In vitro diagnostics is a specialised field of technology that uses a wide variety of devices and techniques to perform diagnostic tests outside of the human body.
The tests could be performed in a laboratory or by a medical device attached to a patient. Examples of in vitro diagnostic tests include cancer screening, genetic testing, pathogenic microbial detection, and blood sugar monitors for diabetics.
In vitro diagnostics is a rapidly developing market and involves both private companies and public bodies working together to provide quick and efficient tests for potentially life threatening conditions. It is estimate that the industry in the UK alone generates a total industry turnover of over £900 million per year (figure sourced from BIVDA).
With such a diverse range of tests falling under the term in vitro diagnostics, there can be an equally diverse range of issue relating to their patentability. Patent law is developing all of the time and one of the most rapidly developing areas is the patentability of diagnostics. We can provide clear advice regarding the potential hurdles for achieving grant of your patents and guide you through the potential exclusions to patentability which can arise during prosecution of in vitro diagnostics.
Protection Strategies and Freedom to Operate
Our attorneys can assist you in developing your protection strategy and growing your existing patent portfolio to ensure the strongest protection of your products. We can also provide you with a better understanding of the patent landscape in your area of technology and ensure that you have freedom to operate.
Other useful rights
If your technology involved a medical device or similar product, our attorneys can also advise you on register and unregistered design rights.
The British In Vitro Diagnostics Association (BIVDA) is the national industry association for companies with major involvement and interest in the in vitro diagnostics (IVD) industry.