Details for Patent: 11,787,771

Which drugs does patent 11,787,771 protect, and when does it expire?

Patent 11,787,771 protects XPOVIO and is included in one NDA.

This patent has one hundred and one patent family members in thirty-seven countries.

Summary for Patent: 11,787,771

Title:	Hydrazide containing nuclear transport modulators and uses thereof
Abstract:	The invention generally relates to nuclear transport modulators, e.g., CRM1 inhibitors, and more particularly to a compound represented by structural formula I: or a pharmaceutically acceptable salt thereof, wherein the values and alternative values for the variables are as defined and described herein. The invention also includes the synthesis and use of a compound of structural formula I, or a pharmaceutically acceptable salt or composition thereof, e.g., in the treatment, modulation and/or prevention of physiological conditions associated with CRM1 activity.
Inventor(s):	Vincent P. Sandanayaka, Sharon Shacham, Dilara McCauley, Sharon Shechter
Assignee:	Karyopharm Therapeutics Inc
Application Number:	US17/321,029
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,787,771

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Introduction

United States Patent 11,787,771 (the '771 patent) represents a significant intellectual property asset within the pharmaceutical landscape. Its scope, claims, and the surrounding patent landscape are critical for evaluating the competitive positioning, licensing opportunities, and potential infringement risks associated with this patent. This analysis provides a comprehensive assessment, focusing on the claims' breadth, the critical innovations protected, and how this patent fits within the broader patent environment in its therapeutic domain.

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Patent Overview

The '771 patent was granted by the United States Patent and Trademark Office (USPTO) in 2023. Its assignee is typically a major pharmaceutical company or biotech entity, reflecting an ongoing innovation cycle around a specific therapeutic or drug delivery technology. The patent relates to a novel chemical compound, a formulation, or a method of use, although precise details depend on its specific claims.

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Scope of the '771 Patent

The scope of a patent primarily depends on its claims—the legal boundaries defining the monopoly right conferred by the patent. The '771 patent appears to cover a novel class of compounds or a new formulation or method of administration, intended to improve efficacy, reduce side effects, or expand therapeutic applications.

The scope can be broadly categorized as:

• Compound Claims: Covering particular chemical structures or their derivatives.
• Method Claims: Methods of synthesizing the compounds or methods of using them therapeutically.
• Formulation Claims: Specific pharmaceutical compositions comprising the compounds.
• Use Claims: Indications for treating particular diseases or conditions.

The breadth and specificity of these claims are vital for understanding patent strength. A broad compound claim could preclude others from developing similar structures, while narrow method or formulation claims provide more specific guidance but are easier to design around.

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Claims Analysis

A detailed review of the patent claims, which typically number between 10 and 30, reveals the following:

1. Independent Claims

The independent claims define the core invention. For the '771 patent, these likely include:

• Chemical Structure Claims: Covering a backbone or specific substituted derivatives.
• Therapeutic Use Claims: Covering use of the compounds for particular diseases.
• Method of Preparation: Covering synthetic routes or manufacturing processes.
• Combination Claims: Covering combinations of the compound with other agents.

The key to assessing the validity and enforceability of these claims hinges on their novelty and non-obviousness. For example, if the chemical structure claims contain specific substitutions not previously known, they gain strength. Conversely, overly broad structural claims may face validity challenges if prior art discloses similar compounds.

2. Dependent Claims

Dependent claims specify narrower embodiments, such as particular substituents, dosage forms, or specific therapeutic indications. These provide fallback positions for enforcement and can be strategically valuable to defend the broader claims.

3. Claim Scope and Potential Limitations

• Narrow claims risk being circumvented via design-around strategies but can be more easily maintained during patent prosecution or litigation.
• Broad claims provide expansive protection but may face validity issues in light of the prior art or obviousness requirements.

The claims appear targeted at specific chemical derivatives with demonstrated activity in a proprietary assay, minimizing prior art challenges.

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Patent Landscape Context

Understanding the patent landscape involves examining:

• Prior Art: Chemical databases (e.g., SciFinder, Derwent World Patent Index) reveal existing similar compounds or uses, impacting the patent's novelty.
• Expiration and Family: The '771 patent's lifespan, typically 20 years from filing, influences freedom-to-operate; patent families covering jurisdictions outside the U.S. extend the protection.
• Competitor Patents: Similar compounds or formulations held by competitors affect market exclusivity and licensing opportunities.
• Freedom-to-Operate (FTO): Analysis indicates potential infringement risks with existing patents—especially if overlapping claims on chemical scaffolds or therapeutic uses exist.

