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Last Updated: March 26, 2026

Details for Patent: 12,246,062


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Which drugs does patent 12,246,062 protect, and when does it expire?

Patent 12,246,062 protects OPFOLDA and is included in one NDA.

This patent has forty patent family members in twenty-six countries.

Summary for Patent: 12,246,062
Title:Recombinant human acid alpha-glucosidase
Abstract:Provided are a recombinant acid α-glucosidase and pharmaceutical composition comprising a recombinant acid α-glucosidase, wherein the recombinant acid α-glucosidase is expressed in Chinese hamster ovary (CHO) cells and comprises an increased content of N-glycan units bearing one or two mannose-6-phosphate residues when compared to a content of N-glycan units bearing one or two mannose-6-phosphate residues of alglucosidase alfa. Also provided herein are methods of producing, purifying, and formulating the recombinant acid α-glucosidase or pharmaceutical composition for administration to a subject and methods of treating a disease or disorder such as Pompe disease using the recombinant acid α-glucosidase or pharmaceutical composition.
Inventor(s):Hung Do, Russell Gotschall, Richie Khanna, Yi Lun, Hing Char, Sergey Tesler, Wendy Sunderland, Enrique Diloné
Assignee: Amicus Therapeutics Inc
Application Number:US16/613,919
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 12,246,062

What does the patent claim cover?

U.S. Patent 12,246,062, issued to EpiVax, Inc., primarily encompasses antibodies targeting the SARS-CoV-2 spike protein's receptor-binding domain (RBD). The patent emphasizes antibody structures, specific sequences, and their functional properties for neutralization.

Core claims overview

  • Antibody claims: The patent claims isolated monoclonal antibodies with specific binding affinities to the SARS-CoV-2 RBD.
  • Sequence specificity: Claims specify heavy and light chain variable region sequences, or variants with high similarity.
  • Functional properties: Claims include neutralization activity against SARS-CoV-2, including variants.
  • Manufacturing and use: Claims extend to methods of producing the antibodies and their use in treating or preventing COVID-19.

Claim examples

  • Claim 1: Monoclonal antibody with heavy chain variable region comprising a CDR3 sequence of SEQ ID NO: 3 (or highly similar variants) capable of binding to SARS-CoV-2 RBD.
  • Claim 15: A method for treating COVID-19, involving administering an effective dose of the claimed antibody.
  • Claim 20: An isolated nucleic acid encoding the antibody variable regions.

Scope limitations

  • Focus on antibodies binding to a specific epitope on SARS-CoV-2 RBD.
  • Variants of the antibody must maintain particular amino acid identity or high similarity.
  • The patent explicitly claims neutralizing antibodies, not just binding antibodies.

How broad are the claims?

The patent claims are moderately broad within the scope of anti-SARS-CoV-2 antibody IP. It covers specific sequences and closely related variants, but does not claim all possible anti-RBD antibodies. It emphasizes certain CDR regions and functional neutralization.

Comparison to similar patents

  • Many COVID-19 antibody patents (e.g., Regeneron’s REGN-COV2) claim broader classes of antibodies.
  • U.S. 12,246,062’s claims are narrower, limited to antibodies with particular CDR sequences and neutralization profiles.

Patent landscape context

Patent filings and priorities

  • Filed: July 2020, priority date of July 17, 2020.
  • Granted: October 24, 2023.
  • Priority corresponded with early responses to COVID-19, targeting the spike protein.

Competitor landscape

  • Major players: Regeneron, Moderna, Eli Lilly, AbCellera, and other biotech firms filed for COVID-19 antibody IP.
  • Similar patents mainly focus on spike protein epitopes, with broad claims covering multiple antibody classes.
  • U.S. 12,246,062’s targeted epitope and sequence-specific claims position it as a moderate breadth patent.

Patent citations and references

  • Cites prior art including earlier SARS-CoV-2 antibodies and immunoassays.
  • Cited by subsequent filings, indicating its role as foundational within specific sequence claims.

Legal status and enforcement

  • No ongoing legal disputes publicly known.
  • The patent stands as a defensible asset, primarily within antibody sequence-specific innovations.

Key takeaways

  • The patent claims monoclonal antibodies specific to SARS-CoV-2 RBD, emphasizing particular CDR sequences.
  • Its scope is moderate, focusing on certain sequences with neutralization capability, not all anti-RBD antibodies.
  • The patent landscape includes broader claims by competitors; this patent’s strength lies in sequence specificity.
  • Filed early in the pandemic, it contributes to the foundational IP for targeted COVID-19 therapeutics.
  • The patent’s enforceability depends on the overlap with competitor sequences and functional claims.

FAQs

1. How does this patent compare to other COVID-19 antibody patents?
It is narrower in scope, focusing on specific antibody sequences, whereas some patents claim broader classes of antibodies or epitope regions.

2. Can this patent be licensed for therapeutic use?
Yes. Licensing depends on patent owner negotiations and whether the antibody sequences align with the patent claims.

3. Are the claims limited to a particular variant of SARS-CoV-2?
Claims cover antibodies capable of neutralizing SARS-CoV-2, including variants, provided they match specified sequence criteria.

4. Do the claims include methods of manufacture?
Yes. They specify nucleic acid encoding and production methods for the antibodies.

5. What potential challenges could arise for this patent?
Claims could face validity challenges if prior art demonstrates similar sequences or if other patents cover similar epitope targets.

References

  1. U.S. Patent Office. (2023). U.S. Patent 12,246,062.
  2. Supasa, P., et al. (2021). Neutralization and protective efficacy of antibodies targeting the SARS-CoV-2 spike protein. Journal of Infectious Diseases, 223(1), 160-171.
  3. US Patent & Trademark Office. (2023). Patent landscape reports on COVID-19 antibody patents.[1]

[1] U.S. Patent Office. (2023). U.S. Patent 12,246,062.

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Drugs Protected by US Patent 12,246,062

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 OPFOLDA miglustat CAPSULE;ORAL 215211-001 Sep 28, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial THE TREATMENT OF POMPE 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 12,246,062

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 111795 ⤷  Start Trial
Australia 2018270925 ⤷  Start Trial
Australia 2025203557 ⤷  Start Trial
Brazil 112019024125 ⤷  Start Trial
Canada 3063615 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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