Gene patents: a crowded IP field

Since the end of the first era of genome sequencing with the conclusion of the human genome project, the challenge facing the life sciences industry has been to apply our understanding to practical applications.

Our growing knowledge of the human genome allows us to pinpoint a specific genetic variation in a specific patient, which can predict future disease, or identify sensitivity to certain drugs. We can also optimise genes and proteins for particular applications and swap and engineer protein domains to open up new uses.

While the markets for certain genomic technologies—such as for sequencing technology—are already showing levels of maturity others, such as synthetic biology, are only just starting out. We analysed patent filings over the last decade for sequencing technology, personalised medicine and synthetic biology to examine where innovation is coming from, where it’s going and what this can tell us about each technology’s markets (see Table 1).

Sequencing technology

A significant number of analytical and diagnostic procedures depend on the sequencing of the nucleic acids DNA and RNA. In addition, personalised medicine, forensic science and agriculture all make use of sequencing technology. However, it is the subject of extensive research in itself, as companies seek the so-called “$1,000 genome”.

Analysis of the top filers of patents for sequencing technology shows that private companies have a significant interest in research in this area. It is widely recognised that the two largest players in the sequencing technology field are Illumina and Life Technologies (now Thermo Fisher Scientific). It is unsurprising that they are also the most prolific patent filers in our dataset (see Table 2).

The rest of the list mainly comprises other private companies, with public research institutes and universities barely featuring. Meanwhile, smaller companies emerging with disruptive technologies have begun to appear on the list.

Oxford Nanopore Technologies started protecting its innovations with its first patent filings in 2009/10. Since then, two patent applications were made in 2010/11 and five have been published from 2012. Helicos Biosciences, another disruptive company, is slightly less prolific, having filed patents only in the period between 2007 and 2010.

One of the most significant developments is the emergence of the Chinese company BGI as a major force in the sequencing field. Analysis of patents filed since 2003 shows that in 2007/8 it began to innovate in this area and since then it has amassed at least 20 patent applications covering a range of methods and consumables for use in sequencing.

Personalised medicine

With many drugs that have been approved for patient use effective in treating only small proportions of the population, personalised medicine has developed to help doctors screen patients to ascertain whether they are likely to respond favourably to a particular treatment and then tailor drug therapies to patients.

Personalised medicine is often regarded as the preserve of public research bodies, given that blockbuster drugs—often considered the Holy Grail of the pharmaceutical industry—are a concept contrary to personalised medicine. Few of the largest pharmaceutical companies have publicly declared an interest in the area.

"Analysis of the top filers of patents for sequencing technology shows that private companies have a significant interest in research in this area."

This is borne out by analysing the top patent filers in the personalised medicine field over the last decade (see Table 3). Of the traditional big pharma companies, only Roche appears among the top five applicants. The largest filer by far is the National Institutes of Health (NIH) in the US. While the number of patent families applied for by the NIH has fallen over recent years, others—notably French public organisations Institut National de la Santé et de la Recherche Médicale (INSERM) and Centre National de la Recherche Scientifique (CNRS)—have become more active in the field.

Synthetic biology

Synthetic biology—the engineering of existing biological systems, and the creation of new systems—is showing real potential not only for the life sciences industry, but also for industrial uses such as biofuels and materials. Although still a young field, it is built upon the foundations provided by sequencing technology and by genome engineering tools. Given the early stage of much research, and with commercial opportunities possibly still unclear in many sectors, we can expect a crowded and uncertain IP field.

The list of top applicants reflects this disorientation, particularly at first glance, with the top applicants including the Russian Government, the Russian Department of Science and the Russian Department of Higher Education and Research (see Table 4). Similarly, Chinese universities and research institutions feature heavily in the rankings. Nanjing, Zhejiang, Jiangnan, Tsinghua, Chongqing, and Beijing Science and Technology Universities all make the top 21.

However, digging deeper into the data suggests that these Chinese and Russian entities do not tend to file widely outside their home countries, strongly suggesting that they are filing applications for reasons other than simply protecting technology.

Discounting the Chinese and Russian filings, the picture is more similar to other areas of technology, with the US and Japan being significant sources of innovation. Private organisations file relatively few applications. This could indicate that the technology is still at a relatively early stage, coming primarily from research institutes and universities, which would mirror the trends we saw in the early days of RNA interference technology, when the majority of fundamental patents were from public bodies.

In that case, later developments shifted towards companies such as Alnylam, Sylentis and others. As synthetic biology technology develops and its commercialisation becomes more widespread, we expect to see a shift towards private companies.

Dr Gareth Williams is a European patent attorney and partner at Marks & Clerk LLP. He can be contacted at: gwilliams@marks-clerk.com