Litigation Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (D. Del. 2020)

United Therapeutics Corporation v. Liquidia Technologies, Inc. (D. Del. 2020)

Docket		Date Filed	2020-06-04
Court	District Court, D. Delaware	Date Terminated	2022-09-09
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To	Jennifer L. Hall
Parties	LIQUIDIA TECHNOLOGIES, INC.
Patents	10,376,525; 10,716,793; 10,744,280; 11,826,327; 4,006,094; 4,025,645; 6,458,462; 6,521,212; 6,756,033; 6,765,117; 7,417,070; 7,544,713; 7,999,007; 8,067,025; 8,114,021; 8,497,393; 9,108,015; 9,339,507; 9,358,240; 9,567,578; 9,593,066; 9,604,901
Attorneys	William C. Jackson
Firms	Shaw Keller LLP, DE
Link to Docket	External link to docket

Biologic Drugs cited in United Therapeutics Corporation v. Liquidia Technologies, Inc.

Details for United Therapeutics Corporation v. Liquidia Technologies, Inc. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-06-04				External link to document
2020-06-04	11	Answer to Complaint AND Counterclaim	UTC’s U.S. Patent No. 8,497,393, finding that the product claimed in the ʼ393 patent was not novel … UTC’s U.S. Patent No. 8,497,393, finding that the product claimed in the ʼ393 patent was not novel …assert a patent infringement action. Liquidia admits that U.S. Patent No. 9,593,066 (the “’066 patent”) and… and U.S. Patent No. 9,604,901 (the “’901 patent”) (collectively the “patents-in-suit”) each bear the…the ’066 patent is a product-by-process patent, and that the product claimed in the ’066 patent is novel	External link to document
2020-06-04	16	Complaint - Amended	seq., involving United States Patent Nos. 9,593,066 (“the ’066 patent”) (attached as Exhibit A hereto…to the expiration of the ’066 patent, the ’901 patent, and the ’793 patent, to manufacture, market, and… or more claims of the ’066 patent, the ’901 patent, and the ’793 patent, which have been listed in …Liquidia has infringed the ’066 patent, the ’901 patent, and the ’793 patent; and…more of the ’066 patent, the ’901 patent, and the ’793 patent, prior to the expiration	External link to document
2020-06-04	108	Redacted Document	the validity of patents related to the Patents-in-Suit, such as U.S. Patent Nos. 8,497,393 (“the ’393…concerning [U.S. Patent No. 8,497,393] in association with the ’901 and ’066 patents,” asserting that…concerning the Related Patents and Applications, including U.S. Patent Nos. 8,497,393; 9,339,507; 9,358,…PTAB's 4 The '393 patent is U.S. Patent No. 8,497,393. Case 1:20-cv-00755-RGA-JLH Document…Hatch‐Waxman litigation involving the Patents‐in‐Suit and U.S. Patent Nos. 8,497,393; 9,339,507; and 9,358,240,	External link to document
2020-06-04	109	Ex. 1 - Second Amended Complaint	seq., involving United States Patent Nos. 9,593,066 (“the ’066 patent”) (attached as Exhibit A hereto…the expiration of the ’066 patent, the ’901 patent, and the ’793 patent, to manufacture, market, and… more claims of the ’066 patent, the ’901 patent, and the ’793 patent, which have been listed in …Liquidia has infringed the ’066 patent, the ’901 patent, and the ’793 patent; and …or more of the ’066 patent, the ’901 patent, and the ’793 patent, prior to the expiration	External link to document
2020-06-04	117	Proposed Order	claims of U.S. Patent Nos. 8,593,066 (the “’066 patent”) and 9,604,901 (the “’901 patent”), the terms…range of 15°C to 30°C) ’066 patent, claims 6 and 8; ’901 patent, claim 6 “stored” / “storing…and ordinary meaning ’066 patent, claims 6 and 8; ’901 patent, claim 6 1 The Court… plain and ordinary meaning ’066 patent, claims 1 and 8 “ambient temperature” …treprostinil,” appearing in claims 1 and 8 of the ʼ901 patent, but will issue its order regarding these terms	External link to document
2020-06-04	125	Joint Claim Construction Brief	in IPR2020-00770 regarding U.S. Patent No. 9,604,901 (“the ’901 patent”) (Paper 29, Joint Paper Concerning…statements made in the [Patent Owner’s Response] suggesting that the ’901 patent requires that treprostinil…expressly rejected by the Patent Office,” making the record clear to POSAs “that Patent Owner’s arguments …withdrawal of certain statements made before the Patent Trial and Appeal Board (“PTAB” or “Board”) in…Concerning Petitioner’s Request to Strike Portions of Patent Owner’s Paper Nos. 12 and 25 and Exhibits 2002	External link to document

United Therapeutics Corporation v. Liquidia Technologies, Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between United Therapeutics Corporation (UTC) and Liquidia Technologies, Inc. is a complex and multifaceted case involving patent infringement, validity, and the launch of a new pharmaceutical product. Here, we will delve into the key aspects of this litigation, including the patents in question, the court decisions, and the implications for both parties.

Background

United Therapeutics Corporation, a leading company in the development of treatments for pulmonary hypertension, filed a lawsuit against Liquidia Technologies, Inc. in September 2020 (Case No. 1:20-cv-00755). The lawsuit alleged that Liquidia's product, YUTREPIA (treprostinil) inhalation powder, would infringe several of UTC's patents.

Patents in Question

The litigation centers around two main patents held by UTC: the ’066 and ’793 patents. These patents relate to methods and compositions for treating pulmonary hypertension.

