Ruling Upholds Gene Patent In Cancer Test

diewlasing writes with a report in the New York Times which begins: "In a closely watched case, a federal appeals court ruled on Friday that genes can be patented, overturning a lower court decision that had shocked the biotechnology industry." Techdirt has some insightful commentary on the ruling.

Comments

Clearly

[blind biker]

Clearly, patents and copyrights are keeping humanity back from development and prosperity.

Re:Clearly

[a_nonamiss]

Really? Then what's the motivation to cure cancer if there's no profit in it? I mean, Pasteur, Salk and Fleming all retired multi-billionaires, right?

Re:Clearly

[Alex Belits]

There is already no profit in cancer cure, as it would be immoral to refuse it to sick people, and people who develop it can not possibly collect enough money from the sick to cover their expenses. This is why it can be only developed in government-run or government-sponsored programs -- and we should better get accustomed to it.

Re:Clearly

[Dr_Barnowl]

I'm astounded none of the siblings get the sarcasm here...

None of these men made fortunes from patent rights on a single notable invention.

Most notably, Jonas Salk said, when asked who owned his vaccine - "The people, I would say. There is no patent. Could you patent the sun?"

Alright, I read the Techdirt article

[Anonymous Coward]

Summary: The appeals court believes that when isolating individual genes, it somehow makes them "unnatural" to the point where they are patentable. Because, at this point, they're no longer "found in nature" (in the form of isolated genes), they're now patentable.

Mike Masnick seems to have the right idea here and notes the following.

Basically, they seem to be arguing that because a severed finger is not attached to a hand, the finger is not naturally occurring, and, thus, is patentable. Think about that. The dissenting judge in this ruling used a slightly less gruesome analogy, saying that the majority was basically saying that while a tree occurs in nature, snapping a leaf off the tree makes that leaf patentable.

And, of course, the opinion of the dissenting judge points this out too and how Myriad hasn't "invented" the gene so this is idiotic.

Me, I gotta agree with that. The technique for isolating specific genes, as the dissenting judge also notes, is probably really difficult and should be patentable. No problem there. But saying something you've *created* with that technique is patentable is complete and utter nonsense. It would be like saying, by processing gold ore (which is the natural form of gold) into refined gold, you now own a patent on all refined gold. (Note that this was also the judge's example and I"m just trying to translate it to something simpler.)

Myriad is claiming the genes themselves, which appear in nature on the chromosomes of living human beings. The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature. While the process of extraction is no doubt difficult, and may itself be patentable, the isolated genes are not materially different from the native genes. In this respect, the genes are analogous to the “new mineral discovered in the earth,” or the “new plant found in the wild” that the Supreme Court referred to in Chakrabarty. It may be very difficult to extract the newly found mineral or to find, extract, and propagate the newly discovered plant. But that does not make those naturally occurring items the products of invention.

Now, if they'd done *something* to the gene to make it better, to make it so that it's inherently different from "natural" genes or at least that they altered it without prior knowledge of other similar genes, I'd give them a pass. But isolating a specific part of a gene and patenting it as if it were something they invented? Hideous.

Re:Next up

[JBMcB]

Good point on aspirin. Aspirin *was* patented a long time ago. The patent has long expired, but companies still seem to make a lot of money off of selling it, even though anyone can buy dirt cheap acetylsalicylic acid from Dow and infuse it into their own tablets for next to nothing.

Re:Next up

[dna_(c)(tm)(r)]

Surely you're kidding about aspirin and ibuprofen. Both were developed by drug companies; they're not apples that fell from the trees into the drugstore.

One of those fell from a willow tree and has been used for more than 25 centuries... (Salicylic acid) the trademark Aspirin was developed by a drug company, around the same time as Heroin.

Obviousness

[JBMcB]

I thought only inventions could be patented, not discoveries? Does the judge need a dictionary?

Re:Obviousness

[JBMcB]

If I develop a new type of super-light but super-strong steel, should I be allowed to patent the chemical formula that makes up compound? Is my new type of steel an invention or a discovery? This compound is a mixture of pre-existing things, carbon, iron, etc., but in a way never before done.

That's pretty much the definition of an invention. You're putting things that already exist in a novel way. The key here is "novel." IE non-obvious. You can't make cantaloupe-flavored gum and patent it - you're just making a new flavor of something that's already flavored. Now, if you make gum that can be used to reliably patch a flat tire - that's novel, nobody has made gum that can do that.

The problem with gene patents is that you are patenting the observation of how something already works. It would be like Niels Bohr patenting chemical interactions, so anyone who mixed substances together to create new compounds would have been infringing on his patent, even though he just figured out exactly how it worked.

DNA, RNA, and Genes

[rockmuelle]

The judge's reasoning in the ruling hinges on the fact that the BRCA1/2 genes do not appear in nature as isolated, unmodified DNA and instead only appear in DNA form as part of a (much) larger chromosome. While technically true, it ignores an important fact of genomics: while the BRCA genes do not appear in vivo as isolated _DNA_, the do appear as isolated _RNA_. The RNA counterpart of the DNA sequence is slightly modified - it is the 'reverse-complement' of the DNA with the T's replaced with U's (for example, AACC - (reverse complement) -> GGTT - (sub U for T) -> GGUU.

So, in a very perverse way, the judge is correct. The isolated, unmodified DNA does not appear in nature.

There is natural mechanism for converting RNA back into DNA called reverse transcription (RT). RT-based methods are how we sequence genes. RNA from genes is isolated and converted back into DNA for sequencing. This is a standard lab method and used for all gene sequencing. (interestingly, if someone were to find RT at work in a cell converting BRCA genes back to DNA, the patent could be invalidated.)

The gene itself, in RNA form, appears isolated in nature. The RNA sequence cannot be patented. But, sequencing methods all rely on converting RNA back to DNA for sequencing. The sequence is read as DNA. But, that's not really the gene, that's just a modified representation of the gene. The functioning gene is the RNA version, not the DNA copy of it.

What's frustrating is that Myriad is using a technical aspect of how gene/RNA sequencing works to claim a patent on a gene itself.

-Chris

Only solution left

[jmorris42]

Since the courts are insane beyond recall there is only one option left. Congress needs to pass a law. Throw the creationists a bone to get them on board. Mandate the Patent Office to assume the design of every existing natural creature was patented by God with the issue date in 4000BC. And to stop the next step direct the Library of Congress to assume He filed a copyright on the full genome of every creature on the same date. Then direct them to assume any gene sequence derived from a naturally occurring creature is a derived work so that only the new material is eligible for a new copyright if it is different enough and separate enough from the original work.