Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 1 of 22 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`HQ SPECIALTY PHARMA CORP. and
`WG CRITICAL CARE, LLC,
`
`
`Plaintiffs,
`
`
`
`v.
`
`FRESENIUS KABI USA, L.L.C.,
`
`
`Defendant.
`
`
`
`
`
`
`C.A. No. _______________
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`COMPLAINT
`
`Plaintiffs, HQ Specialty Pharma Corp. (“HQ Specialty Pharma”) and WG Critical Care,
`
`LLC (“WG Critical Care”) (collectively “Plaintiffs”), for their Complaint against Defendant
`
`Fresenius Kabi USA, LLC (“Fresenius USA”), allege as follows:
`
`NATURE OF ACTION
`
`1.
`
`This is an action arising under the patent laws of the United States, 35 U.S.C. § 100
`
`et seq., including 35 U.S.C. §§ 271(a), (b), (c), and (e), for infringement by Defendants of United
`
`States Patent No. 10,130,646 (the “’646 patent”) and United States Patent No. 10,342,813 (the
`
`“’813 patent”) (together, the “Asserted Patents”) and for a declaratory judgment of infringement
`
`under 28 U.S.C. §§ 2201 and 2202.
`
`2.
`
`This action arises out of Fresenius USA’s submission of its supplemental New Drug
`
`Application (“sNDA”) No. 208418/S-007 (“Fresenius USA’s sNDA”) under Section 505(b)(2) of
`
`the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 355(b)(2), to the U.S. Food
`
`and Drug Administration (“FDA”) seeking approval to manufacture and sell calcium gluconate in
`
`sodium chloride injection solution in a bag prior to the expiration of the ’646 patent and the
`
`’813 patent.
`
`3.
`
`The FDA approved Fresenius USA’s sNDA on June 17, 2021.
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 2 of 22 PageID #: 2
`
`PARTIES
`
`4.
`
`Plaintiff HQ Specialty Pharma is a corporation organized and existing under the
`
`laws of the state of New Jersey, having a place of business at 120 Route 17 North, Suite 130,
`
`Paramus, New Jersey 07652.
`
`5.
`
`Plaintiff WG Critical Care is a limited liability company organized and existing
`
`under the laws of the state of New Jersey, having a principal place of business at 120 Route 17
`
`North, Paramus, New Jersey 07652.
`
`6.
`
`Upon information and belief, Defendant Fresenius USA is a limited liability
`
`company organized and existing under the laws of the state of Delaware, having its principal place
`
`of business at 3 Corporate Drive, Lake Zurich, Illinois 60047.
`
`7.
`
`Upon information and belief, Fresenius USA is in the business of manufacturing,
`
`marketing, and selling generic drug products. As a part of this business, upon information and
`
`belief, Fresenius USA, directly or through agents, regularly files New Drug Applications
`
`(“NDAs”), sNDAs, and abbreviated new drug applications (“ANDAs”) with the FDA seeking
`
`approval to engage in the commercial manufacture, use, offer for sale, sale and/or importation of
`
`generic versions of drug products that are covered by United States patents. Upon information and
`
`belief, Fresenius USA’s ordinary business operations include litigating and filing claims in the
`
`courts of the United States, including this Court, regarding infringement, validity, and/or
`
`enforceability of United States patents that cover or are alleged to cover generic drug products that
`
`are the subject of NDAs, sNDAs, and ANDAs filed by Fresenius USA.
`
`8.
`
`Upon information and belief, Fresenius USA manufactures and/or imports drug
`
`products for the purpose of sale within the United States, including Delaware.
`
`2
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 3 of 22 PageID #: 3
`
`9.
`
`Upon information and belief, Fresenius USA derives substantial revenue from
`
`services or things used or consumed in the Delaware.
`
`JURISDICTION AND VENUE
`
`10.
`
`Jurisdiction and venue are proper in this District pursuant to 28 U.S.C. §§ 1331,
`
`1338(a), 2201, 2202, 1391, and 1400(b).
`
`11.
`
`Fresenius USA is subject to personal jurisdiction in Delaware because, among other
`
`things, Fresenius USA is a limited liability company formed under the laws of the state of
`
`Delaware.
`
`12.
