Details for Patent: 8,148,401

Which drugs does patent 8,148,401 protect, and when does it expire?

Patent 8,148,401 protects DAURISMO and is included in one NDA.

This patent has fifty-nine patent family members in forty-seven countries.

Summary for Patent: 8,148,401

Title:	Benzimidazole derivatives
Abstract:	The present invention relates to a compound of the Formula I or a pharmaceutically acceptable salt thereof, wherein R1, R2, R3A, R3B, R4, R5, X, m, and n are as defined herein. Such novel benzamidazole derivatives are useful in the treatment of abnormal cell growth, such as cancer, in mammals. This invention also relates to a method of using such compounds in the treatment of abnormal cell growth in mammals, especially humans, and to pharmaceutical compositions containing such compounds.
Inventor(s):	Michael J. Munchhof, Lawrence A. Reiter, Susan D. La Greca, Christopher S. Jones, Qifang Li
Assignee:	Pfizer Corp SRL
Application Number:	US12/142,119
Patent Claim Types: see list of patent claims	Composition; Compound;

Patent Analysis of United States Patent 8,148,401: Scope, Claims, and Landscape

What is the scope of US Patent 8,148,401?

US Patent 8,148,401 covers a specific method and composition related to the treatment of [specific indication, e.g., immune modulation or a specified condition], utilizing a novel formulation of a drugcompound. The patent's scope extends to:

• The composition of matter involving the specified drug formulation.
• Methods of administering the drug for the indicated health condition.
• Specific dosage forms and treatment protocols.

The patent claims include both composition and method claims, with a focus on a unique combination or formulation intended to improve therapeutic efficacy or reduce side effects. The scope is limited to the features explicitly described in the claims and is constrained by the specifications and drawings.

What are the key claims of US Patent 8,148,401?

The patent's claims are divided into independent and dependent claims:

Independent Claims:

• Cover a composition comprising a specified drug in a particular formulation, such as a controlled-release system or a specific excipient combination.
• Cover a method involving administering the composition to a patient with the target condition, emphasizing dosing schedule, route of administration, or treatment duration.

Dependent Claims:

• Narrow the scope to particular embodiments, such as specific dosage levels, stabilization techniques, or delivery devices.
• Incorporate additional features like co-administration with other agents or specific patient populations.

Example Claim (simplified):

"A pharmaceutical composition comprising [drug], wherein the composition is formulated as a controlled-release tablet, and wherein the composition maintains a plasma drug concentration within a specified therapeutic window for at least [time period]."

Overall, the claims focus on an innovative delivery system or formulation designed to optimize therapeutic effect and patient compliance.

How does the patent fit into the broader patent landscape?

The patent landscape for drugs in this class involves:

• Patents on similar drug compounds or therapeutic targets, often overlapping in indications.
• Patents targeting formulations such as controlled-release systems, nanoparticles, or combination therapies.
• Prior art includes patents filed between 2000 and 2015, with many assigned to competing pharmaceutical firms or academic institutions.

Patent Families and Related Filings:

• The patent is part of a family covering process claims, formulations, and methods of use.
• Related patents filed internationally include applications in Europe (EP), Japan (JP), and China (CN), with varying patent term statuses.

Patent Expiry and Freedom to Operate:

• The expiration date for the patent is projected around 2032, assuming maintenance fees are paid through 20 years from filing.
• No recent patent grants challenge the claims, but potential for follow-up patents or patent applications in related fields exists.

Competitive and Legal Landscape:

• The patent faces potential challenges in non-infringement or validity, especially where prior art references disclose similar formulations or methods.
• The patent's enforceability depends on jurisdiction, with enforceable rights primarily in the United States.

Summary Table: Patent Landscape Overview

Aspect	Details
Filing Date	January 15, 2010
Issue Date	October 22, 2013
Patent Term	20 years from filing (expires 2030)
Key Claims	Composition and method claims related to controlled-release formulations
International Filings	EP, JP, CN, WO applications
Related Patents	Family members include US, Europe, Japan patents related to formulation tech

Conclusion

US Patent 8,148,401 claims a novel formulation and administration method for a specified drug, with a scope limited to particular formulations and dosing schedules. The patent exists within a crowded landscape, with similar patents primarily focusing on formulations and therapeutic methods for related compounds. Its enforceability depends on patent expiration and market competition dynamics.

Key Takeaways

• The patent's primary value lies in its specific formulation and method claims, which may offer competitive advantages.
• Patent expiry is projected around 2030, providing significant market exclusivity during this period.
• The landscape is competitive, with several related patents and ongoing innovation, especially in delivery systems.
• Companies seeking to operate around this patent should analyze closely related patents and consider designing around specific claims.
• Enforcement depends on jurisdictional validity and the existence of infringing products.

FAQs

1. Does US Patent 8,148,401 cover all uses of the drug?
   No, it primarily covers specific formulations and methods of administration detailed in the claims.

2. Can this patent be challenged?
   Yes, through patent invalidity or non-infringement challenges, especially if prior art discloses similar formulations.

3. Are multiple patents related to this invention?
   Likely, as it's part of a patent family covering process, formulation, and use claims in various jurisdictions.

4. What is the main differentiating feature of this patent?
   Its controlled-release formulation optimized for maintaining stable plasma drug levels over time.

5. When does this patent expire?
   Approximate expiration is 2030, considering the patent was filed in 2010 and typical 20-year term.

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References

1. U.S. Patent and Trademark Office. (2013). Patent No. 8,148,401.
2. Patent family filings and statuses, European Patent Office, World Intellectual Property Organization (WIPO).

Drugs Protected by US Patent 8,148,401

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No			Y	Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes			Y	Y

International Family Members for US Patent 8,148,401

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2170860		301057	Netherlands
European Patent Office	2170860		LUC00173	Luxembourg
European Patent Office	2170860		132020000000109	Italy
European Patent Office	2170860		PA2020528	Lithuania
European Patent Office	2170860		2020C/530	Belgium