A Stable Recipe for a Cancer-Fighting Antibody Drug
This patent describes a specific, stable recipe for a cancer-fighting antibody-drug conjugate (ADC) that targets CD33, using cyclodextrin and a lyoprotectant to keep it effective and reduce impurities.
Original patent title: “Cyclodextrin and antibody-drug conjugate formulations”
This patent describes a specific, stable recipe for a cancer-fighting antibody-drug conjugate (ADC) that targets CD33, using cyclodextrin and a lyoprotectant to keep it effective and reduce impurities. Granted to Seattle Genetics in 2019 with 2 claims and 1 forward citation, and it is expected to expire in 2038.
Coverage
What does this patent actually cover?
The patent describes a specific pharmaceutical mixture, or "formulation," for a type of cancer drug called a benzodiazepine antibody-drug conjugate (ADC). This formulation aims to keep the ADC stable and minimize unwanted byproducts. It includes a specific monoclonal antibody, h2H16ec, designed to target human CD33, with an average of two drug molecules attached to engineered cysteine residues (ClaimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 1(a)). The formulation strictly limits a benzodiazepine-related impurity to no more than 0.1 μM (Claim 1(b)). To achieve stability, it uses 6% w/v hydroxypropyl-β-cyclodextrin (Claim 1(c)), 6% w/v sucrose as a lyoprotectant (Claim 1(d)), and a 20 mM KPhos buffer at pH 7.3 as a diluent (Claim 1(e)). For example, this precise mixture could be prepared and then freeze-dried for storage, ensuring the drug remains potent until it's ready for patient use.
The gap
What does this patent NOT cover?
- Does not cover ADC formulations that do not include a cyclodextrin, such as hydroxypropyl-β-cyclodextrin.
- Does not cover formulations where the specific benzodiazepine-related impurity exceeds 0.1 μM.
- Does not cover ADCs where the antibody does not specifically target human CD33, or is not h2H16ec with engineered cysteine residues.
- Does not cover formulations using different lyoprotectants or diluents outside of 6% w/v sucrose and 20 mM KPhos buffer at pH 7.3.
- Does not cover methods of making the ADC itself, only its final formulation.
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 a very specific combination of excipients—hydroxypropyl-β-cyclodextrin, sucrose, and KPhos buffer—that together stabilize a particular benzodiazepine ADC and keep a specific impurity below a critical threshold. This precise "recipe" solves the challenge of maintaining the drug's integrity and potency.
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
ADC therapies for cancer treatment
Lyophilized (freeze-dried) pharmaceutical products
Formulations for biologics
Seattle Genetics (Seagen) ADC pipeline
Why it matters
The bigger picture
Antibody-drug conjugates are powerful cancer treatments, but they are complex molecules that can be unstable or degrade over time. This patent addresses a critical challenge in drug development: creating a stable, pharmaceutically acceptable formulation for a specific ADC. Ensuring stability and purity is essential for drug safety, efficacy, and shelf-life, which directly impacts patient access and treatment reliability. Seattle Genetics (now Seagen) is a leader in ADC technology, and this patent contributes to the practical application and commercial viability of such therapies.
Filed
April 30, 2018
Granted
August 27, 2019
Market context
Who's building on this
Companies in this space
Seattle Genetics, now known as Seagen, remains a prominent company in the development and commercialization of antibody-drug conjugates. Other major pharmaceutical companies and biotech firms, such as Genentech (Roche), Takeda, and AstraZeneca, are also actively developing and formulating ADCs for various cancer indications. These companies continuously work on improving the stability, manufacturability, and delivery of these complex biological drugs.
Market impact
This patent contributes to the broader field of ADC formulation science, enabling the development of more stable and effective cancer treatments. By providing a specific formulation for a benzodiazepine ADC, it helps ensure the drug's quality and extends its shelf life, which is crucial for manufacturing and distribution. This type of intellectual property strengthens the position of companies like Seagen in the highly competitive oncology market, potentially influencing future drug development and licensing agreements for similar ADC technologies.
Claim 1 — Plain English
What this patent covers
The patent describes a specific pharmaceutical mixture, or "formulation," for a type of cancer drug called a benzodiazepine antibody-drug conjugate (ADC). This formulation aims to keep the ADC stable and minimize unwanted byproducts. It includes a specific monoclonal antibody, h2H16ec, designed to target human CD33, with an average of two drug molecules attached to engineered cysteine residues (Claim 1(a)). The formulation strictly limits a benzodiazepine-related impurity to no more than 0.1 μM (Claim 1(b)). To achieve stability, it uses 6% w/v hydroxypropyl-β-cyclodextrin (Claim 1(c)), 6% w/v sucrose as a lyoprotectant (Claim 1(d)), and a 20 mM KPhos buffer at pH 7.3 as a diluent (Claim 1(e)). For example, this precise mixture could be prepared and then freeze-dried for storage, ensuring the drug remains potent until it's ready for patient use.
The clever bit
The novelty lies in identifying a very specific combination of excipients—hydroxypropyl-β-cyclodextrin, sucrose, and KPhos buffer—that together stabilize a particular benzodiazepine ADC and keep a specific impurity below a critical threshold. This precise "recipe" solves the challenge of maintaining the drug's integrity and potency.
What it does not cover
- Does not cover ADC formulations that do not include a cyclodextrin, such as hydroxypropyl-β-cyclodextrin.
- Does not cover formulations where the specific benzodiazepine-related impurity exceeds 0.1 μM.
- Does not cover ADCs where the antibody does not specifically target human CD33, or is not h2H16ec with engineered cysteine residues.
- Does not cover formulations using different lyoprotectants or diluents outside of 6% w/v sucrose and 20 mM KPhos buffer at pH 7.3.
- Does not cover methods of making the ADC itself, only its final formulation.
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
6/40
Early citations
Claim breadth
1/20
Narrow claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more →
Recency
10/20
Granted 5–10 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
$90K – $288K
Midpoint $180K · 11.6 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
2 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
Jiang, S., Meyer, D., Wallace, M., & Li, H. (2019). A Stable Recipe for a Cancer-Fighting Antibody Drug (U.S. Patent No. 10,391,181). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/10391181/cyclodextrin-and-antibody-drug-conjugate-formulations
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 A Stable Recipe for a Cancer-Fighting Antibody Drug cover?
This patent describes a specific, stable recipe for a cancer-fighting antibody-drug conjugate (ADC) that targets CD33, using cyclodextrin and a lyoprotectant to keep it effective and reduce impurities.
Who owns patent US 10391181?
Seattle Genetics owns this patent, granted in 2019.
When does this patent expire?
This patent is expected to expire on April 30, 2038, when the invention enters the public domain.
What is patent US 10391181 cited by?
This patent has been cited by 1 later patents that build on its ideas.
What problem does this patent solve?
Antibody-drug conjugates are powerful cancer treatments, but they are complex molecules that can be unstable or degrade over time. This patent addresses a critical challenge in drug development: creating a stable, pharmaceutically acceptable formulation for a specific ADC. Ensuring stability and purity is essential for drug safety, efficacy, and shelf-life, which directly impacts patient access and treatment reliability. Seattle Genetics (now Seagen) is a leader in ADC technology, and this patent contributes to the practical application and commercial viability of such therapies.
What does this patent NOT cover?
Does not cover ADC formulations that do not include a cyclodextrin, such as hydroxypropyl-β-cyclodextrin.
Patent monitoring