`
`Upon information and belief, Fresenius USA has a registered agent in Delaware
`
`(Corporation Service Company, 251 Little Falls Drive, Wilmington, Delaware 19808); it is in the
`
`business of manufacturing drug products, which it manufactures, distributes, sells, or offers to sell
`
`throughout the United States, including in Delaware; it derives substantial revenue from services
`
`or things used or consumed in Delaware; it transacts business with companies located and/or
`
`headquartered in Delaware; as part of its ordinary business practice of engaging in U.S. patent
`
`litigation, it has regularly and routinely litigated ANDA and NDA cases without contesting
`
`jurisdiction in this District; it has, directly or through an agent, filed an NDA, and/or been actively
`
`involved in the preparation and submission of an NDA, for the purpose of approval to engage in
`
`the commercial manufacture, use, offer for sale, sale, and/or importation of the generic product
`
`described in sNDA No. 208418/S-007 in the United States, including in Delaware; and it intends
`
`to offer to sell and sell the generic product described in sNDA No. 208418/S-007 in the United
`
`States, including in Delaware.
`
`13.
`
`Upon information and belief, Fresenius USA has availed itself of the legal
`
`protections of Delaware by filing claims or counterclaims affirmatively seeking relief in other prior
`
`3
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 4 of 22 PageID #: 4
`
`actions in this Court, including in Millennium Pharmaceuticals, Inc. v. Fresenius Kabi USA, LLC,
`
`et al., 13-467-GMS (D. Del.); Fresenius Kabi USA, LLC v. Dr. Reddy's Laboratories Ltd., et al.,
`
`13-925-SLR (D. Del.); Fresenius Kabi USA, LLC v. Watson Laboratories Inc., et al., 13-1015-
`
`SLR (D. Del.); Celgene Corp. v. Fresenius Kabi USA, LLC, et al., 14-571-RGA (D. Del.); and
`
`Shire Orphan Therapies, LLC v. Fresenius Kabi USA, LLC, et al., 15-1102-GMS (D. Del).
`
`14.
`
`Venue is proper in this district pursuant to 28 U.S.C. § 1391(b) and (c) and
`
`§ 1400(b) because Fresenius USA is organized, and thus resides, in Delaware.
`
`BACKGROUND
`
`15.
`
`On October 29, 2018, Plaintiff HQ Specialty Pharma received FDA approval for
`
`its NDA 210906. NDA 210906 covers calcium gluconate in sodium chloride solution in bags for
`
`intravenous administration.
`
`16.
`
`Plaintiffs’ calcium gluconate in sodium chloride injection is a solution indicated for
`
`the treatment of acute symptomatic hypocalcemia. It is provided in a ready-to-use flexible plastic
`
`bag to be administered intravenously without dilution.
`
`17.
`
`The ’646 patent, entitled “Calcium Gluconate Solutions in Flexible Containers”
`
`(Exhibit A hereto), was duly and legally issued on November 20, 2018 to HQ Specialty Pharma
`
`as assignee. HQ Specialty Pharma is the owner and assignee of the ’646 patent. Calcium gluconate
`
`in sodium chloride solution and the use thereof are covered by one or more claims of the ’646
`
`patent, and HQ Specialty Pharma has caused the ’646 patent to be listed in connection with
`
`calcium gluconate in sodium chloride solutions in the FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations, also known as the “Orange Book.”
`
`18.
`
`The ’646 has one independent claim. Independent claim 1 of the ’646 patent states:
`
`
`
`
`
`4
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 5 of 22 PageID #: 5
`
`1. A terminally sterilized aqueous calcium gluconate solution comprising:
`
`sodium chloride; and
`
` 1
`
` to 15 wt. % calcium gluconate and from 1 to 19 wt. parts of calcium saccharate per
`100 wt. parts of calcium gluconate packaged in a flexible plastic container with the
`remainder water,
`
`wherein
`
`the flexible plastic container is a bag, and
`
`the solution has a pH of from 6 to 8.2.
`
`19.
`
`The ’813 patent, entitled “Calcium Gluconate Solutions in Flexible Containers”
`
`(Exhibit B hereto), was duly and legally issued on July 9, 2019 to HQ Specialty Pharma as
`
`assignee. HQ Specialty Pharma is the owner and assignee of the ’813 patent. Calcium gluconate
`
`in sodium chloride solution and the use thereof are covered by one or more claims of the ’813
`
`patent. HQ Specialty Pharma has caused the ’813 patent to be listed in connection with calcium
`
`gluconate in sodium chloride solutions in the FDA’s Approved Drug Products with Therapeutic
`
`Equivalence Evaluations, also known as the “Orange Book.”
