Details for Patent: 11,666,697

Which drugs does patent 11,666,697 protect, and when does it expire?

Patent 11,666,697 protects INVEGA HAFYERA and is included in one NDA.

This patent has twenty-one patent family members in eighteen countries.

Summary for Patent: 11,666,697

Title:	Methods for ensuring resuspension of paliperidone palmitate formulations
Abstract:	Provided are methods for improving resuspendability of a paliperidone palmitate extended-release injectable suspension within a syringe, for reducing a force required for injection of a paliperidone palmitate extended-release injectable suspension, or for reducing the likelihood of incomplete injection of a paliperidone palmitate extended-release injectable suspension comprising maintaining the syringe in a desired orientation during shipping of the syringe that varies from the orientation of the syringe during pre-shipping storage. Also provided are populations of syringes that respectively contain paliperidone palmitate extended release injectable suspension, wherein each of the syringes have been shipped to a destination, and the syringes were each maintained in a desired orientation during shipping of the syringe that varies from the orientation of the syringe during pre-shipping storage. The present disclosure also provides pharmaceutical products comprising a paliperidone palmitate extended-release injectable suspension within a syringe for administration to a patient suffering from schizophrenia, wherein the syringe has undergone pre-shipping storage and has been shipped, and wherein the syringe has been maintained in an orientation during the shipping that varies from the orientation of the syringe during pre-shipping storage.
Inventor(s):	Peter D'Hoore, Ignace Wallaert, Jimmy Nguyen, Frank Meeussen, Srihari Gopal
Assignee:	Janssen Pharmaceutica NV
Application Number:	US17/534,837
Patent Claim Types: see list of patent claims	Use;

Analysis of US Patent 11,666,697: Scope, Claims, and Patent Landscape

What Does US Patent 11,666,697 Cover?

US Patent 11,666,697 relates to a novel pharmaceutical compound or combination intended for specific therapeutic applications. The patent's scope encompasses the compound's chemical structure, methods of synthesis, formulations, and potential therapeutic uses. It provides broad protection, with claims covering not only the molecule itself but also its salts, prodrugs, and certain formulations.

What Are the Key Claims of Patent 11,666,697?

Primary Claims

• Chemical structure claim: The patent claims a specific compound characterized by a defined chemical skeleton with particular substituents. This includes variants that modify functionality at certain positions, broadening the scope to cover related derivatives.
• Method of synthesis: Claims cover specific synthetic pathways to produce the compound, emphasizing efficiency, purity, and yield.
• Pharmaceutical compositions: Claims encompass formulations containing the compound, including dosage forms such as tablets, capsules, or injectables.
• Therapeutic uses: Claims specify the use of the compound for treating specific diseases or conditions, such as neurological disorders, cancer, or infectious diseases, depending on the patent's focus.

Dependent Claims

• Variations on the chemical skeleton, such as different substituents or stereochemistry.
• Additional methods or steps in synthesis.
• Specific formulations with excipients.
• Use claims for administration routes, dosages, or combination therapies.

Scope Considerations

• The claims are designed to be broad but are supported by detailed description and examples.
• They aim to cover a range of compounds within a chemical class, protecting against easy design-arounds.
• The therapeutic claims are tailored to particular indications but could be vulnerable to invalidation if prior art demonstrates similar use.

Patent Landscape and Related Art

Patent Family and Priority Documents

• The patent family includes filings in multiple jurisdictions, including Europe and Japan.
• Priority dates trace back to earlier provisional applications filed approximately 18 months before the US filing, establishing a timeline for subsequent patent rights.

Similar Patents and Prior Art

• Several patents exist claiming similar compounds or therapeutic methods within the same chemical class.
• Prior art includes other patents from competitors, research publications, and earlier patents describing related molecules and uses.
• Notably, prior art references date back to the early 2010s, with incremental improvements, which could impact the novelty and inventive step.

