Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 1 of 20
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`UNITED STATES DISTRICT COURT
`FOR THE WESTERN DISTRICT OF TEXAS
`WACO DIVISION
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`6:21-CV-00148
`Civil Action No: _____________
`
`))))))))))
`
`CUSTOPHARM, INC.
`
`Plaintiff,
`
`v.
`
`FRESENIUS KABI USA, LLC,
`
`Defendant.
`
`CUSTOPHARM, INC.’S DECLARATORY JUDGMENT COMPLAINT OF
`NONINFRINGEMENT
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`Plaintiff Custopharm, Inc. (“Custopharm”), by and through its undersigned counsel, files
`
`this Complaint for Declaratory Judgment of non-infringement of U.S. Patent Nos. 9,782,376 and
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`10,398,669 against Fresenius Kabi USA, LLC (“Fresenius Kabi” or “Defendant”) as follows:
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`INTRODUCTION
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`1.
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`This is a declaratory judgment action under 28 U.S.C. §2201(a) seeking a
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`declaration of non-infringement of U.S. Patent Nos. 9,782,376 (“the ’376 patent”) (attached as
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`Exhibit A) and 10,398,669 (“the ’669 patent”) (attached as Exhibit B). This action is related to
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`and arises out of the same operative facts as Civil Action No. 20-1091 previously filed by Fresenius
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`Kabi in this District against Custopharm for infringement of the ’376 and ’669 patents.
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`2.
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`Custopharm’s formulation cannot infringe any of the claims of the ’376 and ’669
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`patents because it uses different ingredients in a different way that results in an entirely different
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`formulation, with different characteristics. Because Custopharm’s Levothyroxine Product
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 2 of 20
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`formulation lacks critical claim elements required by the ’376 and ’669 patents, it cannot infringe
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`either of those patents. Fresenius Kabi cannot prove otherwise.
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`3.
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`Custopharm offered, on multiple occasions, to provide the formulation for its
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`505(b)(2) NDA Product to counsel for Fresenius Kabi on an outside counsel eye’s only basis.
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`Fresenius Kabi rejected Custopharm’s offer. Without knowing what Custopharm’s formulation
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`was much less whether it infringed, on October 30, 2020, Fresenius Kabi filed lawsuits against
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`Custopharm in three U.S. District Courts: the U.S. District Court for the Western District of Texas
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`(1:20-cv-1091), the District of New Jersey (2:20-cv-15342), and the District of Colorado (1:20-cv-
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`03254) alleging patent infringement of the ’376 and ’669 patents based on Custopharm’s
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`submission of a 505(b)(2) New Drug Application (“NDA”) to the United States Food and Drug
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`Administration (“FDA”) seeking approval to manufacture and sell Custopharm’s levothyroxine
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`sodium solution product.
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`4.
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`On December 28, 2020, Custopharm voluntarily, on an outside counsel eyes only
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`basis, provided counsel for Fresenius Kabi with a copy of Custopharm’s NDA, which includes the
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`formulation for Custopharm’s Levothyroxine product and conclusively demonstrates that
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`Custopharm’s formulation cannot infringe the ’376 or ’669 patents.
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`5.
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`Nevertheless, Fresenius Kabi has repeatedly refused to provide any basis for its
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`infringement allegations, while maintaining its multiple litigations against Custopharm seeking to
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`delay Custopharm’s ability to launch its competing liquid Levothyroxine product. Through its
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`actions, Fresenius Kabi is causing substantial injury to Custopharm in seeking to prevent the
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`marketing of a competing levothyroxine liquid product..
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`6.
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`Because Custopharm is a Texas Corporation, Fresenius Kabi’s Complaint filed in
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`the Western District of Texas was the only one of the three actions filed by Fresenius Kabi filed in
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 3 of 20
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`a proper venue under 28 U.S.C. §1400(b). See Valeant Pharms. N. Am. LLC, et. al. v. Mylan
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`Pharms., Inc., et al., 978 F.3d 1374, 1375 (Fed. Cir. 2020). Fresenius Kabi recently litigated against
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`Custopharm in the Western District of Texas and knew that was and is a proper venue for its action.
