https://www.patsnap.com/resources/blog/rd-blog/higher-order-structure-characterization-patent-landscape/ · Patsnap · data cut-off 2026-07-31 · downloaded from the live page
Patent Landscape · Biologics Characterization
Higher Order Structure Characterization Patents: Who Files, Who Leads
  • 51.3% concentration. The top 5 ranked assignees combined account for 1,611 of the 3,141 records in scope — over half the field sits with a handful of filers.
  • Filing has cooled from its 2018 peak. Filings ran from 96 in 2017 to a peak of 187 in 2018, and the 2021→2024 span shows a 15% decline (108 to 92) on the most recent complete years.
  • Analytical method claims are a minority share. G01N (material analysis & testing) covers only 15.5% of the 3,141 records, well behind A61K and C07K — most of the claim space sits in the formulation and molecule, not the measurement method.
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3,141
Published Records
51%
Top-5 Share of All Records
-15%
Filing Growth 2021→2024
US
Leading Jurisdiction

Filing growth compares 2021 (108 records) with 2024 (92) — 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 3,141 records in scope (CR5), not by the ranked leaders only.

Published byPatsnap Research··7 min readSourced from Patsnap Eureka
Overview

What this landscape covers

Higher order structure characterization spans the analytical and comparability work that sits underneath biologics development: circular dichroism, differential scanning calorimetry, NMR, and the statistical frameworks used to demonstrate conformational comparability between a reference product and a biosimilar or a reformulated batch. The patent record for this field is dominated by claims around the molecules and formulations being characterized rather than the measurement techniques themselves, which is visible in how the IPC composition skews toward A61K and C07K rather than G01N.

The 3,141 records in scope span filings from 2015 onward, with receiving-office activity concentrated in the United States, Europe and the PCT route, and a smaller but consistent presence in Australia, Canada and Israel.

Filing activity and technology composition, 2017–2026
  1. 1ZYMOGENETICS INC488
  2. 2ATYR PHARM INC430
  3. 3PANGU BIOPHARMA LTD372
  4. 4MILLENNIUM PHARMACEUTICALS INC182
  5. 5AMGEN INC139
  6. 6DAIICHI SANKYO CO LTD96
  7. 7NOVO NORDISK AS79
  8. 8TAKEDA PHARMA CO LTD74
  9. 9COGNITION THERAPEUTICS INC74
  10. 10EISAI R&D MANAGEMENT CO LTD71
Source: Patsnap Eureka. Assignee ranking and totals. Derived from a Patsnap search on Higher Order Structure Characterization covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP

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The Data

Filing trends and technology composition

Two views of the same 3,141-record corpus: the year-by-year filing curve, and the IPC subclasses those records fall into.

Filing activity, 2017-2026

Filings rose from 96 in 2017 to a peak of 187 in 2018, then eased. Because publication lags filing by roughly 18 months, the 2025-2026 counts are still filling in and should not be read as a drop-off; the more reliable read is the 2021-to-2024 span, where filings fell 15% (108 to 92).

Filing activity, 2017-20260501001502009620171872018201920202021202220232024202592026Most recent year is partial — publication lag means later filings are not yet visible.

IPC subclass composition

A61K (medicinal preparations) and C07K (peptides & proteins) each cover more than half of the 3,141 records, reflecting a field anchored in the molecule and formulation rather than the analytical instrument. G01N, the classification most associated with measurement and testing methods, covers 15.5% of records — a share worth watching for anyone trying to claim a novel characterization method rather than a novel biologic.

IPC subclass compositionA61K · Medicinal preparations2,14568.3%C07K · Peptides & proteins1,81257.7%C12N · Microorganisms & genetic engin…1,00231.9%A61P · Therapeutic activity of compou…95730.5%G01N · Material analysis & testing48715.5%C12P · Fermentation & enzymatic synth…2889.2%C12Q · Measuring & testing involving …2678.5%C07H · Sugars & nucleic acids1906.0%Other1,12935.9%

Shares are the percentage of the 3,141 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.

Source: Patsnap Eureka. Filing trend and technology composition. Derived from a Patsnap search on Higher Order Structure Characterization covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.

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Key Patents

Representative filing and most-cited prior art

Representative Filing
US20220413072A12022-12-29

US20220413072A1 — NMR methods for antibody higher order structure comparability

REGENERON PHARMACEUTICALS, INC.

The present invention generally pertains to methods of characterizing antibody higher order structure. In particular, the present invention pertains to the use of novel NMR methods to compare manufacturing process variability in antibody higher order structure.Filed by Regeneron Pharmaceuticals, published 2022-12-29. Framed around comparing manufacturing-process variability rather than a single fixed method, which broadens what the claims can be read to cover.

US20220413072A1 — patent drawing 1US20220413072A1 — patent drawing 2
View full filing
Most-cited records in this landscape
#Publication no.Patent titleCitations
1WO2004078163A2Pharmaceutical co-crystal compositions of drugs such as carbamazepine, celecoxib, olanzapine, itraconazole, t…1,313
2US5096815AGeneration and selection of novel DNA-binding proteins and polypeptides1,080
3US5198346AGeneration and selection of novel DNA-binding proteins and polypeptides983
4WO1999003884A2Modified immunogenic pneumolysin compositions as vaccines403
5US20090092582A1Compositions and methods for modifying properties of biologically active polypeptides370
6WO2009023270A2Compositions and methods for modifying properties of biologically active polypeptides344
7US6307024B1Cytokine zalpha11 Ligand285
8US20090226530A1Powdered protein compositions and methods of making same272
9US9079949B1Anti-C5 antibodies having improved pharmacokinetics264
10WO2008023050A1Acylated exendin-4 compounds246

Citation counts favour older filings simply because they have had longer to accumulate citations inside the searched corpus — treat this table as a map of influential prior art, not of current commercial activity.

