Litigation Details for UNITED THERAPEUTICS CORPORATION v. FOOD AND DRUG ADMINISTRATION (D.D.C. 2024)

UNITED THERAPEUTICS CORPORATION v. FOOD AND DRUG ADMINISTRATION (D.D.C. 2024)

Docket		Date Filed	2024-02-20
Court	District Court, District of Columbia	Date Terminated	2024-08-20
Cause	05:0706 Judicial Review of Agency Actions	Assigned To	John D. Bates
Jury Demand	None	Referred To
Patents	10,376,525; 10,716,793; 11,723,887; 11,826,327; 8,497,393; 9,339,507; 9,358,240; 9,593,066; 9,604,901
Link to Docket	External link to docket

Details for UNITED THERAPEUTICS CORPORATION v. FOOD AND DRUG ADMINISTRATION (D.D.C. 2024)

Date Filed	Document No.	Description	Snippet	Link To Document
2024-02-20				External link to document
2024-02-20	1	Complaint	17 of 35 ’507 patent”), 9,358,240 (“the ’240 patent”), 8,497,393 (“the ’393 patent”), 9,593,066 (“the…066 patent, the ’901 patent, the ’793 patent, and U.S. Patent No. 10,376,525 (“the ’525 patent”). See United… Patent Data Patent No. Patent Drug Drug Patent Delist …to FDA regarding U.S. Patent No. 10,716,793 (“the ’793 patent”). The ’793 patent was timely submitted …Orange Book patent information for TYVASO—specifically, to the ’507 patent, the ’240 patent, the ’066	External link to document
2024-02-20	12	Exhibit A	of1835of 36 ’507 patent”), 9,358,240 (“the ’240 patent”), 8,497,393 (“the ’393 patent”), 9,593,066 (“the…066 patent, the ’901 patent, the ’793 patent, and U.S. Patent No. 10,376,525 (“the ’525 patent”). See United… Patent Data Patent No. Patent Drug Drug Patent Delist …to FDA regarding U.S. Patent No. 10,716,793 (“the ’793 patent”). The ’793 patent was timely submitted …Orange Book patent information for TYVASO—specifically, to the ’507 patent, the ’240 patent, the ’066	External link to document
2024-02-20	23	Exhibit 3	Orange Book patents — U.S. Patent Nos. 9,339,507 (“’507 patent”), 9,358,240 (“ʼ240 patent”), 9,593,066…Letter points to three patents, the ’793 patent, the ’887 patent, and the ’327 patent, all issuing after …act of patent infringement” of the applicable patent(s) at issue, which in turn can trigger patent infringement…Orange Book patents for TYVASOTM: the ʼ507, ʼ240, ʼ066, ʼ901, ʼ793 patents and U.S. Patent No. 10,376,…regarding the ʼ887 patent. On November 28, 2023, U.S. Patent No. 11,826,327 (“’327 patent”) issued to	External link to document
2024-02-20	24	Memorandum in Opposition	YUTREPIA would infringe two of UTC’s patents—U.S. Patent No. 9,593,066 (“’066 …/18/24 Page 18 of 53 patent”) and U.S. Patent No. 9,604,901 (“’901 patent”). See Compl. ¶ 49. After…action, UTC was issued a new patent, U.S. Patent No. 10,716,793 (the “’793 patent’”), and amended its complaint…was issued a new patent related to PH-ILD, U.S. Patent No. 11,826,327 (“’327 patent”); UTC amended its…NDA may still require patent certifications and may, in turn, generate new patent litiga- tion, the amendment	External link to document
2024-02-20	38	Memorandum in Support	infringe two of UTC’s patents—U.S. Patent No. 9,593,066 (“the ’066 patent”) and U.S. Patent No. 9,604,901 (…the only patent at issue in UTC’s second patent suit is UTC’s newest patent, the ʼ327 patent. See Compl… implicate new patents, old patents, or no patents, must be accompanied by new patent certifications.…(“the ’901 patent”). After UTC filed its suit, UTC was issued another patent, U.S. Patent No. 10,716,…the ’901 patent. And the Patent Trial and Appeal Board invalidated all claims of the ’793 patent, a ruling	External link to document

UNITED THERAPEUTICS CORPORATION v. FOOD AND DRUG ADMINISTRATION: A Comprehensive Litigation Summary and Analysis

Case Overview

The case of United Therapeutics Corporation v. Food and Drug Administration (Case Number: 1:24-cv-00484) is a significant legal battle involving patent litigation, regulatory disputes, and the approval process of pharmaceutical products. Here is a detailed summary and analysis of the key points in this case.