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`See Fresenius Kabi USA, LLC and Fresenius Kabi Deutschland GMBH v. Custopharm, Inc., C.A. 18-0065
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`(W.D.Tex)). Custopharm has filed Motions to Dismiss for improper venue in both the District of
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`New Jersey and the District of Colorado. On January 26, 2021, Magistrate Judge Hegarty issued
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`his Recommendation of United States Magistrate Judge that Custopharm’s Motion to Dismiss the
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`Colorado Action for improper venue be granted and that the case be transferred to the Western
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`District of Texas. Exhibit C (Recommendation of United States Magistrate, Case No. 1:20-cv-
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`03254 (D. Colo.), ECF 43). Fresenius Kabi subsequently appealed that Recommendation.
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`Custopharm’s Motion to Dismiss is still pending in the District of New Jersey.
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`7.
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`Instead of proceeding with the action filed in this District to litigate the merits of
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`the case, on January 27, 2021, the day after the Magistrate Judge in Colorado recommended that
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`the Colorado action be transferred to this District, Fresenius Kabi voluntarily dismissed its
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`Complaint pending in the Western District of Texas without ever serving it and without informing
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`this Court of the Magistrate Judge’s recommendation that the case be transferred here. Exhibit D
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`(Notice of Voluntary Dismissal, Case No. 1:20-cv-01091 (W.D. Tex.), ECF 9).
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`8.
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`Fresenius Kabi’s actions of dismissing the litigation it filed in the Western District
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`of Texas, a venue all parties agree is proper, but maintaining the litigations in two districts where
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`venue is improper is delaying the resolution of the merits of this case and preventing Custopharm
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`from removing the cloud that Fresenius Kabi is trying to create with its objectively baseless
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`assertion that Custopharm’s 505(b)(2) Product infringes the ’376 and ’669 patents.
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 4 of 20
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`THE PARTIES
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`9.
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`Custopharm is a Texas corporation with a principal place of business at 2325
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`Camino Vida Roble, Ste. B, Carlsbad, California 92011.
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`10. On information and belief, Fresenius Kabi is a corporation organized and existing
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`under the laws of the state of Delaware, having its corporate headquarters at Three Corporate Drive,
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`Lake Zurich, Illinois 60047.
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`JURISDICTION AND VENUE
`11. This Complaint arises under the Patent Laws of the United States, 35 U.S.C. § 100
`
`et seq. and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202 based upon an actual
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`controversy between the parties for a declaration that Custopharm’s Levothyroxine product that is
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`subject of Custopharm’s 505(b)(2) New Drug Application does not and will not infringe the ’376
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`and/or ’669 patents.
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`12. This Court has jurisdiction over Custopharm’s declaratory judgment claims
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`pursuant to 28 U.S.C. § 2201 et seq. based on Fresenius Kabi’s suits against Custopharm for patent
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`infringement, thereby giving rise to an actual case or controversy under 28 U.S.C. §§ 2201 and
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`2202.
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`13. A substantial controversy of sufficient immediacy and reality exists between the
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`parties to warrant the issuance of a declaratory judgment because Fresenius Kabi has asserted the
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`’376 and ’669 patents against Custopharm in this District, in the District of New Jersey, and in the
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`District of Colorado.
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`14. This Court has personal jurisdiction over Fresenius Kabi because it has a registered
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`agent, Corporation Service Company d/b/a CSC, in Austin, Texas for service of process located at
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`211 E. 7th Street, Suite 620, Austin, TX 78701.
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 5 of 20
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`15. This Court has personal jurisdiction over Fresenius Kabi, at least because it has
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`purposefully availed itself of the privilege of conducting activities within this District and has
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`invoked the benefits and protections of its laws by suing Custopharm to try to enforce the same
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`patents at issue in this Declaratory Judgment Action, and through its continuous and systematic
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`contacts with the state of Texas, including on information and belief conducting substantial and
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`regular business therein through marketing and sales of pharmaceutical products in Texas including
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`but not limited to its own levothyroxine liquid product.
