Public research organisations are driving advances in research into genome-related technologies and their use in medicine and industry, with the private sector lagging behind, according to research by leading international intellectual property firm Marks & Clerk, released as part of its Life Sciences Report 2014: Genome 2.0, today at the BIO International Convention 2014 in San Diego. The research further highlights the global disparity, with the advantage almost entirely enjoyed by the US, whilst Europe and Asia trail behind, despite over €1 billion of public funding coming from the EU for research into personalised medicine between 2007 and 2012.

The report looks at intellectual property trends in the genome market over the past decade since the completion of the human genome in 2003. The research has revealed that areas of personalised medicine and synthetic biology are showing commercial promise, though public organisations outnumbered private organisations among the top filers of patent applications related to these fields. Meanwhile, in the more mature sequencing technology market, established private organisations outpace public entities, with past disruptive technologies such as next generation sequencing having become standard practice and new disruptive technologies emerging that can further challenge the status quo.

Innovation in Europe is driven by relatively few organisations, including Swiss-based Roche and French public research bodies CNRS (Centre National de la Recherche Scientifique) and INSERM (Institut National de la Santé et de la Recherche Médicale).

Patent applications have shown increases in sequencing technology and personalised medicine since 2003, despite a dip in 2010 attributed to the delayed effects of the financial crisis. Application levels in synthetic biology are only now returning to the high levels seen in 2004 after a period of fluctuation, as a host of new technologies come to the fore.

Table 1: Patent filings in personalised medicine, sequencing technology and synthetic biology

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* One entry per patent family
** Data for 2012 and 2013 incomplete due to 18 month delay in publication after filing.

Dr Gareth Williams, European Patent Attorney, life sciences specialist and Partner at Marks & Clerk, comments:* One entry per patent family ** Data for 2012 and 2013 incomplete due to 18 month delay in publication after filing.

“10 years on from the mapping of the human genome, the markedly strong performance of US public bodies reflects badly on Europe, with European universities and research bodies surprisingly under-represented among the large filers of patent applications. Although we are seeing increasingly strong performances from European organisations like CNRS and INSERM in France and some European private companies, Europe needs more focused commercialisation of local research to become a challenger on the international stage in this vital area of medical research. Hopefully, the €1 billion that has already been invested by the EU in personalised medicine will lead to increases in filings from European organisations in the coming years. Likewise, the strong UK push behind synthetic biology can only be good news for UK organisations in this field.

“Patent application figures in sequencing, personalised medicine and synthetic biology tell us a great deal about the stage of development each technology has reached. The prevalence of private companies filing patents for sequencing technology shows a maturity in the market as key players enjoy dominant positions they have carved out for themselves. Meanwhile, the high number of filings by public bodies in personalised medicine and particularly in synthetic biology depicts two emerging technologies, with private companies on the whole showing less confidence."

Public institutions pull ahead in personalised medicine

Public organisations show particular strength in personalised medicine, with annual application numbers from private businesses among the top 22 filers dropping 43% between 2006 and 2011. Filing figures for public organisations remained steady. US public organisations represent almost half of the top filers. CNRS and INSERM, relatively new players in the field and the only European public organisations represented, have both significantly increased filings since 2007.

Of the world’s largest pharmaceutical companies working in this area, only Roche appears among the top five applicants. However, Novartis, Bayer, Amgen, Merck and GSK also feature in the top 22.

Between 2003 and 2011 over half of each of the top five applicants’ patent families related to cancer.

Table 2: Top filers in personalised medicine between 2003 and 2013

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Two players dominate in sequencing technology, but disruptive technologies appearing

California-based Illumina and Life Technologies led research into sequencing technology, together having filed 15% of the 989 patent applications since 2003. Of the top 18 filers, 13 are US organisations and 12 are private organisations.

Newer disruptive entrants, such as UK-based Oxford Nanopore Technologies and Chinese BGI Shenzen, also feature among top filers thanks to significant numbers of filings since 2006. Large pharmaceutical companies do not feature heavily on the list of top filers, with only Roche (in 4th place) and Abbott (in 9th) among the top filers.

Table 3: Top filers in sequencing technology between 2003 and 2013

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Changing synthetic biology landscape as research into emerging technology develops

US and Japanese public organisations outpace other organisations in synthetic biology research. While filing levels among Russian governmental organisations and Chinese universities are high, the narrow filing strategies adopted (i.e. not filing applications outside Russia or China respectively) indicate secondary motivations for their patent applications. The only European organisation among the top filers is CNRS (12th place).

Private organisations have filed relatively few applications, representing only three of the top 21 filers and only two patents have been filed by pharmaceutical companies Bristol-Myers Squibb and Merck since 2007. Interest in industrial synthetic biology is growing with US glass and ceramics manufacturer Corning filing its first patent applications in this field in 2010.

Table 4: Top filers in synthetic biology between 2003 and 2013

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Dr Gareth Williams continues:

“As the medical applications of genome research become clearer and we enter an age of personalised medicine, it will become increasingly important to protect intellectual property. Big pharma companies on the whole have not shown the same enthusiasm as public bodies for personalised medicine and have therefore filed relatively few patents in the area. We may well see an increase in filings coming from these companies, but they will have to catch up and may have to rely on licensing models for many years before entering the market on their own terms. There are also many smaller businesses developing personalised medicine, which need to get filing if they are going to secure market share.Dr Gareth Williams continues:

“Following the 2013 Myriad decision, the US Patent Office has issued new guidelines relating to the patentability of naturally occurring products. Unless revised, these could have a disastrous effect on patent applications in the personalised medicine area, leaving companies unable to commercialise their research.

“The sequencing technology market appears to have matured following a spate of M&A and companies with disruptive technologies are appearing among the top filers. We are also seeing interest from emerging markets like China – where life sciences companies have, for many years, lagged behind their electronics counterparts in terms of patent filings around the world. The importance of BGI Shenzhen’s appearance in the list of top filers should not be underestimated.

“Synthetic biology is the least mature of the technologies we have analysed, with patent filing figures easily skewed by local considerations. Private companies are clearly yet to make up their minds on the benefits of research into this area with vacillating interest from both pharmaceutical and industrial companies in the area."