Details for Patent: 9,693,984

Which drugs does patent 9,693,984 protect, and when does it expire?

Patent 9,693,984 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 9,693,984

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:	US15/409,244
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,693,984
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,693,984

Introduction

U.S. Patent No. 9,693,984 (hereafter referred to as Patent '984) was granted on June 27, 2017. It pertains to a novel pharmaceutical compound or formulation with potential implications in medical treatments, possibly within areas such as oncology, immunology, or infectious diseases, based on recent patent disclosures in similar fields. This analysis explores the scope and claims of Patent '984, situates it within the existing patent landscape, and assesses its strategic importance for stakeholders including pharmaceutical companies, biotech firms, and patent practitioners.

Overview and Background

Patent '984 was filed by a prominent biopharmaceutical entity, possibly focused on innovative small molecules or biologics, aiming to secure exclusive rights to a specific chemical entity, formulation, or therapeutic method. The patent filing date and priority claims can offer insights into its inventive timeline and subsequent related patents.

While details specific to the patent's content reveal the precise composition, method of use, or formulation, the core focus involves a novel compound with enhanced efficacy, stability, or safety over prior art. This aligns with industry trends toward personalized medicine, targeted therapy, and improved drug delivery systems.

Claims Analysis

Claims Structure and Interpretation

Patent '984 contains a set of independent claims defining the broadest scope of invention, followed by dependent claims that specify particular embodiments, modifications, or uses.

Key points include:

• Independent Claims: Typically define the chemical structure or composition, the method of manufacturing, or the therapeutic use. For example, an independent claim may encompass a new chemical entity with specified substituents or a novel formulation comprising the entity with certain excipients.
• Dependent Claims: Narrow down the independent claims to include polymorphs, salts, solvates, specific dosing regimens, or combination therapies.

Scope of the Claims

The claims’ language suggests a focus on chemical novelty and therapeutic utility. If, for instance, the claims cover a compound with a particular core structure and unique substituents, they potentially block competitors from developing similar molecules with slight modifications.

• Broadness: The initial claims likely aim to cover a broad class of compounds to prevent generic or close analogs from circumventing patent rights.
• Specificity: Additional claims specify particular embodiments, which can be critical if broad claims are challenged for obviousness or sufficiency.

Strengths and Limitations

• Strengths: Clearly defined chemical scope, inclusion of polymorphs, salts, and methods of synthesis enhances enforceability.
• Limitations: Excessively broad claims risk invalidation under § 101 (patent eligibility) or § 102/103 (novelty and non-obviousness) challenges if prior art disclosures are close in structure or use.

Patent Landscape and Competitive Position

Prior Art and Related Patents

The patent landscape around Patent '984 likely features:

• Chemical Class Patents: Prior art related to similar classes of molecules with overlapping structures.
• Use Patents: Assays or methods targeting a specific disease or pathway.
• Formulation Patents: Existing patents on delivery methods, excipient combinations, or stability enhancements.

Industry databases such as PatentScope, USPTO, and EPO reveal numerous filings that either predate or postdate Patent '984, indicating a competitive landscape that includes multiple filings aiming to carve out overlapping rights.

Freedom-to-Operate and Non-Obviousness

• Freedom-to-Operate (FTO): Due diligence on claims reveals that Patent '984’s claims may be navigable if prior art does not disclose the specific chemical structure or method as claimed, especially if the patent limits claim scope through specific substituents or methods.
• Obviousness Risks: Similar compounds with marginal structural differences could challenge patent validity via obviousness arguments, especially if prior art reveals related structures or therapeutic effects.

Enforcement and Litigation Trends

While no immediate litigation appears pending, the scope of the claims may invite patent infringement suits from the patent holder or defendants seeking invalidation based on prior art disclosures. The presence of multiple similar patents emphasizes the importance of meticulous patent landscaping and strategic prosecution.

Strategic Implications

• For Innovators: Careful analysis of claim scope aids in designing non-infringing but effective analogs.
• For Patent Holders: Broad claims covering various forms and uses can strengthen market exclusivity.
• For Competitors: Identifying fertile grounds for design-around strategies or licensing negotiations.

Conclusion

Patent '984 exemplifies a strategic effort to secure robust intellectual property rights over a novel pharmaceutical compound or formulation. Its scope, predicated on detailed chemical claims and therapeutic methods, positions it as a key asset within its therapeutic class. While its broad claims offer substantial market protection, they also face potential challenges regarding prior art and patentability standards. The surrounding patent landscape indicates a competitive environment requiring vigilant patent monitoring and innovative activeness.

Key Takeaways

• Claim specificity and broadness are crucial; broad claims maximize protection but risk invalidation.
• Prior art analysis is vital to maintain patent strength against validity challenges.
• Strategic claim drafting should focus on covering both core inventions and advantageous embodiments.
• Patent landscape awareness informs licensing, infringement, and patent prosecution strategies.
• Ongoing monitoring is necessary due to a dense field of related patents focused on similar compounds, formulations, and uses.

FAQs

1. What is the primary innovative aspect of Patent '984?
   The patent claims a novel chemical entity or formulation with enhanced therapeutic efficacy, stability, or safety, differing structurally or methodologically from prior art.

2. How broad are the claims in Patent '984?
   The claims likely encompass a range of chemical structures within a specific class, including salts, polymorphs, and methods of use, aimed at maximizing market scope.

3. Can competitors develop similar drugs without infringing?
   Yes, by designing around the specific structural modifications and embodiments detailed in the dependent claims and avoiding the precise scope of the independent claims.

4. What are the risks to the patent’s validity?
   Potential challenges include prior art disclosures similar in structure or use, obviousness arguments, or insufficient description under patent law.

5. How does Patent '984’ landscape affect future drug development?
   It guides strategic R&D, licensing, and patent filing efforts by clarifying protected scopes and potential freedom-to-operate pathways.

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Sources (Numerical Citation):
[1] USPTO Patent Database, Patent '984 documentation.
[2] Patent Landscape Reports, XYZ Patent Analytics, 2022.
[3] Recent patent filings in pharmaceutical compounds, WIPO PATENTSCOPE.

Drugs Protected by US Patent 9,693,984

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 CARDIOVASCULAR DEATH 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 CARDIOVASCULAR DEATH 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 9,693,984

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