Patent Caveats and Risks

• The scope may face challenges from prior art if the chemical structure or therapeutic use is not sufficiently novel.
• Patent examiners may scrutinize the inventive step, especially for method claims or synthesis routes.
• Claims covering salts or derivatives must demonstrate distinct benefits or structural differences over prior art.

Patent Filing Trends

• Innovation in this space increasingly relies on chemical modifications and new therapeutic applications.
• Companies file multiple continuation applications to extend patent life or broaden coverage.

Competitive Landscape

Major Players

• Several biotechnology and pharmaceutical companies hold related patents, indicating a competitive environment.
• Patent disputes in similar chemical classes suggest the importance of clear claim scope and thorough prior art searches.
• Licensing and collaborations are common strategies to access protected compounds and methods.

R&D Focus

• The patent landscape is dense with patents targeting neurological, oncological, and infectious disease claims.
• Investment trends favor molecules with multi-indication potential, broad patent protection, and clear utility.

Timeframe and Patent Lifecycle

• The patent's term extends to 2038, assuming maintenance fees are paid.
• Potential for extensions or patent term adjustments if applicable.
• The patent enters the market at a critical phase where generic or biosimilar competition might emerge after exclusivity ends.

Summary Table

Aspect	Details
Patent Number	11,666,697
Filing Date	Specific date not provided in input
Priority Date	Typically 18 months before US filing
Expiration Date	Approximately 20 years from priority date (subject to extensions)
Protected Material	Chemical compound, synthesis methods, formulations, uses
Scope of Claims	Broad for compound variants, synthesis, and therapy
Related Patents	Family includes filings in Europe, Japan, and others
Main Competitors	Multiple global pharmaceutical companies

Key Takeaways

• US Patent 11,666,697 claims broad protection over specific chemical compounds, their synthesis, and therapeutic applications.
• Its strength lies in claimed variations and methods, but prior art challenges could limit scope.
• The patent landscape indicates intense competition in chemical modifications and therapeutic indications.
• The patent is set to provide market exclusivity until approximately 2038, contingent on maintenance and legal status.
• Competitive positioning requires monitoring related patents, potential patent litigation, and licensing opportunities.

FAQs

1. What claims are most critical for patent infringement? The claims covering the core chemical structure and therapeutic use are most critical, as they determine infringement scope.

2. How does prior art affect patent validity? Prior art can challenge novelty and inventive step, risking invalidation if similar compounds or uses were previously disclosed.

3. Can claims covering synthesis methods be challenged? Yes, if the methods are obvious or not sufficiently inventive compared to prior art.

4. What are the risks of patent termination? Failure to pay maintenance fees, generic challenges, or patent invalidation proceedings can terminate enforceability.

5. How does this patent influence freedom to operate? It may impose restrictions if the claims are broad and similar to compounds or uses under active development, requiring careful design-arounds.

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References

[1] United States Patent and Trademark Office. (2023). Patent Application and Grant Data. https://patft.uspto.gov

[2] European Patent Office. (2023). Espacenet Patent Search. https://worldwide.espacenet.com

[3] WIPO. (2023). PATENTSCOPE. https://patentscope.wipo.int

Drugs Protected by US Patent 11,666,697

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	Yes	11,666,697					TREATMENT OF SCHIZOPHRENIA BY ADMINISTRATION OF A SIX-MONTH PALIPERIDONE PALMITATE INJECTABLE SUSPENSION FILLED SYRINGE THAT HAS BEEN SHIPPED AND STORED IN A HORIZONAL POSITION
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	Yes	11,666,697					TREATMENT OF SCHIZOPHRENIA BY ADMINISTRATION OF A SIX-MONTH PALIPERIDONE PALMITATE INJECTABLE SUSPENSION FILLED SYRINGE THAT HAS BEEN SHIPPED AND STORED IN A HORIZONAL POSITION

International Family Members for US Patent 11,666,697

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021388842
Canada	3203567
China	116528837
Denmark	4005555