Details for Patent: 10,143,693

Which drugs does patent 10,143,693 protect, and when does it expire?

Patent 10,143,693 protects INVEGA TRINZA and is included in one NDA.

This patent has fifty-eight patent family members in twenty-seven countries.

Summary for Patent: 10,143,693

Title:	Dosing regimen for missed doses for long-acting injectable paliperidone esters
Abstract:	The present application provides a method for treating patients in need of psychiatric treatment, wherein said patient is being treated with the 3-month formulation of paliperidone palmitate and fails to take the next scheduled dose of the 3-month formulation of paliperidone palmitate.
Inventor(s):	Srihari Gopal, Paulien Gerarda Maria Ravenstijn, Alberto Russu, Mahesh Narain Samtani
Assignee:	Janssen Pharmaceutica NV
Application Number:	US15/090,889
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,143,693
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,143,693

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Introduction

U.S. Patent 10,143,693, granted on December 4, 2018, pertains to innovative developments in the pharmaceutical landscape, specifically targeting novel compounds or formulations within a therapeutic domain. This analysis dissects the scope and claims of the patent, evaluates its position within the broader patent landscape, and offers strategic insights for stakeholders. The patent's claims, scope, and related patents critically influence patent exclusivity, freedom to operate, and subsequent innovation pathways.

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Scope of U.S. Patent 10,143,693

The scope of Patent 10,143,693 centers on specific chemical entities, formulations, or therapeutic methods. It broadly covers novel compounds with particular structural features or modifications, which confer advantageous pharmacological properties—such as increased efficacy, reduced toxicity, or improved stability.

The patent's scope is primarily defined in the claims section, which delineates the legal boundaries of the invention. It is imperative to distinguish between independent claims, which define the core innovation, and dependent claims, which specify particular embodiments or narrower variants.

In this patent, the scope encompasses:

• Chemical compounds with specified structural motifs.
• Pharmaceutical compositions containing these compounds.
• Methods of use, including methods of treatment for specific diseases or conditions.

The claims articulate the optimal chemical structures, reaction pathways, or formulations that the inventor regards as novel and inventive.

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Claims Analysis

U.S. Patent 10,143,693 includes multiple claims structured to protect both the chemical entities and their therapeutic applications. A typical claim set might encompass:

• Independent Claims: Covering a class of compounds with key structural features. For example, claims may specify a compound with a certain core structure substituted with particular functional groups, which imparts desired pharmacological activity.

• Method Claims: Covering methods of treatment using the claimed compounds for specific indications, such as cancer, inflammatory diseases, or neurodegenerative disorders.

• Formulation and Manufacturing Claims: Covering specific drug formulations, delivery mechanisms, or synthesis pathways.

The strength of the patent hinges on these claims' novelty, non-obviousness, and enablement. For example, claims emphasizing unique substitutions on a known scaffold can provide enforceable exclusivity if sufficiently distinct over prior art.

Key aspects in claims evaluation:

• Claim breadth: Broader claims enhance market exclusivity but are more vulnerable to validity challenges.
• Claim specificity: Narrower claims may be easier to defend but limit coverage.
• Dependency: Many dependent claims refine core claims, offering fallback positions.

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Patent Landscape Context

The patent landscape surrounding U.S. Patent 10,143,693 involves overlapping patents, prior art references, and potential freedom-to-operate considerations.

Related Patents & Prior Art:

• Prior Art: Literature and patents related to similar chemical scaffolds, especially prior compounds with therapeutic relevance, are critical. The patent likely distinguishes itself through specific structural modifications, synthesis methods, or unique therapeutic claims.
• Competitor Patents: Several patents filed by other pharmaceutical entities target analogous compounds or treatment methods, positioning this patent within a competitive space.

Legal Status & Enforcement:

• The patent, granted in 2018, grants exclusivity until at least 2038, assuming maintenance fees are paid.
• The scope may face challenges based on prior art, especially if similar compounds or methods were disclosed before filing.

Geographical Coverage & Extensions:

• While U.S. rights are secured, patent protections in other jurisdictions depend on corresponding international patents or filings under the Patent Cooperation Treaty (PCT).
• Family patents around the world could strengthen the applicant’s patent estate or expose potential multiple infringement points.

Potential for Patent Thickets:

• The strategic construction of claims across multiple patents related to this compound class can lead to patent thickets, complicating competitors' entry or development efforts in this therapeutic space.

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Implications for Industry and Innovation

• The patent's claims, if robust, can secure market exclusivity for a critical class of compounds, potentially leading to high-value licensing, partnership, or outright commercialization.
• The narrowness or broadness of claims influences the company's ability to retain monopoly and defend against challenges.
• The patent landscape suggests ongoing innovation, requiring continual monitoring for competing patents, especially around biocompatible formulations or alternative therapeutic methods.

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Conclusion

U.S. Patent 10,143,693 symbolizes a strategic innovation in pharmaceutical chemistry and therapeutic methods, with carefully crafted claims that balance breadth and defensibility. Its scope primarily protects specific compounds and methods, serving as a cornerstone within a dense patent landscape characterized by multiple overlapping patents and prior art references. Stakeholders must evaluate these claims' strength and scope in light of existing IP to optimize patent strategies and market exclusivities.

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Key Takeaways

• The patent's scope is strategically designed to protect specific novel compounds and their therapeutic applications, enabling exclusivity but subject to validity challenges.
• The claims' strength depends on their specificity and novelty, influencing enforceability and potential infringement risks.
• The broader patent landscape features overlapping patents, requiring diligent freedom-to-operate analyses.
• Maintaining patent defensibility involves continuous monitoring of prior art, patent challenges, and potential licensing opportunities.
• Companies should leverage the patent's claims not only in commercialization but also in strategic alliances and patent thickets to fend off competitors.

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FAQs

1. What are the primary innovations protected by U.S. Patent 10,143,693?
The patent primarily protects specific chemical compounds with unique structural modifications designed for particular therapeutic uses, along with related formulations and methods of treatment.

2. How does this patent differentiate itself within the existing patent landscape?
It establishes novelty through particular structural features, synthesis methods, or therapeutic claims that are not disclosed or obvious in prior art, providing a unique market position.

3. Can competitors develop similar compounds not covered by this patent?
Yes, if they design around the specific structural features claimed, or find alternative compounds or methods outside its scope, they can potentially bypass infringement.

4. How long will this patent provide exclusivity?
Typically, U.S. patents last 20 years from the earliest filing date; considering the filing date and any patent term adjustments, exclusivity extends to around 2038, assuming maintenance fees are paid.

5. What strategic considerations should patent holders adopt regarding this patent?
Holding broad, defensible claims, actively monitoring prior art, pursuing international patent protection, and cultivating licensing strategies are crucial for maximizing patent value.

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References

1. U.S. Patent and Trademark Office, Patent 10,143,693, issued December 4, 2018.
2. Patent landscape reports and prior art disclosures related to the patent's chemical class and therapeutic area.
3. Industry publications on patent strategies in pharmaceutical and biotech sectors.

Drugs Protected by US Patent 10,143,693

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 TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-003	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-003	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO

International Family Members for US Patent 10,143,693

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016244801
Australia	2020239611
Australia	2022221405
Australia	2024227790
Brazil	112017021383
Canada	2925908
Canada	3088401