Litigation Details for United Therapeutics Corporation v. ANI Pharmaceuticals, Inc. (D. Del. 2021)

United Therapeutics Corporation v. ANI Pharmaceuticals, Inc. (D. Del. 2021)

Docket		Date Filed	2021-04-01
Court	District Court, D. Delaware	Date Terminated	2022-05-26
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	UNITED THERAPEUTICS CORPORATION
Patents	7,417,070; 7,544,713; 8,252,839; 8,349,892; 8,410,169; 8,747,897; 9,050,311; 9,278,901; 9,393,203; 9,422,223; 9,593,066; 9,604,901
Attorneys	Karen Elizabeth Keller
Firms	Shaw Keller LLP
Link to Docket	External link to docket

Details for United Therapeutics Corporation v. ANI Pharmaceuticals, Inc. (D. Del. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-04-01				External link to document
2021-04-01	1	Complaint	seq., involving United States Patent Nos. 7,417,070 (“the ’070 patent”) (attached as Exhibit A hereto…the ’070 patent, the ’713 patent, ’839 patent, the ’892 patent, the ’169 patent, the ’897 patent, the ’…the ’070 patent, the ’713 patent, ’839 patent, the ’892 patent, the ’169 patent, the ’897 patent, the ’…the ’070 patent, the ’713 patent, ’839 patent, the ’892 patent, the ’169 patent, the ’897 patent, the ’…the ’070 patent, the ’713 patent, ’839 patent, the ’892 patent, the ’169 patent, the ’897 patent, the ’	External link to document
2021-04-01	16	Scheduling Order - Patent	United States Patent Nos. 7,417,070 (“the ’070 patent”), 7,544,713 (“the ’713 patent”), 8,252,839 (“…(“the ’839 patent”), 8,349,892 (“the ’892 patent”), 8,410,169 (“the ’169 patent”), 8,747,897 (“the ’897…’897 patent”), 9,050,311 (“the ’311 patent”), 9,278,901 (“the ’901 patent”), 9,393,203 (“the ’203 patent…United States Patent Nos. 9,593,066 (“the ’066 patent”) and 9,604,901 (“the ’4901 patent”) are asserted…patent”), and 9,422,223 (“the ’223 patent”) Case 1:21-cv-00489-RGA Document 16 Filed 06/23/21 Page 4 of	External link to document
2021-04-01	48	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,417,070 B2; 7,544,713 B2; 8,252,839… 2021 26 May 2022 1:21-cv-00489 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

United Therapeutics Corporation v. ANI Pharmaceuticals, Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between United Therapeutics Corporation (UTC) and ANI Pharmaceuticals, Inc. (ANI) revolves around patent infringement claims related to the drug treprostinil, which is used to treat pulmonary arterial hypertension. Here is a detailed summary and analysis of the key points in this case.

Background

United Therapeutics Corporation, a pharmaceutical and biotechnology company, developed and commercialized ORENITRAM® (treprostinil) Extended-Release Tablets, which are approved by the FDA for treating pulmonary arterial hypertension. ANI Pharmaceuticals, Inc. submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to manufacture, market, and sell generic copies of ORENITRAM® prior to the expiration of several patents held by UTC[3].

Patent Infringement Claims

UTC filed a lawsuit against ANI alleging that ANI's submission of the ANDA and its intention to commercially manufacture, use, sell, offer for sale, or import the generic treprostinil product would infringe several of UTC's patents. Specifically, UTC claimed that ANI's actions would directly infringe and induce infringement of various claims under 35 U.S.C. § 271(a), (b), (c), and (e)[3].

Patents in Question

The litigation involves multiple patents, including but not limited to the '070, '713, '839, '892, '169, '897, '311, '901, '203, '223, '066, and '4901 patents. ANI did not challenge the validity of most of these patents but did contend that certain claims were invalid or not infringed[3].

District Court Findings

Although the specific district court findings in the UTC vs. ANI case are not detailed in the provided sources, similar issues were addressed in the UTC vs. Liquidia Technologies case, which can provide some context.

• Infringement and Validity: In a similar case against Liquidia Technologies, the district court found that the proposed product would directly infringe certain claims of UTC's patents and also induce infringement. The court determined that the administration of the generic product would improve a patient's hemodynamics, thus infringing the relevant claims[1][4].

• Enablement and Written Description: The court also addressed issues of enablement and written description under 35 U.S.C. § 112. It found that the asserted claims were enabled and supported by adequate written description, contrary to the defendant's arguments[4].

Appeal and Cross-Appeal Issues

In the UTC vs. Liquidia case, which shares similar legal grounds, Liquidia raised several issues on appeal, including:

• Claim Construction: Liquidia argued that the district court erred in construing certain claim limitations.
• Enablement and Written Description: Liquidia contended that the court erred in finding the asserted claims enabled and supported by written description.
• Induced Infringement: Liquidia argued that it did not intend to induce infringement.
• Infringement of Specific Claims: Liquidia disputed the infringement findings for certain claims[4].

UTC, on cross-appeal, argued that the district court erred in finding that Liquidia did not infringe certain claims and that some claims were invalid as anticipated by prior art[4].

Relevance to ANI Pharmaceuticals Case

While the specific appeals and cross-appeals in the UTC vs. ANI case are not detailed, the issues raised in the UTC vs. Liquidia case are likely to be similar. ANI would likely argue that the patents are invalid or not infringed, and UTC would argue that ANI's actions constitute direct and induced infringement.

Industry Implications

This litigation highlights the critical importance of patent protection in the pharmaceutical industry. Companies like UTC rely on predictable patent rules to invest in research and development. The outcome of such cases can significantly impact the market entry of generic drugs and the financial stability of both innovator and generic drug manufacturers[5].

Key Takeaways

• Patent Infringement Claims: UTC alleged that ANI's ANDA submission and intended commercial activities would infringe multiple patents.
• Enablement and Written Description: The validity of patents often hinges on whether they meet the requirements of enablement and written description.
• Induced Infringement: The intent to induce infringement is a crucial factor in determining liability.
• Industry Impact: Patent litigation in the pharmaceutical sector can have significant implications for market competition and innovation.

FAQs

Q: What is the main issue in the litigation between United Therapeutics Corporation and ANI Pharmaceuticals, Inc.?

A: The main issue is whether ANI's submission of an ANDA and its intended commercial activities would infringe UTC's patents related to the drug treprostinil.

Q: Which patents are involved in this litigation?

A: The litigation involves multiple patents, including but not limited to the '070, '713, '839, '892, '169, '897, '311, '901, '203, '223, '066, and '4901 patents.

Q: What are the key arguments raised by UTC against ANI?

A: UTC argues that ANI's actions would directly infringe and induce infringement of various claims under 35 U.S.C. § 271(a), (b), (c), and (e).

Q: How does this litigation impact the pharmaceutical industry?

A: This litigation affects the balance between innovator and generic drug manufacturers, influencing market competition and the financial stability of these companies.

Q: What is the significance of enablement and written description in patent litigation?

A: Enablement and written description are critical for determining the validity of patents, ensuring that the inventions are fully disclosed and can be made by a person skilled in the art.

Sources

1. United Therapeutics Corporation v. Liquidia Technologies, Inc., Case: 22-2217, Document: 61, Filed: 07/24/2023.
2. ANI/Novitium, In the Matter of, Federal Trade Commission.
3. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE, Case 1:21-cv-00489-UNA.
4. United Therapeutics Corp. v. Liquidia Techs., 74 F.4th 1360.
5. Amicus Briefs - In the Supreme Court of the United States, MINERVA SURGICAL, INC., v. HOLOGIC, INC.