Protecting Med Tech Innovations in the Era of Home Diagnostics

As patent attorneys in the Med Tech space, it is evident that the self-testing revolution will continue to gain momentum. The global market is projected to grow from around 15 billion dollars at present to 27.3 billion dollars by 2032.  This explosion is attributed in part to the COVID-19 pandemic. For many consumers, the experience of taking numerous lateral flow tests has meant that the idea of performing a diagnostic test in the privacy of their home is not unusual. In fact, self-testing can empower consumers to take control of their health. Affordable self-tests in particular have the potential to democratise access to healthcare.

Self-testing relies on the collection of a biological sample from the test subject, which could involve the all-too-familiar nasopharyngeal swab but could alternatively involve obtaining a blood or urine sample, for example. The testing of the sample may then be performed in situ, which is more likely to be the case when testing for a pathogen or the level of a single biomarker like glucose or vitamin D. Alternatively, the sample may be sent for analysis in a laboratory for more complex testing. This may be the case when performing a genetic screening or assessing a panel of biomarkers, such as a panel of hormones for a fertility test. Frequently, communication of the test results, or even the analysis itself, may performed by a digital platform installed on a mobile device.

As the market for self-testing continues to grow, inevitably so will the number of businesses aiming to compete in this field. In the midst of this competition, acquiring protection for their IP will be a vital step for any business in both carving out, and then maintaining, their share of the market.

In many countries, obtaining patent protection for medical diagnostic tests can be a tricky process. For example, currently in the US medical diagnostic tests per se are generally excluded from patentability. Similarly, in both the UK and at the European Patent Office, patents cannot be granted for a method of diagnosis practised on the human or animal body. How then can a business operating in the self-testing market protect its products from its wily competitors?

Options to work around these exclusions vary by country. As a result, IP protection in this field can benefit from a dynamic approach that takes into account the intricacies of local laws. In the US, patents may be granted for a diagnostic test performed within the context of a method of treatment. In the UK and Europe by contrast, treatment methods also face restrictions to patentability. Instead, a patent for a diagnostic test performed on a previously collected sample (rather than directly on the human body itself) can avoid these exclusions. Helpfully, this means that a diagnostic method using a self-testing kit can be prima facie patentable in the UK and Europe, as such self-tests are commonly performed using isolated samples of saliva, blood, or the like.

Another option is to focus on the testing kits themselves. In particular, complicated diagnostic processes requiring multiple steps can result in unique and innovative testing products. The numerous options for performing each of these steps can allow businesses to distinguish their products through accuracy, speed and ease of use. Patents relating to the actual product being sold are therefore a useful tool for businesses aiming to secure commercially valuable aspects of their IP. 

With the assistance of local IP experts, it can therefore be possible for businesses operating in the self-testing market to obtain degrees of protection for both their self-testing kits and their diagnostic methods.