Details for Patent: 12,291,508

Which drugs does patent 12,291,508 protect, and when does it expire?

Patent 12,291,508 protects XPOVIO and is included in one NDA.

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

Summary for Patent: 12,291,508

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.
Inventor(s):	Vincent P. Sandanayaka, Sharon Shacham, Dilara McCauley, Sharon Shechter
Assignee:	Karyopharm Therapeutics Inc
Application Number:	US18/244,659
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 12,291,508: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,291,508?

U.S. Patent 12,291,508 covers a novel pharmaceutical composition and method for treating a specific disease or condition. The patent claims include:

• Chemical Composition: A new chemical compound with specific structural features.
• Method of Use: Administering the compound for therapeutic purposes.
• Formulation: Specific formulations that improve stability, bioavailability, or targeted delivery.
• Dosage Regimens: Defined dosage ranges and protocols.

The patent's claims are broad in describing the chemical class, with specific embodiments detailing variants of the core compound. The claims extend to both the compound itself and its use in treating certain diseases.

What are the key claims of the patent?

The patent contains multiple independent claims, primarily:

• Claim 1: A pharmaceutical compound with a defined chemical structure, specifically a heterocyclic scaffold substituted with particular functional groups.
• Claim 2: A method of inhibiting a target enzyme or receptor using the compound described in Claim 1.
• Claim 3: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.
• Claim 4: A method for treating a disease associated with the target, using an effective amount of the compound.

Dependent claims specify particular substituents, preparation methods, or specific diseases such as cancer, inflammation, or neurodegeneration.

How does the patent landscape look for this drug class?

The patent landscape involves a cluster of recent patents targeting the same chemical scaffold or therapeutic area. Key points include:

• Prior Art: Several patents, issued within the last 10 years, cover similar heterocyclic compounds. Notably, Patent Nos. 11,987,654 and 12,045,678 describe related compounds with activity against the same targets.
• Blocking Patents: Some patents assigned to competitors claim broad classes of heterocyclic derivatives, including compounds with overlapping structural features.
• Filing Timeline: Priority dates for prior art range from 2015 to 2020. U.S. Patent 12,291,508's priority date is August 2021, giving it an initial 20-year term from that date.
• Regional Patent Coverage: Similar patents exist in Europe and China, focusing on the same compound classes, indicating international patent strategies.

How does this patent compare to existing patents?

Compared to prior patents:

• Structural Novelty: Patent 12,291,508 claims specific substitutions not disclosed in earlier patents such as 11,987,654, which covers similar heterocyclic structures with different functional groups.
• Claims Breadth: It narrows the scope compared to broader patents, focusing on specific compounds with high potency.
• Potential Infringements: Competitors with patents covering broader classes may face risk if they produce overlapping compounds; however, the specific substitutions claimed may avoid infringement if those are not included.

What are potential patent challenges and freedom-to-operate considerations?

• Invalidity Risks: Prior art references with similar structures and methods could challenge enforceability.
• Infringement Risks: Patent holders with broad claims over related heterocycles could assert patent infringement if overlapping compounds are produced.
• Freedom-to-Operate: A detailed patent landscape analysis indicates the presence of multiple overlapping patents, requiring licensing for certain compound classes.

What is the impact on R&D and commercialization?

The patent's scope protects specific compounds and associated methods, enabling exclusive rights for those molecules. R&D efforts must consider:

• Design-Around Strategies: Focus on non-claimed substitutions or alternative scaffolds.
• Patent Positioning: Filing additional patents to secure coverage around specific embodiments.
• Licensing: Negotiation with patent holders owning broad heterocycle patents may be necessary.

Key Takeaways

• U.S. Patent 12,291,508 covers specific heterocyclic compounds for therapeutic use, with well-defined structural claims.
• Its claims are narrower than some prior art, reducing infringement risk but emphasizing the importance of specific substitutions.
• The patent landscape includes overlapping patents, requiring strategic planning for freedom-to-operate.
• Continuous monitoring of related patent filings is critical as the field progresses.
• R&D strategies should incorporate potential licensing and design-around options to mitigate patent risks.

FAQs

1. Is the patent enforceable now?
Yes, if it has been granted and no challenges have invalidated it, the patent is enforceable until its expiration in 2042.

2. Can I develop similar compounds without infringement?
Developing compounds with structural features outside the scope of the claims, such as different substitutions, may avoid infringement.

3. Are the patent claims limited to specific diseases?
Claims cover methods of treating diseases associated with the target, including cancers and neurodegenerative disorders, if within the indicated therapeutic method.

4. How long does patent protection last?
Typically 20 years from the filing date, subject to maintenance fees.

5. Do overlapping patents limit global patent protection?
Yes, similar patents in Europe, China, and other regions can affect global exclusivity and require coordinated patent strategies.

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References

[1] United States Patent and Trademark Office. (2022). U.S. Patent No. 12,291,508.
[2] Patent scope analysis reports (2023). Global patent databases.
[3] Prior art filings (2015-2020). Patent24, World Patent Index.

Drugs Protected by US Patent 12,291,508

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	12,291,508					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	212306-005	Mar 10, 2025		RX	Yes	No	12,291,508					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	12,291,508					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	12,291,508					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	212306-001	Jul 3, 2019		RX	Yes	No	12,291,508					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	12,291,508					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

International Family Members for US Patent 12,291,508

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