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`Case 1:22-cv-00945-UNA Document 1 Filed 07/18/22 Page 1 of 9 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`EXELIXIS, INC.,
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`Plaintiff,
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`v.
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`MSN LABORATORIES PRIVATE LIMITED
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`and MSN PHARMACEUTICALS, INC.,
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`Defendants.
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`C.A. No. ______________________
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`COMPLAINT FOR PATENT INFRINGEMENT
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35 U.S.C. §§ 100, et. seq. as well as the Declaratory Judgment Act, 28 U.S.C. §§
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`2201-02, against Defendants MSN Laboratories Private Limited (“MSN Laboratories”) and MSN
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`Pharmaceuticals Inc. (“MSN Pharmaceuticals” and together with MSN Laboratories, “MSN”).
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`This action arises out of the submission by MSN of Abbreviated New Drug Application
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`(“ANDA”) No. 213878 to the U.S. Food and Drug Administration (“FDA”) seeking approval to
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`manufacture and sell a generic version of CABOMETYX® (“the MSN ANDA Product”) prior to
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`the expiration of U.S. Patent No. 11,298,349.
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`PARTIES
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`Plaintiff Exelixis, Inc. (“Exelixis”) is a corporation organized and existing under
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`2.
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`the laws of the State of Delaware, with its principal place of business at 1851 Harbor Bay Parkway,
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`Alameda, California 94502. Exelixis is engaged in the business of creating, developing, and
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`bringing to market new medicines for difficult-to-treat cancers. Exelixis sells CABOMETYX®
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`throughout the United States, including in Delaware.
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`3.
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`Upon information and belief, MSN Laboratories is a corporation organized and
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`Case 1:22-cv-00945-UNA Document 1 Filed 07/18/22 Page 2 of 9 PageID #: 2
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`existing under the laws of India, having its principal place of business at MSN House, Plot No:
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`C-24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India, 500018.
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`4.
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`Upon information and belief, MSN Pharmaceuticals is a corporation organized and
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`existing under the laws of the State of Delaware, having its principal place of business at 20 Duke
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`Road, Piscataway, New Jersey 08854. Upon information and belief, MSN Pharmaceuticals is a
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`wholly owned subsidiary of MSN Laboratories.
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`5.
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`Upon information and belief, MSN Laboratories, itself and through its
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`subsidiaries and agents, including MSN Pharmaceuticals, develops, manufactures, distributes,
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`and/or imports pharmaceutical products for sale and use throughout the United States, including
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`in Delaware.
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`6.
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`Upon information and belief, MSN Pharmaceuticals develops, manufactures,
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`distributes, and/or imports pharmaceutical products for sale and use throughout the United States,
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`including in Delaware.
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`7.
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`Upon information and belief, MSN Pharmaceuticals has been designated as
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`United States agent for MSN Laboratories in accordance with 21 C.F.R. § 314.50(a) in connection
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`with one or more ANDAs.
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`8.
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`Upon information and belief, MSN Pharmaceuticals and MSN Laboratories
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`acted collaboratively in the preparation and submission of ANDA No. 213878.
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`9.
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`Upon information and belief, following any FDA approval of ANDA No.
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`213878, MSN Laboratories, itself and through its subsidiaries and agents, including MSN
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`Pharmaceuticals, will make, use, offer to sell, and/or sell the MSN ANDA Product that is the
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`subject of ANDA No. 213878 throughout the United States, including in Delaware, and/or import
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`such generic products into the United States, including into Delaware.
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`2
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`Case 1:22-cv-00945-UNA Document 1 Filed 07/18/22 Page 3 of 9 PageID #: 3
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`JURISDICTION AND VENUE
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`This case arises under the patent laws of the United States of America, 35 U.S.C.
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`10.
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`§§ 100, et. seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202, and this Court has
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`subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`11.
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`This Court has personal jurisdiction over MSN because, inter alia, MSN has
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`committed an act of patent infringement under 35 U.S.C. § 271(e)(2) and intends a future course
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`of conduct that includes acts of patent infringement under 35 U.S.C. § 271(a), (b) and/or (c),
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`including in Delaware. These acts have led and will lead to foreseeable harm and injury to
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`Exelixis, a Delaware corporation, in Delaware. For example, on information and belief, following
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`approval of ANDA No. 213878, MSN will make, use, import, sell, and/or offer for sale the MSN
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`ANDA Product in the United States, including in Delaware, prior to the expiration of U.S. Patent
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`No. 11,298,349.
