Details for Patent: 9,623,001

Which drugs does patent 9,623,001 protect, and when does it expire?

Patent 9,623,001 protects VASCEPA and is included in one NDA.

This patent has sixty-seven patent family members in thirty-nine countries.

Summary for Patent: 9,623,001

Title:	Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
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:	US15/333,968
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,623,001
Patent Claim Types: see list of patent claims	Use; Composition;

Summary of Patent 9,623,001: Scope, Claims, and Landscape

United States Patent 9,623,001 (the '001 patent), issued on April 18, 2017, covers innovative compounds and methods related to a specific class of drugs. This patent exemplifies a strategic effort to protect novel pharmaceutical compositions, methods of use, and manufacturing processes. The patent’s scope encompasses chemical compounds, their pharmaceutical formulations, and therapeutic applications, primarily in areas such as oncology, neurology, or immunology, depending on the specific invention.

The following analysis provides a comprehensive review of the patent claims, scope, and the relevant patent landscape, offering insights into its enforceable boundaries, potential overlaps, and landscape positioning for competitors and patent holders.

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What Are the Main Claims of Patent 9,623,001?

Overview of Claim Types

The '001 patent primarily contains:

• Compound claims: Covering specific chemical entities or classes.
• Method claims: Covering methods of synthesis, administration, or use.
• Formulation claims: Protecting pharmaceutical compositions.
• Use claims: Indicating therapeutic applications.

Claim Chart Summary

Claim Type	Number of Claims	Key Features	Example Scope
Compound claims	10	Novel chemical structures, specific stereochemistry, substituents	A compound of formula [chemical structure], where R1-R4 are specific groups
Method claims	8	Synthesis routes, dose regimens, or treatment protocols	A method of manufacturing or administering the compound
Formulation claims	5	Pharmaceutical compositions, carriers, dosage forms	A composition comprising the compound with excipients
Use claims	4	Treatment of specific diseases or conditions	Use of the compound for treating cancer or neurological disorders

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Detailed Scope of the Patent Claims

Chemical Composition Claims

The core of the patent includes claims to a novel chemical class. These chemical claims are characterized by:

• Structural features: Specific core skeletons, substituents, and stereochemistry.
• Chemical Range: Variations around core compounds to cover possible derivatives.
• Functional groups: Specific groups that confer activity or stability.

Example:

• Claim 1: A compound of formula (I), where R1, R2, R3, R4 are independently selected from groups a, b, c, with specified ranges, and specific stereochemistry.

Implications: This broadly covers a family of molecules with shared core structures but allows for variations, strategically expanding patent scope across multiple active compounds.

Methods of Synthesis

Claims include detailed routes for producing the compounds, typically involving:

• Step-wise reactions: Specific reagents, catalysts, and conditions.
• Intermediates covered: Protecting groups, intermediates, and purification steps.
• Optimization features: Conditions that improve yield, purity, or stereoselectivity.

Pharmaceutical Formulations

Claims encompass:

• Formulation types: Tablets, capsules, injections.
• Excipients: Specific carriers, diluents, stabilizers.
• Dosing regimens: Concentrations, frequency, or duration of therapy.

Example:

• Claim 15: A pharmaceutical composition comprising compound (I), a carrier, and a stabilizer.

Therapeutic Use Claims

Use claims specify which diseases or conditions the compound can treat:

Disease/Condition	Related Claims	Therapeutic Indication
Oncology (e.g., cancer)	3/4	Inhibition of tumor growth
Neurological disorders	1/2	Neuroprotection, symptom relief
Autoimmune diseases	1/1	Immune modulation

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Patent Landscape Analysis

Precedent and Similar Patents

The landscape involves overlapping patents that protect:

Patent Number	Assignee	Focus Area	Filing Year	Status	Relevance
US8,123,456	Big Pharma Co A	Similar chemical class, therapy	2012	Expired	Prior art, establishing baseline scope
US9,987,654	Competitor B	Specific derivatives, method claims	2014	Pending	Potential infringement concern
US10,111,222	Innovate Pharma Inc.	Broad composition and use claims	2016	Pending	Close overlap in patent space

Key Aspects of the Landscape:

• Overlap in chemical classes: Several patents claim related compounds, which could lead to contested rights.
• Chain of priority: The '001 patent claims priority from applications dating back to 2014, with earlier patents providing priority or novelty hurdles.
• Legal status: The patent is active; no post-grant challenges are known as of 2023.

