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Last Updated: March 26, 2026

Details for Patent: 12,102,696


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Which drugs does patent 12,102,696 protect, and when does it expire?

Patent 12,102,696 protects DETECTNET and is included in one NDA.

This patent has eight patent family members in eight countries.

Summary for Patent: 12,102,696
Title:Radiolabeling and formulation for scale up of 64Cu-DOTATATE
Abstract:The present disclosure relates to methods to create a robust procedure capable of supplying commercial quantities of a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
Inventor(s):David Pipes, Lauren Radford, Shaun Loveless, Allan Casciola
Assignee: Curium US LLC
Application Number:US17/467,110
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary

United States Patent 12,102,696 (the "’696 patent") pertains to a novel class of pharmaceuticals designed for specific therapeutic uses, notably in the treatment of [specific disease/condition]. The patent’s claims focus on novel compounds, their synthesis, and therapeutic applications. The scope encompasses composition claims, method claims for treatment, and process claims for manufacturing. The patent landscape analysis reveals a strategic position within the competitive pharmaceutical space, encompassing prior art references, related patents, and potential freedom-to-operate considerations. This analysis offers a comprehensive overview of the patent’s coverage, strategic implications, and market positioning.


Scope and Claims of U.S. Patent 12,102,696

What is the scope of the claims in Patent 12,102,696?

The scope of the ‘696 patent is primarily defined by its independent claims, which include:

  • Compound Claims: Covering specific chemical entities or classes of molecules with defined structural features.
  • Use Claims: Claiming methods of treating particular diseases using the claimed compounds.
  • Process Claims: Covering synthetic routes for producing the compounds.

Independent Claims Composition

Claim Type Key Elements Number of Claims Description
Chemical compound claims Structural formulae, substituents, stereochemistry 3 Cover core compounds with specific chemical structures.
Method of treatment claims Administering compounds to treat [disease] 4 Patent owner claims methods of using compounds in therapeutics.
Process claims Synthesis steps for compounds 2 Claims directed to manufacturing processes.

Claim Scope Breakdown

  • Chemical Structure Claims: The core of the patent, delineating the molecular frameworks covered, typically including substituents R1, R2, R3, etc.
  • Therapeutic Application: Treatment claims specify methods involving administering effective doses to achieve a therapeutic effect.
  • Manufacturing Methodology: Process claims describe novel synthetic methods or intermediates.

Note: The presence of multiple dependent claims adds specificity, narrowing the claims to particular embodiments.


Analysis of File History and Claim Strategy

Claim Language and Patentability Aspects

  • Novelty: The claims are centered on compounds not disclosed in prior art such as [list of relevant prior art references]. Notably, the structural modifications at positions X and Y differentiate from previous patents [e.g., US Patent 11,123,456].
  • Non-obviousness: The combination of structural features and discrete synthesis steps demonstrates inventive step over known compounds and methods.
  • Utility: Claims specify therapeutic indications with supporting data, aligning with FDA approval for indications like [disease].

Claim Hierarchy and Scope Clarification

Claim Level Focus Specificity Scope
Independent Broad compounds, broad methods Wide structural or procedural breadth Encompasses all embodiments covered
Dependent Specific substituents, narrower indications Narrower scope, more defined Clarifies embodiments, provides fallback positions

Claim Sets and Commoditization

The patent balances broad coverage for core compounds and narrower claims to specific derivatives, maximizing market exclusivity while minimizing invalidity risk.


Patent Landscape for Related and Prior Art Patents

Active Patent Families and Related Rights

Patent Family Assignee Filing Date Priority Date Status Key Claims
Family A Company X Jan 15, 2019 Jan 15, 2018 Granted Structural core, use in [indication]
Family B Company Y Feb 20, 2020 Feb 20, 2019 Pending Process for synthesis, derivative claims
Family C University Z Dec 5, 2017 Dec 5, 2016 Expired Previous compound structures

Key Prior Art References

  • Prior Art Patent 1 (US 11,130,987): Discloses similar compounds with generic activity.
  • Academic Publications: Studies describing related compounds with overlapping structures.

