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Global IP Report Finds Public Entities, US Driving Genomics Innovation

NEW YORK (GenomeWeb) – Public research entities have been driving innovation in genomics research, especially in the newer fields of personalized medicine and synthetic biology, while private industry has taken the lead in the more mature next-generation sequencing space, according to a report released by IP firm Marks & Clerk today.

The report called Life Sciences Report 2014: Genome 2.0 was released at the BIO International Convention in San Diego and details intellectual property trends in the genomics space during the past decade. It also found that along with the leadership role of public entities, institutions such as the National Institutes of Health and the University of California system have put the US atop the genomics-related patent filings heap, trailed by Europe and Asia, despite more than €1 billion ($1.4 billion) in public funding from the European Union for research into personalized medicine between 2007 and 2012, according to the report.

In a statement, Gareth Williams, a partner in the firm, said that the disparity between the US and Europe "reflects badly on Europe, with European universities and research bodies surprisingly under-represented among the large filers of patent applications." While a handful of public European entities and private firms have taken a lead in commercializing genomics technology, "Europe needs more focused commercialization of local research to become a challenger on the international stage in this vital area of medical research," he added.

The report examines patent filings worldwide in NGS, personalized medicine, and synthetic biology, and Williams said that trends within each field reveals where each technology is in the development stage.

"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," he said. "Meanwhile, the high number of filings by public bodies in personalized medicine and particularly in synthetic biology depicts two emerging technologies, with private companies on the whole showing less confidence."

Between 2003 and 2011, the number of NGS-related patent applications grew from 62 to 142; the number of personalized medicine applications rose from 234 to 619; and the number of synthetic biology applications increased from 243 to 282.

Figures for 2012 and 2013 are incomplete because of delays in publication after a patent application is filed. Preliminarily, there were 117 NGS applications in 2012 and 78 in 2013. There were 555 personalized medicine applications in 2012 and 254 applications in 2013. In 2012, 273 synthetic biology applications were filed, and in 2013 there were 160.

Illumina and Thermo Fisher Scientific's Life Technologies paced patent filings in the NGS space, accounting together for about 15 percent of the 989 patent applications in the space between 2003 and 2013. Pacific Biosciences and Roche followed, while the NIH rounded out the top five.

The report also noted the rise of smaller firms such as Oxford Nanopore, the emergence of BGI, and the presence of Intel, which, despite not being thought of as an NGS player, has filed 20 patents in the past decade directed at a number of sequencing methods and consumables with particular emphasis on techniques using enhanced Raman spectroscopy. It also lists Abbott as among the top 10 filers for sequencing patents with 17 filed between 2003 and 2013.

In the personalized medicine arena, the number of patent filings from public entities remained steady during the past decade while the number of applications from leading private industry players dropped. In particular, between 2006 and 2011, the number of applications from private firms among the top 22 filers in the space shrank 43 percent, Marks & Clerk said.

The NIH led the way with 304 patent filings between 2003 and 2013, followed by Roche (127), the University of California system (85), Johns Hopkins University (81), and the French institution INSERM (80).

Many of the personalized medicine patent applications during the past decade related to cancer, though the report's authors said that moving ahead filings in other disease areas, including respiratory and circulatory disease, neurology, and infectious diseases, are anticipated to rise.

The report also criticized the US Supreme Court decision a year ago that invalidated certain patent claims of Myriad Genetics around BRCA1/2 gene testing, and it took aim at the court's decision in Mayo Collaborative Services v. Prometheus Laboratories that invalidated certain patents held by Prometheus.

"Most crucially, the guidelines extend the Court's ruling in [the Myriad case] to all natural products," the report said. "As such, medicinal formulations containing naturally occurring agents, such as antibiotics, antibodies, or peptides, all of which have traditionally been patentable, may become more difficult to protect [and] … the increased burden in obtaining and defending patent rights may have a negative impact on patent filings in the US, particularly from public entities."

Meanwhile, initiatives in other geographies, such as funding from the EU, as well as research projects and funding in South Korea and Japan "may narrow the filing gap between [the] US and these key jurisdictions over the coming years," the report said.

Lastly, the report found that in synthetic biology, the Russian government and Russia's department of science were especially busy patent filers during the past decade with a total of 77 applications. The NIH had 33 applications, and several Chinese universities and entities are among the top 20 patent filers in the space.

Mark & Clerk noted, though, that the Russian and Chinese entities "do not tend to file widely outside their home country. This strongly suggests reasons for filing other than simply protecting the technology."

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