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`12.
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`The Court also has personal jurisdiction over MSN because, among other things,
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`this action arises from actions of MSN directed toward Delaware, and because MSN has
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`purposefully availed itself of the rights and benefits of Delaware law by engaging in systematic
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`and continuous contacts with Delaware. Upon information and belief, MSN regularly and
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`continuously transacts business within Delaware, including by selling pharmaceutical products in
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`Delaware either directly or indirectly through affiliated companies. Upon information and belief,
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`MSN derives substantial revenue from the sale of those products in Delaware and has availed itself
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`of the privilege of conducting business within Delaware.
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`13.
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`In addition, the Court has personal jurisdiction over MSN Pharmaceuticals
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`because, upon information and belief, it is a Delaware corporation with a registered agent in
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`Delaware and is registered to conduct business in Delaware.
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`Case 1:22-cv-00945-UNA Document 1 Filed 07/18/22 Page 4 of 9 PageID #: 4
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`14.
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`In the alternative, this Court has jurisdiction over MSN Laboratories because the
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`requirements of Federal Rule of Civil Procedure 4(k)(2)(A) are met.
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`15.
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`MSN has previously availed itself of this forum for the purpose of litigating its
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`patent infringement disputes. For example, MSN has filed counterclaims in Millennium
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`Pharmaceuticals, Inc. v. MSN Laboratories Private Ltd., et al., C.A. No. 16-1255-GMS (D. Del.)
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`and Onyx Therapeutics, Inc., v. MSN Pharmaceuticals, Inc., et al., C.A. No. 16-999- LPS (D. Del.).
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`MSN has also filed counterclaims in this forum in Exelixis, Inc. v. MSN Laboratories Private
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`Limited et al., C.A. No. 19-2017-RGA-SRF (D. Del.).1
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`16.
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`Venue is proper in this Court as to MSN Pharmaceuticals under 28 U.S.C. §
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`1400(b) because, upon information and belief, it is incorporated under the state laws of Delaware
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`and therefore resides in the District of Delaware.
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`17.
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`Venue is proper in this Court as to MSN Laboratories under 28 U.S.C. §
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`1391(c)(3), because, upon information and belief, it is not a resident of the United States and may
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`thus be sued in any judicial district.
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`BACKGROUND
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`U.S. Patent No. 11,298,349 (“the ՚349 Patent”) (“Exhibit A”), entitled “Processes
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`18.
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`1 This is the fourth case Exelixis has commenced against MSN with respect to ANDA No.
`213878. Exelixis commenced litigation against MSN on October 29, 2019, in response to a first
`paragraph IV notice letter that MSN sent to Exelixis with respect to ANDA No. 213878. This
`notice letter alleged that U.S. Patent No. 8,877,776 was invalid, unenforceable, and/or would not
`be infringed by the commercial manufacture, use, offer for sale, or sale of the MSN ANDA
`Product. Exelixis brought a second action against MSN in this District on May 11, 2020, in
`response to two additional paragraph IV notice letters with respect to ANDA No. 213878.
`These notice letters alleged that U.S. Patent Nos. 7,579,473 and 8,497,284 were invalid,
`unenforceable, and/or would not be infringed by the commercial manufacture, use, offer for sale,
`or sale of the MSN ANDA Product. Exelixis initiated a third action against MSN in this District
`on February 23, 2022, in response to three additional paragraph IV notice letters with respect to
`ANDA No. 213878. These notice letters alleged that U.S. Patent Nos. 11,091,439, 11,091,440,
`and 11,098,015 were invalid, unenforceable, and/or would not be infringed by the commercial
`manufacture, use, offer for sale, or sale of the MSN ANDA Product.
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`Case 1:22-cv-00945-UNA Document 1 Filed 07/18/22 Page 5 of 9 PageID #: 5
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`for Preparing Quinoline Compounds and Pharmaceutical Compositions Containing Such
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`Compounds,” was duly and legally issued on April 12, 2022. The ՚349 Patent will expire on February
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`10, 2032. The claims of the ՚349 Patent are valid, enforceable, and not expired. All rights and interests
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`in the ՚349 Patent are owned by and assigned to Exelixis.