Background

United Therapeutics Corporation (UTC) is a pharmaceutical company that has been involved in a long-standing patent dispute with Liquidia Technologies, Inc. over the drug treprostinil, which UTC markets under the brand name Tyvaso. Tyvaso is used to treat pulmonary hypertension, including pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)[5].

Nature of the Suit

The lawsuit filed by UTC against the Food and Drug Administration (FDA) and other defendants, including the U.S. Department of Health and Human Services and its officials, falls under the Administrative Procedure Act (APA) for the review or appeal of an agency decision. UTC is challenging the FDA's decision to allow Liquidia to amend its pending drug application for Yutrepia, a competing version of treprostinil, rather than requiring a new submission[4][5].

Key Issues

Amendment vs. New Submission

UTC argues that the FDA erred by allowing Liquidia to amend its existing application to include a new indication for PH-ILD instead of requiring a new drug application (NDA). This amendment process, according to UTC, allows Liquidia to bypass the 30-month stay that would be triggered if a new NDA were filed, which is a period during which the FDA cannot approve a drug application that is the subject of a patent infringement claim[5].

Patent Litigation

The underlying patent dispute between UTC and Liquidia involves several patents, including the ’793 and ’066 patents. The district court had previously found that Liquidia's Yutrepia would infringe certain claims of these patents, but also found some claims to be invalid due to anticipation by prior art (Moriarty)[1].

Injunction and Exclusivity

UTC sought a permanent injunction to prevent the FDA from approving Liquidia's Yutrepia, arguing that the patent infringement and the FDA's rules regarding market exclusivity should prevent Liquidia's product from entering the market. However, the court denied this injunction, stating that UTC was effectively seeking to challenge an agency action before the FDA made one[4].

Court Decisions and Appeals

District Court Decision

The D.C. federal judge denied UTC's request for an injunction, ruling that the company was prematurely challenging the FDA's action. The court held that the FDA had not yet made a final decision on Liquidia's amended application, and thus, there was no agency action to review[4].

Federal Circuit and Supreme Court

In related litigation, the Federal Circuit had upheld the invalidity of certain UTC patents, and the Supreme Court denied UTC's certiorari petition, effectively ending the patent litigation battle and rendering the Federal Circuit appeal moot[3].

Liquidia's Actions and Counterarguments

Liquidia argued that the FDA correctly applied its rules by allowing the amendment to the existing application. Liquidia also contended that maintaining an injunction based on an invalid patent is inequitable and contrary to the public interest. Additionally, Liquidia has filed a separate lawsuit against the FDA, challenging the agency's decision to extend market exclusivity to UTC and thereby preventing competition from Yutrepia[3][5].

Analysis and Implications

• Regulatory Consistency: The case highlights the importance of consistent application of regulatory rules by the FDA. UTC's argument that the FDA should apply its own rules and precedents consistently underscores the need for clarity and predictability in the regulatory process.
• Patent Litigation: The ongoing patent disputes between UTC and Liquidia demonstrate the complexities and challenges in pharmaceutical patent litigation, particularly in cases involving generic or competing products.
• Market Exclusivity: The battle over market exclusivity and the timing of product approvals illustrates the competitive dynamics in the pharmaceutical industry and the significant stakes involved in these legal disputes.
• Public Interest: The case also raises questions about the balance between protecting intellectual property rights and serving the public interest by ensuring timely access to innovative treatments.

Key Takeaways

• UTC's lawsuit against the FDA challenges the agency's decision to allow Liquidia to amend its drug application rather than filing a new NDA.
• The underlying patent litigation involves complex issues of infringement and invalidity.
• The court's denial of the injunction reflects the need for a final agency action before judicial review.
• The case emphasizes the importance of regulatory consistency and the balance between intellectual property protection and public interest.

Frequently Asked Questions (FAQs)

Q: What is the main issue in the lawsuit filed by United Therapeutics Corporation against the FDA? A: The main issue is UTC's challenge to the FDA's decision to allow Liquidia to amend its pending drug application for Yutrepia instead of requiring a new submission.

Q: What is the significance of the 30-month stay in this context? A: The 30-month stay is a period during which the FDA cannot approve a drug application that is the subject of a patent infringement claim. UTC argues that Liquidia's amendment process avoids triggering this stay.

Q: What was the outcome of the district court's decision on UTC's request for an injunction? A: The district court denied UTC's request for an injunction, ruling that the company was prematurely challenging the FDA's action.

Q: How does the Supreme Court's decision impact the ongoing litigation? A: The Supreme Court's denial of UTC's certiorari petition effectively ends the patent litigation battle and renders the Federal Circuit appeal moot.

Q: What are the broader implications of this case for the pharmaceutical industry? A: The case highlights the importance of regulatory consistency, the complexities of patent litigation, and the balance between protecting intellectual property rights and serving the public interest.