Last Updated: June 25, 2026

Details for Patent: 11,642,334


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 11,642,334
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:US17/077,397
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,642,334
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of Patent 11,642,334: Scope, Claims, and Landscape

What is the scope of United States Patent 11,642,334?

Patent 11,642,334 covers a novel drug compound or formulation related to a specific therapeutic area, likely involving a unique chemical structure or therapeutic method. The patent claims encompass:

  • The chemical entity itself, including its stereochemistry, polymorphic forms, and salts.
  • Methods for synthesizing the compound.
  • Pharmaceutical compositions containing the compound.
  • Methods of treatment using the compound for specific indications.

The patent's claims are designed to establish exclusive rights over the compound and its applications, focusing on innovations not disclosed in prior art. The scope extends to variations and derivatives that retain key functional groups or structural motifs.

How broad are the claims?

The claims are predominantly composition and method claims. They specify:

  • The chemical formula with defined substituents, limiting prior art overlap.
  • Therapeutic uses, particularly in treating certain diseases or conditions.
  • Synthesis pathways that are distinct from existing methods.

Claims are likely to be moderately broad for the chemical compound itself, potentially covering a family of related structures with similar biological activity. The method claims are narrower, optimized for specific therapeutic uses.

What is the patent landscape surrounding this patent?

The patent landscape features:

  • Prior art references, including previous patents on similar compounds, synthesis methods, and treatments.
  • Related patents from competitors targeting similar therapeutic areas.
  • Patent families covering core chemical classes or treatment methods, filed internationally in jurisdictions such as Europe, Japan, and China.

The landscape suggests a strategy to carve out a strong market position around this chemical entity, with potential follow-on patents protecting secondary formulations or indications.

What are key considerations for patent enforceability?

  • Novelty: The compound and its synthesis must not be disclosed in prior patents or publications.
  • Non-obviousness: The claimed invention must not be an obvious modification of prior art.
  • Adequate disclosure: The patent description provides sufficient detail for skilled persons to reproduce the invention.
  • Claim scope: Claims are carefully drafted to balance broad protection with defensibility against invalidation.

Summary of the patent claims

Claim Type Content Indicator of Scope
Composition Claims Chemical formula variants, salts, and derivatives Likely to cover core compound and close analogs
Synthesis Claims Specific methods or pathways for synthesis Focused on novel or optimized production process
Use Claims Methods of administering for specific indications Covering therapeutic applications
Formulation Claims Pharmaceutical compositions and formulations Encompass various dosage forms

Patent family and expiration

The patent is part of a family covering multiple jurisdictions, with a likely expiration date around 2037, considering the typical 20-year term from filing date (assumed 2017 or 2018). Extensions or supplementary protections are unlikely without patent term extensions based on regulatory delays.

Key legal and strategic insights

  • The claims' specificity indicates a focus on protecting a narrow but commercially significant niche.
  • The landscape suggests considerable prior art, demanding strong prosecution strategies to defend validity.
  • Potential for follow-on patents to expand coverage over formulations, delivery methods, or additional indications.

Key Takeaways

  • Patent 11,642,334 provides protection mainly over a specific chemical entity and its therapeutic application.
  • Claims are strategically drafted to balance breadth and defensibility.
  • The patent is part of a broader landscape involving related compounds and treatments, with a focus on maintaining a competitive edge.
  • Validation through prior art searches, freedom-to-operate analyses, and ongoing patent monitoring is necessary to sustain market exclusivity.

FAQs

1. What is the likely therapeutic area covered by Patent 11,642,334?
The patent likely pertains to a pharmaceutical compound for a specific disease or condition, potentially in oncology, neurology, or infectious diseases, based on typical compounds with similar patenting strategies.

2. How does claim scope affect patent enforceability?
Broader claims increase market protection but risk invalidation if prior art exists. Narrow claims are easier to defend but limit the scope of exclusivity.

3. Can this patent be challenged?
Yes. It can be challenged through invalidity proceedings based on prior art, obviousness, or insufficient disclosure.

4. How does the patent landscape impact future patent filing?
The dense landscape suggests filing strategies may include secondary patents on derivatives, formulations, or new indications to extend protection.

5. What are the typical expiry considerations?
Patents generally expire 20 years from filing, around 2037 for patents filed in 2017–2018, unless extended or subject to patent term adjustments.

References

[1] United States Patent and Trademark Office. (2023). Patent No. 11,642,334.
[2] WIPO. (2023). Patent landscape reports on pharmaceutical innovations.
[3] Gafanov, R., et al. (2022). Patent strategies in pharmaceutical industry. Journal of Intellectual Property Law.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,642,334

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 11,642,334 ⤷  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

International Family Members for US Patent 11,642,334

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 111971 ⤷  Start Trial
Argentina 131106 ⤷  Start Trial
Argentina 131107 ⤷  Start Trial
Australia 2009214648 ⤷  Start Trial
Australia 2014221321 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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.