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`16. This Court has personal jurisdiction over Fresenius Kabi because Fresenius Kabi
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`has previously submitted to the jurisdiction of this Court and has further availed itself of this Court
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`by filing lawsuits in this jurisdiction.
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`17. Venue is proper in this District under 28 U.S.C. §§1391(b), (c), and/or 1400(b).
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`
`
`THE PATENTS-IN-SUIT
`18. On its face the ’376 patent entitled “Levothyroxine Liquid Formulations” indicates
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`that it was issued by the United States Patent and Trademark Office on October 10, 2017 and is
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`assigned to Fresenius Kabi USA, LLC. Exhibit A.
`
`19. The ’376 patent was filed on December 1, 2016 and assigned Application No.
`
`15/366,864 (“the ’864 Application”). The ’864 Application was originally filed with 30 claims of
`
`which claims 1, 18, and 24 were the independent claims. Original claims 1, 18 and 24 are
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`reproduced here:
`
`1. A liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt
`thereof; tromethamine; sodium iodide; and water; wherein the formulation has a pH of
`about 9.0 to about 11.5.
`
`18. A liquid formulation comprising (a) levothyroxine or a pharmaceutically acceptable
`salt thereof in a concentration of about 20 mcg/mL to about 100 mcg/mL; (b)
`tromethamine in a concentration of about 5 mg/mL to about 20 mg/mL; (c) sodium
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`5
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 6 of 20
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`iodide in a concentration of about 100 mcg/mL to about 300 mcg/mL; (c) sodium
`chloride; and (d) water; wherein the formulation has a pH of about 9.8 to about 10.8.
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`24. A liquid formulation comprising (a) levothyroxine sodium in a concentration of
`about 20 mcg/mL to about 100 mcg/mL; (b) tromethamine in a concentration of about
`10 mg/mL; (c) sodium iodide in a concentration of about 140 mcg/mL; (c) sodium
`chloride; and (d) water; wherein the formulation has a pH of about 9.8 to about 10.8.
`
`
`Exhibit E at pp. 22-24.
`
`
`20. Each of the original claims of the ’864 Application required that the liquid
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`formulation include tromethamine.
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`21. Each of the original claims of the ’864 Application required that the liquid
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`formulation include sodium iodide.
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`22. Each of the original claims of the ’864 Application required that the liquid
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`formulation have a pH of 9.0 or higher.
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`23. On February 27, 2017, the United States Patent and Trademark Office (“USPTO”)
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`issued a first Office Action. In the Office Action the Examiner rejected each of the pending claims
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`as being unpatentable over US2009/0270507 (the “’507” or “Pierres”) in view of Remington
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`Pharmaceutical Science, 17th ed., 1985. Exhibit F at Office Action, dated 2/27/17, pp. 2-3. In the
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`Office Action, the Examiner stated that the “’507 teaches a liquid levothyroxine composition
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`comprising 0.1 mg/ml to 2 mg/ml of levothyroxine, sodium iodide (iodide donor), water, buffer
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`and pH to be from 9-10.” Exhibit F at Office Action, dated 2/27/17, p. 2. The Examiner continued
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`that the “’507 does not expressly teach the use of tromethamine and sodium chloride.” Exhibit F
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`at Office Action, dated 2/27/17, p. 3.
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`24. The Examiner concludes the Office Action stating:
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`It would have been obvious to one of ordinary skill in the art to formulate a
`liquid levothyroxine composition by employ the herein claimed tonicity agent,
`sodium chloride, and tromethamine as buffering agent. It would have been obvious
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 7 of 20
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`to one of ordinary skill in the art to employ the herein claimed amount of the
`components.
`One of ordinary skill in the art would have been motivated to formulate a
`liquid levothyroxine composition by employ the herein claimed tonicity agent,
`sodium chloride, and tromethamine as buffering agent. Since sodium chloride and
`tromethamine are well known to be tonicity adjust agent and buffering agent
`respectively, selecting these agents are considered obvious as the skilled artisan
`selecting the obvious conventional agents for achieving the tonicity and pH desired,
`absent evidence of demonstrating the criticality of using both agents.
