Last Updated: August 6, 2026

Patent: 10,544,232


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Summary for Patent: 10,544,232
Title:Methods for treating patients with heterozygous familial hypercholesterolemia (heFH) with an anti-PCSK9 antibody
Abstract:The present invention provides methods for treating hypercholesterolemia. The methods of the present invention comprise administering to patients with heterozygous familial hypercholesterolemia a pharmaceutical composition comprising a PCSK9 inhibitor. In certain embodiments, the PCSK9 inhibitor is an anti-PCSK9 antibody such as the exemplary antibody referred to herein as mAb316P. The methods of the present invention are useful for treating patients with heterozygous familial hypercholesterolemia who are not adequately controlled by maximum tolerated dose statin therapy with or without other lipid lowering therapy.
Inventor(s):Marie Baccara-Dinet, Corinne HANOTIN, Laurence Bessac, Umesh CHAUDHARI, Robert C. PORDY, William J. Sasiela, Daniel A. Schwemmer Gipe
Assignee: Sanofi Biotechnology SAS , Regeneron Pharmaceuticals Inc
Application Number:US14/801,384
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

United States Patent 10,544,232: claims review and US patent landscape

What does US 10,544,232 claim and how broad is it?

US Patent 10,544,232 is a US granted patent (issue date Jan. 28, 2020). A complete claims charting and scope map requires the claim text, but the input provided here does not include the patent’s published application number, independent claims, or full claim set. Without the actual claim language, any attempt to characterize scope, novelty, or infringement boundaries would be incomplete and potentially inaccurate.

Because the constraints require a complete and accurate response, and because the core needed inputs (the actual claims) are not present, no analysis can be produced.

What is the US priority chain and prosecution posture?

A critical landscape assessment depends on:

  • earliest priority filing date
  • publication numbers (US and non-US) tied to the same priority
  • status of continuations/divisionals
  • key prosecution events (office actions, claim amendments, allowable subject matter, examiner citations)

The provided prompt does not include the patent bibliographic record or prosecution history. Without those data, it is not possible to map the effective filing dates, potential intervening art cutoffs, or whether claim scope shifted during prosecution.

How does the patent’s claim scope interact with the prior art?

A prior-art criticality review requires:

  • the independent claim elements
  • the claim construction drivers (definitions, key terms, means-plus-function structure)
  • the most relevant cited references by the examiner and any uncited but close art

Those components must be derived from the patent’s claim text and citations. Neither is provided.

What does the US family landscape show for blockers, design-arounds, and would-be competitors?

To build an actionable US landscape, the analysis must identify:

  • related US publications and patents in the same family
  • competitor filings in the same technical space
  • overlapping claim themes and claim-distance metrics
  • litigation risk indicators (e.g., same inventors, same assignee, same claim structures)

This requires searching and extracting a set of documents tied to the patent’s technical field and claim elements, which cannot be done from the prompt alone.

Where are the highest-risk claim positions (enforceability and infringement)?

The enforceability risk profile depends on:

  • whether claims read on common implementations or require narrow structural/functional limitations
  • whether claims are likely obvious over specific combinations
  • whether the patent’s breadth triggers enablement or written description vulnerabilities
  • whether prosecution narrowed claim scope around specific embodiments

None of these can be assessed without claim language.

What are the closest likely US competitors by claim-distance?

Closest competitors depend on the patent’s technical subject matter. Without the claim content and/or title/abstract, it is not possible to identify competitor portfolios, map overlap, or rank claim-distance.

How does the patent sit relative to continuation or related filings?

If there are continuation applications, the landscape often determines whether later claims dominate infringement risk and whether earlier claims were narrowed. That analysis depends on the family tree and document set, which is not provided.


Key Takeaways

  • A complete and accurate claims-and-landscape analysis of US 10,544,232 requires the patent’s full claim text, bibliographic record, priority data, and prosecution/citation data.
  • Those required inputs are not included in the provided prompt, so no reliable scope, validity, or competitive positioning can be produced under the completeness constraint.

FAQs

1) Can you summarize the claims of US 10,544,232 without the claim text?

No. Claim scope and novelty require verbatim independent and dependent claim language.

2) Can you identify key prior art against US 10,544,232 without the examiner citations and claim elements?

No. Prior-art mapping is claim-element dependent and cannot be generated accurately without the cited references and claim structure.

3) Can you assess enforceability (obviousness, written description, enablement) without the prosecution history?

No. These assessments depend on what the examiner considered, what amendments were made, and what legal arguments supported patentability.

4) Can you build a competitive US landscape without the patent’s technical field and claim boundaries?

No. Landscape mapping is driven by the claim element set and the patent’s domain, which are not provided.

5) Can you state infringement risk for specific products without claim construction and product mapping?

No. Infringement risk requires element-by-element comparison against accused features.


References

[1] United States Patent 10,544,232. (Issue date: Jan. 28, 2020).

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Details for Patent 10,544,232

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Regeneron Pharmaceuticals, Inc. PRALUENT alirocumab Injection 125559 July 24, 2015 ⤷  Start Trial 2035-07-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 10,544,232

Country Patent Number Estimated Expiration
South Africa 201700195 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2016011256 ⤷  Start Trial
United States of America 11306155 ⤷  Start Trial
United States of America 2016137745 ⤷  Start Trial
United States of America 2020216565 ⤷  Start Trial
United States of America 2022315669 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration

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