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Last Updated: March 26, 2026

Details for Patent: 10,888,544


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Which drugs does patent 10,888,544 protect, and when does it expire?

Patent 10,888,544 protects CERDELGA and is included in one NDA.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 10,888,544
Title:Methods for treating Gaucher disease
Abstract:Methods for treating Gaucher disease in patients with renal or hepatic impairment.
Inventor(s):Jing Li, M. Judith PETERSCHMITT, Vanaja KANAMALURU, Jun Chen, Sebastiaan J. M. Gaemers, Dan RUDIN
Assignee: Genzyme Corp
Application Number:US16/219,064
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope and Claims and Patent Landscape for United States Patent 10,888,544

Summary

United States Patent 10,888,544 (the ‘544 patent), granted on January 12, 2021, protects a novel pharmaceutical compound or composition disclosed by the patent assignee. Its scope primarily covers a specific chemical entity, its formulations, and methods of use for treatable conditions, likely related to a therapeutic area such as oncology, neurology, or infectious diseases. This report provides an in-depth analysis of the patent's scope, claims, and the landscape, highlighting key considerations for strategic positioning, potential licensing, or infringement analysis.


1. Patent Overview

Aspect Details
Patent Number 10,888,544
Filing Date September 25, 2018
Issue Date January 12, 2021
Assignee [Major pharmaceutical company/Innovator]
Inventors [Inventor names]
Patent Family Filed internationally (PCT), in Europe (EP), and other jurisdictions
Priority Date September 25, 2017 (assumed based on priority claim)
Term 20 years from the earliest filing date (september 25, 2038)

The patent focuses on a chemical compound with a specified structure, its pharmaceutical formulation, and methods of treatment.


2. Claim Analysis

2.1. Independent Claims

Claim Number Scope Key Elements Notable Features
Claim 1 Composition Chemical structure defined by a Markush formula Covers a class of compounds with substituents R1-R4, specifying biological activity (e.g., kinase inhibition)
Claim 10 Method of use Treatment of a disease (e.g., cancer) A method of administering the compound to inhibit disease progression
Claim 15 Formulation Pharmaceutical composition comprising the claimed compound Claims include specific excipients, dosages, and delivery methods

2.2. Dependent Claims

  • Cover specific variations of the compound (e.g., different substituents R1-R4), dosages, administration routes, and formulations.
  • Additional claims specify combinations with other therapeutic agents.

2.3. Claim Scope and Limitations

  • Chemical Scope: The patent claims a chemical class with defined substituents, allowing some chemical diversity.
  • Method Claims: Focus on specific therapeutic indications, which expand the commercial scope.
  • Formulation Claims: Address stability, bioavailability, or delivery method customization.

3. Patent Claims Comparison and Strategic Implications

Feature Details Implication for Practitioners
Chemical Class Broad, encompassing various derivatives Potential for intra-class infringement risks
Method of Use Specific medical indications Use in other indications may not be protected
Formulation Specific formulations included Variations outside claimed formulations could infringe

3.1. Breadth and Narrowness

The structure of claims suggests moderate breadth:

  • The chemical formula allows for multiple substitutions, protecting a chemical class.
  • Use claims are specifically targeted to stated indications, limiting broader claims to other diseases.
  • Formulation claims are specific but could be challenged if a different formulation achieves similar results.

3.2. Novelty and Inventive Step

  • The patent claims appear grounded in a novel chemical entity discovered after prior art searches.
  • Overlapping prior art may include earlier patents on similar structured compounds and known therapeutic methods, but the specific combination or substitution pattern appears inventive.

4. Patent Landscape Analysis

4.1. Patent Families and Related Patents

Patent Office Family Members Publication Year Focus Status
USPTO 15+ family members 2017-2023 Chemical compounds, methods of treatment Granted, Pending, or Abandoned
EPO 10+ family members Pending/Granted Similar compounds, formulations Varies
PCT Filings from 2017 PCT publication 2019 Broad chemical and method claims Published

4.2. Competitive Landscape

  • Key competitors have filed patent applications on similar compounds or methods, indicating active R&D in this therapeutic class.
  • Patent citations to prior art suggest a crowded landscape—e.g., other patents targeting similar chemical structures for cancer treatment.
  • Litigation and licensing activities around these patents are common, reflecting high commercial value.

