How a Special Enzyme Helps Deliver Immune Drugs Under the Skin
This patent describes a specific, modified human hyaluronidase enzyme that helps the body absorb immune globulin drugs when injected just under the skin, making treatments easier for patients.
Original patent title: “Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases”
This patent describes a specific, modified human hyaluronidase enzyme that helps the body absorb immune globulin drugs when injected just under the skin, making treatments easier for patients. Granted to Halozyme in 2020 with 11 claims and 7 forward citations, and it is expected to expire in 2038.
Coverage
What does this patent actually cover?
The patent claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more → a method for boosting a subject's immune system by injecting immune globulin (IG) and a special soluble hyaluronidase enzyme under the skin. This specific hyaluronidase is a "soluble neutral active human hyaluronidase glycoprotein" (sHASEGP) that works well at the body's neutral pH. It has at least one sugar molecule attached to an asparagine amino acid and is a shortened version of a larger natural enzyme, specifically containing amino acids 36-464 of SEQ ID NO: 1, but truncated at its C-terminus at specific points like amino acid 477 or 483. This enzyme helps the IG spread and absorb better. For example, a patient needing a large dose of immune globulin can receive it as a less painful subcutaneous injection instead of an intravenous infusion, thanks to this enzyme.
The gap
What does this patent NOT cover?
- Does not cover administering hyaluronidase and immune globulin through methods other than subcutaneous injection (e.g., intravenous infusion).
- Does not cover using this specific hyaluronidase to deliver therapeutic molecules other than immune globulin for immune system modulation.
- Does not cover hyaluronidase enzymes that contain the complete, full-length amino acid sequence of SEQ ID NO: 1.
- Does not cover hyaluronidase enzymes that lack the specific asparagine-linked sugar moiety required by the claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more →.
- Does not cover hyaluronidase polypeptides with C-terminal truncations outside the specified amino acid residues (e.g., 477-494 of SEQ ID NO: 1) or with less than 95% sequence identity to the claimed truncated forms.
These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.
Key facts
What made this novel
The noveltynoveltyThe requirement that an invention be different from anything publicly known before its priority date.Read more → lies in identifying and engineering a specific, truncated, and glycosylated human hyaluronidase that remains soluble and active at neutral pH, making it ideal for co-administration with other drugs to enhance their subcutaneous absorption.
The Patent Drawing
Schematic visualization of the patent's claim structure. Hand-drawn diagrams in progress for each landmark patent.
Where you've seen this
Real-world examples
Halozyme's ENHANZE drug delivery technology platform
Herceptin Hylecta (trastuzumab and hyaluronidase-zzxf)
Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf)
Darzalex Faspro (daratumumab and hyaluronidase-fihj)
Hyqvia (immune globulin infusion 10% with recombinant human hyaluronidase)
Why it matters
The bigger picture
This technology is important because it makes it possible to deliver large volumes of drugs, like immune globulin, through a simple injection under the skin rather than a lengthy intravenous infusion. This significantly improves convenience and quality of life for patients who require regular treatments. Halozyme, the assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →, has built a platform around this type of enzyme to enable subcutaneous delivery for many different therapeutic areas.
Filed
February 23, 2018
Granted
March 17, 2020
Market context
Who's building on this
Companies in this space
Halozyme, the original assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →, is the primary company building on this technology. They licenselicensePermission from the patent owner to make, use, or sell the invention — usually in exchange for payment. Doesn't transfer ownership.Read more → their ENHANZE platform, which utilizes recombinant human hyaluronidase, to numerous major pharmaceutical companies. These partners, including Roche, Takeda, Pfizer, and Janssen, develop and commercialize drugs that incorporate this enzyme to enable subcutaneous administration.
Market impact
This patent, and the underlying technology, has significantly impacted the pharmaceutical market by enabling the subcutaneous delivery of large-molecule drugs that previously required intravenous infusion. This shift has improved patient convenience, reduced healthcare costs by allowing home administration, and created new market opportunities for drug developers. It has become a key enabler for a new generation of biologic therapies.
