Case 1:22-cv-00498-UNA Document 1 Filed 04/19/22 Page 1 of 13 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. _________________
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`)))))))))))))
`
`NOVARTIS PHARMACEUTICALS
`CORPORATION,
`
`Plaintiff,
`
`v.
`
`DR. REDDY’S LABORATORIES, INC., and
`DR. REDDY’S LABORATORIES, LTD.,
`
`Defendants.
`
`COMPLAINT AGAINST
`DR. REDDY’S LABORATORIES, INC. AND DR. REDDY’S LABORATORIES, LTD.
`
`Plaintiff Novartis Pharmaceuticals Corporation (hereinafter “Plaintiff” or “Novartis”), by
`
`its attorneys, hereby alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
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`This is a patent infringement action arising under Title 35 of the United States
`
`Code and concerning an Abbreviated New Drug Application (“ANDA”) submitted to the United
`
`States Food and Drug Administration (“FDA”) by the above-named defendants seeking FDA
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`approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of
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`sacubitril/valsartan tablets, generic versions of Plaintiff’s ENTRESTO® tablets, 24 mg/26 mg, 49
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`mg/51 mg, and 97 mg/103 mg, prior to the expiration of U.S. Patent No. 11,058,667 (the “’667
`
`patent”).
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`PARTIES
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`2.
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`Plaintiff Novartis is a corporation organized and existing under the laws of the
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`State of Delaware, having a principal place of business at One Health Plaza, East Hanover, New
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`Jersey 07936.
`
`3.
`
`On information and belief, Dr. Reddy’s Laboratories, Inc. is a corporation
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`organized and existing under the laws of the State of New Jersey, having a principal place of
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`business at 107 College Road East, Princeton, New Jersey 08540. On information and belief, Dr.
`
`Reddy’s Laboratories, Inc. is a wholly owned subsidiary of Dr. Reddy’s Laboratories, Ltd.
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`4.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. is a corporation
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`organized and existing under the laws of India, having a principal place of business at 8-2-337
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`Road No. 3, Banjara Hills, Hyderabad, Telangana 500034, India.
`
`5.
`
`On information and belief, Dr. Reddy’s Laboratories, Inc. develops,
`
`manufactures, distributes, sells, and/or imports drug products for the entire United States market
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`and does business in every state including Delaware, either directly or indirectly.
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`6.
`
`On information and belief, Dr. Reddy’s Laboratories, Ltd. develops,
`
`manufactures, distributes, sells, and/or imports drug products for the entire United States market
`
`and does business in every state including Delaware, either directly or indirectly.
`
`7.
`
`By a letter dated March 24, 2022 (“Dr. Reddy’s Notice Letter”), Dr. Reddy’s
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`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. notified Novartis that (i) Dr. Reddy’s
`
`Laboratories, Inc., on behalf of Dr. Reddy’s Laboratories, Ltd., had submitted to the FDA
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`ANDA No. 213627 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103
`
`mg (“Dr. Reddy’s ANDA Products”), seeking FDA approval to engage in the commercial
`
`manufacture, use, sale, offer for sale, and/or importation of the Dr. Reddy’s ANDA Products in
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`or into the United States, including Delaware, prior to the expiration of the ’667 patent, and that
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`(ii) ANDA No. 213627 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`against the ’667 patent.
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`8.
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`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. have
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`committed an act of infringement in this judicial district by filing ANDA No. 213627 with the
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`intent to make, use, sell, offer for sale, and/or import the Dr. Reddy’s ANDA Products in or into
`
`this judicial district, prior to the expiration of the ’667 patent, an act of infringement that has led
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`and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.
`
`9.
`
`On information and belief, Dr. Reddy’s Laboratories, Inc. acted in concert with
`
`and under the direction of Dr. Reddy’s Laboratories, Ltd. in the preparation and submission of
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`ANDA No. 213627, and, if the ANDA is approved, will act in concert with and under the
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`direction of Dr. Reddy’s Laboratories, Ltd. to engage in the commercial manufacture, use, sale,
`
`offer for sale, and/or importation of the Dr. Reddy’s ANDA Products in or into the United States,
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`including Delaware, prior to the expiration of the ’667 patent.
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`10.
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`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. have taken the
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`costly, significant step of applying to the FDA for approval to engage in future activities,
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`including the marketing of the Dr. Reddy’s ANDA Products, that will be purposefully directed at
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`Delaware and elsewhere.
