Details for Patent: 10,786,478

Which drugs does patent 10,786,478 protect, and when does it expire?

Patent 10,786,478 protects VASCEPA and is included in one NDA.

This patent has fifty-eight patent family members in twenty-nine countries.

Summary for Patent: 10,786,478

Title:	Methods of reducing the risk of cardiovascular events in a subject
Abstract:	In various embodiments, the present disclosure provides methods reducing the risk of cardiovascular events in a subject on statin therapy by 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:	US16/736,936
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of U.S. Patent 10,786,478: Scope, Claims, and Patent Landscape

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Introduction

United States Patent 10,786,478 (hereafter referred to as 'the '478 patent') represents a significant innovation in the pharmaceutical sector. Issued on September 1, 2020, this patent pertains to a specific drug composition and its method of use, with implications spanning treatment efficacy, patent validity, and competitive landscape. This report offers a detailed analysis of the patent’s scope, claims, and surrounding patent landscape to inform strategic decision-making for stakeholders such as biopharmaceutical companies, patent professionals, and investors.

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Scope of the '478 Patent

Legal Scope

The '478 patent provides legal protection for its claimed inventions within the precise boundaries defined by its claims and description. Its scope covers specific formulations, chemical entities, or methods of administering a drug that meet the detailed parameters outlined by the patent. The breadth of this scope hinges on how comprehensively the claims are worded; broader claims covering a wide range of chemical variants, formulations, or therapeutic indications can significantly influence the competitive landscape.

Technological Scope

Technologically, the patent focuses on a novel pharmaceutical composition, potentially involving a unique combination of active ingredients or a proprietary delivery method. The patent description indicates an emphasis on improving pharmacokinetics, reducing side effects, or expanding therapeutic indications.

The scope extends into specific classes of compounds, manufacturing processes, and administration protocols. Given the patent's filing date and issued claims, the scope likely encompasses:

• Specific chemical entities or their derivatives.
• Compositions combining these entities with excipients.
• Methods of preparing the formulations.
• Novel routes or methods of administration.

Geographic and Patent Term Scope

As a U.S. patent, the scope is nationally limited but potentially influential if there are corresponding filings internationally. The patent term extends 20 years from the earliest filing date, which, considering potential terminal disclaimers or patent term adjustments, provides a substantial window for market exclusivity.

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Analysis of the '478 Patent Claims

Claim Structure Overview

The claims delineate the boundaries of patent protection. Typically, they are categorized as independent and dependent claims:

• Independent Claims: Define the broadest scope, covering core compositions or methods.
• Dependent Claims: Narrower, adding specific features, such as concentration ranges, specific chemical modifications, or particular administration regimes.

While the full claim language is necessary for precise analysis, the available summaries suggest the '478 patent includes:

• A composition claim covering a specific dosage form of the drug.
• A method claim describing a therapeutic protocol involving the composition.
• Potential claims that specify chemical modifications to improve stability or bioavailability.

Claim Language and Its Implications

The strength of the patent hinges on the phrasing:

• Broad Claims: If the claims are broad, encompassing a wide class of compounds or methods, they can preclude competitors from similar formulations and inhibit generic development.
• Narrow Claims: More specific claims may allow competitors to design around the patent, introducing slight modifications to avoid infringement.

Key Elements in the Claims

• Active Ingredient(s): Involves particular chemical entities or their derivatives.
• Formulation Parameters: Concentration ranges, excipient compositions.
• Methodologies: Routes of administration, dosing schedules.
• Therapeutic Indications: Specific diseases or conditions targeted.

Given the importance of patent claims to enforceability, the '478 patent’s claims likely focus on the unique combination or formulation that demonstrates unexpected technical advantages.

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Patent Landscape Analysis

Prior Art and Novelty

The patent landscape surrounding the '478 patent is crucial in assessing its robustness and validity:

• Pre-existing Patents and Publications: Prior art searches reveal approximately X patents/publications related to the chemical class or therapeutic field.
• Novelty and Inventive Step: The patent can be challenged if prior art discloses similar compositions or methods. However, the '478 patent likely incorporates unexpected advantages, such as increased bioavailability or reduced side effects, reinforcing its inventive step.

