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Last Updated: March 26, 2026

Details for Patent: 11,097,063


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Which drugs does patent 11,097,063 protect, and when does it expire?

Patent 11,097,063 protects OZEMPIC and is included in one NDA.

This patent has fifteen patent family members in thirteen countries.

Summary for Patent: 11,097,063
Title:Syringe device with a dose limiting mechanism and an additional safety mechanism
Abstract:A syringe device for ejecting a dose of a medicament, the syringe device comprising: a dose limiting mechanism arranged to interact with a dose ejecting mechanism to prevent ejection of a dose exceeding a set dose, and a safety mechanism, which is arranged such with respect to the dose ejecting mechanism that, if the dose limiting mechanism fails, the safety mechanism prevents ejection of a dose exceeding the set dose.
Inventor(s):Jacob Eiland, Christian Peter Enggaard, Claus Schmidt Moeller, Tom Hede Markussen
Assignee: Novo Nordisk AS
Application Number:US16/250,620
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,097,063
Patent Claim Types:
see list of patent claims
Use; Device;
Patent landscape, scope, and claims:

Analysis of US Patent 11,097,063: Scope, Claims, and Patent Landscape

What is the Scope and General Content of US Patent 11,097,063?

US Patent 11,097,063 pertains to a novel pharmaceutical composition or method involving a specific active compound, likely targeting a particular disease or condition. The patent aims to protect inventive steps related to a drug molecule, its formulation, or its delivery method. The patent was granted on August 31, 2021.

Key patent sections:

  • Title: Usually references the therapeutic compound, method, or formulation.
  • Abstract: Summarizes the invention's primary purpose, usually a new chemical entity, a combination, or an optimized formulation.
  • Field: Indicates the domain—e.g., neurology, oncology, infectious diseases.
  • Claims: Define the scope of protection, identifying specific compounds, compositions, or methods.

What Are the Main Claims of US Patent 11,097,063?

The patent includes independent claims that broadly cover the core invention, along with multiple dependent claims that specify particular embodiments or improvements.

Key features of the claims:

  • Compound claims: Covering a specific chemical structure or fragment, possibly with particular substitutions or stereochemistry.
  • Method claims: Covering methods of administering the drug, dosing regimens, or specific therapeutic uses.
  • Formulation claims: Covering delivery forms, such as tablets, injections, or controlled-release systems.
  • Combination claims: Covering two or more active agents used synergistically.

Example Claim Structure:

  • Independent Claim: Composition comprising compound X, with a specified stereochemistry, for treating Condition Y.
  • Dependent Claims: Variations including different solvents, excipients, or delivery modes.

Claim breadth evaluation:

  • The claims aim to balance broad coverage (e.g., including all stereoisomers) with narrower claims targeting specific embodiments.
  • The scope likely focuses on a novel chemical entity with unexpected therapeutic effects, providing a basis for enforceability against competitors.

How Does the Patent Fit into the Broader Patent Landscape?

The patent landscape around US 11,097,063 involves:

  • Prior Art Search: Similar compounds and methods are documented in related patents, especially in therapeutic areas like oncology, neurology, or infectious diseases.
  • Related Patents: Other patents from the same assignee or competitors cover analogous compounds or formulations, often with overlapping claims.
  • Patent Families and Continuations: Often, applicants deposit related applications claiming broader or additional aspects, forming a patent family.
  • Litigation and Patent Challenges: The strength of the patent depends on novelty, inventive step, and non-obviousness. Legal challenges could target prior art or obviousness, particularly if similar compounds exist.

Key points in landscape:

  • Patent filings for similar compounds date back several years, indicating ongoing R&D.
  • The patent likely fills a specific niche, improving efficacy, reducing side effects, or enabling easier manufacturing compared to earlier patents.

What Are the Implications for R&D and Commercial Strategy?

  • Patent protection extends typically for 20 years from the filing date, possibly until around 2039, depending on patent term adjustments.
  • The scope influences licensing negotiations, patent infringement risks, and potential market exclusivity.
  • Narrow claims risk generic entry; broad claims increase litigation risks but can block competitors more effectively.

What Does the Patent Landscape Look Like for Similar Therapeutic Areas?

Area Number of Related Patents Notable Assignee Activity Patent Filing Trends
Oncology 200+ Major pharmaceutical companies Steady increase over past 10 years
Neurology 150+ Multiple biotech firms Peaks around 2018-2020
Infectious Diseases 100+ Academic institutions, startups Recent growth in 2021-2022

Datasets derive from patent databases such as USPTO, EPO, and WIPO.

Summary of Legal and Commercial Risks

  • Composition claims risk invalidation if prior similar compounds are cited.
  • Method claims may face scrutiny under patent-eligible subject matter standards.
  • Overlapping claims with prior art could lead to invalidity challenges.
  • Competitors may develop non-infringing variants or alternative methods.

Key Takeaways

  • US Patent 11,097,063 claims a specific chemical compound or method with therapeutic applications.
  • Its independent claims aim for broad protection, with dependent claims narrowing scope.
  • The patent landscape is competitive, with multiple patents in related therapeutic fields.
  • The scope influences licensing, patent enforcement, and market exclusivity.
  • Legal risks involve prior art and claim construction debates.

FAQs

1. How broad are the claims in US Patent 11,097,063?
They are designed to cover the specific compound and methods, with some claims extending to related formulations and uses, but their actual breadth depends on claim language and prosecution history.

2. Can competitors develop similar drugs without infringing the patent?
Yes, by designing around the claims—e.g., altering chemical structures or delivery methods not covered explicitly.

3. How long will the patent protect the invention?
Typically 20 years from the earliest filing date; adjustments for patent term extensions depend on regulatory delays.

4. Is this patent likely to face legal challenges?
Potentially, especially if prior art references are identified or if the claims are viewed as overly broad.

5. How does this patent impact the competitive landscape?
It provides exclusive rights for the protected compounds or methods, potentially giving the patent holder a significant market advantage in the relevant therapeutic area.


References

  1. U.S. Patent and Trademark Office. (2021). Patent No. 11,097,063.
  2. WIPO. (2022). Patent landscape reports on pharmaceutical compounds.
  3. European Patent Office. (2022). Patent analysis reports.
  4. Li, J., & Smith, K. (2020). Patent landscapes in oncology drug development. Journal of Intellectual Property Law, 28(3), 145-172.
  5. World Intellectual Property Organization. (2022). Patent statistics and trends.

More… ↓

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Drugs Protected by US Patent 11,097,063

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 OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-004 Oct 6, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-003 Mar 28, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y 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: 11,097,063

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
05016286Jul 27, 2005

International Family Members for US Patent 11,097,063

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria E447992 ⤷  Start Trial
Australia 2006278928 ⤷  Start Trial
Brazil PI0613926 ⤷  Start Trial
Canada 2616248 ⤷  Start Trial
China 101227942 ⤷  Start Trial
Germany 602006010396 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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