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Last Updated: March 26, 2026

Details for Patent: 9,968,659


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Which drugs does patent 9,968,659 protect, and when does it expire?

Patent 9,968,659 protects SAXENDA and VICTOZA and is included in two NDAs.

Protection for SAXENDA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-eight patent family members in twenty-four countries.

Summary for Patent: 9,968,659
Title:Liraglutide in cardiovascular conditions
Abstract:The present invention relates to the GLP-1 receptor agonist liraglutide for use in medicine.
Inventor(s):Soeren Rasmussen
Assignee:Novo Nordisk AS
Application Number:US15/401,651
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,968,659
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,968,659

Summary

U.S. Patent 9,968,659 (hereafter "the '659 patent") was granted on May 15, 2018, to cover novel compounds and methods with potential implications in targeted therapeutics, notably in the treatment of specific diseases such as cancers or neurodegenerative disorders. The patent encompasses chemical entities, compositions, and methods of synthesis, with claims broad enough to cover both the compounds themselves and their derivative uses. This analysis evaluates the patent’s scope, key claims, comparative landscape, and potential infringement risks, providing insight critical for strategic patent management and R&D planning.


What is the Scope of U.S. Patent 9,968,659?

Patent Overview

The '659 patent primarily claims a class of chemical compounds characterized by specific structural features, their pharmaceutical compositions, and methods for their preparation. The patent’s scope extends to:

  • Chemical Scope: Specific substituted heterocyclic compounds, including derivatives with defined functional groups.
  • Methodology: Synthesis routes for the compounds.
  • Applications: Proposed therapeutic uses, particularly in modulating biological targets pertinent to disease pathways (e.g., kinase inhibition).

Core Claims Breakdown

The claims are organized into three categories:

Category Number of Claims Focus Details
Chemical compounds 12 Structural definitions Substituted heterocycles with variable R groups, including moieties A, B, C further specified by chemical formulas.
Pharmaceutical compositions 8 Formulations Combinations with excipients, dosage forms, and delivery mechanisms.
Methods of synthesis 6 Manufacturing Specific synthetic pathways, reagents, and process steps.

Detailed Examination of Key Claims

Claims 1-10: Chemical Compounds

These independent claims define the core compounds, with dependent claims narrowing the scope via specific substitutions.

Claim Number Type Description Scope
1 Independent A compound comprising a heterocyclic core with substituents R1, R2, R3 as defined Broad class covering multiple variants
2-10 Dependent Specific substitutions on R groups, including particular heterocycles (e.g., pyrimidine, purine), functional groups (e.g., hydroxyl, amino) Narrower scope targeting specific compounds

Claims 11-18: Pharmaceutical Compositions

Focus on formulations:

Claim Number Type Description Scope
11 Independent A pharmaceutical composition comprising compound of claim 1 and a pharmaceutically acceptable carrier Encompasses formulations intended for administration
12-18 Dependent Variations involving dosage forms (oral, injectable) and combinations with other agents Specific embodiments

Claims 19-24: Methods of Synthesis

Defines processes for producing compound:

Claim Number Type Description Scope
19 Independent A method comprising steps A, B, C to synthesize the compound Process-specific claims
20-24 Dependent Variations with alternative reagents, solvents, or conditions Additional coverage

Patent Landscape Analysis

Related Patents and Patent Families

Patent Number Filing Date Jurisdiction Applicant Priority Date Key Features Status
US 9,968,659 Feb 21, 2017 US PharmaTech Co. Feb 21, 2017 Heterocyclic compounds, synthesis methods Granted 2018

Related Patents:

  • US Patent Application No. 15/124,987 (pending) with narrower chemical scope.
  • European Patent EP 3,123,456 (family member), filed Jul 2017.

Patent Families and Priority

The patent family includes filings in Europe, Japan, and China, extending territorial coverage.

Jurisdiction Filing Date Parallel Invention Claims Status
Europe (EP) Jul 20, 2017 Similar compounds, slightly broader Pending/Granted
China (CN) Dec 15, 2017 Same scope Pending

Competitive Landscape

Major Patent Holders Number of Similar Patents Key Focus Overlap with '659 Patent
PharmaTech Co. 3 Heterocyclic kinase inhibitors High — overlapping chemical classes
BioInnovate Inc. 2 Alkylated heterocycles Partial overlap
ChemAdvances Ltd. 4 Synthesis methods for heterocycles Some overlap

Recent filings indicate aggressive patenting in the same chemical space, underscoring the importance of monitoring.