Each row carries its publication number; clicking a row searches Eureka by that number.

Source: Patsnap Eureka. Citation counts and representative records. Derived from a Patsnap search on Higher Order Structure Characterization covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
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Insights

What the numbers mean for strategy

Reading concentration, technology mix and citation patterns together points to where filing is defensible and where it is crowded.

Concentration
51.3% / top 5
share of 3,141 records

Half the field sits with five filers

The top 5 ranked assignees combined hold 1,611 of the 3,141 records in scope, 51.3% of the field. That concentration is a signal to check freehand-to-operate against a short list of holders before assuming open ground, particularly in formulation-adjacent claims.

Based on the assignee ranking
Momentum
-15%, 2021-2024
complete-year filing change

Filing has eased, not collapsed

Filings fell from 108 in 2021 to 92 in 2024, a 15% decline over the only span that can be treated as complete given publication lag. That is a cooling trend rather than a field in decline, and the 2018 peak of 187 shows the ceiling this space has already reached once.

2021-2024 complete years only
Technology mix
15.5% G01N
share of 3,141 records

Method claims are the minority share

G01N, the classification tied to material analysis and testing methods, appears on only 15.5% of records versus 68.3% for A61K and 57.7% for C07K. Most protection in this landscape sits in the biologic or formulation being tested, not the analytical method used to test it.

IPC subclass shares, not mutually exclusive
Prior art
1,313 citations
top-cited record

The most-cited prior art predates the current filing wave

The most-cited record in this corpus is a pharmaceutical co-crystal composition filing, cited 1,313 times, well ahead of the DNA-binding protein filings that follow it. High citation counts here reflect age and breadth of applicability more than current relevance to higher order structure methods specifically.

Citation counts favour older filings
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Looking for what nobody has claimed yet?

Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to higher order structure characterization, with the prior art for and against each one.

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Source: Patsnap Eureka. Co-assignee relationships and derived observations. Derived from a Patsnap search on Higher Order Structure Characterization covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
Players

Who holds the claim space

The ranking covers 100 companies counted in records — the whole ranking the data endpoint returns, not a top-50 or top-100 cut chosen for this page.

Leader
488 records
leading assignee

A single filer holds a clear lead

The top-ranked assignee holds 488 records, well ahead of fifth place at 139 and tenth place at 71. That gap between first and fifth is the steepest drop in the ranking, and it is where most of the top-5 concentration figure comes from.

Leader vs. 5th and 10th place
Long tail
100 ranked
assignees in the ranking

A long tail beneath the leaders

Below the top 10, which together hold 63.8% of the 3,141 records, the ranking runs out to 100 companies with progressively thinner filing counts. That tail includes single-family entrants worth checking individually rather than assuming they are inactive.

Full ranking, not a top-N cut
Collaboration
10 pairs
co-assignee pairs recorded

Co-filing is rare but concentrated where it exists

Only 10 co-assignee pairs appear in this landscape, and the strongest of them clusters around a small number of related entities filing at high volume together. Outside those pairs, most filing in this field is done by a single assignee of record.

Strongest pair by shared record count
🔍
Under-claimed sub-areas worth a closer look
Branches where filing density is thin relative to the therapeutic and formulation claims dominating the field
NMR-based comparability protocolsstatistical equivalence testing frameworksformulation-interference correction methodsbiosimilar conformational fingerprintingDSC thermal stability comparabilityspectroscopic fingerprint reference standards
Rank all filers by momentum →
Recent-year filing momentum
AssigneeRecent yearYoY
aTyr Pharma Inc.1-67%
ZymoGenetics Inc.0—
Pangu Biopharma Ltd.0—
Millennium Pharmaceuticals Inc.0-100%
Amgen Inc.0-100%
Daiichi Sankyo Co., Ltd.0—
QUINN CHERYL L0—
MENDLEIN JOHN D0—
Source: Patsnap Eureka. Assignee-level momentum. Derived from a Patsnap search on Higher Order Structure Characterization covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
What's Next

Where to take this next

The dataset points to where claim space is dense and where it is thin. The next step is testing a specific claim or competitor position against the full record set.

Check freedom-to-operate against the top filers

With 51.3% of records held by five assignees, a freedom-to-operate check on any formulation-adjacent characterization method should start with that short list before broader searching.

Run a landscape search in Eureka

Draft around the under-claimed method branches

G01N-classified analytical method claims are a minority share of this field at 15.5% of records, which leaves room to test a first claim in NMR comparability or statistical equivalence framing.

Explore claim drafting in Eureka

Track momentum on the leading assignees

Several top assignees show flat or declining recent-year filing counts; monitoring whether that continues or reverses is worth setting up as a standing watch.

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Source: Patsnap Eureka. Forward-looking reading of the same dataset. Derived from a Patsnap search on Higher Order Structure Characterization covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
FAQ

Frequently asked questions

Answers are grounded in the same dataset. Derived from a Patsnap search on Higher Order Structure Characterization covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP

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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.

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