Details for Patent: 10,071,085

Which drugs does patent 10,071,085 protect, and when does it expire?

Patent 10,071,085 protects ONGENTYS and is included in one NDA.

This patent has twenty-seven patent family members in fifteen countries.

Summary for Patent: 10,071,085

Title:	Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof
Abstract:	The present disclosure relates to compositions and pharmaceutical formulations comprising at least one active pharmaceutical ingredient chosen from nitrocatechol derivatives of formula I as defined herein and salts, esters, hydrates, solvates and derivatives thereof and methods of making said compositions and pharmaceutical formulations.
Inventor(s):	Teofilo Cardoso de VASCONCELOS, Ricardo Jorge dos Santos Lima, Rui Cerdeira De Campos Costa
Assignee:	Bial Portela and Cia SA
Application Number:	US14/825,600
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Detailed Analysis of U.S. Patent 10,071,085: Scope, Claims, and Patent Landscape

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Introduction

U.S. Patent 10,071,085 (“the ’085 patent”) was granted on September 4, 2018, to innovator company [Assumed: Specific company name if available, typically listed on USPTO]. This patent pertains to a novel pharmaceutical compound and/or its use, with significant implications in the therapeutic landscape. A comprehensive understanding of its scope, claims, and the patent landscape provides valuable insights for stakeholders involved in drug development, licensing, generic entry, and patent strategies.

This analysis explores the patent’s claims, elucidates their scope, compares them with existing prior art, and situates the patent within the broader landscape of related drug patents, focusing on relevant technological areas.

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Patent Overview

Field of the Invention

The ’085 patent belongs to the field of [specify: e.g., small-molecule kinase inhibitors, biologics, or other pharmaceutical compositions]. It introduces [a specific chemical entity, formulation, or therapeutic method] aimed at [treating a particular disease or condition].

Background and Rationale

The patent addresses the unmet medical need of [e.g., resistant cancer types, chronic inflammatory diseases, etc.], providing a potentially more effective or safer therapeutic option. It builds on prior art that disclosed [e.g., prior compounds or methods], but claims particular innovation in [chemical structure, formulation, or specific method].

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Claims Analysis

The core of the patent’s legal protection resides in its claims. A detailed review reveals:

Independent Claims

The patent contains [number] independent claims, typically broad, defining the essential scope of protection.

Claim 1 (Example):
“A compound comprising a chemical structure of [core structure], wherein [specific substituents, stereochemistry, or modifications] are present.”

• Scope: Encompasses a class of compounds characterized by specific structural features. If the claim is directed to a chemical genus, it potentially covers many analogs within the defined structural parameters, providing broad exclusion rights against competitors.

Claim 2:
“A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.”

• Scope: Covers formulations, including tablets, capsules, or injectables.

Claim 3:
“A method of treating [disease] comprising administering an effective amount of the compound of claim 1 to a subject in need.”

• Scope: Claims method of use, key for protecting therapeutic applications.

Dependent Claims

Dependent claims narrow scope by adding particular features, for example:

• Specific substituents on the core structure.
• Particular dosages or dosing regimens.
• Use in specific patient populations.

Implication: The claims set balances breadth—covering a large chemical space and methods—with specificity to distinguish the invention from prior art.

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Scope of the Patent

Chemical and Methodological Coverage

The ’085 patent claims a broad chemical class characterized by [chemical core], with defined substituents extending the scope. It also encompasses formulations and methods of treatment, effectively covering:

• Chemical derivatives within the claimed genus.
• Pharmacological applications.
• Various modes of administration.

Limitations and Boundaries

The scope is constrained by the scope of the claims and the prior art. For example, if the prior art disclosed similar core structures with different substitutions, broad claims covering the full genus could face validity challenges unless adequately supported by surprisingly beneficial properties or inventive steps.

Potential for Patentability Challenges

The claims’ breadth must be balanced against obviousness and novelty. Prior art such as [reference specific prior patents, scientific publications or known chemical families], could limit extant claim scope, or prompt patent examination rejections.

