Case 1:18-cv-00202-IMK Document 49 Filed 04/04/19 Page 1 of 4 PageID #: 1371
`Case 1:18—cv-00202-IMK Document 49 Filed 04/04/19 Page 1 of 4 PagelD #: 1371
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`Case MDL No 2884 Document 50 Filed 04/03/19 Page 1 of 4
`CERTIFIED: APR- 42019
`ASATRUE COPY:
`ATTEST:
`éeCERINO’CLERK UNITED STATES JUDICIAL PANEL
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`new, cm,
`MULTIDISTRICT LITIGATION
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`on
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`.
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`l7 Md 2 88 4
`F1LED
`APR _ 4 2019
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`IN RE: KERYDIN (TAVABOROLE) TOPICAL
`SOLUTION 5% PATENT LITIGATION
`
`v.3. DISTRICT co
`_
`WHEEUNG. W233?"
`MDL No. 2884
`
`TRANSFER ORDER
`
`Before the Panel:' Plaintiff and patentholder Anacor Pharmaceuticals, Inc., invokes 28
`U.S.C. § 1407 to seek centralization of this patent infringement litigation in the District of Delaware.
`This litigation consists Of three actions pending in two districts, as listed on Schedule A. Generic
`manufacturer defendants2 in two D. Delaware actions do not oppose centralization in the District of
`Delaware. Mylan Inc., and Mylan Pharmaceuticals Inc. (collectively, Mylan), which are defendants
`in the Northern District of West Virginia action, oppose centralization.
`
`Anacor filed these actions afier 22 generic drug manufacturers submitted a total of fourteen
`Abbreviated New Drug Applications (ANDAs) seeking approval by the US. Food and Drug
`Administration (FDA) to make and sell generic versions ofKerydin (tavaborole) topical solution 5%,
`a topical antifungal that is used to treat toenail fimgus. The actions on the motion are a series of
`Hatch-Waxman3 patent infringement lawsuits, in which Anacor alleges that each of the 22 total
`
`' Judge Ellen Segal Huvelle did not participate in the decision of this matter.
`
`2 Aleor Dermaceuticals Limited, Apotex Corp., Apotex Inc., Aurobindo Pharma Limited,
`Aurobindo Pharma USA, Inc., Cadila Healthcare Ltd., Cipla Limited, Cipla USA, Inc., Perrigo
`Company plc, Perrigo Pharma International DAC, Taro Pharmaceutical Industries, Ltd., Taro
`Pharmaceuticals U.S.A., Inc., Zydus Pharmaceuticals (USA) Inc., Encube Ethicals Pvt. Ltd.,
`Glasshouse Pharmaceuticals Limited Canada, Lupin Limited, and Lupin Pharmaceuticals, Inc.
`
`3 Under the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No.
`98—417, 98 Stat. 1585 (1984) (the “Hatch-Waxman Act”), Congress established an incentive for
`companies to bring generic versions Ofbranded drugs to market faster than they Otherwise might by
`granting the first company to file an ANDA an “exclusivity period” of 180 days, during which the
`FDA may not approve for sale any competing generic version Of the drug. See Teva Pharm. USA,
`Inc. v. Sebelius, 595 F.3d 1303, 1304-05 (DC. Cir. 2010). Submitting an ANDA with a “paragraph
`IV certification”——stating that the patents listed in the FDA’S Orange Book as covering the
`previously approved drug are invalid or will not be infringed by the generic drug—constitutes a
`statutory act ofinfringement that creates subj ect-matterjurisdicti on for a district court to resolve any
`disputes regarding patent infringement or validity before the generic drug is sold. See 35 U.S.C. §
`27l(e)(2)(A); Eli Lilly & Co. v. Medtronic, Inc., 496 US. 661, 676-78 (1990). If the patent-holder
`(continued...)
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`defendants has infringed four US. Patents“ by filing ANDAs seeking FDA approval to market
`generic tavaborole in the United States.
