Litigation Details for Heron Therapeutics, Inc. v. Fresenius Kabi USA, LLC (D. Del. 2022)

Heron Therapeutics, Inc. v. Fresenius Kabi USA, LLC (D. Del. 2022)

Docket		Date Filed	2022-07-27
Court	District Court, D. Delaware	Date Terminated	2024-12-09
Cause	35:271 Patent Infringement	Assigned To	William C. Bryson
Jury Demand	None	Referred To
Parties	HERON THERAPEUTICS, INC.
Patents	10,500,208; 10,624,850; 10,953,018; 11,173,118; 9,561,229; 9,808,465; 9,974,742; 9,974,793; 9,974,794
Attorneys	Anthony David Raucci
Firms	Smith, Katzenstein, & Jenkins LLP
Link to Docket	External link to docket

Details for Heron Therapeutics, Inc. v. Fresenius Kabi USA, LLC (D. Del. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-07-27				External link to document
2022-07-27	150	Order - Memorandum and Order	Hatch-Waxman Act patent case involving U.S. Patent Nos. 9,561,229 (“the ’229 patent”) and 9,974,794 (…the 229 patent is GRANTED. (4) Heron's motion for summary judgment of claims 111 of the 794 patent is DENIED… (“the ’794 patent”). Plaintiff Heron Therapeutics, Inc. is the owner of both patents. Heron moves for…all citations to the ’229 patent’s specification also apply to the ’794 patent at the same line and page…administration.” ’229 patent at col. 1, ll. 47–49. The asserted patents contain both composition	External link to document
2022-07-27	172	Miscellaneous Relief	inter alia, U.S. Patent Nos. 9,561,229 (“the ’229 patent”) and 9,974,794 (“the ’794 patent”) (collectively…with the additional patents asserted in Heron’s Complaint, “Heron’s Asserted Patents”), based on Fresenius… 9, 10, and 21 of the ’229 patent; and claims 9 and 10 of the ’794 patent; NOW THEREFORE, …1-8 and 11-20 of the ’229 patent or claims 1-8 and 11-21 of the ’794 patent. 2. Pursuant…infringes Heron’s Asserted Patents, except for claims 9, 10, and 21 of the ’229 patent, and claims 9 and 10	External link to document
2022-07-27	175	Redacted Document	Heron’s U.S. Patent Nos. 9,561,229 (“the ’229 patent”) (JTX-001) and 9,974,794 (“the ’794 patent”) (JTX-007…-007) (collectively, “patents-in-suit”). The inventions of the patents-in-suit paved the way for the …two patents: two claims narrowly directed to the formulation (claims 9 and 10 of the ’229 patent), one…formulation is the subject of the patents-in-suit. Heron’s patented formulation is an emulsion of aprepitant…which was considered by the Patent Office and never became an issued patent or covered any actual products—and	External link to document
2022-07-27	176	Redacted Document	(“the ’793 patent”), 10,500,208 (“the ’208 patent”), 10,624,850 (“the ’850 patent”), 10,953,018 (“the …asserting two patents in this litigation: United States Patent Nos. 9,561,229 (“the ’229 patent”) and 9,974,794…,974,794 (“the ’794 patent”) (collectively, “the patents-in- suit”). The patents-in-suit are listed in…asserted United States Patent Nos. 9,808,465 (“the ’465 patent”), 9,974,742 (“the ’742 patent”), 9,974,793 (“… This is an action alleging patent infringement arising under the patent laws of the United States,	External link to document

Heron Therapeutics, Inc. v. Fresenius Kabi USA, LLC: A Comprehensive Litigation Summary and Analysis

Background of the Litigation

The litigation between Heron Therapeutics, Inc. and Fresenius Kabi USA, LLC began in July 2022, when Fresenius submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a generic version of Heron's CINVANTI® (aprepitant) injectable emulsion. This move prompted Heron to file a patent infringement suit against Fresenius, alleging that the proposed generic product would infringe on Heron's patents related to CINVANTI®[2][4].

Key Patents in Dispute

The litigation centered around the validity and infringement of several patents held by Heron Therapeutics, specifically U.S. Patent Nos. 9,561,229 and 9,974,794. These patents, which are set to expire in 2035, cover the formulation and composition of CINVANTI® injectable emulsion, a critical antiemetic drug used to prevent chemotherapy-induced nausea and vomiting[2][4].

Court Proceedings and Ruling

The case was heard in the U.S. District Court for the District of Delaware, with Judge William C. Bryson presiding. The court's decision, announced on December 3, 2024, upheld the validity of Heron's patents and found that Fresenius' proposed generic product would indeed infringe on these patents. This ruling concluded the litigation initiated in July 2022[2][3][4].