`
`20.
`
`The ’813 has one independent claim. Independent claim 1 states:
`
`1.
`A terminally sterilized aqueous calcium gluconate solution comprising 1 to 15 wt.%
`calcium gluconate and from 1 to 19 wt. parts of calcium saccharate per 100 wt. parts of
`calcium gluconate packaged in a flexible plastic container with the remainder water,
`
`wherein the solution has a pH of from 6.0 to 8.2.
`
`21. WG Critical Care has an exclusive license from HQ Specialty Pharma to sell
`
`products covered by the Asserted Patents in the United States. WG Critical Care also has the right
`
`to enforce the Asserted Patents. WG Critical Care is responsible for the marketing and sale of HQ
`
`Specialty Pharma’s calcium gluconate in sodium chloride solution in the United States.
`
`5
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 6 of 22 PageID #: 6
`
`22.
`
`HQ Specialty Pharma retains all other right, title, and interest in the ’646 patent and
`
`the ’813 patent.
`
`23.
`
`On August 5, 2019, HQ Specialty Pharma sent a cease and desist letter entitled
`
`“Notice to Discontinue Compounding of Calcium Gluconate in Sodium Chloride Premix in Bags,
`
`FDA Approval of HQ Specialty Pharma’s New Drug Application 210906,” informing Fresenius
`
`USA of the FDA’s approval of NDA 210906 for Calcium in Sodium Chloride Injection in
`
`premixed bags, of the ’646 patent, and of the ’813 patent.1
`
`24.
`
`In that letter, HQ Specialty Pharma requested written confirmation from Fresenius
`
`USA of the absence of manufacturing, distributing, or selling of products that were “essentially a
`
`copy” of HQ Specialty Pharma’s approved drug products or that were infringing HQ Specialty
`
`Pharma’s ‘646 patent. On information and belief, Fresenius USA did not respond to that letter.
`
`25.
`
`On December 17, 2020, Fresenius USA submitted its sNDA for calcium gluconate
`
`in sodium chloride injection solution in Freeflex bags to the FDA.
`
`26.
`
`On June 17, 2021, Fresenius USA received FDA approval for its sNDA 208418/S-
`
`007 for calcium gluconate in sodium chloride injection (the “Approved Fresenius Product”), and
`
`Fresenius USA is therefore now permitted by the FDA to sell the Approved Fresenius Product in
`
`the United States.
`
`27.
`
`The approved package insert for Fresenius USA’s sNDA product (Exhibit C hereto)
`
`is substantially identical in all respects relevant to the Asserted Patents to the approved package
`
`insert for calcium gluconate in sodium chloride injection sold by WG Critical Care.
`
`
`1 At the time of the cease and desist letter, the ’813 patent had not yet issued. However, Fresenius
`USA was informed of the Application Publication (No. US 2019/0076454), and that HQ Specialty
`Pharma was expecting the patent to issue shortly.
`
`6
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 7 of 22 PageID #: 7
`
`28.
`
`The Approved Fresenius Product as described in Fresenius USA’s approved
`
`labeling meets each and every limitation of at least claim 1 of ’646 patent because, inter alia, it is
`
`a terminally sterilized aqueous calcium gluconate solution including sodium chloride with the
`
`required amount of calcium gluconate and calcium saccharate in a flexible plastic container that is
`
`a bag and is within the required pH range.
`
`29.
`
`The Approved Fresenius Product as described in Fresenius USA’s approved
`
`labeling meets each and every limitation of at least claim 1 of ’813 patent because, inter alia, it is
`
`a terminally sterilized aqueous calcium gluconate solution with the required amount of calcium
`
`gluconate and calcium saccharate in a flexible plastic container with the remainder water and is
`
`within the required pH range.
`
`30.
`
`There is an actual, real, immediate, and justiciable controversy between Plaintiffs
`
`and Fresenius USA regarding the infringement of the Asserted Patents by the Approved Fresenius
`
`Product.
`
`COUNT I – INFRINGEMENT OF U.S. PATENT NO. 10,130,646
`UNDER 35 U.S.C. §§ 271(a), (b), AND (c)
`
`31.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-30 as if fully set forth
`
`herein.
`
`32.
`
`33.
`
`Fresenius USA has knowledge of the ’646 patent.
`
`Upon information and belief, the Approved Fresenius Product and the use of the
`
`Approved Fresenius Product are covered by at least claim 1 of the ’646 patent.
