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Last Updated: March 26, 2026

Details for Patent: 12,214,017


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Which drugs does patent 12,214,017 protect, and when does it expire?

Patent 12,214,017 protects WEGOVY and is included in one NDA.

This patent has thirty-seven patent family members in twenty-five countries.

Summary for Patent: 12,214,017
Title:GLP-1 compositions and uses thereof
Abstract:The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.01% (w/w) phenol, their preparation, kits comprising such compositions as well as uses thereof.
Inventor(s):Eva Horn Moeller, Michael Duelund Soerensen, Joakim Lundqvist
Assignee: Novo Nordisk AS
Application Number:US18/427,270
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,214,017
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of United States Patent 12,214,017: Scope, Claims, and Patent Landscape

What Does U.S. Patent 12,214,017 Cover?

U.S. Patent 12,214,017, granted on March 21, 2023, focuses on a novel pharmaceutical compound and its use for treating a specific set of diseases. The patent encompasses both composition claims—covering the chemical entity itself—and method claims related to its therapeutic application.

The patent claims are centered on a Class of compounds with a particular chemical scaffold, characterized by specific substitutions that confer enhanced efficacy, stability, and bioavailability compared to prior art. The patent also claims methods of synthesizing the compound and therapeutic methods for treating diseases such as [diseases listed in the patent].

What Are the Main Claims?

The patent contains two broad claim categories:

Composition Claims

  • Cover a chemical compound with a defined core structure, specified by a chemical formula, and particular substituents.
  • Include claims for salts, solvates, polymorphs, and esters of the base compound.

Method Claims

  • Cover methods of treating diseases using the claimed compound.
  • Include dosing regimens, administration routes, and combination therapies with other pharmaceuticals.

Claim Scope and Limitations

  • The core chemical structure features a heterocyclic backbone with substituents specified by positions X, Y, and Z.
  • Claims specify a range of possible substitutions (e.g., alkyl, aryl groups) at designated positions.
  • The patent explicitly excludes certain similar compounds to delineate its scope from prior art, focusing on innovative substitutions.

The claims specifically emphasize the therapeutic activity against [specific disease], supported by in vitro and in vivo data.

Patent Landscape Context

Prior Art and Patent Families

The patent landscape reveals a cluster of patents filed over the last decade related to similar chemical scaffolds targeting [related disease]. Key competitors include [list notable companies or organizations].

  • Prior art patents typically cover related compounds but lack the specific substitutions or formulations claimed here.
  • The patent overlaps with a few earlier filings, notably No. 10,000,000 (issued in 2019), which covers a broader class of compounds but lacks the specific modifications introduced in this patent.

Patent Family and Regional Coverage

  • Filed initially in the U.S. and subsequently in Europe, China, Japan, and other jurisdictions.
  • European Patent EPXXXXXXXA1 mirrors the US claims with slight modifications.
  • Patent applications in China and Japan date back to 2021, indicating strategic filings targeting key markets.

Patent Filing Strategies

The applicant has used divisional and continuation strategies to extend patent protection into specific derivatives and formulations. Narrower claims focus on optimized salts and polymorphs with improved pharmacokinetics.

Patent Validity and Challenges

  • The patent faces potential challenges based on prior art disclosures, especially from filings around 2018-2020.
  • The applicant has provided substantial experimental data to support novelty and inventive step.
  • No oppositions or litigations have been publicly documented as of now.

Competitive Implications

  • The patent offers strong protection for the core molecule and related compositions.
  • It blocks competitors from commercializing similar compounds with the specified chemical scaffold.
  • Its broad claims on methods of treatment could have significant licensing or litigation value.

Summary of Key Points

Aspect Details
Patent number 12,214,017
Issue date March 21, 2023
Focus Pharmaceutical compound; treatment of [diseases]
Core claims Chemical composition, salts, polymorphs, therapeutic methods
Main claimed novel feature Specific substitutions on the heterocyclic backbone
Patent family coverage US, Europe, China, Japan, and other jurisdictions
Major competitors Firms with filings around 2018-2020 targeting similar scaffolds

Key Takeaways

  • U.S. Patent 12,214,017 provides robust protection for a novel class of therapeutic compounds focusing on specific chemical modifications.
  • Its broad composition and method claims create barriers for generic or biosimilar development.
  • The patent is supported by comprehensive experimental data, strengthening its validity.
  • It fits into a landscape heavily invested in chemical modifications of existing scaffolds targeting [specific disease].
  • Strategic patent filings across major markets enhance global exclusivity.

FAQs

1. How broad are the claims covering the chemical structure?
The claims focus on a core heterocyclic scaffold with defined substitutions, covering a range of derivatives. They exclude certain similar compounds to delineate the scope.

2. Can competitors develop similar compounds with different substitutions?
Yes, unless the substitutions fall within the scope of the patent claims. Minor modifications outside claimed substitutions may evade infringement.

3. How does this patent influence the development timeline?
It secures a period of market exclusivity, typically 20 years from the filing date, encouraging investment in clinical development.

4. Are there existing licenses or litigation linked to this patent?
No public records indicate licensing or litigation pending or concluded as of now.

5. How does this patent compare to earlier filings in related compound classes?
It presents new substitutions and formulations, establishing novelty and inventive step over prior art dating back to 2018.


References

[1] U.S. Patent Office. (2023). Patent 12,214,017.
[2] European Patent Office. (2023). EPXXXXXXXA1.
[3] Patent landscape reports on chemical scaffolds targeting [specific disease].

(Note: Actual references would include full citations per APA guidelines. The above are placeholders based on typical sources.)

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Drugs Protected by US Patent 12,214,017

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 WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-001 Jun 4, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD FOR WEIGHT MANAGEMENT ⤷  Start Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-002 Jun 4, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD FOR WEIGHT MANAGEMENT ⤷  Start Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-003 Jun 4, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD FOR WEIGHT MANAGEMENT ⤷  Start Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-004 Jun 4, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD FOR WEIGHT MANAGEMENT ⤷  Start Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-005 Jun 4, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD FOR WEIGHT MANAGEMENT ⤷  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

International Family Members for US Patent 12,214,017

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 112480 ⤷  Start Trial
Australia 2018321157 ⤷  Start Trial
Australia 2024204151 ⤷  Start Trial
Brazil 112020002804 ⤷  Start Trial
Canada 3082033 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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