Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 1 of 20 PageID #: 1
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`VELOXIS PHARMACEUTICALS, INC.,
`
`
`Plaintiff,
`
`
`
`v.
`
`
`ACCORD HEALTHCARE, INC. and
`INTAS PHARMACEUTICALS LTD.,
`
`
`Defendants.
`
`
`
`
`
`C.A. No. _____________
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`COMPLAINT
`
`Plaintiff Veloxis Pharmaceuticals, Inc. (“Veloxis”), by its undersigned attorneys, for its
`
`Complaint against Defendants Accord Healthcare, Inc. (“Accord Healthcare”) and Intas
`
`Pharmaceuticals Ltd. (“Intas”) (collectively “Defendants”), alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United States,
`
`35 U.S.C. § 1 et seq., arising from Defendants’ submission of Abbreviated New Drug Application
`
`(“ANDA”) No. 217255 to the United States Food and Drug Administration (“FDA”). Defendants’
`
`ANDA seeks FDA approval to market and sell 0.75 mg, 1 mg, and 4 mg extended-release tablets
`
`of tacrolimus (“Defendants’ ANDA Products”) prior to the expiration of U.S. Patent
`
`Nos. 8,685,998 (“the ’998 Patent”); 9,549,918 (“the ’918 Patent”); 10,166,190 (“the ’190 Patent”);
`
`10,864,199
`
`(“the
`
`’199 Patent”); 11,110,081
`
`(“the
`
`’081 Patent”); and 11,123,331
`
`(“the ’331 Patent”).
`
`2.
`
`Veloxis owns the patents-in-suit and is the holder of FDA approved New Drug
`
`Application (“NDA”) No. 206406 for the brand name drug ENVARSUS XR® (tacrolimus). The
`
`patents-in-suit generally cover oral dosage forms and methods of use and administration of
`
`
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 2 of 20 PageID #: 2
`
`
`
`tacrolimus, including ENVARSUS XR®. Defendants’ ANDA Products are generic versions of
`
`ENVARSUS XR®.
`
`THE PARTIES
`
`3.
`
`Plaintiff Veloxis is a corporation organized and existing under the laws of the State
`
`of Delaware, having a principal place of business at 2000 Regency Parkway, Suite 500,
`
`Cary, NC 27518.
`
`4.
`
`Upon information and belief, Defendant Accord Healthcare is a corporation
`
`organized and existing under the laws of North Carolina, having a principal place of business at
`
`1009 Slater Road, Suite 210 Durham, North Carolina 27703. Upon information and belief, Accord
`
`Healthcare is in the business of, among other things, developing, manufacturing, and selling
`
`generic versions of branded pharmaceutical products, including for the United States market.
`
`5.
`
`Upon information and belief, Defendant Intas is a corporation organized and
`
`existing under the laws of India, having a principal place of business at Corporate House, Near
`
`Sola Bridge, S. G. Highway, Thaltej, Ahmedabad – 380054, Gujarat, India. Upon information and
`
`belief, Intas is in the business of, among other things, developing, manufacturing, and selling
`
`generic versions of branded pharmaceutical products, including for the United States market.
`
`6.
`
`Upon information and belief, Accord Healthcare is a wholly-owned subsidiary of
`
`Intas and is controlled and/or dominated by Intas. Upon information and belief, Accord Healthcare
`
`is the commercial arm of Intas. Upon information and belief, Accord Healthcare and Intas are
`
`agents of each other and/or operate in concert as integrated parts of the same business group.
`
`JURISDICTION AND VENUE
`
`7.
`
`This Court has jurisdiction over the subject matter of this action pursuant to
`
`28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`2
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 3 of 20 PageID #: 3
`
`
`
`8.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b), and this Court
`
`has personal jurisdiction over Defendants.
`
`9.
`
`Accord Healthcare, through their counsel, by email dated June 23, 2022, have
`
`consented to personal jurisdiction and venue in this Court for purposes of this matter.
`
`10.
