About the authors:
Sarah Abou-Shehada is a trainee patent attorney at Appleyard Lees IP LLP. Sarah has worked within a consortium of large pharmaceutical companies, universities, and small/medium-sized entities across Europe, whose aim was to develop sustainable manufacturing methods for the pharmaceutical industry.
Claire Devine is a patent attorney at Appleyard Lees IP LLP. Claire has worked with a range of clients in the biotechnology and pharmaceutical areas, on applications related to a broad range of technologies, including antibodies, industrial biotechnology, gene therapies, RNA therapies, new chemical entities and drug repurposing.
In our everyday lives, we are used to seeing digital innovation having a transformative impact. For example, nowadays it is common for us to leave the house without even bothering to pick up a wallet, safe in the knowledge that it will be possible to pay for anything using either a phone or even a watch! These innovations help to streamline our lives and make everyday tasks more efficient.
Over the last decade, digital innovation has also found its way into the healthcare space. In particular, pharmaceutical and biotechnology companies commonly use computation tools and innovations to streamline the drug discovery process or the development of diagnostics. There are multiple companies currently utilising artificial intelligence (AI) and machine learning to facilitate and/or inform methods for processing data from clinical trials, monitoring patients and facilitating patient engagement.
The healthcare space generates vast volumes of data annually. A significant challenge with this data is in how to accurately analyse and interpret it to inform research accurately and comprehensively. As such, any innovation in the digital health space demands an interdisciplinary approach requiring expertise in, at least, the healthcare technology in question, analytics, and data processing. Due to this interesting blend of technologies and expertise, innovations in digital health can cover an array of different products and methods. Many of these innovations can be patent protected.
In this article, we look at some of the recent patenting trends and challenges in the digital healthcare space, with a spotlight on digital healthcare for medicine development.
1. Patent filing trends in the digital healthcare space
The patent filing results and trends are based on a dataset of patents filed and classified as relating to both healthcare technologies and computer implemented healthcare technologies (under IPC or CPC).
The trend in priority filings over the past 20 years is shown in Graph 1. For the purposes of this article, the graph only shows the trend in priority filings up to and including 2019. This is because the complete dataset for priority filings in 2020 will not be available until mid-2022, and the current information consequently shows an apparent drop in priority patent filings (as it does for 2021).
The trend in priority filings in the digital healthcare space shows an increase in the number of filings from, at least, the 1990s. A dramatic increase in priority filings is observed between 2010 and 2019, which is indicative of an escalation in the research and development efforts in digital healthcare technologies and their growing commercial value.
Graph 1 – Trend in priority filings between 1999 and 2019 for patents classified as relating to both computer implemented healthcare technologies, and healthcare technologies (under IPC or CPC)
Table 1 below provides the top 10 companies (assignees) filing in this technology space. Six of the top 10 filers are entities that are, or are associated with, companies known for their expertise in the computational and electronics field. This confirms that Big Tech companies have entered the digital healthcare space.
Table 1 – Top 10 filers (assignees) of patents classified as relating to both computer implemented healthcare technologies, and healthcare technologies (under IPC or CPC).
|1||Philips Koninkll NV|
|3||Siemens Healthcare GmbH|
|4||Fujifilm Holdings Corp.|
|5||Ethicon LLC (subsidiary of J&J)|
|7||General Electric Co.|
|9||Konica Minolta Holdings Inc.|
|10||Abbott Diabetes Care Inc.|
A review of the trends in priority filing data provides an intriguing insight into the “state of play” with respect to the top filers in this technological area. Interestingly, although Abbot Diabetes makes it into the top 10 prolific filers, a significant proportion of Abbot’s priority filings in this dataset were all filed in 2007. Also noteworthy is Ethicon’s position as one of the top 10 filers given that, according to priority filing data, Ethicon only entered the digital healthcare space in 2012 and has since filed >250 priority filings, 83% of which were filed in 2017. A similar observation is made with respect to top filer Philips Koninkll, who are also a relatively new entrant in this technical space, with the majority of their priority filings (86%) arising in the last decade.
So which innovations are leading the way in the field of digital healthcare? A review of the top CPC and IPC classifications for the dataset revealed that over half of all of the patent filings relate to three areas of digital healthcare technologies. These are:
- Computer implemented inventions relating to diagnosis (25% of total families in the dataset);
- Computer implemented inventions relating to the management or operation of medical equipment or devices (23% of total families in the dataset) and
- Computer implemented inventions relating to processing medical images (8% of total families in the dataset)
2. SPOTLIGHT – Patent filing trends in the digital healthcare for medicine development
The patent filing data was limited across all of the above groups to patent families that were also classified under chemical or medicinal preparations with specific therapeutic activity to create our “spotlight” dataset for a more detailed analysis. Table 2 below provides the top 10 companies (assignees) filing in this spotlight technology space.
