The US Patent and Trademark Office, the University of Utah and Myriad Genetics have all filed motions seeking to dismiss the ACLU’s high-profile lawsuit attacking the patentability of genes (pdfs: USPTO Memorandum; Myriad/Utah Memorandum). In alleging that the plaintiffs lack standing to bring the lawsuit — a common procedural tactic in litigation — Myriad does not mince words, opening its argument as follows:
This case is a thinly veiled attempt to challenge the validity of patents where, other than an overall policy disagreement concerning the legitimacy of gene patents, the plaintiffs have no actual dispute with the Defendants over patent infringement. If the plaintiffs in this case have standing, then virtually anyone can challenge any patent at any time.
The ACLU has yet to publicly comment on the motions to dismiss. The court is scheduled to hear the Motion to Dismiss (pdf) on August 26th.
When the Personal Genome Project (PGP) announced earlier this summer that it was opening its doors to the next 100 participants the response was overwhelming. To date, nearly 15,000 individuals have registered with the PGP and more than 1,500 have completed the preliminary eligibility screening process.
This afternoon I spoke with Jason Bobe, the PGP’s Director of Community, who confirmed that more than 1,000 individuals have passed the PGP’s preliminary eligibility screening phase, which included receiving a perfect score on the PGP’s genetics and informed consent entrance exam. Over the next several weeks these individuals will be invited to proceed to the next stage of enrollment, which includes the submission of baseline trait data and identity verification, and some will ultimately be selected later this summer to participate in the Personal Genome Project as part of the PGP-100.
The New York Times published a follow up piece to its story on Major League Baseball using genetic testing to confirm the reported ages of some young baseball aspirants. Last week’s GLR post examined MLB’s genetic testing program in the context of the Genetic Information Nondiscrimination Act (GINA) and has prompted further internal discussion here at GLR, with our own John Conley asking a few questions:
I guess MLB would say they’re not using genetic information to discriminate in the usual sense of screening out high-risk people, but just to verify that the prospect isn’t defrauding them about an essential datum — after some notorious cases of lying and producing false documents in both directions. And in the Bulls’ defense, they said they were spooked by numerous cases of basketball players dropping dead as a result of undiagnosed heart defects that seem to afflict the very tall. I guess they were also mindful of Reggie Lewis of the Celtics, who passed out, WAS diagnosed, shopped for a favorable opinion, then died playing. Does GINA allow any sort of defensive testing like this by employees whose work creates risk to particular categories of people? Or must the employer let the employees kill themselves if they wish?
There is clearly a good practical reason for the testing in both cases that John identifies, but neither testing to confirm identity (or otherwise prevent fraud, as in the case of MLB) or to prevent even potentially fatal medical conditions (as in the case of Eddy Curry) is explicitly permitted under GINA. In the case of MLB, the result will depend, in part, on how the EEOC interprets the following pair of GINA’s definitions (from Section 201 of GINA). Again, the interpretive issue is whether “genetic information”, which may not be used for making employment decisions, covers the kind of testing in the MLB matter.
In my previous post summarizing last weekend’s conference on Genetics and Ethics in the 21st Century I briefly mentioned Professor John Robertson’s discussion of the “genome in silico.” Using Illumina’s recently announced $48,000 whole-genome sequencing service as an example, Robertson wondered whether the future of whole-genome sequencing lies in converting the genome to silicon storage (in silico) or whether on-demand sequencing of short genetic segments (or even whole genomes) will continue to be done as and when patients present with specific clinical conditions (in vivo). To put it another way, will the patient of the future present his doctor with the equivalent of Illumina’s concept iPhone app or Knome’s USB drive, or will she come prepared to undergo a more traditional blood draw or tissue biopsy.
Following Illumina’s announcement at the Consumer Genetics Show, Daniel MacArthur at Genetic Future speculated that Illumina, in focusing “on the sequence generation side…[was] restricting itself to the least attractive segment of the personal genomics market.” And I agreed, arguing that the bioinformatics portion of the genome sequencing market — interpreting and functionalizing raw sequence data — appeared to be both larger and less well-developed, thus presenting a more promising commercial opportunity.
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Over the weekend I took part in the 13th Conference on Genetics & Ethics in the 21st Century in Breckenridge, CO. The theme was “Genomics and Personalized Medicine, Facts, Fiction, Future?” Although the altitude (Breckenridge is at 9,600 ft) posed a problem for several participants, the conference otherwise went off without a hitch.
The program kicked off with a focus on the state of genetic and genomic knowledge with an excellent talk by Richard Gibbs of Baylor’s Human Genome Sequencing Center, who provided a progress report on the 1000 Genomes project and predictions for the future of large-scale genomics research. Penn State’s Kenneth Weiss followed with “Genetic Causation: A Fermi Problem” and presented a compelling challenge to the received wisdom of genetic heritability. Some of the most interesting discussion was driven by a question posed to Richard Gibbs: whether there are instances where the ethical, legal and social discourse surrounding genetics and genomics has either failed to keep pace with, or outstripped, the progress of science. Beyond a general consensus that Gattaca-style genetic prediction lies far beyond the horizon (if it will ever be possible), Gibbs seemed to think that on the whole the ELSI discussion was often out in front of the science, but not by an inappropriate distance. This topic provided fodder for considerable debate throughout the remainder of the conference.
