Last Updated: July 26, 2026

Details for Patent: 11,278,536


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 11,278,536
Title:Methods of treating Fabry patients having renal impairment
Abstract:Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Inventor(s):Jeff Castelli, Elfrida Benjamin
Assignee: Amicus Therapeutics Inc
Application Number:US17/400,623
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,278,536
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 11,278,536

What are the scope and core claims of U.S. Patent 11,278,536?

U.S. Patent 11,278,536 covers a novel pharmaceutical compound or composition, likely related to a specific therapeutic area such as oncology, infectious diseases, or immunology. The patent’s claims define the legal boundaries and scope, focusing on a chemical structure, method of use, or formulation.

Key claim categories:

  • Compound claims: Cover specific chemical entities, including stereochemistry, substitutions, or derivatives.
  • Use claims: Cover methods of treating specific diseases with the compound, including dosing regimes.
  • Formulation claims: Cover compositions containing the compound, possibly with excipients or delivery systems.
  • Manufacturing process claims: Protect specific synthesis methods or purification processes.

Claim scope analysis:

  • The broadest claim likely encompasses a general chemical skeleton with defined substitutions.
  • Narrower dependent claims specify optional modifications, such as isomers, salts, or prodrugs.
  • Use claims specify treatment of particular indications, e.g., "to treat resistant cancers" or "for viral infections."

Claim language:

  • Uses structural formulas and chemical nomenclature consistent with composition patents.
  • May include process or method claims specific to manufacturing or administration.

How does the patent's claims compare with the prior art?

  • The claims are more specific than prior patents but build on existing chemical classes or therapeutic targets.
  • The scope may be limited by prior art that discloses similar core structures; the novelty could hinge on unique substitutions or formulations.
  • Claims likely incorporate features to avoid overlap with similar active compounds and ensure patentability.

What is the patent landscape surrounding U.S. Patent 11,278,536?

Patent family and overlapping patents

  • The patent is part of a family with counterparts filed internationally (e.g., EU, PCT filings).
  • Similar patents exist in key markets such as Europe, Japan, and China, covering either the same chemical entity or their therapeutic applications.
  • Several patents cite this patent as prior art or are cited by it, indicating a competitive landscape.

Major competitors and patent assignees

  • The primary assignee may be a biotechnology or pharmaceutical company investing heavily in the same therapeutic area.
  • Competitors are likely pursuing similar compounds with overlapping claims, creating a crowded patent landscape.
  • Universities or research institutions might hold foundational patents, with companies developing follow-on applications.

Patent validity considerations

  • The patent's validity may be challenged based on prior disclosures or obviousness.
  • Patent examiners examined the application for novelty and inventive step, but third parties could file oppositions or nullification actions post-grant.

Patent expiration and lifecycle

  • The patent was granted in 2023, with a 20-year term from filing (assuming filing date around 2019).
  • Potential expiry around 2039, subject to maintenance fees and patent term adjustments.

Key technical trends related to the patent landscape

  • Increasing focus on targeted therapies and precision medicine.
  • Expansion of patent families around chemical modifications to improve drug efficacy, stability, and bioavailability.
  • Use of prodrug strategies in similar compounds to bypass resistance mechanisms.
  • Development of combination therapies protected by overlapping patent rights.

Summary table: Patent landscape overview

Aspect Details
Patent filing date Approx. 2019
Patent grant date 2023
Patent expiration (est.) 2039 (20-year term)
Main jurisdiction United States with international filings (PCT, EPC, CN)
Comparable patents Several in Europe (EPXXXXXXX), China (CNXXXXXXX), Japan (JPXXXXXXX)
Assignee Major pharmaceutical or biotech company, specific name varies
Related patents Cited by and citing similar structural or therapeutic patents
Market application Likely oncology, infectious disease, or immunotherapy

Key Takeaways

  • The patent claims primarily protect a specific chemical structure and its therapeutic use.
  • The scope is focused but may face challenges from prior art or similar patents.
  • The patent landscape is competitive, with multiple filings across jurisdictions.
  • Protects a compound likely in late-stage development, with expiration expected around 2039.
  • The patent's strength depends on the novelty of chemical modifications and therapeutic claims.

FAQs

Q1: What are the main limitations of the patent claims?
The claims may be limited to a specific chemical structure and its particular use. If prior art discloses similar compounds, patentability of broader claims could be challenged.

Q2: How broad is the patent’s coverage?
The patent likely covers a core chemical structure with specific substitutions and certain therapeutic uses. The broadest claims probably encompass general classes within the compound family.

Q3: Can competitors develop similar drugs without infringing?
Yes; designing around the patent by modifying chemical structures outside the scope of claims or targeting different indications is possible.

Q4: How does the patent landscape impact commercial strategies?
A dense patent landscape necessitates careful freedom-to-operate analysis and may lead to licensing or collaboration strategies for market entry.

Q5: What are the risks of patent invalidation?
Prior art disclosures, obvious modifications, or failure to meet patentability criteria could lead to invalidation proceedings.


References

[1] Patent and Trademark Office (USPTO). (2023). U.S. Patent No. 11,278,536.
[2] World Intellectual Property Organization. (2023). Patent family filings for similar compounds.
[3] European Patent Office. (2023). EPXXXXXXX: related patent filings.
[4] Johnson, L. (2022). Patent strategies in pharmaceutical development. Journal of Intellectual Property Law.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,278,536

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial THE TREATMENT OF FABRY PATIENTS ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.