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`Filed: February 8, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`and
`
`DR. REDDY’S LABORATORIES, INC.,
`
`Petitioners
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY,
`Patent Owners.
`____________________________
`
`Case No. IPR2017-019951
`U.S. Patent No. 9,220,698
`____________________________
`
`SUPPLEMENTAL BRIEF ON APPLICABILITY OF
`CLICK-TO-CALL TECHNOLOGIES, LP V. INGENIO, INC.
`
`
`
`
`1 Petitioner Dr. Reddy’s Laboratories, Inc. (“DRL”), from IPR2018-00894, has
`
`been joined as a Petitioner to this proceeding.
`
`

`

`
`Mylan respectfully submits this supplemental brief to address whether the
`
`Federal Circuit’s decision in Click-to-Call Technologies, LP v. Ingenio, Inc., 899
`
`F.3d 1321 (Fed. Cir. 2018) warrants reversal of the Board’s repeated prior
`
`decisions concluding that Mylan’s Petition is not time-barred under 35 U.S.C.
`
`§ 315. The answer to that question is unequivocally no. The relevant facts2 are as
`
`follows:
`
` February 19, 2016. Mylan filed an answer and counterclaims to Patent
`
`Owners’ second amended complaint in “Case 2” (Case No. 15-3327
`
`(D.N.J.)), which included counterclaims for declarations of invalidity and
`
`non-infringement of the ’698 patent. Ex. 2005.
`
` March 7, 2016. Patent Owners answered these counterclaims, but did not
`
`assert any affirmative claims or file an amended complaint. Ex. 2006.
`
` August 25, 2016. Mylan was for the first time served with a complaint
`
`alleging infringement of the ’698 patent, filed and served in “Case 3” (Case
`
`No. 16-4921 (D.N.J.)). Paper No. 34 at 3.
`
` February 23, 2017. The district court dismissed without prejudice Mylan’s
`
`counterclaims regarding the ’698 patent in Case 2. Ex. 1047.
`
` August 24, 2017. Mylan petitioned for inter partes review of the ’698
`
`patent and was accorded an August 24, 2017 filing date.
`
`
`2 The dispute here relates only to Petitioner Mylan Pharmaceuticals Inc.
`1
`
`
`

`

`
`
`On the facts above, Patent Owners have twice pressed that Mylan’s Petition
`
`is time barred, first, in their preliminary response (Paper No. 10 at 10), and again in
`
`a request for rehearing of the institution decision (Paper No. 24). The Board has
`
`twice (correctly) rejected that theory. See Paper Nos. 18 & 34.
`
`
`
`In its institution decision, the Board concluded that the Petition was not
`
`time-barred because Mylan’s February 2016 counterclaims were dismissed without
`
`prejudice. Paper No. 18 at 12-13. This without-prejudice dismissal “place[d] the
`
`parties in a position as if the action was never filed.” Id. at 13. While the Board’s
`
`ultimate decision rested on the nature of the dismissal, the Board also noted a
`
`second reason the petition was not time barred: “Patent Owner does not direct us
`
`to any persuasive authority to support the proposition that § 315(a) was intended to
`
`apply to a counterclaim challenging the validity of patent claims where the patent
`
`is not the subject of the complaint.” Id. Indeed, as noted by the Board, a
`
`counterclaim challenging validity simply “is not a civil action.” Id. at 12.
`
`
`
`The Board later affirmed its ruling in denying Patent Owners’ request for
`
`rehearing. Paper No. 34 at 4-5. The crux of Patent Owners’ argument was that the
`
`counterclaims were not dismissed without prejudice, but instead consolidated into
`
`a later-filed case, and thus the bars of both § 315(a) and (b) applied. See Paper No.
`
`24 at 1, 8. In denying the request for rehearing, the Board not only disagreed that
`
`the counterclaims were, in fact, consolidated into the later-filed case, but also
`
`2
`
`

`

`appropriately made clear that the Patent Owners “did not assert that Petitioner
`
`infringed the ’698 patent” and “did not file a complaint against [Mylan] alleging
`
`infringement of the ’698 patent in the earlier case ….” Paper No. 34 at 3-5.3
`
`
`
`Click-to-Call does not warrant a departure from the Board’s repeated prior
`
`decisions. In Click-to-Call, the Federal Circuit held that § 315(b)’s time bar
`
`applies “when an IPR petitioner was served with a complaint for patent
`
`infringement more than one year before filing its petition, but the district court
`
`action in which the petitioner was so served was voluntarily dismissed without
`
`prejudice.” 899 F.3d at 1328 n.3. In other words, under Click-to-Call, while
`
`§ 315(b) requires both (1) a complaint and (2) service of a complaint to start the
`
`time-bar clock, events transpiring after service (e.g., dismissal) do not set the clock
`
`back. See id. at 1330-36. As to what constitutes a complaint and service thereof,
`
`the Click-to-Call court found that the words of the statute were unambiguous. Id.
`
`at 1330. The term “complaint” means “[t]he initial pleading that starts a civil
`
`action and states the basis for . . . the plaintiff’s claim.” Id. (quoting Black’s Law
`
`Dictionary 323 (9th ed. 2009)). The common meaning of “serve” is “[t]o make
`
`legal delivery of (a notice or process).” Id. (quoting Black’s Law Dictionary 1491
`
`(9th ed. 2009)); see also id. (“[t]o present (a person) with a notice or process as
`
`3 Patent Owners also asserted that DRL’s petition is barred, IPR2018-00894, Paper
`
`No. 8 at 1-2; the Board again disagreed, id., Paper No. 10 at 5 n.4.
`
`3
`
`

