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GINA Is Only Part of the Employment Law Puzzle
Recently the Genomics Law Report discussed a legal action brought by an employee alleging she was dismissed from her job when her employer learned of her genetic test results. The claim is that the employer’s action was in violation of the Genetic Information Nondiscrimination Act (GINA), and is the first publicly reported action of its kind. As GINA, which was enacted in 2008 and is still being implemented by regulatory agencies, becomes an established part of the legal landscape, more claims are bound to follow. The following article discusses a hypothetical set of facts that raise questions for an employer under GINA as well as other employment laws.
Another Monday morning, another administrative headache. Your marketing VP has taken fifteen minutes complaining – again – about Julie. In short, her performance has been in the tank for weeks. She’s missed numerous internal meetings and deadlines, and customer feedback has gone from highly favorable to “please send someone else next time, if there is a next time.”
Weekly Twitter Roundup
Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:
- Well-designed genomics career resource from NHGRI: http://bit.ly/buhcbs Something for everybody on there. HT @GenomeWeb_News
- NIH Foundation, Biomarkers Consortium Team on Breast Cancer Trials: http://bit.ly/co1ZPq v @GenomeWeb_News
- Top Genomics Journalists: http://bit.ly/9LWjmR v @AccessDNA | Agree w/ entire list: @markgfh @tgoetz @emilysinger @matthewherper @Duncande
- RT @PGorg: PGP-100 enrollment starting now! And other news items: http://www.personalgenomes.org/newsletter/03.html
- Genomics Law Report: Evaluating the NIH’s New Genetic Testing Registry: http://bit.ly/a4NmCt
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Another Pathway Opens Up for DTC Consumers
In July, Pathway Genomics announced that it would become the latest entrant in the direct-to-consumer (DTC) consumer genomics space. Only now, however, has Pathway begun to return results to its customers, and Kevin Davies of Bio-IT World has a first look at the results.
Of note is Pathway’s decision not to report relative or lifetime risk as numeric values―a decision prompted, perhaps, by the recent commentary of Venter et al. in the journal Nature, which highlighted substantial differences between disease risk predictions offered by 23andMe and Navigenics. Also a bit of a surprise is the disclosure that, at least for the moment, Pathway’s customers will not be receiving access to their raw genetic information (although the company assures Davies that it is coming).
There have certainly been some changes in the DTC marketplace since Pathway announced it was joining the fray five months ago. One of Pathway’s direct competitors, deCODE genetics, filed for bankruptcy and another, 23andMe, announced several changes to the structure, pricing and features of its own DTC service. As the field of consumer genomics enters its third year, there are no obvious signs that the pace of scientific and commercial change is likely to be any slower in the coming five months than over the previous five.
deCODE Declares. Now What?
If you’re a regular reader of the Genomics Law Report – or the Wall Street Journal for that matter – by now you have probably heard the news: deCODE genetics, Inc. has filed for Chapter 11 Bankruptcy protection.
Given deCODE’s recent financial struggles, this latest development is hardly a surprise. Indeed, two months ago, we anticipated this very event when we asked a hypothetical question: “What Happens if a DTC Genomics Company Goes Belly Up?” That’s precisely the question that deCODE’s customers and creditors are asking today.
In our original article, which was initially published in three parts on September 14, 15 and 16 at Genetic Future, we looked at the interplay between the privacy policies of DTC genomics companies and the relevant bankruptcy law statutes, and offered some educated guesses as to how courts and companies would handle the sale of a bankrupt company’s sale of its customers’ genetic information.
The coming weeks will see that analysis tested in Delaware bankruptcy court. In the meantime, there is a lot to unpack in this morning’s deCODE announcement.
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The Open Secret of DTC Medical Genetic Testing
This is the third of four related posts analyzing 23andMe’s decision to separate its health and ancestry DTC genetic testing services. For more please see 23andMe’s New Game Plan: What it Means for the Company and for DTC Genetic Testing, A Fundamental Right to Genetic Information (Now More Expensive Than Before) and DTC Genomic Research: Revolution or Minor Uprising?
For well over a year, the DTC genetic testing industry in general, and 23andMe in particular, has been undergoing a shift in the way it characterizes and promotes its offerings. Where they once focused on the educational and recreational features of their services, DTC companies have rolled out an increasing array of tests and reports that appear unambiguously aimed at influencing their customers’ clinical or medical decision-making.
