Case 2:23-cv-04343-CCC-MAH Document 1 Filed 08/11/23 Page 1 of 13 PageID: 1
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`FRESENIUS KABI USA, LLC,
`Plaintiff,
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`v.
`AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and
`AMNEAL EU, LIMITED,
`Defendants.
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`COMPLAINT
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`Civil Action No.
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`
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`Fresenius Kabi USA, LLC (“Fresenius” or “Plaintiff”) brings this action for patent
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`
`
`
`
`
`
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`infringement against Defendants Amneal Pharmaceuticals LLC (“Amneal Pharma”), Amneal
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`Pharmaceuticals of New York, LLC (“Amneal NY”), and Amneal EU, Limited (“Amneal EU”)
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`(collectively, “Amneal” or “Defendants”).
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`1.
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`This is an action by Fresenius against Defendants for infringement of United States
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`Patent No. 8,476,010 (“the ʼ010 patent”). This action arises out of Defendants’ filing of an
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`Abbreviated New Drug Application (“ANDA”) seeking approval by the United States Food and
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`Drug Administration (“FDA”) to sell a generic version of Diprivan®, an innovative intravenously
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`administered sedative and anesthetic, prior to the expiration of the ʼ010 patent.
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`
`Plaintiff
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`
`2.
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`THE PARTIES
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`Fresenius is a Delaware limited liability company with its principal place of
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`business at Three Corporate Drive, Lake Zurich, Illinois 60047. Fresenius was formerly known
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`as APP Pharmaceuticals, LLC.
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`Defendants
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`3.
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`Upon information and belief, Defendant Amneal Pharma is a limited liability
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`company organized and existing under the laws of Delaware, having a principal place of business
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`at 400 Crossing Boulevard, 3rd Floor, Bridgewater, NJ 08807.
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`4.
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`Upon information and belief, Defendant Amneal NY is a limited liability company
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`organized and existing under the laws of the State of Delaware, having a principal place of business
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`at 400 Crossing Boulevard, 3rd Floor, Bridgewater, NJ 08807. Upon information and belief,
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`Amneal NY is a wholly owned subsidiary of Amneal Pharma. Upon information and belief,
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`Amneal NY is the U.S. agent for Amneal EU.
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`5.
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`Upon information and belief, Defendant Amneal EU is a company organized and
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`existing under the laws of Ireland, having a place of business at Cahir Road, Cashel, Co. Tipperary,
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`Ireland E25 XD5l. Upon information and belief, Amneal EU is an indirect wholly owned
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`subsidiary of Amneal Pharma.
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`JURISDICTION AND VENUE
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`Subject Matter Jurisdiction
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`6.
`This action for patent infringement arises under 35 U.S.C. § 271.
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`7.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`Personal Jurisdiction
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`8.
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`Upon information and belief, this Court has personal jurisdiction over Defendants
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`because, inter alia, they have maintained continuous and systematic contacts with the State of New
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`Jersey.
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`9.
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`Upon information and belief, this Court also has personal jurisdiction over
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`Defendants because, inter alia, they have committed, or aided, abetted, contributed to, or
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`participated in the commission of, tortious conduct, which will lead to foreseeable harm and injury
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`to Fresenius in the State of New Jersey, and by doing so, Defendants have purposefully directed
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`their activities at the residents of this forum.
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`10.
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`Upon information and belief, this Court has personal jurisdiction over Defendant
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`Amneal Pharma because it has its principal place of business in New Jersey.
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`11.
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`Upon information and belief, this Court has personal jurisdiction over Defendant
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`Amneal NY because it has its principal place of business in New Jersey.
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`12.
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`Upon information and belief, this Court has personal jurisdiction over Defendant
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`Amneal EU because its U.S. agent, Amneal NY, has its principal place of business in New Jersey.
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`13.
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`Upon information and belief, Defendants have previously availed themselves of
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`this Judicial District by not contesting personal jurisdiction in at least the following actions: Cubist
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`Pharms. LLC v. Amneal Pharms. LLC et al., Civil Action No. 3:19-cv-15439 (D.N.J. filed July
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`16, 2019); and TherapeuticsMD, Inc. v. Amneal Pharms., Inc. et al., Civil Action No. 3:20-cv-
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`05256-FLW-TJB (D.N.J. filed Apr. 29, 2020).
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`14.