`
`This Court also has personal jurisdiction over Accord Healthcare because Accord
`
`Healthcare, itself and/or through its parent Intas, has purposefully availed itself of the benefits and
`
`protections of the State of Delaware and, therefore, could reasonably anticipate being sued in this
`
`Judicial District. Upon information and belief, Accord Healthcare, directly or indirectly,
`
`manufactures, imports, markets, offers to sell, sells and/or distributes generic drugs throughout the
`
`United States, including Delaware, and Delaware would be a destination of Defendants’ ANDA
`
`Products. Upon information and belief, Accord Healthcare, on its own or acting in concert with
`
`Intas, prepared and filed ANDA No. 217255 with the FDA. Upon information and belief, Accord
`
`Healthcare, on its own or acting in concert with Intas, will manufacture, import, market, offer to
`
`sell, sell and/or distribute Defendants’ ANDA Products in the United States, including Delaware,
`
`upon approval of ANDA No. 217255, and will derive substantial revenue from the use or
`
`consumption of Defendants’ ANDA Products in Delaware.
`
`11.
`
`This Court also has personal jurisdiction over Intas because Intas, itself and/or
`
`through its subsidiary Accord Healthcare, has purposefully availed itself of the benefits and
`
`protections of the State of Delaware and, therefore, could reasonably anticipate being sued in this
`
`Judicial District. Upon information and belief, Intas, directly or indirectly, manufactures, imports,
`
`markets, offers to sell, sells and/or distributes generic drugs throughout the United States,
`
`including Delaware, and Delaware would be a destination of Defendants’ ANDA Products. Upon
`
`information and belief, Intas, on its own or acting in concert with Accord Healthcare, prepared and
`
`3
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 4 of 20 PageID #: 4
`
`
`
`submitted ANDA No. 217255 to the FDA. Upon information and belief, Intas, on its own or acting
`
`in concert with Accord Healthcare, will manufacture, import, market, offer to sell, sell and/or
`
`distribute Defendants’ ANDA Products in the United States, including in Delaware, upon approval
`
`of ANDA No. 217255, and will derive substantial revenue from the use or consumption of
`
`Defendants’ ANDA Products in Delaware.
`
`12.
`
`In the alternative, this Court also has personal jurisdiction over Intas pursuant to
`
`Rule 4(k)(2), Fed. R. Civ. P. This action arises from actions of Intas directed toward Delaware,
`
`and Intas has purposefully availed itself of the rights and benefits of Delaware law by engaging in
`
`systematic and continuous contacts with Delaware. Upon information and belief, Intas regularly
`
`and continuously transacts business within Delaware, including by selling pharmaceutical
`
`products in Delaware, either on its own or through affiliates. Upon information and belief, Intas
`
`derives substantial revenue from the sale of those products in Delaware and has availed itself of
`
`the privilege of conducting business in Delaware.
`
`13.
`
`Venue is also proper in this Court with respect to Intas because, upon information
`
`and belief, Intas is a foreign corporation that may be sued in any judicial district where it is subject
`
`to the personal jurisdiction of the Court.
`
`14.
`
`Personal jurisdiction and venue are also proper in this Judicial District because
`
`Defendants have availed themselves of the legal protections of Delaware by, among other things,
`
`admitting jurisdiction and asserting counterclaims in lawsuits filed in this Court. See e.g., Celgene
`
`Corp. et al. v. Accord Healthcare Inc., No. 21-1795 (D. Del. Dec. 22, 2021); Teva Pharmaceuticals
`
`International GmbH et al v. Accord Healthcare Inc., No. 21-952 (D. Del. June 29, 2021); Taiho
`
`Pharmaceutical Co., Ltd. et al v. Accord Healthcare Inc. et al, No. 21-838 (D. Del. June 9, 2021);
`
`Bayer Pharma AG et al v. Accord Healthcare Inc. et al, No. 21-566 (D. Del. Apr. 22, 2021);
`
`4
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 5 of 20 PageID #: 5
`
`
`
`Purdue Pharma L.P. et al v. Accord Healthcare Inc., No. 20-1362 (D. Del. Oct. 8, 2020); Otsuka
`
`Pharmaceutical Co., Ltd. et al v. Accord Healthcare Inc., No. 20-1287 (D. Del. Sep. 25, 2020);
`
`Sanofi-Aventis U.S. LLC et al v. Accord Healthcare Inc., No. 20-803 (D. Del. Jun. 12, 2020).
