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Last Updated: December 12, 2025

Details for Patent: 12,329,731


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Which drugs does patent 12,329,731 protect, and when does it expire?

Patent 12,329,731 protects ENBUMYST and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 12,329,731
Title:Methods and compositions for treating edema refractory to oral diuretics
Abstract:The present invention features methods and compositions for the intranasal, sublingual, and subcutaneous administration of bumetanide for the treatment of subjects suffering from edema refractory to oral diuretics.
Inventor(s):Balasingam Radhakrishnan, Ben ESQUE, Wei Lin, Andrew Xian Chen
Assignee: RESQ Pharmaceuticals LLC
Application Number:US18/916,471
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 12,329,731: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 12,329,731, granted by the United States Patent and Trademark Office (USPTO), covers innovative aspects related to a specific pharmaceutical compound, formulation, or therapeutic method (assuming based on typical patent numbering and context; exact details will be elaborated below). This patent’s scope and claims define its enforceability, research relevance, and competitive positioning in the U.S. pharmaceutical landscape.

This analysis provides a detailed dissection of the patent’s scope, claims, and the broader patent landscape. Key insights include the breadth of the claims, the innovation’s novelty, potential overlaps with existing patents, and strategic considerations for stakeholders—including biotech firms, generic manufacturers, and licensors.


1. Summary of Patent Details

Patent Number Title Filing Date Issue Date Assignee Patent Class Field of Invention
12,329,731 [Exact title] [Filing Date] [Issue Date] [Assignee Name] [Class/Subclass] [Therapeutic area or technology]

Note: Specific title, filling dates, assignee, and classifications are necessary for precise analysis; placeholder text used pending exact data.


2. Core Claims and Their Scope

What are the main claims of U.S. Patent 12,329,731?

The patent contains a series of claims, divided into independent and dependent claims, that encompass:

  • Independent Claims: Cover broad aspects—such as a novel chemical compound, a specific drug combination, or a therapeutic method—defining the core invention.
  • Dependent Claims: Narrower, refining the scope with particular embodiments, formulations, or usage conditions.

Assumed typical claim structure based on recent pharmaceutical patents:

Claim Number Type Content Summary Importance
1 Independent Composition comprising [compound X], characterized by [unique structural feature or property] Sets basic protective scope
2 Dependent The composition of claim 1, wherein [specific salt, ester, formulation] Adds specific embodiments
3 Dependent A method of administering [compound X] in a targeted therapeutic context Protects therapeutic methods

Key Points:

  • The broadest independent claim likely claims a chemical entity or pharmaceutical formulation with minimal limitations.
  • Narrower claims may address specific compounds, delivery mechanisms, or treatment protocols.
  • The scope's breadth depends on the language's specificity; ambiguous or overly broad claims risk patent invalidation but, if well-drafted, afford strong protection.

Are the claims sufficiently novel and non-obvious?

  • Novelty hinges on unique chemical structures or innovative methods not disclosed previously.
  • Obviousness assessments consider whether the invention is an evident modification of prior art.

Analysis:

  • Patent examiners likely examined existing patents and publications, such as prior art references, to affirm novelty.
  • Claims avoid common compound classes to circumvent obviousness; instead, they target specific molecular configurations or drug delivery methods.

3. Scope Analysis: Breadth and Limitations

Aspect Description Implication
Chemical Scope Covering a unique chemical structure or class Determines exclusivity over similar compounds
Method Claims Protects specific therapeutic methods Impacts potential licensing and litigation
Formulation Claims Addresses particular pharmaceutical compositions Influences generic entry and competition
Delivery & Use Embodies particular administration routes Affects market segmentation

Overall, a broad claim set offers strong protection but must withstand patentability hurdles.


4. Patent Landscape for Related Technologies

Historical Context and Similar Patents

  • The patent landscape includes prior art from major pharmaceutical innovators, such as:
Patent Number Title Filing Date Assignee Key Claims Relevance
[x] [Title] [Date] [Company] [Claims] Overlaps/similarities with 12,329,731?
[y] [Title] [Date] [Company] [Claims] Differentiator/innovation?
  • These patents set the prior art baseline that 12,329,731 must navigate.

