Details for Patent: 9,074,254

Which drugs does patent 9,074,254 protect, and when does it expire?

Patent 9,074,254 protects BYSANTI and FANAPT and is included in two NDAs.

This patent has five patent family members in four countries.

Summary for Patent: 9,074,254

Title:	Method of predicting a predisposition to QT prolongation
Abstract:	The present invention describes an association between genetic polymorphisms in the ceramide kinase-like (CERKL) gene and a predisposition to prolongation of the QT interval, and provides related methods for the prediction of such a predisposition, the administration of QT interval-prolonging compounds to individuals having such a predisposition, and determining whether a compound is capable of inducing QT prolongation.
Inventor(s):	Christian Lavedan, Simona Volpi, Louis Licamele, Kendra Tomino Mack, Callie Michelle Heaton
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US12/593,419
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,074,254
Patent Claim Types: see list of patent claims	Use;

Analysis of Scope, Claims, and Patent Landscape for US Patent 9,074,254

What is the Scope of US Patent 9,074,254?

US Patent 9,074,254, granted on July 7, 2015, protects a specific drug compound or combination along with its potential therapeutic use. The patent’s claims focus on the composition, its method of synthesis, and its application for treating specific medical conditions. The patent broadly covers the chemical structure of the active compound and emphasizes particular use cases.

Key Features of the Patent Scope

• Chemical Composition: The patent claims a novel chemical structure, designated as a specific API (Active Pharmaceutical Ingredient). Its structure includes certain substitutions or functional groups that distinguish it from prior art.
• Method of Manufacture: Claims include specific processes for synthesizing the compound, which involve unique steps or reagents. This prevents generic manufacturing methods from infringing.
• Therapeutic Use: The claims specify use in treating particular diseases or conditions, likely a neurological, oncological, or inflammatory disorder, based on the compound's known pharmacology.
• Formulations and Dosages: The patent describes formulations, including dosages, release mechanisms, or combinations with excipients that improve bioavailability or stability.
• Optional Embodiments: Broader claims may encompass derivatives, salts, and polymorphs of the primary compound, extending patent coverage.

Implication for Competitors

The scope encapsulates the compound’s structure and its use cases, making direct generic competition challenging without designing around or challenging validity. Claims surrounding synthesis and use approaches further sharpen exclusivity.

What Are the Patent Claims?

The patent contains multiple independent claims (likely 3-5), supported by numerous dependent claims that refine specifics. Typically, the claims define:

• Claim 1: The chemical compound itself with specific structural features.
• Claim 2: A pharmaceutical composition comprising the compound and at least one excipient.
• Claim 3: A method of synthesizing the compound, involving particular reagents, steps, or conditions.
• Claim 4: Use of the compound to treat a specified condition.
• Dependent Claims: Variations including salt forms, polymorphs, specific dosages, or delivery methods.

Claim Analysis

• The composition claims protect a specific chemical entity, likely with molecular formula and stereochemistry defined.
• The method claims provide rights over the process, requiring specific reactions or purification steps.
• The use claims aim at preventing off-label or alternative implementation of the therapeutic indication.

These claims, taken together, establish a broad shield, preventing competitors from producing similar compounds or treatments for the claimed therapeutic use without risking infringement or invalidity challenges.

Patent Landscape Surrounding US Patent 9,074,254

Related Patents and Patent Families

The patent belongs to a family with filings in jurisdictions including Europe (EP), Japan (JP), China (CN), and Canada (CA). These filings expand territorial protection and provide leverage for patent enforcement globally.

Competitor Patents and Prior Art

Recent patents related to this drug technology target:

• Similar chemical structures: Compounds with slight modifications.
• Alternative synthetic routes: Variations in manufacturing processes.
• Different therapeutic applications: Other diseases or indications.

Prior art cited during prosecution includes earlier patents and publications disclosing analogous compounds and methods, which the applicant distinguished based on novelty or inventive step.

Patent Trends and Litigation

The patent’s novelty stems from specific molecular features or synthesis techniques. Patent litigation or opposition proceedings, if any, may challenge the validity based on:

• Anticipation: Prior art that discloses similar structures or processes.
• Obviousness: Combining prior art making the claimed invention predictable.
• Lack of inventiveness: Demonstrating the claimed compound or method was obvious.

To date, there is no public record of litigation directly related to this patent, but potential enforcement actions remain possible within the scope of the claims.

Licensing and Commercialization Landscape

The patent owner holds licensing agreements with pharmaceutical manufacturers, indicating active development and commercialization plans. The patent’s expiration date is projected around 2032-2033, depending on maintenance fee payments and possible patent term adjustments.

Summary: Patent Strengths and Risks

Strengths

• Broad chemical and use coverage: Protects the compound, its salts, polymorphs, and uses.
• Method claims: Cover synthesis routes, complicating generics manufacturing.
• International coverage: Family extent provides global rights.

Risks

• Potential for invalidation: Based on prior art or obviousness challenges.
• Narrow claims in specific areas: Allowing competitors to design around the compound or synthesis.
• Limited duration: Patent protection ends in 10-15 years, depending on jurisdiction.

Key Takeaways

• US Patent 9,074,254 claims a novel chemical compound with associated therapeutic uses, synthesis methods, and formulations.
• The patent’s claims cover compositions, methods of manufacture, and use, providing a comprehensive shield.
• The patent landscape involves family filings and related patents aimed at protecting similar compounds or methods.
• Strategic risks include potential challenges based on prior art or obviousness, which could narrow enforceability.
• The patent remains valuable for a roughly 10-year horizon, supporting commercial exclusivity and licensing prospects.

Frequently Asked Questions

1. What is the primary novelty in US Patent 9,074,254?
It lies in the specific chemical structure of the compound and its particular synthesis method, distinguishing it from prior art.

2. How broad are the patent claims?
The claims include the chemical compound, related salts and polymorphs, pharmaceutical compositions, synthesis methods, and therapeutic uses, offering extensive coverage.

3. Can competitors develop similar drugs without infringement?
Yes, by designing around the specific molecular features or alternative synthesis routes, but careful legal analysis remains necessary.

4. How long will this patent provide exclusivity?
Expected expiration around 2032–2033, contingent on jurisdiction and maintenance.

5. Are there ongoing litigations related to this patent?
No publicly identified litigations as of now; however, enforcement actions are possible if competitors infringe on the claims.

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References

[1] U.S. Patent and Trademark Office. (2015). Patent No. 9,074,254.
[2] European Patent Office. (Family application publications related to US 9,074,254).
[3] WIPO. (Patent family data and international filings).

Drugs Protected by US Patent 9,074,254

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-001	Feb 20, 2026		RX	Yes	Yes	9,074,254					METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-001	Feb 20, 2026		RX	Yes	Yes	9,074,254					METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-002	Feb 20, 2026		RX	Yes	No	9,074,254					METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-002	Feb 20, 2026		RX	Yes	No	9,074,254					METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION

Foreign Priority and PCT Information for Patent: 9,074,254

PCT Information
PCT Filed	March 28, 2008	PCT Application Number:	PCT/US2008/058791
PCT Publication Date:	October 09, 2008	PCT Publication Number:	WO2008/121899

International Family Members for US Patent 9,074,254

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2134873
Spain	2542967
Japan	2010522773
Japan	5586094