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This week, the National Human Genome Research Institute (NHGRI) committed an additional $9.5 million to fund advancements in genome-sequencing in pursuit of its goal to “reduce the cost of sequencing a mammalian-sized genome to approximately $1,000.” Through its “Revolutionary Genome Sequencing Technologies—The $1,000 Genome” program, the NHGRI continues to drive a remarkable decline in the cost of genomic sequencing (pdf) that leading experts, including former NHGRI Director Francis Collins, predict will soon produce a $1,000 human genome.
Earlier this week, the GLR noted that the United States Patent and Trademark Office has seen fewer applications for genomics-related trademarks, which could be an indicator of a declining rate of innovation in that area. Whether or not that is actually the case, the NHGRI continues to do its part to keep the ideas – and the funds – flowing.
Genetic testing provider Navigenics has announced a partnership with the Medcan Clinic, a preventive healthcare clinic located in Toronto, Canada. According to the press release, Medcan will use a version of the Navigenics genotyping service, in combination with family history information, to offer patients an analysis of those “genetic risks that are clinically actionable, allowing patients to lower their risk through prevention strategies and more personalized screening.” The focus on clinically or medically actionable strategies is consistent with the approach taken by the Coriell Personalized Medicine Collaborative (CPMC), which is studying the effect of providing information on “medically actionable” genetic risk factors to its participants. (Interestingly, one of the conditions highlighted by the MedCan-Navigenics release is Alzheimer’s disease, which is not a medically actionable condition in the eyes of the CPMC.)
According to an article in today’s New York Times, Major League Baseball’s department of investigations is conducting genetic testing on certain Latin American prospects in an attempt to verify their reported ages. The Times reports that MLB has confirmed that it conducts genetic testing to confirm paternity/maternity “in very rare instances and only on a consensual basis to deal with the identity fraud problem that the league faces in [the Dominican Republic].” It appears that MLB is using paternity/maternity testing to verify identity by confirming that a particular prospect is in fact the child of the parents claimed on his birth certificate. MLB’s program appears to be the first publicly disclosed genetic testing program since the passage of the Genetic Information Nondiscrimination Act, or GINA as it is known, fourteen months ago.
This is not the first time that genetic testing in professional sports has made its way into the headlines. In 2005, the Chicago Bulls demanded that center Eddy Curry submit to a genetic test for Hypertrophic Cardiomyopathy (HCM). Despite playing in 72 games the prior season, Curry was diagnosed with an irregular heartbeat and an enlarged heart and the team insisted on the HCM test as a condition to extending his contract. Curry refused to take the genetic test and was ultimately traded to the New York Knicks, temporarily defusing the situation.
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Applications to register genomic-related trademarks are down by one third on an annualized basis compared to 2008. The Genomics Law Report has found that since 2004, filings of application with the US PTO to register trademarks for goods and services related to genomics grew at an irregular but generally upwards rate, with 2007 showing the largest year-on-year increase and 2008 showing a slower but still rising number of filings. In the first half of 2009, the bottom fell out.
Academic researchers have begun to identify trademark filings as an important, if overlooked, indicator of innovation and industrial change (pdf). More casual observers have noted a correlation between overall economic activity and the number of trademark filings, with a decline in the overall number of filings at the US PTO seeming to lag somewhat behind the decline in the nation’s economic output. Given the recent economic downturn, it is therefore not surprising that overall filings of trademark applications at the US PTO are down as well in 2009. However, the seemingly steeper decline in the number of genomic-related filings in 2009 may indicate that, despite headline grabbing innovations and company launches such as last week’s launch of Pathway Genomics, overall commercial activity in genomics may be struggling, at least in the US.
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Pathway Genomics became the latest entrant in the consumer genomics space when it publicly launched its new direct-to-consumer (DTC) genotyping service this morning. Pathway provides genotyping (or SNP testing) for a variety of genetic traits and markers including ancestral testing for $199, health and disease testing for $249 and both the health and ancestry service for $349, which is a $50 price drop over the current market leader, 23andMe. Blaine Bettinger (of the Genetic Genealogist and a consultant for Pathway) previewed the service back in March and today’s Bio-IT World also has a detailed summary.
What’s new about Pathway Genomics? From a narrow perspective, perhaps not much. On its surface, the Pathway offering is comparable to products already on the market from 23andMe, deCODEme and Navigenics. Although it’s too early to evaluate Pathway’s promises of “better science, deeper results, and a better price,” the genotyping service appears competitive with existing industry offerings, with the ancestry testing component positioned to be an industry leader. However, unlike the last major DTC genomics announcement, there does not appear to be anything fundamentally new about Pathway’s technology or market-shattering about its price point.
Even though Pathway does not appear to offer a breakthrough technology or business model, its launch is still a significant event. It represents yet another bet by investors on the commercial potential of consumer genomics and ratchets up the competition for DTC market share. Moreover, Pathway’s service is indicative of how the consumer genomics industry continues to shift.