Posted on 30 January 2019

With a growing economy, and a large, ageing population, China is attracting attention from global pharmaceutical and biotechnology companies. China’s home grown therapeutics companies are thriving, benefiting from a large pool of talented researchers, substantial research and development infrastructure, and the potential rewards offered by the world’s second largest pharmaceutical market.

Precision medicine in particular is attracting massive interest, with the government capitalising on its expertise in biotechnology, combined strong track record in computing hardware and the ability to put in place the infrastructure necessary to support large bioinformatics projects. The large population of China is an advantage here, enabling the collection and analysis of a large volume of patient data, creating a powerful database of genetic information. 

The patent system

China’s patent system, however, prohibits the grant of patents to “methods of diagnosis”, and this is interpreted very strictly. Whilst some jurisdictions have restrictions around the grant of patents to methods of diagnosis, there are often specific exclusions. Europe, for example, prevents the grant of patents to diagnostic methods practiced on the human body, but will allow claims to methods practiced on samples previously obtained from those patients, and thus diagnosis by genomic or proteomic analysis are rarely problematic. Similarly, the USA will not grant patents that broadly claim the diagnostic correlation between biomarker and disease (rejecting these as an attempt to monopolise a law of nature), but uses of that correlation, such as in methods of treatment using particular agents can be obtained.  

China, on the other hand, has a very restrictive patent system in this area. This may be at odds with the Chinese government’s investment in the space, as the ability to obtain patents is often cited as incentive for companies to innovate.

Will this result in China missing out on significant precision medicine innovations?

Companies could be unwilling to launch new diagnostic tests on the Chinese market, if they are unable to obtain IP rights to enforce against copycats. However, the scale of the Chinese market may mean that it is just too attractive to pass up, despite the absence of patent protection. As such companies may be required to be smart in how they approach the Chinese market. Innovators may need to be creative in their use of IP to try to protect their innovations as best they can. Companies will be keen to establish strong brand identity around new diagnostic tests launched into the Chinese market, filing appropriate trademarks to protect that brand, rather than the innovation behind test itself. As such, there may be significant first-to-market advantages, where such tests can become established as the standard of care.

Innovators may also seek to develop tests that are bespoke for the Chinese market, to try to develop a product that contains elements such as novel antibodies or testing reagents that are themselves eligible for patent protection. This may mean that the test launched in China includes elements that are new, inventive, and protectable by patents, but which may not actually be the best agent for the job, if commercial considerations are prioritised over patient care.

It will be interesting to see whether the ability to obtain patents in this area develops, as more and more Chinese companies develop technologies in this space. Given the scale of the Chinese market, overseas companies will still be keen to invest. However, innovators should think about their likely patent position in China at an early stage in the development process.

Read the other blogs in the series:
Precision medicine: the next revolution in healthcare
Ethics, regulation and patent law
China - a key player in the global precision medicine race

Patient stratification

Mewburn Ellis are experts in obtaining patent protection in the field of precision medicine, with a diverse line-up of experienced IP professionals forming a dedicated precision medicine team.

Speak to a member of the teamThis blog was written by Frances Salisbury and Tanis Keirstead, both members of our dedicated precision medicine team. 

More about Tanis Keirstead
Tanis has over 10 years’ experience drafting and prosecuting patent applications in the pharmaceutical, biotechnology and food & beverage sectors. Tanis works with a wide range of clients on invention capture and filing strategy, as well as global portfolio management. Her clients include SMEs, Universities (in the UK and elsewhere), domestic and overseas multi-national companies, as well as start-ups. Tanis visits Japan several times a year and handles large European portfolios for a number of Japanese companies. Tanis has a degree in Microbiology and Virology from the University of Warwick and a PhD in Molecular Biology from the Sir William Dunn School of Pathology, University of Oxford. Tanis is a member of the Patentanwaltskammer and authorised to provide patent services from Germany.

Frances Salisbury

Contact Frances Salisbury

Fran is a member of our life sciences patent team with expertise in the biotechnology, bioinformatics, pharmaceutical and agricultural science sectors. Fran prepares and prosecutes applications relating to a range of precision medicine inventions. She handles a number of applications relating to biomarkers and diagnostics, including methods for the identification of biomarkers and biomarker panels, and their use in diagnosing and prognosing disease. Fran enjoys the particular challenges that prosecution of these cases around the world brings, arising from the divergent approaches taken by the different patent offices. Her clients include universities and research organisations, start-ups, spin outs and multi-national companies. She has a degree in Biological Sciences from the University of Bristol and a PhD in molecular plant genetics is from the University of Edinburgh.

Related Posts