Shining a Light on Diagnostics
Marks & Clerk is one of the world’s leading intellectual property firms and the UK’s largest firm of Patent and Trade Mark Attorneys. Ahead of the firms Co-Sponsorship of 2021 Bionow Precision Medicine Conference, Paul Chapman (Partner) introduces Bionow members to the importance of diagnostic testing and how to combat potential challenges in this space.
COVID-19 has triggered an unprecedented shift in global consciousness towards the importance of diagnostic testing. Terms such as ‘lateral flow’ and ‘PCR testing’ are no longer the preserve of the medical profession, and as a result the world of Diagnostics is firmly under the global microscope.
As a firm, Marks & Clerk has been very active over the last year advising and protecting our client’s Intellectual Property (IP) in relation to new Covid-19 tests, which they have developed. Some of these tests are already being marketed, with others in late stages of their development. However, the importance of diagnostic testing extends way beyond the field of detecting COVID-19 infection, and indeed our knowledge and expertise in the area is wide ranging.
Diagnostic testing is understood to relate to any kind of medical test, which is performed to aid in the diagnosis, or detection of a suspected disease or condition. Such tests are also vital for screening people for a predisposition to and/or being at high-risk of developing a disease. Whilst strictly speaking this is not a diagnostic test, it can certainly be argued that the end-goal is the prevention of disease development and so the ultimate aim is to assist the physician in delivering treatment, even if it is preventative.
Whilst public awareness of diagnostics has undoubtedly increased, there is still education to be done and as a firm, Marks & Clerk is well positioned to contribute. When one starts to consider the field of medical diagnosis and screening, and the tests and procedures used, you begin to realise that the field is more wide-ranging and cross-disciplinary than is often first realised. Diagnostic testing extends across the fields of biology, chemistry, physics, electronics, mechanics and software, with many sub-categories in between. Moreover, each test that is developed may rely on a number of these fields and specialisms. It is perhaps due to our breadth of available technical experience and significant knowledge why we have a considerable number of diagnostic clients.
Whilst I do not want to list every type of test or procedure, which may be considered a diagnostic test, I will instead refer you to the Encyclopaedia Britannica ("List of medical tests and diagnostic procedures". Encyclopedia Britannica, 6 Sep. 2016, https://www.britannica.com/topic/list-of-medical-tests-and-diagnostic-procedures-2074273), which provides a useful list conveying the wide variety of diagnostic tests which are available. However, such a generic list does not touch upon some of the specifics or more recent developments in the field. For example, the list does not mention the field of point-of-care testing, or high-throughput nucleic acid sequencing. Moreover, the list does not inform the reader how such tests are being employed in the developing field of precision medicine, for example.
Precision medicine, recognises that there is not a one-size, or one-drug fits all approach when it comes to treating subjects. Thus, precision medicine looks to tailor treatments to specific sub-groups or even individual patients. For example, a physician may have a variety of dugs they could use to treat a cancer patient, but does not know which one would be best suited for the particular individual. At present, the physician may simply have to adopt a try it and see approach. However, if a particular drug does not work for the patient, time has been wasted and their cancer may have developed further. Diagnostic testing, including nucleic acid testing, will play a significant role in seeking to address issues such as this. A hope for precision medicine is that one day, a patient will be able visit their local GP; a test is conducted on-site in minutes; and the GP is be able to prescribe a treatment or drug, specifically tailored to the individual patient’s needs. There is certainly a considerable amount of effort being directed towards this and workers in the field hope that this could be realised sooner than you may think.
As well as the clear patient benefits of improved diagnostic testing, there are also significant economic or socio-economic advantages. The Longitude Prize was developed to shine a light on these potential advantages by creating an affordable, accurate, rapid and easy-to-use diagnostic test for bacterial infections. The result will allow health professionals worldwide to administer the right antibiotics at the right time. Not only will this provide an immediate benefit to the individual, as they may be treated in a suitable manner, but reducing the inappropriate prescribing of antibiotics, will benefit the community at large, as this will help tackle the growth of antibiotic resistance. The prize is one many such initiatives supported by myself and Marks & Clerk.
Innovators are thinking creatively when it comes to new ways of conducting diagnostics. For example, it is estimated that there are 3.80 billion smartphone users in the world today, which equates to almost 50% of the world’s population and increasing. Innovators are looking at ways of using smartphones for evermore-complex medical diagnostic purposes. In developing countries, the use of smartphones is significant and will only increase. For example, in India, which has a population of over 1 billion people, it is estimated that over 25% of the population already own a smart phone. This offers the exciting possibility of allowing physicians to test and diagnose subjects even in remote regions, where it has historically been difficult for a patient to see a physician face-to-face – although as we have all learnt during lockdown, virtual meetings can be almost as good and certainly very efficient. Thus, smartphones offer the possibility to conduct appointments and provide the physician with diagnostic information at the same time.
Collection of and analysing diagnostic data, often using AI techniques, is also becoming of increasing importance in diagnostics and is another area were Marks & Clerk has seen significant growth and where we are already advising and protecting our client’s IP. However, there are challenges in the diagnostics filed, when it comes to the protection of the valuable IP. In the US for example, protecting diagnostic methods, is often considered not patentable. Moreover, when it comes to protecting software for use in diagnostic tests, some countries allow this to be protected by way of patents, whereas others do not. There are also regulatory aspects to consider when bringing a diagnostic test to market and some rules/requirements may have changed following Brexit, with different approaches being adopted by the UK and the EU.
In view of these rapid advancements in the Diagnostics space, and our significant technical and legal IP experience, we believe this is a good opportunity to for our readers to consider their own potential challenges within Diagnostics, and how well we are placed to help support. I hope this brief introductory piece has whet your appetite. Over the coming months we intend producing a number of articles which will address some of these issues, using our knowledge and expertise of the field. We also hope to interview some of our clients and provide their valuable insight in this fascinating and extremely important area. If you are particularly interested in learning more about this, please contact us, or your Marks & Clerk contact, to ensure you are placed on our mailing list for future articles. We are also delighted to be sponsoring the 2021 Bionow Precision Medicine Conference on 3rd-4th March and look forward to you joining us then.