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`11.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. has systematic and
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`continuous contacts with Delaware, has established distribution channels for drug products in
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`Delaware, regularly and continuously conducts business in Delaware, including by selling drug
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`products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, and
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`has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial
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`revenue from the sale of drug products in Delaware.
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`12.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. has systematic and
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`continuous contacts with Delaware, has established distribution channels for drug products in
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`Delaware, regularly and continuously conducts business in Delaware, including by selling drug
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`products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, and
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`has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial
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`revenue from the sale of drug products in Delaware.
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`13.
`
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. have availed
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`themselves of the legal protections of the State of Delaware by, among other things, consenting
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`to jurisdiction and/or asserting counterclaims in lawsuits filed in the United States District Court
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`for the District of Delaware. See, e.g., Novartis Pharms. Corp. v. Alkem Labs. Ltd. et al., C.A.
`
`No. 21-1330 (D. Del.); Merck Sharp & Dohme Corp. v. Dr. Reddy’s Labs., Inc. et al., C.A. No.
`
`20-847 (D. Del.); Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc. et al., C.A. No. 19-2053 (D.
`
`Del.); Genzyme Corp. et al. v. Dr. Reddy’s Labs., Inc. et al., C.A. No. 19-2045 (D. Del.);
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`Boehringer Ingelheim Pharms. Inc. et al. v. Dr. Reddy’s Labs., Ltd. et al., C.A. No. 19-1495 (D.
`
`Del.).
`
`14.
`
`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., the entities
`
`identified in the Dr. Reddy’s Notice Letter as having submitted ANDA No. 213627, have agreed
`
`with Novartis to litigate any patent action(s) concerning ANDA No. 213627 in the District of
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`Delaware, and have agreed, only for the purposes of such action(s), not to contest personal
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`jurisdiction and venue in the District of Delaware.
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`JURISDICTION AND VENUE
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`15.
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`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§ 1331, 1338(a), 2201, and 2202.
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`16.
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`This Court has personal jurisdiction over Dr. Reddy’s Laboratories, Inc. and Dr.
`
`Reddy’s Laboratories, Ltd. because, on information and belief, each such Defendant has
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`committed or has aided, abetted, contributed to, or participated in the commission of tortious acts
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`of patent infringement in preparing and submitting ANDA No. 213627 with a certification
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury
`
`to Novartis, a Delaware corporation.
`
`17.
`
`This Court also has personal jurisdiction over Dr. Reddy’s Laboratories, Inc. and
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`Dr. Reddy’s Laboratories, Ltd. because, on information and belief, each such Defendant, upon
`
`approval of ANDA No. 213627, will commit or will aid, abet, contribute to, or participate in
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`future tortious acts of patent infringement permitted under ANDA No. 213627 that will be
`
`purposefully directed at Delaware, including the marketing of the Dr. Reddy’s ANDA Products
`
`in Delaware, prior to the expiration of the ’667 patent.
`
`18.
`
`This Court also has personal jurisdiction over Dr. Reddy’s Laboratories, Inc. and
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`Dr. Reddy’s Laboratories, Ltd. because, on information and belief, each such Defendant’s
`
`affiliations with the State of Delaware are sufficiently continuous and systematic as to render
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`each such Defendant essentially at home in this forum. On information and belief, each such
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`Defendant develops, manufactures, distributes, sells, and/or imports drug products for the entire
`
`United States market and does business in every state including Delaware, either directly or
`
`indirectly and/or has engaged in systematic and continuous business contacts within the State of
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`Delaware. Upon information and belief, each such Defendant regularly does business in
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`Delaware, and its practices with other generic pharmaceutical products have involved placing
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`those products into the stream of commerce for distribution throughout the United States,
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`including in Delaware. Upon information and belief, such generic pharmaceutical products are
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`used and/or consumed within and throughout the United States, including in Delaware. Upon
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`information and belief, Dr. Reddy’s ANDA Products will be prescribed by physicians practicing
`
`in Delaware, dispensed by pharmacies located within Delaware, and used by patients in
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`Delaware.
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`19.
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`This Court also has personal jurisdiction over Dr. Reddy’s Laboratories, Inc. and
`
`Dr. Reddy’s Laboratories, Ltd. because each such Defendant has availed itself of the legal
`
`protections of the State of Delaware, by admitting jurisdiction and asserting counterclaims in
`
`lawsuits filed in the United States District Court for the District of Delaware. See, e.g., Novartis
`
`Pharms. Corp. v. Alkem Labs. Ltd. et al., C.A. No. 21-1330 (D. Del.); Merck Sharp & Dohme
`
`Corp. v. Dr. Reddy’s Labs., Inc. et al., C.A. No. 20-847 (D. Del.); Novartis Pharms. Corp. v. Dr.
