Litigation Details for Ferring Pharmaceuticals Inc. v. Fresenius Kabi USA, LLC (D. Del. 2020)

Ferring Pharmaceuticals Inc. v. Fresenius Kabi USA, LLC (D. Del. 2020)

Docket		Date Filed	2020-03-26
Court	District Court, D. Delaware	Date Terminated	2023-01-30
Cause	35:271 Patent Infringement	Assigned To	Maryellen Noreika
Jury Demand	Plaintiff	Referred To
Parties	FERRING INTERNATIONAL CENTER S.A.
Patents	10,695,398; 10,729,739; 10,973,870; 11,040,032; 9,415,085; 9,579,359
Attorneys	Ben Bourke
Firms	Golo LLC
Link to Docket	External link to docket

Details for Ferring Pharmaceuticals Inc. v. Fresenius Kabi USA, LLC (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-03-26				External link to document
2020-03-26	141	Order - -Memorandum and Order	of U.S. Patents Nos. 9,579,359 (“the ’359 Patent”), 10,729,739 (“the ’739 Patent”), 9,415,085 (“the ’…the ’081 Patent, the ’999 Patent, U.S. Patent No. 8,828,938 (“the ’938 Patent”), and U.S. Patent No. 10,973,870…359 Patent cl. 1; ’739 Patent cl. 1, 14, 27; ’085 Patent cl. 1; ’398 Patent cl.…claim terms of the ’359 Patent, the ’739 Patent, the ’085 Patent, the ’398 Patent, Case 1:20-cv-00431-MN… The ’359 Patent, ’739 Patent, and ’870 Patent share a first specification, the ’085 Patent and	External link to document
2020-03-26	157	Notice of Service	Objective Evidence of Non-Obviousness of U.S. Patent Nos. 9,415,085 and 10,695,398; (4) Opening Expert Report…F.A.C.S. Regarding Infringement of U.S. Patent Nos. 9,415,085 and 10,695,398; (5) Opening Expert Report…Regarding Objective Evidence of Non-Obviousness of U.S. Patent Nos. 9,579,359, 10,729,739, and 10,973,870; (6)…Shore, M.D., FACS Regarding Infringement of U.S. Patent Nos. 9,579,359, 10,729,739, and 10,973,870; (7)…on Objective Evidence of Non-Obviousness of U.S. Patent Nos. 8,841,081 and 9,877,999, and (8) Opening Expert	External link to document
2020-03-26	159	Notice of Service	F.R.C.S.I., F.A.C.S. Regarding Validity of U.S. Patent Nos. 9,415,085 and 10,695,398, and (4) Rebuttal Expert …. Higano, M.D., FACP Regarding Validity of U.S. Patent Nos. 8,841,081 and 9,877,999; (2) Rebuttal Expert…D. Shore, M.D., FACS Regarding Validity of U.S. Patent Nos. 9,579,359, 10,729,739, and 10,973,870; (3)…2020 30 January 2023 1:20-cv-00431 835 Patent - Abbreviated New Drug Application(ANDA) Plaintiff	External link to document

Ferring Pharmaceuticals Inc. v. Fresenius Kabi USA, LLC: A Comprehensive Litigation Summary and Analysis

Overview of the Case

The litigation between Ferring Pharmaceuticals Inc. and Fresenius Kabi USA, LLC revolves around patent infringement claims related to Ferring's drug product, Firmagon® (degarelix acetate), which is used for the treatment of advanced prostate cancer. Here is a detailed breakdown of the case.

Parties Involved

• Plaintiffs: Ferring Pharmaceuticals Inc., Ferring International Center S.A., Ferring B.V., and Polypeptide Laboratories A/S.
• Defendant: Fresenius Kabi USA, LLC, a wholly-owned subsidiary of Fresenius Kabi AG[1][3][4].

Nature of the Case

This is a Hatch-Waxman action, a type of litigation that arises when a generic drug manufacturer files an Abbreviated New Drug Application (ANDA) with the FDA, challenging the patents of a brand-name drug. In this case, Fresenius Kabi USA, LLC filed an ANDA seeking approval to market a generic version of Firmagon®[2][4].

Patents-in-Suit

The litigation involves several U.S. patents held by Ferring, including:

• U.S. Patent No. 9,579,359 (the '359 patent)
• U.S. Patent No. 10,729,739 (the '739 patent)
• U.S. Patent No. 10,973,870 (the '870 patent)
• U.S. Patent No. 9,415,085 (the '085 patent)
• U.S. Patent No. 10,695,398 (the '398 patent)
• U.S. Patent No. 8,828,938 (the '938 patent)[2][4].

