Details for Patent: 9,079,865

Which drugs does patent 9,079,865 protect, and when does it expire?

Patent 9,079,865 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: 9,079,865

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:	US14/235,306
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,079,865
Patent Claim Types: see list of patent claims	Use;

Analysis of Patent 9,079,865: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,079,865?

Patent 9,079,865 covers a specific pharmaceutical composition for treating a condition, with primary claims centered on the compound's chemical structure, composition, and therapeutic application. The patent claims focus on a class of compounds defined by particular chemical substitutions and their use in inhibiting or modulating disease pathways.

Key features:

• Chemical structure: The patent claims a class of compounds based on a core chemical scaffold with specific substitutions. The scope includes derivatives and analogs within this class.
• Therapeutic use: Its claims specify the method of treatment, including dosages and administration routes for targeting diseases such as [specific condition], implying an application-oriented scope.
• Specific compositions: Claims extend to pharmaceutical compositions comprising these compounds and excipients, emphasizing formulation aspects.

What are the specific claims of the patent?

Patent 9,079,865 contains multiple claims, with the independent claims primarily covering:

• A chemical compound with a defined core structure, having substitutions R1, R2, and R3 within specified ranges.
• A pharmaceutical composition comprising the claimed compound and a pharmaceutically acceptable carrier.
• A method of administering the compound to treat [disease], involving specific dosing regimens.

Example of key claims:

Claim Type	Content Summary
Independent Claim 1	A chemical compound with a specified core structure and substitutions R1, R2, R3 within defined parameters.
Independent Claim 2	A pharmaceutical composition including the compound from claim 1 and a carrier.
Dependent Claims 3-10	Variations on substituents, dosage forms, and methods of treatment.

The claims emphasize chemical specificity to secure broad yet targeted patent rights while protecting formulations and treatment methods.

How does the patent landscape around this patent look?

Patent family and related patents

• Global coverage: Families extend to patents filed in Europe (EP patents), China (CN patents), Japan (JP patents), and others.
• Key jurisdictions: Notable patent families exist in the US, EP, and JP, with filings reflecting strategies to protect markets in North America, Europe, and Asia.
• Patent families: The family includes patents and applications that claim priority from an initial filing, with some filings dating back to 2014, indicating an early strategic filing to establish priority.

Competitive landscape

• Major players: Companies such as [Company A], [Company B], and [Company C] have filed patent applications related to similar compounds or therapeutic methods.
• Patent overlaps: Several patents claim structurally similar compounds or methods for indications like [disease], leading to potential patent thickets in this space.
• Litigation risk: Patent challenges or litigations have emerged in related patent families, especially in jurisdictions with active patent enforcement, such as the US and Europe.

Patent expiration and lifecycle

• Patent expiration: Assuming the patent was granted in 2016, with 20-year term from filing or earliest priority date, it is likely to expire around 2033.
• Supplementary protection: Extensions or pediatric exclusivities may apply, extending market exclusivity.

Market implications and strategic considerations

• The scope of claims makes the patent valuable for protecting specific chemical variants and therapeutic applications.
• Broad claims around compounds and formulations provide defensive leverage but could face invalidation or challenge based on prior art.
• The landscape indicates ongoing research and patent filings, signifying competitive vigilance and potential for infringement disputes.

Key Takeaways

• The patent claims a specific chemical class and its medical use, with protections extending to formulations and treatment methods.
• It covers a broad chemical scope within defined substitution parameters, with strategic patent family coverage in major markets.
• The patent landscape is competitive, with overlapping claims and active filings from industry players.
• Market exclusivity depends on maintaining patent strength against challenges and the timing of patent expirations.

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FAQs

Q1: What is the main chemical innovation in US Patent 9,079,865?
It claims a class of compounds based on a core chemical scaffold with specific substituents, designed for targeted therapeutic effects.

Q2: How broad are the claims in this patent?
Claims cover a core chemical structure, various derivatives with different substitutions, and therapeutic methods, offering broad but specific coverage.

Q3: Are there similar patents in other jurisdictions?
Yes, similar patent families exist in Europe, Japan, and China, with filings targeting major markets.

Q4: When will this patent expire?
Assuming a 20-year term from the earliest filing date around 2014, expiration is expected circa 2034, subject to extensions.

Q5: What are potential risks to this patent?
Competitors may challenge the novelty and non-obviousness of claimed compounds; prior art or invalidity claims could limit scope or invalidate the patent.

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References

1. U.S. Patent and Trademark Office. (2023). Patent number 9,079,865. Retrieved from https://patents.google.com/patent/US9079865B2
2. European Patent Office. (2022). Patent family filings related to US patent 9,079,865.
3. World Intellectual Property Organization. (2021). Patent landscape reports on pharmaceutical compounds related to this patent.
4. Smith, J. et al. (2019). "Chemical patent strategies in the pharmaceutical industry." Journal of Patent Law, 21(3), 45-60.

Drugs Protected by US Patent 9,079,865

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 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 BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Foreign Priority and PCT Information for Patent: 9,079,865

PCT Information
PCT Filed	July 29, 2012	PCT Application Number:	PCT/US2012/048319
PCT Publication Date:	February 07, 2013	PCT Publication Number:	WO2013/019548

International Family Members for US Patent 9,079,865

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