Antibody Patenting – A Comparison Of Trends At The EPO & USPTO

This study contrasts antibody patenting trends at the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO). A bespoke dataset was curated via Questel Orbit Innovation using appropriate IPC & CPC classifications and a tailored keyword strategy. Legal status data is based on INPADOC legal status.

In figure 1, the publication year and application/filing year trends for patent applications and the grant year trends for granted patents are investigated for antibody related patents at the EPO. Patent application publications grew at a compound annual growth rate (CAGR) of 8.3% during 2015-2024. The application year trends are capped to 2022 to account for the 18-month publication delay impacting data during 2023 & 2024. The grant year trends are influenced by the potential impact of the COVID-19 pandemic and the EPO's general time to grant, which is around three to five years. All of which can impact the granted trendline since 2020. For example, applications filed since 2020 may not have completed the examination phase.

In figure 2, the publication year and application/filing year trends for patent applications and the grant year trends for granted patents are investigated for antibody related patents at the USPTO. Patent publications grew at a compound annual growth rate of 5% during 2015-2024. The application year trends are capped to 2022 to account for the 18-month publication delay impacting data during 2023 & 2024. The rate of growth is slower than at the EPO, however, given the much higher publication totals the growth rate is harder to sustain. There is a more consistent grant year trend when compared with the EPO.

In figure 3, there were 36,511 published applications related to antibody technology at the EPO during 2015-24. Over 50% of the applications are currently pending. To date, approx.22% of the applications are granted. The legal status data is INPADOC based.

In figure 4, there were 61,349 published applications related to antibody technology at the USPTO during 2015-24. The proportion of granted patents is almost double the EPO at 41% with 30% pending.

Despite the proportion of alive patents being reasonably similar at both the EPO (~73.8%) & USPTO (71.5%) there is a noticeable difference for granted patents, where the proportion of granted patents at the USPTO are 1.87 times greater than the EPO granted proportion. Approx. 52% of patents at the EPO are pending compared with approx.30% at the USPTO.

Cumulative analysis – evolution of granted proportions

Figure 5 visualises the cumulative growth of patent filings during 2013-22 at the EPO & USPTO for antibody technologies. The cumulative grant trend reveals the growth of the number of granted patents by filing year.

The cumulative growth of the number of filings which are granted at the EPO appears to be much slower than at the USPTO, based on the granted trendline in figure 5. During 2013-22 there were 33,790 applications filed at the EPO, of which 7209 are granted (21.3%). At the USPTO there were 63,683 applications filed during 2013-22, of which 27,480 are granted (43.2%). The examination timeframe at the EPO is generally between 3-5 years which impacts the number of grants in recent years. However, there is a large difference between the two offices (21.9%).

Cumulative analysis by filing year

To investigate the differences in the granted patent levels between the USPTO & EPO shown in figure 5, the cumulative grant distributions are visualised in figure 6. The charts visualise the proportion of how many filings in a specific year are granted based on cumulative counts. The analysis reveals how the proportion of granted patents has changed over time, For example in 2022, at the EPO there are now 33790 filings since 2013, of which 7209 are granted (21.3%).

At the EPO, the cumulative grants peaked in 2015 at 44.6% (44.6% of the filings from 01/01/2013-31/12/2015 are granted) in figure 6. The data is impacted by the delay in grant procedures with 3-5 years for potential examination at the EPO. Nevertheless, the cumulative grant rate peaks at 44.6% at the EPO whilst this figure is much higher at 52.9% in 2018 at the USPTO. The cumulative grant percentages at the USPTO have been both more consistent with higher proportions of filings that are granted since 2014. The analysis suggests a more challenging environment at the EPO to achieve patent granted status for antibody related subject matter since 2014.

Grant rate by filing year

To further supplement the legal status analysis, the grant rate by filing year was analysed in figure x. Here the number of patents which are granted are divided by the total number of patents which are deemed to be ‘closed’ e.g. a status such as granted, lapsed, expired or revoked (excluding pending). The EPO grant rate post 2019-2020 is affected by the delays encountered during the examination stage (3-5 years). However, the EPO grant rate by filing year during 2019 is 36.5% and much lower than the USPTO at 62.1%.