Claim 1 — Plain English
What this patent covers
The patent claims a method for boosting a subject's immune system by injecting immune globulin (IG) and a special soluble hyaluronidase enzyme under the skin. This specific hyaluronidase is a "soluble neutral active human hyaluronidase glycoprotein" (sHASEGP) that works well at the body's neutral pH. It has at least one sugar molecule attached to an asparagine amino acid and is a shortened version of a larger natural enzyme, specifically containing amino acids 36-464 of SEQ ID NO: 1, but truncated at its C-terminus at specific points like amino acid 477 or 483. This enzyme helps the IG spread and absorb better. For example, a patient needing a large dose of immune globulin can receive it as a less painful subcutaneous injection instead of an intravenous infusion, thanks to this enzyme.
The clever bit
The novelty lies in identifying and engineering a specific, truncated, and glycosylated human hyaluronidase that remains soluble and active at neutral pH, making it ideal for co-administration with other drugs to enhance their subcutaneous absorption.
What it does not cover
- Does not cover administering hyaluronidase and immune globulin through methods other than subcutaneous injection (e.g., intravenous infusion).
- Does not cover using this specific hyaluronidase to deliver therapeutic molecules other than immune globulin for immune system modulation.
- Does not cover hyaluronidase enzymes that contain the complete, full-length amino acid sequence of SEQ ID NO: 1.
- Does not cover hyaluronidase enzymes that lack the specific asparagine-linked sugar moiety required by the claims.
- Does not cover hyaluronidase polypeptides with C-terminal truncations outside the specified amino acid residues (e.g., 477-494 of SEQ ID NO: 1) or with less than 95% sequence identity to the claimed truncated forms.
Patent timeline
Application submitted to the patent office
Application published, typically 18 months after filing
Patent officially issued
Patent enters public domain
PatentBrief Score
Impact Score
Early stage
Citation count
18/40
Early citations
Claim breadth
7/20
Moderate scope
Recency
10/20
Granted 5–10 years ago
Assignee scale
0/20
Independent or smaller assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →
PatentBrief Impact Score — based on citation count, claim breadth, recency, and assignee scale. Not a legal assessment.
Heuristic Value Estimate
What this patent might be worth
$180K – $576K
Midpoint $360K · 11.4 yr remaining · industry ×3.0
Heuristic only — blends forward/backward citation counts, claim scope, time remaining, litigation history, and CPC-derived industry baseline. Real valuations need a professional appraisal.
Claim text not yet imported for this patent
The original legal language
Original claims
11 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
Kundu, A., Frost, G. I., & Bookbinder, L. H. (2020). How a Special Enzyme Helps Deliver Immune Drugs Under the Skin (U.S. Patent No. 10,588,983). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/10588983/soluble-glycosaminoglycanases-and-methods-of-preparing-and-using-soluble-glycosa
Auto-generated from the patent record. Double-check author order and the issue date against the official USPTO document before submitting.
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Common Questions
Frequently Asked Questions
What does How a Special Enzyme Helps Deliver Immune Drugs Under the Skin cover?
This patent describes a specific, modified human hyaluronidase enzyme that helps the body absorb immune globulin drugs when injected just under the skin, making treatments easier for patients.
Who owns patent US 10588983?
Halozyme owns this patent, granted in 2020.
When does this patent expire?
This patent is expected to expire on February 23, 2038, when the invention enters the public domain.
What is patent US 10588983 cited by?
This patent has been cited by 7 later patents that build on its ideas.
What problem does this patent solve?
This technology is important because it makes it possible to deliver large volumes of drugs, like immune globulin, through a simple injection under the skin rather than a lengthy intravenous infusion. This significantly improves convenience and quality of life for patients who require regular treatments. Halozyme, the assignee, has built a platform around this type of enzyme to enable subcutaneous delivery for many different therapeutic areas.
What does this patent NOT cover?
Does not cover administering hyaluronidase and immune globulin through methods other than subcutaneous injection (e.g., intravenous infusion).
Patent monitoring