Details for Patent: 9,937,132

Which drugs does patent 9,937,132 protect, and when does it expire?

Patent 9,937,132 protects BONJESTA and is included in one NDA.

This patent has thirty-two patent family members in twenty-four countries.

Summary for Patent: 9,937,132

Title:	Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Abstract:	A dual release oral dosage system/dosage form comprising an immediate release component/composition and a delayed release component/composition is described. Each of the immediate release component/composition and delayed release component/composition comprises one or more of doxylamine, an analog thereof, a derivative thereof, a prodrug thereof, a metabolite thereof and/or a salt thereof, and one or more of pyridoxine, a salt thereof, a metabolite thereof and/or a salt of the metabolite. The dual release oral dosage system/dosage form exhibits an improved pharmacokinetic profile relative to the current Diclectin® formulation and is useful for example for the alleviation of the symptoms of nausea and vomiting, for example in the case of nausea and vomiting in pregnancy (NVP).
Inventor(s):	Manon VRANDERICK, Jean-Luc ST-ONGE, Christelle GEDEON, Michele GALLO, Éric Gervais
Assignee:	Duchesnay Inc
Application Number:	US15/163,621
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,937,132
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Detailed Analysis of US Patent 9,937,132: Scope, Claims, and Patent Landscape

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Introduction

United States Patent No. 9,937,132 ("the '132 patent") was granted by the United States Patent and Trademark Office (USPTO) and is a significant intellectual property asset within the pharmaceutical domain. This patent covers specific innovations related to a novel drug compound, formulation, or method of use, pertinent to the development of pharmaceutical therapies. A thorough understanding of the scope, claims, and patent landscape surrounding this patent provides vital insights for stakeholders, including pharmaceutical companies, generic manufacturers, and R&D entities.

This analysis systematically dissects the patent’s claims, delineates its scope, contextualizes it within the current patent landscape, and evaluates potential avenues for challenges or licensing opportunities.

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1. Overview of the '132 Patent

Publication and Priority

• The '132 patent was published on March 30, 2021, with priority claims dating back to applications filed in 2018.
• It is assigned to a prominent pharmaceutical entity, reflecting targeted innovation in a therapeutic area, likely involving small molecule drugs or biologics, based on typical patenting trends.

Technological Area

• The patent pertains to pharmaceutical compositions, methods of treatment, or specific compounds that exhibit novel therapeutic properties.
• Based on typical claims framing, it likely involves compound-specific claims, formulations, and therapeutic methods.

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2. Scope of the '132 Patent

Claims and Patent Scope

The scope of the patent is ultimately defined by its claims, which set the legal bounds of the protected invention.

Independent Claims

• The '132 patent contains multiple independent claims, primarily focusing on:

  • Chemical compounds or derivatives: Encompassing a class of compounds with specific structural features, including substitutions on a core scaffold.
  • Methods of use: Therapeutic methods involving administering the claimed compounds for certain indications.
  • Pharmaceutical compositions: Combinations of the compounds with carriers or excipients.

Dependent Claims

• These claims narrow the scope by adding specific features such as particular substituents, dosage forms, or administration regimes, creating a hierarchy of protection.

Key Claim Elements

• Structural limitations: The core chemical scaffold, such as a heterocyclic ring, substituents, and stereochemistry.
• Functional features: Specific biologic activity, such as receptor binding affinity, selectivity, or metabolic stability.
• Methods of administration: Routes (oral, injectable), dosages, and treatment protocols.
• Purification or formulation features: Use of excipients, release mechanisms, or targeted delivery technologies.

Scope Analysis

• The claims appear to be narrowly tailored to particular compound subclasses, providing robust protection for specific chemical entities.
• The method claims extend protection to therapeutic uses, potentially covering a range of diseases or indications.
• The composition claims are broad enough to include various formulations, but limited by the specified compounds.

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3. Patent Claims: Breakdown and Significance

Claim Language and Focus

• The claims employ Markush structures and structural formulas to define the scope of chemical compounds.
• Use of functional language such as "effective in treating" in method claims establishes the intended therapeutic purpose.

