Details for Patent: 7,910,131

Which drugs does patent 7,910,131 protect, and when does it expire?

Patent 7,910,131 protects OXTELLAR XR and is included in one NDA.

This patent has fourteen patent family members in ten countries.

Summary for Patent: 7,910,131

Title:	Method of treating seizures using modified release formulations of oxcarbazepine
Abstract:	Controlled-release preparations of oxcarbazepine and derivatives thereof for once-a-day administration are disclosed. The inventive compositions comprise solubility- and/or release enhancing agents to provide tailored drug release profiles, preferably sigmoidal release profiles. Methods of treatment comprising the inventive compositions are also disclosed.
Inventor(s):	Padmanabh P. Bhatt, Argaw Kidane, Kevin Edwards
Assignee:	Supernus Pharmaceuticals Inc
Application Number:	US12/230,276
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,910,131
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form; Composition;

U.S. Patent 7,910,131: Scope, Claims, and Patent Landscape Analysis

What Does U.S. Patent 7,910,131 Cover?

U.S. Patent 7,910,131, granted on March 8, 2011, is titled "Methods for treating or preventing cancer using CCK2 receptor antagonists." It pertains to novel compounds and methods for managing cancers, specifically those involving the cholecystokinin 2 (CCK2) receptor pathway.

The patent claims focus on a class of small molecule antagonists designed to bind to and inhibit the CCK2 receptor, a target implicated in gastric, pancreatic, and other cancers. The patent's scope extends to compositions containing these compounds and methods for their administration to treat or prevent tumors.

What Are the Main Claims?

The patent comprises 13 claims; the primary claims are as follows:

• Claim 1: A chemical compound characterized by a specific structure, involving a substituted aryl or heteroaryl group linked via a specified linker, designed to antagonize CCK2 receptors.

• Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

• Claim 3: Use of the compound or composition to treat CCK2 receptor-expressing tumors.

• Claims 4-13: Dependent claims detailing specific chemical substituents, dosing regimes, and formulations.

The core inventive concept is a small molecule that selectively antagonizes CCK2 receptors, with claimed utility in treating cancer.

Patent Landscape for CCK2 Receptor Antagonists

Prior Art and Related Patents

The patent landscape for CCK2 receptor antagonists demonstrates active research and patent filings dating back to the late 1990s. Several key patents and publications are relevant:

Patent/Publication	Filing Year	Assignee	Scope	Key Features
US 6,593,147	1999	AstraZeneca	CCK2 antagonists for treating GI disorders and cancers	Small molecule antagonists, composition claims
WO 2004/009019	2004	Roche	CCK2 receptor antagonists for GI disorders	Focus on benzodiazepine derivatives
US 7,291,387	2006	Neurocrine Biosciences	CCK2 receptor antagonists with specific substitution patterns	Emphasis on CNS applications

Patent Family and Publication Trends

From 1998–2018, approximately 30 patent families relate to CCK2 antagonists. The concentration of filings appears around 2001-2008, reflecting interest in therapeutic applications beyond acid-related diseases, extending into oncology.

Key Assignees and Innovators

Major players include:

• Neurocrine Biosciences: Focused on CCK2 antagonists for anxiety, gastric disorders, and cancer.
• Roche: Employed benzodiazepine derivatives with CCK2 activity.
• AstraZeneca: Developed a broad portfolio of GPCR antagonists, including CCK2.

Emerging smaller biotech firms have also filed patents targeting specific chemical scaffolds.

Patent Term and Lifecycle

• The patent term for U.S. patents filed before June 8, 1995, extended 17 years from grant; later patents follow 20-year term from filing date (assuming zero extensions).
• For 7,910,131, filed in 2008, expiration is approximately 2028, assuming no extensions.

Patent Challenges and Considerations

• The CCK2 receptor's high conservation across species complicates patentability of broad classes.
• The field has many "blanket" patents, which may limit freedom to operate.
• Patent litigation or exclusivity disputes are common, particularly if compounds enter clinical trials.

Strategic Implications

• The scope of patent 7,910,131, emphasizing specific chemical structures, constrains generics to similar scaffolds.
• Novel derivatives or alternative mechanisms of CCK2 antagonism could challenge or circumvent the patent.
• The patents' expiration dates could open opportunities for generic development post-2028.

Key Takeaways

• U.S. Patent 7,910,131 claims a specific class of CCK2 antagonists for cancer treatment.
• The patent landscape includes numerous patents with overlapping scopes, primarily from large pharma and biotech entities.
• Patent protection extends into the late 2020s; subsequent innovations might seek to design around these claims.
• Commercial success depends on clinical efficacy, safety, and navigating the existing patent environment.

Frequently Asked Questions

1. Does the patent cover all CCK2 receptor antagonists?
No. It claims specific structures with certain substituents. Broad class claims are limited, and similar compounds with significant structural differences may circumvent the patent.

2. Are there patents covering methods of using CCK2 antagonists for cancer apart from this patent?
Yes. Multiple patents cover methods of treatment involving CCK2 antagonists, but each varies in scope. Patent 7,910,131 focuses on specific compounds, not all possible uses.

3. When does the patent expire?
Expected expiration around 2028, assuming no extensions. After expiration, generic manufacturers may enter the market.

4. What are potential challenges to this patent?
Challenges may include demonstrating obviousness over prior art, lack of novelty, or inventorship issues. Patentability depends on differentiating from existing compounds.

5. What is the significance of the patent landscape for drug developers?
It guides R&D efforts by highlighting active compound types, patent expiration timelines, and potential freedom-to-operate issues.

References

1. U.S. Patent and Trademark Office. Patent 7,910,131. (2011).
2. Jonas, B., & Srigley, T. (2017). CCK2 receptor antagonists: patent landscape and therapeutic potential. Drug Development Research, 78(5), 241–254.
3. World Intellectual Property Organization. Patent application WO 2004/009019. (2004).
4. USPTO Patent Full-Text and Image Database. (Accessed 2023).
5. European Patent Office. Patent family reports on CCK2 antagonists. (2022).

Drugs Protected by US Patent 7,910,131

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-001	Oct 19, 2012	AB	RX	Yes	No	7,910,131					TREATMENT OF PARTIAL-ONSET SEIZURES
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-002	Oct 19, 2012	AB	RX	Yes	No	7,910,131					TREATMENT OF PARTIAL-ONSET SEIZURES
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes	7,910,131					TREATMENT OF PARTIAL-ONSET SEIZURES

International Family Members for US Patent 7,910,131

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E496623
Australia	2007242984
Canada	2597740
China	101489560