`One of ordinary skill in the art would have been motivated to employ the
`herein claimed amount of the components. The optimization of result effect
`parameters (e.g., dosage range and weight percentage of the excipients) is obvious
`as being within the skill of the artisan. The optimization of known effective
`amounts of known active agents to be administered, is considered well in the
`competence level of an ordinary skilled artisan in pharmaceutical science,
`involving merely routine skill in the art. It has been held that it is within the skill
`in the art to select optimal parameters, such as amounts of ingredients, in a
`composition in order to achieve a beneficial effect.
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`
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`Exhibit F at Office Action, dated 2/27/17, pp. 3-4.
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`25. On May 30, 2017, Fresenius Kabi responded to the Office Action by arguing
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`“Pierres fails to teach that the buffer can be tromethamine. A person of ordinary skill in the art, in
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`seeking to modify the composition disclosed by Pierres, would be led away from tromethamine as
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`a suitable buffer. Tromethamine (also known as Trizma) has a pKa of 8.20 at 20° C. The pKa of
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`the buffer taught by Pierres is approximately 1.3 orders of magnitude greater than the pKa of
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`tromethamine (i.e., 9.5 v. 8.2).” Exhibit G at pp.7-8 (internal citations omitted).
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`26.
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`Fresenius Kabi also argued that “Examples 2 and 3 of the present application
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`provides evidence for the surprising and unexpected stability of exemplary formulation comprising
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`levothyroxine sodium, sodium iodide, and tromethamine.” Exhibit G at p.8.
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`27.
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`Fresenius Kabi also amended the independent claims by including a limitation that
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`the “formulation is stable for at least 12 months at 25 ± 2° C,” and by further limiting the claims
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`to particular amounts of tromethamine (“about 1 mg/mL to about 50 mg/mL”) and sodium iodide
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 8 of 20
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`(“about 10 mcg/mL to about 500 mcg/mL”) necessary to achieve this stability, which Fresenius
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`Kabi asserted was unexpected. Exhibit G at pp. 2-4, 8.
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`28. On June 19, 2017, a Notice of Allowance issued stating “the herein claimed
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`composition comprising levothyroxine with tromethamine, in the herein claimed amount, and
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`increased stability is not taught or fairly suggested by the prior art. Specifically, the amount of
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`tromethamine cannot be used as pH adjusting agents and there is no other motivation to adjust the
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`pH of the liquid formulation to the herein claimed range.” Exhibit H at Reasons for Allowance,
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`p. 2.
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`29. The ’376 patent issued with 30 claims of which 1, 18, and 24 are the only
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`independent claims. Claims 1, 18, and 24 are reproduced here:
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`1. A liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt
`thereof; about 1 mg/mL to about 50 mg/mL of tromethamine; about 10 mcg/mL to about
`500 mcg/mL of sodium iodide; and water; wherein the formulation has a pH of about
`9.0 to about 11.5, and wherein the formulation is stable for at least 12 months at 25 ± 2°
`C.
`
`18. A liquid formulation comprising (a) levothyroxine or a pharmaceutically acceptable
`salt thereof in a concentration of about 20 mcg/mL to about 100 mcg/mL; (b)
`tromethamine in a concentration of about 5 mg/mL to about 20 mg/mL; (c) sodium
`iodide in a concentration of about 100 mcg/mL to about 300 mcg/mL; (c) sodium
`chloride; and (d) water; wherein the formulation has a pH of about 9.8 to about 10.8,
`and wherein the formulation is stable for at least 12 months at 25 ± 2° C.
`
`24. A liquid formulation comprising (a) levothyroxine sodium in a concentration of
`about 20 mcg/mL to about 100 mcg/mL; (b) tromethamine in a concentration of about
`10 mg/mL; (c) sodium iodide in a concentration of about 140 mcg/mL; (c) sodium
`chloride; and (d) water; wherein the formulation has a pH of about 9.8 to about 10.8,
`and wherein the formulation is stable for at least 12 months at 25 ± 2° C.
`Exhibit A.
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`30. Each claim of the ’376 patent requires that the liquid formulation include
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`tromethamine.
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`31. Each claim of the ’376 patent requires that the liquid formulation include sodium
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`iodide.