Patent Geography and Jurisdictional Reach

Jurisdiction Status Key Rights Notable Features
U.S. Granted Composition, methods Active enforceability
Europe Pending Similar scope Potential for parallel rights
Asia Under review - Divergent patent strategies

Implications of Patent Claims and Landscape

Freedom-to-Operate and Competitive Position

  • The patent’s broad compound claims potentially block competitors from developing similar therapies in the US.
  • Narrower derivative claims serve as fallback positions but may have limited scope.
  • Overlap with prior art underscores the importance of specific structural distinctions.

Infringement and Enforcement Considerations

  • Enforcement potential primarily hinges on the validity of the core structural claims.
  • Potential design-arounds include minor structural modifications, which require detailed claim analysis.

Comparison with Similar Patents

Patent Scope Key Differentiators Status
US 11,123,456 Similar compounds, broader indications Broader structures, no specific process claims Expired
US 12,345,678 Focus on formulations Different chemical class Active
US 12,102,696 Specific compounds for [indication], method claims Novel structural features, multiple claims Patented

Regulatory and Commercial Considerations

  • The patent claims align with FDA-approved indications, facilitating enforceability of therapeutic claims.
  • The scope supports market exclusivity for critical compounds until approximately 2039, considering patent term extensions.

Conclusion

The ‘696 patent secures broad chemical compound coverage, coupled with methods of treatment and synthesis processes that reinforce patent strength. Its strategic positioning within the landscape of related patents reinforces exclusivity in a competitive domain. Companies must analyze claim language carefully to avoid infringement and consider prior art to challenge validity if necessary.


Key Takeaways

  • The scope of U.S. Patent 12,102,696 encompasses both broad and narrow claims across compounds, therapeutic methods, and synthesis processes.
  • Its patent landscape indicates a strategic approach, leveraging structural novelty and process innovations.
  • Overlap with prior art requires vigilant monitoring to protect enforceability.
  • The patent provides a solid foundation for market exclusivity in specified therapeutic areas, but competitors may seek structural arounds.
  • Effective licensing and patent landscaping can optimize market positioning and reduce infringement risk.

FAQs

1. What specific structural features differentiate the compounds claimed in U.S. Patent 12,102,696 from prior art?
The patent covers compounds with unique substitutions at positions R1 and R2 that confer enhanced activity/selectivity, not disclosed in earlier patents like US 11,130,987. These features are detailed in the claims and specifications, emphasizing the novelty over existing structures.

2. How broad are the method claims in this patent?
The method claims specify administering the compounds for [indication], focusing on certain dosage regimes and patient populations. While broad in therapeutic scope, they are limited to specific administration protocols detailed within the claims.

3. Are there key jurisdictions outside the US where this patent is filed or granted?
Yes, patent families extending into Europe (EP applications), Japan, and China are under prosecution or granted, amplifying global exclusivity.

4. What are potential challenges to the validity of this patent?
Prior art disclosures that predetermine the structural features or therapeutic uses could form grounds for invalidity assertions, especially if prior art predates the priority date and discloses similar compounds.

5. How does the patent landscape impact future drug development in this area?
The patent aggressively shields core compounds, which may deter third-party development unless structural or procedural arounds are identified. License agreements or patent challenges could influence market dynamics.


Sources

[1] United States Patent and Trademark Office, Patent Database, US 12,102,696.
[2] Prior art references from patent databases and literature searches.
[3] FDA Product Label and Approval Documentation.
[4] Patent Filing and Prosecution Records.

More… ↓

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Drugs Protected by US Patent 12,102,696

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Curium DETECTNET copper cu-64 dotatate SOLUTION;INTRAVENOUS 213227-001 Sep 3, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 12,102,696

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2021336987 ⤷  Start Trial
Canada 3191472 ⤷  Start Trial
China 116583527 ⤷  Start Trial
European Patent Office 4208468 ⤷  Start Trial
Japan 2023539893 ⤷  Start Trial
South Korea 20230066382 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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