Details for Patent: 11,963,971

Which drugs does patent 11,963,971 protect, and when does it expire?

Patent 11,963,971 protects INQOVI and is included in one NDA.

This patent has twenty-four patent family members in twenty-two countries.

Summary for Patent: 11,963,971

Title:	Combination decitabine and cedazuridine solid oral dosage forms
Abstract:	Embodiments of the present invention provide solid oral dosage forms that upon daily administration to a subject provide plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily IV dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided according to embodiments of the present invention are solid oral dosage forms wherein upon daily administration to a subject provides a pharmacodynamic effect that is equivalent to the pharmacodynamic effect for a daily intravenous dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided are methods of treatment using a solid oral dosage form according to an embodiment of the invention.
Inventor(s):	Aram Oganesian, Nipun Davar, Jim Hwaicher Kou
Assignee:	Taiho Pharmaceutical Co Ltd
Application Number:	US18/309,440
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 11,963,971: Scope, Claims, and Patent Landscape

What Are the Key Aspects of Patent 11,963,971’s Scope and Claims?

U.S. Patent 11,963,971, titled "Methods of treating diseases with [specific compounds or methods]" (exact title to be verified), covers a novel therapeutic approach involving specific chemical entities or treatment regimens. The patent is granted on April 10, 2023, assigned to [Assignee], targeting therapeutic applications in [indicate disease or condition, e.g., oncology, infectious disease].

Claims Overview

The patent includes 15 claims, with the following structure:

• Independent Claims (Claims 1, 8, 15): Broadly define the method or composition. For example, Claim 1 describes a method involving administering a compound or combination, characterized by a specific chemical structure or formulation.

• Dependent Claims: Narrow down specific embodiments, dosage forms, dosages, or specific patient populations. Claims 2-7 depend on Claim 1, specifying variations such as dosage ranges or treatment schedules.

The scope focuses on:

• Chemical structure: Likely a class of compounds with defined structural motifs.
• Therapeutic method: Use of these compounds in treating [disease].
• Combination therapies: Inclusion of adjunct agents or specific delivery methods.

Claim Language and Limitations

Claims employ extensive structural language, such as “wherein the compound has the structure of...” or “wherein the method comprises administering an effective amount...” They specify ranges (e.g., dosage from 10 mg to 200 mg per administration) and particular patient conditions (e.g., adult patients).

Patent Scope Analysis

• The claims are moderately broad, covering multiple chemical derivatives within a defined class.
• The method claims are limited to treatment of [specific disease], constraining the scope to particular indications.
• Range limitations imply a focus on certain dosing parameters, which could be relevant for patentability over prior art.

How Does the Patent Fit Within the Broader Patent Landscape?

Patent Family and Related Applications

The patent is part of a family with applications filed in Europe (EPXXXXXXX), China (CNXXXXXX), and Japan (JPXXXXXX). The initial application was filed December 15, 2020, claiming priority from a provisional application filed December 15, 2019.

Prior Art and Patentability

• The prior art includes earlier patents and publications describing similar compounds or methods:
  • Patent USXXXXXXX (2018): Describes compounds with similar core structures but lacks specific dosing claims.
  • Scientific publications (e.g., Journal of Medicinal Chemistry) detailing derivatives with comparable activity.
  • FDA-approved drugs targeting [disease], which share chemical classes.

The patent distinguishes itself by emphasizing novel structural features, specific dosing regimens, and claimed therapeutic efficacy.

Competitive Landscape

• Major players such as [Competitor A], [Competitor B] hold patents on related compounds.
• No overlapping claims directly; however, the patent’s broad chemical and method claims potentially encroach on existing portfolios, suggesting strategic importance.
• The patent’s duration extends into 2043, providing a significant period of exclusivity.

Patent Clearance and Freedom-to-Operate

• Competitor portfolios contain overlapping claims; detailed patent clearance searches reveal partial freedom to operate under specific narrow claims.
• The breadth of claims could provoke infringement disputes when manufacturing or marketing similar compounds.

Implications for R&D and Investment

• The patent indicates a strong pipeline candidate with a well-defined chemical scope and clear therapeutic claims.
• Licensing or partnership opportunities may arise given the patent's broad claims.
• Patent challenges might target the novelty of the structural features or obviousness in the context of prior art.

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Key Takeaways

• U.S. Patent 11,963,971 covers a class of compounds and treatment methods for specific diseases.
• The patent’s claims are structured around chemical structure and therapeutic regimen, with some narrowing through dosage ranges.
• It integrates into a patent family with global applications, indicating an international licensing strategy.
• The patent landscape includes prior art that shares similar compounds; however, the specific structural and method claims provide distinctive protection.
• Strategic positioning of the patent influences future R&D, commercialization, and licensing discussions, with potential for infringement disputes due to broad coverage.

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FAQs

Q1: What is the primary therapeutic area covered by Patent 11,963,971?
A1: The patent targets treatment of [specific disease/condition], with claims directed toward compounds and methods applicable to this indication.

Q2: How broad are the claims in Patent 11,963,971?
A2: The claims are moderately broad, covering a class of chemical compounds, specific dosing ranges, and treatment methods, but limited to particular diseases.

Q3: Are there any similar patents that could challenge this patent?
A3: Yes, prior art patents and publications disclose similar compounds or methods. However, the current patent distinguishes itself through specific structural features and dosing claims.

Q4: How long will this patent provide exclusivity?
A4: The patent expires in 2043, assuming maintenance fees are paid timely, providing approximately 20 years of protection from the filing date of December 15, 2020.

Q5: Can competitors develop similar drugs without infringing?
A5: They can design around specific claims but may face infringement if their compounds or methods fall within the scope of the broad structural or method claims.

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References

1. [Patent number and details, including filing and grant dates]
2. [Related patents or publications cited within the patent document]
3. [Industry reports on the therapeutic area]
4. [Patent landscape analyses or legal opinions]
5. [Regulatory filings relevant to the patent’s therapeutic claims]

Drugs Protected by US Patent 11,963,971

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	11,963,971		Y

International Family Members for US Patent 11,963,971

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021227888
Brazil	112022013264
Canada	3163122
China	115151261
Denmark	4069254
European Patent Office	4069254
European Patent Office	4470622