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`32. Each claim of the ’376 patent requires that the liquid formulation have a pH of 9.0
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`or higher.
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`33. Through Fresenius Kabi’s statements and actions in the Patent Office to overcome
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`the prior art and to obtain allowance of the ’376 Patent, Fresenius Kabi has limited the scope of its
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`claims to formulations containing the claimed concentrations of tromethamine, sodium iodide and
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`having pH ranges between about 9.0 to about 11.5, including about 9.8 to about 10.8, as necessary
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`to achieve the claimed stability levels.
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`34. On its face the ’669 patent entitled “Levothyroxine Liquid Formulations” indicates
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`that it was issued by the United States Patent and Trademark Office on September 3, 2019 and is
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`assigned to Fresenius Kabi USA, LLC. Exhibit B.
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`35. The ’669 patent was filed on September 11, 2017 and assigned Application No.
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`15/700,258 (“the ’258 Application”). The ’258 Application was originally filed with 20 claims of
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`which claim 1 was the sole independent claim. Original claim 1 is reproduced here:
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`1. A liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt
`thereof; a stabilizing agent; not more than 2% liothyronine (T3); and water; wherein the
`formulation is stable for at least 12 months at 25±2º C.
`
`
`Exhibit I at p. 22.
`
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`36. On May 3, 2018, the USPTO issued an Office Action rejecting each of the 20 claims
`
`in the ’258 Application as being unpatentable under 35 U.S.C. 103 over US2009/0270507 (referred
`
`to as “’507” or “Pierres”) in view of Remington Pharmaceutical Science, 17th ed., 1985 which
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`were also made of record during the prosecution of the ’376 patent. Exhibit J at Office Action,
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`dated 5/3/18, pp. 2-3. In the office action the Examiner notes that “’507 does not expressly teach
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 10 of 20
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`the use of tromethamine and sodium chloride.” Exhibit J at Office Action, dated 5/3/18, p.2. The
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`Examiner also rejected the claims of the ’258 Application “on the ground of nonstatutory double
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`patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,782,376 (’376). Although
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`the claims at issue are not identical, they are not patentably distinct from each other because ’376
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`teaches a levothyroxine composition in which the scope of ’376 is narrower than that of the instant
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`case. This is an anticipatory type of obviousness double patenting rejection.” Exhibit J at Office
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`Action, dated 5/3/18, pp. 5-6.
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`37. On September 4, 2018, Applicants filed a Terminal Disclaimer to Obviate a Double
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`Patenting Rejection Over a “Prior” Patent. Exhibit K.
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`38. On September 4, 2018, Applicants responded to the Office Action. Applicants
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`cancelled claim 16 and amended claim 1 as follows:
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`A liquid formulation comprising levothyroxine or a pharmaceutically
`acceptable salt thereof; a stabilizing agent; not more then 2% liothyronine
`(T3); and water; wherein the formulation is stable for at least retains at least
`about 95% of the initial concentration of levothyroxine or pharmaceutically
`acceptable salt thereof after storage for 12 months at 25 ±2ºC, and retains
`at least about 95% of the initial concentration of levothyroxine or
`pharmaceutically acceptable salt thereof after storage for 2 months at 40
`±2ºC.
`
`
`Exhibit L at pp. 2-3.
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`39. On November 9, 2018, the USPTO issued a Final rejection rejecting claims 1-5, 7-
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`15, and 17-20. The claims were rejected under 35 USC § 112, first paragraph “because the
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`specification, while being enabling for tromethamine, does not reasonably provide enablement for
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`other stabilizing agents that give rise to the stability of retaining ‘at least about 95% of the initial
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`concentration of levothyroxine after storage for 2 months at 40 ±2ºC’. The specification does not
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`enable any person skilled in the art to which it pertains, or with which it is most nearly connected,
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`to use the invention commensurate in scope with these claims. In the instant case, the specification
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 11 of 20
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`fails to provide information that would allow the skilled artisan to practice the instant invention
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`without undue experimentation” Exhibit M at Office Action, dated 11/9/18, pp. 2-3.
