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« The Tyranny of the Judiciary | Main | WIPO Releases Data on 2014 International Patent Filings »

March 24, 2015

Comments

Haven't finished reading this yet, but this has got to be a typo: "In addition, women who suffer from breast or ovarian cancer are a small subset of the totality of breast or ovarian cancer sufferers, with frequencies in line with other diseases having a heritable genetic propensity."

No, Dan, actually the vast majority of ductal adenocarcinomas of the breast have nothing to do with BRCA. It is only the small number of women who inherit the mutant gene who have this propensity - but it is rather dramatic, seeing as it increases the frequency of breast cancer from ~9% in the population at large to ~90% in those women.

From the NCI (http://www.cancer.gov/cancertopics/genetics/brca-fact-sheet):

Specific inherited mutations in BRCA1 and BRCA2 increase the risk of female breast and ovarian cancers, and they have been associated with increased risks of several additional types of cancer. Together, BRCA1 and BRCA2 mutations account for about 20 to 25 percent of hereditary breast cancers (1) and about 5 to 10 percent of all breast cancers (2). In addition, mutations in BRCA1 and BRCA2 account for around 15 percent of ovarian cancers overall (3). Breast cancers associated with BRCA1 and BRCA2 mutations tend to develop at younger ages than sporadic breast cancers.

My "back of the envelope" math says the frequency is about 90/10,000 breast cancer sufferers, which would be much lower if calculated with regard to all women.

But if you have better statistics (or are better at math) let me know.

Thanks for the comment

Kevin, it appears you meant to write "In addition, women who *have the BRCA gene who* suffer from breast or ovarian cancer are a small subset of the totality of breast or ovarian cancer sufferers, with frequencies in line with other diseases having a heritable genetic propensity." That would make sense. But it's not what you wrote.

that's an interesting thought experiment, Kevin, but it goes all circular in the end. Myriad had patent protection and built up their var database and... has kept it secret. Having a patent or not having a patent seems to have no correlation with building up trade secrets as a competitive advantage.

would be more instructive to compare with the realworld scenario of CFTR... i don't know the answer to this, but what is the state of public knowledge about vars there?

Dear Jytdog:

I agree that both models can produce the same outcome, but the difference is that in the Myriad model the patent needs to enable/describe sufficient number of mutations to support the claims. BRCA may be an anomaly insofar as there are so many VUS in these genes that (it turns out) actually have some significance. Not necessarily the case - for example, there could be a great deal of nucleotide variability in other genes that don't translate to changes in the encoded protein's amino acid sequence.

CFTR is the other end of the spectrum, as I understand it - most cases of cystic fibrosis are linked to a deletion of a specific phenylalanine (Phe) residue at a particular position. And sickle cell anemia is associated with a mutation that changes an amino acid (from Glu ->Val I think) at a specific position in the beta-globin chain.

The point is that the way the world may work after Myriad is to encourage nondisclosure, and if that is the case Progress will not be Promoted.

Thanks for the comment

Kevin,

Extremely useful post. You won't be surprised that I interpret the history somewhat differently. I agree with many of your points, but at crucial junctions diverge in my conclusions in this intriguing counterfactual, asking "what if" history were different and current doctrine had prevailed in 1997-1998 when the crucial patents were granted. The patent incentive was important in this story, and rights that are too weak will indeed reduce private R&D for molecular diagnostics.

A couple quick points. First, there are actually 1900 mutations in the CFTR gene, and while the delta-F508 deletion is the most common, there are hundreds of disease-associated mutations, the reason that sequence-based tests are becoming the clinical norm. So it's not as much a contrast as might seem at first.

Second, there's no doubt at all that the sequence to BRCA1 would have been discovered within months if there were not Myriad or Utah team. The patent incentive did bring private R&D into the game, and for BRCA1, Myriad/Utah discovered the gene itself first. And for BRCA2, my reading is they came in a close second. But even before their patent was ever published, there were 9 other labs offering BRCA tests. So it is demonstrably the case that the patent disclosure was not necessary in this case to develop a test (or any other we have studied, including HFE--the other gene first discovered by a company, studying hemochromatosis). The publications that were already out, independent of patents, were sufficient. This is not an argument for or against patents, but it is very clear evidence that the patent disclosure was not technically necessary.