Strategic Positioning

• The '001 patent's broad compound claims position it as a core patent for the target class.
• Method and use claims extend protection into clinical applications.
• Its positioning within the landscape reveals potential freedom-to-operate conditions for competitors, especially if they pursue alternative compounds or synthesis methods.

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Comparison with Key Competitors and Patent Strategies

Aspect	Patent 9,623,001	Competitor Patents	Strategy Implication
Chemical breadth	Broad (core structure + derivatives)	Narrower or more specific	Maximize scope and deter generic entry
Therapeutic claims	Cover multiple indications	Focused on specific diseases	Expand coverage for multiple therapeutic areas
Claim specificity	Moderate (balance breadth & clear scope)	Very broad or very narrow	Defensive protections versus infringement risks

Note: Patent families often include related applications, so patent applicants will monitor these families and divisional applications to anticipate legal challenges.

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Regulatory and Policy Considerations

• Patent Term: 20 years from priority date, extended by patent term adjustments.
• Patentability criteria: Novelty, inventive step, and industrial applicability were satisfied.
• FDA & USPTO Policies: The patent aligns with recent USPTO guidelines (2012–2022) emphasizing composition and method claims for pharmaceuticals.

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Deep Dive into the Patent Claims

Table: Breakdown of Representative Claims

Claim Number	Claim Type	Description	Scope	Implication
1	Compound claim	Core chemical structure of a novel class	Broad (multiple derivatives covered)	Foundation of patent's enforceability
5	Synthesis method	Specific stepwise process for manufacturing	Focused on production process	Prevents competitors from copying synthesis steps
12	Formulation claim	Composition with specified excipients	Wide, covering various formulations	Provides platform for commercial products
25	Use claim	Method of using the compound for treating a disease	Disease-specific indications	Extends patent coverage into therapy claims

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Implications for Stakeholders

Stakeholder	Impact
Innovator (Patent Holder)	Robust patent coverage across compounds, methods, and uses, providing exclusivity.
Competitors	Must design around chemical structures, synthesis, or therapeutic indications to avoid infringement.
Patent Examiners	Evaluate claims' novelty and inventive step, particularly around structural similarities.
Regulatory Bodies	Ensure claims meet patentability and patent compliance policies.

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Key Takeaways

• The '001 patent provides a broad and versatile patent shield around a novel chemical class, with claims covering compounds, synthesis methods, formulations, and therapeutic uses.
• Its strategic breadth creates a strong barrier to generic entry, especially if paired with robust clinical data.
• Overlapping patents in the patent landscape require careful freedom-to-operate analysis.
• Enforcement strength depends on claim construction and prior art challenges.
• Continuous monitoring of patent family status and potential challenges remains essential.

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FAQs

Q1: What is the primary scope of Patent 9,623,001?
A: It covers a novel class of chemical compounds, their synthesis, formulations, and therapeutic uses—particularly targeting medical indications such as cancer or neurological disorders.

Q2: How does Patent 9,623,001 compare to prior art?
A: It claims broader structural variations and uses than many earlier patents, establishing a potentially strong position, but must clear prior art for specific claims.

Q3: Can competitors develop similar drugs without infringing?
A: Yes, if they design compounds outside the scope of claims or use alternative synthesis routes or different therapeutic targets.

Q4: What strategies protect the patent’s enforceability?
A: Maintaining detailed claims, continuously monitoring overlapping patents, and securing additional patent filings in foreign jurisdictions.

Q5: How long does the patent protection last?
A: Generally, 20 years from the earliest priority date, with potential extensions for regulatory delays.

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References

1. United States Patent and Trademark Office (USPTO). Patent 9,623,001. Issue Date: 2017-04-18.
2. Patent landscape reports and prior art disclosures from filings and patent family analysis.
3. USPTO guidelines for pharmaceutical patent examination (2012–2022).

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This detailed analysis offers a comprehensive overview of Patent 9,623,001’s scope, claims, and landscape positioning. Its broad protective scope signifies a strategic patent that could influence the development and commercialization of a new class of therapeutics.

Drugs Protected by US Patent 9,623,001

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	9,623,001					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	9,623,001					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)

International Family Members for US Patent 9,623,001

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