DTC Genomic Research: Revolution or Minor Uprising?
This is the fourth of four related posts analyzing 23andMe’s decision to separate its health and ancestry DTC genetic testing services. For more please see 23andMe’s New Game Plan: What it Means for the Company and for DTC Genetic Testing, A Fundamental Right to Genetic Information (Now More Expensive Than Before) and The Open Secret of DTC Medical Genetic Testing.
In sifting through all of the discussion surrounding 23andMe’s newly separated health and genealogy services I noticed one other interesting piece of information by omission: the $99 Research Edition appears to have recently disappeared from 23andMe’s product line.
In July, 23andMe announced a “new research model [that] makes it possible for large groups of people to assemble themselves into large-scale genetic studies without having to raise millions of dollars in funding, and then wait years for things to get rolling.” Termed the Research Revolution, the model was simple:
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Prometheus and Medical Methods Patents
On September 16 the Federal Circuit decided a patent case called Prometheus Laboratories Inc. v. Mayo Collaborative Services (pdf). Prometheus sued Mayo for infringing two patents on a method of optimizing drug therapy for autoimmune diseases. The question in the case was whether the method met the patentable subject matter standard of section 101 of the Patent Act, as interpreted in the Federal Circuit’s 2008 In re Bilski decision (pdf) (which is now before the Supreme Court). The patentable subject matter standard is an initial threshold that must be crossed on the way to patentability. To satisfy the standard, the claimed invention must be within the broad categories of things (machines, manufactures, compositions of matter, or processes/methods) that the Patent Act permits to be patented. If not, the inquiry ends; if so, the invention must still be shown to be novel, useful, and nonobvious. This is the standard that the ACLU has focused on in its motion for summary judgment in the Myriad Genetics case, which we have been following closely.
What Happens if a DTC Genomics Company Goes Belly Up?
The following post was originally published in three parts on September 14, 15 and 16 in Genetic Future.
Direct-to-consumer (DTC) genomics companies are not immune to the current recession. When TruGenetics, a new player in the DTC genomics space, announced in June that it would be handing out 10,000 free genome scans, both Genetic Future and the Genomics Law Report raised questions about the financial viability of its business model, particularly in the current economic climate. Sure enough, on August 21, TruGenetics announced that it had been unable to secure funding sufficient to support its business model as contemplated. Frequent readers know that TruGenetics is not the only DTC genomics company that is struggling. The financial struggles of deCODE Genetics have been well chronicled (see here, here and here) and even new market leader 23andMe has undergone a dramatic shift in its top management as it pursues a new round of financing.
Ultimately, it was a recent headline here at Genetic Future—“deCODE Genetics on the brink of insolvency”—that started us thinking: what would happen if an established DTC genomics company actually went bankrupt? More specifically, what would happen to the genomic (and other) data held by the company? Genomic data is likely to be the company’s most valuable asset. Can that data be sold off to help meet the company’s debts? Bankruptcy can be a confusing and arcane process, with real risks and uncertainties for companies, their creditors and their customers.
Duke Finds a Second Alzheimer’s Gene—What Does It Mean?
The recent discovery of a gene linked to Alzheimer’s disease provides a timely context for revisiting the significance of gene patents. Researchers at Duke University Medical Center recently announced that they have identified a second gene (called TOMM40) associated with an increased risk of late-onset Alzheimer’s, which affects people over the age of 65. A team of Duke gene hunters originally identified the first Alzheimer’s gene (APOE) in 1993. Although the announcement prompted warnings about the need for further confirmation, the Duke researchers hope that the analysis of which versions, or alleles, of the two genes that people carry will significantly sharpen geneticists’ ability to predict susceptibility to Alzheimer’s. Those predictions might prove especially useful in both diagnosing Alzheimer’s disease and in developing future Alzheimer’s drugs.
One of the first questions on everyone’s mind, particularly in light of the high-profile lawsuit by the ACLU and others against Myriad Genetics, is whether this newly discovered Alzheimer’s gene could be patented. In principle, yes. Going back at least to the early 1980s, the U.S. Patent and Trademark Office (US PTO) and the federal courts have repeatedly taken the position that genes in isolation from their natural environment (that is, outside the body) are patentable subject matter, just like any other chemical compound. Individual cases have turned on such specifics as whether others had previously identified the gene, or whether and when the patent applicant or others had first disclosed the gene. But there is no general prohibition against patenting genes.