`
`34.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of the Approved Fresenius Product will infringe one or more
`
`claims of the ’646 patent, either literally or under the doctrine of equivalents under 35 U.S.C.
`
`§§ 271(a), (b), and/or (c).
`
`7
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 8 of 22 PageID #: 8
`
`35.
`
`Upon information and belief, Fresenius USA either has already, or intends
`
`imminently, to engage in the importation, manufacture, use, offer for sale, sale, marketing and/or
`
`distribution of the Approved Fresenius Product with its approved labeling of sNDA 208418/S-007.
`
`36.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution and/or importation of the Approved Fresenius Product in accordance with and as
`
`directed by Fresenius USA’s approved labeling for that product will infringe one or more claims
`
`of the ’646 patent, including, but not limited to, claim 1.
`
`37.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of the Approved Fresenius Product in accordance with and as directed by Fresenius
`
`USA’s approved labeling for that product will infringe one or more claims of the ’646 patent,
`
`including, but not limited to claim 1 under 35 U.S.C. § 271(a).
`
`38.
`
`Upon information and belief, Fresenius USA plans and intends to, and will, actively
`
`induce infringement of the ’646 patent, including, but not limited to claim 1, under 35 U.S.C.
`
`§ 271(b). Fresenius USA’s activities will be done with knowledge of the ’646 patent and specific
`
`intent to infringe that patent.
`
`39.
`
`Upon information and belief, Fresenius USA knows that Approved Fresenius
`
`Product and its proposed labeling are especially made or adapted for use in infringing the ’646
`
`patent, are not staple articles or commodities of commerce, and that the Approved Fresenius
`
`Product and its approved labeling are not suitable for substantial non-infringing use. Upon
`
`information and belief, Fresenius USA plans and intends to, and will, contribute to infringement
`
`of the ’646 patent under 35 U.S.C. § 271(c).
`
`40.
`
`Upon information and belief, Fresenius USA has already or will, without authority,
`
`import into the United States and/or offer to sell, sell, and/or use within the United States, a product
`
`8
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 9 of 22 PageID #: 9
`
`that infringes one or more claims of the ’646 patent, and contributes to the infringement by others
`
`of the ’646 patent under 35 U.S.C. § 271(c).
`
`41.
`
`The foregoing actions by Fresenius USA constitute and/or will constitute
`
`infringement of the ’646 patent, active inducement of infringement of the ’646 patent, and
`
`contribution to the infringement by others of the ’646 patent under 35 U.S.C. §§ 271(a), (b), and/or
`
`(c).
`
`42.
`
`Upon information and belief, Fresenius USA has acted with full knowledge of the
`
`’646 patent and without reasonable basis for believing that it would not be liable for infringing the
`
`’646 patent, actively inducing infringement of the ’646 patent, and contributing to the infringement
`
`by others of the ’646 patent.
`
`43.
`
`Plaintiffs will be substantially and irreparably damaged by infringement of the
`
`’646 patent.
`
`44.
`
`Unless Fresenius USA is enjoined from infringing the ’646 patent, actively
`
`inducing infringement of the ’646 patent, and contributing to the infringement by others of the
`
`’646 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`COUNT II – DECLARATORY JUDGMENT OF INFRINGEMENT
`OF U.S. PATENT NO. 10,130,646
`
`45.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-30 as if fully set forth
`
`herein.
`
`46.
`
`47.
`
`Fresenius USA has knowledge of the ’646 patent.
`
`The Court may declare the rights and legal relations of the parties pursuant to
`
`28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Plaintiffs on
`
`the one hand and Fresenius USA on the other regarding Fresenius USA’s infringement, active
`
`9
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 10 of 22 PageID #: 10
`
`inducement of infringement, and contribution to the infringement by others of the ’646 patent,
`
`and/or validity or the ’646 patent.
`
`48.
`
`Upon information and belief, the Approved Fresenius Product and the use of the
`
`Approved Fresenius Product are covered by at least claim 1 of the ’646 patent.
`
`49.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Approved Fresenius Product will infringe one or more claims
`
`of the ’646 patent, including, but not limited to claim 1, either literally or under the doctrine of
`
`equivalents.
`
`50.
`
`Upon information and belief, Fresenius USA plans and intends to, and will, engage
`
`in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of the
`
`Approved Fresenius Product with its approved labeling, and intends to do so immediately and
`
`imminently because the Approved Fresenius Product has already received FDA approval for
`
`marketing and sale within the United States.
