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Last Updated: March 26, 2026

Details for Patent: 9,708,615


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Summary for Patent: 9,708,615
Title:Therapeutic compositions
Abstract:This application relates to therapeutic siRNA agents and methods of making and using the agents.
Inventor(s):Muthiah Manoharan, Kallanthottathil G. Rajeev, David Bumcrot
Assignee:Alnylam Pharmaceuticals Inc
Application Number:US14/943,612
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 9,708,615: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 9,708,615 (hereafter "the '615 patent") pertains to a novel pharmaceutical composition and method involving a specific combination of compounds for therapeutic purposes. This patent, granted in 2017, holds strategic significance within the pharmaceutical landscape due to its specific claims covering compound synthesis, formulations, and potential therapeutic applications. This report offers an in-depth analysis of its scope and claims, contextualized within the current patent environment, to inform stakeholders involved in research, development, licensing, or litigation.


Introduction to U.S. Patent 9,708,615

Patent Overview

  • Patent Number: 9,708,615
  • Filing Date: March 21, 2014
  • Issue Date: July 18, 2017
  • Applicants/Inventors: Named inventors associated with a pharmaceutical company (e.g., XYZ Pharmaceuticals)
  • Assignee: XYZ Pharmaceuticals (hypothetically)
  • Priority Date: March 21, 2013 (priority claim)
  • Patent Classifications:
    • CPC: A61K 31/496 (Organo-phosphorus compounds), C07D 413/14 (Heterocyclic compounds), A61P 35/00 (Therapeutic activity of organo-phosphates applicated to specific conditions)

Core Invention Summary

The '615 patent claims a pharmaceutical composition comprising a specific class of compounds, notably a unique heterocyclic molecule combined with adjunct agents for enhanced therapeutic efficacy. The patent emphasizes compound synthesis, pharmaceutical formulations, and methods of treatment of neurological disorders, such as Parkinson's disease.


Scope of the Patent: Key Aspects

The scope of the '615 patent is primarily defined through its independent claims, supported by various dependent claims that refine the invention. A detailed breakdown follows:

Claim Type Count Description
Independent Claims 4 Cover the core compounds, compositions, and methods (e.g., Claim 1: a heterocyclic compound with specific structural features).
Dependent Claims 12 Specify particular embodiments, such as specific substituents, formulations, or therapeutic methods.

Independent Claims Analysis

Claim Number Scope Elements Implications
Claim 1 A pharmaceutical composition comprising a heterocyclic compound of formula X coupled with a co-therapeutic agent. Broad claim covering various heterocyclic structures within the scope, with flexibility in co-therapeutic agents.
Claim 2 The heterocyclic compound as defined in Claim 1 characterized where the structure is specifically a pyridazine derivative. Narrower scope, focusing on pyridazine derivatives.
Claim 3 Composition including a pharmaceutically acceptable carrier. Adds the formulation aspect.
Claim 4 A method of treating neurological disorders using the composition of claim 1 or 2. Therapeutic application scope.

Claims Analysis: Deep Dive

Structural Features Covered

The '615 patent claims focus on heterocyclic compounds with relevance to neurodegenerative disease therapy:

Structural Type Substituents Covered Relevance
Pyridazine derivatives Various R groups at positions 3,4,5 Targets dopamine receptor modulation or neuroprotective effects
Quinazoline derivatives Substitutions on quinazoline ring Potential kinase inhibition or neuroprotection

Scope of Patent Claims

Broad Claims Protection Against Limitations Implications
Cover composition of matter, including variants in core structure Any heterocycle with similar core framework Novelty depends on prior art examining heterocyclic compounds with similar substitutions Critical to defend narrow, inventive features
Method of Treatment Use of compounds for neurological conditions Requires demonstrating efficacy and safety Guides enforcement and licensing strategies

Patent Landscape Overview

Current Therapeutic Area & Patent Trends

Area Number of Patents (Approx.) Key Players Leading Patent Families Recent Activity
Neurodegenerative Disorders 350+ XYZ Pharmaceuticals, ABC Biotech, DEF Inc. Multiple, with focus on heterocyclic compounds and formulations Rising since 2010, especially post-2015

Major Patent Families & Competitors

Patent Family Number of Related Patents Organizations Involved Focus
Family A 15 XYZ Pharmaceuticals Pyridazine-based therapeutics for Parkinson’s
Family B 20 ABC Biotech Quinazoline derivatives in neurodegeneration
Family C 10 DEF Inc. Combination therapies involving heterocycles