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`19.
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`CABOMETYX® (cabozantinib) is a tyrosine kinase inhibitor, for oral
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`administration, approved by the FDA for the treatment of patients with advanced kidney cancer
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`(renal cell carcinoma), patients with liver cancer (hepatocellular carcinoma) who have been
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`previously treated with the medicine sorafenib, and patients with advanced or metastatic thyroid
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`cancer (differentiated thyroid cancer) who have progressed following prior VEGFR-targeted
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`therapy and who are radioactive iodine-refractor or ineligible. Exelixis sells CABOMETYX® in
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`the United States pursuant to New Drug Application No. 208692 which was approved by the FDA
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`in 2016.
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`20.
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`21.
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`CABOMETYX® is covered by at least, inter alia, claim 3 of the ’349 Patent.
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`The ՚349 Patent has been listed in connection with CABOMETYX® in the
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`FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations, referred
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`to as the “Orange Book.”
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`22.
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`By letter dated June 6, 2022, and received via Federal Express on June 7, 2022
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`(the “Notice Letter”), MSN notified Exelixis that MSN had submitted ANDA No. 213878 to the
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`FDA for Cabozantinib (S)-Malate Tablets, 20 mg, 40 mg, and 60 mg, a generic version of
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`CABOMETYX®.
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`23.
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`By submitting ANDA No. 213878, MSN has necessarily represented to the FDA
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`that the MSN ANDA Product has the same active ingredient as CABOMETYX®, has the same
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`dosage forms and strengths as CABOMETYX®, and is bioequivalent to CABOMETYX®.
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`Case 1:22-cv-00945-UNA Document 1 Filed 07/18/22 Page 6 of 9 PageID #: 6
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`24.
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`In the Notice Letter, MSN stated that its ANDA included a paragraph IV
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`certification pursuant to 21 U.S.C. § 355(j) with respect to the ՚349 Patent and alleged that the
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`՚349 Patent is “not valid, unenforceable, and/or will not be infringed by the commercial
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`manufacture, use, or sale” of the MSN ANDA Product. The Notice Letter also informed Exelixis
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`that MSN seeks approval to engage in the commercial manufacture, use, offer for sale, sale, or
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`importation of the MSN ANDA Product before the ՚349 Patent expires.
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`25.
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`Upon information and belief, MSN had knowledge of the ՚349 Patent at least as
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`of the time it submitted its paragraph IV certification.
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`26.
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`Upon information and belief, MSN intends to engage in the manufacture, use,
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`offer for sale, sale, and/or importation of the MSN ANDA Product immediately and imminently
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`upon approval of ANDA No. 213878.
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`27.
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`This action is being commenced before the expiration of forty-five days from the
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`date of Exelixis’ receipt of the Notice Letter.
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`CLAIMS FOR RELIEF
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`COUNT I: INFRINGEMENT OF U.S. PATENT NO. 11,298,349
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`Exelixis incorporates each of the preceding paragraphs 1–27 as if fully set forth
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`28.
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`herein.
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`29.
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`MSN’s submission of ANDA No. 213878 to obtain approval to engage in the
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`commercial manufacture, use, offer for sale, sale, and/or importation of the MSN ANDA Product
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`before the expiration of the ՚349 Patent constituted an act of infringement of at least claim 3 of
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`the ՚349 Patent (“the ’349 Asserted Claim”) under 35 U.S.C. § 271(e)(2)(A).
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`30.
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`MSN’s commercial manufacture, use, offer for sale, sale and/or importation of
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`the MSN ANDA Product and/or its active ingredient prior to expiration of the ՚349 Patent, and
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`MSN’s inducement of and/or contribution to such conduct, would further infringe at least the
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`Case 1:22-cv-00945-UNA Document 1 Filed 07/18/22 Page 7 of 9 PageID #: 7
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`’349 Asserted Claim, either literally or under the doctrine of equivalents, under 35 U.S.C. §
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`271(a), (b), and/or (c).
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`31.