Claims and Allegations

Ferring alleged that Fresenius Kabi's ANDA product would infringe several of its patents. Specifically, Ferring claimed that Fresenius Kabi's actions would induce infringement of the '359 and '739 patents, which relate to the reduction of side effects associated with the use of degarelix acetate. Ferring also alleged infringement of the '938 patent and disputed the validity of the '870, '085, and '398 patents[2][4].

Court Findings

After a four-day bench trial and post-trial briefing, the court made several key findings:

• Infringement of '359 and '739 Patents: The court concluded that Fresenius Kabi would induce infringement of claims 3 and 13 of the '359 patent and claims 16 and 26 of the '739 patent. However, it also found that these patents were invalid for obviousness based on prior art that taught splitting the initiation dose of degarelix acetate into two subcutaneous injections[2][4].

• Non-Infringement of '870, '085, and '398 Patents: The court found that Ferring did not prove that Fresenius Kabi would infringe the '870, '085, or '398 patents. Specifically, the court agreed with Fresenius Kabi that its ANDA label did not instruct healthcare providers to select patients based on their cardiovascular history or to reduce cardiovascular events[2][4].

• Validity of Patents: Fresenius Kabi successfully argued that the '359 and '739 patents were invalid due to obviousness. The court found that the prior art provided ample evidence that a skilled artisan would have an expectation of success in administering the initiation dose in two injections. Secondary considerations presented by Ferring were deemed insufficient to overcome the obviousness finding[4].

Personal Jurisdiction

The court also determined that it had personal jurisdiction over Fresenius Kabi USA, LLC due to its continuous and systematic contacts within the State of Delaware. These contacts included the filing of patent infringement actions, the development and sale of FDA-approved generic pharmaceuticals, and the intention to market and sell the ANDA product in Delaware[1][3].

Appeal

The case is currently on appeal at the U.S. Court of Appeals for the Federal Circuit, with Ferring Pharmaceuticals Inc. and Fresenius Kabi USA, LLC filing appeals related to the district court's findings[5].

Key Takeaways

• Patent Infringement: Fresenius Kabi's ANDA product was found to induce infringement of certain Ferring patents, but those patents were deemed invalid.
• Obviousness: The court's ruling highlights the importance of prior art in determining the validity of patents.
• Jurisdiction: The case underscores the significance of a defendant's activities within a jurisdiction for establishing personal jurisdiction.
• Hatch-Waxman Litigation: This case illustrates the complexities and challenges involved in Hatch-Waxman actions, particularly in the pharmaceutical industry.

FAQs

Q: What is the main issue in the Ferring Pharmaceuticals Inc. v. Fresenius Kabi USA, LLC litigation?

A: The main issue is whether Fresenius Kabi's ANDA product infringes Ferring's patents related to the drug Firmagon® (degarelix acetate).

Q: Which patents were found to be infringed by Fresenius Kabi?

A: The court found that Fresenius Kabi would induce infringement of claims 3 and 13 of the '359 patent and claims 16 and 26 of the '739 patent.

Q: Why were the '359 and '739 patents deemed invalid?

A: These patents were found to be invalid for obviousness based on prior art that taught the same method of administering the initiation dose of degarelix acetate.

Q: Did the court find any other patents to be infringed?

A: No, the court did not find infringement of the '870, '085, or '398 patents.

Q: What is the current status of the case?

A: The case is on appeal at the U.S. Court of Appeals for the Federal Circuit.

Cited Sources

1. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE FERRING PHARMACEUTICALS INC., FERRING INTERNATIONAL CENTER S.A., FERRING B.V., and POLYPEPTIDE LABORATORIES A/S Plaintiffs, v. FRESENIUS KABI USA, LLC, Defendant. [PDF]
2. Ferring Pharm. v. Fresenius Kabi U.S., 645 F. Supp. 3d 335 - Casetext
3. Case 1:20-cv-00431-MN Document 58 Filed 11/16/20 Page 1 of 53 ...
4. Ferring Pharms. Inc. v. Fresenius Kabi USA, LLC - JD Supra
5. Ferring Pharmaceuticals Inc. v. Fresenius Kabi USA, LLC 23-1559