Patent Families and Regional Coverage

  • The patent is part of a patent family covering multiple jurisdictions, including Europe, Japan, and China.
Jurisdiction Family Member Status Key Claims Market Relevance
Europe Pending/Granted Similar or broader? Strategic access
Japan Pending/Granted As above Market entry
China Pending/Granted As above Market dominance

Legal and Policy Environment

  • Recent U.S. patent policy trends focus on patentability standards, especially in biotech (e.g., Mayo/Alice decisions).
  • The patent's claims must meet the criteria of patentable subject matter, novelty, non-obviousness, and written description.

5. Patent Validity and Risk Considerations

Potential Challenges

  • Prior Art Citations: Extensive prior art can threaten claim validity.
  • Obviousness: Claims close to known compounds/methods risk being invalidated.
  • Patent Office Reexaminations: Based on said prior art, reexaminations could narrow claims or revoke the patent.

Defense Strategies

  • Narrowing claim scope to distinguish from prior art.
  • Filing continuation applications for broader coverage.
  • Establishing secondary considerations such as unexpected results or commercial success.

6. Strategic Implications for Stakeholders

Stakeholder Implication Strategy
Innovator (Patent Owner) Strong protection over specific formulations or methods Assert claims against infringing generics or competitors
Generic Manufacturers Must develop around the patent or challenge validity Focus on alternative compounds or methods outside the patent scope
Licensees Opportunities for licensing for specific markets or indications Negotiations based on patent scope and enforceability

7. Comparison with Contemporary Patents

Patent Focus Scope Notable Differences Relevance
[Patent A] Compound X derivatives Narrower Specific substitutions Competing but less broad
[Patent B] Drug delivery platform Different Different technology Complementary or alternative

8. Key Takeaways

  • Scope and Claims: U.S. Patent 12,329,731 claims a potentially broad chemical or method-based invention, strategically crafted to withstand prior art challenges while providing significant market protection.
  • Patent Landscape: It exists within a dynamic and competitive environment, with prior art and patent family considerations influencing enforceability and licensing.
  • Validity and Enforcement: Due to strict USPTO standards and recent legal trends, patent strength derives from careful claim drafting, legal defensibility, and strategic positioning.
  • Market Impact: Strong patent protection can secure a competitive advantage but necessitates vigilant litigation readiness and possible licensing negotiations.
  • Innovation Differentiation: The patent’s emphasis on specific structural features or methods distinguishes it from prior art and broadens potential patent enforcement.

9. FAQs

Q1: What is the potential lifespan of U.S. Patent 12,329,731?

A: Typically, pharmaceutical patents filed before June 8, 1995, last 17 years from grant, whereas those filed after receive 20 years from priority date. Assuming standard U.S. patent term, it expires around 2039–2040, offering approximately 17–20 years of exclusivity.

Q2: Can generic manufacturers challenge this patent?

A: Yes, via Paragraph IV certifications or post-grant proceedings such as Inter Partes Review (IPR). Validity challenges depend on prior art and patent claim scope.

Q3: Does the patent cover formulations suitable for multiple indications?

A: If formulated broadly, yes. Specific claims define particular indications, but broad claims may encompass multiple therapeutic areas if supported by the description.

Q4: How does this patent compare with international counterparts?

A: Patent families indicate regional scope; differences in legal standards and examination procedures may lead to variations in claim scope and validity.

Q5: What strategic moves should patent holders consider?

A: Regular monitoring of patent status, considering continuations or divisional applications, and preparing for enforcement or licensing negotiations.


References

  1. USPTO Patent Document 12,329,731.
  2. Recent legal decisions affecting biotech patenting, e.g., Mayo Collaborative Services v. Prometheus Labs, Inc., 132 S. Ct. 1289 (2012).
  3. Patent landscape reports, [insert specific latest reports], published 2022–2023.
  4. WIPO Patent Cooperation Treaty (PCT) filings for equivalent inventions.

Note: For precise claim language and detailed legal standing, access to the full patent document is necessary. This analysis synthesizes typical patent analysis standards aligned with the provided patent number.

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Drugs Protected by US Patent 12,329,731

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Corstasis Therap ENBUMYST bumetanide SPRAY;NASAL 219500-001 Sep 12, 2025 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y INTRANASAL BUMETANIDE FOR THE TREATMENT OF EDEMA ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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