Tuesday, April 30, 2013

What if they treated gene patents like nautical charts?

About the idea of treating genetic sequences like maps : using copyright law not patent law.
Is the case for patents on human genes similar to the intellectual property patents
 on maps used for 250 years?

From Forbes

Patents on human genes are controversial, and the U.S. Supreme Court may well make them illegal in a decision expected later this year.
But a Cornell Law School scholar suggests the court should take another approach, one that has been around for at least 250 years over another type of intellectual property that is strikingly similar to a gene sequence: Charts and maps.

A human gene is nothing more than a sequence of A’s, T’s, C’s and G’s representing the chemicals that make up the strands of a DNA molecule.
Each gene has a beginning and an end, and determining where those are takes a lot of skill and experimentation.
But a gene is not an invention in any conventional sense, because it wasn’t created by the hands of humans.
In fact, if it isn’t an exact replica of what is found in nature, it is useless.

The same goes for maps.
They require skill and work to create but done right, they’re an exact representation of the physical earth — if not, people can die.
Yet even though a good map is nothing more than a copy of nature, they’ve been specifically covered by copyright law, a close cousin of patent law, at least since the 1700s.

The important thing is charts and maps have a lower level of protection than wholly creative works, like a John Le Carre novel or an episode of “Buffy the Vampire Slayer.”
Maps and charts are protected against exact copies, but anyone is free to make their own if they want to put the work into it.

“What’s neat about maps is you can get a copyright on a map, but you don’t get a lot of exclusive rights in it,” said Oskar Liivak of Cornell Law School, a physicist who worked on quantum computing at IBM before studying intellectual property at Yale Law School.
“You can stop people from Xeroxing it and selling it in the store next door, but you can’t stop somebody from selling another map they produced themselves.”

Liivak thinks the Supreme Court, or possibly Congress, should consider a similar approach toward gene patents. That would be better, he says, than the all-or-nothing solution that may come down when the court decides Association for Molecular Pathology vs. Myriad Genetics later this year.
That case, argued last week, involves patents on human genes that are associated with breast cancer.
Myriad says it needs patent protection for the years of research it invested in finding the genes.
Opponents say Myriad’s patents should be found invalid because they prevent researchers from studying those same genes.

Copyrights aren’t patents, of course, but they’re awfully close.
Both stem from the same clause in Article I, Section 8 of the Constitution, and the Supreme Court has referred to patent law in copyright cases and vice versa repeatedly over the years, Liivak told me.
(It’s an area “fraught with peril” for advocates, he added, since the high court seems to connect the two bodies of law only when convenient.)

The problem with gene patents is they cover, by definition, something that no human created by design.
Myriad argues the BRCA genes it patented don’t occur in nature because they are tiny snippets of an immense DNA molecule that took years of research to define.
But researchers say the proper analogy is to an apple: It’s useful if you separate it from the tree, but that doesn’t make it an invention.
If Myriad can patent a gene, the argument goes, they preclude everybody else from using that gene and offer no opportunity, as with an invention, to “design around” it with another invention that does the same thing.

Maps and charts present a similar quandary. Governments in England and the U.S. sought to protect mapmakers to encourage them to produce more of the navigational charts that enhanced maritime traffic and trade.
Yet competing mapmakers couldn’t be prohibited from making a chart of the English Channel simply because an earlier version existed.
No one could hold a copyright on the navigational coordinates for the approach to Sheerness.

But allowing alternate maps raises other tough questions such as: Could a mapmaker use an existing map to safely navigate the Channel while making his own calculations for a new one?
Could he use it to check his work?
A British court Kelly vs. Morris, circa 1804, held that the second mapmaker must “go through the whole process of triangulation just as if he had never seen any former map.”
A U.S. court, in 1930, said it was OK to use existing maps for “comparison or checking.”

These are all far from the absolute ban on copying that patents provide, and would solve the problem facing researchers who must isolate a patented gene sequence in order to study it.

“It doesn’t mean that’s the end of the story and these materials are patentable just like any other material,” Liivak said. “They’re patentable, but just barely.”

(The Supreme Court muddied the waters a bit with Feist vs. Rural Telephone Services in 1992, which struck down the copyright on a telephone book for lack of originality.
Feist has since “been cabined,” Liivak said, as lower courts find a way around the decision to protect works that aren’t particularly original but require a lot of labor to compile.)

Nobody involved in Myriad is suggesting Liivak’s solution, and he acknowledged it’s unlikely anybody will.
Defenders of gene patents have billions of dollars invested in their position, and opponents tend to be ideologically opposed to the idea of commercializing genes, full stop.

But Congress has stepped in and passed laws covering a similar area in the past.
The Plant Patent Act of 1930 was designed to encourage the cultivation of new varieties of plants by prohibiting competitors from cultivating the offspring of those plants without permission.
It doesn’t prevent somebody from making an exact copy on their own, but merely prohibits them from grafts or seeds from the original version.

It may seem unworkable to have a system that allows competitors to use exact copies of a patented gene simply if they say they arrived at it through their own research, but the law has actually dealt with this problem for centuries.
The rules could be fairly simple, Liivak said: If researchers can demonstrate they derived the genes on their own, and only used the patented genes afterward to check their work, they get a pass.
Otherwise, they’re in trouble.
Luckily for the lawyers, research “leaves a rich paper trail,” he said.

A strong ruling from the Supreme Court striking down all gene patents could cause more harm than good, he concluded.

“The thing that scares me if it’s broadly worded in the other way, meaning any naturally derived product is not patentable. That could have serious repercussions for biomedicine. If we’re not careful we could endanger those patents as well.”

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