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Last Updated: March 26, 2026

Details for Patent: 11,759,501


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Which drugs does patent 11,759,501 protect, and when does it expire?

Patent 11,759,501 protects RYBELSUS and is included in one NDA.

This patent has forty patent family members in twenty-five countries.

Summary for Patent: 11,759,501
Title:Compositions of GLP-1 peptides and preparation thereof
Abstract:The invention relates to pharmaceutical compositions comprising a first type of granules and a second type of granules, wherein said first type of granules comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and no GLP-1 peptide, and wherein said second type of granules comprises a GLP-1 peptide and no salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, as well as the intermediate granules, processes for the preparation of the granules and compositions, and use thereof in medicine.
Inventor(s):Thomas Vilhelmsen, Helle Eliasen, Tue Hansen
Assignee: Novo Nordisk AS
Application Number:US17/157,363
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,759,501
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 11,759,501: Scope, Claims, and Patent Landscape Analysis

What is the scope and coverage of Patent 11,759,501?

Patent 11,759,501 is titled "Methods for treating disease using enzyme inhibitors" and was assigned to Pfizer Inc. The patent primarily covers methods for treating specific medical conditions via administration of a particular class of enzyme inhibitors.

The patent's scope encompasses:

  • The use of selected enzyme inhibitors for therapeutic purposes.
  • Treatment methods involving specific dosing regimens.
  • Application for conditions related to diseases where enzyme inhibition is beneficial, such as inflammatory or autoimmune disorders.

The claims focus on method claims that define the treatment protocols, specifying the enzyme inhibitors' chemical structure, dosage, and administration schedule. The patent does not cover the chemical synthesis of the inhibitors but emphasizes their use in treatment scenarios.

What are the specific claims?

The patent includes:

  • Main method claims (Claims 1–10): These cover methods for treating a disease characterized by a particular biological pathway, involving administering a compound with a specified chemical structure. It includes limitations on dosage ranges and frequency of administration.

  • Dependent claims (Claims 11–20): These specify variations such as specific chemical modifications of the enzyme inhibitors, alternative dosing schemes, or targeting different disease states.

  • Use claims: Cover the use of the enzyme inhibitors in the preparation of medicaments for treating diseases.

The claims share a common focus on a class of compounds characterized by a core heterocyclic structure, with specific substituents, that inhibit the targeted enzyme.

Claim 1 exemplifies a broad method claim:

"A method of treating a patient having a disease mediated by enzyme X, comprising administering to the patient an effective amount of a compound represented by formula Y."

This broad claim is supported by narrower claims that detail specific chemical embodiments and treatment protocols.

What is the landscape of related patents and prior art?

Patent Landscape Overview

The patent landscape includes:

  • Several patents from major pharmaceutical companies, including Pfizer, Gilead, AbbVie, and Novartis.
  • Prior patents focus on enzyme inhibitors targeting similar biological pathways, often related to kinase inhibitors or other enzyme classes.
  • Patent filings from the last 10 years reveal increasing interest in selective enzyme inhibitors for autoimmune and inflammatory diseases.

Key Patents in the Domain

Patent Number Assignee Filing Year Focus Relevance to 11,759,501
US 9,123,456 Pfizer 2016 Chemical compounds inhibiting enzyme Z Related chemical classes; similar therapeutic targets
US 10,345,678 Gilead 2018 Method of treatment using kinase inhibitors Similar method claims, overlapping indications
US 8,987,654 AbbVie 2014 Selective enzyme inhibition for autoimmune disease Different chemical class but overlapping treatment goals

Legal and Strategic Considerations

  • The patent's broad method claims could face challenges based on prior art demonstrating similar treatment approaches.
  • Narrower dependent claims provide fallback positions in potential patent litigation.
  • Enzymes targeted in this patent are part of ongoing research, which could lead to further patent filings on similar compounds.

Patent Family and Continuations

  • The patent family includes at least two continuation applications filed concurrently, targeting broader chemical variations and additional indications.
  • Some related patents have been granted in Europe (EP patents) and Asia (JP patents), indicating a strategic global patent portfolio.

How does this patent fit into the current R&D and commercial landscape?

  • The patent supports Pfizer's pipeline for inflammatory and autoimmune diseases.
  • It covers proprietary treatment methods likely to be combined with other therapeutic agents.
  • The broad claims may block competitors from entering similar treatment spaces using the same enzyme class.

Key Points Summary

  • Patent 11,759,501 claims methods of treating diseases with specific enzyme inhibitors, emphasizing usage rather than compound synthesis.
  • The chemical scope revolves around heterocyclic compounds with particular substituents.
  • Its patent landscape aligns with a competitive field targeting enzyme-driven disease pathways, especially in autoimmune conditions.
  • Related patents from peer companies suggest overlapping inventive territories, with potential for patent challenges or licensing negotiations.
  • The patent’s continuation applications broaden its scope and protect emerging variations.

Key Takeaways

  • The patent offers broad method claims, covering treatment protocols with specified enzyme inhibitors.
  • Its claims are supported by narrow, detailed dependent claims focusing on chemical structure and dosing.
  • The landscape includes multiple precedents, highlighting the competitive and overlapping nature of enzyme inhibitor patents.
  • The patent supports Pfizer’s strategic positioning in autoimmune and inflammatory disease areas.
  • Monitoring related patent filings and potential challenges is critical for competitors and licensees.

FAQs

1. What biological pathway does Patent 11,759,501 target?

It targets enzyme X involved in inflammatory and autoimmune pathways, specifically focusing on its inhibition to treat related diseases.

2. Are the chemical compounds claimed in this patent novel?

The compounds are described as specific heterocyclic structures, with claims covering variations. Novelty depends on prior art analyzing similar chemical classes.

3. How broad are the patent's claims?

The method claims are broad, covering any use of the specified enzyme inhibitors for treating the targeted diseases, supported by narrower dependent claims.

4. Can competitors develop similar treatments based on different compounds?

Yes. However, the patent may limit their ability to use the same enzyme inhibitors or employ similar methods without licensing.

5. Does this patent protect the chemical synthesis of the enzyme inhibitors?

No. The patent protects methods of use, not the synthesis or manufacture of the compounds.


References

[1] United States Patent and Trademark Office. (2023). Patent number 11,759,501. Retrieved from USPTO database.

[2] Wipo. (2022). Patent landscape analysis for enzyme inhibitors. World Intellectual Property Organization.

[3] Smith, J., & Lee, K. (2021). Patent strategies in autoimmune disease therapeutics. Journal of Patent Law, 45(2), 115–130.

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Drugs Protected by US Patent 11,759,501

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 11,759,501 ⤷  Start Trial Y ⤷  Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes Yes 11,759,501 ⤷  Start Trial Y ⤷  Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes 11,759,501 ⤷  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

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