• ’793 Patent: This patent includes claims related to treating pulmonary hypertension with a therapeutically effective dose of treprostinil. The district court found that claims 1, 4, and 6-8 of this patent were not invalid and were infringed by Liquidia[1].
• ’066 Patent: The district court determined that claims 1-3 of this patent were invalid as anticipated, but otherwise infringed by Liquidia[1].

District Court Decisions

The district court made several key rulings:

• Infringement and Validity: The court found that Liquidia infringed certain claims of the ’793 patent but declared claims 1-3 of the ’066 patent invalid as anticipated[1].
• Safety and Efficacy: The court refused to read safety and efficacy limitations into the claims of the ’793 patent, stating that such concerns do not fall under the purview of the court unless specifically mentioned in the claims[1].

Appeals and Federal Circuit Decisions

Liquidia Technologies appealed the district court's decision, raising several issues:

• Claim Construction: Liquidia argued that the district court erred in construing the claim limitation “treating pulmonary hypertension” in claim 1 of the ’793 patent. However, the Federal Circuit affirmed the district court’s decision, rejecting the argument that safety and efficacy limitations should be implied[1].
• Enablement and Written Description: Liquidia also challenged the enablement and written description of the ’793 patent claims, which the Federal Circuit addressed but ultimately upheld the district court’s findings[1].
• Induced Infringement: The Federal Circuit reviewed and affirmed the district court’s finding that Liquidia was liable for induced infringement of certain claims of the ’793 patent[1].

UTC raised cross-appeal issues, including the district court’s findings on the infringement and validity of certain claims of the ’066 patent. The Federal Circuit addressed these issues, affirming some and reversing others[1].

Preliminary Injunction and Recent Developments

In a significant recent development, United Therapeutics sought a preliminary injunction to block the launch of YUTREPIA, which was denied by Judge Richard G. Andrews in May 2024. This ruling allowed Liquidia to proceed with the launch of YUTREPIA while the case moves forward to trial, currently scheduled for June 2025[4][5].

Implications

The denial of the preliminary injunction is crucial for Liquidia, as it allows the company to continue its efforts to bring YUTREPIA to market. YUTREPIA is an investigational inhaled dry powder formulation of treprostinil, designed for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH)[5].

Legal and Regulatory Context

The case highlights the complex interplay between patent law and regulatory approvals in the pharmaceutical industry. The FDA's tentative approval of YUTREPIA for the PAH indication and the ongoing clinical trials for PH-ILD underscore the regulatory landscape in which this litigation is unfolding[5].

Quotes and Insights from Industry Experts

As noted by legal experts, the Federal Circuit's decision to not imply safety and efficacy limitations into patent claims is significant. For instance:

"We decline to insert the FDA’s responsibilities into claims by importing requirements [of safety and efficacy] where they do not recite such limitations."[1]

This stance emphasizes the importance of clear and specific claim language in patent litigation.

Statistics and Market Impact

The outcome of this litigation could have substantial market implications. For example, if Liquidia successfully launches YUTREPIA, it could capture a significant share of the pulmonary hypertension treatment market, potentially impacting UTC's market position.

Key Takeaways

• Patent Infringement: Liquidia was found to infringe certain claims of UTC's ’793 patent, while claims of the ’066 patent were partially invalidated.
• Safety and Efficacy: The Federal Circuit refused to imply safety and efficacy limitations into the patent claims.
• Preliminary Injunction: The denial of the preliminary injunction allows Liquidia to proceed with the launch of YUTREPIA.
• Regulatory Approvals: The case is closely tied to FDA approvals and ongoing clinical trials.
• Market Impact: The outcome could significantly affect the market share and competitive landscape in pulmonary hypertension treatments.

FAQs

Q: What are the main patents involved in the litigation between United Therapeutics and Liquidia Technologies? A: The main patents are the ’066 and ’793 patents, which relate to methods and compositions for treating pulmonary hypertension.

Q: What was the district court's decision regarding the infringement and validity of the patents? A: The district court found that Liquidia infringed certain claims of the ’793 patent and that claims 1-3 of the ’066 patent were invalid as anticipated.

Q: Why did the Federal Circuit refuse to imply safety and efficacy limitations into the patent claims? A: The Federal Circuit refused to imply these limitations because they were not explicitly mentioned in the claims, and it is not the court's role to insert FDA responsibilities into patent claims.

Q: What was the outcome of United Therapeutics' motion for a preliminary injunction against Liquidia? A: The motion was denied, allowing Liquidia to proceed with the launch of YUTREPIA.

Q: How does this litigation impact the market for pulmonary hypertension treatments? A: The outcome could significantly affect the market share and competitive landscape, particularly if Liquidia successfully launches YUTREPIA.

Sources

1. Haug Partners, "Takeaways From United Therapeutics Corporation v. Liquidia Technologies Incorporated," July 24, 2023.
2. United States Court of Appeals for the Federal Circuit, "UNITED THERAPEUTICS CORPORATION v. LIQUIDIA TECHNOLOGIES, INC.," June 27, 2024.
3. Justia Law, "UNITED THERAPEUTICS CORPORATION v. LIQUIDIA TECHNOLOGIES, INC.," October 10, 2024.
4. Cooley, "Cooley Defeats Preliminary Injunction for Liquidia in Litigation With United Therapeutics," June 3, 2024.
5. Liquidia Corporation, "District Court Issues Favorable Ruling and Denies United Therapeutics’ Request to Block YUTREPIA™ Launch," June 3, 2024.