Prothrombin Time & INR Patents: Leaders, Trends & Gaps 2026
- 35.0% of all 2,568 records sit with just five assignees, while a long tail of single- and few-filing entrants makes up the rest of the field.
- Filings peaked in 2017 at 155 and 2021-to-2024 activity fell 50%, from 94 to 47 — though 2025-2026 counts are still filling in due to publication lag.
- G01N material testing touches 64.6% of records while healthcare informatics (G16H) appears in only 8.2%, marking a comparatively open branch of the claim space.
Filing growth compares 2021 (94 records) with 2024 (47) — 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 2,568 records in scope (CR5), not by the ranked leaders only.
What this landscape covers
This dataset tracks patent families filed against prothrombin time (PT) and international normalized ratio (INR) standardization — the methods and instruments used to harmonise clotting-time results across reagents, instruments and point-of-care devices. The search spans local calibration, reagent-instrument pairing, warfarin monitoring, and external quality assessment, covering 2,568 published records from 2015 through mid-2026.
The field sits at the intersection of diagnostic hardware, enzymatic assay chemistry and anticoagulant therapy management, which is why material analysis and testing (G01N) dominates the classification mix while a smaller but persistent share of records touches medicinal preparations and therapeutic activity classes tied to warfarin and related anticoagulants.
Filing trends and technology composition
Two views of the same 2,568-record corpus: how filing activity has moved year over year, and how records distribute across the IPC subclasses that define the technical scope of PT/INR standardization work.
Filing trend: a 2017 peak followed by a multi-year pullback
Filings rose to a peak of 155 in 2017, then declined; the 2021-to-2024 window shows a 50% drop from 94 to 47 records. Because publication trails filing by roughly 18 months, the 2025 and 2026 figures are still incomplete and should not be read as evidence the field has stopped moving.
Technology composition across eight IPC subclasses
G01N (material analysis and testing) appears in 64.6% of the 2,568 records, well ahead of B01L lab apparatus (20.2%) and C12Q enzyme/DNA-based testing (19.0%). A61K medicinal preparations (18.7%) and A61P therapeutic activity (10.3%) reflect the warfarin-monitoring dimension of the field, while G16H healthcare informatics, at 8.2%, is the thinnest of the eight tracked classes.
Shares are the percentage of the 2,568 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Prothrombin Time and INR Standardization with Eureka
This page is one run against one query. Ask Eureka your own question about prothrombin time and inr standardization and every answer comes back with the patent numbers behind it.
Try EurekaRepresentative filing and most-cited prior art
Method for determining prothrombin time (US20090263903A1)
The filing addresses monitoring of oral anticoagulation therapy and hepatocellular carcinoma by determining prothrombin time while accounting for the effect of protein induced by vitamin K absence or antagonists (PIVKA) on clotting time and INR result. Its stated aim is to harmonise PT methods for INR reporting and to measure an INR variant adjusted for PIVKA interference.Filed by an individual inventor (Horsti, Juha), published 2009-10-22 — illustrates how INR harmonisation claims can originate outside the large device manufacturers.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US20040078219A1 | Healthcare networks with biosensors | 1,294 |
| 2 | US6066243A | Portable immediate response medical analyzer having multiple testing modules | 832 |
| 3 | US20040189311A1 | Assay cartridges and methods of using the same | 759 |
| 4 | US20050101841A9 | Healthcare networks with biosensors | 612 |
| 5 | US20050054078A1 | Immunoassay device with improved sample closure | 594 |
| 6 | US20060160164A1 | Immunoassay device with immuno-reference electrode | 530 |
| 7 | WO2005026689A2 | Immunoassay device with immuno-reference electrode | 501 |
| 8 | US5628961A | Apparatus for assaying viscosity changes in fluid samples and method of conducting same | 414 |
| 9 | US7005857B2 | Device for measuring blood coagulation and method thereof | 404 |
| 10 | US20040072357A1 | Device for measuring blood coagulation and method thereof | 401 |
Citation counts favour older filings that have had more time to accumulate references — read them as a signal of influence within this searched corpus, not as a ranking of current technical importance.
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 read against each other: where ownership concentrates, where the technology classes cluster, and where the most-cited prior art actually sits.
Ownership is concentrated but not locked
The five leading assignees combined account for 35.0% of all 2,568 records in scope, and the top ten reach 47.4%. That leaves more than half the field to entrants outside the ranked leaders, which is unusual concentration for a diagnostics niche this specific.
Testing methodology, not informatics, dominates claims
Nearly two-thirds of records carry a G01N material-testing classification, while healthcare informatics (G16H) appears in only 8.2%. Software-driven result harmonisation and networked result reporting remain comparatively lightly claimed relative to the assay and instrument side.
