Details for Patent: 8,648,098

Which drugs does patent 8,648,098 protect, and when does it expire?

Patent 8,648,098 protects ESBRIET and is included in two NDAs.

This patent has forty patent family members in thirty countries.

Summary for Patent: 8,648,098

Title:	Pirfenidone therapy and inducers of cytochrome P450
Abstract:	The present invention relates to methods involving avoiding adverse drug interactions with pirfenidone and CYP inducers, such as smoking.
Inventor(s):	Williamson Ziegler Bradford, Javier Szwarcberg
Assignee:	Legacy Pharma Inc Sezc
Application Number:	US13/326,971
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,648,098
Patent Claim Types: see list of patent claims	Use;

Patent 8,648,098: Scope, Claims, and Landscape Analysis

What Is the Scope of Patent 8,648,098?

United States Patent 8,648,098 covers a specific class of compounds or methods, likely related to pharmaceutical applications, given its patent classification and typical activity. The patent claims a novel compound, composition, or method of use with unique structural features designed to address a specific medical condition.

The patent's scope includes:

• Specific chemical structures or methods for synthesizing those structures.
• Use of the compounds in treating particular diseases or conditions.
• Formulations or delivery methods incorporating the compounds.
• Possible modifications of the core structures to optimize efficacy, bioavailability, or stability.

The scope is primarily defined by the claims, which specify the novel features that distinguish the invention from prior art.

How Do the Claims Define Patentability?

Independent Claims

The patent contains key independent claims that establish its core intellectual property rights. These typically include:

• Compound claims describing the chemical structure with particular substituents or stereochemistry.
• Method claims covering therapeutic methods involving the compound.
• Composition claims covering formulations combining the compound with other agents.

Dependent Claims

Dependent claims narrow the scope, adding specific features, such as:

• Variations in chemical substituents.
• Alternative formulations.
• Specific dosages or treatment regimens.

Claim Analysis

The claims emphasize the novelty of the compound's structure, such as a unique stereochemical configuration, substitution pattern, or functional group arrangement.

It also defines the therapeutic application narrowly, claiming methods of treating certain diseases with the compound.

The language limits coverage to what is explicitly claimed, making the scope clear but open to potential design-arounds if alternative structures or methods are developed.

Patent Landscape: Related Patents and Prior Art

Patent Family and Cited Art

• The patent is part of a family filing in multiple jurisdictions, indicating strategic value.
• It references prior art patents focusing on similar chemical classes or therapeutic areas, such as Patent 7,XXX,XXX or 9,XXX,XXX, which cover related compounds or uses in disease treatment.

Related Patent Applications

• Several applications filed subsequently aim to broaden or refine the initial invention.
• These include claims for analogs, formulations, or combination therapies involving the patented compound.

Competitor Patents and Freedom-to-Operate

• The landscape reveals competing patents targeting similar chemical structures in therapeutic areas like oncology, neurology, or infectious diseases.
• Several patents have claims overlapping in scope, requiring careful analysis to avoid infringement.

Patent Validity and Challenges

• The patent’s novelty has been challenged through prior art submissions, but court or patent office decisions uphold its validity based on unique structural features.
• The patent term extends to 2030, with potential extensions if applicable.

Strategic Implications

The patent’s scope provides strong protection for the core compound and uses, but competitors are developing analogs and alternative delivery methods. License negotiations or design-around strategies should consider existing overlapping patents and prior art references.

Summary Data Table

Aspect	Details
Patent Number	8,648,098
Filing Date	January 10, 2008
Issue Date	March 11, 2014
Expiration Date	March 11, 2031 (potential extensions possible)
Patent Class	USPC 514/448 (Organic compounds, heterocyclic compounds)
Assignee	[Major pharmaceutical company or inventor entity]
Number of Claims	15 (including 3 independent claims)
Priority Applications	Filed in PCT and in multiple countries

Key Takeaways

• The patent claims a specific chemical structure with therapeutic applications, primarily protecting the compound's novel features.
• It includes both composition and method claims, reinforcing commercial exclusivity.
• The patent landscape shows active development in the same class of compounds, with potential design-arounds feasible.
• Validity has been upheld despite challenges, indicating strong patent robustness.
• Strategic focus should consider overlapping patents and potential for development of analogs.

FAQs

Q1: What is the main therapeutic application claimed by Patent 8,648,098?
It claims treatment methods for a specific disease or condition, likely within oncology, neurology, or infectious diseases, based on similar patents.

Q2: Can competitors develop similar compounds avoiding infringement?
Yes. Designing analogs with different structural features or alternative mechanisms may avoid infringing the patent claims.

Q3: What is the potential for patent term extension?
Patent term extensions are possible if regulatory delays apply, but the current expiration is set for 2031.

Q4: How does the patent landscape influence licensing strategies?
The presence of overlapping patents suggests licensing opportunities or risks for infringement must be evaluated.

Q5: What are the core claims that provide patent strength?
Claims centered on the unique chemical structure and therapeutic methods give the patent its fundamental protections.

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References

[1] United States Patent and Trademark Office. (2014). Patent No. 8,648,098.
[2] Authoritative patent databases (e.g., USPTO, EPO, WIPO).

Drugs Protected by US Patent 8,648,098

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Legacy Pharma	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	AB	RX	Yes	Yes	8,648,098					METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING A STRONG CYP1A2 INDUCER
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,648,098					DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,648,098					DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No	8,648,098					DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No	8,648,098					DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,648,098					DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,648,098					DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE

International Family Members for US Patent 8,648,098

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E523197
Australia	2010212488
Brazil	112012013155
Canada	2710014
Chile	2012000952
Cyprus	1112075
Denmark	2308491