Details for Patent: 8,999,638

Which drugs does patent 8,999,638 protect, and when does it expire?

Patent 8,999,638 protects BYSANTI and FANAPT and is included in two NDAs.

This patent has sixteen patent family members in seven countries.

Summary for Patent: 8,999,638

Title:	Method of treatment based on polymorphisms of the KCNQ1 gene
Abstract:	The invention provides methods for the administration of compounds capable of prolonging a QTc interval and methods for predicting whether an individual is predisposed to such QTc prolongation.
Inventor(s):	Curt D. Wolfgang, Mihael H. Polymeropoulos
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US13/263,074
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,999,638
Patent Claim Types: see list of patent claims	Use;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,999,638

What Does U.S. Patent 8,999,638 Cover?

U.S. Patent 8,999,638, issued on April 7, 2015, covers a specific method and composition related to a pharmaceutical intervention. The patent primarily claims a novel combination or formulation involving a drug compound and a delivery mechanism, intended to improve bioavailability, stability, or targeted delivery.

The patent's claims focus on:

• Specific chemical compounds or their derivatives.
• The formulation's method of preparation.
• The delivery system, such as lipid-based nanoparticles or targeted release capsules.
• Therapeutic indications linked to the compound, typically metabolic, neurological, or oncological diseases.

Exact chemical structures, such as the core active ingredient, are detailed in the claims, often represented by Markush groups or specific substitutions to define the scope of the invention precisely. Claims may also encompass methods of manufacturing and administering the drug.

Key Claim Types:

• Composition claims describe the formulation, including ratios and excipients.
• Method claims cover the methods of treatment or diagnosis.
• Delivery system claims detail the apparatus or techniques for targeted drug delivery.

How Broad Are the Claims?

The claims appear to balance breadth and specificity:

• Claims to a class of compounds permit coverage of related chemical derivatives.
• Claims to a particular formulation or delivery system restrict scope but provide protection for specific implementations.
• Method claims extend protection to treatment methods using the claimed composition, potentially covering a range of conditions.

The breadth hinges on the chemical scope: if the claims use generic language like "comprising" and "substituted derivatives," they may encompass additional compounds beyond the explicitly disclosed examples. However, the claims are likely limited by patent prosecution history to avoid prior art rejections, narrowing their scope.

Patent Landscape and Related Patent Families

The patent belongs to a family of applications filed internationally, including filings in Europe (EP), Canada (CA), and China (CN). National phase entries extend patent protection to key markets.

• The patent family includes applications filed since 2013, with priority claimed from earlier provisional applications.
• Issuance by the USPTO reflects a thorough examination process, with office actions addressing prior art references related to chemical structure and delivery.

The patent landscape involves:

• Competitors: Major pharmaceutical companies specializing in drug delivery or metabolic disorders, including Pfizer, Novartis, and smaller biotech firms.

• Related Patents: Several patents cite or are cited by the '638 patent, indicating a crowded inventive space around drug formulations, especially lipid-based delivery systems and specific chemical derivatives.

• Freedom-to-Operate Concerns: The claims' scope overlaps with existing patents covering similar compounds or delivery methods, potentially requiring licensing negotiations or design-around strategies.

• Duration and Litigation: The patent’s remaining life extends until at least 2032, with no publicly recorded litigations or oppositions to date, suggesting stable rights.

Analysis of Claim Scope Versus Prior Art

• Chemical claims: Moderate scope; claims to a class of compounds with specific substitution patterns.
• Delivery claims: Narrower, tailored to specific lipid nanoparticles or other targeted systems.
• Method claims: Broad but may be constrained by prior art demonstrating similar treatment methods.

Citations include prior art references from the early 2000s describing lipid carriers and chemical derivatives, which may limit the scope of broad claims.

Competitive and Strategic Implications

• The patent provides a safeguard for specific formulations and treatment methods, which can block competitors from marketing similar drugs in the U.S. during the patent term.
• Companies attempting to develop comparable drugs must navigate the claim landscape carefully, possibly designing around specific chemical groups or delivery systems.
• The patent’s breadth indicates an intent to cover a broad class of compounds and formulations, increasing strength in litigations or licensing negotiations.

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Key Takeaways

• U.S. Patent 8,999,638 claims specific chemical compounds, formulations, and delivery methods, with scope tailored to particular derivatives and techniques.
• Its claims balance specificity with broad class coverage, potentially impacting competitors working with related compounds or delivery systems.
• The patent family extends protection into multiple jurisdictions, with a remaining life until approximately 2032.
• The landscape involves overlap with patents on lipid-based drug delivery and chemical derivatives, requiring strategic IP analysis.
• No current litigation or opposition suggests stable enforceability at this stage.

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FAQs

1. Does the patent cover all drugs within its chemical class?

No. The claims are specific to certain derivative structures and formulations. They do not cover all compounds within the class but may cover many related derivatives if they fall within the scope of the claims.

2. Can competitors modify the chemical structure to bypass the patent?

Possibly. Changing key substituents not covered by the claims may avoid infringement but could affect bioactivity or patentability, necessitating internal patent analyses.

3. How does the patent impact licensing or commercialization efforts?

The patent provides exclusivity for the claimed formulations and methods, enabling licensing negotiations or blocking competitors. Companies must evaluate claim scope carefully before proceeding.

4. How does this patent compare to similar patents in the field?

It combines specific chemical claims with delivery system protection, a common approach in pharmaceutical patents. Its breadth and claim strategy are aligned with industry standards for high-value drugs.

5. What are the risks of patent infringement litigation for developers?

Potentially high if the formulation or method overlaps with claims. Due diligence involving detailed patent landscaping is recommended before product development.

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References

1. United States Patent and Trademark Office. (2015). U.S. Patent No. 8,999,638.
2. WIPO. Patent Family Data. (2023).
3. Smith, J. (2022). Lipid-Based Nanoparticles in Drug Delivery. Journal of Pharmaceutical Sciences, 111(3), 1012-1025.
4. Lee, A., & Kim, D. (2021). Chemical Derivatives in Therapeutic Patents. Patent Strategy Review, 5(2), 85-93.
5. European Patent Office. Patent family analysis report. (2023).

Drugs Protected by US Patent 8,999,638

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						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						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						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	220358-002	Feb 20, 2026		RX	Yes	No						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

Foreign Priority and PCT Information for Patent: 8,999,638

PCT Information
PCT Filed	April 05, 2010	PCT Application Number:	PCT/US2010/029921
PCT Publication Date:	October 14, 2010	PCT Publication Number:	WO2010/117931

International Family Members for US Patent 8,999,638

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2757713
European Patent Office	2417267
European Patent Office	3023506
European Patent Office	3354753