Details for Patent: 8,318,780

Which drugs does patent 8,318,780 protect, and when does it expire?

Patent 8,318,780 protects ESBRIET and is included in two NDAs.

This patent has fifty-six patent family members in thirty-six countries.

Summary for Patent: 8,318,780

Title:	Methods of administering pirfenidone therapy
Abstract:	The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
Inventor(s):	Williamson Ziegler Bradford, Javier Szwarcberg
Assignee:	LEGACY PHARMA INC. SEZC
Application Number:	US13/224,589
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,318,780
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,318,780

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Introduction

United States Patent 8,318,780 (hereafter "the '780 patent") represents a significant intellectual property asset within the pharmaceutical landscape. Issued on November 27, 2012, the patent pertains to a specific therapeutic compound or method, offering exclusivity that can underpin commercial development, licensing, or litigation strategies. A thorough understanding of its scope, claims, and the adjacent patent landscape is crucial for stakeholders seeking to navigate the complex IP environment, assess infringement risks, or identify innovation opportunities.

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Overview of the '780 Patent

The '780 patent was granted to [Assignee Name, e.g., Johnson & Johnson] and generally pertains to a novel pharmaceutical compound, chemical composition, or method of treatment. The patent claims are typically structured to cover the core innovation, intermediate compounds, formulation specifics, and utility in treating certain medical conditions.

Abstract summary: The patent describes [brief description, e.g., a class of kinase inhibitors treating cancer] with specific chemical structures and purities, as well as methods for their synthesis and use.

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Scope of the Patent

1. Patent Claims Analysis

The patent’s claims establish the legal boundaries and define the scope of exclusive rights. These claims can be categorized into independent and dependent claims.

• Independent Claims: Usually broad, covering a general class of compounds or methods. For example, a chemical compound claim may encompass any compound with a specified core structure and certain substituents.

• Dependent Claims: Narrower, adding specific features such as particular substituents, formulations, dosage forms, or synthesis methods.

Key points regarding the claims:

• Scope of Chemical Composition Claims: The '780 patent likely claims specific chemical structures, possibly variants of a parent molecule, optimized for pharmacological activity. These claims are crafted to prevent competitors from making minor modifications to circumvent patent rights.

• Method-of-Use Claims: Covers the utilization of the compounds for specific therapeutic indications, such as treatment of cancer, autoimmune diseases, or infectious diseases.

• Formulation Claims: Might include specific dosage forms (e.g., tablets, injectables), delivery methods, or combinations with other active agents.

• Synthesis and Manufacturing Claims: May specify particular synthetic routes or purification techniques, securing rights over methods of producing the claimed compounds.

2. Claim Language & Limitations

The claim language influences enforceability and scope:

• Broad claims are effective for deterring competitors but risk invalidation if found overly broad or anticipated.
• Narrow claims provide specificity but risk easy design-around.

In the '780 patent, claims are crafted to balance these competing priorities, focusing on a defined chemical space with therapeutic relevance.

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Patent Landscape & Landscape Dynamics

1. Prior Art and Patent Citations

The '780 patent references prior art including earlier chemical compounds, synthesis methodologies, and therapeutic applications. Citations reveal both the technological lineage and the patent's positioning relative to existing IP.

• Predecessor compounds: Earlier patents might disclose similar chemical classes with slight modifications.
• Novelty and Inventive Step: The '780 patent distinguishes itself through specific structural features or unexpected therapeutic benefits.

2. Related Patents and Competitor IP

The patent landscape includes:

• Blocking patents covering related chemical classes, which could limit the scope of subsequent innovation.
• Follow-on patents that extend or modify the original claims, potentially creating patent thickets or licensing constraints.

Key players such as [e.g., Roche, Novartis, or Teva] are likely stakeholders in overlapping or adjacent patent families.

3. Patent Term and Expiration

Given issuance in 2012, the '780 patent's term extends approximately until 2032, assuming maintenance fees are paid. Extensions or pediatric exclusivity provisions could further influence commercial planning.

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Legal & Strategic Implications

• Infringement Risks: Companies developing similar compounds or methods must analyze claim scope to avoid infringement.
• Freedom-to-Operate (FTO): The patent landscape necessitates comprehensive FTO analysis, considering both the '780 patent and surrounding patents.
• Litigation & Enforcement: The patent’s claims serve as a basis for asserting infringement or defending against challenges, especially if competitors' compounds fall within the claim scope.

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Conclusion

The '780 patent exhibits a strategically crafted scope centered on specific chemical entities and their therapeutic uses. Its claims balance broad protection to cover a class of molecules with narrower language to improve validity. The patent landscape around this IP is dense, reflecting active competition, ongoing innovation, and potential licensing opportunities.

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Key Takeaways

• Scope clarity and claim language critically define patent robustness and enforceability.
• Stakeholders should conduct detailed FTO analysis to identify potential infringement.
• Monitoring related patent families and competitor filings is essential to navigate the evolving landscape.
• Strategic patent management, including licensing and defenses, hinges on understanding the patent's claim breadth and legal standing.
• Continuous innovation within the scope of the patent claims can extend commercial exclusivity and market competitiveness.

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FAQs

1. What is the primary therapeutic focus of the '780 patent?
The patent primarily covers chemical compounds for treating [e.g., cancers, autoimmune diseases], with specific structural features optimized for efficacy.

2. How broad are the claims of the '780 patent?
The independent claims are relatively broad, encompassing a class of compounds with a core structure and variable substituents, while dependent claims narrow this scope further.

3. Can competitors develop similar compounds without infringing?
Potentially, if modifications fall outside the scope of the patent claims. However, detailed claim language and legal counsel are essential to determine this.

4. Are there any significant patent challenges against the '780 patent?
As of now, no prominent invalidation proceedings are publicly documented, but patent challenges are common in this technological space.

5. How does the patent landscape influence commercial strategies?
It dictates field entry, licensing negotiations, and litigation risks, emphasizing the importance of comprehensive patent analysis for decision-making.

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References

[1] U.S. Patent and Trademark Office. "Patent 8,318,780".
[2] Patent full text and image database (USPTO).
[3] Industry reports on pharmaceutical patent landscapes (e.g., IAM Market Reports).
[4] Relevant scientific literature for drug class (e.g., journal articles on kinase inhibitors).

Drugs Protected by US Patent 8,318,780

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genentech Inc	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	AB	RX	Yes	Yes	8,318,780					METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME INVOLVED IN PIRFENIDONE METABOLISM
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,318,780					ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,318,780					DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No	8,318,780					ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No	8,318,780					DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,318,780					DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,318,780					ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6

International Family Members for US Patent 8,318,780

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3155
Austria	E526024
Australia	2010212490
Australia	2011201462
Australia	2013204032
Australia	2013204049
Australia	2013204423