Table 2 – Top 10 filers (Assignees) of patents classified as both computer implemented healthcare technologies, and healthcare technologies relating to chemical or medicinal preparations (under IPC or CPC) across all jurisdictions
|1||Astrazeneca UK Ltd.|
|4||Ipsen Biopharm Ltd.|
|6||MIR Scientific LLC|
|7||Univ. Johns Hopkins|
|8||Uni of California|
|9||Takeda Pharmaceutical Co. Ltd.|
|10||Scipher Medicine Corp.|
The patent filings in this spotlight technology relate to digital health innovations directed to: gene expression, single nucleotide polymorphisms (SNPs), cancer and combination therapies. Within those groups, the technologies in this patent space centre around the following digital health innovations:
- predicting the efficacy of, or the response to, a given therapy;
- methods for personalised therapy selection;
- methods for developing classifiers for stratifying patients and/or cancers;
- methods for the identification and treatment of diseases such as cancer;
- methods for determining the likelihood of a subject to respond to particular therapies;
- methods for assessing late clinical points in specific cancers; and
- methods for determining a risk of developing particular diseases based on genetic risk factors.
As such there is significant innovation in the precision medicine space, with an aim to use computational tools to develop tailored treatments for subjects, or for matching subjects with, the most suitable treatment.
2.1. SPOTLIGHT – Patent grant analytics – a comparison between the US Patent Office (USPTO) and the European Patent office (EPO)
For this “spotlight” dataset, we also analysed the time it took for a patent to grant, based on grant statistics for patent families that have corresponding applications in the US and Europe. In brief, the average time to grant for patents within this technical area at the EPO is just under 7 years from the filing date, whereas the time to grant in the US is only 3.5 years from filing date. This is illustrated in Graph 2 below.
Graph 2 – Time to grant statistics at the EPO and the USPTO for spotlight dataset
There are many reasons why one patent office maybe slower than another. However, the disparity between these two jurisdictions is noteworthy, as both diagnostic/medical treatment applications and computational applications are assessed very differently in Europe and the US. In both jurisdictions, there are statutory exclusions that apply to these types of inventions, but the exclusions are different in each case.
Under the European Patent Convention (EPC), methods of treatment by therapy or surgery of the human or animal body are not patentable. Diagnostic methods practiced on the human or animal body are also not patentable. However, it is generally possible to overcome these exclusions by using different claim language. Further, in order for a computer implemented invention to be considered patentable, it must exhibit a “technical effect”.
In contrast, in the US, methods of treatment are inherently patentable. However, inventions related to diagnostic methods and computer implemented inventions related to digital health may be patent ineligible subject matter under US law. In the US, these inventions are assessed for eligibility under the so-called “Alice” test. This test involves:
(i) determining whether the claims at issue are directed to a patent ineligible concept (i.e., law of nature, natural phenomena, or abstract idea); and
(ii) if so, determining whether the claims contain additional element(s) sufficient to ensure that the claims amount to significantly more than the ineligible concept itself.
Therefore, Europe and the US both pose different challenges for innovators wishing to protect digital health innovations. However, it appears that in the US, patent applications related to digital healthcare for medicine development may proceed to grant quicker. As such innovators in this space may want to consider a filing strategy which comprises a first filing in the US to take advantage of the faster timeline for grant.
Based on our analysis of patent filings in the digital healthcare space, it is clear that innovation in this area has shown a marked escalation over the past 10 years, and there is no reason to expect that the observed growth is likely to slow over the coming years. As would be expected, most of the patent filings, and therefore innovation, in this space originates from Big Tech companies. Within this broad technical space, it appears that most patent filings centre around 3 main digital healthcare technologies relating to diagnosis, the management or operation of medical equipment or devices, and the processing of medical images.
Digital healthcare for medicine development represents a comparatively small fraction of filings in this technical space. However, those filings follow a similar marked upwards trend in priority filings over the last 10 years, and we expect the trend in filings in this area to continue to grow over the coming years. Those filings mark the entry of traditional pharmaceutical companies into the digital healthcare space, specifically within the area of digital technologies for medicine development (as shown in Table 2). Within that space, the innovations are centred around facilitating the development of personalised therapies and medicines.
For those innovating in this space and seeking patent protection in the US and Europe, for inventions relating to computer aided diagnosis or treatment, there is a complex array of different exclusions that need to be navigated. As such it is important to have a clear patent strategy at the outset, to ensure efficient prosecution of the patent application to its grant, and secure appropriate protection for the invention in Europe and the US.