Implications of the Ruling

The court's decision has significant implications for both parties involved:

• Market Exclusivity: The ruling ensures that Heron Therapeutics maintains market exclusivity for CINVANTI® until the patents expire in 2035, preventing Fresenius from launching a generic version during this period. This extends Heron's revenue stream from CINVANTI®, which is a vital part of their product portfolio[2][4].
• Financial Impact: The decision eliminates a major near-term threat to Heron's business model and cash flow. With the protection of their patents, Heron can continue to invest in research and development (R&D) and commercial operations without the immediate pressure of generic competition[2][4].
• Shareholder Value: The outcome is expected to provide significant shareholder value by ensuring long-term market exclusivity for CINVANTI®, a key product for Heron Therapeutics. The stock price of Heron Therapeutics reflected this positive news, with a notable increase in premarket trading following the announcement[4].

Future Actions and Appeals

Following the ruling, Heron Therapeutics plans to seek a court order to prevent Fresenius from launching its generic version of CINVANTI® until the patents expire in 2035. However, Fresenius has the option to appeal the decision, although such patent decisions are often upheld at the appellate level[2][4].

CEO's Statement

Craig Collard, CEO of Heron Therapeutics, expressed satisfaction with the outcome, stating, "We are pleased with the anticipated result of this case and will continue to vigorously defend the CINVANTI® patent estate in the future." He emphasized the strength of Heron's intellectual property and the importance of innovative drugs like CINVANTI® in serving patients with serious unmet needs[1][4].

Legal and Regulatory Context

The case falls under the Hatch-Waxman Act, which governs the approval of generic drugs and the resolution of patent disputes related to branded pharmaceuticals. The court's analysis and ruling were guided by this regulatory framework, ensuring that the intellectual property rights of Heron Therapeutics were protected while also considering the public interest in access to generic medications[5].

Conclusion and Key Takeaways

• Patent Validity: The U.S. District Court for the District of Delaware upheld the validity of Heron Therapeutics' patents related to CINVANTI®.
• Infringement: The court found that Fresenius' proposed generic product would infringe on Heron's patents.
• Market Exclusivity: Heron maintains market exclusivity for CINVANTI® until 2035.
• Financial Impact: The decision secures Heron's revenue stream and eliminates a significant threat to their business model.
• Future Actions: Heron will seek a court order to block Fresenius' generic launch, while Fresenius may appeal the decision.

Key Takeaways

• The ruling protects Heron Therapeutics' intellectual property and market exclusivity for CINVANTI® until 2035.
• This decision has substantial financial implications, securing Heron's revenue stream and allowing continued investment in R&D and commercial operations.
• The outcome highlights the importance of robust patent protection in the pharmaceutical industry.
• The case underscores the legal and regulatory framework governing patent disputes in the context of the Hatch-Waxman Act.

Frequently Asked Questions (FAQs)

Q: What was the basis of the litigation between Heron Therapeutics and Fresenius Kabi USA, LLC? A: The litigation was based on Fresenius' submission of an Abbreviated New Drug Application (ANDA) for a generic version of Heron's CINVANTI® injectable emulsion, which Heron alleged would infringe on their patents.

Q: Which patents were at the center of the dispute? A: The dispute centered around U.S. Patent Nos. 9,561,229 and 9,974,794, which cover the formulation and composition of CINVANTI®.

Q: What was the outcome of the court ruling? A: The U.S. District Court for the District of Delaware ruled in favor of Heron Therapeutics, upholding the validity of their patents and finding that Fresenius' proposed generic product would infringe on these patents.

Q: How does this ruling impact Heron Therapeutics and Fresenius Kabi USA, LLC? A: The ruling ensures Heron maintains market exclusivity for CINVANTI® until 2035, securing their revenue stream and preventing Fresenius from launching a generic version during this period.

Q: Can Fresenius appeal the decision? A: Yes, Fresenius has the option to appeal the decision, although such patent decisions are often upheld at the appellate level.

Cited Sources

1. PR Newswire: "U.S. District Court Upholds Validity of CINVANTI® Patents"
2. Stock Titan: "U.S. District Court Upholds Validity of CINVANTI® Patents"
3. RPX Insight: "Heron Therapeutics, Inc. v. Fresenius Kabi USA, LLC DC"
4. Nasdaq: "Heron Therapeutics Wins Patent Lawsuit Against Fresenius Kabi For CINVANTI"
5. District of Delaware: "22-985.pdf - District of Delaware"