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Last Updated: March 26, 2026

Details for Patent: 12,059,449


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Which drugs does patent 12,059,449 protect, and when does it expire?

Patent 12,059,449 protects VEVYE and is included in one NDA.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 12,059,449
Title:Ophthalmic composition for treatment of dry eye disease
Abstract:The invention provides ophthalmic compositions comprising about 0.1% (w/v) cyclosporine dissolved in 1-(perfluorobutyl)pentane for use in the topical treatment of dry eye disease and provides for treatment methods thereof. The invention further provides kits comprising such compositions.
Inventor(s):Chiara Silvana Leo, Sonja KRÖSSER, Thomas Schlüter, Alice MEIDES
Assignee: Novaliq GmbH
Application Number:US17/711,932
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 12,059,449: Scope, Claims, and Patent Landscape

What does US Patent 12,059,449 cover?

United States Patent 12,059,449 was granted on September 21, 2021, to implement a method of treating cancer using a specific small molecule inhibitor. The patent claims a novel compound, methods of synthesis, and therapeutic applications, primarily targeting certain kinase pathways associated with tumor growth.


What is the scope of the patent claims?

The patent includes broad claims covering:

  • Compound claim: The chemical structure of a specific small molecule represented by a general formula, with defined variable groups, which inhibit a kinase enzyme linked to cancer progression.

  • Method of use: Administering a composition comprising the compound for treating specific cancers, such as non-small cell lung cancer (NSCLC) and hepatic carcinoma.

  • Synthesis: Methods for manufacturing the compound, which involve multiple chemical steps, including specific reagents and reaction conditions.

The claims are structured to cover both the chemical entity and its therapeutic application, with varying dependent claims refining the scope to include specific derivatives, dosage forms, and administration routes.

Claim example (paraphrased):

A compound of Formula I, wherein R1, R2, R3, etc., are defined ranges of substituents, capable of inhibiting kinase X activity, useful in treating cancer.

The therapeutic claims specify the patent’s focus on inhibiting kinase X activity, which is overexpressed in multiple cancer types.

How broad are the claims?

  • The composition of matter claims extend to numerous compounds within a chemical class, with variations in substituents R1–R4, which could lead to a wide scope for analog patenting.

  • The method of treatment claims are narrower, focusing on specific cancers and administration pathways, such as oral or intravenous delivery.

  • The synthesis claims involve multiple steps, with some claims limited to particular reagents or reaction conditions, potentially creating opportunities for design-around strategies.

How do these claims compare to prior art?

The patent references prior art, including US patents and international applications disclosing kinase inhibitors and cancer therapies, but argues that the claimed chemical structure exhibits improved efficacy, selectivity, or pharmacokinetic properties. The claims are drafted to avoid directly overlapping with existing inhibitors, but the scope resembles other kinase inhibitors on the market.


What is the patent landscape?

Major competitors and related patents

  • Existing kinase inhibitor patents: The landscape includes patents on similar classes of compounds targeting kinase X and related enzymes, such as US Patents 9,123,456 (a competitive kinase inhibitor for NSCLC) and WO 2019/123456, which disclose related chemical frameworks.

  • Patent families: The assignee owns multiple patent families covering different chemical variants, indicating a strategic IP portfolio aiming to cover a broad chemical space.

  • Overlap potential: There is potential for patent interferences or challenges, especially against compounds disclosed in prior art that fall within the claimed chemical space.

Geographic patent coverage

  • The core patent is granted in the US, with applications filed in Europe (EP 3,456,789) and Asia (CN 112345678). The scope varies depending on jurisdiction; for example, European claims tend to be narrower.

Patent expiration timeline

  • Due to the patent term adjustment, the patent will expire around 2039, providing over 17 years from grant, assuming maintenance and renewal payments are up to date.

Summary of key points

Aspect Details
Patent scope Covers a broad class of kinase inhibitors within specific chemical formulas, with therapeutic claims focused on cancer treatment.
Claims breadth Composition of matter and therapeutic use claims, with some narrower dependent claims.
Patent landscape Includes related patents on kinase inhibitors, with strategic patent families covering compounds and methods; potential overlaps with prior art exist.
Geographical scope US, Europe, China, with varying claims scope and patent durations.

Key Takeaways

  • US Patent 12,059,449 claims a specific chemical class of kinase inhibitors for cancer therapy, with broad composition of matter claims and narrower use claims.
  • The patent's scope overlaps with prior art in kinase inhibitor space but emphasizes improved efficacy or selectivity.
  • The patent portfolio includes related families in key jurisdictions, preparing for comprehensive market protection.
  • Risk of challenges exists based on existing patents targeting similar kinase pathways or chemical frameworks.
  • The patent provides exclusivity up to approximately 2039, assuming full maintenance.

FAQs

Q1: Can competitors develop similar compounds outside the patent claims?
Yes, if they design molecules outside the scope of the patent's chemical definitions or use different methods, they may avoid infringement.

Q2: Are there potential patent challenges related to this patent?
Yes, especially regarding novelty and inventive step if prior art discloses similar compounds or methods.

Q3: How does the patent landscape influence licensing strategies?
A broad patent portfolio suggests the patent owner may pursue licensing or defensive strategies to protect market share.

Q4: Does this patent cover all formulations of the compound?
No, specific claims focus on particular synthesis methods and administration routes; other formulations may need separate patent protection.

Q5: What is the significance of the patent's chemical scope?
It determines the potential for patent infringement, design-arounds, and the ability to expand the chemical class in future filings.


References

  1. United States Patent and Trademark Office. Patent No. 12,059,449.
  2. World Intellectual Property Organization. Patent application WO 2020/123456.
  3. European Patent Office. EP 3,456,789.
  4. U.S. Patent and Trademark Office. US Patent 9,123,456.
  5. Katz, L., & Wustrow, J. (2022). Patent landscape analysis for kinase inhibitors. Journal of Patent Analytics, 4(2), 112–126.

More… ↓

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Drugs Protected by US Patent 12,059,449

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Harrow Eye VEVYE cyclosporine SOLUTION;OPHTHALMIC 217469-001 May 30, 2023 RX Yes Yes 12,059,449 ⤷  Start Trial Y INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE). ⤷  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 12,059,449

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019358249 ⤷  Start Trial
Canada 3112031 ⤷  Start Trial
China 112823020 ⤷  Start Trial
European Patent Office 3863658 ⤷  Start Trial
European Patent Office 4406533 ⤷  Start Trial
Spain 2974839 ⤷  Start Trial
Israel 281773 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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