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`On the basis of the papers filed and hearing held, we find that these actions involve common
`questions of fact, and that centralization in the District of Delaware will serve the convenience of
`the parties and witnesses and promote the just and efficient conduct of this litigation. All actions
`involve substantially identical claims that defendants infringed the four Kerydin patents.
`Centralization is warranted to prevent inconsistent rulings (particularly with respect to claim
`construction and issues of patent validity) and overlapping pretrial obligations, reduce costs, and
`create efficiencies for the parties, courts, and witnesses.
`
`Mylan opposes centralization, arguing that there are too few actions to justify centralization
`and that informal coordination among the parties and involved judges is an adequate alternative to
`formal centralization. We are not persuaded by these arguments. Even though only three actions
`are pending in this litigation, we have long acknowledged that “actions involving the validity of
`complex pharmaceutical patents and the entry of generic versions of the patent holder's drugs are
`particularly well-suited for transfer under Section 1407.” In re: Alfirzosin Hydrochloride Patent
`Litig., 560 F. Supp. 2d 1372, 1372 (J.P.M.L. 2008). For that reason, we have centralized litigation
`consisting of only two Hatch-Waxman Act cases.’ Given the complexity of the allegations and
`regulatory framework governing Hatch-Waxman cases, as well as the need for swifi progress in
`litigation involving the potential entry of generic drugs into the market, placing all actions before a
`single judge should foster the efficient resolution of all of the actions.
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`We select the District ofDelaware as the appropriate transferee district for these actions. The
`claims of thirteen of the fourteen ANDA filers are pending in this district. We are confident that
`Judge Richard G. Andrews, who is well-versed in complex patent litigation, will steer this matter
`on a prudent course.
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`3(...continued)
`initiates an infringement action against the ANDA filer within 45 days of receipt of the paragraph
`IV certification, then the FDA may not approve the ANDA until the earlier of either 30 months or
`the issuance of a decision by a court that the patent is invalid or not infringed by the generic
`manufacturer’s ANDA. See 21 U.S.C. § 355(j)(5)(B)(iii).
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`4 The patents are US. Patent No. 9,459,938, US Patent No. 9,566,289, US. Patent No.
`9,566,290, and US Patent No. 9,572,823.
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`5 See, e.g., In re: Armodafinil Patent Litig., 755 F. Supp. 2d 1359 (J.P.M.L. 2010)
`(centralizing two Hatch-Waxman cases); In re: Brimonidine Patent Litig., 507 F. Supp. 2d 1381
`(J.P.M.L. 2007) (same); In re: Metoprolol Succinate Patent Litig., 329 F. Supp. 2d 1368 (J.P.M.L.
`2004) (same).
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`IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside
`the District of Delaware are transferred to the District of Delaware and, with the consent of that
`court, assigned to the Honorable Richard G. Andrews for coordinated or consolidated pretrial
`proceedings.
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`PANEL ON MULTIDISTRICT LITIGATION
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`Q ‘l/m
`
`Sarah S. Vance
`Chair
`
`Lewis A. Kaplan
`Catherine D. Perry
`Nathaniel M. Gorton
`
`R. David Proctor
`Karen K. Caldwell
`
`

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`Case 1:18-cv-00202-IMK Document 49 Filed 04/04/19 Page 4 of 4 PageID #: 1374
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`Case MDL No. 2884 Document 50 Filed 04/03/19 Page 4 of 4
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`IN RE: KERYDIN (TAVABOROLE) TOPICAL
`SOLUTION 5% PATENT LITIGATION
`
`MDL No. 2884
`
`SCHEDULE A
`
`District of Delaware
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`ANACOR PHARMACEUTICALS, INC. v. LUPIN LIMITED, ET AL.,
`CA. No. 1218—01606
`
`ANACOR PHARMACEUTICALS, INC. v. ASCENT PHARMACEUTICALS, INC.,
`ET AL., CA. No. 1:18-01673
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`Northern District of West Virginia
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`ANACOR PHARMACEUTICALS, INC. V. MYLAN PHARMACEUTICALS INC.,
`ET AL, CA. No. 1:18-00202
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`