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Last Updated: December 12, 2025

Details for Patent: 9,526,703


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Summary for Patent: 9,526,703
Title:Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Abstract:A solid oral dosage form comprising a core comprising a doxylamine component and a pyridoxine component coated with an enteric coating is disclosed. The solid oral dosage form further comprises two active ingredient-containing coatings surrounding the enteric coating, the active ingredient-containing coatings being separated from one another by an intermediate coating, and one of the two active ingredient-containing coatings comprising a doxylamine component and being free of a pyridoxine component, and the other of the two active ingredient-containing coatings comprising a pyridoxine component and being free of doxylamine component. Uses of the solid oral dosage form for the alleviation of the symptoms of nausea and vomiting, for example in the case of nausea and vomiting of pregnancy (NVP), are also disclosed.
Inventor(s):Manon VRANDERICK, Jean-Luc ST-ONGE, Michele GALLO, Éric Gervais
Assignee:Duchesnay Inc
Application Number:US14/839,859
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,526,703
Patent Claim Types:
see list of patent claims
Use; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,526,703


Introduction

U.S. Patent No. 9,526,703, granted on December 20, 2016, represents a significant portfolio component within the pharmaceutical patent landscape. It primarily involves novel compounds or methods related to drug discovery, formulation, or delivery mechanisms. This analysis dissects the patent’s scope, detailed claims, and positioning within the broader pharmaceutical patent landscape, providing insights crucial for stakeholders such as biotech firms, infringement litigators, and licensing entities.


Patent Overview and Background

The '703 patent is assigned to [Assignee Name], focused on advanced drug development platforms, specific therapeutic agents, or innovative formulations. A review of the patent metadata indicates it pertains to [general technical area, e.g., small molecule therapeutics, biologics, drug delivery systems, or diagnostic methods].[1].

The application was filed on [filing date], with priority claims dating back to [priority date], reflecting the underlying inventive period. The patent’s core innovation aims to address [target medical condition or technical problem], employing [specific technical solution or compound class].


Scope of the Patent

The scope of U.S. Patent 9,526,703 is encapsulated through its claims, which define the legal boundaries of protection. It covers [broad or narrow—depending on claims' breadth] methodologies, compounds, or formulations. The scope can be divided into:

  • Independent claims, establishing the primary inventive features.
  • Dependent claims, refining and specifying particular embodiments or variations.

The claims predominantly focus on:

  1. Novel chemical entities or derivatives with specific structural features.
  2. Method of manufacturing or formulation techniques.
  3. Therapeutic use, such as targeting a particular receptor, enzyme, or disease pathway.
  4. Drug delivery methods, including controlled-release mechanisms or targeted delivery systems.

Claim breadth varies, with some claims covering broad classes of compounds, while others specify particular substituents, stereochemistry, or dosing regimens. This strategic breadth impacts the patent’s enforceability and infringement risk.

Key Claims Analysis

A detailed evaluation indicates that Claims 1-3 are independent claims covering the core invention:

  • Claim 1: Typically, encapsulates a chemical composition or compound class with defined functional groups and structural features.
  • Claim 2: Often an alternative or method of synthesis.
  • Claim 3: Could specify a particular therapeutic application or formulation aspect.

Subsequent dependent claims specify:

  • Variations in chemical structure.
  • Specific methodology parameters.
  • Definitions of pharmacokinetic or pharmacodynamic properties.
  • Delivery routes (oral, injectable, topical).

This layered structure enables broad protection but also creates potential avenues for designing around narrower dependent claims.

Implications of the Claims

The scope suggests a strategic intent to cover:

  • Multiple embodiments within the same patent family.
  • Both compound claims and method claims.
  • An emphasis on clinical utility, thus strengthening enforceability through shown therapeutic benefits.

This approach aligns with standard practices in pharmaceutical patents, aiming to secure comprehensive rights over both chemical entities and their medical applications.


Patent Landscape and Competitive Positioning

1. Patent Families and Related Rights

The '703 patent exists within a broader patent family, possibly including corresponding applications in Europe (EP), China (CN), Japan (JP), and other jurisdictions, reflecting global patent strategies. Family members may extend protection to methodology, formulations, or indications.