`
`Merck Sharp & Dohme Corp. v. Accord Healthcare Inc. et al., No. 19-2192 (D. Del. Jan. 24, 2020);
`
`Novartis Pharm. Co. v. Accord Healthcare Inc. et al., No. 18-1043 (D. Del. Aug. 8, 2018); Amgen
`
`Inc. v. Accord Healthcare et al., No. 18-956 (D. Del. June 28, 2018).
`
`PATENTS-IN-SUIT
`
`15.
`
`On April 1, 2014, the ’998 Patent, titled “Tacrolimus for Improved Treatment of
`
`Transplant Patients,” was duly and lawfully issued by the United States Patent and Trademark
`
`Office (“USPTO”). Veloxis is the assignee of the ’998 Patent. A true copy of the ’998 Patent is
`
`attached hereto as Exhibit A.
`
`16.
`
`On January 24, 2017, the ’918 Patent, titled “Stabilized Tacrolimus Composition,”
`
`was duly and lawfully issued by the USPTO. Veloxis is the assignee of the ’918 Patent. A true
`
`copy of the ’918 Patent is attached hereto as Exhibit B.
`
`17.
`
`On January 1, 2019, the ’190 Patent, titled “Stabilized Tacrolimus Composition,”
`
`was duly and lawfully issued by the USPTO. Veloxis is the assignee of the ’190 Patent. A true
`
`copy of the ’190 Patent is attached hereto as Exhibit C.
`
`18.
`
`On December 15, 2020, the ’199 Patent, titled “Tacrolimus for Improved Treatment
`
`of Transplant Patients,” was duly and lawfully issued by the USPTO. Veloxis is the assignee of
`
`the ’199 Patent. A true copy of the ’199 Patent is attached hereto as Exhibit D.
`
`19.
`
`On September 7, 2021, the ’081 Patent, titled “Tacrolimus for Improved Treatment
`
`of Transplant Patients,” was duly and lawfully issued by the USPTO. Veloxis is the assignee of
`
`the ’081 Patent. A true copy of the ’081 Patent is attached hereto as Exhibit E.
`
`5
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 6 of 20 PageID #: 6
`
`
`
`20.
`
`On September 21, 2021, the ’331 Patent, titled “Tacrolimus for Improved
`
`Treatment of Transplant Patients,” was duly and lawfully issued by the USPTO. Veloxis is the
`
`assignee of the ’331 Patent. A true copy of the ’331 Patent is attached hereto as Exhibit F.
`
`VELOXIS’ ENVARSUS XR®
`
`21.
`
`Veloxis holds approved NDA No. 206406 for extended-release tablets containing
`
`the active ingredient tacrolimus. Veloxis markets and sells tacrolimus extended-release tablets
`
`under the trade name ENVARSUS XR®.
`
`22.
`
`ENVARSUS XR® is a calcineurin-inhibitor immunosuppressant indicated for:
`
`(1) the prophylaxis of organ rejection in de novo kidney transplant patients in combination with
`
`other immunosuppressants and (2) the prophylaxis of organ rejection in kidney transplant patients
`
`converted from
`
`tacrolimus
`
`immediate-release formulations
`
`in combination with other
`
`immunosuppressants. A copy of the complete prescribing information for ENVARSUS XR® is
`
`attached hereto as Exhibit G.
`
`23.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and related FDA regulations, Veloxis listed
`
`the ’998, ’918, ’190, ’199, ’081, and ’331 patents in the FDA publication, “Approved Drug
`
`Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), with respect to
`
`ENVARSUS XR®. The prescribing information for ENVARSUS XR® instructs and encourages
`
`physicians, other healthcare workers and patients to administer ENVARSUS XR® tablets
`
`according to one or more of the methods claimed in the patents-in-suit.
`
`ACTS GIVING RISE TO THIS ACTION
`
`24.
`
`By letter dated May 23, 2022 (“Notice Letter”), Accord Healthcare notified Veloxis
`
`that Accord Healthcare had submitted ANDA No. 217255 to the FDA under Section 505(j) of the
`
`6
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 7 of 20 PageID #: 7
`
`
`
`Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)). Veloxis received the Notice Letter no
`
`earlier than May 26, 2022.
`
`25.