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`Upon information and belief, Defendants have engaged in continuous and
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`systematic contacts with the State of New Jersey and/or purposefully have availed themselves of
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`this forum by, inter alia, individually and/or in concert, making, marketing, shipping, using,
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`offering to sell or selling Defendants’ pharmaceutical products in this Judicial District, and
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`deriving substantial revenue from such activities.
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`15.
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`Upon information and belief, Defendants have engaged in and maintained
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`systematic and continuous business contacts within the State of New Jersey, and have purposefully
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`availed themselves of the benefits and protections of the laws of the State of New Jersey, rendering
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`them at home in the State of New Jersey.
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`16.
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`Upon information and belief, Defendants operate as a single vertically-integrated
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`business with respect to the regulatory approval, manufacturing, marketing, sale and distribution
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`of pharmaceutical products throughout the United States, including in this Judicial District.
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`17.
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`Upon information and belief, Defendants, individually and/or in concert, have
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`committed, or aided, abetted, contributed to and/or participated in the commission of the tortious
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`action of patent infringement that has led to foreseeable harm and injury to Fresenius, which sells
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`Diprivan® for use throughout the United States, including the State of New Jersey.
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`18.
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`Upon information and belief, Defendants have applied for FDA approval to market
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`and sell a generic version of Diprivan® throughout the United States, including the State of New
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`Jersey.
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`19.
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`Defendants’ submission of their ANDA to FDA evinces their intent to subject
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`themselves to the jurisdiction of the courts where the drug that is the subject of the ANDA will be
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`sold, including in the State of New Jersey.
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`20.
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`Defendants sent a letter, dated June 28, 2023 (the “Notice Letter”), to Fresenius
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`stating that Defendants had filed ANDA No. 217525 seeking FDA approval to market generic
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`Diprivan® products (“Defendants’ generic Diprivan® products”) prior to the expiration of the ʼ010
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`patent. The Notice Letter was sent from the State of New Jersey by Bryan Sommese, Esq., Senior
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`Patent Litigation Counsel IP, for Amneal Pharma in Bridgewater, New Jersey, on behalf of Amneal
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`NY and Amneal EU.
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`21.
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`Upon information and belief, Defendants acted in concert to prepare and submit
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`ANDA No. 217525.
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`22.
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`Upon information and belief, Defendants, individually and/or in concert, will
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`market, sell and offer for sale Defendants’ generic Diprivan® products in the State of New Jersey
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`following FDA approval of those products.
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`23.
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`Upon information and belief, as a result of Defendants’ marketing, selling, or
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`offering for sale of Defendants’ generic Diprivan® products in the State of New Jersey, Fresenius
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`will lose sales of Diprivan® and be injured in the State of New Jersey.
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`24.
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`This Court’s exercise of jurisdiction over Defendants is fair and reasonable.
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`Defendants are not burdened by litigating this suit in the State of New Jersey. The State of New
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`Jersey has an interest in providing a forum to resolve Hatch-Waxman litigation, including in this
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`case, because this case involves products that will be sold in the State of New Jersey by New
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`Jersey-based companies and injury to Fresenius in the State of New Jersey. This Court’s exercise
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`of jurisdiction serves the interests of the judicial system in efficient resolution of Hatch-Waxman
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`litigation.
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`25.
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`Upon information and belief, this Court has personal jurisdiction over Defendants
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`for the reasons stated herein, including, inter alia, Defendants’ activities in the forum, activities
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`directed at the forum, and significant contacts with the forum, all of which render Defendants at
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`home in the forum. Personal jurisdiction is proper at least under Acorda Therapeutics Inc. v. Mylan
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`Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016).
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`26.
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`In the alternative, Defendant Amneal EU is subject to personal jurisdiction in this
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`forum under Federal Rule of Civil Procedure 4(k)(2).
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`Venue
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`27.
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`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400(b). In
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`re HTC Corp., 889 F.3d 1349, 1354 (Fed. Cir. 2018).
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`28.
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`Upon information and belief, Defendants have a regular and established place of
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`business in this Judicial District and have committed and/or will commit acts of infringement in
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`this Judicial District.
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`29.
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`Upon information and belief, Defendants have not contested venue in this Judicial
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`District in at least the following actions: Cubist Pharms. LLC v. Amneal Pharms. LLC et al., Civil
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`Action No. 3:19-cv-15439 (D.N.J. filed July 16, 2019); and TherapeuticsMD, Inc. v. Amneal
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`Pharms., Inc. et al., Civil Action No. 3:20-cv-05256-FLW-TJB (D.N.J. filed Apr. 29, 2020).
