How to Keep High-Concentration Antibody Medicines Stable in Liquid Form
Novartis's patent describes a specific liquid recipe for keeping high concentrations of E25 anti-IgE antibodies stable and usable for medical injections.
Original patent title: “Stable liquid formulations of antibodies”
Novartis's patent describes a specific liquid recipe for keeping high concentrations of E25 anti-IgE antibodies stable and usable for medical injections. Granted to Novartis AG in 2010 with 52 claims and 17 forward citations.
Key facts
Coverage
What does this patent actually cover?
This patent details a way to create a stable liquid solution containing a high concentration (at least 80 mg/ml) of E25 anti-IgE antibodies. The core of the invention is using acetic acid as a stabilizing agent to prevent the antibodies from clumping together or degrading over time. By maintaining the solution within a specific pH range and avoiding certain salts like sodium acetate, the formulation remains effective for storage. This allows for smaller injection volumes, which is critical for patient comfort when delivering high doses of therapeutic proteins.
The gap
What does this patent NOT cover?
- Does not cover antibody formulations that use sodium acetate as a buffer.
- Does not cover liquid formulations containing antibody types other than E25 anti-IgE.
- Does not cover solutions where the antibody concentration is below 80 mg/ml.
- Does not cover dry or lyophilized (freeze-dried) antibody powders.
These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.
What made this novel
The inventors discovered that by using acetic acid specifically—and excluding sodium acetate—they could push antibody concentrations to levels previously thought to be unstable, without the proteins aggregating or losing their structure.
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
Xolair (omalizumab) injectable formulations
High-concentration monoclonal antibody drug delivery systems
Why it matters
The bigger picture
High-concentration antibody formulations are essential for drugs like Xolair (omalizumab), which is used to treat severe asthma and hives. If these proteins clump, they lose their medical efficacy and can cause immune reactions in patients. This patent provided a technical roadmap for Novartis to produce stable, high-dose liquid versions of these biologics, which are easier to administer than traditional, lower-concentration infusions.
Filed
May 31, 2002
Granted
June 22, 2010
Market context
Who's building on this
Companies in this space
Novartis and Genentech have historically been the primary entities involved in the development and commercialization of omalizumab (E25). The broader biopharmaceutical industry continues to build on these stabilization techniques to develop high-concentration subcutaneous injections for a variety of monoclonal antibodies.
Market impact
This patent helped establish the feasibility of high-concentration liquid biologics, moving the industry away from cumbersome intravenous infusions toward more convenient, patient-administered subcutaneous injections. It secured a technical advantage in the manufacturing process for blockbuster asthma therapies, influencing how pharmaceutical companies design stable, long-lasting protein-based drugs.
Claim 1 — Plain English
What this patent covers
This patent details a way to create a stable liquid solution containing a high concentration (at least 80 mg/ml) of E25 anti-IgE antibodies. The core of the invention is using acetic acid as a stabilizing agent to prevent the antibodies from clumping together or degrading over time. By maintaining the solution within a specific pH range and avoiding certain salts like sodium acetate, the formulation remains effective for storage. This allows for smaller injection volumes, which is critical for patient comfort when delivering high doses of therapeutic proteins.
The clever bit
The inventors discovered that by using acetic acid specifically—and excluding sodium acetate—they could push antibody concentrations to levels previously thought to be unstable, without the proteins aggregating or losing their structure.
What it does not cover
- Does not cover antibody formulations that use sodium acetate as a buffer.
- Does not cover liquid formulations containing antibody types other than E25 anti-IgE.
- Does not cover solutions where the antibody concentration is below 80 mg/ml.
- Does not cover dry or lyophilized (freeze-dried) antibody powders.
Patent timeline
Application submitted to the patent office
Application published, typically 18 months after filing
Patent officially issued
PatentBrief Score
Impact Score
Moderate
Citation count
25/40
Moderately cited
Claim breadth
20/20
Very broad protection
Recency
5/20
Granted 10–20 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
$65K – $207K
Midpoint $130K · expired or expiring · 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.
The original legal language
Original claims
52 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
Fauquex, P. F., & Arvinte, T. (2010). How to Keep High-Concentration Antibody Medicines Stable in Liquid Form (U.S. Patent No. 7,740,842). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/7740842/herceptin-adjuvant-therapy
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 to Keep High-Concentration Antibody Medicines Stable in Liquid Form cover?
Novartis's patent describes a specific liquid recipe for keeping high concentrations of E25 anti-IgE antibodies stable and usable for medical injections.
Who owns patent US 7740842?
Novartis AG owns this patent, granted in 2010.
When does this patent expire?
This patent is expected to expire on June 22, 2030, when the invention enters the public domain.
What is patent US 7740842 cited by?
This patent has been cited by 17 later patents that build on its ideas.
What problem does this patent solve?
High-concentration antibody formulations are essential for drugs like Xolair (omalizumab), which is used to treat severe asthma and hives. If these proteins clump, they lose their medical efficacy and can cause immune reactions in patients. This patent provided a technical roadmap for Novartis to produce stable, high-dose liquid versions of these biologics, which are easier to administer than traditional, lower-concentration infusions.
What does this patent NOT cover?
Does not cover antibody formulations that use sodium acetate as a buffer.
Same assignee
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