’s declaratory judgment action
`appears to trigger § 315(a)(1)’s time bar.
`Mylan argues that it escapes § 315(a)(1)’s bar because § 315(a)(3),
`which provides that “[a] counterclaim challenging the validity of a claim of
`a patent does not constitute a civil action challenging the validity of a claim
`of a patent for purposes of this subsection,” applies to its counterclaim.
`Paper 65, 5. We, therefore, must decide whether Mylan’s “Twelfth
`Counterclaim – Declaratory Judgment of Invalidity” of the ’698 patent
`qualifies as “a counterclaim challenging the validity of a claim of a patent”
`under § 315(a)(3). We determine that it does not.
`Mylan’s argument raises an issue as to the meaning in § 315(a)(3) of
`“a counterclaim challenging the validity of a claim of a patent.”
`Specifically, to what “patent” does § 315(a)(3) refer? Is it: (1) only the
`patent(s) that a defendant is charged with infringing, or (2) any patent that a
`defendant alleges is invalid in responding to infringement allegations, even
`if the patent has not been asserted against the defendant? The plain language
`of § 315(a)(3) is not clear in that regard. However, the legislative history
`convinces us that the former is the correct answer. Senator Kyl, in
`discussing § 315, stated:
`
`
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`
`Subsections (a) and (b) of sections 315 and 325 impose time
`limits and other restrictions when inter partes and post-grant
`review are sought in relation to litigation. Sections 315(a) and
`325(a) bar a party from seeking or maintaining such a review if
`he has sought a declaratory judgment that the patent is invalid.
`This restriction applies, of course, only if the review petitioner
`has filed the civil action. These two subsections (a) do not
`restrict the rights of an accused infringer who has been sued
`and is asserting invalidity in a counterclaim. That situation is
`governed by section 315(b), which provides that if a party has
`been sued for infringement and wants to seek inter partes
`review, he must do so within 6 months of when he was served
`with the infringement complaint.
`157 Cong. Rec. S1375 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl)
`(emphasis added). Senator Kyl was discussing a version of the statute that
`was slightly different from the statute eventually codified as §§ 315(a) and
`(b). Id. In a later Congressional hearing, Senator Kyl stated:
`Another set of changes made by the House bill concerns the
`coordination of inter partes and postgrant review with civil
`litigation. The Senate bill, at proposed sections 315(a) and
`325(a), would have barred a party or his real party in interest
`from seeking or maintaining an inter partes or postgrant
`review after he has filed a declaratory-judgment action
`challenging the validity of the patent. The final bill will still
`bar seeking IPR or PGR after a declaratory-judgment action
`has been filed, but will allow a declaratory-judgment action to
`be filed on the same day or after the petition for IPR or PGR
`was filed.
`157 Cong. Rec. S5429 (daily ed. Sept. 8, 2011) (statement of Sen. Kyl)
`(emphasis added). The only discussion in the legislative history of a
`counterclaim in relation to § 315 is in relation to a counterclaim asserting
`invalidity of a patent already asserted against an accused infringer. As
`discussed above, Patent Owners did not assert the ’698 patent against Mylan
`before Mylan challenged the validity of the ’698 patent through a
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`declaratory judgment. Mylan’s declaratory judgment action, though
`designated by Mylan as a “counterclaim,” does not qualify as a counterclaim
`under § 315(a)(3) that avoids § 315(a)(1). Rather, it constitutes a “civil
`action challenging the validity of a claim of the patent” under 35 U.S.C.
`§ 315(a)(1), barring institution of an inter partes review.
` Whether Patent Owners’ Answer to Mylan’s Non-infringement
`Counterclaim on the ’698 Patent Triggered § 315(b)
`Patent Owners also contend that service of their Answer to Mylan’s
`counterclaims for declaratory judgment of non-infringement triggered
`§ 315(b)’s time bar and that we should not have instituted this inter partes
`review. It appears that Patent Owners’ Answer to Mylan’s counterclaims
`(Ex. 2005) did not allege that Mylan infringes the ’698 patent. See
`Ex. 2006, 6 (¶¶ 37–44). For example, Mylan’s non-infringement
`counterclaim alleged “Mylan believes [Patent Owners] will assert that
`Mylan’s proposed naproxen/esomeprazole products are infringing the claims
`of the ’698 patent. . . .” Ex. 2005, 41 (¶ 41). Patent Owners’ Answer to the
`counterclaim stated that “Plaintiffs [i.e., Patent Owners] deny the allegations
`in Paragraph 41.” Ex. 2006, 6. (¶ 41).4 However, we need not address
`whether Patent Owners’ Answer to Mylan’s counterclaims constitute “a
`complaint alleging infringement” of the ’698 patent that triggered § 315(b)’s
`time bar, in view of our decision that Mylan’s counterclaim alleging that the
`’698 patent is invalid triggered § 315(a)’s time bar. We turn next to the
`appropriate remedy.