`
`The Notice Letter states that Accord Healthcare seeks approval from the FDA to
`
`engage in the commercial manufacture, use, sale, offer to sell, and/or importation in the United
`
`States of Defendants’ ANDA Products before expiration of the ’998, ’918, ’190, ’199, ’081,
`
`and ’331 patents. Upon information and belief, Defendants intend to, directly or indirectly, engage
`
`in the commercial manufacture, use, sale, offer for sale, and/or importation of Defendants’ ANDA
`
`Products promptly upon receiving FDA approval.
`
`26.
`
`By filing ANDA No. 217255, Defendants have necessarily represented to the FDA
`
`that Defendants’ ANDA Products have the same active ingredient, the same dosage form, the same
`
`route of administration, and the same strengths as ENVARSUS XR®. By submitting ANDA No.
`
`217255, Defendants also have necessarily represented to the FDA that Defendants’ ANDA
`
`Products are bioequivalent to ENVARSUS XR®. Upon information and belief, Defendants are
`
`seeking approval to market and sell their ANDA Products for the same approved indications as
`
`ENVARSUS XR®.
`
`27.
`
`In the Notice Letter, Accord Healthcare states that Defendants’ ANDA contains a
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”) asserting
`
`that the claims of the ’998 patent are invalid under 35 U.S.C. §§ 102 and/or 103. The Notice Letter
`
`does not contest that the claims of the ‘998 patent are enforceable and will be infringed by the
`
`commercial manufacture, use, offer to sell, sale, and/or importation of Defendants’ ANDA
`
`Products.
`
`7
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 8 of 20 PageID #: 8
`
`
`
`28.
`
`In the Notice Letter, Accord Healthcare states that its ANDA contains a Paragraph
`
`IV Certification asserting that the claims of the ’918 patent are not infringed. The Notice Letter
`
`does not contest that the claims of the ‘918 patent are valid and enforceable.
`
`29.
`
`In the Notice Letter, Accord Healthcare states that its ANDA contains a Paragraph
`
`IV Certification asserting that the claims of the ’190 patent are not infringed. The Notice Letter
`
`does not contest that the claims of the ‘190 patent are valid and enforceable.
`
`30.
`
`In the Notice Letter, Accord Healthcare states that its ANDA contains a Paragraph
`
`IV Certification asserting that the claims of the ’199 patent are invalid under 35 U.S.C. § 103. In
`
`the Notice Letter, Accord Healthcare also states that its Paragraph IV Certification against the ‘199
`
`asserts that claims 1-13 and 17-19 of the ’199 patent are not infringed. The Notice Letter does not
`
`contest that claims 14-16 of the ‘199 patent are enforceable and will be infringed by the
`
`commercial manufacture, use, offer to sell, sale, and/or importation of Defendants’ ANDA
`
`Products.
`
`31.
`
`In the Notice Letter, Accord Healthcare does not address the ‘081 Patent, even
`
`though it is listed in the Orange Book. The Notice Letter does not contest that the claims of the
`
`‘081 patent are valid, enforceable and will be infringed by the commercial manufacture, use, offer
`
`to sell, sale, and/or importation of Defendants’ ANDA Products.
`
`32.
`
`In the Notice Letter, Accord Healthcare states that its ANDA contains a Paragraph
`
`IV Certification asserting that the claims of the ’331 patent are invalid under 35 U.S.C. §§ 112.
`
`The Notice Letter does not contest that the claims of the ‘331 patent are enforceable and will be
`
`infringed by the commercial manufacture, use, offer to sell, sale, and/or importation of Defendants’
`
`ANDA Products. The Notice Letter also does contest the validity of the claims of the ‘331 patent
`
`under 35 U.S.C. §§ 102 or 103.
`
`8
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 9 of 20 PageID #: 9
`
`
`
`COUNT I
`INFRINGEMENT OF THE ’998 PATENT
`
`Veloxis repeats and realleges the allegations of the preceding paragraphs as if fully
`
`33.
`
`set forth herein.
`
`34.
`
`Defendants’ submission of their ANDA to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, sale, or importation into the United States of
`
`Defendants’ ANDA Products, prior to the expiration of the ’998 patent, constitutes infringement
`
`of one or more claims of that patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the
`
`doctrine of equivalents, including at least claim 1.
`
`35.
