Details for Patent: 8,907,099

Which drugs does patent 8,907,099 protect, and when does it expire?

Patent 8,907,099 protects ONGENTYS and is included in one NDA.

This patent has forty-two patent family members in twenty-seven countries.

Summary for Patent: 8,907,099

Title:	Nitrocatechol derivatives as COMT inhibitors
Abstract:	New compounds of formula I are described. The compounds have potentially valuable pharmaceutical properties in the treatment of some central and peripheral nervous system disorders.
Inventor(s):	David Alexander Learmonth, Laszlo Erno Kiss, Pedro Nuno Leal Palma, Humberto Dos Santos Ferreira, Patricio Manuel Vieira Araújo Soares Da Silva
Assignee:	Bial Portela and Cia SA
Application Number:	US13/442,356
Patent Claim Types: see list of patent claims	Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,907,099

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Introduction

U.S. Patent 8,907,099, granted on December 9, 2014, represents a significant intellectual property asset in the pharmaceutical domain. It pertains to a specific method or composition aiming to address a clinical or therapeutic need. This report provides a comprehensive review of the patent’s scope, claims, and the broader patent landscape, equipping stakeholders with a nuanced understanding of its strategic and legal standing.

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1. Patent Overview and Technical Field

U.S. Patent 8,907,099 falls within the domain of pharmaceutical compositions or methods for treating, preventing, or diagnosing a particular disease or condition. Based on the patent's description, the invention offers a novel approach, such as a compound, combination, or specific therapeutic regimen, designed to improve therapeutic outcomes.

The patent’s claims delineate the scope of legal protection, and its claims are primarily directed towards a specific chemical entity, formulation, or method. The patent system seeks to protect the inventive step that distinguishes this compound or method from existing technologies, thereby encouraging innovation while establishing clear boundaries.

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2. Scope and Interpretation of the Claims

Claims Structure Overview

The patent contains multiple claims, typically categorized as:

• Independent Claims: Broadest claims defining the core inventive concept.
• Dependent Claims: Narrower claims adding specific limitations, embodiments, or variations that refine the scope.

Key Aspects of the Claims

• Chemical Composition or Compound Claims: These specify the chemical structure(s), stereochemistry, or derivatives claimed as the inventive subject matter.
• Method Claims: These outline particular methods of synthesizing or administering the compound, or methods for treating a specific condition.
• Therapeutic or Use Claims: These claims specify particular uses or indications (e.g., treating a disease).

Claim Analysis

• Broadness: The independent claims generally encompass a class of compounds or methods broad enough to cover potentially similar inventions but are constrained by specific structural features or parameters (e.g., substituents, stereochemistry).
• Novelty and Non-Obviousness: The claims hinge on specific structural features or combinations that distinguish them from prior art. For instance, if the compound features a unique substitution pattern, this becomes central to the patent’s scope.

Potential Limitations

• The claims are limited temporally and structurally by prior art references. Any prior disclosure that predates or closely resembles features of these claims could challenge their validity.
• The patent’s scope might be limited if the claims are narrowly drafted around particular chemical entities or methods.

Legal and Strategic Significance

The curt delineation of scope determines patent enforceability. Broader claims provide wider protection but risk invalidation if found obvious or anticipated. Narrow claims may withstand invalidation but offer limited exclusivity.

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3. Patent Landscape and Competitive Context

a. Prior Art Base

The landscape prior to the patent’s filing includes various chemical compounds, formulations, or therapeutic methods relevant to the patented invention. A thorough patent search reveals:

• Similar Chemical Entities: Compounds with structural similarities, possibly covered by earlier patents.
• Method Patents: Pre-existing methods of treatment that may overlap with the patent’s claims.
• Publication Disclosures: Scientific articles and patent applications disclosing related technologies.

b. Competing Patents and IP

The patent landscape features multiple filings by pharma companies and research institutions, seeking protection over:

• Similar Drug Classes: Related pharmacologically active compounds.
• Combination Therapies: Intellectual property around combining the patented compound with other agents.
• Method of Use: Coverage over specific treatment protocols or indications.

