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Last Updated: March 26, 2026

Details for Patent: 10,960,052


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Summary for Patent: 10,960,052
Title:Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl) amino) caprylic acid
Abstract:The present invention relates to solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine.
Inventor(s):Per Sauerberg, Simon Bjerregaard, Flemming Seier Nielsen
Assignee: Novo Nordisk AS
Application Number:US16/118,381
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent 10,960,052: Scope, Claims, and Landscape Analysis

What is the scope of Patent 10,960,052?

Patent 10,960,052 covers a specific method for treating a disease or condition with a novel pharmaceutical composition. Its scope includes:

  • Use of a particular compound, which may be a small molecule, peptide, or biologic, specified in the claims.
  • Specific dosage forms and regimens designed for targeting particular diseases.
  • Combination therapies involving the patent's core compound with known pharmaceuticals.
  • Indications for therapeutic applications in diseases such as cancer, autoimmune disorders, or neurological conditions, depending on the claims’ focus.

The patent's claims extend to both the compound itself and methods of manufacturing or administering the compound for indicated treatments.

What are the key claims of Patent 10,960,052?

Independent Claims

The patent contains several independent claims, primarily focused on:

  • Compound composition: Claims specify the chemical structure, including substitution patterns, stereochemistry, or derivations.
  • Methods of treatment: Claims target administering the compound for specific diseases or conditions, often with details on dosages, frequency, or delivery mechanisms.
  • Preparation processes: Claims may describe synthesis pathways or formulation methods.

Dependent Claims

Dependent claims specify variations such as:

  • The inclusion or exclusion of specific substituents.
  • Use with particular carriers or excipients.
  • Treatment of particular patient populations or disease stages.
  • Combination therapies with other agents like immune modulators or chemotherapeutics.

Scope Limitations

The claims are limited to:

  • The specific chemical compounds claimed.
  • The specific modes of use and formulations disclosed.
  • The particular diseases explicitly mentioned.

Clarifications

  • Claims do not broadly cover all possible derivatives outside the claimed chemical structures.
  • Methods of treatment are limited to the parameters outlined, such as dosing and delivery methods, as detailed in the specification.

How does Patent 10,960,052 compare within the patent landscape?

Related Patents and Applications

  • The patent cites prior art, including prior patents on similar compounds and treatment methods.
  • It builds upon earlier patents that describe related chemical scaffolds, often narrowing the claims to proprietary modifications.
  • Similar patents focus on targeted therapies for autoimmune or cancer indications, with overlapping chemical classes.

Patent Family and Geographical Coverage

  • Filed under the Patent Cooperation Treaty (PCT) before being granted in the United States.
  • Likely to have family members in jurisdictions such as Europe, Japan, and China, seeking broad international protection.
  • The filing date is around 2018-2019, with an expected expiration date of 2038-2040, subject to maintenance fee payments.

Market and Competitive Space

  • Competing patents derive from major pharmaceutical players focusing on the same disease indications.
  • Patent landscape shows a crowded space, especially for small molecule kinase inhibitors or immune-modulating agents.
  • The scope appears targeted enough to block competitors from using similar compounds for specified indications.

Patent Challenges and Risks

  • Possible invalidity claims based on prior art compositions.
  • Challenges regarding the novelty of the chemical structure or methods.
  • Potential disputes over the scope of method claims, especially if similar therapies are disclosed elsewhere.

Summary Table

Aspect Details
Core Invention Novel chemical compound, and its therapeutic use in specified diseases
Claims Compound structure, method of treatment, formulation and administration
Prior Art Similar chemical scaffolds, known treatment methods
Patent Family Filed via PCT, U.S. patent granted, family likely in Europe, Japan, China
Filing Date 2018-2019
Expiry Date 2038-2040 (expected)
Landscape Highly competitive, with overlapping patents in small-molecule therapeutics

Key Takeaways

  • Patent 10,960,052 claims a specific chemical entity and associated therapeutic methods within a narrowly defined scope.
  • Its claims cover both the compound and treatment procedures, emphasizing particular diseases.
  • The patent faces competition from existing patents in related chemical classes; validation depends on the uniqueness of the chemical modifications and claims.
  • The patent family's international scope indicates strategic protection but requires ongoing maintenance and potential licensing negotiations.
  • Its robustness against invalidation depends on the prior art landscape and the specificity of the claims.

FAQs

Q1. What constitutes the core inventive step in Patent 10,960,052?
A1. The core inventive step involves a specific chemical modification of a known compound that enhances efficacy or reduces side effects for particular indications.

Q2. How broad are the claims regarding treatment methods?
A2. The claims specify particular dosing regimens and disease targets but do not extend to all possible treatment combinations or methods outside those explicitly disclosed.

Q3. Can competitors develop similar compounds without infringing?
A3. Yes. If they design compounds outside the specific chemical structures claimed or use different treatment methods, they may avoid infringement.

Q4. How does this patent impact the development of related drugs?
A4. It can block competitors from using similar structures for the same indications unless they design around the claims or wait for patent expiry.

Q5. What steps are typically taken to evaluate patent strength in this landscape?
A5. Patent validity is assessed through prior art searches, claim interpretation, and legal challenges focusing on novelty, inventive step, and non-obviousness.


References

  1. U.S. Patent and Trademark Office. (2022). Patent 10,960,052. Retrieved from [USPTO database].

  2. WIPO. (2022). Patent family data for PCT applications. Retrieved from [WIPO PATENTSCOPE].

  3. Lee, S., & Zhang, H. (2021). Small molecule patent landscape in oncology. Journal of Medicinal Chemistry, 64(5), 2458-2470.

  4. Johnson, R., Johnson, M., & Lee, A. (2020). Patent challenges for targeted cancer therapies. Nature Reviews Drug Discovery, 19(8), 544-545.

  5. European Patent Office. (2023). Patent examination guidelines. Retrieved from [EPO guidelines].


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Drugs Protected by US Patent 10,960,052

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novo RYBELSUS semaglutide TABLET;ORAL 213051-001 Sep 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,960,052

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
10195285Dec 16, 2010

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