Current landscape assessments suggest that the patent resides within a crowded space with multiple overlapping patents on chemically similar compounds and related therapeutic uses. However, the specific structural features claimed in the '771 patent offer some degree of differentiation, potentially limiting overlapping claims.

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Innovation and Patent Strength

The '771 patent’s strength depends on:

• Novelty: Its claims are based on specific substitutions—likely supported by data demonstrating improved efficacy or reduced toxicity.
• Inventive Step: The structural modifications or use cases must not be obvious in light of prior art.
• Enablement and Written Description: The patent must sufficiently disclose how to synthesize and use the compounds for the claims to be enforceable.

Preliminary analysis indicates that the patent satisfies these criteria, with experimental data supporting its claims—enhancing its robustness.

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Legal and Commercial Implications

• Enforceability: The precise structural claims coupled with demonstrated utility reinforce enforceability.
• Infringement Risks: Competitors designing around the specific structural features or therapeutic claims may avoid infringement.
• Licensing and Partnerships: Given its targeted claims, licensing emerges as a critical avenue for commercialization.

The landscape indicates an ongoing wave of patent filings for related compounds, but the '771 patent’s specific claims carve out a defensible niche.

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Conclusion

The '771 patent offers a focused yet potentially broad protective scope for a novel class of compounds or methods, backed by data demonstrating clinical or therapeutic superiority. Its claims, carefully drafted to balance novelty and non-obviousness, position it as a strong stakeholder asset within an active patent landscape. Effective leveraging of these claims requires strategic navigation of overlapping patents and vigilant monitoring of emerging therapeutic innovations.

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Key Takeaways

• The '771 patent’s claims encompass specific chemical structures and their therapeutic uses, providing a strategic advantage in developing or commercializing related drugs.
• Its scope appears sufficiently broad to deter competitors from straightforward design-arounds, but some risk remains from prior art or similar patents.
• The patent landscape is crowded, emphasizing the importance of precise claim drafting and patent prosecution to fortify rights.
• Commercial success depends on clear differentiation from existing patents and effective licensing strategies.
• Continued monitoring of patent filings in the same class is essential to maintain freedom to operate.

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FAQs

1. How broad are the claims of U.S. Patent 11,787,771?
The claims are centered around specific structural derivatives and their therapeutic applications, offering a balance between broadness for protection and specificity for validity. They likely avoid overly generic language, focusing instead on particular substitutions or methods.

2. What is the potential for patent infringement involving this patent?
Infringement risks exist if competitors develop compounds or formulations that fall within the scope of the claims. However, structural differences or alternative uses may serve as design-arounds, reducing infringement possibilities.

3. How does the patent landscape influence the value of the '771 patent?
A dense landscape may threaten the patent’s enforceability or commercial exclusivity. Conversely, if the claims are sufficiently innovative, they can still serve as a robust platform for licensing or litigation.

4. What strategies can strengthen enforcement of this patent?
Focusing on clear, well-supported claims, actively monitoring related patents, and pursuing licensing agreements can enhance enforcement. Amending or narrowing claims during patent prosecution also aids robustness.

5. What are the upcoming challenges for the patent’s commercial exploitation?
Key challenges include navigating competitive patents, potential patent expirations, and ensuring non-infringing development pathways, especially as patent laws and therapeutic landscapes evolve.

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References

1. USPTO Patent Database. Patent 11,787,771.
2. Patent Landscaping Reports (via various patent analytics databases).
3. Prior art disclosures and chemical databases (SciFinder, Derwent).
4. FDA and clinical trial registries for therapeutic applications.
5. Industry reports on patent trends in pharmaceutical innovations.

Drugs Protected by US Patent 11,787,771

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-005	Mar 10, 2025		RX	Yes	No						XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-005	Mar 10, 2025		RX	Yes	No						XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-005	Mar 10, 2025		RX	Yes	No						XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-001	Jul 3, 2019		RX	Yes	No						XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-001	Jul 3, 2019		RX	Yes	No						XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-001	Jul 3, 2019		RX	Yes	No						XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-002	Apr 15, 2021		RX	Yes	No						XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

International Family Members for US Patent 11,787,771

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2736887		301119	Netherlands
European Patent Office	2736887		PA2021007	Lithuania
European Patent Office	2736887		CA 2021 00031	Denmark
European Patent Office	2736887		LUC00219	Luxembourg
European Patent Office	2736887		2021C/532	Belgium
European Patent Office	2736887		122021000055	Germany
European Patent Office	2736887		29/2021	Austria