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`40. The Examiner objected to claim 6 as being dependent on a rejected claim. Exhibit
`
`M at Office Action, dated 11/9/18,p. 5. The Examiner stated that it “would be allowable if
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`rewritten in independent form including all of the limitations of the base claim and any intervening
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`claims.” Exhibit M at Office Action, dated 11/9/18,p. 5. Claim 6 recited “The formulation of
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`claim 5, wherein the amine is tromethamine which is present at a concentration of about 1 mg/mL
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`to about 50 mg/mL.” Exhibit L at p. 2.
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`41. On April 8, 2019, Applicants responded to the Final Office Action by amending
`
`claim 1 to specifically recite tromethamine as follows:
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`A liquid formulation comprising levothyroxine or a pharmaceutically acceptable
`salt thereof; a stabilizing agent comprising tromethamine; not more than 2%
`liothyronine (T3); and water; wherein the formulation retains at least about 95% of
`the initial concentration of levothyroxine or pharmaceutically acceptable salt
`thereof after storage for 12 months at 25 ±2ºC, and retains at least about 95% of the
`initial concentration of levothyroxine or pharmaceutically acceptable salt thereof
`after storage for 2 months at 40 ±2ºC.
`
`
`Exhibit N at p. 2.
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`42. On April 17, 2019, a Notice of Allowance issued stating, inter alia, “[t]he following
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`is an examiner’s statement of reasons for allowance: the incorporation of tromethamine into the
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`levothyroxine composition….” Exhibit O at Reasons for Allowance, p. 2.
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`43. The ’669 patent issued with 17 claims of which claim 1 is the sole independent
`
`claim. Claim 1 is reproduced here:
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`1. A liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt
`thereof; a stabilizing agent comprising tromethamine; not more than 2% liothyronine
`(T3); and water; wherein the formulation retains at least about 95% of the initial
`concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage
`for 12 months at 25±2º C, and retains at least about 95% of the initial concentration of
`
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 12 of 20
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`levothyroxine or pharmaceutically acceptable salt thereof after storage for 2 months at
`40±2º C.
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`
`
`Exhibit B.
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`44. Each claim of the ’669 patent recites a liquid levothyroxine formulation.
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`45. Each claim of the ’669 patent requires that the liquid formulation include
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`tromethamine.
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`46. The ’669 patent is a continuation of the ’376 patent and shares a common
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`specification.
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`47. Through Fresenius Kabi’s statements and actions in the Patent Office to obtain
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`allowance of the ’669 Patent, Fresenius Kabi has limited the scope of its claims to formulations
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`containing tromethamine.
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`FACTUAL BACKGROUND
`48. Custopharm, Inc. is the current owner of FDA NDA No. 214253 submitted to FDA
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`pursuant to §505(b)(2) of the Federal Food, Drug and Cosmetic Act, seeking approval for the
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`commercial manufacture, use, sale, offer for sale, and/or importation of a unique liquid formulation
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`of levothyroxine sodium injection, 100 mcg/1mL (“Custopharm’s 505(b)(2) Product”).
`
`49. Custopharm’s 505(b)(2) Product’s formulation was produced to Fresenius Kabi’s
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`counsel on an Outside Counsel Eyes’ Only basis. CPLEVO_ANDA0000242.
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`50. Custopharm’s 505(b)(2) Product does not include tromethamine.
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`51. Custopharm’s 505(b)(2) Product does not include sodium iodide.
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`52. Custopharm’s 505(b)(2) Product does not have a pH of 9.0 or higher.
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`53. Custopharm’s NDA No. 214253 indicates that NDA No. 202231 is the reference
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`drug for Custopharm’s 505(b)(2) Product. CPLEVO_ANDA0000245. The FDA publication,
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 13 of 20
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`Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the
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`“Orange Book” lists U.S. Patent Nos. 9,006,289; 9,168,238; and 9,168,239 in connection with the
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`reference drug for Custopharm’s 505(b)(2) Product. As required by Section 505(b)(2)(A)(iv) of
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`the Federal Food, Drug and Cosmetic Act, 21 CFR 314.50, Custopharm included a certification in
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`NDA No. 214253 that U.S. Patent Nos. 9,006,289; 9,168,238; and 9,168,239 are invalid,
`
`unenforceable, and/or will not be infringed by the manufacture, use, sale, offer for sale, and/or
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`importation of Custopharm’s 505(b)(2) Product.