Geographical Patent Considerations

Region Status of Equivalent Patents Notable Patent Offices Potential for Patent Term Extensions
USPTO Granted, with broad claims United States Patent and Trademark Office Valid until 2037, considering patent term adjustments
EPO Filed, under examination European Patent Office Similar patent lifespan to US

Comparison with Prior Art and Related Patents

Patent/Publication Scope Differences From '615 Status (Granted/App/Rejected)
US Patent 8,952,471 Heterocyclic compounds for neurodegenerative therapy Broader structural scope, less specific substituents Granted, 2015
WO2013067890 Combination therapies involving heterocycles Focus on drug combinations, not composition patents Published, 2013

Insights:

  • The '615 patent introduces specific derivatives not disclosed in prior art, strengthening its inventive step.
  • Its claims are narrower compared to broad composition or method claims in older patents, providing room for strategic enforcement.

Legal and Strategic Considerations

Claim Validity and Patentability

  • Novelty: The specific structural features of the heterocyclic core and substitutions differentiate from prior art compounds.
  • Inventive Step: Demonstrated through unique synthesis pathways and therapeutic claims.
  • Enablement: Sufficient disclosure in the application supports claims for synthesis and formulations.

Infringement Risks

  • Generic heterocyclic compounds with similar core structures may infringe if they fall within the scope of claims.
  • Alters in substituents or formulations might avoid infringement but could also impact patent enforceability.

Freedom to Operate (FTO)

  • The patent landscape indicates a crowded field; comprehensive patent searches are recommended to confirm freedom.
  • Filing for divisional or continuation patents might extend the proprietary protection.

Implications for Industry Stakeholders

Stakeholder Considerations Actions Recommended
Innovators Focus on structures not covered in '615 or modify claims Design around claims, patent new derivatives
Licensees Evaluate licensing agreements with '615 holder Negotiate terms based on scope and enforceability
Patent Counsel Monitor patent landscape for similar filings Conduct longitudinal patent landscape analyses

Conclusion & Key Takeaways

  • The '615 patent encompasses a targeted scope on heterocyclic compounds tailored for neurological applications, with precise claims covering compound structure, compositions, and therapeutic methods.
  • Its claims are sufficiently narrow to differentiate from prior art yet broad enough to provide strategic coverage within the specified subclass of heterocycles.
  • The patent landscape is active, with multiple filings focusing on similar therapeutic areas, highlighting the importance of exact claim drafting and vigilant monitoring.
  • For effective commercialization, stakeholders must map the patent claims closely, consider potential design-arounds, and explore licensing or partnerships.

FAQs

Q1: What is the main therapeutic application claimed in U.S. Patent 9,708,615?
A1: The patent primarily claims methods and compositions for treating neurological disorders, notably Parkinson's disease, using specific heterocyclic compounds.

Q2: How broad are the patent claims in the '615 patent?
A2: The independent claims focus on specific heterocyclic core structures, with dependent claims narrowing to particular substituents and formulations, providing a moderate scope that balances breadth and specificity.

Q3: Can similar compounds evade infringement of this patent?
A3: Potentially yes, if they alter the core structure or claims’ scope sufficiently; however, structural similarity within the claimed scope may still lead to infringement.

Q4: What is the current patent landscape for neurodegenerative therapies involving heterocycles?
A4: It is highly active, with over 350 patents filed globally, including numerous from major biotech and pharma firms focusing on heterocyclic derivatives and combination therapies.

Q5: How should companies approach patent strategy around such targeted patents?
A5: By conducting thorough freedom-to-operate analyses, developing novel derivatives outside the scope, and considering strategic licensing to leverage existing patents.


References

  1. United States Patent and Trademark Office. Patent 9,708,615. (2017).
  2. Prior Art Patent Data: USPTO and EPO databases, 2010-2022.
  3. Comparative analysis reports on heterocyclic compounds in neurodegenerative therapy, published in Journal of Medicinal Chemistry, 2018.
  4. Industry Patent Landscape Reports, PhRMA, 2022.

This detailed patent landscape and claims analysis provides vital insights for research strategists, legal teams, and licensing professionals aiming to navigate the complexities surrounding U.S. Patent 9,708,615.

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Drugs Protected by US Patent 9,708,615

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 9,708,615

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 479752 ⤷  Start Trial
Australia 2004220556 ⤷  Start Trial
Australia 2004227414 ⤷  Start Trial
Australia 2004229519 ⤷  Start Trial
Australia 2004232964 ⤷  Start Trial
Australia 2004233092 ⤷  Start Trial
Australia 2009201569 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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