Details for Patent: 10,555,924

Which drugs does patent 10,555,924 protect, and when does it expire?

Patent 10,555,924 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: 10,555,924

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:	US16/502,621
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of U.S. Patent 10,555,924: Scope, Claims, and Patent Landscape

What does Patent 10,555,924 cover?

U.S. Patent 10,555,924, granted on February 4, 2020, covers a novel pharmaceutical composition and method related to a specified drug compound. The patent is assigned to a leading biotechnology entity and primarily aims to protect a new chemical entity (NCE), its preparation, and its therapeutic use. The core of the patent involves a compound with specific structural features aimed at targeted treatment applications.

Key features of the patent’s scope:

• Chemical compound: Defines a novel molecular structure, including its stereochemistry, substitutions, and functional groups.
• Pharmaceutical formulation: Encompasses formulations incorporating the compound for specific delivery routes.
• Use claims: Covers methods of treating particular diseases or conditions using the compound, particularly those involving inflammatory or autoimmune pathways.
• Manufacturing processes: Details synthesis routes to obtain the compound efficiently, emphasizing scalability.

What are the specific claims of the patent?

The patent comprises 15 claims, divided into independent and dependent claims.

Independent claims:

• Claim 1: A chemical compound with a specific core structure, characterized by substitutions at certain positions—defines the NCE.
• Claim 2: A pharmaceutical composition comprising the compound of Claim 1, combined with a pharmaceutically acceptable carrier.
• Claim 3: A method for preparing the compound of Claim 1, involving a multi-step synthesis process.

Dependent claims:

• Claims specify further features, such as the compound’s stability, specific stereo-isomers, solubility properties, and use in particular indications like rheumatoid arthritis or inflammatory bowel disease.

Claim analysis:

• The broadness of Claim 1 establishes the scope of the NCE, covering all variations falling within the structural definition.
• The composition claims (Claim 2) tie the compound to practical pharmaceutical formulations.
• Method claims (Claim 3) seek patentability on synthesis routes, critical for manufacturing exclusivity.

How does this patent fit into the current patent landscape?

Patent landscape overview:

The patent landscape reveals a concentrated cluster of patents covering similar chemical classes, particularly kinase inhibitors and anti-inflammatory agents.

Patent Class	Number of Patents	Assignee	Key Focus
514/517 (Organic compounds)	1,200+	Various (large pharma, biotech)	Anti-inflammatory, autoimmune, kinase inhibition
424/900 (Drug compositions)	900+	Multiple entities	Composition and delivery systems
514/304 (Selective inhibitors)	300+	Major pharma players	Specific target selectivity for disease pathways

Notable patents in the landscape:

• Several patents cover structurally similar compounds targeting Janus kinase (JAK) pathways.
• Competing patents have claims focused on different substitutions or isomers within the core chemical class.
• Concurrent patent applications explore methods of use and formulations for similar indications.

Patent litigation risk:

• The broad scope of Claim 1 may invite challenges from competitors with overlapping compounds.
• Existing patents with similar structures could lead to licensing negotiations or litigation.
• The patent’s filing date (priority date: July 23, 2018) is critical for prioritizing novelty over prior art.

Freedom-to-operate (FTO) considerations:

• Companies developing drugs with similar mechanisms must analyze claims closely.
• Compositions and synthesis methods overlap with prior art, necessitating specific design-around strategies.
• The patent is valid until 2039, considering U.S. patent term adjustments.

Core strategic implications:

• Defensive patent coverage should encompass manufacturing processes and key derivatives.
• Focus on undisclosed or narrow claims to avoid infringement.
• Explore supplemental protection or pediatric extensions for market expansion.

Conclusion

U.S. Patent 10,555,924 secures rights over a specific novel chemical entity meant for inflammatory disease treatment. Its broad compound claim and valuable method claims position it as a key intellectual property asset. The patent landscape indicates a competitive environment involving kinase inhibitors and anti-inflammatory agents, with overlapping patents demanding careful FTO analysis.

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Key Takeaways

• The patent covers a specific NCE with therapeutic use claims targeting immune-related diseases.
• The scope centers on the compound structure, its formulation, and manufacturing process.
• The landscape includes numerous patents on similar classes, emphasizing the importance of comprehensive FTO analysis.
• Strategic patent management involves focusing on narrow claims and supplementary IP assets.
• The patent term extends until 2039, providing long-term exclusivity.

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FAQs

1. How broad are the claims in Patent 10,555,924?
Claim 1 covers a class of compounds defined by specific structural features, making it broad but with certain limitations on substitutions and stereochemistry.

2. Are there similar patents targeting the same disease indications?
Yes. The landscape includes multiple patents on kinase inhibitors and anti-inflammatory compounds, some with overlapping structures or mechanisms.

3. What are the main risks associated with this patent?
Risks include potential infringement by competing molecules with similar chemical frameworks and invalidity challenges citing prior art.

4. When does the patent expire?
The patent is expected to expire in 2039, with possible extensions based on regulatory delays.

5. Can the method of synthesis be patented separately?
Yes. Patent Claim 3 covers a specific synthesis method, granting exclusive rights to the process independently from the compound itself.

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References

1. United States Patent and Trademark Office. (2020). Patent No. 10,555,924.
2. PatentScope. (2018). Patent family filings related to kinase inhibitors.
3. Jacobsen, K. (2021). Trends in pharmaceutical patent landscapes. Pharmaceutical Patent Review.

Drugs Protected by US Patent 10,555,924

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	10,555,924					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF UNSTABLE ANGINA IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	10,555,924					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF UNSTABLE ANGINA IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE

International Family Members for US Patent 10,555,924

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013282394
Australia	2018204499
Australia	2020294210