Summary

The study findings suggest there is a relative slowdown in the patent grant process at the EPO, when compared with the USPTO:

  • There exists a large distribution of pending patents (figure 3) at the EPO (51%) when compared with the USPTO (figure 4 – 30.5%) based on published applications (2015-24). The proportion of granted patents at the USPTO (41.04%) are 1.87 times greater than the EPO granted proportion (21.94%).
  • At the EPO, the cumulative grant percentage during 2013-2022 peaked at 44.6% in 2015 and has declined since (figure 6).
  • At the USPTO, the cumulative grant percentage during 2013-2022 peaked at 52.9% in 2018 and has slowly declined since (figure 6). However, the cumulative grant percentage in 2022 at the USPTO is more than double the EPO distribution.
  • The cumulative analysis revealed that that since 2014, the USPTO has consistently had a higher proportion of cumulative granted patents when compared with the EPO (figure 6) which exhibits a much slower growing trendline (figure 5).
  • To potentially account for the delay due to the EPO examination phase approx. 3-5 years. The average grant rate by filing year at the EPO during 2013-2019 was 47.5%. However, during this period at the USPTO, the average grant rate by filing year was much higher at 54.5%. Capping the data at 2019 enables calculations with data likely not impacted by examination delays. However, there have been a large number of filings since 2019 so this calculation may not be sufficient, a rough guide at best.
  • Examination phases at the EPO are undoubtedly impacting the recent figures, it appears applicants have achieved higher grant rates at the USPTO in shorter timeframes (figure 7).

Antibody subtopics

The dataset was further analysed to identify 20 antibody related subgroup areas to investigate if there were any differences in the trends identified when accounting for specific subject matter.

EPO subtopics

The antibody related subtopic totals for the EPO dataset are shown in figure 8. The totals are based on applications published during 2015-2024. The largest subtopic, Biosequence related, is a proxy for applications which have disclosed a sequence or sequence ID. Patent applications can belong to more than one subtopic to account for multiple invention embodiments.

The EPO antibody dataset has two large distributions where patents disclose a sequence and secondly the antibodies are used for cancer therapeutics. The compound annual growth rates (CAGR) of the subtopics are shown in table 1.

Rank Topic CAGR Rank Topic CAGR
1 Chimeric antigen receptors 38.3 11 Chimeric, humanised, etc. 9.4
2 Nanobody / single domain 18.5 12 Immunomodulators 9.2
3 T-cell related 17.6 13 Respiratory & cardiovascular system 8.2
4 Single chain antibodies 17.2 14 Biosequence related 8.0
5 Multispecific antibodies 16.5 15 Neurological disorders 6.7
6 Fusion polypeptides 13.8 16 Immunoassay & diagnostics for cancer 3.9
7 Bispecific antibodies 12.5 17 Immunoassay & diagnostics 2.5
8 Gene therapy related 11.4 18 Joint disorders e.g. arthritis 1.9
9 Cancer therapeutics 11.3 19 Monoclonal antibodies 1.8
10 Antibody conjugates e.g. ADCs 10.6 20 Polyclonal antibodies -4.8
Table 1. CAGR of antibody subtopics based on published applications at the EPO during 2015-2024

There are 10 subtopics with growth rates above 10%, led by chimeric antigen receptors (38.3%). Other high growth areas include nanobodies, fusion polypeptides, t-cell related (e.g. immunotherapy), bispecific & multispecific antibodies. Despite the relative slowdown in grant rates there exists high demand at the EPO for antibody patenting across a variety of subtopics.

USPTO subtopics

The antibody subtopic totals for patent applications published 2015-24 at the USPTO are shown in figure 9.

The USPTO antibody dataset has two large distributions where patents disclose a sequence and secondly the antibodies are used for cancer therapeutics. The compound annual growth rates (CAGR) of the subtopics are shown in table 2.

