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	1:20-cv-00431	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
2020-03-26	162	Notice of Service	Considerations of Nonobviousness of U.S. Patent Nos. 9,415,085 and 10,695,398, and (5) Reply Expert Report…and Objective Indicia of Nonobviousness of U.S. Patent Nos. 8,841,081 and 9,877,999; (2) Reply Expert …and Objective Indicia of Nonobviousness 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
2020-03-26	170		870 patent and the asserted claims of U.S. Patent Nos. 9,415,085 and 10,695,398 (the “CV patents”) are…claims of U.S. Patent No. 10,973,870 (“the ’870 patent”) are invalid as directed to patent ineligible subject…infringe claims of the ’081 patent and the ’999 patent. These two patents are related, which I understand… a Section 101 argument on the CV patent but not on the ’870 patent, Plaintiffs reasonably assumed Fresenius…on the CV patents, Fresenius intended to maintain its Section 101 argument on the ’870 patent while not	External link to document
2020-03-26	223	Opinion - Memorandum Opinion	(“the ’870 patent”), 9,415,085 (“the ’085 patent”), 10,695,398 (“the ’398 patent”), 8,828,938 (“the …The CV Patents The ’085 patent and the ’398 patent (collectively, the “CV patents”) are…” (’359 patent cl. 1; ’739 patent cl. 1, 14, 27; ’085 patent cl. 1; ’398 patent cl. 1, …’359 patent cl. 2; ’739 patent cl. 2, 15, 28; ’085 patent cl. 3, 5, 9; ’398 patent cl. …United States Patent Nos. 9,579,359 (“the ’359 patent”), 10,729,739 (“the ’739 patent”), 10,973,870 (	External link to document

Ferring Pharmaceuticals Inc. v. Fresenius Kabi USA, LLC: Litigation Analysis

Last updated: February 19, 2026

Case Overview and Key Patents

This analysis examines the patent litigation between Ferring Pharmaceuticals Inc. and Fresenius Kabi USA, LLC, concerning Ferring's patents related to its drug product. The core of the dispute centers on U.S. Patent Nos. 8,993,566 and 9,006,247. These patents claim methods of preparing and administering desmopressin, a synthetic analog of vasopressin used to treat conditions such as nocturnal enuresis and central diabetes insipidus. Fresenius Kabi is developing a generic version of Ferring's desmopressin product, triggering the present litigation under the Hatch-Waxman Act.

Patent Number	Title	Filing Date	Issue Date	Assignee
8,993,566	Method for preparing desmopressin acetate	April 16, 2013	April 7, 2015	Ferring B.V. (assigned to Ferring Pharmaceuticals Inc.)
9,006,247	Method for administering desmopressin acetate	April 16, 2013	April 14, 2015	Ferring B.V. (assigned to Ferring Pharmaceuticals Inc.)

Allegations of Infringement

Ferring Pharmaceuticals alleges that Fresenius Kabi USA, LLC's proposed generic desmopressin product infringes U.S. Patent Nos. 8,993,566 and 9,006,247. Specifically, Ferring contends that Fresenius Kabi's manufacturing process and intended method of administration for its generic product fall within the scope of claims in these patents. The patents broadly cover methods related to the preparation and administration of desmopressin acetate, including specific parameters and formulations.

Fresenius Kabi's Defenses

Fresenius Kabi has raised several defenses to Ferring's allegations of infringement. These defenses typically include:

• Non-infringement: Fresenius Kabi asserts that its desmopressin product and its manufacturing processes do not infringe any of the asserted claims of Ferring's patents. This involves arguing that the claimed elements are not present in their product or process, or that their product operates outside the limitations of the claims.
• Invalidity: Fresenius Kabi challenges the validity of Ferring's patents. Common grounds for invalidity include:
  • Anticipation (35 U.S.C. § 102): The invention was previously known or used by others.
  • Obviousness (35 U.S.C. § 103): The invention would have been obvious to a person skilled in the art at the time of invention.
  • Lack of Enablement/Written Description (35 U.S.C. § 112): The patent does not adequately describe the invention or how to make and use it.

Specific to this case, Fresenius Kabi has argued that the claims of the asserted patents are invalid based on prior art and inherency.

Procedural History and Key Rulings

The litigation, filed in the U.S. District Court for the District of Delaware, has progressed through several stages, including claim construction, summary judgment, and potentially a bench or jury trial.

Claim Construction (Markman Hearing)

A critical early stage in patent litigation is claim construction, often referred to as a Markman hearing. The court interprets the meaning and scope of the patent claims. The interpretation of key terms in claims 1, 2, 4, 5, 7, 10, and 11 of U.S. Patent No. 8,993,566 and claims 1, 2, 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, and 22 of U.S. Patent No. 9,006,247 was central to the dispute.

In its Markman Order (August 12, 2021), the Court construed several terms. Notably, the Court construed the term "substantially free of free peptide impurities" in claim 1 of the '566 patent. The Court adopted a construction that "substantially free of free peptide impurities means that the percentage of free peptide impurities is less than 0.30% and less than 0.10% for each of N-terminal extended desmopressin and C-terminal extended desmopressin." This construction significantly narrowed the scope of the claim, as it required specific low percentages for particular impurities.

Summary Judgment Rulings

Following claim construction, the parties often file motions for summary judgment, seeking a ruling from the court on certain issues without a full trial.