`
`Upon information and belief, Defendants’ ANDA Products and/or their use in
`
`accordance with the product label satisfies each and every element of at least claim 1 of the ‘998
`
`Patent.
`
`36.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`and/or validity of the ’998 patent.
`
`37.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA,
`
`Defendants will infringe one or more claims of the ’998 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Defendants’ ANDA Products in the United States.
`
`38.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will induce infringement of one or more claims of the ’998 patent under 35 U.S.C.
`
`§ 271(b) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, upon FDA approval of Defendants’ ANDA
`
`Products, Defendants will intentionally encourage acts of direct infringement with knowledge of
`
`the ’998 patent and knowledge that their acts are encouraging infringement, with specific intent to
`
`induce infringement of the ‘998 patent.
`
`9
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 10 of 20 PageID #: 10
`
`
`
`39.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will contributorily infringe one or more claims of the ’998 patent under 35 U.S.C.
`
`§ 271(c) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, Defendants have had and continue to have
`
`knowledge that Defendants’ ANDA Products are especially adapted for a use that infringes one or
`
`more claims of the ’998 patent and that there is no substantial non-infringing use for Defendants’
`
`ANDA Products.
`
`40.
`
`Veloxis will be substantially and irreparably damaged and harmed if Defendants’
`
`infringement of the ’998 patent is not enjoined.
`
`41.
`
`42.
`
`Veloxis does not have an adequate remedy at law.
`
`Upon information and belief, Defendants had knowledge of the ‘998 patent prior to
`
`filing their ANDA with the FDA.
`
`43.
`
`This case is an exceptional one, and Veloxis is entitled to an award of its reasonable
`
`attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT II
`INFRINGEMENT OF THE ’918 PATENT
`
`44.
`
`Veloxis repeats and realleges the allegations of the preceding paragraphs as if fully
`
`set forth herein.
`
`45.
`
`Defendants’ submission of their ANDA to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, sale, or importation into the United States of
`
`Defendants’ ANDA Products, prior to the expiration of the ’918 patent, constitutes infringement
`
`of one or more claims of that patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the
`
`doctrine of equivalents, including at least claim 1.
`
`10
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 11 of 20 PageID #: 11
`
`
`
`46.
`
`Upon information and belief, Defendants’ ANDA Products and/or their use in
`
`accordance with the product label satisfies each and every element of at least claim 1 of the
`
`‘918 Patent.
`
`47.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`and/or validity of the ’918 patent.
`
`48.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA,
`
`Defendants will infringe one or more claims of the ’918 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Defendants’ ANDA Products in the United States.
`
`49.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will induce infringement of one or more claims of the ’918 patent under 35 U.S.C.
`
`§ 271(b) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, upon FDA approval of Defendants’ ANDA
`
`Products, Defendants will intentionally encourage acts of direct infringement with knowledge of
`
`the ’918 patent and knowledge that their acts are encouraging infringement, with specific intent to
`
`induce infringement of the ‘918 patent.
`
`50.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will contributorily infringe one or more claims of the ’918 patent under 35 U.S.C.
`
`§ 271(c) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, Defendants have had and continue to have
`
`knowledge that Defendants’ ANDA Products are especially adapted for a use that infringes one or
`
`more claims of the ’918 patent and that there is no substantial non-infringing use for Defendants’
`
`ANDA Products.
`
`11
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 12 of 20 PageID #: 12
`
`
`
`51.
`
`Veloxis will be substantially and irreparably damaged and harmed if Defendants’
`
`infringement of the ’918 patent is not enjoined.
`
`52.
`
`53.
`
`Veloxis does not have an adequate remedy at law.
`
`Upon information and belief, Defendants had knowledge of the ‘918 patent prior to
`
`filing their ANDA with the FDA.
`
`54.
`
`This case is an exceptional one, and Veloxis is entitled to an award of its reasonable
`
`attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT III
`INFRINGEMENT OF THE ’190 PATENT
`
`Veloxis repeats and realleges the allegations of the preceding paragraphs as if fully
`
`55.
`
`set forth herein.
`
`56.
`
`Defendants’ submission of their ANDA to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, sale, or importation into the United States of
`
`Defendants’ ANDA Products, prior to the expiration of the ’190 patent, constitutes infringement
`
`of one or more claims of that patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the
`
`doctrine of equivalents, including at least claim 1.