Activity has cooled from its 2017 peak
Filings peaked at 155 in 2017 and the last fully comparable window shows a 50% decline from 94 (2021) to 47 (2024). Because publication lags filing by about 18 months, 2025-2026 counts will rise as later filings publish, so this should be read as a plateau rather than a confirmed exit from the space.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to prothrombin time and inr standardization, with the prior art for and against each one.
| Assignee | Co-assignee | Shared families |
|---|---|---|
| Theranos Inc | Theranos IP Co LLC | 31 |
| Akebia Therapeutics Inc | Tanabe Seiyaku Co., Ltd. | 26 |
| Theranos Inc | Labrador Diagnostics LLC | 24 |
| Labrador Diagnostics LLC | Theranos IP Co LLC | 24 |
| T2 Biosystems Inc | RITTERSHAUS CHARLES WILLIAM | 8 |
| T2 Biosystems Inc | DEMAS VASILIKI | 8 |
| T2 Biosystems Inc | CHEPIN JAMES FRANKLIN | 8 |
| Perosphere Technologies Inc | Perosphere Inc | 6 |
Only 10 co-assignee pairs appear in the corpus; the strongest pairing links a corporate entity to its own IP holding subsidiary, and a second links a therapeutics company to a partner via a 26-record joint filing pattern — evidence that most work in this field is filed solo rather than through joint ventures.
Who holds the ground, and where filing has stalled
The leader board is dominated by point-of-care diagnostics and blood-testing device makers, several of which have gone quiet in the most recent year even as their historical filings continue to anchor the top of the ranking.
One point-of-care specialist holds the largest single share
The leading assignee's 323 records sit well ahead of the fifth-place holder's 89, indicating a filer that has built a genuinely deep portfolio around point-of-care coagulation testing rather than a handful of core patents.
Even active recent filers are pulling back
Among assignees with any activity in the latest tracked year, the steepest mover shows a 94% year-on-year drop to a single filing, and several previously prolific names show zero filings in the latest year — consistent with the broader post-2017 cooling rather than a single company's retreat.
Filing is largely solo, not joint
With only 10 co-assignee pairings identified across 2,568 records, most assignees are filing independently. Where pairs do appear, they tend to link a parent company to its own IP-holding subsidiary rather than to an external partner.
| Assignee | Recent year | YoY |
|---|---|---|
| Velico Medical Inc | 1 | -94% |
| Abbott Point of Care Inc | 0 | — |
| Theranos Inc | 0 | — |
| Labrador Diagnostics LLC | 0 | — |
| T2 Biosystems Inc | 0 | — |
| Akebia Therapeutics Inc | 0 | — |
| Meso Scale Technologies LLC | 0 | — |
| Theranos IP Co LLC | 0 | — |
Where to take this analysis
The landscape points to a mature core around instrument-based PT/INR testing and a comparatively open edge around informatics and harmonisation software. Two directions follow from that.
Stress-test a claim against the dense G01N cluster
Before drafting new assay or instrument claims, check them against the 64.6% of records already classified under material analysis and testing — this is where prior art density is highest and freedom-to-operate risk concentrates.
Run a claim comparison in Eureka →Map the informatics gap in detail
G16H healthcare informatics sits at only 8.2% of records despite the field's dependence on result harmonisation across reagents and instruments — a candidate area for a more granular novelty search.
Explore white space in Eureka →Common questions about this landscape
The leading assignee in this corpus holds 323 of the 2,568 records in scope, well ahead of the fifth-ranked holder at 89. That single filer's portfolio, combined with the next four largest, accounts for 35.0% of all records, which is a meaningful concentration for a diagnostics niche. Beyond the top ten holders — who together reach 47.4% of records — ownership spreads across a long tail of smaller and single-filing entrants, so the field is not a closed market dominated by two or three names.
Filings peaked in 2017 at 155 records and have declined since; the most recent fully comparable window shows a 50% drop from 94 records in 2021 to 47 in 2024. That said, publication typically lags actual filing by around 18 months, so the 2025 and 2026 counts in any dataset are understated and will rise as later filings are published. The honest read is a cooling trend through 2024 rather than a confirmed end to activity.
Material analysis and testing (IPC class G01N) is the dominant classification, appearing in 64.6% of the 2,568 records in scope. Lab apparatus (B01L, 20.2%) and enzyme- or DNA-based testing methods (C12Q, 19.0%) follow, alongside medicinal preparation and therapeutic activity classes tied to warfarin monitoring. Healthcare informatics (G16H) is comparatively thin at 8.2%, suggesting that software-driven result harmonisation is less heavily claimed than the underlying assay and instrument technology.
Based on class density, healthcare informatics and networked result-harmonisation methods are the most under-claimed branch relative to the core testing and apparatus classes. Specific sub-areas worth checking include PIVKA-adjusted INR calculation methods, external quality assessment scoring algorithms, and cartridge-based whole-blood sensing, all of which sit below the density of the dominant G01N/B01L cluster. A prior-art search focused on these areas is likely to surface less crowded claim space than a general PT/INR assay filing.
Ownership is concentrated at the top but not monopolised: the top five assignees hold 35.0% of all 2,568 records, and the top ten hold 47.4%. The leading single assignee alone accounts for 323 records, more than triple the fifth-place holder's 89. Co-assignee filing is rare, with only 10 identified pairs across the entire corpus, meaning most organisations file independently rather than through joint ventures or shared IP arrangements.
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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.