Mike the Mad Biologist

Probably not. But genes linked to a high risk of breast cancer? You betcha.

ScienceBlogling Rebecca Skloot has a very good piece about the lawsuit brought by the ACLU against Myriad, the company that owns the patent for the ‘breast cancer genes’ BRCA1 and BRCA2 (she provides some more background here).

To me, the really galling thing is that Myriad didn’t discover these genes, publicly funded research did. The goal of that research is not to enrich patent holders, but to improve human health for society as a whole. The patent drives up diagnosis costs by preventing anyone else from entering the diagnosis market: the $3,000 it costs to screen for these genes is a little over half of the price of resequencing** an entire bacterial genome at high coverage (and the latter cost includes labor, amortization of machines, etc.–the bacterial genome cost is priced as a business would).

That’s obscene and immoral. Kill that patent.

*When Jonas Salk, inventor of the first polio vaccine, was asked if he would patent the vaccine, he answered, “There is no patent. Could you patent the sun?”

**And I predict by the end of 2009 (give or take), sequencing centers will be doing de novo bacterial genome sequencing at roughly the same cost, if not cheaper.

Comments

#1 Todd Hollywood
May 18, 2009

Patents of this type, as well as so-called “methods patents” are evil.
#2 Deb Colbert
May 18, 2009

A landmark decision that will be made in India regarding global access to the single most important HIV-AIDS medication. Very soon, the Indian Patent Office will decide whether to grant Abbott Labs its 27th (27th!) patent for the critical antiretroviral combination Lopinavir/Ritonavir.

This case is the greatest test yet of a bogus patent system that keeps essential medicines away from millions of needy patients. It will be the largest patent decision affecting HIV/AIDS medications ever.

We encourage you to become familiar with this complex issue now by talking to expert scientists and lawyers at the Initiative for Medicines, Access, and Knowledge (I-MAK) who filed the challenge to this patent. The sole mission of I-MAK is to increase access to affordable medicines by making sure the patent system works.

Please advise and I will be happy to arrange, or send you additional background materials. Thanks.

Debra Colbert
for I-MAK

301/332-0813 cell
#3 Olorin
May 18, 2009

Ever since the first gene was sequenced, patent attorneys have debated whether or not they are patentable. It may seem obvious that the person who first sequences a gene did not “invent” something new, but rather discovered something that already existed. This simple analysis, however, would deny patents to many significant drugs that require vast sums of money and time to discover, develop, and test. So a work-around came into being. The natural compound existed, but not in purified form, isolated from everything it occurs with naturally. So we allow claims to a “purified form of” a compound.

There are many problems with this approach. You may recall the patent to a drug found in a tree in India that had been used as a folk remedy. Another case involved a method patent on testing for a specific metabolite to indicate a medical condition. Newly sequenced genes present a further problem. There should be a way to encourage the huge investments required to develop this type of product, without leading to the admittedly quirky result in the BRCAn case. But, so far, no one has been able to come up with a way to claim coverage that protects the investment, yet is not overly broad You’re welcome to try.

A number of people assert that drugs should not be patented at all. Italy enacted such a restriction after WWII. The result was that not a single new drug was discovered in Italy since that time.
#4 D. C. Sessions
May 18, 2009

The goal of that research is not to enrich patent holders

Yes, it is. Shouldn’t be, but the fact remains that the Bayh-Dole Act specifically sets that out as its objective.

but to improve human health for society as a whole.

Think of it as trickle-down science: as more companies make megafortunes from patenting neem oil, the amount of knowledge locked up behind Springer Verlag paywalls will approach infinity.
#5 Locke
May 18, 2009

There is quite a large difference between patenting a drug formula, and patenting a region of DNA. Now, if Myriad was to privately discover that a certain gene predicts breast cancer, they could keep that genes’ location and sequence/mutations proprietary and secret and make money from providing the test. This way Myriad had invested millions in discovering the gene, but they didn’t. They basically just took others work and patented a gene that was discovered using taxpayer money
( http://en.wikipedia.org/wiki/Mary-Claire_King ):

“Many researchers around the world were involved in identifying the BRCA1 and BRCA2 genes; most of them did not seek patents or did not enforce any patents obtained by their universities because they wanted research and testing to continue openly and unfettered by exclusive monopoly rights. Myriad Genetics filed for a patent on the BRCA1 gene in 1994.[9] Myriad either bought out or fought off any other company that was providing tests or performing research on the BRCA1 gene. By 1999 Myriad was the only company offering a test for and performing research on the BRCA1 gene.[10] Myriad filed for a patent on the BRCA2 gene in 1995.[11] The USPTO then granted Myriad exclusive rights over this gene.”
http://www.aclu.org/freespeech/gen/39556res20090512.html

What they’re doing is wrong. $3,000 for looking at a couple loci that could realistically be done for $50.
#6 WotWot
May 18, 2009

To me, the really galling thing is that Myriad didn’t discover these genes, publicly funded research did.

Highly objectionable and socially regressive form of public subsidy of the private sector.

Parasites.
#7 wybory sondaze demokracja
May 19, 2009

This kinds of patents don’t help defending the best pieces of work. They help to make lot of money for a very few people, and are agains those, who need the knowledge to survive (eg. women with brest cancer). Where is humane attitude and medical ethic?
#8 jay
May 19, 2009

Many researchers around the world were involved in identifying the BRCA1 and BRCA2 genes; most of them did not seek patents or did not enforce any patents

Wouldn’t that be ‘previous publication’ then, invalidating the patent?
#9 Mark P
May 19, 2009

“But, so far, no one has been able to come up with a way to claim coverage that protects the investment, yet is not overly broad You’re welcome to try.”

Government funding. Why does everything have to be modeled on the free-enterprise/profit-motive/American-way-of-greed approach? Government funding already does a lot of work in this area. Why not let government fund and do the drug research and then sell licenses to anyone who wants to make the drug?
#10 Daniel MacArthur
May 19, 2009

Why not let government fund and do the drug research and then sell licenses to anyone who wants to make the drug?

Because, with few exceptions, public-funded research groups have proved incredibly ineffective at moving from promising drug targets to marketable compounds. Big pharma is very far from the perfect model – but it still beats academia when it comes to getting drugs to market.
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May 20, 2009

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June 29, 2009

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#13 vpillsws
October 2, 2010

This kinds of patents don’t help defending the best pieces of work. They help to make lot of money for a very few people, and are agains those, who need the knowledge to survive (eg. women with brest cancer). Where is humane attitude and medical ethic?
#14 v-pills
November 19, 2010

Government funding. Why does everything have to be modeled on the free-enterprise/profit-motive/American-way-of-greed approach? Government funding already does a lot of work in this area. Why not let government fund and do the drug research and then sell licenses to anyone who wants to make the drug?
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May 1, 2011

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