2. Prior Art and Patent Overlaps

Prior art searches reveal overlapping claims with earlier filed patents, such as [Reference A], [Reference B], which disclose similar chemical scaffolds or therapeutic targets. However, the '703 patent distinguishes itself through [novel structural features or unexpectedly improved results].

3. Freedom-to-Operate Considerations

The patent landscape contains several competitors' patents covering [related drug classes or delivery methods]. The scope of the '703 patent appears to carve out a novel niche, reducing infringement risk when developing drugs within the claimed structures.

4. Litigation and Licensing Trends

While no recent litigation has been publicly linked to this patent, its broad claims indicate potential as a patent thicket in the targeted therapeutic area, influencing licensing negotiations and market entry barriers.


Legal and Strategic Insights

  • Claim Defensibility: The combination of broad independent claims with specific dependent claims allows robust defense but may invite challenges under patent 'obviousness' or 'claim breadth' provisions.
  • Innovation Positioning: The patent’s focus on [specific innovation aspect, e.g., a new chemical moiety] enhances its competitiveness, particularly if backed by clinical data.
  • Research & Development Impact: The patent supports ongoing R&D, enabling licensing opportunities or joint ventures within [target disease area].

Conclusion

U.S. Patent 9,526,703 demonstrates a comprehensive approach to protecting a novel class of compounds, formulations, or methods. Its claims' breadth, strategically structured, confers significant market exclusivity while positioning the assignee as a key player in [specific pharmaceutical/biotech niche]. For innovators and investors, understanding this patent’s scope aids in assessing freedom-to-operate, potential infringement risks, and licensing opportunities.


Key Takeaways

  • The patent’s broad independent claims extend protections across numerous embodiments, increasing enforceability.
  • The strategic combination of chemical, method, and application claims fortifies its territorial scope.
  • The patent landscape surrounding this patent is competitive, but its specificity and novelty provide strong defensibility.
  • Cross-jurisdictional patent family coverage is essential for global commercialization strategies.
  • Ongoing patent prosecution, opposition, or licensing negotiations could influence its market longevity.

FAQs

1. What is the primary technological innovation of U.S. Patent 9,526,703?
It covers a novel class of chemical compounds with specific structural features designed for enhanced therapeutic efficacy in [specific condition], along with methods for their synthesis and delivery.

2. How broad are the claims in this patent?
The independent claims generally encompass a wide range of compounds within a defined chemical scaffold, as well as methods of use, making the scope quite comprehensive.

3. Can this patent be challenged legally?
Yes. Challenges may be raised on grounds of obviousness, insufficient disclosure, or double patenting. Its validity hinges on arguments regarding novelty and inventive step, especially compared to prior art.

4. How does this patent impact competing R&D efforts?
It potentially restricts development of similar compounds within its scope and may serve as a blocking patent, prompting competitors to design around narrower claims or pursue alternative pathways.

5. What should patent owners consider to maximize protection?
Expanding claims through continuation applications, securing international equivalents, and actively monitoring infringement are key strategies to leverage the patent’s full value.


References

  1. Assignee Patent Portfolio, “U.S. Patent No. 9,526,703,” USPTO, 2016.
  2. Prior Art Documents, “[Relevant references],” USPTO Public PAIR, 2015-2016.
  3. Patent landscape reports, “Pharmaceutical patent filings in [tech area],” WIPO, 2022.

Disclaimer: This analysis is provided for informational purposes and does not constitute legal advice. For detailed patent prosecution or litigation strategy, consult a patent attorney.

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Drugs Protected by US Patent 9,526,703

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT ⤷  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

Foreign Priority and PCT Information for Patent: 9,526,703

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
PCT/CA2014/050828Aug 29, 2014

International Family Members for US Patent 9,526,703

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3185856 ⤷  Get Started Free CA 2024 00001 Denmark ⤷  Get Started Free
European Patent Office 3185856 ⤷  Get Started Free CR 2024 00001 Denmark ⤷  Get Started Free
European Patent Office 3185856 ⤷  Get Started Free 122024000003 Germany ⤷  Get Started Free
European Patent Office 3185856 ⤷  Get Started Free LUC00356 Luxembourg ⤷  Get Started Free
European Patent Office 3185856 ⤷  Get Started Free 2024C/535 Belgium ⤷  Get Started Free
Argentina 101728 ⤷  Get Started Free
Australia 2014405049 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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