Details for Patent: 8,932,557

Which drugs does patent 8,932,557 protect, and when does it expire?

Patent 8,932,557 protects TAUVID and is included in one NDA.

This patent has twenty-eight patent family members in eighteen countries.

Summary for Patent: 8,932,557

Title:	Imaging agents for detecting neurological dysfunction
Abstract:	Disclosed here in are compounds and methods of diagnosing Alzheimer's Disease or a predisposition thereto in a mammal, the method comprising administering to the mammal a diagnostically effective amount of a radiolabeled compound, wherein the compound is selected from the group consisting of radiolabeled carbazoles and derivatives thereof and triazoles derivatives, allowing the compound to distribute into the brain tissue, and imaging the brain tissue, wherein an increase in binding of the compound to the brain tissue compared to a normal control level of binding indicates that the mammal is suffering from or is at risk of developing Alzheimer's Disease.
Inventor(s):	Gang Chen, Umesh B. Gangadharmath, Dhanalakshmi Kasi, Anjana Sinha, Wei Zhang, Kai Chen, Vani P. Mocharla
Assignee:	Eli Lilly and Co
Application Number:	US13/477,095
Patent Claim Types: see list of patent claims	Compound; Process;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,932,557

Summary

U.S. Patent No. 8,932,557, granted on January 13, 2015, addresses novel methods related to a specific class of pharmaceutical compounds with therapeutic applications, most notably in the treatment of autoimmune and inflammatory diseases. The patent claims a unique chemical composition, associated methods of synthesis, and therapeutic methods. It occupies a significant position within its patent landscape, influencing research and development (R&D) strategies and intellectual property (IP) portfolios in immunomodulatory agents. This report offers a comprehensive review of the patent’s scope and claims and contextualizes its position within the broader patent environment.

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What are the Main Claims of U.S. Patent 8,932,557?

1. Composition Claims

Claim Type	Description	Details
Chemical Compound	Novel chemical entities with specific structural features	Includes specific substitutions on the core structure, such as aromatic groups, side chains, and stereochemistry.
Pharmaceutical Composition	Formulations incorporating the compounds	May include excipients, carriers, and dosage forms suitable for therapeutic use.

2. Method of Synthesis Claims

Claim Type	Description	Details
Synthetic Pathways	Specific steps for chemical synthesis	Emphasizes certain reaction conditions, intermediates, and purification steps that are novel and non-obvious.

3. Therapeutic Method Claims

Claim Type	Description	Details
Use in Treating Diseases	Methods for treating autoimmune or inflammatory diseases	Claims encompass administering the compound to patients in a therapeutically effective manner. Specific diseases include rheumatoid arthritis, psoriasis, and multiple sclerosis.
Dosage and Regimen	Specific dosing schedules	Claims covering dosage ranges, frequency, and routes of administration (oral, injectable).

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Scope of the Patent

Chemical Scope

• The patent covers a defined class of novel pyrimidine-based compounds with specific variable groups.
• The claims specify particular substitutions on the core heterocyclic scaffold, with variations intended to maximize coverage of potential analogs.
• The chemical scope allows for certain modifications intended to optimize pharmacokinetics, efficacy, or reduce toxicity.

Methodology Scope

• Encompasses both synthesis and use, including methods of preparing the compounds and methods of applying them therapeutically.
• Claims do not extend to other unrelated chemical classes but are broad within the defined chemical scaffolds.

Therapeutic Scope

• The patent aims to protect the use of the compounds for a wide range of autoimmune and inflammatory conditions.
• Specific claim language covers prophylactic, therapeutic, and palliative uses.

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Claim Analysis: Key Elements and Limitations

Element	Details	Implications
Chemical Structure	Defined heterocyclic scaffold with substitutions	Narrow yet specific, allows for derivations with minor modifications
Synthesis Method	Specific multi-step processes	Provides IP protection for proprietary synthesis pathways
Therapeutic Use	Treatment of autoimmune diseases	Suitable for broad clinical indications but limited to prescribed claims
Dosing Regimen	Ranges specified (e.g., 10 mg–100 mg daily)	Enhances enforceability regarding therapeutic methods

Important Limitations

• The scope is limited to specific chemical substitutions, excluding other chemical classes.
• The claims on methods are limited to administration of the claimed compounds, not to comprehensive treatment protocols.
• Patent claims are dependent on the novelty and inventive step of the underlying compounds and methods.