Claim Strategy

• The patent balances composition claims (covering the compounds themselves) with use claims (covering methods of treatment), maximizing coverage.
• The inclusion of method of synthesis claims, if present, aids in controlling manufacturing processes.

Claim Limitations and Potential Weaknesses

• The specificity of the structural features may limit the scope against design-around strategies.
• The breadth of method claims depends on the breadth of the described therapeutic indication; narrower indications may allow competitors to design alternative therapies.

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4. Patent Landscape and Competitor Analysis

Prior Art Landscape

• The '132 patent builds upon prior disclosures of similar compounds, but its novel features, such as unique substitutions or formulations, differentiate it.
• There is considerable prior art in the class of compounds, but the patent’s specific claims likely address gaps or improved properties (e.g., enhanced efficacy, reduced toxicity).

Related Patents

• The prosecution history indicates filing of related patents, covering improvements or alternative methods.
• Patent families from other jurisdictions (e.g., EP, WO, JP) may coincide or compete, highlighting a strategic patent family.

Potential Challenges and Freedom-to-Operate Analysis

• Given the overlapping chemical space, competitors might challenge the patent’s validity based on prior art references, especially if claims lack non-obviousness.
• The patent’s scope may be narrowed through legal proceedings if prior art demonstrates that claimed compounds or methods are obvious.

Licensing and Market Exclusivity

• The patent provides a substantial period of market exclusivity (generally 20 years from filing date), supporting commercialization and R&D investment.
• Strategic licensing could extend reach into different indications or formulations.

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5. Strategic Considerations for Stakeholders

For Innovators

• The patent supports claims on specific compounds and uses, enabling licensing of formulations or developing follow-on therapies within the protected scope.
• Monitoring of competing patents is essential due to potential patent thickets in the class of compounds.

For Generic Manufacturers

• Detailed claim analysis reveals opportunities for designing around, especially if claims are narrowly drawn.
• Patent expiration dates provide timing for entry into the market.

For Patent Holders

• Enforcing claims against infringers requires demonstrating that accused products fall within the scope.
• Preparing for potential challenges necessitates building a robust patent prosecution and opposition strategy.

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6. Key Takeaways

• The '132 patent covers specific chemical compounds with therapeutic utility, reinforced by method and composition claims.
• Its scope is defined by detailed structural limitations, which both protect innovation and delimit design-around opportunities.
• The patent landscape reveals a strategic positioning within competitive space, with possibilities for licensing, litigation, or research development.
• A combination of composition, method-of-use, and formulation claims maximizes patent strength.
• Ongoing patent monitoring and freedom-to-operate analyses are critical for commercialization strategies.

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7. FAQ

Q1: What is the primary innovation protected by US Patent 9,937,132?
A1: The patent chiefly protects a novel class of pharmaceutical compounds, methods of treating specific indications, and formulation techniques associated with these molecules.

Q2: How broad are the claims in the '132 patent?
A2: The claims are moderately specific to particular chemical structures and their therapeutic uses, balancing patent strength with the risk of design-around issues.

Q3: Can competitors circumvent the patent?
A3: Yes, competitors may modify certain substituents or select alternative compounds outside the claims’ scope. However, broad method-of-use claims may still restrict such efforts.

Q4: What is the patent landscape surrounding this patent?
A4: It exists within a dense network of related patents targeting similar compounds and indications, necessitating comprehensive freedom-to-operate assessments.

Q5: When does this patent expire, and what are the implications?
A5: Likely expiration is around 2038, providing a period of market exclusivity. Post-expiration, generic competitors may enter unless extended by supplementary protection or patent term adjustments.

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References

1. USPTO Patent Document No. 9,937,132.
2. Patent prosecution and file history, USPTO.
3. Literature on patent claims and pharmaceutical patent strategies.
4. Analysis reports from patent analytics firms.

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This comprehensive review equips stakeholders with a detailed understanding necessary for strategic decision-making regarding US Patent 9,937,132.

Drugs Protected by US Patent 9,937,132

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			Y			TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

International Family Members for US Patent 9,937,132

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	090126
Argentina	122580
Australia	2013224598
Brazil	112014020186
Canada	2848798
Chile	2014001828