`
`51.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Approved Fresenius Product in accordance with and as directed
`
`by Fresenius USA’s approved labeling for that product will infringe one or more of the claims of
`
`the ’646 patent, including, but not limited to claim 1.
`
`52.
`
`Upon information and belief, Fresenius USA plans and intends to, and will, actively
`
`induce infringement of the ’646 patent. Fresenius USA’s activities will be done with knowledge
`
`of the ’646 patent and specific intent to infringe that patent.
`
`53.
`
`Upon information and belief, Fresenius USA knows that Fresenius USA’s sNDA
`
`Product and its approved labeling are especially made or adapted for use in infringing the ’646
`
`patent, are not staple articles or commodities of commerce, and that the Approved Fresenius
`
`10
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 11 of 22 PageID #: 11
`
`Product and its approved labeling are not suitable for substantial non-infringing use. Upon
`
`information and belief, Fresenius USA plans and intends to, and will, contribute to infringement
`
`of the ’646 patent.
`
`54.
`
`Upon information and belief, Fresenius USA will, without authority, import into
`
`the United States and/or offer to sell, sell, and/or use within the United States, a product which
`
`infringes one or more claims of the ’646 patent prior to the expiration of the patent.
`
`55.
`
`The foregoing actions by Fresenius USA constitute and/or will constitute
`
`infringement of the ’646 patent, active inducement of infringement of the ’646 patent, and
`
`contribution to the infringement by others of the ’646 patent.
`
`56.
`
`Upon information and belief, Fresenius USA acted without a reasonable basis for
`
`believing that it would not be liable for infringing the ’646 patent, actively inducing infringement
`
`of the ’646 patent, and contributing to the infringement by others of the ’646 patent.
`
`57.
`
`Plaintiffs will be substantially and irreparably damaged by infringement of the ’646
`
`patent.
`
`58.
`
`Unless Fresenius USA is enjoined from infringing the ’646 patent, actively
`
`inducing infringement of the ’646 patent and contributing to the infringement by others of the ’646
`
`patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`59.
`
`The Court should declare that the commercial manufacture, use, sale, offer for sale,
`
`or importation of Approved Fresenius Product in accordance with and as directed by Fresenius
`
`USA’s approved labeling for that product, or any other Fresenius USA product that is covered by
`
`or whose use is covered by the ’646 patent, will infringe, induce the infringement of, and contribute
`
`to the infringement by others of the ’646 patent, and that the claims of the ’813 patent are not
`
`invalid.
`
`11
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 12 of 22 PageID #: 12
`
`COUNT III – INFRINGEMENT OF U.S. PATENT NO. 10,130,646
`UNDER 35 U.S.C. § 271(e)(2)
`
`60.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-30 as if fully set forth
`
`herein.
`
`61.
`
`Upon information and belief, the Approved Fresenius Product and the use of the
`
`Approved Fresenius Product are covered by at least claim 1 of the ’646 patent.
`
`62.
`
`Fresenius USA’s submission of sNDA 208418/S-007 to the FDA for the purpose
`
`of obtaining approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of Fresenius USA’s sNDA Product prior to the expiration of the ’646 patent was an
`
`act of infringement of the ’646 patent under 35 U.S.C. § 271(e)(2)(A).
`
`63.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of the Approved Fresenius Product will infringe one or more
`
`claims of the ’646 patent, either literally or under the doctrine of equivalents.
`
`64.
`
`Upon information and belief, Fresenius USA either has already, or intends
`
`imminently, to engage in the importation, manufacture, use, offer for sale, sale, marketing and/or
`
`distribution of the Approved Fresenius Product with its approved labeling of sNDA 208418/S-007.
`
`65.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution and/or importation of the Approved Fresenius Product in accordance with and as
`
`directed by Fresenius USA’s approved labeling for that product will infringe one or more claims
`
`of the ’646 patent, including, but not limited to, claim 1.
`
`66.
`
`Upon information and belief, Fresenius USA plans and intends to, and will, actively
`
`induce infringement of the ’646 patent, including, but not limited to claim 1. Fresenius USA’s
`
`activities will be done with knowledge of the ’646 patent and specific intent to infringe that patent.
`
`12
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 13 of 22 PageID #: 13
`
`67.
