Making Antibody Drug Conjugate Medicines Consistent Across Batches
This patent describes methods for precisely controlling the drug amount in antibody drug conjugate (ADC) medicines, ensuring each batch has a consistent strength and effect.
Original patent title: “Methods for formulating antibody drug conjugate compositions”
This patent describes methods for precisely controlling the drug amount in antibody drug conjugate (ADC) medicines, ensuring each batch has a consistent strength and effect. Owned by Immunogen with 52 claims, and it is expected to expire in 2042.
Coverage
What does this patent actually cover?
The patent provides ways to make sure different batches of antibody drug conjugate (ADC) medicines have the same strength. It focuses on reducing "potency variability," meaning how much the drug's effect changes from one batch to another. One method (ClaimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 1) involves deciding on a specific amount of drug to aim for, based on a set amount of antibody and a fixed "drug antibody ratio" (DAR), then mixing the medicine to hit that target. Another detailed method (Claim 6) involves measuring the DAR, defining acceptable ranges for both antibody and drug concentrations, then calculating precise upper and lower limits for the drug concentration using a specific formula. Finally, the medicine is formulated to a drug concentration that is exactly in the middle of these calculated limits, ensuring consistency. For example, if a batch of ADC medicine needs to have a drug concentration within a tight range of 95-105 µg/mL, this method helps achieve that precise target.
The gap
What does this patent NOT cover?
- Does not cover methods that *only* target a specific antibody concentration without also considering drug concentration (ClaimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 16).
- Does not cover methods that do not involve determining a target drug concentration (ClaimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 1).
- Does not cover methods that do not use a fixed or variable drug antibody ratio (DAR) in their calculations (ClaimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 1, 2, 6).
- Does not cover methods that formulate outside the specified concentration ranges, such as ±5% or ±10% of the targeted drug concentration (ClaimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 3, 16).
- Does not cover methods that do not involve comparing calculated and defined drug specificationspecificationThe main body of the patent — describes the invention in detail. Used to interpret the claims.Read more → limits to find effective limits (ClaimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 6).
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 the precise mathematical methods for defining and hitting a target drug concentration, especially by integrating the drug antibody ratio (DAR) and overlapping specificationspecificationThe main body of the patent — describes the invention in detail. Used to interpret the claims.Read more → ranges, rather than just focusing on antibody concentration alone. This ensures the *active drug component* is consistent, not just the antibody carrier.
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
Manufacturing processes for cancer drugs like Kadcyla (trastuzumab emtansine) or Enhertu (trastuzumab deruxtecan)
Quality control for new ADC therapies in clinical trials
Production of ADCs using maytansinoid or auristatin drug components
Why it matters
The bigger picture
Antibody drug conjugates (ADCs) are powerful cancer treatments, but their effectiveness can vary if batches aren't made consistently. This patent addresses a critical manufacturing challenge in the pharmaceutical industry: ensuring that every dose a patient receives has the same strength. By reducing potency variability, these methods help make ADC therapies safer and more reliable, which is essential for patient outcomes and regulatory approval.
Filed
December 23, 2022
Market context
Who's building on this
Companies in this space
Immunogen Inc., the assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →, is a biotechnology company focused on developing ADCs for cancer treatment. Other major pharmaceutical companies like AstraZeneca, Daiichi Sankyo, Seagen (now part of Pfizer), and Genentech (Roche) are also heavily invested in ADC research, development, and manufacturing, and would benefit from or employ similar quality control methods.
Market impact
This patent addresses a critical need for robust manufacturing and quality control in the rapidly expanding antibody drug conjugate market. By providing methods to reduce potency variability, it helps ensure the reliability and safety of these complex drugs, which is crucial for regulatory approval and patient trust. This can enable broader adoption of ADC therapies and reduce manufacturing risks for companies developing new treatments.
Claim 1 — Plain English
What this patent covers
The patent provides ways to make sure different batches of antibody drug conjugate (ADC) medicines have the same strength. It focuses on reducing "potency variability," meaning how much the drug's effect changes from one batch to another. One method (Claim 1) involves deciding on a specific amount of drug to aim for, based on a set amount of antibody and a fixed "drug antibody ratio" (DAR), then mixing the medicine to hit that target. Another detailed method (Claim 6) involves measuring the DAR, defining acceptable ranges for both antibody and drug concentrations, then calculating precise upper and lower limits for the drug concentration using a specific formula. Finally, the medicine is formulated to a drug concentration that is exactly in the middle of these calculated limits, ensuring consistency. For example, if a batch of ADC medicine needs to have a drug concentration within a tight range of 95-105 µg/mL, this method helps achieve that precise target.
The clever bit
The novelty lies in the precise mathematical methods for defining and hitting a target drug concentration, especially by integrating the drug antibody ratio (DAR) and overlapping specification ranges, rather than just focusing on antibody concentration alone. This ensures the *active drug component* is consistent, not just the antibody carrier.
What it does not cover
- Does not cover methods that *only* target a specific antibody concentration without also considering drug concentration (Claim 16).
- Does not cover methods that do not involve determining a target drug concentration (Claim 1).
- Does not cover methods that do not use a fixed or variable drug antibody ratio (DAR) in their calculations (Claim 1, 2, 6).
- Does not cover methods that formulate outside the specified concentration ranges, such as ±5% or ±10% of the targeted drug concentration (Claim 3, 16).
- Does not cover methods that do not involve comparing calculated and defined drug specification limits to find effective limits (Claim 6).
Patent timeline
Application submitted to the patent office
Patent enters public domain
PatentBrief Score
Impact Score
Moderate
Citation count
0/40
No citations yet
Claim breadth
20/20
Very broad protection
Recency
0/20
Older than 20 years
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
$72K – $230K
Midpoint $144K · 16.3 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
52 claims as filed with the patent office.
Concepts involved
Cite this patent
Bridgewater, J., Payne, G., & Herbst, R. W. Making Antibody Drug Conjugate Medicines Consistent Across Batches (U.S. Patent No. 20,230,364,252). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/20230364252/methods-for-formulating-antibody-drug-conjugate-compositions
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 Making Antibody Drug Conjugate Medicines Consistent Across Batches cover?
This patent describes methods for precisely controlling the drug amount in antibody drug conjugate (ADC) medicines, ensuring each batch has a consistent strength and effect.
Who owns patent US 20230364252?
This patent is owned by Immunogen.
When does this patent expire?
This patent is expected to expire on December 23, 2042, when the invention enters the public domain.
What problem does this patent solve?
Antibody drug conjugates (ADCs) are powerful cancer treatments, but their effectiveness can vary if batches aren't made consistently. This patent addresses a critical manufacturing challenge in the pharmaceutical industry: ensuring that every dose a patient receives has the same strength. By reducing potency variability, these methods help make ADC therapies safer and more reliable, which is essential for patient outcomes and regulatory approval.
What does this patent NOT cover?
Does not cover methods that *only* target a specific antibody concentration without also considering drug concentration (Claim 16).
Patent monitoring