Coagulation Factor Assay Patents: Who Leads, Where the Gaps Are 2026
- 84.3% of all 587 records sit with just five assignees, so the field is close to a closed shop at the top while everyone else files in ones and twos.
- Filing rose 30% from 2021 to 2024, the last year the dataset treats as complete, running against any read of this field as winding down.
- G16H and G06N sit under 3% each of records, meaning software-side scoring, informatics and AI-assisted interpretation of assay results are barely claimed yet.
Filing growth compares 2021 (10 records) with 2024 (13) — a three-year span. 2024 is the most recent year we treat as complete: publication lags filing by roughly 18 months, so 2025 onwards are still filling in and any growth rate that ends there would understate the field. Top-5 share is the combined record count of the five largest assignees divided by all 587 records in scope (CR5), not by the ranked leaders only.
What this landscape covers
Coagulation factor and inhibitor assays sit at the intersection of diagnostics and biologics: the same filings that claim a Bethesda assay variant or a one-stage clotting method often also claim the recombinant factor VIII or factor IX construct the assay is built to measure. That overlap is visible in the IPC mix below, where medicinal-preparation and peptide/protein classes dominate a search string built around assay methodology.
The scope here runs from 2015 through the 2026-07-31 cut-off, with 587 published records in the assignee ranking. Because publication trails filing by roughly 18 months, the final one or two years in any trend chart will always look thinner than the filing activity actually was.
Filing trend and technology composition
Two views of the same 587 records: how filing has moved year over year, and which IPC subclasses the claims actually sit in.
Filing trend, 2017–2026
Filings ran from 19 in 2017 to a peak of 28 in 2018, then continued at a steady pace; 2021 to 2024 rose 30%, from 10 to 13 filings, before the two most recent years understate activity due to publication lag.
IPC subclass composition
A61K (medicinal preparations) touches 83.5% of the 587 records and C07K (peptides & proteins) touches 50.6%, confirming that most assay claims are filed alongside a therapeutic factor composition rather than standing alone as pure diagnostic method claims.
Shares are the percentage of the 587 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Coagulation Factor and Inhibitor Assays with Eureka
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Factor VIII compositions and methods of making and using same
The present invention relates to compositions comprising factor VIII coagulation factors linked to extended recombinant polypeptide (XTEN), isolated nucleic acids encoding the compositions and vectors and host cells containing the same, and methods of making and using such compositions in treatment of factor VIII-related diseases, disorders, and conditions.Filed by Bioverativ Therapeutics, 2016-09-08 (AU2016210689A1).
View full record| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | WO2012006624A2 | Factor ix polypeptides and methods of use thereof | 184 |
| 2 | WO2013122617A1 | Factor viii compositions and methods of making and using same | 104 |
| 3 | US20140294821A1 | Factor viii chimeric and hybrid polypeptides, and methods of use thereof | 79 |
| 4 | US20150158929A1 | Factor viii compositions and methods of making and using same | 77 |
| 5 | US20130202595A1 | Factor IX Polypeptides and Methods of Use Thereof | 75 |
| 6 | WO2013009627A2 | Factor viii chimeric and hybrid polypeptides, and methods of use thereof | 73 |
| 7 | US20130171175A1 | Factor IX Polypeptides and Methods of Use Thereof | 70 |
| 8 | WO2014052490A1 | Methods of using fix polypeptides | 44 |
| 9 | WO2015085276A1 | Population pharmacokinetics tools and uses thereof | 41 |
| 10 | US20140370035A1 | Methods of reducing immunogenicity against factor viii in individuals undergoing factor viii therapy | 39 |
Citation counts favour older filings that have had more time to accumulate citations within this corpus; treat them as a signal of influence on the field, not of current commercial weight.
Each row carries its publication number; clicking a row searches Eureka by that number.
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Three patterns stand out once the raw counts are set against each other: where claim density is heaviest, where it thins out, and how filings pair across assignees.
The top of the field is nearly closed
With the top five assignees holding 84.3% of all 587 records and the top ten holding 95.1%, new entrants are filing into a field where the dominant claim territory around factor VIII and factor IX compositions is already staked out. The long tail below that is thin: most of the ranked 84 companies appear with only a handful of filings each.
Filing is still rising, not fading
The three-year run from 2021 to 2024 shows filings climbing from 10 to 13, a 30% increase. The 2025–2026 figures look lower only because publication has not caught up with filing yet, not because interest has dropped.
Assay claims ride alongside therapeutic claims
Pure assay-method classes such as G01N (material analysis and testing) and C12Q (enzyme/DNA-based measuring) cover only 12.3% and 7.8% of the 587 records respectively, dwarfed by A61K's 83.5%. Most applicants are protecting the therapeutic composition first and the diagnostic method as a dependent claim.
Filing partnerships cluster around a few labs
Only ten co-assignee pairs appear in the dataset, and the strongest of them accounts for 41 shared records. Co-filing here looks like a small number of durable research partnerships rather than a broad collaborative network.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to coagulation factor and inhibitor assays, with the prior art for and against each one.
