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`Case 1:22-cv-00023-JPB Document 34 Filed 08/05/22 Page 1 of 5 PageID #: 3040
`CERTIFIED: AUG — 5/2022
`AS.A TRUE COPY:
`ATTEST:
`A. CERINO,
`A
`
`UNITED STATES JUDICIAL PANEL
`on
`
`JOHN
`BY
`
`
` Deputy Clerk
`
`MULTIDISTRICT LITIGATION
`
`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
`
`MDL No. 3038
`
`TRANSFER ORDER
`
`Before the Panel:* Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S (collectively,
`Novo Nordisk) move under 28 U.S.C.
`§ 1407 to centralize this litigation in the District of
`Delaware. This litigation consists of six actions, five in the District of Delaware and onein the
`Northern District of West Virginia, as listed on Schedule A. The defendantin the West Virginia
`action, Mylan Pharmaceuticals Inc., opposes centralization. Alternatively, it suggests the Northern
`District of West Virginia as the transferee district. No other defendant respondedto the motion.
`
`Novo Nordisk filed these actions after the various generic drug manufacturer defendants
`submitted Abbreviated New Drug Applications (ANDAs) seeking approval by the U.S. Food and
`Drug Administration (FDA) to makeandsell generic versions of Ozempic (semaglutide), which
`is prescribed for the treatment of type 2 diabetes and for long-term weight management. The
`actions on the motion are a series of Hatch-Waxman! patent infringement lawsuits, in which the
`plaintiffs allege that each defendanthas infringed one or more claims of between two and eighteen
`
`* Judge Roger T. Benitez did not participate in the decisionof this matter.
`
`' Underthe 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 of branded drugs to market faster than they otherwise might
`by granting the first companyto file an ANDAan “exclusivity period” of 180 days, during which
`the FDA may not approvefor sale any competing generic version of the drug. See Mova Pharm.
`Corp. v. Shalala, 140 F.3d 1060, 1063-65 (D.C. Cir. 1998). Submitting an ANDA with a
`
`“paragraph IV certification”—stating that the patents listed in the FDA publication “Approved
`Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book) as covering the
`previously approved drug are invalid or will not be infringed by the generic drug—constitutes a
`statutory act of infringement that creates subject-matter jurisdiction for a district court to resolve
`any disputes regarding patentinfringementor validity before the generic drug is sold. See 35
`U.S.C. § 271(e)(2)(A); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676-78 (1990).
`If the
`patentholderinitiates an infringementaction against the ANDAfiler within 45 days of receipt of
`the paragraphIV certification, then the FDA maynotapprove the ANDAuntil the earlier of either
`30 monthsorthe issuanceof a decision by a court that the patentis invalid or notinfringed by the
`generic manufacturer’s ANDA. See 21 U.S.C. § 355(j)(5)(B)(iii).
`
`

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`U.S. patents covering Ozempic’ by filing an ANDA seeking FDA approval to market generic
`versions of Ozempic in the United States.
`
`Onthe basis of the papers filed andthe hearing session held, we find that the actionslisted
`on Schedule A involve common questions of fact, and that centralization in the District of
`Delaware will serve the convenienceofthe parties and witnesses and promotethe just and efficient
`conduct of this litigation. These actions involve substantially similar claims that defendants
`infringed two or more of the Ozempic patents. While the patents asserted in each action vary
`somewhat, there is significant overlap. Two patents—No. 9,132,239, entitled “Dial-Down
`Mechanism for Wind-Up Pen” and No. 10,335,462, entitled ‘Use of Long-Acting GLP-1
`Peptides”—are asserted in all six actions. Another eight patents are asserted in multiple actions
`pending in both of the involved districts. Centralization is warranted to eliminate duplicative
`discovery; prevent inconsistentpretrial rulings (particularly with respect to claim construction and
`issues of patent validity); and conserve the resourcesofthe parties, their counsel, and the judiciary.
`
`Wehavecentralized similar patentlitigations, citing “the complexity ofthe allegations and
`regulatory framework governing Hatch-Waxmancases, as well as the need for swift progress in
`litigation involving the potential entry of generic drugs into the market.” See In re Kerydin
`(Tavaborole) Topical Solution 5% Patent Litig., 366 F. Supp. 3d 1370, 1371 (J.P.M.L. 2019); see
`also In re Xarelto (Rivaroxaban) (‘310) Patent Litig., MDL No. 3017, 2021 WL 5872990,at *2
`(J.P.M.L. Dec. 10, 2021); In re Entresto (Sacubitril/Valsartan) Patent Litig., 437 F. Supp. 3d 1372,
`1373 (J.P.M.L. 2020); In re Palbociclib Patent Litig., 396 F. Supp. 3d 1360, 1361-62 (J.P.M.L.
`2019). Mylan argues that, unlike these prior patent litigations (each of which involved, as here,
`one or more Delaware actions andasingle action against Mylan filed in West Virginia), the West
`Virginia action here involves eight unique patents, containing a total of 125 unique claims,notat
`issue in the Delaware actions. Mylanalsostresses that mostofthe patents asserted againstit relate
`to the injection pen for delivering the medication, rather than the formulation and use of
`semaglutide.
`
`This argumentis not persuasive. To begin, counsel for plaintiffs stated at oral argument
`that they have agreed to withdraw claims as to eleven device patents in the West Virginia action.
`Thus, while the West Virginia action at present involves eight unique patents, this may be a
`temporary distinction. Further, many of the “non-common”patents asserted in the West Virginia
`action derive from the samepatent family as patents asserted in the Delaware actions, andthus are
`likely to share similar terms and claims. Compare, e.g., U.S. Patent No. 8,129,343 (asserted in
`four actions and relating to “[p]rotracted GLP-1 compounds and therapeutic uses thereof), with
`USS. Patent No. 8,536,122 (asserted in the West Virginia action, a continuation of the application
`that led to the ‘343 patent).
`In any event, the West Virginia action also involves ten patents that
`are asserted in the Delaware actions. “Transfer under Section 1407 does not require a complete
`identity, or even majority, of common factualissues as a prerequisite to transfer.” Jn re Ameriquest
`Mortg. Co. Mortg. Lending Practices Litig., 408 F. Supp. 2d 1354, 1355 (J.P.M.L. 2005). That
`someof these patents relate to the injection device, as opposed to semaglutideitself, is irrelevant
`to this analysis.
`
`* The patents at issue include U.S. Patent Nos. 8,114,833; 8,129,343; 8,536,122; 8,684,969;
`8,920,383; 9,108,002; 9,132,239; 9,457,154; RE46,463; 9,616,180; 9,687,611; 9,775,953;
`9,861,757; 10,220,155; 10,335,462; 10,357,616; 10,376,652; and 11,097,063.
`
`

