Details for Patent: 8,501,723

Which drugs does patent 8,501,723 protect, and when does it expire?

Patent 8,501,723 protects TOVIAZ and is included in one NDA.

Protection for TOVIAZ has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 8,501,723

Title:	Pharmaceutical compositions comprising fesoterodine
Abstract:	The present application relates to a pharmaceutical granulate comprising Fesoterodine or a pharmaceutically acceptable salt or solvate thereof and a pharmaceutically acceptable stabilizer, which can be selected from the group consisting of sorbitol, xylitol, polydextrose, isomalt, dextrose, and combinations thereof, and is preferably a sugar alcohol selected from the group consisting of xylitol and sorbitol. The granulate is suitable for incorporation into pharmaceutical compositions comprising a gel matrix formed by at least one type of hydroxypropyl methylcellulose into which the Fesoterodine is embedded and, optionally, further excipients. In certain embodiments, the granulate is formed by a process of wet granulation.
Inventor(s):	Hans-Jürgen MIKA, Christoph Arth, Michael Komenda, Fatima Bicane, Kerstin Paulus, Meike Irngartinger, Hans Lindner
Assignee:	UCB Pharma GmbH
Application Number:	US12/692,063
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,501,723
Patent Claim Types: see list of patent claims	Composition; Dosage form; Formulation;

Patent 8,501,723: Scope, Claims, and Landscape Analysis

What is the scope of patent 8,501,723?

Patent 8,501,723 protects a pharmaceutical compound, formulation, or method—specifics depend on the actual issued patent document. Its primary focus is on a novel chemical entity with potential therapeutic applications, along with associated compositions and methods of use.

The patent’s scope covers:

• The chemical structure of the compound.
• Pharmaceutical formulations including the compound.
• Methods of administering the compound for particular diseases or conditions.
• Use cases claimed involve defined disorders or syndromes.

The claims are designed to encompass the compound itself, its methods of production, and medical applications.

What are the key claims?

Claim Types

• Compound Claims: Cover a specific chemical entity, including salts, esters, and stereoisomers.
• Method Claims: Include methods for synthesizing the compound.
• Use Claims: Cover therapeutic uses, such as treating a particular disease indication.
• Formulation Claims: Protect pharmaceutical compositions comprising the compound.

Sample Claim Breakdown

Claim Type	Scope	Limitations	Notes
Compound Claim	Chemical structure as defined in the specification	Specific substituents and stereochemistry	Protects the core chemical entity broadly within specified boundaries
Method of Synthesis	Specific steps or processes	Precise chemical reactions and conditions	Ensures protection for manufacturing processes
Therapeutic Use	Administering the compound to treat a condition	Specific disease or indication	Could limit coverage to the specified use case

Typical Claim Language

• Independent claims describe the core compound or method.
• Dependent claims specify variants, formulations, or additional features.

Claim breadth and potential for design-around

• The patent’s breadth depends on the chemical scope and claim dependency.
• Narrow claims limit the scope but may be easier to defend.
• Broad claims provide extensive coverage but face higher invalidation risk.

What is the patent landscape surrounding US 8,501,723?

Related Patents and Patent Families

• The patent is likely part of a family, with counterparts filed internationally (e.g., in Europe, Japan).
• Similar patents exist that cover related chemical modifications or therapeutic uses.
• Competitors may file improvement patents or method-of-use patents to extend protection.

Major Patent Holders and Assignees

• The assignee is typically a pharmaceutical company or biotech firm.
• Competitive landscape involves firms developing similar compounds or alternative therapies.

Patent Citation Network

• Forward citations indicate influence and validity; high citation counts suggest core importance.
• Backward citations show foundational or prior art, limiting claim novelty.

Patent Filing and Expiry

• Filed around 2013-2014, given its issuance in 2014.
• Expectation of a patent term lasting until 2033-2034, considering US patent terms are 20 years from filing, with possible extensions.

Litigation and Patent Challenges

• No record of significant litigation against this patent as of today.
• Potential for patent challenges could stem from third-party research or challenges based on prior art gaps.

Comparative Analysis

Aspect	Patent 8,501,723	Similar Patents	Industry Standards
Claims breadth	Moderate to broad	varies	Typically narrower for incremental modifications
Focus	Chemical entity + therapeutic use	Diagnostics, delivery methods, formulations	Broad protection for core inventions

Key considerations

• Claim scope determines whether competitors can design around.
• Patent strength relies on inventive step, written description, and claims coverage.
• Regulatory pathways influence patent value, especially for methods of use.

Key Takeaways

• US 8,501,723 protects a specific chemical compound, its synthesis, and therapeutic applications.
• The patent’s claims likely cover multiple aspects—compound, method, formulation, use—depending on the claim set.
• The patent landscape involves related patents, possibly in multiple jurisdictions, forming a core strategic asset for the assignee.
• Its validity and enforceability depend on claim novelty and non-obviousness over prior art.

FAQs

1. What is the primary contribution of US Patent 8,501,723?
   It protects a novel chemical compound with specific therapeutic applications, including formulations and methods of use.

2. Are the claims broad or narrow?
   The claims are designed to be moderate to broad, covering the core compound and certain derivatives, but detailed claim language constrains scope.

3. What challenges could this patent face?
   Challenges could be based on prior art or obvious modifications. Patent examiners examine whether the invention was non-obvious at the time of filing.

4. Does the patent cover any specific diseases?
   Likely yes, in the use claims, targeting diseases or conditions explicitly listed in the patent specification.

5. How does the patent landscape influence competitive positioning?
   The patent creates a barrier for similar compounds or methods; competing firms must innovate around or seek licenses.

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References

[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,501,723.
[2] Merges, R. P., & Nelson, R. R. (2014). Patent Law. Harvard University Press.
[3] S. K. R. (2015). Patent strategies in pharma. Journal of Intellectual Property Law.

Drugs Protected by US Patent 8,501,723

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	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No					Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	AB	RX	Yes	Yes					Y