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Looking Back at Myriad: A User’s Guide
The Genomics Law Report has provided ample coverage throughout the litigation over Myriad Genetics’ BRCA1/2 patents. The saga had a rather lengthy procedural history, so a timeline of key landmarks with hyperlinks to GLR coverage as appropriate (in the “where” column) may be useful.
| When | Where | Action | Citation |
| 1997 | USPTO | US Patent 5693473 issued to Myriad Genetics Inc. | |
| March 2010 | SDNY | US Patent 5693473 invalidated | AMP v. USPTO, 702 F.Supp.2d 181 |
| July 2011 | Fed Cir NY | SDNY decision affirmed in part, reversed in part | AMP v. USPTO, 653 F.3d 1329. |
| March 2010 | SCOTUS | Certiorari granted, Fed Cir NY judgment vacated, case remanded to Fed Cir NY | AMP v. Myriad, 132 S.Ct. 1794 |
| August 2012 | FedCir NY | Subsequent determination made (in light of Mayo v. Prometheus) | AMP v. USPTO, 689 F.3d 1303 |
| November 2012 | SCOTUS | Certiorari granted | AMP v. Myriad, 133 S.Ct. 694 |
| April 2013 | SCOTUS | Heard oral arguments | |
| June 2013 | SCOTUS | Fed Cir decision affirmed in part, reversed in part | AMP v. Myriad, 569 US – |
Twitter Roundup
With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:
- Clearly a long ways to go. RT @phylogenomics: YHGTBFKM: Science mag article on open data is not freely/openly available http://ff.im/-xKTil
- RT @genomesunzipped: A guest post on GNZ by @razibkhan about his own voyage of genomic self-discovery http://bit.ly/ghmIzQ
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Twitter Roundup
With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:
- RT @eurogene: Our paper: EU regs on personal genetic testing is now online at Eur J Hum Gen: http://bit.ly/fKliuQ
- RT @genomesunzipped: Good response to the Reader Survey so far, but we still need more data! MORE RESPONSES PLEASE: http://bit.ly/g8mqV1
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Twitter Roundup
With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:
- NinePoint Medical raises $33M for optical inspection of cancer cells during biopsies: http://bit.ly/d8EUHs by @Ryan_McBride
- Interview w/ Salzberg in @NatureNews re: open source BRCA screen: http://bit.ly/9RBQ0w A “poke in the eye” of Myriad, gene patents
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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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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.
