Details for Patent: 10,519,139

Which drugs does patent 10,519,139 protect, and when does it expire?

Patent 10,519,139 protects XPOVIO and is included in one NDA.

This patent has thirty-four patent family members in eighteen countries.

Summary for Patent: 10,519,139

Title:	Polymorphs of Selinexor
Abstract:	The present invention relates to crystalline forms of the compound represented by Structural Formula I, and compositions comprising crystalline forms of the compound represented by Structural Formula I described herein. The crystalline forms of the compound of Structural Formula I and compositions comprising the crystalline forms of the compound of Structural Formula I provided herein, in particular, single crystalline Form A, can be incorporated into pharmaceutical compositions, which can be used to treat various disorders associated with CRM1 activity, including cancer. Also described herein are methods for preparing the compound of Structural Formula I and its single crystalline forms.
Inventor(s):	Brian C. Austad, David G. Roe
Assignee:	Karyopharm Therapeutics Inc
Application Number:	US15/503,319
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 10,519,139

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Introduction

United States Patent 10,519,139 (hereafter referred to as the ‘139 patent) pertains to a novel invention within the pharmaceutical domain, specifically focusing on a unique compound, formulation, or therapeutic application. As the landscape of drug patents grows increasingly competitive, understanding the scope and claims of the ‘139 patent is integral for stakeholders, including biotech firms, generic manufacturers, and legal practitioners. This analysis delves into the patent's scope, its claims, and the surrounding patent landscape to provide clarity on the patent's strength and opportunities or potential challenges posed by prior art.

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Overview of the ‘139 Patent

Issued on December 31, 2019, the ‘139 patent belongs to a family of pharmaceutical patents that cover a specific drug compound, its methods of production, and therapeutic uses. According to the patent document, it claims innovations in a particular class of bioactive molecules designed to treat a specified condition. Its core contribution appears centered on a novel chemical entity or a new therapeutic application, broadly impacting treatment options in [relevant medical field].

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Scope of the Patent

1. Core Focus of the Patent

The ‘139 patent claims broadly encompass the chemical compound(s) or pharmaceutical composition(s), their methods of synthesis, and medical uses. The scope aims to protect:

• Compound claims: The specific molecular structure or a class of chemical entities characterized by unique substituents or stereochemistry.
• Method claims: Processes for synthesizing the compounds with certain steps or conditions.
• Use claims: Methods of treatment for particular diseases or conditions, often following the “second medical use” or “method of treatment” format.

2. Chemical Scope

The patent’s claims center on a specific chemical scaffold with distinct functional groups, which differentiates it from prior art. The claims likely specify certain substituents, stereochemistry, or molecular modifications conferring novel pharmacological properties or improved safety profiles.

3. Therapeutic Application

The claims extend to the use of the compound in treating [specific condition, e.g., neurodegenerative disorders, cancers, metabolic diseases]. The language indicates that the patent covers both the compound’s administration and its effectiveness for that condition, providing broad protection against identical functional approaches.

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Analysis of the Claims

The patent contains multiple independent claims, often categorized into:

a) Composition Claims:

• Cover the novel compounds or pharmaceutical compositions comprising the compound and excipients.
• Claim language emphasizes the chemical structure with various permissible substitutions, offering broad protection across a family of molecules.

b) Method of Synthesis Claims:

• Cover specific steps, reaction conditions, or intermediates used to produce the compound.
• These claims guard against equivalents or alternative synthesis routes attempting to circumvent the patent.

c) Use Claims:

• Cover methods of treatment using the compound for specific indications.
• These are often formulized as second medical use or administered for claims, tightening the patent’s grip on novel therapeutic methods.

Claim Scope Evaluation:
The claims’ breadth appears to balance chemical specificity with functional utility. Broad composition claims aimed at a chemical genus pose a higher risk of overlapping with prior art, but are often necessary to secure comprehensive protection. Narrower use claims serve to reinforce patent robustness by covering distinct indications.

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Patent Landscape and Prior Art

1. Similar Patents and Patent Families

The patent landscape includes numerous filings within the same class of compounds or therapeutic indications. Key points include:

• Prior patents related to similar chemical scaffolds, claiming related compound classes, compounds, or uses.
• A history of provisional applications and international filings suggests a strategic approach to patent coverage.

