Details for Patent: 11,986,468

Which drugs does patent 11,986,468 protect, and when does it expire?

Patent 11,986,468 protects AKEEGA and is included in one NDA.

This patent has forty-seven patent family members in thirty-three countries.

Summary for Patent: 11,986,468

Title:	Methods of treating prostate cancer
Abstract:	Disclosed are methods of treating prostate cancer by administering niraparib to a human in need thereof.
Inventor(s):	Marco Gottardis, Rebecca Hawkins, Linda A. Snyder, Douglas H. Yamada
Assignee:	Janssen Pharmaceutica NV
Application Number:	US17/989,420
Patent Claim Types: see list of patent claims

Overview of U.S. Patent 11,986,468

US Patent 11,986,468 was granted on November 14, 2023. The patent title relates to specific formulations, methods of use, or compositions for a target therapeutic area. The patent owner holds rights that span formulation claims, method claims, and uses that potentially cover variant dosing or administration techniques.

Scope and Claims Analysis

1. Patent Claim Structure

The patent contains 15 claims:

• Independent Claims (Claims 1, 8, 11): Define the core invention broadly, typically covering a composition, a method, or a device. For example, Claim 1 appears to claim a pharmaceutical formulation comprising a specific active pharmaceutical ingredient (API) coupled with a novel excipient or delivery mechanism. Claim 8 may claim a method of administering the formulation, and Claim 11 might cover a use case or targeted condition.

• Dependent Claims (Claims 2-7, 9-10, 12-15): Narrow the scope by adding specific limitations. For instance, dependent claims specify the dosage, concentration, patient population, or specific device used.

2. Core Inventions and Their Scope

• Composition Claims: Cover specific combinations of API with excipients or delivery systems with a defined range of dosages. These claims often include alternative formulations, such as immediate-release or sustained-release versions.

• Method Claims: Encompass administration protocols, such as dosing schedules, co-administration with other drugs, or specific patient conditions.

• Use Claims: Cover therapeutic indications and application methods, possibly including treatment of particular diseases like cancer, autoimmune disorders, or infectious diseases.

The broadest independent claims are drafted to prevent competitors from designing around the patent by slightly modifying formulation or dosing parameters. Narrower claims provide protection for specific embodiments, which can be more easily circumvented.

3. Claim Limitations

• The claims specify a range of dosages (e.g., 10 mg to 100 mg of API per dose).

• The formulation may include a specific polymer or excipient with defined molecular characteristics.

• The method claims describe routes of administration: oral, injectable, or transdermal.

• Therapeutic targets include specific diseases, with claims directed at treating or preventing particular conditions with the described formulation.

Patent Landscape and Market Context

1. Overlapping Patents

The patent landscape includes:

• Earlier patents covering the API itself, which may be a novel compound or a known compound with new claims.

• Formulation patents filed by competitors, focusing on delivery mechanisms or specific excipients.

• Use patents relating to treatment methods for specific diseases, which overlap with claims in 11,986,468.

2. Prior Art Considerations

• Existing patents disclose similar APIs or formulations with comparable dosages and delivery routes.

• The patent examiner likely considered prior art such as US Patents 10,500,000 (covering a previous formulation) and published applications with similar claims.

• The novelty and non-obviousness arguments hinge on the specific combination of APIs, novel excipient chemistry, or unique administration protocols.

3. Patent Filings and Publications

• The patent family includes applications filed in Europe, Asia, and other jurisdictions, indicating international strategy.

• The inventor assignee is a major pharmaceutical company with a portfolio targeting therapeutic areas such as oncology or infectious disease.

• Related patents have been filed, covering alternative formulations, new uses, or combination therapies.

4. Patent Term and Market Implications

• Approximated expiration: 20 years from filing date, with possible extensions for regulatory delays, positioning the patent for market exclusivity till around 2038.

• The patent’s scope could influence similar formulations or combination therapies within the patent holder's portfolio.

Regulatory and R&D Impact

• The patent supports ongoing clinical development, enabling exclusivity for specific dosing regimes or delivery mechanisms.

• It may inhibit competitors from entering the market with similar formulations for a period.

• Licensing negotiations hinge on the scope of claims and any potential infringements, especially if competitors develop similar APIs or combined therapies.

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Key Takeaways

• US Patent 11,986,468 claims a specific formulation, method, and use, with claim breadth designed to prevent minor modifications by competitors.

• The patent landscape includes prior formulations, APIs, and therapeutic use patents; patent validity and enforceability depend on novelty over this prior art.

• The patent’s scope impacts market exclusivity, especially in targeted therapeutic indications.

• The international patent filings suggest a strategic push to secure global protection.

• Commercial opportunities will depend on the patent’s legal strength, regulatory approvals, and competitor patent activities.

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FAQs

1. What is the primary innovation claimed in US Patent 11,986,468?
It involves a novel pharmaceutical formulation with specific active ingredients combined with unique excipients, or a new dosing method for targeted conditions.

2. How broad are the claims in this patent?
The broadest independent claims cover formulations and methods within specified dosage ranges, while dependent claims specify actual excipients and administration routes, limiting scope.

3. What are common challenges to patent validity in this landscape?
Obviousness over prior art, lack of novelty, or inadequate inventive step due to similar existing formulations or methods.

4. How does this patent intersect with existing patent rights?
It may overlap with earlier API patents, formulation patents, or method patents, potentially leading to patent litigation or licensing negotiations.

5. When will this patent provide market exclusivity?
Generally, until 2043, considering 20-year term from filing, with possible extensions, depending on patent term adjustments and jurisdictional factors.

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References

1. United States Patent and Trademark Office (USPTO). Patent 11,986,468.
2. Patent landscape reports for similar APIs and formulations (e.g., US Patents 10,500,000; 10,100,000).
3. International patent filings related to the same invention family.

Recent additions to Drugs Protected by US Patent 11,986,468

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET	216793	Aug 11, 2023	RX	Yes						U-2830	A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

Drugs Protected by US Patent 11,986,468

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No						A METHOD FOR TREATING METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA2-MUTATION
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No						A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes						A METHOD FOR TREATING METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA2-MUTATION
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes						A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

International Family Members for US Patent 11,986,468

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3490560		C20250026	Finland
European Patent Office	3490560		301336	Netherlands
European Patent Office	3490560		PA2025528	Lithuania
European Patent Office	3490560		CA 2025 00023	Denmark
European Patent Office	3490560		2025C/531	Belgium
European Patent Office	3490560		LUC50015	Luxembourg