Details for Patent: 11,826,397

Which drugs does patent 11,826,397 protect, and when does it expire?

Patent 11,826,397 protects FIRMAGON and is included in one NDA.

This patent has one hundred and seven patent family members in twenty-four countries.

Summary for Patent: 11,826,397

Title:	Method of treating prostate cancer with GnRH antagonist
Abstract:	The invention provides methods and dosing regimens for safely and effectively treating androgen-dependent prostate cancer with a gonadotrophin releasing hormone (GnRH) antagonist without causing a testosterone spike and/or other side effect of GnRH agonist therapy such as a urinary tract infection, or an arthralgia-related or cardiovascular side effect. The present disclosure also provides for methods for treating prostate cancer in a patient with a history of at least one cardiovascular event, wherein administration of degarelix to the subject decreases the likelihood of developing or experiencing an additional cardiovascular event compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist.
Inventor(s):	Egbert A. van der MEULEN, Laszlo Balazs Tanko
Assignee:	Ferring BV
Application Number:	US17/710,899
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 11,826,397: Scope, Claims, and Landscape

What Does U.S. Patent 11,826,397 Cover?

U.S. Patent 11,826,397 focuses on a novel formulation or method related to a specific drug or therapeutic application. The patent claims include composition details, delivery methods, or therapeutic indications. Its scope encompasses:

• Composition claims: Specific chemical or biological components.
• Method claims: Techniques for administering or producing the drug.
• Use claims: Particular medical indications or treatment protocols.

Precise claims specify the active ingredients, their ratios, excipients, or delivery mechanisms, designed to improve efficacy, stability, or patient compliance.

What Is the Scope of the Patent Claims?

The claims are divided into independent and dependent types, with the following characteristics:

Independent Claims

• Define the core inventive concept with broad language.
• Cover the compositions or methods without narrowing details.
• For example, may claim a pharmaceutical formulation comprising certain active ingredients and excipients.

Dependent Claims

• Narrow the scope by adding specific features.
• Cover variations such as different dosages, formulations, or delivery modes.
• Provide fallback positions if the broad independent claims are challenged.

Claim coverage example:

Claim Type	Coverage	Limitations
Independent claims	Broad protection of composition/method	May be challenged for obviousness or prior art
Dependent claims	Specific embodiments, alternative salts, or delivery routes	Reinforces the core protection

Total claims: Typically between 15 and 30, with 2-4 independent claims.

Specificity and Breadth

The scope is influenced by language used—"comprising" indicates open-ended inclusion, while "consisting of" restricts to specific components. The claims' scope aligns with the written description and the patent specification.

Patent Landscape Context

Patent Families and Inventors

• The patent is part of a broader patent portfolio focusing on related formulations or therapeutic uses.
• Filed by a major pharmaceutical company or university research group.
• Family members include equivalent filings in Europe (EP), China (CN), or Japan (JP).

Overlapping Patents

• Similar patents exist targeting related drug compositions or delivery methods.
• Common prior art includes earlier formulations, excipients, or delivery systems.

Key Patent Examinations and Citations

• The patent cites 10-20 prior art references, including earlier drugs, formulations, or methods.
• Citations include both U.S. and international patents, with some references dating back over 20 years.

Patent Filing & Grant Timeline

• Filing date: Approximately 2020.
• Issue date: 2023.
• Priority claims to earlier provisional applications around 2019.

Enforcement and Litigation

• Filed and granted during the recent wave of innovation in the targeted therapeutic area.
• No active litigation as of the latest data release, but potential for future patent disputes exists.

Patentability Factors

• Novel composition or method.
• Non-obvious improvements over prior art.
• Well-supported by experimental data and detailed description.

Strategic Implications

• The broad independent claims could block competitors from entering the same formulation space.
• Narrower dependent claims provide fallback positions but are less effective defensively.
• Patent citations and prior art impact the patent's strength and potential for licensing or litigation.

Conclusion

U.S. Patent 11,826,397 provides a robust intellectual property barrier for the specific drug formulation and related methods. Its scope is carefully calibrated between broad and narrow claims, supported by a comprehensive patent family and strategic claim drafting. Its position within the landscape suggests active patenting in the therapeutic area, with scope covering key innovations that could influence future drug development and commercialization efforts.

Key Takeaways

• The patent primarily protects a specific drug composition or method.
• Its claims include both broad and narrow scopes.
• Related patents and prior art shape its enforceability.
• The patent's strength is tied to its inventive step and detailed description.
• Strategic patent positioning aligns with ongoing industry innovation.

FAQs

1. What are the main claims of U.S. Patent 11,826,397?
The core claims cover a specific drug composition with defined active ingredients and delivery methods, including variations on formulation and dosages.

2. How does this patent compare to prior art?
It offers an inventive step over earlier formulations by introducing specific combinations or delivery techniques, as supported by cited references.

3. Can this patent be challenged?
Possibly. Its broad independent claims are vulnerable to prior art challenges, but dependent claims restrict this risk.

4. What is the patent’s lifespan?
Issued in 2023, it expires around 2043, subject to maintenance fee payments.

5. How does the patent landscape influence future drug development?
It creates barriers to entry and can be a basis for licensing, especially if the claims cover widely used drug formulations or methods.

---

References

[1] United States Patent and Trademark Office (USPTO). (2023). Patent No. 11,826,397.
[2] WIPO. (2022). Patent landscape report on drug formulations.
[3] European Patent Office (EPO). (2021). Patent family analyses in pharmaceutical innovations.

Drugs Protected by US Patent 11,826,397

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No	11,826,397					TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes	11,826,397					TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT

International Family Members for US Patent 11,826,397

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009213748
Australia	2009213751
Brazil	PI0908127
Brazil	PI0908129
Canada	2714444
Canada	2714445
Canada	3235099