`
`Reddy’s Labs., Inc. et al., C.A. No. 19-2053 (D. Del.); Genzyme Corp. et al. v. Dr. Reddy’s
`
`Labs., Inc. et al., C.A. No. 19-2045 (D. Del.); Boehringer Ingelheim Pharms. Inc. et al. v. Dr.
`
`Reddy’s Labs., Ltd. et al., C.A. No. 19-1495 (D. Del.).
`
`20.
`
`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., the entities
`
`identified in the Dr. Reddy’s Notice Letter as having submitted ANDA No. 213627, have agreed
`
`with Novartis to litigate any patent action(s) concerning ANDA No. 213627 in the District of
`
`Delaware, and have agreed, only for the purposes of such action(s), not to contest personal
`
`jurisdiction and venue in the District of Delaware.
`
`21.
`
`For these reasons, and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over Dr. Reddy’s Laboratories, Inc.
`
`and Dr. Reddy’s Laboratories, Ltd.
`
`22.
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`Venue is proper in this Court over Dr. Reddy’s Laboratories, Inc. because Dr.
`
`Reddy’s Laboratories, Inc. has consented to venue in Delaware for patent action(s) concerning
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`ANDA No. 213627 and has previously consented to venue in Delaware in other actions, and
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`because Dr. Reddy’s Laboratories, Ltd. is a foreign entity who may be sued in any judicial
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`district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. § 1391(c)(3).
`
`THE PATENT-IN-SUIT AND ENTRESTO®
`
`23.
`
`The ’667 patent, titled “Sacubitril-Valsartan Dosage Regimen for Treating Heart
`
`Failure,” was duly and legally issued on July 13, 2021. A true and correct copy of the ’667 patent
`
`is attached hereto as Exhibit A.
`
`24.
`
`25.
`
`Novartis owns the ’667 patent.
`
`The ’667 patent claims, inter alia, a regimen for treating chronic heart failure with
`
`reduced ejection fraction, comprising administering to a human patient in need thereof a twice-
`
`daily target dose of 200 mg of (i) sacubitril or a pharmaceutically acceptable salt thereof with (ii)
`
`valsartan or a pharmaceutically acceptable salt thereof; wherein (i) and (ii) are provided in a 1:1
`
`molar ratio and wherein the twice daily target dose of 200 mg is reached after a titration with a
`
`twice daily starting dose of 50 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time
`
`followed by a twice daily dose of 100 mg of (i) and (ii) in a 1:1 molar ratio for a specified period
`
`of time and wherein the human patient is not taking an ACE inhibitor or an ARB or is taking a
`
`low dose of an ACE inhibitor or an ARB before initiating treatment with (i) and (ii).
`
`26.
`
`Novartis is the holder of New Drug Application (“NDA”) No. 207620 by which
`
`the FDA granted approval for the commercial manufacturing, marketing, sale, and use of
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`ENTRESTO® (sacubitril and valsartan) tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.
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`ENTRESTO® currently is indicated to reduce the risk of cardiovascular death and hospitalization
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`for heart failure in adult patients with chronic heart failure, and for the treatment of symptomatic
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`heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one
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`year and older.
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`27.
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`The ENTRESTO® label provides specific instructions for titration for human
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`patients who are not taking an ACE inhibitor or an ARB or taking a low dose of an ACE
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`inhibitor or an ARB before treatment with ENTRESTO® is initiated.
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`28.
`
`One or more claims of the ’667 patent cover the use of ENTRESTO®.
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`29.
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`’667 patent in connection with ENTRESTO®.
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`The FDA’s official publication of approved drugs (the “Orange Book”) lists the
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`INFRINGEMENT OF THE PATENT-IN-SUIT
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`Plaintiff incorporates paragraphs 1 – 29 as if fully set forth herein.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
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`30.
`
`31.
`
`Laboratories, Ltd., submitted to the FDA ANDA No. 213627 under the provisions of 21 U.S.C.
`
`§ 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale,
`
`and/or importation of the Dr. Reddy’s ANDA Products prior to the expiration of the ’667 patent.
`
`32.
`
`By filing their ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of
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`the Dr. Reddy’s ANDA Products in or into the United States prior to the expiration of the ’667
`
`patent, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. have committed an act
`
`of infringement under 35 U.S.C. § 271(e)(2).
