Details for Patent: 7,335,799

Which drugs does patent 7,335,799 protect, and when does it expire?

Patent 7,335,799 protects NEXLETOL and NEXLIZET and is included in two NDAs.

This patent has twenty-three patent family members in thirteen countries.

Summary for Patent: 7,335,799

Title:	Hydroxyl compounds and compositions for cholesterol management and related uses
Abstract:	The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents.
Inventor(s):	Dasseux; Jean-Louis Henri (Brighton, MI), Oniciu; Carmen Daniela (Ann Arbor, MI)
Assignee:	Esperion Therapeutics, Inc. (Ann Arbor, MI)
Application Number:	10/743,470
Patent Claim Types: see list of patent claims	Composition; Compound;

United States Patent 7,335,799: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,335,799, titled "Hydroxyl Compounds and Compositions for Cholesterol Management and Related Uses," was issued on February 26, 2008. This patent is significant in the pharmaceutical industry, particularly for the management of cholesterol and related cardiovascular diseases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Inventors and Assignee

The patent was invented by Jean-Louis Henri Dasseux and Carmen Daniela Oniciu, with Esperion Therapeutics, Inc. as the assignee[4][5].

Scope of the Patent

The patent covers novel hydroxyl compounds, compositions comprising these compounds, and methods useful for treating and preventing diseases related to cholesterol management. These compounds are designed to inhibit the enzyme ATP-citrate lyase, which plays a crucial role in the biosynthesis of cholesterol and fatty acids[4].

Claims of the Patent

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

• Compound Claims: The patent claims novel hydroxyl compounds and their derivatives, which are synthesized to have specific pharmacological properties for cholesterol management[4].
• Composition Claims: It includes claims for compositions that contain these hydroxyl compounds, either alone or in combination with other therapeutic agents[4].
• Method Claims: The patent also covers methods for treating and preventing diseases associated with cholesterol, such as hypercholesterolemia and atherosclerosis, using these compounds and compositions[4].

Patent Term and Extensions

The patent was originally set to expire, but it has been extended under 35 U.S.C. § 156 due to regulatory review periods. The extension period has been determined to be 5 years, making the new expiration date December 3, 2030[2][5].

Patent Landscape

Related Patents

The patent is part of a broader portfolio related to cholesterol management and bempedoic acid, a key compound covered under this patent. Other related patents include U.S. Patent Nos. 11,760,714 and 11,613,511, which also pertain to methods of making bempedoic acid and its compositions[5].

Litigation and Enforcement

Esperion Therapeutics has been actively enforcing its patent rights. For instance, the company has filed lawsuits against generic drug manufacturers, such as Dr. Reddy’s Laboratories, to prevent the early market entry of generic versions of NEXLETOL® and NEXLIZET®, which are products covered by these patents[5].

Regulatory Approvals

The patent covers the human drug product known by the tradename NEXLETOL® (bempedoic acid), which has received regulatory approvals. These approvals are crucial for the commercialization and use of the drug in managing cholesterol levels[2].

Metrics for Patent Scope

The scope of the patent can be analyzed using metrics such as independent claim length (ICL) and independent claim count (ICC). These metrics help in understanding the breadth and clarity of the patent claims. Generally, narrower claims with shorter lengths and fewer counts are associated with a higher probability of grant and a shorter examination process[3].

Impact on Innovation

The patent has significant implications for innovation in the pharmaceutical industry. By protecting novel compounds and methods, it incentivizes further research and development in cholesterol management. However, broad or unclear claims can lead to increased licensing and litigation costs, potentially hindering innovation[3].

Citations and Prior Art

The patent cites various prior art documents, including earlier patents and scientific publications related to hydroxyl compounds and cholesterol management. These citations highlight the evolutionary nature of the invention and its roots in existing scientific knowledge[1][4].

Commercial Significance

The commercial significance of this patent is substantial, given the market demand for effective cholesterol management treatments. NEXLETOL® and NEXLIZET®, the products covered by this patent, are part of a lucrative market segment, and the patent's extension ensures continued exclusivity for Esperion Therapeutics[2][5].

Key Takeaways

• Novel Compounds: The patent covers novel hydroxyl compounds and their compositions for cholesterol management.
• Method Claims: It includes methods for treating and preventing diseases associated with cholesterol.
• Patent Term Extension: The patent has been extended by 5 years due to regulatory review periods.
• Litigation: Esperion Therapeutics is actively enforcing its patent rights against generic manufacturers.
• Regulatory Approvals: The patent covers approved drug products like NEXLETOL®.
• Metrics for Scope: The patent's scope can be analyzed using ICL and ICC metrics.

FAQs

Q: What is the main subject of United States Patent 7,335,799?

A: The patent covers novel hydroxyl compounds, compositions, and methods for cholesterol management and related uses.

Q: Who are the inventors of this patent?

A: The inventors are Jean-Louis Henri Dasseux and Carmen Daniela Oniciu.

Q: What is the current expiration date of the patent?

A: The patent currently expires on December 3, 2030, after a 5-year extension.

Q: What products are covered by this patent?

A: The patent covers NEXLETOL® (bempedoic acid) and related compositions.

Q: Why is the patent significant in the pharmaceutical industry?

A: It protects novel compounds and methods for cholesterol management, incentivizing further research and development in this area.

Cited Sources

1. United States Patent and Trademark Office, "US7335799B2 - Hydroxyl compounds and compositions for cholesterol management and related uses," February 26, 2008.
2. Regulations.gov, "NOTICE OF FINAL DETERMINATION," April 4, 2024.
3. Hoover Institution, "Patent Claims and Patent Scope," August 2016.
4. Google Patents, "US7335799B2 - Hydroxyl compounds and compositions for cholesterol management and related uses."
5. Insight.RPXcorp.com, "Case 2:24-cv-06391 Document 1 Filed 05/23/24 Page 1 of 44 PageID."

Drugs Protected by US Patent 7,335,799

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes	7,335,799			Y
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	7,335,799			Y

International Family Members for US Patent 7,335,799

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2404890		301062	Netherlands
European Patent Office	2404890		LUC00174	Luxembourg
European Patent Office	2404890		122020000048	Germany
European Patent Office	2404890		132020000000112	Italy
European Patent Office	2404890		2020C/534	Belgium
European Patent Office	2404890		CA 2020 00041	Denmark