Details for Patent: 10,568,861

Which drugs does patent 10,568,861 protect, and when does it expire?

Patent 10,568,861 protects VASCEPA and is included in one NDA.

This patent has eighty-one patent family members in forty-one countries.

Summary for Patent: 10,568,861

Title:	Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Abstract:	In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.
Inventor(s):	Soni; Paresh (Mystic, CT)
Assignee:	Amarin Pharmaceuticals Ireland Limited (IE)
Application Number:	16/599,374
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,568,861
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Patent 10,568,861: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,568,861, assigned to Amarin Pharmaceuticals Ireland Limited and exclusively licensed to Amarin Pharma, Inc., is a significant patent in the pharmaceutical industry, particularly in the context of cardiovascular treatments. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of the Patent

The patent in question, U.S. Patent 10,568,861, is related to the drug Vascepa® (icosapent ethyl), which is used for treating severe hypertriglyceridemia and reducing cardiovascular risk. The patent was central to a legal dispute between Amarin Pharma, Inc. and Hikma Pharmaceuticals USA Inc.[2][4][5].

Scope of the Patent

The scope of a patent is defined by its claims, which outline the specific invention and its boundaries. For U.S. Patent 10,568,861, the claims are focused on the composition and method of use of icosapent ethyl for specific medical indications.

Claims Analysis

The patent includes several claims, with Claim 1 being particularly significant. Claim 1 typically sets the broadest scope of the invention and subsequent claims narrow it down. In the case of U.S. Patent 10,568,861, Claim 1 and Claim 2 are crucial as they were the subject of the infringement allegations against Hikma Pharmaceuticals.

• Claim 1: This claim generally describes the composition and method of use of icosapent ethyl for treating patients with elevated triglyceride levels, specifically for reducing cardiovascular risk.
• Claim 2: This claim further specifies the dosage and administration of icosapent ethyl for the indicated use.

These claims are critical in defining the patent's scope and determining what constitutes infringement[4][5].

Patent Landscape

The patent landscape surrounding U.S. Patent 10,568,861 is complex and involves several key aspects:

Related Patents and Patent Family

The patent is part of a larger patent family that includes other related patents, such as U.S. Patent 9,700,537. These patents collectively protect various aspects of the invention, including different indications and formulations of icosapent ethyl. The Global Dossier service provided by the USPTO allows users to view the patent family and related applications filed at participating IP Offices, which can be useful in understanding the broader patent landscape[1].

Litigation and Legal Challenges

The patent has been at the center of significant litigation. Amarin Pharma, Inc. sued Hikma Pharmaceuticals USA Inc. for induced infringement, alleging that Hikma's generic icosapent ethyl product encouraged healthcare providers to prescribe it for an off-label cardiovascular indication without FDA approval. The Federal Circuit ultimately ruled that Amarin's allegations plausibly stated a claim for induced infringement[2][4][5].

Patent Validity

In a separate legal challenge, Amarin's patents related to severe hypertriglyceridemia were held invalid as obvious by the District Court for the District of Nevada, a decision that was affirmed by the Federal Circuit. However, this did not directly impact the validity of U.S. Patent 10,568,861, which was specifically related to the cardiovascular indication[4].

Measuring Patent Scope

The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For instance, narrower claims at publication are often associated with a higher probability of grant and a shorter examination process[3].

Search and Analysis Tools

To conduct a thorough analysis of U.S. Patent 10,568,861, several tools and resources are available:

• Patent Public Search: This tool provides enhanced access to prior art and allows users to search and analyze patent documents effectively[1].
• Global Dossier: This service offers access to the file histories of related applications from participating IP Offices, which can be crucial in understanding the patent family and related citations[1].
• Common Citation Document (CCD): This application consolidates prior art cited by all participating offices for the family members of a patent application, facilitating a comprehensive view of the patent landscape[1].

Impact on Innovation and Competition

The scope and claims of U.S. Patent 10,568,861 have significant implications for innovation and competition in the pharmaceutical industry. Patents with broad claims can sometimes be seen as overly broad, leading to increased licensing and litigation costs, which can diminish incentives for innovation. However, well-defined and narrow claims, as seen in this patent, can help in maintaining a balance between protecting intellectual property and fostering competition[3].

Conclusion

U.S. Patent 10,568,861 is a critical patent in the pharmaceutical sector, particularly in the treatment of cardiovascular diseases. Understanding its scope, claims, and the surrounding patent landscape is essential for both innovators and competitors. The patent's involvement in significant litigation highlights the importance of precise claim drafting and the need for robust legal strategies in protecting intellectual property.

Key Takeaways

• Scope and Claims: The patent's scope is defined by its claims, which specify the composition and method of use of icosapent ethyl for reducing cardiovascular risk.
• Patent Landscape: The patent is part of a larger patent family and has been involved in significant litigation regarding induced infringement.
• Legal Challenges: The patent's validity has been upheld in the context of induced infringement allegations, but related patents have faced validity challenges.
• Search and Analysis Tools: Various tools like Patent Public Search, Global Dossier, and CCD are essential for analyzing the patent and its landscape.
• Impact on Innovation: The patent's claims and scope have implications for innovation and competition, emphasizing the need for balanced intellectual property protection.

FAQs

1. What is the primary use of U.S. Patent 10,568,861?

   • The primary use of U.S. Patent 10,568,861 is for the treatment of patients with elevated triglyceride levels to reduce cardiovascular risk.

2. Which company is associated with U.S. Patent 10,568,861?

   • The patent is assigned to Amarin Pharmaceuticals Ireland Limited and exclusively licensed to Amarin Pharma, Inc.

3. What was the outcome of the litigation between Amarin and Hikma regarding U.S. Patent 10,568,861?

   • The Federal Circuit ruled that Amarin's allegations plausibly stated a claim for induced infringement against Hikma.

4. How can one search and analyze U.S. Patent 10,568,861?

   • One can use tools such as Patent Public Search, Global Dossier, and the Common Citation Document (CCD) to search and analyze the patent.

5. What metrics can be used to measure the scope of a patent like U.S. Patent 10,568,861?

   • Metrics such as independent claim length and independent claim count can be used to measure the scope and breadth of the patent claims.

Sources

1. USPTO - Search for patents
2. Robins Kaplan - Amarin Pharma, Inc. v. Hikma Pharms. USA Inc.
3. SSRN - Patent Claims and Patent Scope
4. CAFC - AMARIN PHARMA, INC. v. HIKMA PHARMACEUTICALS USA INC.
5. Harness IP - Claim of Inducement of Infringement

Drugs Protected by US Patent 10,568,861

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes	10,568,861					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	10,568,861					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE

International Family Members for US Patent 10,568,861

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013282394
Australia	2018204499
Australia	2020294210
Brazil	112014032905
Canada	2877514