Rank Topic CAGR Rank Topic CAGR
1 Chimeric antigen receptors 41.6 11 Chimeric, humanised, etc. 5.3
2 Nanobody / single domain 15.1 12 Immunomodulators 5.2
3 Single chain antibodies 14.7 13 Biosequence related 4.9
4 T-cell related 14.4 14 Respiratory & cardiovascular system 2.6
5 Multispecific antibodies 14.4 15 Neurological disorders 2.2
6 Fusion polypeptides 11.0 16 Immunoassay & diagnostics for cancer 0.4
7 Bispecific antibodies 10.2 17 Immunoassay & diagnostics -0.3
8 Antibody conjugates e.g. ADCs 8.3 18 Monoclonal antibodies -1.1
9 Cancer therapeutics 7.6 19 Joint disorders e.g. arthritis -1.9
10 Gene therapy related 6.3 20 Polyclonal antibodies -8.4
Table 2. CAGR of antibody subtopics based on published applications at the USPTO during 2015-2024

There are 7 subtopics with growth rates above 10%, led by chimeric antigen receptors (41.6%). The CAGR of specific subtopics may be lower than the EPO due to the larger number of publications at the USPTO such that high growth rates become harder to sustain. High growth areas include single chain antibodies, fusion polypeptides, t-cell related (immunotherapy), and bispecific & multispecific antibodies.

The publication trends of the antibody subtopics at the EPO are visualised in figure 10. The publication trends are based on published applications during 2015-2024.

In figure 10, there exists a high level of annual publications in the biosequence related subtopic (proxy for patents disclosing sequences) with more than 2000 publications per year since 2018, recently peaking in 2023 (2803 publications). Cancer therapeutics exceeded the 2000 published application threshold in 2019 (2108 publications). Across multiple subtopics there is evidence of growing patenting activities. However, 2024 represents a levelling off period or slight decline across some of the fastest growing topics. Topics such as immunoassay & diagnostics and monoclonal antibodies have been consistent during the last 10 years.

The publication trends of the antibody subtopics at the USPTO are visualised in figure 11. The publication trends are based on published applications during 2015-2024.

In figure 11, there exists a very high level of annual publications in the biosequence related subtopic (proxy for patents disclosing sequences) with more than 3000 publications per year since 2013, recently peaking in 2024 (4435 publications). Cancer therapeutics has exceeded the 2000 published application threshold since 2013 and also peaked in 2024 (4483 publications). Across multiple subtopics there is evidence of growing patenting activities. However, 2024 represents a levelling off period or slight decline across some of the fastest growing topics. Topics such as immunoassay & diagnostics have been consistent during the last 10 years. The rapid growth of chimeric antigen receptors and nanobody / single domain antibody topics are both peaking in 2024 with 711 and 488 publications respectively.

Cumulative grant proportions by filing year - USPTO

The cumulative distribution of granted patents by filing year for antibody subtopics at the USPTO, is shown in figure 12. The visualisation tracks how the proportion of granted patents has evolved over time. For example, there were in total 14442 filings during 2013-22, of which 6396 are granted by the end of 2022 (47.8%) within the antibody conjugates e.g. ADCs topic.

  • In 2022, the ADC topic comprises the highest cumulative grant levels with 47.8% of the cumulative filings between 2013-22 being granted.
  • Due to the delays during the examination stage many of the peak levels of granted patents occur earlier in the decade.
  • However, it can be observed that there are cumulative grant proportions above 40% in 2022 and higher cumulative grant proportions earlier in the decade.
  • Subtopics such as chimeric antigen receptors are lagging behind other topics in recent years due to the large quantity of recent filings.

Cumulative grant proportions by filing year – EPO

The cumulative grant distributions of granted patents by filing year for antibody subtopics at the EPO, is shown in figure 13. For illustrative purposes there were 7475 cumulative filings by 2022 in the antibody drug conjugates topic, 1867 are granted (25.9%). The EPO’s general time to grant is around 3 to 5 years, many applications filed since at least 2021 (possibly earlier) may not yet have completed examination.

  • However, it is interesting to observe that earlier in the decade the higher grant proportions still lag behind the USPTO trends where there is less of an impact from patents still undergoing examination, etc.
  • The biosequence related (sequence ID proxy) topic has not achieved a cumulative grant distribution above 50%, based on the filings during 2013-2022.
  • There is a noticeable drop off post 2016. If 2019 is used as a reference year to allow for any lag due to examination timeframes, the cumulative grant distributions are around 40% and lower for many topics. There is a difference of 10-20% with the higher USPTO trends.