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`30.
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`Upon information and belief, Defendant Amneal Pharma has a regular and
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`established place of business in this Judicial District at least because it: (1) has a principal place
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`of business in the State of New Jersey; (2) has acted in concert with Amneal NY and Amneal EU
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`to seek approval from FDA to market and sell Defendants’ generic Diprivan® products in this
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`Judicial District; (3) has engaged in regular and established business contacts with the State of
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`New Jersey by, inter alia, contracting and engaging in related commercial activities related to the
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`marketing, making, shipping, using, offering to sell or selling Defendants’ products in this Judicial
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`District, and deriving substantial revenue from such activities; and (4) has made agreements with
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`retailers, wholesalers or distributors providing for the distribution of Defendants’ products in the
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`State of New Jersey.
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`31.
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`Upon information and belief, Defendant Amneal NY has a regular and established
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`place of business in this Judicial District at least because it: (1) has a principal place of business
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`in New Jersey; (2) has acted in concert with Amneal Pharma and Amneal EU to seek approval
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`from FDA to market and sell Defendants’ generic Diprivan® products in this Judicial District; (3)
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`has engaged in regular and established business contacts with the State of New Jersey by, inter
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`alia, contracting and engaging in related commercial activities related to the marketing, making,
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`shipping, using, offering to sell or selling Defendants’ products in this Judicial District, and
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`deriving substantial revenue from such activities; and (4) has made agreements with retailers,
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`wholesalers or distributors providing for the distribution of Defendants’ products in the State of
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`New Jersey.
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`32.
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`Upon information and belief, Defendant Amneal EU has a regular and established
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`place of business in this Judicial District at least because it: (1) conducts business, individually
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`and/or in concert with its U.S. agent, which is located in the State of New Jersey, in this Judicial
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`District; and (2) has engaged in regular and established business contacts with the State of New
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`Jersey by, inter alia, marketing, making, shipping, using, offering to sell or selling Defendants’
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`products in this Judicial District, and deriving substantial revenue from such activities.
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`33.
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`Venue is also proper in this Judicial District for Amneal EU at least because, inter
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`alia, Amneal EU is a foreign corporation organized and existing under the laws of Ireland and may
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`be sued in any judicial district in which it is subject to personal jurisdiction, including in the State
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`of New Jersey.
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`BACKGROUND
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`The Patent-in-Suit: United States Patent No. 8,476,010
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`34.
`The ʼ010 patent, entitled “Propofol Formulations with Non-Reactive Container
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`Closures,” was duly and lawfully issued on July 2, 2013, to inventors Neil P. Desai, Andrew Yang,
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`and Sherry Xiaopei Ci. The named inventors assigned the ʼ010 patent to APP Pharmaceuticals,
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`LLC, which later changed its name to Fresenius Kabi USA, LLC. Accordingly, Fresenius is the
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`owner of all rights, title and interest in the ʼ010 patent. The ʼ010 patent will expire, with a period
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`of pediatric exclusivity, on June 1, 2025. A true and accurate copy of the ʼ010 patent is attached
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`hereto as Exhibit A.
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`35.
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`The ʼ010 patent is listed in FDA’s publication entitled, “Approved Drug Products
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`with Therapeutic Equivalence Evaluations,” commonly referred to as “The Orange Book,” with
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`respect to Diprivan®.
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`36.
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`On or about January 16, 2020, after the conclusion of inter partes review (and the
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`appeal therefrom), the United States Patent and Trademark Office cancelled claims 1, 13-15, 17,
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`18, 20 and 24-28 of the ’010 patent. Fresenius is not asserting any of claims 1, 13-15, 17, 18, 20
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`and 24-28 of the ’010 patent in this action. The remaining claims of the ’010 patent are, and
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`remain, valid and enforceable.
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`The Diprivan® Drug Product
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`37.
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`Fresenius currently sells, promotes, distributes and markets Diprivan® (propofol)
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`injectable emulsion in the United States.
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`38.
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`Diprivan® is indicated, generally speaking, for the induction and maintenance of
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`general anesthesia and sedation in certain patient populations.
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`39.
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`Fresenius holds an approved New Drug Application (“NDA”) No. 19627, under
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`Section 505(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(a), for and in
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`connection with the Diprivan® (propofol) injectable emulsion product containing 10 mg propofol
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`per 1 mL of emulsion.