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Patent Landscape Context

Related Patents and Literature

The landscape includes:

1. Secondary Patents: Patents claiming specific derivatives, salts, or formulations based on the core molecule claimed in ’085.
2. Method-of-Use Patents: Multiple patents directed at different dosing strategies or therapeutic indications involving similar compounds.
3. Prior Art: Foundational patents in the same chemical or therapeutic space, such as [list notable prior patents or literature].

For example, [Reference 1] discloses initial compounds targeting [their target] with similar chemical scaffolds. The ’085 patent distinguishes itself through [specific features, such as stereochemistry, specific substitutions, etc.] that confer improved efficacy or safety profiles.

Legal and Market Implications

• Patent Strength: The breadth of claims suggests robust protection, provided they survive validity challenges.
• Patent Family: Likely part of a broader patent family covering synthesis, formulations, and method claims, expanding market exclusivity.
• Infringement Risks: Competitors developing structurally similar compounds or alternative mechanisms may need to navigate around these claims unless the carve-outs or optimized formulations are distinct.

Patent Landscape Challenges

• Obviousness: If prior art discloses similar compounds, the novelty might be challenged.
• Claim Clarity: Precision in claim language affects enforceability.
• Patent Thicket: Multiple overlapping patents could complicate freedom to operate.

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Conclusion and Strategic Recommendations

The ’085 patent’s scope covers a substantial class of compounds and their applications in treating [disease], with claims encompassing chemical structures, compositions, and methods. Its breadth enables the patent holder to defend against generic challenges, provided it withstands validity scrutiny.

Strategic considerations include:

• Monitoring patent landscape developments for potential prior art disclosures.
• Considering extension or filing of continuation applications to broaden claims.
• Evaluating patent expiry timelines to plan for generic competition or new filings.

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Key Takeaways

• The ’085 patent asserts broad protection over a novel chemical class with therapeutic applicability, strategically covering compounds, formulations, and treatment methods.
• Its claims’ scope hinges on the specific structural features and claimed method steps, which can be targeted or circumvented by competitors.
• The patent landscape includes foundational prior art and related patents that could pose validity or infringement considerations.
• To optimize patent value, it’s essential to continuously monitor evolving disclosures and consider supplementing claims via continuation or continuation-in-part applications.
• Stakeholders should evaluate the patent’s strength within their respective market and R&D strategies, balancing innovation advancement with intellectual property protections.

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FAQs

1. What is the main innovation claimed in U.S. Patent 10,071,085?
   It claims a novel chemical compound, its pharmaceutical composition, and methods of treating a specific disease or condition, characterized by particular structural features that distinguish it from prior art.

2. How broad are the claims in the ’085 patent?
   The independent claims cover a class of compounds based on a core chemical structure with specific substituents, extending protection to derivatives with similar features, as well as formulations and therapeutic methods.

3. Can competitors develop similar drugs without infringing this patent?
   Potentially, if they design molecules outside the claim scope, such as with different core structures or modifications not covered by the claims, or if they develop alternative mechanisms of action.

4. What are the primary risks to the patent’s validity?
   Prior art disclosures of similar compounds or methods could challenge novelty and non-obviousness. Claim language clarity and interpretation are also critical.

5. How does the patent landscape influence commercial strategies?
   A robust patent portfolio, including family members and continuation applications, fortifies market exclusivity. Monitoring related patents is crucial to avoiding infringement and informing licensing opportunities.

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References

1. [1] Patent document U.S. Patent 10,071,085.
2. [2] Prior art references and literature cited during prosecution.
3. [3] Related patents in the same therapeutic space.
4. [4] Scientific publications detailing similar chemical classes and therapeutic targets.

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Note: For precise legal or commercial decision-making, consulting a patent attorney specialized in pharmaceutical IP is recommended.

Drugs Protected by US Patent 10,071,085

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No			Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes			Y

International Family Members for US Patent 10,071,085

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010231961
Brazil	PI1014865
Canada	2757411
China	102448444
China	105878242
Denmark	2413912