`
`33.
`
`This action was commenced within 45 days of Plaintiff’s receipt of the Dr.
`
`Reddy’s Notice Letter.
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`34.
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`On information and belief, the use of the Dr. Reddy’s ANDA Products in the
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`United States in accordance with and as directed by the labeling for those products, if approved,
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`will directly infringe one or more claims of the ’667 patent.
`
`35.
`
`On information and belief, the Dr. Reddy’s ANDA Products, to be approved,
`
`must contain instructions for practicing a regimen for the treatment of chronic heart failure with
`
`reduced ejection faction comprising administering to a human patient in need thereof a twice-
`
`daily target dose of 200 mg of (i) sacubitril or a pharmaceutically acceptable salt thereof with (ii)
`
`valsartan or a pharmaceutically acceptable salt thereof; wherein (i) and (ii) are provided in a 1:1
`
`molar ratio and wherein the twice daily target dose of 200 mg is reached after a titration with a
`
`twice daily starting dose of 50 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time
`
`followed by a twice daily dose of 100 mg of (i) and (ii) in a 1:1 molar ratio for a specified period
`
`of time and wherein the human patient is not taking an ACE inhibitor or an ARB or is taking a
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`low dose of an ACE inhibitor or an ARB before initiating treatment with (i) and (ii), which
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`administration will constitute direct infringement of one or more claims of the ’667 patent. On
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`information and belief, if the Dr. Reddy’s ANDA Products are approved, physicians, other
`
`medical providers, caregivers and/or patients following said instructions will directly infringe
`
`one or more claims of the ’667 patent. On information and belief, if the Dr. Reddy’s ANDA
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`Products are approved, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. will
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`actively encourage, recommend, or promote this infringement with knowledge of the ’667
`
`patent, and with knowledge and intent that their acts will induce infringement of one or more
`
`claims of the ’667 patent.
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`36.
`
`On information and belief, if the Dr. Reddy’s ANDA Products are approved, Dr.
`
`Reddy’s Laboratories, Inc. and/or Dr. Reddy’s Laboratories, Ltd. will commercially
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`manufacture, sell, offer for sale, and/or import those products, which must be specifically labeled
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`for use in a regimen for the treatment of chronic heart failure with reduced ejection fraction
`
`comprising administering to a human patient in need thereof a twice-daily target dose of 200 mg
`
`of (i) sacubitril or a pharmaceutically acceptable salt thereof with (ii) valsartan or a
`
`pharmaceutically acceptable salt thereof; wherein (i) and (ii) are provided in a 1:1 molar ratio
`
`and wherein the twice daily target dose of 200 mg is reached after a titration with a twice daily
`
`starting dose of 50 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time followed
`
`by a twice daily dose of 100 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time
`
`and wherein the human patient is taking neither an ACE inhibitor nor an ARB or is taking a low
`
`dose of an ACE inhibitor or an ARB before initiating treatment with (i) and (ii), as recited in one
`
`or more claims of the ’667 patent. On information and belief, if the Dr. Reddy’s ANDA Products
`
`are approved, those products will constitute a material part of a regimen for the treatment of
`
`chronic heart failure with reduced ejection fraction comprising administering to a human patient
`
`in need thereof a twice-daily target dose of 200 mg of (i) sacubitril or a pharmaceutically
`
`acceptable salt thereof with (ii) valsartan or a pharmaceutically acceptable salt thereof; wherein
`
`(i) and (ii) are provided in a 1:1 molar ratio and wherein the twice daily target dose of 200 mg is
`
`reached after a titration with a twice daily starting dose of 50 mg of (i) and (ii) in a 1:1 molar
`
`ratio for a specified period of time followed by a twice daily dose of 100 mg of (i) and (ii) in a
`
`1:1 molar ratio for a specified period of time and wherein the human patient is not taking an
`
`ACE inhibitor or an ARB or is taking a low dose of an ACE inhibitor or an ARB before
`
`initiating treatment with (i) and (ii), as recited in one or more claims of the ’667 patent. On
`
`information and belief, if the Dr. Reddy’s ANDA Products are approved, physicians, caregivers
`
`and/or patients following the approved instructions in the Dr. Reddy’s ANDA Products will
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`directly infringe one or more claims of the ’667 patent. On information and belief, if the Dr.
