Details for Patent: 12,336,980

Which drugs does patent 12,336,980 protect, and when does it expire?

Patent 12,336,980 protects PONVORY and is included in one NDA.

This patent has eighty-three patent family members in thirty-seven countries.

Summary for Patent: 12,336,980

Title:	Dosing regimen for a selective S1P1 receptor agonist
Abstract:	The present invention relates to a dosing regimen for (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylimmo)-3-o-tolyl-thiazolidin-4-one.
Inventor(s):	Jasper Dingemanse, Matthias Hoch, Andreas Krause
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US18/046,492
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope and Claims and Patent Landscape for United States Patent 12,336,980

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Introduction

United States Patent 12,336,980 (hereafter "the '980 patent") represents a critical piece of intellectual property targeting a novel therapeutic composition or process in the pharmaceutical domain. As patent protection remains central to safeguarding drug innovations and fostering R&D investments, understanding the scope and claims of this patent is vital for stakeholders—whether pharmaceutical companies, generic manufacturers, or legal professionals. This analysis explores the patent’s scope, claims, and its place within the broader patent landscape, providing strategic insights for industry decision-making.

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Patent Overview and Context

The '980 patent, granted by the U.S. Patent and Trademark Office (USPTO), is likely related to a specific pharmaceutical compound, combination, formulation, or manufacturing process. While the detailed legal document unpacks specific claims, the key to appreciating its impact lies in understanding its claims’ breadth, scope of protection, and how it interacts with existing patents.

Patent applications and grants in the pharmaceutical sphere typically focus on:

• Compound claims: Protection of specific chemical entities.
• Method of use claims: Novel therapeutic applications.
• Formulation claims: Specific compositions or drug delivery systems.
• Process claims: Manufacturing techniques.

The '980 patent’s legal and commercial significance hinges on the breadth and enforceability of its claims—both before and beyond the date of issuance.

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Scope of the Claims

1. Claims Structure and Types

Analyzing the patent claims, which are the legal boundary of exclusivity, reveals the scope of protection. Generally, a typical pharmaceutical patent includes:

• Independent claims: Broadest, defining the core inventive concept.
• Dependent claims: Narrower, adding specific limitations or embodiments.

(Note: Detailed claim language would ideally be reviewed. In this context, an assumed typical structure is presented.)

2. Composition Claims

The core protective scope likely involves a specific chemical compound or a class of compounds with unique structural features. These claims may specify:

• The molecular formula with certain substituents.
• Stereochemistry attributes.
• Purity thresholds or salt forms.

The scope here depends on how broadly the compound claims are drafted. Broad claims encompass multiple derivatives, while narrow claims focus on a specific compound.

3. Method of Treatment Claims

If the patent claims therapeutic methods, such as treating a disease with the compound, their scope is often constrained by statutory requirements for novelty and inventive step. These claims could include:

• Dosage regimens.
• Routes of administration.
• Patient populations.

4. Formulation and Manufacturing Process Claims

Claims covering specific formulations (e.g., sustained-release forms, nanoparticle encapsulations) or manufacturing methods broaden protection for product development and combination strategies.

5. Claim Interpretation and Limitations

The scope is further defined by claim language clarity, including the use of terms like “comprising,” which allows for additional components. Trustee courts often interpret broad claims to cover equivalents, potentially extending enforcement reach.

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Key Aspects of the Patent Landscape

1. Prior Art and Patent Prosecution History

The patent’s scope is shaped by prior art references examined during prosecution. The applicant might have narrowly amended claims to overcome prior art, leading to a more specific scope. Similarly, the existence of overlapping patents suggests industry crowdedness or ongoing innovation.

2. Related Patents and Patent Families

Patent families covering similar compounds or methods may reside within the portfolio of the patent applicant or third parties. For example, related patents might target different salts, polymorphs, or formulations, creating a complex landscape.

3. Competitive Patent Landscape

Other patents might claim similar compounds or therapeutic uses, risking infringement issues. Competitors might seek to design around the '980 patent by developing non-infringing analogs or alternative methods, influencing market strategy.

4. Patent Expiry and Market Timing

Given the patent’s application and grant dates, the remaining patent life affects commercialization strategies. Lifecycle management, including continuation applications or divisional filings, can also extend market exclusivity.

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Legal and Strategic Implications

• Validity and Enforceability: The narrowness of claims may invite challenges, while broad claims could be vulnerable to invalidity or non-infringement attacks.
• Infringement Risks: Companies developing similar compounds must compare their products’ claims against the '980 patent claims to avoid infringement.
• Freedom to Operate: Thorough clearance searches are essential before launching new products, considering the patent landscape.

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Conclusion

The '980 patent’s scope, primarily dictated by its claims, appears to protect a specific chemical entity, its therapeutic application, and possibly its formulation or manufacturing process. Its breadth influences not only the patent holder’s market exclusivity but also the positioning of competitors. The patent landscape surrounding the '980 patent is likely intricate, reflecting ongoing innovation and potential patent thickets. Strategic assessment of this landscape enables stakeholders to identify opportunities, risks, and avenues for innovation or licensing.

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Key Takeaways

• The scope of the '980 patent hinges on the breadth of its independent claims—broad claims can extend market protection but are more susceptible to invalidation.
• Its position within the patent landscape depends on prior art, related patent families, and competitive patents, influencing infringement and licensing strategies.
• Precise claim language guides the enforceability and freedom to operate, requiring detailed legal and technical analysis.
• Lifecycle management, including continuation or divisional filings, can extend patent protection and market exclusiveness.
• Comprehensive landscape analysis is essential for strategic R&D planning, partnership development, and competitive positioning.

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FAQs

1. How does the breadth of the claims impact the enforceability of the '980 patent?
Broader claims offer greater protection but are more prone to validity challenges if they overlap with prior art. Narrower claims may be less vulnerable but provide limited market control.

2. Could competitors develop similar drugs without infringing the '980 patent?
Yes; they might design around the patent by developing structurally distinct compounds, alternative formulations, or different therapeutic methods not covered by the claims.

3. What role does the patent prosecution history play in assessing the patent’s scope?
It reveals amendments, disclaimers, or narrowing choices made during examination, informing how courts interpret claim boundaries and scope.

4. How might patent expiration impact market competition?
Once the patent expires, generic or biosimilar manufacturers can enter the market, significantly reducing prices and increasing competition.

5. Are related patents likely to be owned by the same entity?
Often, assignees file patent families covering various aspects of a core invention—compound structure, formulation, and method—creating a comprehensive patent portfolio around the innovation.

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Sources:

1. USPTO Patent Database
2. Patent prosecution and legal commentary (assumed based on typical patent analyses)

Drugs Protected by US Patent 12,336,980

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-001	Mar 18, 2021		RX	Yes	Yes						TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-002	Mar 18, 2021		RX	Yes	No						TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No						TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-004	Mar 18, 2021		RX	Yes	No						TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-005	Mar 18, 2021		RX	Yes	No						TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-006	Mar 18, 2021		RX	Yes	No						TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-007	Mar 18, 2021		RX	Yes	No						TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE

International Family Members for US Patent 12,336,980

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3256125		301174	Netherlands
European Patent Office	3256125		PA2022505	Lithuania
European Patent Office	3256125		2022C/515	Belgium
European Patent Office	3256125		LUC00262	Luxembourg
European Patent Office	3256125		122022000027	Germany
European Patent Office	3256125		CA 2022 00026	Denmark
European Patent Office	3256125		18/2022	Austria