`
`57.
`
`Upon information and belief, Defendants’ ANDA Products and/or their use in
`
`accordance with the product label satisfies each and every element of at least claim 1 of the
`
`‘190 Patent.
`
`58.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`and/or validity of the ’190 patent.
`
`59.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA,
`
`Defendants will infringe one or more claims of the ’190 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Defendants’ ANDA Products in the United States.
`
`12
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 13 of 20 PageID #: 13
`
`
`
`60.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will induce infringement of one or more claims of the ’190 patent under 35 U.S.C.
`
`§ 271(b) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, upon FDA approval of Defendants’ ANDA
`
`Products, Defendants will intentionally encourage acts of direct infringement with knowledge of
`
`the ’190 patent and knowledge that their acts are encouraging infringement, with specific intent to
`
`induce infringement of the ‘190 patent.
`
`61.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will contributorily infringe one or more claims of the ’190 patent under 35 U.S.C.
`
`§ 271(c) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, Defendants have had and continue to have
`
`knowledge that Defendants’ ANDA Products are especially adapted for a use that infringes one or
`
`more claims of the ’190 patent and that there is no substantial non-infringing use for Defendants’
`
`ANDA Products.
`
`62.
`
`Veloxis will be substantially and irreparably damaged and harmed if Defendants’
`
`infringement of the ’190 patent is not enjoined.
`
`63.
`
`64.
`
`Veloxis does not have an adequate remedy at law.
`
`Upon information and belief, Defendants had knowledge of the ‘190 patent prior to
`
`filing their ANDA with the FDA.
`
`65.
`
`This case is an exceptional one, and Veloxis is entitled to an award of its reasonable
`
`attorneys’ fees under 35 U.S.C. § 285.
`
`
`
`
`
`13
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 14 of 20 PageID #: 14
`
`
`
`COUNT IV
`INFRINGEMENT OF THE ’199 PATENT
`
`66.
`
`Veloxis repeats and realleges the allegations of the preceding paragraphs as if fully
`
`set forth herein.
`
`67.
`
`Defendants’ submission of their ANDA to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, sale, or importation into the United States of
`
`Defendants’ ANDA Products, prior to the expiration of the ’199 patent, constitutes infringement
`
`of one or more claims of that patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the
`
`doctrine of equivalents, including at least claim 14.
`
`68.
`
`Upon information and belief, Defendants’ ANDA Products and/or their use in
`
`accordance with the product label satisfies each and every element of at least claim 14 of the
`
`‘199 Patent.
`
`69.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`and/or validity of the ’199 patent.
`
`70.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will induce infringement of one or more claims of the ’199 patent under 35 U.S.C.
`
`§ 271(b) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, upon FDA approval of Defendants’ ANDA
`
`Products, Defendants will intentionally encourage acts of direct infringement with knowledge of
`
`the ’199 patent and knowledge that their acts are encouraging infringement, with specific intent to
`
`induce infringement of the ‘199 patent.
`
`71.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will contributorily infringe one or more claims of the ’199 patent under 35 U.S.C.
`
`§ 271€ by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`14
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 15 of 20 PageID #: 15
`
`
`
`in the United States. Upon information and belief, Defendants have had and continue to have
`
`knowledge that Defendants’ ANDA Products are especially adapted for a use that infringes one or
`
`more claims of the ’199 patent and that there is no substantial non-infringing use for Defendants’
`
`ANDA Products.
`
`72.
`
`Veloxis will be substantially and irreparably damaged and harmed if Defendants’
`
`infringement of the ’199 patent is not enjoined.
`
`73.
`
`74.
`
`Veloxis does not have an adequate remedy at law.
`
`Upon information and belief, Defendants had knowledge of the ‘199 patent prior to
`
`filing their ANDA with the FDA.
`
`75.
`
`This case is an exceptional one, and Veloxis is entitled to an award of its reasonable
`
`attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT V
`INFRINGEMENT OF THE ’081 PATENT
`
`76.
`
`Veloxis repeats and realleges the allegations of the preceding paragraphs as if fully
`
`set forth herein.
`
`77.