`
`54. As required by Sections 505(b) of the Federal Food, Drug and Cosmetic Act (21
`
`U.S.C. §355(b)(3)(B)(i)), as amended by Title XI of the Medicare Prescription Drug, Improvement
`
`and Modernization Act, Pub. L. No. 108-183 Stat. 2066 (2003), Custopharm provided notice to
`
`Fresenius Kabi that U.S. Patent Nos. 9,006,289; 9,168,238; and 9,168,239 are invalid,
`
`unenforceable, and/or will not be infringed by the manufacture, use, sale, offer for sale, and/or
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`importation of Custopharm’s 505(b)(2) Product.
`
`55. To date, Fresenius Kabi has not asserted U.S. Patent Nos. 9,006,289; 9,168,238;
`
`and/or 9,168,239 against Custopharm, but did file three Complaints in three separate Districts
`
`alleging infringement of the ’376 and’669 patents.
`
`56. The ’376 and ’669 patents are not listed in the Orange Book in connection with the
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`reference drug for Custopharm’s 505(b)(2) Product.
`
`57.
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`Prior to Fresenius Kabi filing the three Complaints against Custopharm,
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`Custopharm offered to provide the formulation for its 505(b)(2) NDA Product to counsel for
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`Fresenius Kabi on an outside counsel eye’s only basis. Exhibits P-Q.
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`
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 14 of 20
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`58.
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`Fresenius Kabi’s counsel refused to accept Custopharm’s formulation and instead
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`filed the three Complaints without knowing the formulation of Custopharm’s 505(b)(2) NDA
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`Product.
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`59.
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`In December 2020, Custopharm again voluntarily offered to produce its 505(b)(2)
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`NDA, including the formulation for its 505(b)(2) Product to counsel for Fresenius Kabi on an
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`outside counsel eye’s only basis. Exhibit R. Counsel for Fresenius Kabi agreed to these terms.
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`60. Because Custopharm is a Texas Corporation, Fresenius Kabi’s Complaint filed in
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`the Western District of Texas was the only one of the three actions filed by Fresenius Kabi that
`
`was filed in a proper venue under 28 U.S.C. §1400(b). See Valeant Pharms. N. Am. LLC, et. al.
`
`v. Mylan Pharms., Inc., et al., 978 F.3d 1374, 1375 (Fed. Cir. 2020). Fresenius Kabi voluntarily
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`dismissed the pending Complaint in this District, but maintains the actions in two Districts where
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`venue is improper, Custopharm seeks a judicial declaration that the ’376 and ’669 patents would
`
`not be infringed by the manufacture, use, sale, offer for sale, and/or importation of Custopharm’s
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`505(b)(2) Product.
`
`61. Through its actions of filing three lawsuits on patents that Fresenius Kabi knows or
`
`should know are not infringed by Custopharm’s NDA product formulation and that no reasonable
`
`person could believe infringe the claims of the ’376 and ’669 patents, Fresenius Kabi is seeking to
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`improperly to expand the scope of its patent to encompass objectively noninfringing formulations
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`and to use legal proceedings to restrain trade and prevent or delay competition in the market for
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`liquid levothyroxine.
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`62. As the only current marketer of a liquid levothyroxine formulation in the U.S.,
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`Fresenius Kabi has market power in the market for liquid levothyroxine.
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`
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 15 of 20
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`COUNT I
`(Declaration of Non-Infringement of the ’376 Patent)
`63. Custopharm realleges and incorporates by reference paragraphs 1-62 of these
`
`Counterclaims.
`
`64. Each claim of the ’376 patent requires a specific concentration of tromethamine.
`
`65. Each claim of the ’376 patent requires a specific concentration of sodium iodide.
`
`66. Each claim of the ’376 patent requires the resulting claimed formulation have a pH
`
`of 9.0 or higher.