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`Mylan also contends that centralization wouldinterfere with its right to litigate the action
`in a proper forum. This argument is not well taken—under 28 U.S.C. § 1407, this Panel is
`authorized to select the appropriate venue for coordinated or consolidate pretrial proceedings of
`actions involving common factual questions. Moreover, “the transferee judge has all
`the
`jurisdiction and powers over pretrial proceedings in the actions transferred to him that the
`transferor judge would have had in the absenceof transfer.” Jn re Delta Dental Antitrust Litig.,
`509 F. Supp. 3d 1377, 1379 (J.P.M.L. 2020) (quoting Jn re FMC Corp. Patent Litig., 422 F. Supp.
`1163, 1165 (J.P.M.L. 1976) (internal citations omitted)).
`
`The District of Delaware is an appropriate transferee district for this litigation. Five of the
`six actions on the motion are pending in this district. Additionally, several patent infringement
`actions involving Saxenda(liraglutide), a related drug marketed by Novo Nordisk that uses the
`sameinjection device, are pendingin the District of Delaware. One of these actions, Novo Nordisk
`Inc. v. Teva Pharms., Inc., C.A. No. 1:21-01782 (D. Del.), involvesfifteen of the eighteen patents
`at issue in the Ozempic litigation. Centralization in this district thus offers the potential for
`realizing substantial efficiencies. We assign this litigation to the Honorable Colm F. Connolly,
`who is well-versed in complex patent litigation and who presides over both the Ozempic and
`Saxenda actions. We are confident that Judge Connolly will steer this litigation on a prudent and
`expeditious course.
`
`IT IS THEREFORE ORDEREDthatthe action listed on Schedule A and pending outside
`the District of Delaware is transferred to the District of Delaware and, with the consent ofthat
`court, assigned to the Honorable Colm F. Connolly for coordinated or consolidated pretrial
`proceedings.
`
`PANEL ON MULTIDISTRICT LITIGATION
`
`
`
`K. Caldwell
`Karen
`Chair
`
`Nathaniel M. Gorton
`David C. Norton
`Madeline Cox Arleo
`
`Matthew F. Kennelly
`Dale A. Kimball
`
`3 Mylan contendsthatcentralization in Delaware will notyield efficiencies because that court does
`not permit summary judgment motions in Hatch-Waxmanlitigation. Given the District of
`Delaware’s extensive experience with such litigation and the time constraints imposed by the
`Hatch-Waxman process, we decline Mylan’s invitation to second guess the efficiency of that
`court’s case managementpractices. Mylan maytake upthis issue with the transferee court.
`
`

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`
`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
`
`MDLNo.3038
`
`SCHEDULE A
`
`District of Delaware
`
`NOVO NORDISKINC., ET AL. v. RIO BIOPHARMACEUTICALS,INC., ET AL.,
`C.A. No. 1:22-00294
`NOVO NORDISK A/S, ET AL. v. SUN PHARMACEUTICAL INDUSTRIESLTD.,
`ET AL., C.A. No. 1:22-00296
`NOVO NORDISKINC., ET AL. v. ZYDUS WORLDWIDE DMCC,ETAL.,
`C.A. No. 1:22—00297
`NOVO NORDISKINC., ET AL. v. DR. REDDY'S LABORATORIESLTD., ET AL.,
`C.A. No. 1:22-00298
`NOVO NORDISKINC., ET AL. v. ALVOGEN,INC., C.A. No. 1:22-00299
`
`Northern District of West Virginia
`
`NOVO NORDISKINC., ET AL. v. MYLAN PHARMACEUTICALS,INC.,
`C.A. No. 1:22-00023
`
`