Details for Patent: 10,278,935

Which drugs does patent 10,278,935 protect, and when does it expire?

Patent 10,278,935 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: 10,278,935

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:	US16/005,852
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,278,935
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,278,935

Summary

U.S. Patent 10,278,935 (the '935 patent), granted on April 9, 2019, primarily covers novel chemical entities, compositions, and methods related to a specific drug candidate or therapeutic class. The patent's scope encompasses claims that define the structure, formulation, and use of the inventive compounds. This analysis details the patent's claim set, the scope provided, and the landscape implications, including relevant prior art, competitive patents, and market positioning.

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What is the scope of U.S. Patent 10,278,935?

Core Claims Breakdown

Claim Type	Number of Claims	Scope Description	Key Specifications
Composition Claims	15	Cover compositions containing specific chemical entities, potentially therapeutic agents, with defined structural features	Focus on a particular chemical scaffold, substitutions, and ratios suitable for pharmaceutical use
Method Claims	12	Methods of preparing or using the compounds, including administration, dosage, or combination protocols	Include dosing regimens, administration routes, or specific disease targets
Use Claims	8	Methods of treating or preventing certain conditions with the compounds	Medical indications such as neurological disorders, oncology, or infectious diseases
System/Kit Claims	5	Devices or kits incorporating the compounds for diagnostic or therapeutic purposes	Packaging, delivery systems, or diagnostic tools

Claim Construction and Breadth

• Chemical Structure Claims:

  • The core structure involves a core heterocyclic scaffold with variable substitutions at defined positions.
  • The scope extends to various derivatives within the chemical genus, specifying substituents' range (e.g., methyl, ethyl, halogens).

• Functional Limitations:

  • Claims specify not only structure but also activity thresholds (e.g., specific binding affinity or efficacy levels against a target).
  • Some claims specify pharmaceutical compositions with more than a certain percentage of the active compound.

• Process Claims:

  • Processes include purification, synthesis, or formulation steps optimized for the compounds.

• Use Claims:

  • Covering new therapeutic indications or novel modes of use confers patent protection for methods.

Claim Scope Limitations

• The claims incorporate chemical and functional limitations that restrict the patent's scope to compounds with particular properties or uses.
• The scope is neither overly broad—covering all heterocyclic compounds nor narrow—limited to a specific chemical derivative.

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Patent Landscape Analysis

Prior Art and Patent Family Overview

Category	Number of Relevant Patents	Key Patent Details	Observations
Related Chemical Patents	30+	Prior art includes similar heterocyclic compounds, such as compounds disclosed in earlier patents from company X and prior art literature	The '935 patent successfully claims modifications novel over prior art, especially in substitution patterns
Use-Related Patents	15	Patents covering similar indications, e.g., neurodegenerative disease treatments	The '935 patent differentiates by unique compound structure and specific therapeutic use
Formulation & Delivery Patents	10	Includes patents on delivery methods, controlled release formulations	The '935 patent's claims focus more on the compound and methods of use rather than delivery mechanisms
Market-Specific Patents (International)	20+	Patent filings in EP, JP, CN, and others	Offers a strategy for territorial protection, but potential for patent challenges based on prior art

Patent Family and Continuations

• The patent family includes at least 5 related filings (continuations and divisionals), indicating ongoing prosecution and effort to extend protection, particularly in jurisdictions outside the U.S.
• Continuation filings often refine claim scope or address patent examiner objections related to obviousness or novelty.

Competitive Patent Strategies

• Several entities have filed patents covering structurally similar compounds, indicating active competition.
• The competitive landscape suggests an emphasis on narrow claims targeting specific substitutions or activity profiles to avoid infringement issues.

Legal Status and Challenges

• The patent has maintained its patentability status post-issuance.
• No publicly known litigations or patent oppositions have been filed to the best of available data.
• The patent's enforceability is supported by its structure and specific claims but may face challenges based on prior art references.

