Details for Patent: 7,544,713

Which drugs does patent 7,544,713 protect, and when does it expire?

Patent 7,544,713 protects ORENITRAM and is included in one NDA.

This patent has nineteen patent family members in seven countries.

Summary for Patent: 7,544,713

Title:	Compounds and methods for delivery of prostacyclin analogs
Abstract:	This invention pertains generally to prostacyclin analogs and methods for their use in promoting vasodilation, inhibiting platelet aggregation and thrombus formation, stimulating thrombolysis, inhibiting cell proliferation (including vascular remodeling), providing cytoprotection, preventing atherogenesis and inducing angiogenesis. Generally, the compounds and methods of the present invention increase the oral bioavailability and circulating concentrations of treprostinil when administered orally. Compounds of the present invention have the following formula: ##STR00001##
Inventor(s):	Phares; Ken (Chapel Hill, NC), Mottola; David (Cary, NC)
Assignee:	United Therapeutics Corporation (Silver Spring, MD)
Application Number:	11/603,116
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,544,713
Patent Claim Types: see list of patent claims	Use; Delivery;

United States Patent 7,544,713: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 7,544,713, titled "Compounds and methods for delivery of prostacyclin analogs," is a significant patent in the pharmaceutical industry, particularly in the field of vascular diseases. This patent, issued on June 9, 2009, is owned by United Therapeutics Corporation (UTC) and has been a subject of interest in various legal and pharmaceutical contexts.

Background and Inventors

The patent was invented by Ken Phares and David Mottola, and it is part of a broader portfolio of patents related to prostacyclin analogs. Prostacyclin analogs are crucial in medical treatments due to their ability to promote vasodilation and inhibit platelet aggregation and thrombus formation[1][2].

Scope of the Patent

Vasodilation and Platelet Aggregation

The patent covers compounds and methods for the delivery of prostacyclin analogs, which are essential for treating conditions such as pulmonary arterial hypertension (PAH). These analogs help in reducing blood pressure in the pulmonary arteries, thereby alleviating strain on the heart and preventing complications like heart failure and death[2].

Specific Compounds

The patent specifically mentions treprostinil, a well-known prostacyclin analog used in the treatment of PAH. The methods described include various formulations and delivery systems for these compounds, ensuring effective administration and therapeutic efficacy[1].

Claims of the Patent

Key Claims

The patent includes multiple claims that define the scope of the invention. Here are some of the key claims:

• Claims 1-22: These claims describe the chemical structures of the prostacyclin analogs, including specific ester groups and other functional groups that are critical for their therapeutic activity[1].
• Claims 23-25: These claims are particularly contentious and have been the focus of patent infringement lawsuits. They detail specific methods for the delivery of these analogs, including formulations and administration routes[2].

Claim Validity and Infringement

The validity and infringement of these claims have been subjects of legal disputes. For instance, ANI Pharmaceuticals, Inc. has been involved in a lawsuit with UTC and Supernus Pharmaceuticals, Inc., where ANI argued that the patents, including the ’713 patent, are invalid, unenforceable, or not infringed by their products[2].

Patent Landscape

Related Patents

The ’713 patent is part of a larger family of patents related to prostacyclin analogs. Other patents in this family include US7,417,070, US8,252,839, US8,349,892, and several others, all of which are owned by UTC and cover various aspects of these compounds and their delivery methods[2].

Litigation and Enforcement

The patent has been involved in significant litigation. UTC has actively enforced its rights under this patent, filing lawsuits against companies alleged to infringe on these patents. The legal battles highlight the importance of these patents in the pharmaceutical industry and the competitive landscape surrounding PAH treatments[2].

Metrics for Patent Scope

Independent Claim Length and Count

Research on patent scope suggests that metrics such as independent claim length and count can provide insights into the breadth and clarity of patent claims. Narrower claims, as measured by these metrics, are often associated with a higher probability of grant and a shorter examination process. This is relevant to the ’713 patent, as the examination process likely narrowed the scope of the claims to ensure their validity and enforceability[3].

Impact on Innovation and Competition

Innovation Incentives

The scope and claims of the ’713 patent can influence innovation in the pharmaceutical industry. Broad patents with clear and valid claims can protect intellectual property, thereby incentivizing further research and development. However, overly broad or unclear patents can lead to increased litigation costs and diminished innovation incentives[3].

Competitive Landscape

The patent landscape around prostacyclin analogs is highly competitive. Companies like ANI Pharmaceuticals and others are developing generic or alternative treatments, which often lead to legal disputes over patent infringement. The enforcement of patents like the ’713 patent plays a crucial role in shaping the competitive dynamics in this market[2].

Conclusion

The United States Patent 7,544,713 is a critical patent in the field of prostacyclin analogs, particularly for the treatment of PAH. Its scope and claims define the boundaries of innovation and competition in this area. Understanding the patent's claims, the related litigation, and its impact on the pharmaceutical industry is essential for both legal and business strategies.

Key Takeaways

• Prostacyclin Analogs: The patent covers compounds and methods for delivering prostacyclin analogs, which are vital for treating PAH.
• Treprostinil: A key compound mentioned in the patent, used in PAH treatment.
• Litigation: The patent has been involved in significant litigation over infringement and validity.
• Patent Scope: Metrics like independent claim length and count can help assess the patent's breadth and clarity.
• Innovation and Competition: The patent's scope influences innovation incentives and competitive dynamics in the pharmaceutical industry.

FAQs

What is the main subject of the United States Patent 7,544,713?

The main subject of the patent is compounds and methods for the delivery of prostacyclin analogs, particularly for treating conditions like pulmonary arterial hypertension (PAH).

Who are the inventors of the patent?

The inventors of the patent are Ken Phares and David Mottola.

What is the significance of treprostinil in this patent?

Treprostinil is a specific prostacyclin analog mentioned in the patent, which is used in the treatment of PAH.

Why is this patent involved in litigation?

The patent is involved in litigation due to disputes over patent infringement and validity, particularly with companies developing generic or alternative treatments.

How does the patent impact innovation in the pharmaceutical industry?

The patent can protect intellectual property, thereby incentivizing further research and development, but overly broad or unclear claims can lead to increased litigation costs and diminished innovation incentives.

What metrics can be used to assess the scope of the patent?

Metrics such as independent claim length and count can be used to assess the breadth and clarity of the patent claims.

Drugs Protected by US Patent 7,544,713

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No						USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013		RX	Yes	No						USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes						USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013		RX	Yes	No						USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016		RX	Yes	No						USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).

International Family Members for US Patent 7,544,713

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2526534
Canada	2736406
Canada	2851309
Canada	2959852
China	100558351