How Specific Antibody Drugs Are Stabilized for Storage and Use
Genentech's 2013 patent details a precise recipe for an antibody drug, like Pertuzumab, using a special buffer, sugar, and cleaning agent to keep it stable for patients.
Original patent title: “Antibody formulations”
Genentech's 2013 patent details a precise recipe for an antibody drug, like Pertuzumab, using a special buffer, sugar, and cleaning agent to keep it stable for patients. Granted to Genetech Inc in 2013 with 31 claims and 35 forward citations.
Key facts
Coverage
What does this patent actually cover?
This patent describes a very specific liquid recipe, or formulation, for antibody medicines, particularly those targeting a protein called HER2. It claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more → a combination of an antibody (like Pertuzumab, which targets HER2's domain II), a histidine-acetate buffer to control the acidity (pH between 5.5 and 6.5), a sugar like sucrose to help stabilize it, and a cleaning agent called polysorbate 20. The patent specifies exact amounts, such as antibody concentration between 20-40 mg/mL, sucrose from 60-250 mM, and polysorbate 20 from 0.01-0.1%. This precise mix is designed to keep the antibody drug stable and effective, especially in its liquid form, ready for injection into patients. For example, claimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 8 specifies a formulation with about 30 mg/mL Pertuzumab, about 20 mM histidine-acetate, about 120 mM sucrose, and about 0.02% polysorbate 20 at pH 6.0.
The gap
What does this patent NOT cover?
- Antibody formulations not using a histidine-acetate buffer.
- Formulations with antibodies that do not bind to domain II of HER2.
- Antibody concentrations outside the 20 mg/mL to 40 mg/mL range.
- Formulations that have been freeze-dried (lyophilized) before use.
- Formulations using different sugars or surfactants than specified.
- Antibody formulations with a pH outside the 5.5 to 6.5 range.
These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.
What made this novel
The innovation lies in identifying a precise combination of buffer, sugar, and surfactant at specific concentrations and pH that prevents the antibody from degrading or clumping in a liquid state, making it ready for use without requiring freezing or lyophilization.
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
Pertuzumab (Perjeta) formulations
Liquid antibody drug formulations
Pharmaceuticals requiring high stability
Why it matters
The bigger picture
This patent is significant because it addresses the critical challenge of keeping complex biological drugs, like monoclonal antibodies, stable and effective outside of a frozen state. Stable liquid formulations are crucial for easier storage, handling, and administration to patients, especially for targeted cancer therapies like Pertuzumab (marketed as Perjeta).
Filed
September 4, 2009
Granted
February 12, 2013
Market context
Who's building on this
Companies in this space
Genentech, a member of the Roche Group, is the assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more → and likely continues to leverage this formulation technology for its antibody-based therapies. The development of stable liquid formulations is a common goal for many biopharmaceutical companies developing monoclonal antibodies.
Market impact
This patent likely helped establish a stable, liquid formulation for Pertuzumab, simplifying its use and distribution. It also contributes to the broader field of biopharmaceutical formulation, setting benchmarks for stability and shelf-life in liquid antibody products, potentially influencing how similar drugs are developed and protected.
Claim 1 — Plain English
What this patent covers
This patent describes a very specific liquid recipe, or formulation, for antibody medicines, particularly those targeting a protein called HER2. It claims a combination of an antibody (like Pertuzumab, which targets HER2's domain II), a histidine-acetate buffer to control the acidity (pH between 5.5 and 6.5), a sugar like sucrose to help stabilize it, and a cleaning agent called polysorbate 20. The patent specifies exact amounts, such as antibody concentration between 20-40 mg/mL, sucrose from 60-250 mM, and polysorbate 20 from 0.01-0.1%. This precise mix is designed to keep the antibody drug stable and effective, especially in its liquid form, ready for injection into patients. For example, claim 8 specifies a formulation with about 30 mg/mL Pertuzumab, about 20 mM histidine-acetate, about 120 mM sucrose, and about 0.02% polysorbate 20 at pH 6.0.
The clever bit
The innovation lies in identifying a precise combination of buffer, sugar, and surfactant at specific concentrations and pH that prevents the antibody from degrading or clumping in a liquid state, making it ready for use without requiring freezing or lyophilization.
What it does not cover
- Antibody formulations not using a histidine-acetate buffer.
- Formulations with antibodies that do not bind to domain II of HER2.
- Antibody concentrations outside the 20 mg/mL to 40 mg/mL range.
- Formulations that have been freeze-dried (lyophilized) before use.
- Formulations using different sugars or surfactants than specified.
- Antibody formulations with a pH outside the 5.5 to 6.5 range.
Patent timeline
Application submitted to the patent office
Application published, typically 18 months after filing
Patent officially issued
PatentBrief Score
Impact Score
Strong
Citation count
31/40
Moderately cited
Claim breadth
20/20
Very broad protection
Recency
5/20
Granted 10–20 years ago
Assignee scale
20/20
Major company or institution
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
$378K – $1.2M
Midpoint $756K · 3.2 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.
The original legal language
Original claims
31 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
Gwee, S. C., Andya, J., Liu, J., & Shen, Y. (2013). How Specific Antibody Drugs Are Stabilized for Storage and Use (U.S. Patent No. 8,372,396). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/8372396/tysabri-natalizumab
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 Specific Antibody Drugs Are Stabilized for Storage and Use cover?
Genentech's 2013 patent details a precise recipe for an antibody drug, like Pertuzumab, using a special buffer, sugar, and cleaning agent to keep it stable for patients.
Who owns patent US 8372396?
Genetech Inc owns this patent, granted in 2013.
When does this patent expire?
This patent is expected to expire on February 12, 2033, when the invention enters the public domain.
What is patent US 8372396 cited by?
This patent has been cited by 35 later patents that build on its ideas.
What problem does this patent solve?
This patent is significant because it addresses the critical challenge of keeping complex biological drugs, like monoclonal antibodies, stable and effective outside of a frozen state. Stable liquid formulations are crucial for easier storage, handling, and administration to patients, especially for targeted cancer therapies like Pertuzumab (marketed as Perjeta).
What does this patent NOT cover?
Antibody formulations not using a histidine-acetate buffer.
Patent monitoring