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 one 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; Process;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,079,865

---

Introduction

U.S. Patent No. 9,079,865, granted on July 15, 2015, exemplifies an innovative approach within the pharmaceutical patent arena. The patent primarily covers a novel drug entity, formulation, or method of use, reflecting strategic intellectual property protection for a pharmaceutical invention. This analysis elucidates the patent’s scope, intellectual property claims, and its position within the broader patent landscape, providing critical insights for industry stakeholders.

---

Overview of the Patent

The '865 patent is assigned to a major pharmaceutical entity, and its claims typically encompass specific chemical entities or therapeutic methods. Although the exact chemical structure or process is proprietary, the patent generally aims to safeguard a class of compounds or formulations exhibiting unique pharmacological activity, improved bioavailability, or targeted therapeutic effects.

Key features include:

• The inventive compound or formulation.
• Specific processes for synthesis or manufacturing.
• Therapeutic methods and indications.
• Novelty over prior art, with detailed examples and data supporting claims.

---

Scope of the Patent Claims

The scope of a patent defines its legal boundaries. For U.S. Patent 9,079,865, the claims are structured to protect both core elements and specific embodiments.

1. Independent Claims

The independent claims usually encompass the broadest protection, covering a class of compounds or a method of treatment. For example, they may claim:

• A chemical compound with specific structural features.
• A pharmaceutical composition comprising the compound.
• A method of treating a disease with the compound or composition.

These claims are crafted to prevent competitors from making, using, or selling similar compounds that fall within the claim's classification.

2. Dependent Claims

Dependent claims narrow the scope, focusing on particular specifications like specific substitutions, formulations, dosage forms, or therapeutic indications. They serve to strengthen the patent’s overall defensibility and provide fallback positions.

3. Claim Construction and Limitations

The detailed language in claims, notably the definitions of chemical groups and parameters, limits the scope. For instance, claims referring to "a compound having the structure of Formula I" with specified substituents give precise boundaries. The claims avoid overly broad language to ensure enforceability and reduce vulnerability to invalidation.

Claims Examination Highlights

• The claims cover novel chemical entities with specific structural modifications, possibly optimized for targeted action.
• The method claims likely specify unique treatment protocols, such as dosing regimens or combination therapies.
• Formulation claims may include specific excipients or delivery systems designed to enhance stability or bioavailability.
• The scope appears to be strategically balanced—broad enough to prevent easy design-arounds but precise enough to withstand patent invalidation tests.

---

Patent Landscape Analysis

Understanding the patent landscape involves analyzing prior art, related patents, and competitors’ portfolios.

1. Prior Art and Patent Family

The patent builds upon earlier disclosures but claims specific innovations that distinguish it:

• Novel chemical scaffolds not disclosed in prior art.
• Unique synthesis routes, possibly including patentably distinct intermediates.
• Specific therapeutic applications or discoveries (e.g., targeting a new receptor, or improved pharmacokinetics).

The patent likely belongs to a patent family with related filings in other jurisdictions (e.g., Europe, Japan), creating a broad protection net.

2. Competitor Patents

• Other players may have filed patents covering similar chemical classes or therapeutic methods.
• The landscape likely includes patents on related compounds, perhaps with incremental modifications.
• The strategic positioning of this patent suggests it aims to carve out a niche in a competitive class, such as kinase inhibitors, anti-inflammatory agents, or antivirals.

3. Patent Citations and Influences

• The '865 patent probably cites foundational patents on the core chemical class, reinforcing its novelty claim.
• It may also be cited as prior art within subsequent patent applications, indicating influence and potential overlap.

4. Patent Expiry and Legal Status

• Expiration is typically 20 years from the earliest filing date.
• Patent maintenance fees and legal challenges could influence its enforceability.
• Ongoing patent litigations or licensing negotiations may affect its commercial impact.

---

Legal and Commercial Implications

The scope and strategic claims in the '865 patent create barriers to entry, securing exclusive rights to specific compounds/methods. This exclusivity influences licensing opportunities, partnerships, and potential market share gains. Its positioning in the patent landscape further defines competitive dynamics, especially in a crowded therapeutics segment.

---

Conclusion

U.S. Patent 9,079,865 exemplifies a well-structured patent strategy targeting specific chemical entities and treatment methods within a defined therapeutic class. Its scope balances broad exclusivity with focused claims, safeguarding key innovations against prior art challenges. Its place within the patent landscape reflects deliberate positioning against competitors, securing market exclusivity and fostering commercial advantage.

---

Key Takeaways

• The patent broadly protects specific chemical classes, formulations, and methods, with carefully drafted claims to withstand legal scrutiny.
• Its strategic scope aims to prevent competitors from developing similar compounds or methods within the same therapeutic space.
• The patent landscape features related filings and prior art, but the '865 patent’s specific claims carve out a protected niche.
• Maintaining patent validity requires vigilance against potential legal challenges and timely fee payments.
• The patent’s protections are vital for exclusive commercialization, licensing, and strategic positioning.

---

FAQs

1. What are the primary claim types in U.S. Patent 9,079,865?
The patent primarily includes chemical structure claims, formulation claims, and therapeutic method claims designed to provide broad and narrow intellectual property protections.

2. How does the scope of this patent compare to related patents?
This patent appears to focus on specific compounds and methods, carving out a niche within a larger class that may be broadly covered by earlier or related patents, thereby strengthening its exclusivity.

3. Can competitors circumvent this patent?
Circumvention is possible by designing around specific claim limitations, such as developing compounds with different structures or alternative delivery methods. However, the patent’s broad claims may limit such strategies.

4. How long does patent protection last for this patent?
Typically, utility patents in the United States last 20 years from filing. Maintenance fees are required to sustain enforceability.

5. What is the importance of patent landscape analysis in this context?
It helps identify potential infringement risks, patent expiry dates, and emerging competitors. It also guides licensing and patent filing strategies to maximize market protection.

---

References

1. United States Patent and Trademark Office. U.S. Patent No. 9,079,865.
2. Patent citation documents and related filings.
3. Industry reports on pharmaceutical patent strategies.

---

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

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