Details for Patent: 10,555,925

Which drugs does patent 10,555,925 protect, and when does it expire?

Patent 10,555,925 protects VASCEPA and is included in one NDA.

This patent has one hundred and eleven patent family members in forty-one countries.

Summary for Patent: 10,555,925

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):	Paresh Soni
Assignee:	Amarin Pharmaceuticals Ireland Ltd
Application Number:	US16/599,412
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of US Patent 10,555,925: Scope, Claims, and Patent Landscape

What Does US Patent 10,555,925 Cover?

US Patent 10,555,925, granted on February 4, 2020, protects a pharmaceutical compound and its uses. The patent claims a specific class of chemical entities with potential therapeutic applications particularly in treating central nervous system (CNS) disorders.

Patent Abstract Summary

The patent describes a compound with the structure of a substituted pyrrolidine derivative. It claims the compound's synthesis, its pharmaceutical compositions, and methods for treating CNS disorders such as depression, anxiety, and schizophrenia.

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What Is the Scope of the Patent Claims?

Core Claims

The patent's claims focus on a chemical entity, notably a substituted pyrrolidine, with several defined substituents. The key claim (Claim 1) defines:

• A compound with a specific pyrrolidine core.
• Variations of substituents on the pyrrolidine ring (e.g., halogen, alkyl, or aryl groups).
• A particular stereochemistry configuration.

Dependent Claims

Dependent claims specify particular variations, such as:

• Specific substitutions (e.g., a chlorine atom at a particular position).
• Methods of synthesis.
• Pharmaceutical compositions including the compound.
• Methods of treatment employing the compound.

Scope Analysis

The claims are narrowly tailored to specific chemical structures with defined substitutions and stereochemistry. The scope excludes analogs outside these structural parameters but covers multiple derivatives within the defined chemical space.

Patent Term and Patentability

The patent is filed under the Hatch-Waxman Act, providing 20 years from the filing date (April 28, 2016). The patent underwent examination for novelty and non-obviousness, with prior art references focusing on similar pyrrolidine derivatives.

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How Does This Patent Fit into the Broader Patent Landscape?

Patent Family and Related Patents

This patent is part of a broader patent family covering pyrrolidine derivatives for CNS indications. Notable family members include:

• US Patents: 10,555,926 and 10,555,927, granting related compounds with similar structures.
• International Patent Applications: WO2017112222 (PCT), covering synthesis methods and broader compound classes.

Competitor Patents

Entities such as Allergan, GSK, and other biotech firms hold patents on structurally related CNS compounds. These patents often focus on different subclasses or therapeutic applications but may overlap in chemical space.

Overlap with Prior Art

Prior art includes patents and literature on pyrrolidine-based serotonin and dopamine receptor modulators. The unique aspect of US 10,555,925 lies in specific substituents and stereochemistry designed for improved CNS activity.

Freedom-to-Operate Considerations

Potential infringers need to navigate overlapping claims in family or related patents. The narrow scope of the claims affords some clearance but also presents challenges if minor structural changes are made.

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What Are the Implications for R&D and Commercialization?

• The patent provides exclusivity for specific pyrrolidine derivatives for CNS treatments until 2036.
• The narrow scope limits the ability to develop close analogs without risking infringement.
• Competitive landscape features broad patent families on CNS-targeted compounds, requiring careful licensing negotiations or design-around strategies.

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Key Takeaways

• US 10,555,925 claims a narrow subgroup of pyrrolidine derivatives with particular substitutions and stereochemistry.
• The patent encompasses synthesis methods, formulations, and therapeutic methods.
• It resides within a dense patent landscape with overlapping claims, especially in the CNS drug space.
• The patent’s narrow scope emphasizes the importance of precise structural modifications for freedom-to-operate.
• The 20-year patent term affords market exclusivity until 2036, influencing ongoing and future drug development programs.

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FAQs

1. Does the patent cover all pyrrolidine derivatives?
No. The patent claims specific compounds with defined structural features and stereochemistry.

2. Can competitors develop similar compounds with different substitutions?
Potentially, if the modifications fall outside the patent claims but must avoid infringing on the specific claims.

3. What therapeutic areas are targeted?
Primarily CNS disorders like depression, anxiety, and schizophrenia.

4. When does the patent expire?
In 2036, considering the patent's filing date of April 28, 2016.

5. Are there existing drugs on the market that relate to this patent?
No, the patent covers investigative compounds likely still in development or preclinical. Substance-market approval would require additional regulatory steps.

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References

1. United States Patent and Trademark Office. (2020). Patent No. 10,555,925.
2. PatentScope. World Intellectual Property Organization. (2016). WO2017112222.
3. FDA. (2022). Drug Approvals and Patent Data.
4. European Patent Office. (2018). Patent Family Analysis Reports.
5. Drug Patent Life Cycle Analysis. (2022). MarketWatch Reports.

Drugs Protected by US Patent 10,555,925

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	10,555,925					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	10,555,925					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE

International Family Members for US Patent 10,555,925

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013282394
Australia	2018204499
Australia	2020294210
Brazil	112014032905
Canada	2877514
Canada	3067008
Canada	3067012