`

`required by law,” … “[t]he formal delivery of a writ, summons, or other legal
`
`process” (quoting Black’s Law Dictionary 1491 (9th ed. 2009)).
`
`
`
`
`
`Properly applied, Click-to-Call does not detract from—but supports—the
`
`propriety of institution here. Under Click-to-Call, Patent Owners’ answer to
`
`Mylan’s counterclaim was not “serv[ing] a complaint alleging infringement of the
`
`patent” on Mylan, as required under 35 U.S.C. § 315(b). Paper No. 16 at 2; Paper
`
`No. 34 at 3-4. “[T]he phrase ‘served with a complaint’ has a specific legal
`
`connotation synonymous with formal delivery of a complaint in a civil action.”
`
`Amkor Tech., Inc. v. Tessera, Inc., IPR2013-00242, 2014 WL 2864151 (P.T.A.B.
`
`Jan. 31, 2014), Paper No. 98 (cited with approval in Click-to-Call); Click-to-Call,
`
`899 F.3d at 1330 (“§ 315(b)’s time bar is implicated once a party receives notice
`
`through official delivery of a complaint in a civil action, irrespective of subsequent
`
`events”). Patent Owners’ answer fulfills neither requirement—Patent Owners filed
`
`no complaint, let alone served a complaint on Mylan, as expressly required by
`
`§ 315(b). And, unlike the patent owner in St. Jude Medical, Cardiology Div., Inc.
`
`v. Volcano Corp., IPR2013-00258, Paper 29 (P.T.A.B. Oct. 16, 2013), Patent
`
`Owners here did not file an amended complaint or raise affirmative ’698 patent
`
`counterclaims in Case 2. Paper No. 34 at 3-5. Mylan thus was not “served with a
`
`complaint alleging infringement of a patent” until August 25, 2016, less than one
`
`4
`
`

`

`year before the filing of Mylan’s Petition. Accordingly, the Petition is not barred
`
`under § 315(b).
`
`
`
`Patent Owners are therefore left with only their challenge under 35 U.S.C.
`
`§ 315(a)(1). This too fails. Namely, Mylan’s 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). In fact, §315(a) is unequivocal 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
`
`[§ 315(a)].” 35 U.S.C. § 315(a)(3); see also Paper No. 18 at 13 (“Patent Owner
`
`does not direct us to any persuasive authority to support the proposition that
`
`§ 315(a) was intended to apply to a counterclaim challenging the validity of patent
`
`claims where the patent is not the subject of the complaint.”). Patent Owner’s
`
`reliance on Amkor Technology, Inc., 2014 WL 2864151 (P.T.A.B. Jan. 31, 2014)—
`
`which addresses whether a Patent Owner’s counterclaims may trigger the bar under
`
`§ 315(b)—is thus misplaced.
`
`
`
`Under the reasoning of Click-to-Call, Mylan’s Petition is therefore timely,
`
`and the Board’s institution decision and denial of rehearing were proper.
`
`Accordingly, for the reasons described above and in Mylan’s prior submission
`
`(Paper No. 16), Petitioner respectfully requests the Board again affirm its decision
`
`that the Petition is not time barred under 35 U.S.C. § 315(a) or (b).
`
`5
`
`

`

` Dated: February 8, 2019
`
`
`
`/Brandon M. White/
`
`
`
`
`
`Brandon M. White
`Reg. No. 52,354
`
`PERKINS COIE LLP
`700 13th Street, NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`Facsimile: (202) 654-6211
`Email: bmwhite@perkinscoie.com
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
`6
`
`

`

`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that the foregoing Supplemental Brief on
`
`the Applicability of Click-to-Call Technologies, LP v. Ingenio, Inc. was served
`
`
`
`
`
`
`electronically via email as follows:
`
`
`Patent Owners:
`
`Thomas A. Blinka
`Jonathan G. Graves
`Susan Krumplitsch
`Ellen Scordino
`Lauren Krickl
`Cooley LLP
`zIPR2017-01995@cooley.com
`
`Margaret J. Sampson
`Stephen M. Hash
`Jeffrey S. Gritton
`Baker Botts LLP
`pozen-
`vimovoBB@bakerbotts.com
`Petitioner Dr. Reddy’s:
`
`Alan H. Pollack
`Dmitry V. Shelhoff
`Stuart D. Sender
`Louis H. Weinstein
`apollack@buddlarner.com
`dshelhoff@buddlarner.com
`ssender@buddlarner.com
`lweinstein@buddlarner.com
`
`
`7
`
`

`

`
`Dated: February 8, 2019
`
`
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`8
`
`

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