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`Defendants’ ANDA
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`40.
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`Defendants filed with the FDA an ANDA, under 21 U.S.C. § 355(j) (“Defendants’
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`ANDA”), seeking approval to manufacture, use, offer for sale, sell in and import into the United
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`States Defendants’ generic Diprivan® products (Propofol Injectable Emulsion USP, 10 mg/mL, in
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`20 mL, 50 mL and 100 mL single-dose vials), prior to the expiration of the ʼ010 patent.
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`41.
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`The FDA assigned Defendants’ ANDA the number 217525.
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`42.
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`Defendants filed with FDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), a
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`certification alleging that the claims of the ʼ010 patent are invalid, unenforceable and/or would not
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`be infringed by the manufacture, use, importation, sale or offer for sale of Defendants’ generic
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`Diprivan® products (“Defendants’ Paragraph IV Certification”). Defendants notified Fresenius of
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`Defendants’ Paragraph IV Certification in their Notice Letter, dated June 28, 2023, sent by United
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`Parcel Service.
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`43.
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`This action is being commenced within forty-five (45) days of Fresenius’ receipt of
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`Defendants’ Notice Letter.
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`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,476,010
`BY DEFENDANTS
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`The allegations of paragraphs 1-43 are realleged and incorporated herein by
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`44.
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`reference.
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`45.
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`Defendants have infringed the ʼ010 patent by submitting and maintaining
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`Defendants’ ANDA to and before FDA seeking approval to market Defendants’ generic Diprivan®
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`products before the expiration of the ʼ010 patent.
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`46.
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`The use of Defendants’ generic Diprivan® products is covered by one or more
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`claims of the ʼ010 patent literally and/or under the doctrine of equivalents.
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`47.
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`Upon information and belief, the commercial manufacture, use, offer for sale, sale,
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`marketing, distribution and/or importation of Defendants’ generic Diprivan® products would
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`infringe one or more claims of the ʼ010 patent, for example, at least claim 21 of the ’010 patent.
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`48.
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`Claim 21, which depends directly from claim 1, claims and is directed to: a sterile
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`pharmaceutical composition of propofol in a container, comprising: a container which includes a
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`closure and a composition in the container, and the composition in the container comprising from
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`0.5% to 10% by weight propofol and from about 0 to about 10% by weight solvent for propofol,
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`where when the composition in the container sealed with the closure is agitated at a frequency of
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`300-400 cycles/minute for 16 hours at room temperature, the composition maintains a propofol
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`concentration (w/v) measured by HPLC that is at least 93% of the starting concentration (w/v) of
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`the propofol; where the closure is selected from the group consisting of siliconized bromobutyl
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`rubber, metal, and siliconized chlorobutyl rubber; and wherein the closure also comprises metal.
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`49.
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`Upon information and belief, Defendants’ generic Diprivan® products comprise: a
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`sterile pharmaceutical composition of propofol in a container; a container which includes a closure
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`and a composition in the container; a composition in the container comprising from 0.5% to 10%
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`by weight propofol and from about 0 to about 10% by weight solvent for propofol, where when
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`the composition in the container sealed with the closure is agitated at a frequency of 300-400
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`cycles/minute for 16 hours at room temperature, the composition maintains a propofol
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`concentration (w/v) measured by HPLC that is at least 93% of the starting concentration (w/v) of
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`the propofol; a closure selected from the group consisting of siliconized bromobutyl rubber, metal,
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`and siliconized chlorobutyl rubber; and wherein the closure also comprises metal.
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`50.
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`Defendants’ Notice Letter does not contest, or otherwise assert any grounds
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`challenging, the validity or enforceability of claim 21 of the ’010 patent.
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`51.
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`Defendants were aware of the ʼ010 patent prior to the submission of Defendants’
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`ANDA and were further aware that filing Defendants’ ANDA with Defendants’ Paragraph IV
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`Certification constituted an act of infringement of the ’010 patent.
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`52.
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`Upon information and belief, Defendants intend to engage, or direct or induce
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`others to engage, in the manufacture, use, offer for sale, sale, marketing, distribution and/or
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`importation of Defendants’ generic Diprivan® products immediately and imminently upon
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`approval of Defendants’ ANDA.
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`53.
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`The foregoing actions by Defendants constitute and/or would constitute direct,
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`induced and/or contributory infringement of the ʼ010 patent.
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`54.