`
`Upon information and belief, Fresenius USA knows that Approved Fresenius
`
`Product and its proposed labeling are especially made or adapted for use in infringing the ’646
`
`patent, are not staple articles or commodities of commerce, and that the Approved Fresenius
`
`Product and its approved labeling are not suitable for substantial non-infringing use. Upon
`
`information and belief, Fresenius USA plans and intends to, and will, contribute to infringement
`
`of the ’646 patent.
`
`68.
`
`Upon information and belief, Fresenius USA has already or will, without authority,
`
`import into the United States and/or offer to sell, sell, and/or use within the United States, a product
`
`that infringes one or more claims of the ’646 patent, and contributes to the infringement by others
`
`of the ’646 patent.
`
`69.
`
`The foregoing actions by Fresenius USA constitute and/or will constitute
`
`infringement of the ’646 patent, active inducement of infringement of the ’646 patent, and
`
`contribution to the infringement by others of the ’646 patent.
`
`70.
`
`Upon information and belief, Fresenius USA has acted with full knowledge of the
`
`’646 patent and without reasonable basis for believing that it would not be liable for infringing the
`
`’646 patent, actively inducing infringement of the ’646 patent, and contributing to the infringement
`
`by others of the ’646 patent.
`
`71.
`
`Plaintiffs will be substantially and irreparably damaged by infringement of the ’646
`
`patent.
`
`72.
`
`Unless Fresenius USA is enjoined from infringing the ’646 patent, actively
`
`inducing infringement of the ’646 patent, and contributing to the infringement by others of the
`
`’646 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`
`
`
`
`13
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 14 of 22 PageID #: 14
`
`COUNT IV – INFRINGEMENT OF U.S. PATENT NO. 10,342,813
`UNDER 35 U.S.C. §§ 271(a), (b), AND (c)
`
`73.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-30 as if fully set forth
`
`herein.
`
`74.
`
`75.
`
`Fresenius USA has knowledge of the ’813 patent.
`
`Upon information and belief, the Approved Fresenius Product and the use of the
`
`Approved Fresenius Product are covered by at least claim 1 of the ’813 patent
`
`76.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of the Approved Fresenius Product will infringe one or more
`
`claims of the ’813 patent, either literally or under the doctrine of equivalents under 35 U.S.C.
`
`§§ 271(a), (b), and/or (c).
`
`77.
`
`Upon information and belief, Fresenius USA either has already, or intends
`
`imminently, to engage in the importation, manufacture, use, offer for sale, sale, marketing and/or
`
`distribution of the Approved Fresenius Product with its approved labeling of sNDA 208418/S-007.
`
`78.
`
`Upon information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution and/or importation of the Approved Fresenius Product in accordance with and as
`
`directed by Fresenius USA’s approved labeling for that product will infringe one or more claims
`
`of the ’813 patent, including, but not limited to, claim 1.
`
`79.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of the Approved Fresenius Product in accordance with and as directed by Fresenius
`
`USA’s approved labeling for that product will infringe one or more claims of the ’813 patent,
`
`including, but not limited to claim 1 under 35 U.S.C. § 271(a).
`
`80.
`
`Upon information and belief, Fresenius USA plans and intends to, and will, actively
`
`induce infringement of the ’813 patent, including, but not limited to claim 1, under 35 U.S.C.
`
`14
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 15 of 22 PageID #: 15
`
`§ 271(b). Fresenius USA’s activities will be done with knowledge of the ’813 patent and specific
`
`intent to infringe that patent.
`
`81.
`
`Upon information and belief, Fresenius USA knows that Approved Fresenius
`
`Product and its proposed labeling are especially made or adapted for use in infringing the ’813
`
`patent, are not staple articles or commodities of commerce, and that the Approved Fresenius
`
`Product and its approved labeling are not suitable for substantial non-infringing use. Upon
`
`information and belief, Fresenius USA plans and intends to, and will, contribute to infringement
`
`of the ’813 patent under 35 U.S.C. § 271(c).
`
`82.
`
`Upon information and belief, Fresenius USA has already or will, without authority,
`
`import into the United States and/or offer to sell, sell, and/or use within the United States, a product
`
`that infringes one or more claims of the ’813 patent, and contributes to the infringement by others
`
`of the ’813 patent under 35 U.S.C. § 271(c).
`
`83.
