(I am the author of the paper that showed how much of the human genome is patented. "Intellectual property landscape of the human genome", Science 2005. http://www.sciencemag.org/cgi/content/summary/310/5746/239 )
The brief filed by the government does not alter the law, it's just a letter to the court that says "this is the current, consensus opinion of the executive branch." The current law states that DNA (or any other naturally occurring chemical) cannot be patented unless it is significantly transformed from it's natural state. However, purification of the DNA is usually enough to render it patentable. That, of course, is not difficult with current molecular biology techniques.
But, like any other technology, patent applications covering DNA must meet many other requirements including non-obviousness and usefulness. Thus, the claims granted by the USPTO have become increasingly narrow as the field has matured and there is more prior art. That is, just like any new technology area the initially granted patents are broad, but they narrow over time.
So, that is a long way of saying, this might be a tempest in a teapot. Especially because most court watchers expect the Federal Circuit to reverse the District Court and keep the status quo.
EDIT: I should have also mentioned, another option is to ask the courts to invalidate the patent (for obviousness, lack of enablement, or any other statutory requirement) if you are involved in a lawsuit. Even if you are not sued you can begin such a lawsuit by filing a "declaratory judgement" complaint against somebody who you reasonably feel might sue you.
- the scope and content of the prior art;
- the level of ordinary skill in the art;
- the differences between the claimed invention and the prior art; and
- objective evidence of nonobviousness.
I'd argue that the "problem" is that the entire idea that ownership, even temporary, can be claimed on a pre-existing string of bits (and not just some particular method of extracting or using that information) that exists inside all of our bodies, is downright offensive. Moreso because the techniques to isolate and exploit these bit strings have now become commonplace and all but trivial.
And, unlike software patents, they are more likely to represent a significant R&D investment by the applicant.
But the patent system is not a subsidy for R&D costs, it's supposed to protect innovative inventions. I'm appalled at the idea that a research group might be prevented from researching novel therapies that target a particular gene just because some other company happened to successfully isolate it using standard techniques ten years ago.
Could you explain a little more about what this means? DNA in its natural state is impure?
The DNA for a specific naturally occuring gene is only a tiny portion of the total DNA extracted from a cell.
Since 1990 or so, purification of this (relatively) small piece of DNA for a particular gene (from the enormous quantity of genomic DNA) has become pretty trivial in most cases. This is largely due to the invention of the Polymerase Chain Reaction [http://en.wikipedia.org/wiki/PCR] and the maturation of gene cloning techniques.
Yeah, it's ludicrous - imagine that I tried to file for a patent on using a random (but useful!) phrase in English on the basis that I was able to write a Perl regex to pull it out of a web page.
And I won't even qualify that with the usual "poor analogy" disclaimer - it's almost exactly what the current law allows for, just replace "random phrase in English" with "snippet of DNA", and "Perl regex" with "biochemical reaction".
DNA is just a sequence of bits, software is too.
Genetics has turned into a minefield because of patents.
Cross-licensing crap worse than even software.
It will probably take another decade if this ever changes, but I'm hopeful!
That's not the argument being made by DOJ. They're not saying that DNA sequences per se are unpatentable. On the contrary, they agree that man-made DNA sequences are indeed potentially patentable (assuming they're not "obvious" in view of other pre-existing DNA sequences, including for example genes in the wild). The brief argues only that if a DNA sequence occurs in nature, you shouldn't be able to get a patent on the isolated sequence.
I'll give a more concrete example. Certain zinc finger proteins can bind to particular DNA sequences. By chaining together a few of these units, we can engineer proteins that bind to a particular sequence of DNA and promote or inhibit its transcription into RNA -- obviously a very useful thing to be able to do.
Do these custom zinc finger proteins count as patentable? On the one hand, we're mostly plagiarizing from nature. On the other hand, there are a lot of tough issues to solve in order to get to where we can reliably use these things. Personally, I think the bioengineering challenges are a bigger barrier to competition than a patent could be: if someone set up a company that could sell custom zinc finger arrays at a reasonable price, their expertise would matter a lot more than any patent.
(One of my partners at my former law firm told a story about representing a major university in seeking a patent for a biotech invention. It took a number of years for the PTO to do the initial examination of the patent application. The patent examiner perfunctorily rejected the application, asserting that the claimed invention would have been obvious in view of the prior art. My partner responded that in the years that the inventors had been waiting on the PTO to examine the patent application, they had been awarded the Nobel Prize for that very invention. Result: Obviousness rejection withdrawn. Of course, I could well be misremembering, but it nicely illustrates the principle.)
I don't quite see how that plays into it. You can just as easily dismiss any physical creation as a collection of elements.
Sure, you can describe your patented process/machine/etc. with text, which you can in turn represent as a sequence of bits. But there's a difference between the patented thing being described with a series of bits and it actually being a series of bits.
Genes are purely a series of bits. But unless you want to specify the exact place where every atom goes through some crazy coordinates, you can't represent an actual machine as a series of bits--you can just describe it with a series of bits.
"While the government took the plaintiffs’ side on the issue of isolated DNA, it sided with Myriad on patentability of manipulated DNA."
I think that "prior art" and "obviousness" claims for certain classes of manipulations should (in a world run by biologists) be useful. For example, if you discover New Gene X and manipulate its DNA to tag its protein product with a fluorescent protein, that's pretty damn obvious because that's what we do with every other protein.
Firms are forced to pay for their research toward FDA approval, and that approval is extended only to a very specific drug or treatment. The narrowness of this channel yields one of the only business situations where patent law, from an innovation perspective, makes sense.
Contrast this with business method patents and software patents: you can use a zillion different idea, each independently patentable, for any business or product, there is a much smaller barrier to entry, and there are many ways to accomplish the same thing. Patents go from being quite valuable for the innovator to being, at best, a distraction, and at worst, a minefield.
Whether a synthetic gene is an invention is a different story to me. That's much more closely related to whether software is patentable. But no one would seriously argue that they could patent RSA if they turned a rock over and found the algorithm written down, no matter how many stones they had to turn to find it.
Love the vivid analogy. But couldn't the same thing be said about any "method" invention?
In the absence of a patent incentive, the alternative, then, will hopefully be large government and other large public investments making up the difference.
The draft human reference genome was published 10 years ago. Prior to this, dozens of genes were discovered and patented by Celera. Celera gave free access to these genes to academics, but required payment for any for-profit activity. By one analysis, genes that were ever controlled by Celera, despite these relatively loose restrictions, as of 2009 had 30% less research done on them than those genes that were never controlled by Celera.