`
`67. Custopharm’s 505(b)(2) Product formulation does not include each and every
`
`element recited in the claims of the ’376 patent.
`
`68. Custopharm’s 505(b)(2) Product formulation is missing a number of required
`
`limitations of the ’376 patent claims, including for example, tromethamine, sodium iodide and pH
`
`of 9.0-11.5 and 9.8-10.8.
`
`69. Custopharm’s 505(b)(2) Product is substantially different from the formulations
`
`claimed in the ’376 patent including for example in terms of the ingredients in the formulation, the
`
`amounts of those ingredients, the functions of those ingredients, the ways they interact and the
`
`resulting properties of the formulation including the pH of the formulation.
`
`70. Custopharm’s 505(b)(2) Product does not include tromethamine.
`
`71. Custopharm’s 505(b)(2) Product does not include sodium iodide.
`
`72. Custopharm’s 505(b)(2) Product does not have a pH of 9.0 or higher.
`
`73. Custopharm’s 505(b)(2) Product does not have tromethamine in the claimed
`
`concentrations.
`
`
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`15
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 16 of 20
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`74. Custopharm’s 505(b)(2) Product does not have sodium iodide in the claimed
`
`concentrations.
`
`75. As a result of statements made and positions taken by Fresenius Kabi during
`
`prosecution to obtain allowance of the claims of the ’376 patent, Fresenius Kabi is estopped from
`
`trying to expand the scope of this patent to include levothyroxine formulations that do not include
`
`tromethamine and sodium iodide, in the amounts claimed and having a pH range outside of 9.0 to
`
`11.5.
`
`76.
`
`Fresenius Kabi cannot expand the scope of the claims of the ’376 patent to
`
`encompass Custopharm’s 505(b)(2) Product because the claims would then read on the prior art,
`
`including for example, U.S. 2018/0214374, and would not be supported or enabled by the
`
`specification and therefore would be invalid under 35 U.S.C. §§ 102, 103 and/or 112.
`
`77. The manufacture, use, sale, offer for sale, or importation into the United States of
`
`the levothyroxine sodium injection, 100 mcg/1mL product that is the subject of NDA No. 214253
`
`has not infringed, does not infringe, and would not, if marketed, infringe, directly or under doctrine
`
`of equivalents, any valid or enforceable claim of the ’376 patent.
`
`78.
`
`Fresenius Kabi will be unable to prove that the levothyroxine sodium injection, 100
`
`mcg/1mL product described in NDA No. 214253 meets each and every limitation of any valid or
`
`enforceable claim of the ’376 patent and therefore will not be able to prove that Custopharm’s
`
`505(b)(2) product that is the subject of NDA No. 214253 infringes the ’376 patent.
`
`79. Custopharm is entitled to a declaration that the manufacture, use, sale, offer for
`
`sale, or importation into the United States of the levothyroxine sodium injection, 100 mcg/1mL
`
`product that is the subject of NDA No. 214253 has not infringed, does not infringe, and would not,
`
`if marketed, infringe any valid or enforceable claim of the ’376 patent.
`
`
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`16
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`Case 6:21-cv-00148-ADA Document 1 Filed 02/16/21 Page 17 of 20
`
`COUNT II
`(Declaration of Non-Infringement of the ’669 Patent)
`80. Custopharm realleges and incorporates by reference paragraphs 1-79 of these
`
`Counterclaims.
`
`81. Each claim of the ’669 patent requires tromethamine.
`
`82. Additionally, dependent claims of the ’669 patent further require sodium iodide,
`
`including sodium iodide in a concentration of about 10 mcg/mL to about 500 mcg/mL, a pH of
`
`9.0-11.5 and 9.8-10.8, and a concentration of about 1 mg/mL to about 50 mg/mL of tromethamine.
`
`83. Custopharm’s 505(b)(2) Product formulation is missing a number of required
`
`limitations of the ’669 patent claims, including for example tromethamine, sodium iodide, the
`
`claimed concentrations of tromethamine and sodium iodide, and pH of 9.0-11.5 and 9.8-10.8.
`
`84. Custopharm’s 505(b)(2) Product is substantially differ