Antibiotic diagnostics: Report shows downward trend in innovation
CPA global conducted research into patents and connected patent families using keywords relevant to point-of-care (POC) diagnostic tests for addressing antimicrobial resistance. This research analysed what patents are being filed and therefore what technology is being developed. Marks and Clerk conducted the analysis and assessed the implications on the market for diagnostics to reduce antimicrobial resistance.
This study reveals a year-on-year decline in patent filings for point-of-care diagnostics to tackle infectious disease and detect pathogens and AMR through 2014 and 2015. Following a dip in innovation as a possible result of the financial crisis of 2008, patent filings reached their highest levels for the past decade in 2014, with 118 patents for point-of-care diagnostics for infectious disease filed globally. By 2015 this figure had dropped significantly to 94 patents. The global market for point-of-care diagnostics for infectious disease, and particularly those looking to tackle AMR, remains in its infancy.
Most diagnostics are routinely done in a laboratory setting so that the introduction of a new point-of-care diagnostic requires the creation of new markets. Much of the recent new funding in AMR has been allocated for early research into new antibiotics and so far funds to support diagnostics have been limited.
The report, ‘Innovation in AMR: patent trends for novel diagnostics’, can be viewed and downloaded here.
Overall filling trends
The last 10 years has seen a general increase in the number of patent filings relating to POC diagnostics aimed at pathogens and infectious diseases. Since 2013, the annual number of fillings has been slowly declining.
The US continues to dominate filings in this area with 60 per cent, the UK is the second largest source of patents at 8 per cent, followed by Europe (6 per cent), Japan (4 per cent), Korea (3 per cent) and China (2 per cent).
“The fact that patents on AMR diagnostics are slowing is concerning but another equally important challenge for test makers is the dearth of available grants and venture capital funding for tests that will reduce and improve the use of antibiotics."
- Daniel Berman, Lead, Global Health Team at the Challenge Prize Centre
There is an upward trend in filings during this period for Japan, Australia, India and South Africa.
The term European Patent is used to refer to patents granted under the European Patent Convention (EPC).
Patent Cooperation Treaty (PCT) is an international patent law treaty providing a unified procedure for filing patent applications. A patent application filed under the PCT is called an international application.
Note: EPC and PCT have different procedures for patent filings. An inventor might want to market and sell their invention in one country first, which would not require international protection and the cost of protection is therefore lower for continued protection. The inventor then would get a priority date if they decided to file internationally.
Innovations in POC diagnostic tests for AMR are largely dominated by private companies (60%) in the USA and Europe, and academic institutions (32%).
9 out of the 10 academic institutions in terms of numbers of patents are in the US. University of California is leading and the only UK academic institution in the top 10 is the University of Edinburgh.
- The relative number of patent filings have decreased in the last 5 years, however the percentage relating to detection of bacteria has increased.
- There was significant activity in patent filings for WHO priority pathogens between 2009-2012, but this has tailed off more recently. It may be that diagnostic device/assay developers have been focusing on more broadly applicable devices/assays rather than looking to target specific bacteria.
- Will the publication of WHO priority pathogens (2017) lead to a change in focus of researchers/test developers in the future?
“The role of medtech in delivering quicker and more reliable diagnoses, and the impact this can have in tackling AMR, is often underestimated. It’s encouraging therefore to see that there is a great deal of innovation in this space."
- Paul Chapman, Partner, Marks & Clerk and member of Longitude Prize advisory panel
This report demonstrates that there is significant innovation in the diagnostic space that could lead to tests coming to market that would avoid the unnecessary use of antibiotics and better target antibiotic therapy. However, the Longitude Prize that currently has 75 teams competing from 14 countries, has received feedback from test developers that is cause for concern. Longitude Prize teams are struggling to attract adequate funding and investment to ready their tests for market and gather enough data to validate tests and reach regulatory standards.
“Everyone says the world wants a rapid POC diagnostic, but companies don’t see those desires translated into sales revenue. These devices won’t magically appear without the structures that build, distribute, sell, use and regulate them.”
- Kevin Outterson Professor of Law at Boston University School of Law. Executive Director of CARB-X, and Director of Social Innovation in Drug Resistance (SIDR) at Boston University.
Investors are concerned that prize expectations are too low to ensure return on investment and are not convinced that financing will be available to create this new market for rapid diagnostic tests. This is a warning to policy makers that that initially there will be a need to ring-fence funds to make sure that new products are purchased.