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`Upon FDA approval of ANDA No. 213878, MSN will infringe at least the ’349
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`Asserted Claim, either literally or under the doctrine of equivalents, by making, using, offering
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`to sell, selling, and/or importing the MSN ANDA Product and/or its active ingredient, and/or by
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`actively inducing and contributing to infringement of the ’349 Asserted Claim by others, under
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`35 U.S.C. § 271(a), (b), and/or (c), unless enjoined by the Court. Such infringement is imminent
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`because, among other things, MSN has notified Exelixis of the submission of MSN’s ANDA
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`seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of the MSN ANDA Product before the expiration of the ’349 Patent.
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`32.
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`A substantial and justiciable controversy exists between the parties hereto as to
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`the infringement of the ’349 Patent.
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`33.
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`Pursuant to 28 U.S.C. § 2201, Exelixis is entitled to a declaratory judgment that
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`MSN’s making, using, offering to sell, selling, and/or importing the MSN ANDA Product,
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`inducement thereof or contribution thereto, will infringe the ’349 Patent pursuant to 35 U.S.C.
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`§§ 271(a), (b), and/or (c).
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`34.
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`Upon information and belief, MSN acted, and upon FDA approval of ANDA No.
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`213878, will act, without a reasonable basis for believing that they would not be liable for directly
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`and/or indirectly infringing the ’349 Patent. This is an exceptional case.
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`35.
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`Unless MSN is enjoined from directly or indirectly infringing the ’349 Patent,
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`Exelixis will suffer irreparable injury. Exelixis has no adequate remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Exelixis asks that this Court grant the following relief:
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`A judgment that the claims of the ՚349 Patent are not invalid, are not
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`(a)
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`Case 1:22-cv-00945-UNA Document 1 Filed 07/18/22 Page 8 of 9 PageID #: 8
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`unenforceable, and were infringed by MSN’s submission of ANDA No. 213878 under 35 U.S.C.
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`§ 271(e)(2)(A), and that MSN’s manufacture, use, offer to sell, sale, or importation of the MSN
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`ANDA Product, inducement thereof or contribution thereto, prior to the expiration of the ՚349
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`Patent, will infringe the ’349 Asserted Claim, either literally or under the doctrine of equivalents,
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`under 35 U.S.C. § 271(a), (b), and/or (c);
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`(b)
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`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date
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`of any FDA approval of MSN’s ANDA No. 213878 shall not be earlier than the expiration of the
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`՚349 Patent, including any extensions and/or additional periods of exclusivity to which Exelixis
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`is or becomes entitled;
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`(c)
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`A declaratory judgment that MSN’s manufacture, use, offer to sell, sale, or
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`importation, including inducement thereof and contribution thereto, of the MSN ANDA Product
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`and/or its active ingredient prior to the expiration of the ՚349 Patent, would infringe at least the
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`’349 Asserted Claim, either literally or under the doctrine of equivalents, under 35 U.S.C.
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`§ 271(a), (b), and/or (c);
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`(d)
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`An Order permanently enjoining MSN, and its affiliates, subsidiaries, and each
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`of its officers, agents, servants and employees and those acting in privity or concert with MSN,
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`from making, using, offering to sell, selling, or importing the MSN ANDA Product and/or its
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`active ingredient until after the ՚349 Patent’s expiration, including any extensions and/or
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`additional periods of exclusivity to which Exelixis is or becomes entitled;
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`(e)
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`Damages or other monetary relief, including costs, fees, pre-judgment interest
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`and post-judgment interest to Exelixis if MSN engages in commercial manufacture, use, offers to
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`sell, sale, or importation into the United States of the MSN ANDA Product prior to the expiration
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`of the ՚349 Patent, including any extensions and/or additional periods of exclusivity to which
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`Case 1:22-cv-00945-UNA Document 1 Filed 07/18/22 Page 9 of 9 PageID #: 9
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`Exelixis is or becomes entitled; and
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`(f)
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`Such further and other relief as this Court deems proper and just.
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`OF COUNSEL:
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`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Kevin M. Yurkerwich
`Amy L. Mahan
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
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`Amy K. Wigmore
`Gerard A. Salvatore
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`1875 Pennsylvania Avenue NW
`Washington, DC 20006
`(202) 663-6000
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`July 18, 2022
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Anthony D. Raucci
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`Jack B. Blumenfeld (#1014)
`Anthony D. Raucci (#5948)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`araucci@morrisnichols.com
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`Attorneys for Plaintiff Exelixis, Inc.
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`9
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