Diagnostics & Personalised Medicine
Understanding and addressing the challenges in this increasingly important area
Diagnostics has always been an important area of biotechnology but its importance is growing as we enter the era of personalised medicine. In addition to personalised genomics and companion diagnostics, we work with our clients in areas as varied as pathogen biosurveillance, infection detection, non-invasive prenatal testing and oncology.
We have assisted our clients with some of the key developments in this field. For example, we worked closely with Verinata Health (now a subsidiary of Illumina) on its non-invasive Verifi® test. This uses bioinformatic analysis of sequencing data derived from circulating cell-free DNA in maternal blood to provide valuable information on fetal chromosomal health, helping to avoid invasive procedures such as amniocentesis – a major advance in prenatal testing.
Our breadth of technical and legal expertise means that we are equipped to help our clients overcome the challenges that arise in protecting diagnostic inventions around the world. This is an area where we see particular divergence in practice between different jurisdictions and we are adept at adjusting our global approach to take these diverging practices into account. We also recognise that differences between laboratory-based and point-of-care diagnostics must be taken into account for successful patent drafting, prosecution and defence strategies. Our expertise is further reflected in our understanding of the commercial relevance of companion diagnostics and of their importance to effective patent and SPC strategies.
Navigating patentability restrictions in Europe – Guardant Health, Inc.
Guardant Health is a leading precision oncology company dedicated to helping conquer cancer through ‘liquid biopsies’. Its tests are centred on the high-sensitivity detection of tumour-derived DNA in blood using comprehensive nucleic acid sequencing-based approaches. This enables early detection, monitoring and personalised treatment for cancer. Guardant’s patent applications span a wide range of technologies, from the initial wet lab techniques used to prepare sequencing libraries, to the bioinformatic analysis of sequencing data. Carpmaels & Ransford has helped Guardant navigate the restrictions surrounding the patentability of computer-implemented and information-based inventions at the EPO, which are increasingly common obstacles in the biotechnology sector.