`
`
`4 Additionally, Patent Owners stated that “The allegations contained in
`[Mylan’s counterclaim of non-infringement] are legal conclusions as to
`which no response is required. To the extent a response is required,
`Plaintiffs deny the allegations.” Ex. 2006, 6 (para. 43).
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`
`IV. VACATUR OF INSTITITION AND TERMINATION
`Mylan filed its Petition requesting an inter partes review of the ’698
`patent on August 24, 2017. Paper 2. In view of our finding that Mylan’s
`February 9, 2016 counterclaim alleging that the ’698 patent is invalid
`triggered § 315(a)’s time bar, we determine that vacating our Institution
`Decision in this proceeding is appropriate.
`Pursuant to 37 C.F.R. § 42 and 35 U.S.C. § 318(a), we may dismiss
`the Petition (Paper 2), thereby terminating this proceeding. In particular,
`37 C.F.R. § 42.71(a) provides that “[t]he Board may take up petitions or
`motions for decisions in any order, may grant, deny, or dismiss any petition
`or motion, and may enter any appropriate order.” The regulations expressly
`provide the Board with broad authority to dismiss a petition where
`appropriate, and to terminate a trial without rendering a final written
`decision, where appropriate. 37 C.F.R. §§ 42.71(a) and 42.72; see also
`37 C.F.R. § 42.5(a) (“The Board may determine a proper course of conduct
`in a proceeding for any situation not specifically covered by this part . . . .”).
`These regulations are consistent with 35 U.S.C. § 318(a), which specifically
`contemplates dismissal of petitions after institution. 35 U.S.C. § 318(a) (“If
`an inter partes review is instituted and not dismissed under this chapter, the
`Patent Trial and Appeal Board shall issue a final written decision . . . .”
`(emphasis added).
`Having considered the parties’ arguments in light of the facts at issue
`and applicable law, we determine that 35 U.S.C § 315(a)(1) barred us from
`instituting an inter partes review based on Mylan’s Petition. Because
`§ 315(a) barred us from instituting this proceeding, we also lacked authority
`to join Dr. Reddy’s as a petitioner to this proceeding. See I.M.L. SLU v.
`
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`WAG Acquisition, LLC, Case IPR2016-01658, slip op. 14–15 (PTAB Feb.
`27, 2018) (Paper 46) (vacating a grant of joinder after dismissing the petition
`that supported the joined party’s petition and joinder motion). In other
`words, absent joinder, we could not have instituted an inter partes review
`based on Dr. Reddy’s Petition because Dr. Reddy’s filed its Petition more
`than one year after it was served with a complaint alleging that it infringes
`the ’698 patent. See 894 IPR Paper 1, 3 (Dr. Reddy’s acknowledging that it
`“filed the Petition more than one year after the date on which Petitioner was
`served with a complaint alleging infringement of the ’698 patent,” but
`asserting that “the Petition is timely because Petitioner has filed it no later
`than one month after the institution date of an inter partes review for which
`joinder is requested” and explaining that “[t]he time period set forth in §
`42.101(b) does not apply because the Petition is accompanied by a request
`for joinder” to the 1995 IPR). Accordingly, we vacate our Institution
`Decision in this proceeding (Paper 18), vacate our Decision instituting an
`inter partes review in the 894 IPR and granting Dr. Reddy’s motion for
`joinder to this proceeding (894 IPR Paper 10), and terminate this proceeding.
`
`
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`V. ORDER
`
`Accordingly, it is:
`ORDERED that our March 8, 2018, decision instituting an inter
`partes review of the ’698 patent Case IPR2017-01995 is hereby vacated;
`FURTHER ORDERED that our August 14, 2018 decision instituting
`an inter partes review of the ’698 patent in Case IPR2018-00894 and
`granting Dr. Reddy’s motion for joinder to Case IPR2017-01995 is hereby
`vacated;
`FURTHER ORDERED that the Petition in Case IPR2017-01995
`(Paper 2) is hereby dismissed;
`FURTHER ORDERED that Case IPR2017-01995 is hereby
`terminated with respect to all Petitioners and Patent Owners; and
`FURTHER ORDERED that the oral argument scheduled for June 14,
`2019, is cancelled with respect to Case IPR2017-01995 and the ’698 patent.
`
`
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`IPR2017-01995
`Patent 9,220,698 B2
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`PETITIONERS:
`
`Brandon M. White
`Emily Greb
`PERKINS COIE LLP
`white-ptab@perkinscoie.com
`greb-ptab@perkinscoie.com
`
`Alan Pollack
`Louis Weinstein
`BUDD LARNER PC
`apollack@buddlarner.com
`lweinstein@buddlarner.com
`
`PATENT OWNERS:
`
`Thomas A. Blinka
`COOLEY LLP
`tblinka@cooley.com
`
`
`Margaret J. Sampson
`BAKER BOTTS LLP
`Margaret.Sampson@bakerbotts.com
`
`
`
`
`15
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