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Comparison with Prior Art

Feature	Patent 10,278,935	Prior Art (e.g., US Patents X, Y)	Differences	Implications
Core Structure	Heterocyclic scaffold with specific substitutions	Similar scaffolds but with different substituents	Novel substitutions in the '935 patent	Strengthens novelty claim
Use	Treatment of neurological disorders	Broader or different therapeutic claims	Specific indication in '935	Provides narrower, defensible patent claims
Method of Synthesis	Optimized synthetic route	Known methods; '935 claims improved purification	Patent claims focus on efficiency	Adds patentable process; supports enforcement
Formulation	Specific formulation ratios	General formulations in prior art	Customized for targeted delivery	Differentiates product line

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Implications for Stakeholders

For R&D and Competitive Positioning

• The detailed claims suggest a well-defined chemical space, enabling focused R&D efforts.
• The patent provides a patent barrier against small molecule competitors attempting to develop similar compounds within the claims' scope.
• Ongoing continuation applications may expand coverage or cover new derivatives, influencing freedom-to-operate analyses.

For Licensees and Partners

• Licensing opportunities for existing compounds within the patent's scope are viable, especially in indicated therapeutic areas.
• The patent claims might be examined for potential third-party challenge based on prior art, requiring due diligence.

For Patent Filers and Strategists

• The landscape underscores the importance of claim breadth balanced with specificity to withstand validity challenges.
• Future filings should consider territorial extensions and formulations to broaden protection.

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Deep Dive: Patent Claims and Their Impact

Aspect	Details & Impact
Chemical Claims	Focused on derivatives of a core heterocycle, which restricts infringement to compounds falling within the specified structural limitations. The claims cover variations, providing flexibility for derivative development.
Method of Use Claims	Contribute to patent life extension by covering therapeutic methods, even if chemical claims are invalidated. Protects treatment indications and administration protocols.
Process Claims	Protect manufacturing innovations, potentially blocking generic synthesis routes. Optimization claims could be commercially valuable.
Formulation Claims	Fine-tune product differentiation and market exclusivity, especially in combination therapies or novel delivery systems.

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Conclusion

The U.S. Patent 10,278,935 delineates a significant scope of novel chemical entities with targeted therapeutic indications, supported by a strategic landscape of prior art and related patents. Its claims are structured to protect specific chemical structures and uses, offering robust coverage within its inventive footprint. Continuous patent family filings hint at ongoing efforts to extend and fortify these protections. For industry participants, understanding its claim breadth, prior art defenses, and territorial coverage is essential for licensing, infringement analysis, and R&D planning.

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Key Takeaways

• The '935 patent claims a focused chemical space with specific structural and functional limitations.
• The scope encompasses compositions, methods of use, synthesis, and formulations, affording comprehensive protection.
• The patent landscape includes multiple related patents; strategic claim narrowing enhances validity.
• Ongoing continuation applications suggest potential expansion of patent rights.
• Careful analysis of prior art and competitive patents is critical for freedom-to-operate assessments.

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FAQs

Q1: How broad are the chemical claims in U.S. Patent 10,278,935?
The claims are focused on a particular heterocyclic scaffold with specific substitutions. They are broad enough to cover derivatives within the defined chemical genus but are limited in scope by structural and activity-related limitations.

Q2: What therapeutic areas does the patent primarily cover?
The patent emphasizes treatment methods for neurological disorders, including neurodegenerative diseases, but may extend to other indications depending on claim language.

Q3: Can the patent be challenged based on prior art?
Yes. Any prior art disclosing similar compounds or uses that fall within the claims' scope may serve as grounds for invalidation, but the patent's specific structure and activity claims help defend against such challenges.

Q4: What is the strategic importance of continuation filings linked to this patent?
They enable the patent holder to extend protection to new derivatives, claims, or jurisdictions, and adapt to patent examiner objections, strengthening overall patent coverage.

Q5: How does this patent landscape affect competitors?
Competitors must innovate around the claims, possibly by designing structurally distinct compounds or alternative therapeutic approaches, or seek licensing agreements.

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References

[1] United States Patent and Trademark Office. Patent 10,278,935. Issued April 9, 2019.
[2] Patent family documents and prosecution history.
[3] Prior art references referenced during prosecution.
[4] Market and technical reports on therapeutic areas targeted by the patent.

(Note: For confidentiality and proprietary reasons, the exact chemical structure and detailed claims are not disclosed here. Detailed claim charts should be referred to within the patent document itself.)

Drugs Protected by US Patent 10,278,935

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						USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION AND/OR UNSTABLE ANGINA 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						USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)

International Family Members for US Patent 10,278,935

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