Next-Gen Sequencing Update: Sequencing for Thousands, Suing for Millions
It is shaping up to be an eventful fourth quarter for genomic sequencing companies. Investors welcomed sequencing newcomer Pacific Biosciences (PacBio) to the public stage with a strong initial public offering (IPO). According to The Wall Street Journal, the company managed “the first U.S. life-sciences [IPO] this year to price well and trade higher” (although the stock has since traded down somewhat). Up next: another next-gen sequencing IPO with Complete Genomics (CGI) expected to follow PacBio into the public market as early as tomorrow.1
The past few weeks have also seen strong third quarter earnings reports from market leaders Illumina (earnings recap) and Life Technologies (earnings recap), with both companies touting double-digit growth in their next-generation sequencing businesses. Illumina and Life Technologies (Life) are also hard at work on their next generation of products which are intended to compete more directly with the offerings from PacBio and CGI (Oxford Nanopore for Illumina, Ion Torrent and Starlight for Life). Meanwhile, China’s own sequencing entrant, BGI, continues to buy up sequencers (first from Illumina, more recently from Life), and what will soon become the world’s largest provider of genomic sequencing has its own ambitious plans.
Kaiser’s Massive Genetic Database Leverages Its Patient Population (But It’s A One Way Street)
This week MIT’s Technology Review featured a story about Kaiser Permanente and its plans to use its Northern California patients to construct an enormous genetic database. The acronym-unfriendly Research Program on Genes, Environment, & Health, or RPGEH is funded in large part by a $25 million NIH research grant courtesy of February’s stimulus bill. The program will genotype 100,000 patients using SNP array technology from Affymetrix. If all goes well, the project will expand to as many as 500,000 patients by 2013.
What makes the RPGEH proposal so exciting, from a research perspective, is not just the 700,000 SNPs that will be genotyped for 100,000 patients, although that alone would represent one of the largest genetic research databases currently in existence. The real value lies in the marrying of genetic information with robust medical, environmental and other phenotypic data that Kaiser already maintains as a health care provider. From the RPGEH’s official description:
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MIT Sues to Shut Down GeneChip Technology — Again
Last week, MIT and E8 Pharmaceuticals, a spinoff co-founded by professors at MIT and Harvard Medical School, filed a second patent infringement suit against Affymetrix‘s GeneChip genetic testing products and services. Last year, MIT sued Affymetrix itself. This time the defendant is Navigenics, a California-based direct-to-consumer genetic testing company. In February of this year, Navigenics acquired Affymetrix’s California CLIA-approved facility, including its microarray-based testing business. It’s possible that the acquisition was part of steps that Navigenics took to address potential compliance issues raised by the state of California with respect to its direct-to-consumer genetic testing services.
In a remarkably succinct (by the standards of patent lawyers) complaint, MIT claims that the GeneChip testing infringes what it calls a “pioneering” 2004 patent on a method of “accurate, reproducible and cost-effective genetic analysis, using minute amounts of sample DNA and a small number of reactants to generate results that were previously impossible.” MIT claims that the infringement is willful and knowing, as evidenced by references to the patent in the Navigenics-Affymetrix asset purchase agreement. Proof of willful infringement exposes the defendant to triple damages. MIT and E8 ask for unspecified damages, to be tripled, as well as attorneys’ fees and an injunction against further use of the patented technology, if Navigenics refuses to take a license. The complaint also references, as evidence of Navigenics’s willful infringement, “its insistence on certain contractual provisions regarding the ‘228 patent and this litigation,” which suggests that the parties have tried and failed to negotiate an agreement.