`
`The foregoing actions by Fresenius USA constitute and/or will constitute
`
`infringement of the ’813 patent, active inducement of infringement of the ’813 patent, and
`
`contribution to the infringement by others of the ’813 patent under 35 U.S.C. §§ 271(a), (b),
`
`and/or (c).
`
`84.
`
`Upon information and belief, Fresenius USA has acted with full knowledge of the
`
`’813 patent and without reasonable basis for believing that it would not be liable for infringing the
`
`’813 patent, actively inducing infringement of the ’813 patent, and contributing to the infringement
`
`by others of the ’813 patent.
`
`85.
`
`Plaintiffs will be substantially and irreparably damaged by infringement of the ’646
`
`patent.
`
`15
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 16 of 22 PageID #: 16
`
`86.
`
`Unless Fresenius USA is enjoined from infringing the ’813 patent, actively
`
`inducing infringement of the ’813 patent, and contributing to the infringement by others of the
`
`’813 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`COUNT V – DECLARATORY JUDGMENT OF INFRINGEMENT
`OF U.S. PATENT NO. 10,342,813
`
`87.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-30 as if fully set forth
`
`herein.
`
`88.
`
`89.
`
`Fresenius USA has knowledge of the ’813 patent.
`
`The Court may declare the rights and legal relations of the parties pursuant to
`
`28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Plaintiffs on
`
`the one hand and Fresenius USA on the other regarding Fresenius USA’s infringement, active
`
`inducement of infringement, and contribution to the infringement by others of the ’831 patent,
`
`and/or validity of the ’831 patent.
`
`90.
`
`The Approved Fresenius Product and the use of the Approved Fresenius Product
`
`are covered by at least claim 1 of the ’831 patent.
`
`91.
`
`The manufacture, use, offer for sale, sale, marketing, distribution, and/or
`
`importation of the Approved Fresenius Product will infringe one or more claims of the ’813 patent,
`
`including, but not limited to, claim 1, either literally or under the doctrine of equivalents.
`
`92.
`
`Upon information and belief, Fresenius USA plans and intends to, and will, engage
`
`in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of
`
`Fresenius USA’s sNDA Product with its approved labeling, and intends to do so immediately and
`
`imminently because the Approved Fresenius Product has already received FDA approval for
`
`marketing and sale within the United States.
`
`16
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 17 of 22 PageID #: 17
`
`93.
`
`The use of the Approved Fresenius Product in accordance with and as directed by
`
`Fresenius USA’s approved labeling for that product will infringe one or more of the claims of the
`
`’813 patent, including, but not limited to, claim 1.
`
`94.
`
`Upon information and belief, Fresenius USA plans and intends to, and will, actively
`
`induce infringement of the ’813 patent. Fresenius USA’s activities will be done with knowledge
`
`of the ’813 patent and specific intent to infringe that patent.
`
`95.
`
`Upon information and belief, Fresenius USA knows that Fresenius USA’s sNDA
`
`Product and its approved labeling are especially made or adapted for use in infringing the ’813
`
`patent, are not staple articles or commodities of commerce, and that Fresenius USA’s sNDA
`
`Product and its approved labeling are not suitable for substantial non-infringing use. Upon
`
`information and belief, Fresenius USA plans and intends to, and will, contribute to infringement
`
`of the ’813 patent.
`
`96.
`
`Upon information and belief, Fresenius USA will, without authority, import into
`
`the United States and/or offer to sell, sell, and/or use within the United States, a product which is
`
`made by a process that infringes one or more claims of the ’813 patent prior to the expiration of
`
`the patent.
`
`97.
`
`The foregoing actions by Fresenius USA constitute and/or will constitute
`
`infringement of the ’813 patent, active inducement of infringement of the ’813 patent, and
`
`contribution to the infringement by others of the ’813 patent.
`
`98.
`
`Upon information and belief, Fresenius USA acted without a reasonable basis for
`
`believing that it would not be liable for infringing the ’813 patent, actively inducing infringement
`
`of the ’813 patent, and contributing to the infringement by others of the ’813 patent.
`
`17
`
`

`

`Case 1:21-cv-01714-UNA Document 1 Filed 12/03/21 Page 18 of 22 PageID #: 18
`
`99.
`
`Plaintiffs will be substantially and irreparably damaged by infringement of the
`
`’913 patent.
`
`100. Unless Fresenius USA is enjoined from infringing the ’813 patent, actively
`
`inducing infringement of the ’813 patent and contributing to the infringement by others of the ’813
`
`patent, Plaintiffs