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`Fresenius will be substantially and irreparably harmed by Defendants’ infringing
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`activities unless the Court enjoins those activities. Fresenius will have no adequate remedy at law
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`if Defendants are not enjoined from the commercial manufacture, use, offer to sell, sale in and
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`importation into the United States of Defendants’ generic Diprivan® products.
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`COUNT II FOR DECLARATORY JUDGMENT OF INFRINGEMENT OF
`U.S. PATENT NO. 8,476,010 BY DEFENDANTS
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`55.
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`The allegations of paragraphs 1-54 are realleged and incorporated herein by
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`
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`reference.
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`56.
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`Upon information and belief, Defendants plan to begin manufacturing, marketing,
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`selling, offering to sell and/or importing Defendants’ generic Diprivan® products soon after FDA
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`approval of Defendants’ ANDA.
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`57.
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`Upon information and belief, such conduct will constitute direct or indirect
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`infringement of one or more claims of the ’010 patent under 35 U.S.C. § 271.
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`58.
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`Defendants’ infringing activity complained of herein is imminent and will begin
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`following FDA approval of Defendants’ ANDA.
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`59.
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`As a result of the foregoing facts, there is a real, substantial and continuing
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`justiciable controversy between Fresenius and Defendants as to liability for infringement of the
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`’010 patent. Defendants’ actions have created in Fresenius a reasonable apprehension of
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`irreparable harm and loss resulting from Defendants’ threatened imminent actions.
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`60.
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`Fresenius will be irreparably harmed if Defendants are not enjoined from infringing
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`the ’010 patent.
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`PRAYER FOR RELIEF
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`WHEREFORE, Fresenius respectfully requests the following relief:
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`a.
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`A judgment that Defendants’ submission of Defendants’ ANDA No. 217525
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`infringes one or more claims of the ʼ010 patent and that the making, using, offering to sell or
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`selling in the United States, or importing into the United States of Defendants’ generic
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`Diprivan® products prior to the expiration of the ʼ010 patent will infringe one or more claims
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`of the ʼ010 patent;
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`b.
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`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date
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`of any FDA approval of Defendants’ ANDA No. 217525 seeking approval to manufacture, use,
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`offer for sale, sell in and import into the United States Defendants’ generic Diprivan® products
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`or any product or compound the use of which infringes the ʼ010 patent, shall be a date that is
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`not earlier than the expiration of the ’010 patent, including any period of pediatric exclusivity;
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`c.
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`An Order permanently enjoining Defendants and all persons acting in concert
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`with Defendants from commercially manufacturing, using, offering for sale, selling, marketing,
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`distributing or importing Defendants’ generic Diprivan® products, or any other product or
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`compound the use of which infringes the ʼ010 patent, or inducing or contributing to the
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`infringement of the ʼ010 patent, until after the expiration of the ’010 patent;
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`d.
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`An Order enjoining Defendants and all persons acting in concert with
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`Defendants from seeking, obtaining or maintaining approval of Defendants’ ANDA No.
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`217525 before the expiration of the ʼ010 patent;
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`e.
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`An award of Fresenius’ damages or other monetary relief to compensate
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`Fresenius if Defendants engage in the commercial manufacture, use, offer to sell, sale or
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`marketing or distribution in, or importation into, the United States of Defendants’ generic
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`Diprivan® products, or any product or compound the use of which infringes the ʼ010 patent,
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`prior to the expiration of the ʼ010 patent in accordance with 35 U.S.C. § 271(e)(4)(C);
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`f.
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`g.
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`An award of Plaintiff’s reasonable costs and expenses in this action; and
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`An award of any further and additional relief to Plaintiff as this Court deems just
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`and proper, including attorneys’ fees under 35 U.S.C. § 285 if supported by the totality of the
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`circumstances.
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`
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`Dated: August 11, 2023
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`Respectfully submitted,
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`/s/ Eric I. Abraham
`ERIC I. ABRAHAM
`
`
`HILL WALLACK LLP
`21 Roszel Road
`Princeton, New Jersey 08543
`(609) 924-0808
`(609) 452-1888 (Fax)
`Email: eia@hillwallack.com
`
`OF COUNSEL:
`
`William A. Rakoczy (wrakoczy@rmmslegal.com)
`Steven J. Birkos (sbirkos@rmmslegal.com)
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL 60654
`(312) 527-2157
`
`Attorneys for Plaintiff Fresenius Kabi USA, LLC
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`13
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