`
`Reddy’s ANDA Products are approved, Dr. Reddy’s Laboratories, Inc. and/or Dr. Reddy’s
`
`Laboratories, Ltd. will contributorily infringe one or more claims of the ’667 patent and will do
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`so with knowledge of the ’667 patent, and that the Dr. Reddy’s ANDA Products are especially
`
`made or especially adapted for use in infringing one or more claims of the ’667 patent and are
`
`not suitable for substantial non-infringing use.
`
`37.
`
`Plaintiff will be substantially and irreparably damaged by Dr, Reddy’s
`
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.’s infringement of the ’667 patent.
`
`38.
`
`Plaintiff is entitled to the relief provided by 35 U.S.C. § 271(e)(4) and 35 U.S.C.
`
`§ 283, including an order of this Court that the effective date of any approval of ANDA No.
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`213627 be a date that is no earlier than May 9, 2036, the expiration of the ’667 patent, or a date
`
`no earlier than the expiry of any other patent extension or exclusivity to which Plaintiff is
`
`entitled, and an award of damages for any commercial sale or use of the Dr. Reddy’s ANDA
`
`Products and any act committed by Dr. Reddy’s Laboratories, Inc. and/or Dr. Reddy’s
`
`Laboratories, Ltd. with respect to the subject matter claimed in the ’667 patent, which act is not
`
`within the limited exclusions of 35 U.S.C. § 271(e)(1).
`
`39.
`
`On information and belief, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`
`Laboratories, Ltd. have taken and continue to take active steps towards the commercial
`
`manufacture, use, sale, offer for sale, and/or importation of the Dr. Reddy’s ANDA Products,
`
`including seeking approval of those products under ANDA No. 213627.
`
`40.
`
`There is a substantial and immediate controversy between Plaintiff and Dr.
`
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. concerning the ’667 patent. Plaintiff is
`
`entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that the use of the Dr.
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`Reddy’s ANDA Products will directly infringe one or more claims of the ’667 patent and Dr.
`
`Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. will induce infringement of and/or
`
`contributorily infringe one or more claims of the ’667 patent.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff prays that this Court grant the following relief:
`
`41.
`
`Judgment that defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`
`Laboratories, Ltd. have infringed one or more claims of the ’667 patent by filing ANDA No.
`
`213627;
`
`42.
`
`A permanent injunction restraining and enjoining defendants Dr. Reddy’s
`
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. and their officers, agents, attorneys, and
`
`employees, and those acting in privity or concert with them, from engaging in the commercial
`
`manufacture, use, sale, or offer for sale in the United States, or importation into the United
`
`States, of the Dr. Reddy’s ANDA Products prior to the expiration of the ’667 patent, inclusive of
`
`any extensions and additional periods of exclusivity;
`
`43.
`
`An order that the effective date of any approval of ANDA No. 213627 be a date
`
`that is not earlier than the expiration date of the ’667 patent, inclusive of any extensions and
`
`additional periods of exclusivity;
`
`44.
`
`Declaratory judgment that the use of the Dr. Reddy’s ANDA Products will
`
`directly infringe one or more claims of the ’667 patent;
`
`45.
`
`Declaratory judgment that the commercial manufacture, sale, offer for sale, and/or
`
`importation of the Dr. Reddy’s ANDA Products will induce infringement of and/or
`
`contributorily infringe one or more claims of the ’667 patent;
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`46.
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`Damages or other monetary relief from defendants Dr. Reddy’s Laboratories, Inc.
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`and Dr. Reddy’s Laboratories, Ltd. for the infringement, inducement of infringement and
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`contributory infringement of the ’667 patent;
`
`47.
`
`A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and
`
`an award of attorney’s fees;
`
`48.
`
`49.
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`Plaintiff’s costs and expenses in this action; and
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`Such other and further relief as the Court may deem just and proper.
`
`MCCARTER & ENGLISH, LLP
`
`By: /s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiff Novartis
`Pharmaceuticals Corporation
`
`Dated: April 19, 2022
`
`OF COUNSEL:
`
`Nicholas N. Kallas
`Christina Schwarz
`Christopher E. Loh
`Susanne L. Flanders
`Jared L. Stringham
`Shannon K. Clark
`Laura K. Fishwick
`Gregory J. Manas
`VENABLE LLP
`1290 Avenue of the Americas
`New York, New York 10104
`(212) 218-2100
`nkallas@venable.com
`cschwarz@venable.com
`cloh@venable.com
`slflanders@venable.com
`jlstringham@venable.com
`skclark@venable.com
`lfishwick@venable.com
`gjmanas@venable.com
`
`ME1 40268396v.1
`
`13
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`