New Scientist asks about yesterday’s New York Federal District Court ruling that patents on two genes linked to breast cancer are invalid: Is this the end of gene patenting?

The ACLU and its supporters, including the American Society for Human Genetics and the American Medical Association, contend that the patents never should have been awarded because the genes are natural. They argue that women may be denied tests if they or their doctors can’t afford the tests. By owning the patents, Myriad [Genetics of Salt Lake City, Utah] has been able to stop others developing cheaper or free versions of the tests, and to block research towards cheaper versions.

The court backed the ACLU’s main rationale for challenging the patents – that they are products of nature. “Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter,” it says in its verdict. “Purification of a product of nature, without more, cannot transform it into patentable subject matter,” it argues.

We know the NY judge is right. Cory Doctorow:

I think that the problem here is in the untested idea that imparting exclusive rights to the genome will incentivize more research than allowing anyone to build on discoveries in the genome. It’s clear that some exclusive rights provide an incentive so some people to do work. But these exclusive rights also scare off people who have good ideas but are worried about being bankrupted by someone who beat them to the patent.

Combined with that is the natural abhorrence many of us feel at the thought that genes might be patented. Genes aren’t a good subject for propertization. Your genes aren’t even yours — you didn’t create them. Your parents didn’t really create them, either. You’re your genes’ steward, as are we all, and so many of us have a strong intuition that when someone else claims to own something from our genome, they’re being ridiculous, or evil, or both.

The case is so stunning that John Conley and Dan Vorhaus headlined their Genomics Law Report analysis of the jaw-dropping summary judgment ruling, Pigs Fly: Federal Court Invalidates Patent Claim:

Why is this so radical? Since the inception of gene patenting a generation ago, patent lawyers have taken the position that genes are just chemicals. Their information-carrying function is irrelevant to their patentability, the lawyers say. Because genes are chemically different in isolation, at least in a literal sense, they can’t be considered products of nature. The USPTO and the courts, including the Federal Circuit (the patent court of appeals), have uniformly acquiesced. Now a federal court has said that, no, genes aren’t just chemicals—precisely because they carry information. Genetic exceptionalism has become a principle of law, at least in Judge Sweet’s court.

Where do we go from here?

Myriad will surely appeal to the Federal Circuit (it has a right to that appeal), a process that could take a year or more. It is possible that the District Court’s judgment invalidating the Myriad patents will be stayed, or suspended, during that appeal. Judge Sweet’s order will not affect any patents not directly involved in the case, nor be binding on any other court, and it is highly unlikely that the USPTO will change its gene patent examination standards just because of this decision.

Then it will be up to the Federal Circuit. Our initial guess is that the court will end up affirming Judge Sweet on some or all of the process claims, but will cut way back on his broad attack on gene patents. But that decision is way down the road and…even farther down the road is an appeal from the Federal Circuit to the Supreme Court, where all bets would be off. […]

In the broader policy debate surrounding gene and biotechnology patents, however, this decision is the latest, unmistakable shot across the bow of gene patent holders, particularly those such as Myriad Genetics that have developed businesses around patent-protected genetic tests supported by exclusive rights in underlying gene patents. As we wrote last summer, and as the SACGHS report pointed out in detail, there is a coming crisis at the intersection of multiplex genetic testing and whole-genome sequencing and biotechnology patents, particularly gene patents. This decision is sure to intensify the public policy discussion surrounding the appropriateness of gene patents, and ratchet up the media and public attention paid to the issue.

Josh Rosenau of Science Blogs’ Thoughts from Kansas says that’s how it should be:

This does not invalidate patents on organisms with modified genes or genomes, nor does it invalidate the act of modifying a gene in order to insert it into an organism. This does not, by my reading, set up Monsanto’s genetically modified Roundup Ready crops to lose patent protection, though it may free up competitors to develop similar genes, and may give farmers an easier way to protect themselves against a claim when Monsanto asserts patent violations because of crosspollination.

The court was asked to consider the chilling effect on research produced by patents for naturally occurring genes. Fortunately, the decision seems to have avoided that line of argument, as it opens a massive can of worms. In general, I’m inclined to oppose patents and copyright laws that restrict research, artistic development, medical care, or other humanitarian services. On the other hand, I don’t think that’s a call judges ought to be making. I’d rather see the laws themselves fixed when such chilling effects are seen.

I got to Genomics Law Report via Daniel MacArthur at Science Blogs’ Genetic Future; he has a rich comment thread going there. Be sure to check it out. Here’s the ACLU release. The NYTimes story tops their most emailed. Dna rendering, a Creative Commons Attribution (2.0) image from ynse’s photostream via Boing Boing.

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