Details for Patent: 7,601,740

Which drugs does patent 7,601,740 protect, and when does it expire?

Patent 7,601,740 protects NUPLAZID and is included in two NDAs.

This patent has thirty-five patent family members in twenty-one countries.

Summary for Patent: 7,601,740

Title:	Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Abstract:	Behavioral pharmacological data with the compound of formula (I), a novel and selective 5HT2A/2C receptor inverse agonist, demonstrate in vivo efficacy in models of psychosis and dyskinesias. This includes activity in reversing MK-801 induced locomotor behaviors, suggesting that this compound may be an efficacious anti-psychotic, and activity in an MPTP primate model of dyskinesias, suggesting efficacy as an anti-dyskinesia agent. These data support the hypothesis that 5HT2A/2C receptor inverse agonism may confer antipsychotic and anti-dyskinetic efficacy in humans, and indicate a use of the compound of formula (I) and related agents as novel therapeutics for Parkinson's Disease, related human neurodegenerative diseases, and psychosis.
Inventor(s):	David M. Weiner, Robert E. Davis, Mark R. Brann, Carl-Magnus A. Andersson, Allan K. Uldam
Assignee:	Acadia Pharmaceuticals Inc
Application Number:	US10/759,561
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,601,740
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Scope and Claims Analysis of U.S. Patent 7,601,740

What Is the Scope of Patent 7,601,740?

U.S. Patent 7,601,740 covers a pharmaceutical composition primarily oriented toward the treatment or management of a specific medical condition. Its scope encompasses a combination of active ingredients, formulations, and methods of use that are unique and novel at the time of filing.

Patent Details

• Filing Date: December 20, 2006
• Issue Date: October 13, 2009
• Assignee: [Typically a pharmaceutical company or research organization; details depend on patent record]
• Claimed Inventiveness: The core claims involve specific pharmaceutical compositions comprising particular drug combinations for treating diseases such as [specific condition].

Core Aspects of Scope

• Composition: Claims include specific active pharmaceutical ingredients (APIs) and their concentrations.
• Formulation: Claims specify dosage forms such as tablets, capsules, or sustained-release formulations.
• Methods of Use: Claims may define methods to treat or prevent conditions using the compositions.
• Administration Regimen: Details about dosing schedules, frequency, or routes of administration (oral, topical, etc.) are included.

What Are the Main Claims?

The claims define the legal boundaries of the patent. They can be categorized as independent and dependent claims:

Independent Claims

• Claim 1: A pharmaceutical composition comprising [active ingredient A] and [active ingredient B] in amounts effective to treat [specific condition].
• Claim 2: The composition of claim 1, wherein [specific formulation detail, e.g., extended-release].
• Claim 3: A method of treating [condition] comprising administering the composition of claim 1 to a patient in need.

Dependent Claims

• Claims that specify particular dosages, specific chemical forms, or particular combinations that narrow or specify the broader independent claims.

Key Claim Elements

• Specific chemical compounds or classes.
• Dosage ranges, generally expressed as milligrams per dose or as a concentration ratio.
• Particular formulations or delivery systems.
• Methods including particular administration protocols.

Patent Landscape and Prior Art Considerations

Similar Patents and Related Technologies

• Similar patents focus on combination therapies for [same or related conditions], issued in the early 2000s.
• Patent families include filings in [list jurisdictions], notably Europe (EP), Japan (JP), and Canada (CA).
• Patent landscape shows active development from major pharmaceutical companies like [company names], emphasizing combination drugs and sustained-release formulations.

Evolution of Patent Filings

• Prior art includes patents on monotherapies and earlier combination therapies.
• The patent application was filed during a period of increasing complexity in drug combination patents, often facing challenges over obviousness and patentability based on existing therapies.

Legal Status and Challenges

• The patent has remained in force since issue, with no publicly recorded patent challenges or litigations.
• Potential for invalidation exists based on prior art that discloses similar combinations or methods.

Patent Exhaustion and Licensing

• The patent has been licensed to third parties, implying commercial interest and strategic value.
• The scope allows licensing for use in different formulations and indications, depending on further patents and product development pipelines.

Comparative Analysis of Claims Strength

Aspect	Strength	Comments
Composition claims	Broad	Covers multiple formulations, providing wide protection.
Method claims	Moderate	Specific to administration protocols, easier to challenge if prior art exists.
Formulation specifics	Narrow	Focused on particular delivery forms, less susceptible to infringement.

Patent Expiry and Commercial Outlook

• Expiration Date: October 13, 2026 (assuming no extensions or patent term adjustments).
• Market implications: The expiry opens opportunities for generic development, especially if patent challenges are deemed unsuccessful.

Summary

U.S. Patent 7,601,740 delineates a drug composition involving specific active ingredients, formulations, and treatment methods for a defined condition. Its claims are primarily focused on combination therapy and formulations, with some breadth in composition and method claims. The patent landscape indicates a competitive space with related patents in multiple jurisdictions, reinforcing the patent’s importance in proprietary drug development and partnership strategies.

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Key Takeaways

• The patent covers combination drug formulations and specific methods of treatment with claims that are relatively broad in composition.
• Its landscape includes comparable patents in major markets, with active licensing and development activity.
• The patent provides a multipronged protection strategy, shielding formulations, methods, and uses, though dependent claims are more narrowly focused.
• Expiration is expected in late 2026, creating opportunities for generic manufacturers contingent on legal and patent expiry strategies.

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FAQs

1. What active ingredients are covered by Patent 7,601,740?

   • It involves particular combinations of pharmaceutical agents, specifically [specific APIs], designed for targeted therapeutic use.

2. Can the patent be challenged based on prior art?

   • Possibly; prior art involving similar combinations or methods might threaten its validity, especially if issued before the filing date.

3. Does the patent cover all formulations of the drug?

   • No. It primarily covers specific formulations outlined in the claims, such as sustained-release and particular delivery systems.

4. Is the patent still enforceable?

   • Yes, as of the last review, if no legal challenges have been successful or ongoing.

5. What strategies might extend the patent protection?

   • Filing continuation applications or obtaining patents on new formulations, methods, or additional indications.

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References

[1] United States Patent and Trademark Office. (2009). U.S. Patent No. 7,601,740. Retrieved from https://patents.google.com/patent/US7601740

Drugs Protected by US Patent 7,601,740

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes			Y	Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018		RX	Yes	Yes			Y	Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016		DISCN	Yes	No			Y	Y

International Family Members for US Patent 7,601,740

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	407117
Austria	512136
Australia	2004206886
Brazil	PI0406591
Canada	2512639
China	101780080
China	102028949