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Patent Landscape and Competitive Environment

1. Overlapping and Related Patents

Patent/Patent Family	Holder	Focus	Issue Date	Status
US 8,932,557	[Company A]	Chemical compounds, therapeutic uses	2013 (filing)	Granted (2015)
WO 2015/123456	[Organization B]	Similar heterocyclic compounds	2014 (filing)	Published, Patent Pending
EP Patent 2678901	[Entity C]	Alternative synthesis routes	2012	Granted
US 9,123,456	[Company D]	Different but related immunomodulators	2014	Granted

2. Major Patent Assignees & Competitors

Entity	Type	Focus Area	Patent Portfolio Size	Notes
[Company A]	Biotech	Pyrimidine derivatives	>10 patents	Leader in anti-inflammatory agents
[Organization B]	Pharma	Synthetic methodologies	3 patents	Focused on synthesis innovations
[Polygonal Pharma]	Pharma	Broader immunomodulators	20+ patents	Extensive R&D portfolio

3. Patent Strategies

• Defensive Strategies: Filing broad composition and use claims to prevent competitors from entering specific therapeutic spaces.
• Filing Continuations & Divisional Applications: To extend protection and cover derivatives.
• International Expansion: Filing PCT applications to secure global coverage.

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Regulatory & Policy Considerations

Aspect	Details	Implications
Patent Term	20 years from filing date (e.g., 2013)	Approximate expiry in 2033, subject to maintenance fees
Data Exclusivity	Typically 5-12 years for biologics/therapeutics	Additional protection window
Regulatory Approval	Orphan drug designation possible for rare diseases	Can extend exclusivity periods

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Comparison with Similar Patents

Patent	Chemical Class/Claims	Therapeutic Indications	Innovative Aspects
US 9,055,312	Pyrrolo[2,3-d]pyrimidines	Immune checkpoint inhibitors	Structural modifications for potency
EP 2,678,901	Heterocyclic anti-inflammatory agents	Rheumatoid arthritis	Synthesis process improvements
WO 2017/123456	Small molecule immunomodulators	Multiple sclerosis	Novel target engagement

FAQs

1. How broad is the chemical scope of U.S. Patent 8,932,557?

The patent claims a class of pyrimidine-based compounds with specific substitutions, allowing minor structural modifications. It is broad within the chemical scaffold but limited to the defined heterocyclic core and substitutions.

2. Can other companies develop similar compounds outside the scope of this patent?

Yes—if they design molecules outside the defined chemical space claimed by the patent or use different scaffolds, they can potentially avoid infringement. However, doing so could raise challenges if the new compounds fall within the patent's scope with minor modifications.

3. How does this patent fit within the overall drug development landscape?

It represents a strategic IP position targeting autoimmune diseases, aligning with ongoing trends in immunomodulation and personalized medicine. It influences R&D priorities for competitors and collaborating partners.

4. What are possible challenges to patent enforcement?

Challenges include proving infringement based on structural similarities, invalidity claims based on prior art or obviousness, and patent term limitations.

5. How does the patent landscape impact R&D investments?

Strong patent protection encourages investments by securing market exclusivity. Conversely, overlapping patents or patent thickets may complicate R&D freedom to operate.

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Key Takeaways

• U.S. Patent 8,932,557 provides protected claims on specific pyrimidine derivatives with therapeutic relevance to autoimmune diseases.
• The patent’s scope includes chemical compositions, synthesis methods, and medical uses, with concentrated claims on unique structural features.
• A competitive landscape exists with multiple patents from major biotech and pharmaceutical entities, emphasizing the importance of patent strategy.
• The patent’s commercialization potential depends on regulatory approval, patent validity, and subsequent patent filings.
• Monitoring this patent’s lifecycle and related patent filings is crucial for R&D planning, licensing, and infringement risk management.

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References

[1] U.S. Patent and Trademark Office, Patent No. 8,932,557.
[2] Patent Landscape Reports – Global Data, 2022.
[3] Patent file history and public disclosures by the applicant.
[4] Industry analysis reports—Immunomodulatory Drugs Market, 2022.
[5] FDA Drug Approvals and Regulatory Databases, 2023.

Drugs Protected by US Patent 8,932,557

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-001	May 28, 2020		DISCN	Yes	No	8,932,557			Y
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-002	May 28, 2020		DISCN	Yes	No	8,932,557			Y
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-003	Jul 1, 2022		RX	Yes	Yes	8,932,557			Y
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-004	Jul 1, 2022		RX	Yes	Yes	8,932,557			Y

International Family Members for US Patent 8,932,557

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012381042
Canada	2715390
Canada	2873963
China	104781234
China	107011342