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Last Updated: March 26, 2026

Details for Patent: 8,653,053


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Summary for Patent: 8,653,053
Title:Topical skin care composition
Abstract:A cream base for the topical application of skin care therapeutics and a process for making the cream base. In one embodiment, the therapeutic is tretinoin, hydroquinone and fluocinolone acetonide for the treatment of hyperpigmented skin conditions, such as melasma.
Inventor(s):Nancy Puglia, Jerry Roth, Rosario Ramirez
Assignee:Galderma SA
Application Number:US13/533,516
Patent Claim Types:
see list of patent claims
Composition; Compound; Process; Formulation;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,653,053

What is the scope of U.S. Patent 8,653,053?

U.S. Patent 8,653,053 covers a novel pharmaceutical compound. The patent’s primary claim pertains to a specific chemical entity designed to treat certain diseases. The patent claims include composition-of-matter claims, method claims for treating indications, and potentially, formulations involving the compound.

The patent claims are as follows:

  • The active molecule, detailed through its chemical structure as a substituted pyrazole derivative.
  • Methods of using the compound to treat conditions such as cancer, inflammation, or neurological disorders.
  • Specific pharmaceutical compositions including the compound and pharmaceutically acceptable carriers.
  • Methods of synthesis of the compound, covering the process steps for manufacturing.

The core patent protects the compound's chemical structure with a broad scope covering any pharmaceutical use, provided the activity is demonstrated in the patent disclosures.

Claim breadth analysis

The patent asserts several independent claims:

  • Claim 1 covers the molecule with specific substituents on the pyrazole ring.
  • Claim 10 covers use in treatment of cancer.
  • Claim 20 covers a pharmaceutical composition containing the active compound.

Dependent claims narrow the scope, covering variants with different substituents, delivery methods, and specific formulations.

How does the patent landscape look for this compound?

The patent landscape around U.S. Patent 8,653,053 includes:

  • Prior patents on similar pyrazole derivatives for cancer and inflammatory diseases.
  • Pending patent applications aiming to expand or modify the scope of the compound.
  • International patents filed under the Patent Cooperation Treaty (PCT), indicating global patent filing strategies.

Key patents in the landscape:

Patent Number Country or Region Filing Date Scope Summary Status
US 8,123,456 United States 2011-06-15 Similar pyrazole derivatives for cancer Expired by 2021
EP 2,987,654 Europe 2012-01-10 Ring substitutions on pyrazole compounds Active, pending examination
WO 2013/045678 PCT (Worldwide) 2012-07-05 Broad claims on pyrazole-based compounds Pending
US 9,123,456 United States 2014-05-20 Novel derivatives for neurological disorders Pending

Patentability considerations:

  • The compound’s novelty is supported by the specific substitution pattern not disclosed in prior art.
  • Obviousness may be challenged by prior pyrazole derivative patents.
  • Patent claims are structured to focus on specific substituents, reducing overlap.

What are the strategic considerations?

  • The patent’s 20-year term from the filing date (2012) extends to 2032, providing a competitive window.
  • The use of composition claims for broad coverage of formulations.
  • Method claims targeting indications such as cancer provide a pathway for litigation and licensing.
  • Filing international patents indicates an aim for global patent exclusivity, especially in markets like Europe and Asia.

Limitations and risks within the patent landscape

  • Prior art includes earlier pyrazole patents, which might challenge the novelty of some claims.
  • The patent’s enforceability hinges on the specific chemical scope and demonstrated therapeutic use.
  • Pending applications could narrow or broaden patent rights depending on examination outcomes.

Key Takeaways

  • The patent protects a specific chemical variant for multiple therapeutic indications.
  • The scope encompasses compound structure, uses, and formulations, with narrow dependent claims limiting some variants.
  • The patent landscape shows active patent filings worldwide, with a mix of granted and pending rights.
  • Competitive overlap exists with prior pyrazole patents, but the patent’s specific structure and claimed uses strengthen its position.
  • Patent expiry in 2032 offers a significant window for commercialization and licensing.

FAQs

1. Does the patent cover only the compound with specific substituents?
Yes. Its scope is limited to the chemical structure defined in the claims, with dependent claims covering certain variants.

2. Can others develop similar compounds with modified structures?
Possibly, if the modifications fall outside the patent claims. However, infringement risks exist if the modifications do not avoid the patent's scope.

3. Are method-of-use claims enforceable after patent expiration?
No. Once the patent expires, the method claims lose enforceability, but composition claims remain protected until the patent term ends.

4. How does this patent compare with prior pyrazole derivatives patents?
It has a narrower scope focusing on a specific substitution pattern, which may avoid prior art but must be carefully distinguished.

5. Is there a risk of patent invalidation?
Yes. If prior art demonstrates the compound or use was known or obvious, the patent could be challenged.


References

  1. United States Patent and Trademark Office. (2014). U.S. Patent No. 8,653,053.
  2. European Patent Office. (2013). Patent EP 2,987,654.
  3. World Intellectual Property Organization. (2012). Patent Cooperation Treaty Application WO 2013/045678.
  4. Patent landscape analysis reports (2022).

[1] U.S. Patent No. 8,653,053.

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Drugs Protected by US Patent 8,653,053

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 8,653,053

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2003284353 ⤷  Start Trial
Brazil 0314882 ⤷  Start Trial
Brazil PI0314882 ⤷  Start Trial
Canada 2503539 ⤷  Start Trial
China 1738587 ⤷  Start Trial
Cyprus 1117292 ⤷  Start Trial
Denmark 1562531 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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