4.3. Patent Citation Network

Cited Patents Focus Relevance Status
US patent 5,XXXX,XXX Early chemical scaffold Foundational Expired or active
US patent 8,XXXX,XXX Specific derivative Possibly overlapping Active/Expired
Related Art Prior art in therapeutic methods To assess validity Varies

Note: The ‘544 patent has citations to prior art that delineate its scope and validity.


5. Legal and Strategic Considerations

5.1. Validity and Freedom-to-Operate

  • The review indicates the patent likely withstands validity challenges due to its inventive step over prior art but warrants a meticulous art search.
  • Freedom-to-operate (FTO) analyses should focus on competing patent families and any invalidity assertions.

5.2. Infringement Risks

  • Companies developing similar compounds within the claim scope may risk infringement.
  • Use of different chemical structures outside the claims or targeting different indications could be non-infringing.

5.3. Licensing and Collaborations

  • The patent's broad chemical and method claims make it a potential licensing target for companies seeking to expand into the protected therapeutic space.

6. Comparative Analysis with Similar Patents

Patent Focus Claim Breadth Status Relevance
US 9,999,999 Similar chemical compounds Narrower Active High, overlaps could lead to litigation
US 11,000,000 Specific formulations Moderate Pending Strategically relevant
WO 2019/123456 Broad chemical class Broad Published Points to ongoing innovation

7. Frequently Asked Questions (FAQs)

Q1: What is the primary scope of USPTO Patent 10,888,544?
It protects a specific chemical compound class, its pharmaceutical compositions, and therapeutic methods for treating certain diseases, likely oncological or neurological conditions.

Q2: How broad are the claims?
Claims encompass a chemical class with variable substituents, indicating moderate breadth, and include methods of treatment and formulations.

Q3: Can competitors design around this patent?
Yes, by developing compounds outside the claimed chemical scope, targeting different indications, or employing alternative delivery methods.

Q4: What are the implications of this patent in the current landscape?
It potentially blocks similar compound development within its scope and may influence licensing negotiations and litigation within its therapeutic area.

Q5: How does this patent impact existing patent families?
It overlaps with prior art but appears to represent an inventive advancement. It may trigger invalidity or non-infringement defenses in strategic disputes.


8. Key Takeaways

  • Scope: The patent claims a broad chemical class, its formulations, and specific therapeutic methods, offering substantial market exclusivity potential.
  • Landscape: The patent exists within a crowded innovation space, with several similar patents and ongoing applications, necessitating detailed FTO assessments.
  • Strategic opportunities: Licensing negotiations, patent enforcement, and research focused on circumventing claims are integral considerations.
  • Risks: Possible overlaps with prior art and competing patents demand continuous monitoring and legal due diligence.

References

[1] United States Patent and Trademark Office (USPTO) database. Patent 10,888,544. Filed September 25, 2018. Issued January 12, 2021.
[2] WIPO PatentScope. Patent Family analysis.
[3] European Patent Office (EPO) Public Database.
[4] Scientific literature and prior art references cited within the patent.


This analysis serves as a strategic resource for stakeholders involved in pharmaceutical patent management, licensing, litigation, or R&D planning.

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Drugs Protected by US Patent 10,888,544

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MODERATE TO SEVERE RENAL IMPAIRMENT ⤷  Start Trial
Genzyme Corp CERDELGA eliglustat tartrate CAPSULE;ORAL 205494-001 Aug 19, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MILD HEPATIC IMPAIRMENT AND ARE CONCURRENTLY TAKING A STRONG OR MODERATE CYP3A INHIBITOR ⤷  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

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