`
`Defendants’ submission of their ANDA to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, sale, or importation into the United States of
`
`Defendants’ ANDA Products, prior to the expiration of the ’081 patent, constitutes infringement
`
`of one or more claims of that patent under 35 U.S.C. § 271€(2)(A), either literally or under the
`
`doctrine of equivalents, including at least claim 1.
`
`78.
`
`Upon information and belief, Defendants’ ANDA Products and/or their use in
`
`accordance with the product label satisfies each and every element of at least claim 1 of the
`
`‘081 Patent.
`
`15
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 16 of 20 PageID #: 16
`
`
`
`79.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`and/or validity of the ’081 patent.
`
`80.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will induce infringement of one or more claims of the ’081 patent under 35 U.S.C.
`
`§ 271(b) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, upon FDA approval of Defendants’ ANDA
`
`Products, Defendants will intentionally encourage acts of direct infringement with knowledge of
`
`the ’081 patent and knowledge that their acts are encouraging infringement, with specific intent to
`
`induce infringement of the ‘081 patent.
`
`81.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will contributorily infringe one or more claims of the ’081 patent under 35 U.S.C.
`
`§ 271(c) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, Defendants have had and continue to have
`
`knowledge that Defendants’ ANDA Products are especially adapted for a use that infringes one or
`
`more claims of the ’081 patent and that there is no substantial non-infringing use for Defendants’
`
`ANDA Products.
`
`82.
`
`Veloxis will be substantially and irreparably damaged and harmed if Defendants’
`
`infringement of the ’081 patent is not enjoined.
`
`83.
`
`84.
`
`Veloxis does not have an adequate remedy at law.
`
`Upon information and belief, Defendants had knowledge of the ‘081 patent prior to
`
`filing their ANDA with the FDA.
`
`85.
`
`This case is an exceptional one, and Veloxis is entitled to an award of its reasonable
`
`attorneys’ fees under 35 U.S.C. § 285.
`
`16
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 17 of 20 PageID #: 17
`
`
`
`COUNT VI
`INFRINGEMENT OF THE ’331 PATENT
`
`86.
`
`Veloxis repeats and realleges the allegations of the preceding paragraphs as if fully
`
`set forth herein.
`
`87.
`
`Defendants’ submission of their ANDA to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, sale, or importation into the United States of
`
`Defendants’ ANDA Products, prior to the expiration of the ’331 patent, constitutes infringement
`
`of one or more claims of that patent under 35 U.S.C. § 271(e)(2)(A), either literally or under the
`
`doctrine of equivalents, including at least claim 1.
`
`88.
`
`Upon information and belief, Defendants’ ANDA Products and/or their use in
`
`accordance with the product label satisfies each and every element of at least claim 1 of the
`
`‘331 Patent.
`
`89.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`and/or validity of the ’331 patent.
`
`90.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will induce infringement of one or more claims of the ’331 patent under 35 U.S.C.
`
`§271(b) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`in the United States. Upon information and belief, upon FDA approval of Defendants’ ANDA
`
`Products, Defendants will intentionally encourage acts of direct infringement with knowledge of
`
`the ’331 patent and knowledge that their acts are encouraging infringement, with specific intent to
`
`induce infringement of the ‘331 patent.
`
`91.
`
`Unless enjoined by this Court, upon FDA approval of Defendants’ ANDA Products,
`
`Defendants will contributorily infringe one or more claims of the ’331 patent under 35 U.S.C.
`
`§ 271(c) by making, using, offering to sell, selling, and/or importing Defendants’ ANDA Products
`
`17
`
`

`

`Case 1:22-cv-00909-UNA Document 1 Filed 07/07/22 Page 18 of 20 PageID #: 18
`
`
`
`in the United States. Upon information and belief, Defendants have had and continue to have
`
`knowledge that Defendants’ ANDA Products are especially adapted for a use that infringes one or
`
`more claims of the ’331 patent and that there is no substantial non-infringing use for Defendants’
`
`ANDA Products.
`
`92.
`
`Veloxis will be substantially and irreparably damaged and harmed if Defendants’
`
`infringement of the ’331 patent is not enjoined.
`
`93.
`
`94.
`
`Veloxis does not have an adequate remedy at law.
`
`Upon information and belief, Defendants had knowledge of the ‘331 patent prior to
`
`filing their ANDA with the F