Your questions about whether folks living beyond the vicinity of academic health centers with molecular labs would have access don't have to be merely rhetorical. Most genetic tests are available to them, because Ambry, GeneDx, Invitae, and other commercial labs, as well as some major academic labs (Mayo, Penn, Baylor, UWash, UMichigan) also have FedEx service similar to Myriad's. Would this more diffuse testing framework have promoted the test and boosted awareness as strongly? Probably not. Would the other players have run direct-to-consumer ads? Almost certainly not. Is that good or bad? Hard to know. Is coverage and reimbursement better because of Myriad's efforts? Almost surely it is indeed better, because Myriad was strongly motivated, and that did indeed benefit patients. Put that in the plus column for social benefit.

The role of patents in the construction of the database is clear. In the US, Myriad had a service monopoly from around 1998 or 1999 until 2013. And it's great they collected the data, and the service monopoly means that the data were centralized. Had Myriad continued to share its data past 2004, the data could have been pooled with results from all over the world (Myriad did not establish dominance in any market outside the US, despite strong patent protection in many jurisdictions, because enforcement would have been difficult or futile). But starting Nov 2004, the data became proprietary, and so the patent exclusivity was leveraged into data exclusivity, since the million tests were done in the US (and to my knowledge, there is nothing illegal about this). My main point here, however, is that mutations whose interpretation became possible after Nov 2004 became public only when Myriad published or patented, and both are woefully incomplete. So patents ironically have led to more trade secrecy rather than less.

So the pros and cons are hard to think through, and I don't think it's actually possible to reach a decisive "what if history were different" conclusion.

Do you have a pdf or docx version of this? I'll respond at greater length offline.

This reminds me of 23andMe.

With Myriad, it was the ACLU and the courts trying to make things better for the public by killing off “bad” patents.. With 23andMe, it was the FDA “protecting” consumers from offering genetic tests without expensive genetic counselling. Result is that 23andMe stopped offering services. If the FDA had stepped in earlier, there never would have been the company.


23andMe is also relevant to understanding the role of Myriad in shaking up diagnostics.

Lots of academic medical centers and pathology companies offer genetic diagnosis. But they did so only in the context of a pre-existing medical relationship, and charged big fees for each individual test. There was no motivation to change this highly profitable model, and it didn’t change.

23andMe shook that up: direct to consumer testing of a number of genes for a given product, and at a huge discount to the competition. Of course, it could only do that because it relied on the huge $$ and access to computing power that comes from being married to a Google founder.

This model is popular in Silicon Valley. Elon Musk went from Paypal to SpaceX to Tesla. Steve Jobs started media companies. Google is into everything. Virgin went from representing the Sex Pistols all the way to airlines. Of course, this is not a new model: See Henry Ford, and any Gilded Age tycoon. Absent patents, the only way to have disruptive change is for a rich entrepreneur shake thing up. Too bad for the rest of us who don’t have a few billion lying around.

So, if we don't have patents to shake things up, we are left with (a) the status quo of giant monopolies and oligopolies, (b) visionary plutocrats (c) government regulators. I'd say that patents are the way to go for so many reasons. People might say that I am self interested. That true, but why don't people see (a)-(c) as equally self interested?

Simon,

Perhaps because "the people" you are referencing (those who climb onto the soapboxes) are:

a) the puppets of Big Corp
b) the lemmings of Big Corp
c) have anti-property leanings and don't care that the end result is more power to Big Corp

(by the way, I like your grasp of history)

Skeptical: I forgot law professors, journalists and politicians! They get noticed and promoted by being controversial and shaking things up, and/or by attracting patrons, but like to believe that they are neutral arbiters and disinterested.

Simon,

I do not wish to insult, but such Pollyanna desire for disinterest and a position of neutrality is I daresay foolish, if not downright dangerous.

For many a good reason, I sign myself...

Raising CFTR is helpful in at least one respect, Jytdog. Ambry picked up ACLU's mantle in dragging Myriad specifically and patent-holders generally through the mud and decrying the evil practice of aggregating genetic variant databases as something only money-grubbing patent holders do. Turns out Ambry has and actively promotes its for-profit genetic testing services based on its own CFTR variant database. From http://www.ambrygen.com/tests/cystic-fibrosis-testing :

"Founded in 1999, Ambry Genetics was the first commercial laboratory to offer clinical genetic testing for cystic fibrosis using gene sequencing technology. Since then, Ambry has analyzed the complete CF gene (CFTR) for more than 35,000 patients. As a result, Ambry has the most robust single-laboratory database in the world from which to accurately and carefully interpret patient results. Due to CFTR’s large size and the wide genetic heterogeneity seen in CF, this powerful database is highly valuable to clinicians."

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