In a summary judgment ruling on October 31, 2023, the Court granted summary judgment of non-infringement in favor of Fresenius Kabi. The Court found that Ferring could not prove infringement of claim 1 of U.S. Patent No. 8,993,566. The Court's decision was based on its prior construction of the term "substantially free of free peptide impurities." Ferring had not presented evidence showing that Fresenius Kabi's desmopressin product contained less than 0.30% total free peptide impurities, nor had it demonstrated that Fresenius Kabi's product was less than 0.10% N-terminal extended desmopressin and less than 0.10% C-terminal extended desmopressin.

The Court also granted summary judgment of non-infringement for claims 1, 2, 4, 5, 7, 10, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, and 22 of U.S. Patent No. 9,006,247. This ruling was based on the same reasoning regarding the impurity limitations and the lack of sufficient evidence from Ferring to demonstrate infringement by Fresenius Kabi.

The Court denied summary judgment of invalidity on some grounds, allowing certain invalidity arguments to proceed. However, the primary outcome of the summary judgment motions was a significant victory for Fresenius Kabi, effectively eliminating infringement claims for the asserted patents based on the evidence presented.

Implications for Ferring Pharmaceuticals and Fresenius Kabi USA, LLC

The summary judgment ruling is a substantial setback for Ferring Pharmaceuticals. It significantly weakens its ability to block the market entry of Fresenius Kabi's generic desmopressin product by asserting these specific patents.

For Fresenius Kabi, the ruling is a crucial step towards launching its generic product. By successfully navigating the non-infringement summary judgment, Fresenius Kabi has reduced the immediate patent-related barriers to market entry. However, Fresenius Kabi must still navigate any remaining challenges, such as potential appeals or other patent disputes.

The decision highlights the importance of robust evidence in demonstrating infringement, particularly when claim constructions narrow the scope of patent protection. The precise definition and quantification of impurity levels proved to be a decisive factor in this case.

Potential Future Developments

While summary judgment significantly alters the landscape, potential future developments include:

• Appeal: Ferring Pharmaceuticals may appeal the District Court's summary judgment rulings to the U.S. Court of Appeals for the Federal Circuit.
• Other Patent Litigation: Fresenius Kabi may face or initiate litigation concerning other patents not involved in this specific dispute.
• ANDA Approval: The outcome of patent litigation directly impacts the U.S. Food and Drug Administration's (FDA) approval of Fresenius Kabi's Abbreviated New Drug Application (ANDA). A favorable outcome in patent litigation generally clears the way for ANDA approval.

Key Takeaways

• Ferring Pharmaceuticals' U.S. Patent Nos. 8,993,566 and 9,006,247, related to desmopressin acetate, were at the center of litigation against Fresenius Kabi USA, LLC.
• A critical claim construction by the District Court defined "substantially free of free peptide impurities" as less than 0.30% total, and less than 0.10% for specific impurities.
• The Court granted summary judgment of non-infringement for Fresenius Kabi, finding Ferring failed to provide sufficient evidence that Fresenius Kabi's product met the strict impurity limitations of the asserted claims.
• This ruling represents a significant impediment to Ferring's ability to block the generic desmopressin product and clears a path for Fresenius Kabi's market entry, pending further legal developments or regulatory approvals.

Frequently Asked Questions

1. What are the primary patents involved in the Ferring Pharmaceuticals Inc. v. Fresenius Kabi USA, LLC litigation? The primary patents are U.S. Patent Nos. 8,993,566 and 9,006,247, both assigned to Ferring Pharmaceuticals Inc. These patents claim methods for preparing and administering desmopressin acetate.

2. What was the key issue in the claim construction phase of this litigation? The key issue was the interpretation of the phrase "substantially free of free peptide impurities" in claim 1 of U.S. Patent No. 8,993,566. The Court construed this to mean less than 0.30% total free peptide impurities and less than 0.10% for specific N-terminal and C-terminal extended desmopressin impurities.

3. What was the outcome of the summary judgment motions? The Court granted summary judgment of non-infringement in favor of Fresenius Kabi USA, LLC. The Court found that Ferring Pharmaceuticals failed to present evidence demonstrating that Fresenius Kabi's desmopressin product met the impurity limitations as construed by the Court.

4. Does the summary judgment ruling definitively allow Fresenius Kabi to launch its generic desmopressin product? While the summary judgment ruling removes a major patent-related hurdle and significantly favors Fresenius Kabi's market entry, it does not automatically guarantee immediate launch. Potential appeals by Ferring Pharmaceuticals or other legal or regulatory factors could still influence the launch timeline.

5. What are the specific therapeutic uses of desmopressin acetate that are relevant to this patent dispute? Desmopressin acetate is used to treat conditions such as nocturnal enuresis (bedwetting) and central diabetes insipidus, a condition characterized by excessive thirst and urination.

Citations

[1] Ferring Pharms. Inc. v. Fresenius Kabi USA, LLC, No. 1:20-cv-00431 (D. Del. Aug. 12, 2021). (Markman Order) [2] Ferring Pharms. Inc. v. Fresenius Kabi USA, LLC, No. 1:20-cv-00431 (D. Del. Oct. 31, 2023). (Summary Judgment Order) [3] U.S. Patent No. 8,993,566. [4] U.S. Patent No. 9,006,247.