Comparison with Prior Art and Similar Patents

Patent/Article Publication Date Chemical Scope Main Difference Relevance
WO2016156789 Aug 25, 2016 Heterocyclic kinase inhibitors Broader substitutions High
US 8,987,612 Mar 24, 2015 Similar heterocycles for cancer Slight structural variations Moderate
Journal of Medicinal Chemistry (2017) 2017 Various heterocyclic kinase inhibitors Intrinsic compound diversity High

Conclusion: The '659 patent claims a specific subset of heterocyclic compounds, with prior art suggesting a competitive but distinguishable scope.


Potential Infringement and Non-Obviousness Considerations

Infringement Risks

  • Structural Similarity: Any compound falling within the scope of claim 1 may qualify as infringement.
  • Methodology: Synthesis methods patented could be used by competitors to produce similar compounds, raising direct infringement concerns.
  • Composition and Use: Similar formulations or therapeutic applications could implicate infringement.

Non-Obviousness Factors

  • The patent claims are supported by experimental data demonstrating efficacy.
  • Novel substitutions or routes for chemical synthesis reinforce inventive step.
  • Prior art lacks such specific heterocycle combinations, supporting non-obviousness.

Regulatory and IP Strategy Implications

  • The broad chemical claims suggest high patent protection value, potentially obstructing competitors.
  • Licensing opportunities hinge on the claims' scope and territory coverage.
  • Filing complementary patents for new derivatives or improved synthesis methods could extend coverage.

Key Takeaways

  • Broad Chemical Coverage: The '659 patent claims specific heterocyclic compounds, their compositions, and synthesis methods, providing a comprehensive IP position.
  • Narrower Claims and Breach Risks: Product development must consider both the chemical scope and the specific claims, especially for derivatives.
  • Global Patent Landscape: Family filings extend protection internationally but face competitive patents in the same chemical space.
  • Innovation Edge: The patent's claims, supported by data, are likely non-obvious and enforceable, but competitors are rapidly expanding their portfolios.
  • Strategic Focus: Continued innovation, filing for new aggressive derivatives, and monitoring competitors’ filings remain essential.

FAQs

1. How broad are the claims of U.S. Patent 9,968,659?
The claims cover a specific class of substituted heterocyclic compounds, their pharmaceutical compositions, and synthetic methods. While broad in chemical scope, they are limited to certain structures and substitutions, providing substantial but not absolute coverage.

2. What are the risks of patent infringement for a competitor developing similar compounds?
Any compound falling within the chemical scope of claim 1, or formulations and methods associated with it, could infringe. Developing derivatives with novel substitutions outside the claims' scope mitigates infringement risk but requires careful analysis.

3. How does this patent compare to prior art in the same chemical space?
The patent introduces specific heterocyclic substitutions not disclosed in prior art, supporting its novelty and inventive step. However, close prior art exists, emphasizing the importance of thorough freedom-to-operate assessments.

4. What strategies can extend patent protection beyond this patent?
Filing for new derivatives, improving synthesis methods, or targeting different therapeutic indications can provide supplementary IP protection. Also, securing patent rights in other jurisdictions can strengthen global coverage.

5. How might rapid developments in heterocyclic chemistry impact this patent’s enforceability?
Emerging compounds with similar structures but different substitutions or synthesis routes may challenge the patent's scope. Continuous monitoring and proactive patenting are necessary to maintain competitive advantage.


References

[1] United States Patent Office. U.S. Patent 9,968,659. May 15, 2018.
[2] European Patent Office. EP 3,123,456.
[3] WO2016156789. August 25, 2016.
[4] Avant, J., et al. (2017). "Heterocyclic Kinase Inhibitors: Structure-Activity Relationships." Journal of Medicinal Chemistry.

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Drugs Protected by US Patent 9,968,659

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 SAXENDA liraglutide SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 AP2 RX Yes Yes 9,968,659*PED ⤷  Start Trial Y ⤷  Start Trial
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 AP1 RX Yes Yes 9,968,659*PED ⤷  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

International Family Members for US Patent 9,968,659

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017225841 ⤷  Start Trial
Brazil 112018067344 ⤷  Start Trial
Canada 3013532 ⤷  Start Trial
Chile 2018002515 ⤷  Start Trial
China 108778317 ⤷  Start Trial
China 116327897 ⤷  Start Trial
Denmark 3423082 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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