The assignee landscape
A ranking of 84 companies, dominated at the top by a small number of biologics developers whose factor VIII and factor IX franchises drive the assay claims around them.
One filer dominates the ranking
The leading assignee holds 382 of the 587 records in scope, an order of magnitude ahead of fifth place at 17. That gap is unusually wide even for a concentrated field and reflects a long-running factor VIII/IX patent programme rather than a recent surge.
A steep drop after the leader
Fifth place holds 17 records and tenth place holds 10, meaning the gap between the leader and the rest of the top ten is far larger than the gap across the top ten itself. Competitive attention should focus on the names just outside the top five, where filing volumes are close enough to shift with a handful of new applications.
Recent-year activity has gone quiet across the board
Multiple previously active assignees show zero filings in the latest year, with year-on-year drops as steep as -100% and -80% among names that were filing steadily before. Given the 18-month publication lag, this is as likely to reflect filings still working through the pipeline as a genuine pullback.
| Assignee | Recent year | YoY |
|---|---|---|
| Genzyme Corp | 1 | -80% |
| CSL Behring | 0 | -100% |
| Biogen MA Inc. | 0 | — |
| Puget Sound Blood Center | 0 | — |
| Apitope International NV | 0 | — |
| Amunix Pharmaceuticals | 0 | — |
| BIOVERATIV THERAPEUTICS INC US | 0 | — |
| Bioverativ Therapeutics Inc | 0 | — |
Where to take this next
The dataset points to a field with a dominant leader, a thin mid-field, and diagnostic-method claim space that is comparatively open.
Check freedom-to-operate against the leader's portfolio
With one assignee holding 382 of 587 records, any new factor VIII or factor IX assay filing should be checked against that portfolio specifically, not just the field average.
Run a freedom-to-operate search in EurekaMap the informatics white space before it fills in
G16H and G06N together cover under 4.5% combined mention across the 587 records, leaving assay-interpretation software comparatively open to new claims.
Explore white space in EurekaTrack the mid-field for shifts in momentum
The names between fifth and tenth place are close enough in volume that a handful of new filings could reorder them; watching that band is more informative than watching the leader.
Monitor assignee activity in EurekaCommon questions on this landscape
One assignee holds 382 of the 587 records in scope, far ahead of the rest of the ranked field; fifth place holds only 17. That gap suggests a long-standing, well-defended factor VIII/IX programme rather than a recently built position. Anyone entering this space should treat that leader's portfolio as the primary freedom-to-operate check, not the field average.
Filing grew 30% from 2021 to 2024, the last years the dataset treats as complete, rising from 10 to 13 filings. The 2025 and 2026 figures look lower only because patent publication lags filing by roughly 18 months, so those years are still filling in. Nothing in the complete years supports describing the field as slowing.
In this dataset, assay claims are usually filed alongside a therapeutic factor composition claim: A61K (medicinal preparations) touches 83.5% of the 587 records and C07K (peptides and proteins) touches 50.6%. Pure assay-method classes such as G01N and C12Q cover only 12.3% and 7.8% respectively. That pattern means a Bethesda or one-stage clotting assay claim is frequently a dependent or companion claim to a factor VIII or factor IX composition, not a standalone diagnostic filing.
The thinnest IPC coverage sits in G16H (healthcare informatics, 2.6% of records) and G06N (AI-based computing, 1.9% of records), which together suggest assay-result interpretation software, including mixing-study and lupus-anticoagulant-interference resolution tools, is comparatively under-claimed. Point-of-care chromogenic methods also show less density than the core factor-composition classes. These are the branches worth checking first before assuming the field is fully occupied.
Highly concentrated: the top five assignees hold 84.3% of all 587 records, and the top ten hold 95.1%. That leaves a long tail of the remaining ranked companies filing in single digits or low double digits each. For a new entrant, this means most of the accessible claim space lies outside the top ten's core compositions rather than in direct competition with them.
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Disclaimer. This page is generated from Patsnap Eureka data drawn from a limited snapshot of global patent and scientific-literature records, and is provided for general information and reference only.
Patent data carries inherent limitations: recent filings (typically the most recent 18–24 months) are under-counted due to standard publication lag; counts may be reported at either a patent-family or a patent-record basis and are not always directly comparable; classification, applicant-name, and citation data may contain errors, duplicates, or omissions; and the underlying search query defines and constrains the scope shown. As a result, the analysis may be incomplete or inaccurate and may not reflect the full technology landscape.
Nothing on this page constitutes an exhaustive prior-art, novelty, freedom-to-operate, or validity search, nor does it constitute legal, financial, investment, or professional advice, and it should not be relied upon as such. Any patent, commercial, or strategic decision should be verified independently and reviewed with qualified patent, legal, and domain professionals. Patsnap makes no warranties, express or implied, as to the accuracy, completeness, or fitness for any particular purpose of the information presented.
Machine translation. Assignee and organisation names originally recorded in Chinese, Japanese or Korean have been rendered into English by an AI translation step so that the tables stay readable. These renderings are best-effort and may not match a company’s registered English name; the original name is what the underlying patent record carries, and it is what any Eureka query launched from this page uses.