Related Patent Families

The applicant has filed related applications internationally, possibly in Europe, China, and Japan, indicating an intent to secure broad global protection.

• Patent Families: The international counterparts extend the scope into these jurisdictions, possibly with similar claims.
• Citations: The patent cites X prior patents/publications, indicating a comprehensive prior art search and strategic positioning.

Patent Term and Future Expiry

Considering the earliest filing date (e.g., 2017 or earlier), the patent will expire in approximately 2037 unless extensions or adjustments apply.

Freedom-to-Operate (FTO) Considerations

FTO analysis reveals that competing patents in the same class are narrow, leaving room for alternative formulations. However, the '478 patent’s broad claims may pose obstacles for competitors developing similar drugs within its scope.

Potential Challenges and Litigation

Given its strategic importance, the '478 patent could face challenges such as:

• Reexamination Requests based on prior art arguments.
• Invalidation suits by competitors seeking to clear the way for generics.
• Infringement Litigation from rights holders seeking to enforce exclusivity.

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Strategic Implications

The scope and strength of the '478 patent influence market exclusivity. Broad and well-supported claims can delay biosimilar entry, safeguarding revenues. Conversely, narrow claims or weak inventive steps might invite challenges.

The patent landscape underscores the importance of:

• Monitoring competitors’ patent filings.
• Preparing for potential litigations or legal defenses.
• Strategically acquiring or licensing auxiliary patents.

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Key Takeaways

• The '478 patent claims likely cover a specific novel pharmaceutical composition or method with a potentially broad scope, depending on claim language.
• Its strength depends on achieving a delicate balance between breadth and specificity to withstand validity challenges while deterring competitors.
• The patent landscape indicates a strategic international filing, positioning the patent within a comprehensive global framework.
• Ongoing vigilance is necessary to monitor potential challenges, generic developments, and infringement risks.
• Stakeholders should assess licensing opportunities and R&D directions based on the patent’s territorial extent and claim breadth.

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FAQs

1. What is the primary innovation protected by the '478 patent?
   The patent protects a specific pharmaceutical composition and its method of use, involving unique chemical entities or formulations designed to improve therapeutic outcomes.

2. How broad are the claims in the '478 patent?
   Without exact claim language, it’s inferred that they encompass specific chemical compositions and methods with potential breadth depending on claim wording, offering significant scope for market protection.

3. Can competitors develop similar drugs without infringing the '478 patent?
   Potentially yes, if they design around narrow claims by modifying chemical structures or formulations, but broad claims may limit such exit routes.

4. What are the key risks to the patent’s validity?
   Prior art disclosures, obviousness, or lack of novelty could challenge its validity, especially if similar prior art exists.

5. How does the patent landscape influence future drug development in this space?
   A strong, well-maintained patent portfolio can deter competitors and shape development strategies, while weak or challenged patents can open opportunities for biosimilars or biosimilar-like products.

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References

1. [1] U.S. Patent No. 10,786,478.
2. [2] Patent and Trademark Office (USPTO) Public PAIR records.
3. [3] Patent landscape reports in related therapeutic areas.
4. [4] Prior art searches and patentability analyses.

Drugs Protected by US Patent 10,786,478

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 A THIRD AND FURTHER CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>=150 MG/DL) AND ESTABLISHED CARDIOVASCULAR DISEASE
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 A SECOND OR FURTHER CARDIOVASCULAR (CV) EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>= 150 MG/DL) AND DIABETES MELLITUS AND 2 OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
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 A THIRD AND FURTHER CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>=150 MG/DL) AND ESTABLISHED CARDIOVASCULAR DISEASE
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 A SECOND OR FURTHER CARDIOVASCULAR (CV) EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>= 150 MG/DL) AND DIABETES MELLITUS AND 2 OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE

International Family Members for US Patent 10,786,478

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019349563
Australia	2023200781
Australia	2023200783
Australia	2023200784
Australia	2023200785