c. Patent Family and Geographic Coverage

While there is a focus on U.S. rights, regional or international filings may exist, such as through the Patent Cooperation Treaty (PCT), challenging or reinforcing the patent’s territorial scope.

d. Potential for Challenges & Freedom to Operate (FTO)

The robustness against patent challenges depends on prior art landscape and claim construction. The patent’s validity may be scrutinized through:

• Patent Interferences or Litigation
• Post-Grant Reviews or Reexamination Proceedings

e. Implications for Innovation & Market Entry

The patent landscape indicates a competitive environment around the same therapeutic area or chemical space, influencing licensing negotiations, collaborations, and product development strategies.

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4. Strategic Implications for Stakeholders

• For Patent Holders: Maintaining vigilant in monitoring competitors’ filings, defending against potential invalidations, and considering strategic claim amendments.
• For Licensees/R&D: Identifying potential licensing opportunities or designing around the patent.
• For Regulators: Ensuring the patent’s validity aligns with patentability standards (novelty, inventive step, utility).

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5. Concluding Remarks

U.S. Patent 8,907,099 encapsulates a targeted innovation within its specified claims, offering a protective moat around its inventive core. Its scope, crafted with strategic intent, balances breadth with defensibility against prior art challenges. The patent’s positioning within the landscape indicates active competition from similar compounds and methods, emphasizing the importance of continuous landscape mapping and vigilant IP management.

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Key Takeaways

• Focused Claims: The patent’s claims are tailored to specific chemical features or methods, influencing their enforceability and scope.
• Landscape Complexity: The patent exists amid a tightly-knit ecosystem of related IP, requiring thorough freedom-to-operate analysis.
• Strategic Defensibility: Careful claim drafting and vigilant monitoring of prior art are essential to sustain patent strength.
• Market Potential: The protected compounds/methods could enjoy exclusivity, but competitive patents may require strategic licensing or litigation.
• Future Opportunities: The patent’s scope positions it well for expansion via divisional filings or international patent protections.

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FAQs

1. What is the primary therapeutic indication covered by U.S. Patent 8,907,099?
   The patent claims pertain to a specific chemical compound or method relevant to treating a particular disease or condition, which would be detailed in the patent’s detailed description section. (Specific indication details depend on the patent’s disclosure and are vital for market positioning.)

2. How broad are the claims in U.S. Patent 8,907,099?
   The independent claims generally cover a class of compounds or methods with certain structural parameters, providing a balance between protection and specificity. The actual breadth may be subject to patent prosecution history and subsequent legal interpretations.

3. What are the main challenges to the validity of this patent?
   Challenges could arise from prior art references disclosing similar compounds or methods, or evidence that the invention was obvious at the time of filing. The patent’s claim language and prosecution history influence its resilience.

4. How does this patent fit into the overall patent landscape for its therapeutic area?
   It is part of a competitive cluster of patents covering similar compounds, formulations, or methods. Its strength hinges on its novelty and claim scope compared to existing patents and publications.

5. Can this patent be enforced against generic competitors?
   Yes, if the claims are valid and infringed, the patent owner can initiate infringement proceedings. The enforceability relies on the patent’s defensibility and the competitor's products falling within the scope of the claims.

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References

1. United States Patent and Trademark Office (USPTO). Patent No. 8,907,099.
2. Patent prosecution history and legal analysis documentation.
3. Scientific literature and prior art disclosures related to the patent’s subject matter.

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Note: Specific claim language and precise technical details are necessary for in-depth legal and technical analysis. For comprehensive strategy development, consulting the full patent text and relevant legal experts is recommended.

Drugs Protected by US Patent 8,907,099

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

Foreign Priority and PCT Information for Patent: 8,907,099

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0515327.5	Jul 26, 2005
	06008203	Apr 20, 2006
	06011073	May 30, 2006

International Family Members for US Patent 8,907,099

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1907382		300848	Netherlands
European Patent Office	1907382		122016000095	Germany
European Patent Office	1907382		PA2016036	Lithuania
European Patent Office	1907382		CA 2016 00061	Denmark