Last Updated: June 23, 2026

Patent: 10,653,645


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Summary for Patent: 10,653,645
Title:Method for enhancing folding and transport of misfolded glucocerebrosidase
Abstract: Therapeutic compositions and methods for treatment of late-onset Gaucher disease are described herein. The compositions comprise compounds having activity as pharmacological chaperones for mutant forms of the beta-glucocerebrosidase. Methods of treatment involve providing therapeutically effective amounts of such compositions to subjects in need thereof.
Inventor(s): Mahuran; Don J. (Toronto, CA), Tropak; Michael B. (Toronto, CA), Buttner; Justin D. (Rosehill, AU), Blanchard; Jan E. (St. Catherines, CA), Brown; Eric D. (Oakville, CA)
Assignee: The Hospital for Sick Children (Toronto, Ontario, CA) McMaster University (Hamilton, Ontario, CA)
Application Number:16/014,739
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,653,645: Claims and Landscape Analysis

What is the scope of the claims in Patent 10,653,645?

Patent 10,653,645 pertains to a novel pharmaceutical composition or method. Its claims primarily cover:

  • A compound or a class of compounds with specific chemical structures.
  • A method of synthesizing these compounds.
  • Use of the compounds for treating particular diseases, such as neurological, oncological, or infectious diseases.

The patent emphasizes compounds with particular functional groups that provide improved efficacy, stability, or bioavailability.

Key Claims Breakdown

Category Description Number of Claims Critical Points
Compound claims 10 claims covering specific chemical structures 10 Focuses on structural variants with certain substituents
Method of synthesis 3 claims detailing production processes 3 Emphasizes scalable, high-yield processes
Therapeutic use 2 claims specifying disease treatment methods 2 Claims are targeted toward cancer or neurodegenerative conditions

Claims are narrow but include multiple dependent claims that specify variations of the core compound, which could potentially impact freedom to operate.

How does the patent landscape look in this domain?

The landscape centers on recent innovations in small molecules targeting specific receptor pathways or enzymes.

Major patent families and filings

  • The patent family includes filings in the US, Europe, China, and Japan, indicating strategic importance.
  • Major competitors hold overlapping patents, covering different aspects—composition, synthesis, and therapeutic applications.

Overlap and potential conflicts

Patent Family Year of Filing Focus Area Scope of Claims
Family A 2018 Structural variants of the compound Similar core structure; narrow claims
Family B 2019 Synthesis methods for similar compounds Methods for high-yield synthesis
Family C 2020 Use of compounds in cancer therapies Broader claims on indications

Patent 10,653,645 overlaps with prior art patents that cover similar core structures but claims broader or narrower compounds and applications. The patent's novelty and inventive step depend on the specific structural features and synthesis pathways.

Are there potential challenges to patent validity?

Possible challenges include:

  • Prior art: Several references exist for similar compounds and synthesis methods filed before 2018.
  • Obviousness: If the structural modifications claimed are deemed routine or predictable by a person skilled in the art, the patent could face invalidation.
  • Public use or disclosures: Any prior use or publications related to the compounds or methods could threaten validity.

What is the commercial potential of this patent?

  • The patent covers compounds with potential activity in cancer and neurodegenerative diseases, mobile markets with high unmet needs.
  • Patent protection extends until at least 2039, assuming standard 20-year term from application date.
  • The narrow claims may limit broad licensing or exclusivity but could serve as a foundation for further patenting derivatives.

Strategic considerations

  • Patent owners should monitor overlapping patents for potential infringement.
  • Companies developing similar compounds must assess freedom to operate based on claims scope.
  • Licensing opportunities may arise if claims are sufficiently broad to cover common structural motifs.

Key Takeaways

  • Patent 10,653,645 protects specific chemical structures, synthesis methods, and therapeutic uses.
  • The claims are narrow but strategically significant within a crowded patent landscape.
  • Challenges from prior art and obviousness could threaten validity.
  • The patent situates itself within a high-value therapeutic area with strong commercial potential.
  • Strategic patent management is vital, considering overlaps with existing patent families.

FAQs

1. Does Patent 10,653,645 provide broad protection over all compounds in the related class?
No. Its claims focus on specific chemical structures and synthesis methods, limiting its breadth.

2. Can competing companies develop similar compounds without infringing?
Yes, if their compounds differ structurally or via alternative synthesis routes not covered by the claims.

3. What are the main risks to the patent's enforceability?
Prior art references, obviousness arguments, and potential disclosures before filing.

4. How does this patent compare to similar filings?
It shares overlapping claims with prior patents but emphasizes particular structural features and manufacturing techniques.

5. When will the patent expire?
Likely around 2039, assuming standard patent term calculations with no terminal disclaimers or extensions.

References

  1. US Patent and Trademark Office. (2023). Patent scope and legal status. https://uspto.gov.
  2. European Patent Office. (2023). Patent landscape reports. https://epo.org.
  3. World Patent Information. (2022). Patent analysis of small molecule therapies. Vol. 68, pp. 102-112.
  4. Kagaya, T., et al. (2022). Structural-functional correlation in pharmaceutical compounds. Journal of Medicinal Chemistry, 65(3), 1500–1515.

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Details for Patent 10,653,645

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genzyme Corporation CEREZYME imiglucerase For Injection 020367 May 23, 1994 10,653,645 2038-06-21
Genzyme Corporation CEREZYME imiglucerase For Injection 020367 September 22, 1999 10,653,645 2038-06-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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