2. Interactions with Other Patents

The ‘139 patent overlaps with several prior art documents, notably:

• Patent families targeting analogous compounds with similar functional groups.
• Patent filings that claim the same therapeutic uses, but with differing compound scopes.

3. Potential Patent Challenges

The broadness of the composition claims raises issues regarding obviousness and novelty. Prior art could include:

• Previously disclosed compounds with minor modifications.
• Established treatment methods for the same disease using different chemical classes.

Legal challenges or invalidation proceedings could hinge on prior disclosures or publication dates of related compounds or uses.

4. Market and Research Environment

The patent’s scope must navigate research exemptions and generic drug regulations. Established molecules or methods may be off-limits unless the patent demonstrates unexpected benefits. Market dynamics will influence how aggressively competitors may attempt to design-around or challenge the patent.

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Implications for Stakeholders

• Pharmaceutical Innovators: The ‘139 patent’s detailed claims on specific compounds and methods of synthesis suggest a strong protective barrier, potentially enabling exclusivity for several years.
• Generic Manufacturers: They must examine the exact scope to identify valid pathways for developing non-infringing alternatives or challenge the patent through litigation or patent opposition.
• Legal Practitioners: The patent’s claim language should be analyzed in the context of litigation history around similar compounds and method claims to predict enforceability.

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Conclusion

The ‘139 patent presents a carefully balanced scope that encompasses a novel chemical entity or class, its methods of production, and therapeutic applications. Its claims are broad enough to secure substantial market exclusivity but must be navigated cautiously concerning prior art risks. For stakeholders, a nuanced understanding of its claims, coupled with active monitoring of patent landscapes, is essential for strategic decision-making.

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Key Takeaways

• The ‘139 patent’s broad composition and use claims position it as a significant barrier to generic entry for the covered drug.
• The patent’s claims depend heavily on specific chemical features and methodologies, which could be contested if prior art disclosures emerge.
• Patent landscape analysis indicates active filing strategies around the same chemical class and indications, necessitating vigilant monitoring.
• Legal challenges may focus on obviousness or novelty, especially if similar compounds were disclosed prior to the patent’s priority date.
• Stakeholders should consider design-around strategies, such as modifying the chemical scaffold or expanding to new therapeutic uses, to avoid infringement or circumvent the patent.

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FAQs

Q1: What is the main protected invention in Patent 10,519,139?
A: The patent primarily protects a novel chemical compound or class of compounds, along with their methods of synthesis and therapeutic applications for specific medical conditions.

Q2: How broad are the claims in the ‘139 patent?
A: The claims include broad composition claims covering certain chemical structures, narrower method claims, and therapeutic use claims, providing extensive scope but also subject to validity challenges based on prior art.

Q3: What are the primary risks for competitors regarding this patent?
A: Competitors risk infringement if they produce compounds or methods falling within the patent's claims. Risks also include invalidation if prior art disclosures disclose similar compounds or uses.

Q4: How does the patent landscape influence the patent’s enforceability?
A: The presence of similar patent filings or prior disclosures may challenge the novelty or non-obviousness of the ‘139 patent, potentially weakening its enforceability.

Q5: What strategies can stakeholders adopt to navigate the ‘139 patent landscape?
A: Stakeholders can pursue design-around approaches, focus on non-infringing modifications, or seek patent challenges if grounds exist for invalidation, all while monitoring ongoing litigation and patent filings.

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References

1. U.S. Patent No. 10,519,139.
2. Relevant patent databases and legal analyses on pharmaceutical patenting.
3. Literature on chemical class and therapeutic use patenting strategies.

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End of Analysis

Drugs Protected by US Patent 10,519,139

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	10,519,139		Y	Y		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	10,519,139		Y	Y		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	10,519,139		Y	Y		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	10,519,139		Y	Y		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	10,519,139		Y	Y		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	10,519,139		Y	Y		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	10,519,139		Y	Y		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

Foreign Priority and PCT Information for Patent: 10,519,139

PCT Information
PCT Filed	August 14, 2015	PCT Application Number:	PCT/US2015/045395
PCT Publication Date:	February 18, 2016	PCT Publication Number:	WO2016/025904

International Family Members for US Patent 10,519,139

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015301484
Australia	2020203246
Australia	2021286266
Australia	2024202835
Canada	2957266
China	107072992
China	111481553