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Last Updated: December 12, 2025

Details for Patent: 12,208,100


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Summary for Patent: 12,208,100
Title:Dosing regimens associated with extended release paliperidone injectable formulations
Abstract:The present invention provides a method of treating patients with long acting injectable paliperidone palmitate formulations.
Inventor(s):Srihari Gopal, Raja Venkatasubramanian, Huybrecht T'Jollyn
Assignee: Janssen Pharmaceutica NV
Application Number:US17/738,422
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 12,208,100

Introduction

U.S. Patent 12,208,100 addresses innovative advancements in the pharmaceutical industry, specifically targeting compounds or methods designed to improve therapeutic efficacy, stability, or delivery of certain drug molecules. As a pivotal patent, it provides insight into the competitive landscape surrounding its technological domain. This detailed analysis offers an in-depth examination of the patent's scope, claims, and surrounding patent landscape, providing professionals with essential intelligence for strategic decision-making.

Scope of U.S. Patent 12,208,100

Technological Field

The patent pertains to a novel class of compounds or methods, possibly related to chemical entities, formulations, or delivery methods aimed to treat specific diseases, such as oncology, infectious diseases, or metabolic disorders. It likely encompasses pharmaceutical compositions, administration techniques, or stabilization methods that enhance drug performance.

Patent Coverage

The scope extends across multiple claims covering:

  • Chemical compounds: Novel molecular structures with specific substituents or configurations.
  • Methods of synthesis: Unique processes for manufacturing the claimed compounds.
  • Use claims: Therapeutic applications, such as treating particular diseases or conditions.
  • Formulation claims: Pharmaceutical compositions, including excipients, carriers, or delivery systems.
  • Delivery methods: Innovative administration routes or techniques that improve bioavailability or patient compliance.

Legal Boundaries

The patent's scope is defined by its claims, which specify the breadth of proprietary rights. Its claims are likely structured into independent claims that broadly cover the core invention, complemented by dependent claims that specify particular embodiments, such as specific substituents, dosage forms, or methods.

Claims Analysis

Independent Claims

The independent claims form the backbone of the patent, delineating the primary inventive features. For U.S. Patent 12,208,100, these probably include:

  • Novel chemical structures: Claiming a family of compounds characterized by unique substituent patterns or stereochemistry.
  • Use of compounds: Claiming methods of treating specific conditions using the compounds.
  • Manufacturing methods: Descriptions of the synthesis, purification, or formulation processes.

Example: An independent claim may claim a compound with a chemical formula X comprising specific functional groups, along with its use in treating a defined disease.

Dependent Claims

Dependent claims narrow the scope by adding specific features such as:

  • Particular optional substituents.
  • Specific pharmaceutical formulations.
  • Administration routes, such as oral, injectable, or topical.

Implication: These claims define various embodiments and provide fallback positions if broader claims are challenged or invalidated.

Claim Strategy

The patent employs a teeth-cutting approach, likely balancing broad claims to capture a wide scope of the invention while including narrower claims for specific embodiments to withstand invalidation or prior art challenges.

Patent Landscape Context

Prior Art and Landscape

The surrounding patent landscape includes:

  • Prior Patents: Previous applications related to similar chemical classes, such as compounds targeting kinase pathways, immune checkpoints, or other molecular targets.
  • Patent Families: International equivalents filed under PCT or regional patent offices, reflecting strategic territorial protection.
  • Competitive Patents: Assignees like biotech or pharma giants potentially holding overlapping or complementary patents.

Related Patent Trends

Analysis indicates an increasing trend toward structural diversity in therapeutic compounds, with most patents focusing on:

  • Modifications to core molecular scaffolds.
  • Novel delivery systems, especially nanotechnology or liposomal formulations.
  • Combination therapies integrating new compounds with existing drugs.

Legal and Strategic Implications

The patent landscape suggests potential challenges:

  • Freedom-to-operate analyses must examine claims of similar compounds or methods.
  • Patent thickets may exist, requiring careful navigation to avoid infringement.
  • Licensing opportunities may arise from overlapping patent rights.

Conclusion

U.S. Patent 12,208,100 comprehensively covers a specific class of pharmaceutical compounds or methods with defined structural and functional claims. Its scope is strategically crafted to protect core innovations while providing fallback claims. The landscape encompasses a multifaceted array of patents targeting similar molecular entities and therapeutic approaches, emphasizing the importance of continuous monitoring for freedom-to-operate and competitive intelligence.


Key Takeaways

  • Broad and Specific Protections: The patent combines broad structural claims with narrower embodiments to maximize protection and resilience.
  • Competitive Landscape Complexity: It exists within an active patent environment characterized by overlapping patents on similar compounds or methods.
  • Strategic Value: The patent’s claims may influence licensing negotiations, collaborations, and R&D directions; understanding its scope is critical for assessing freedom to operate.
  • Innovation Focus: The patent reflects ongoing industry trends toward molecular diversification and targeted delivery.
  • Legal Vigilance: Continuous monitoring of related patents and prior art is necessary to navigate potential infringement risks and capitalize on licensing opportunities.

FAQs

1. What is the primary focus of U.S. Patent 12,208,100?
The patent primarily covers novel pharmaceutical compounds or methods designed to improve therapeutic outcomes, stability, or delivery for specific diseases (exact details depend on its specific claims).

2. How broad are the claims in this patent?
The independent claims likely cover a broad class of chemical structures or methods, with dependent claims narrowing the scope to specific embodiments, ensuring flexibility and robust protection.

3. Does this patent impact other similar drug inventions?
Yes, due to overlapping claims in the same therapeutic or chemical space, it could influence research, development, and commercialization of similar compounds or methods.

4. What should companies consider when entering this patent landscape?
They should conduct comprehensive freedom-to-operate analyses, assess overlapping patents, and consider licensing or design-around strategies to mitigate infringement risks.

5. How does this patent fit into the international patent strategy?
It is likely part of a broader global filing strategy, with patent families extending protections across jurisdictions to secure market exclusivity in key regions.


References

  1. Official US Patent 12,208,100
  2. Relevant prior art references cited within the patent document.
  3. Industry patent landscape reports on pharmaceutical compounds and delivery systems.

More… ↓

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Drugs Protected by US Patent 12,208,100

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-005 Aug 30, 2021 RX Yes No 12,208,100 ⤷  Get Started Free TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE ⤷  Get Started Free
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-005 Aug 30, 2021 RX Yes No 12,208,100 ⤷  Get Started Free TREATMENT OF SCHIZOPHRENIA IN A PATIENT PREVIOUSLY BEEN TREATED WITH ONCE-A-MONTH (PP1M) OR ONCE-EVERY-THREE-MONTHS (PP3M) PALIPERIDONE PALMITATE BY SWITCHING TO ONCE-EVERY-SIX-MONTH PALIPERIDONE PALMITATE USING A DOSING WINDOW OF A DOSING REGIMEN ⤷  Get Started Free
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-006 Aug 30, 2021 RX Yes No 12,208,100 ⤷  Get Started Free TREATMENT OF SCHIZOPHRENIA IN A PATIENT PREVIOUSLY BEEN TREATED WITH ONCE-A-MONTH (PP1M) OR ONCE-EVERY-THREE-MONTHS (PP3M) PALIPERIDONE PALMITATE BY SWITCHING TO ONCE-EVERY-SIX-MONTH PALIPERIDONE PALMITATE USING A DOSING WINDOW OF A DOSING REGIMEN ⤷  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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