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Gene patents have not been a "problem" in the same way as software patents. And, unlike software patents, they are more likely to represent a significant R&D i

Gene patents have not been a "problem" in the same way as software patents. And, unlike software patents, they are more likely to represent a significant R&D investment by the applicant. (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 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.

_delirium 16y ago
Is non-obviousness actually applied in this sphere? In my corner of computer science, the non-obviousness bar is so low as to be basically non-existent. There are tons of patents where A and B each have significant prior art, but the completely straightforward combination "A+B" somehow gets patented.
- kljensen 16y ago
  It is applied, and it should also be in the CS space. But, as always, there are bad patents issued because they are examined by busy humans. In these cases, opponents of the patent have a number of options, most notably asking for a reexamination of the patent. During reexam, you can bring missed prior art to the USPTO's attention in an effort to invalidate the patent. 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.
- reader5000 16y ago
  As of 2007ish courts rely on the "Graham factors": - 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. e.g. http://en.wikipedia.org/wiki/Inventive_step_and_non-obviousness#United_States http://en.wikipedia.org/wiki/Inventive_step_and_non-obviousn...
pingswept 16y ago
"However, purification of the DNA is usually enough to render it patentable." Could you explain a little more about what this means? DNA in its natural state is impure?
- sandipc 16y ago
  Genomic DNA is always present with a ton of other biomolecules within a cell. Extracting pure DNA from the typical cellular mix of DNA, RNA, proteins, carbohydrates, lipids, etc. isn't much of a challenge anymore using modern molecular biology, but it is still necessary to study specific genes. 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 http://en.wikipedia.org/wiki/PCR] and the maturation of gene cloning techniques.
  - pingswept 16y ago
    Do I understand correctly that just physically extracting a certain piece of DNA from a cell ("purifying" it) makes it patentable? That seems silly.
    - ewjordan 16y ago
      Do I understand correctly that just physically extracting a certain piece of DNA from a cell ("purifying" it) makes it patentable? That seems silly. 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".
    - kljensen 16y ago
      Yes. That is basically the case.
Natsu 16y ago
I was under the impression that people were patenting genes as soon as they were identified and then going after anyone who did the research to discover what those genes were useful for because they found it first (even if they didn't know what it did).
- kljensen 16y ago
  There aren't many documented cases like you describe.
j_baker 16y ago
Not in the field of medicine. However, I wouldn't advise mentioning that gene patents aren't a problem to any farmers unless you want to hear a long spiel. The big agricultural companies go to great lengths to enforce their patents on certain strains of seed (including hiring PIs to spy on farmers, blacklisting farmers, and suing them for saving seeds).
ewjordan 16y ago
Gene patents have not been a "problem" in the same way as software patents. 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.
- kljensen 16y ago
  The claims are not just on the sequences, but can be on uses of the sequences, combinations, whatever. This is why genes are be patented in some cases up to 25+ times. Each patent owner claimed something unique that passed the USPTO's tests for patentability.

_delirium 16y ago

Is non-obviousness actually applied in this sphere? In my corner of computer science, the non-obviousness bar is so low as to be basically non-existent. There are tons of patents where A and B each have significant prior art, but the completely straightforward combination "A+B" somehow gets patented.

kljensen 16y ago
It is applied, and it should also be in the CS space. But, as always, there are bad patents issued because they are examined by busy humans. In these cases, opponents of the patent have a number of options, most notably asking for a reexamination of the patent. During reexam, you can bring missed prior art to the USPTO's attention in an effort to invalidate the patent. 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.
reader5000 16y ago
As of 2007ish courts rely on the "Graham factors": - 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. e.g. http://en.wikipedia.org/wiki/Inventive_step_and_non-obviousness#United_States http://en.wikipedia.org/wiki/Inventive_step_and_non-obviousn...

pingswept 16y ago

"However, purification of the DNA is usually enough to render it patentable." Could you explain a little more about what this means? DNA in its natural state is impure?

sandipc 16y ago
Genomic DNA is always present with a ton of other biomolecules within a cell. Extracting pure DNA from the typical cellular mix of DNA, RNA, proteins, carbohydrates, lipids, etc. isn't much of a challenge anymore using modern molecular biology, but it is still necessary to study specific genes. 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 http://en.wikipedia.org/wiki/PCR] and the maturation of gene cloning techniques.
- pingswept 16y ago
  Do I understand correctly that just physically extracting a certain piece of DNA from a cell ("purifying" it) makes it patentable? That seems silly.
  - ewjordan 16y ago
    Do I understand correctly that just physically extracting a certain piece of DNA from a cell ("purifying" it) makes it patentable? That seems silly. 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".
  - kljensen 16y ago
    Yes. That is basically the case.

Natsu 16y ago

I was under the impression that people were patenting genes as soon as they were identified and then going after anyone who did the research to discover what those genes were useful for because they found it first (even if they didn't know what it did).

kljensen 16y ago
There aren't many documented cases like you describe.

j_baker 16y ago

Not in the field of medicine. However, I wouldn't advise mentioning that gene patents aren't a problem to any farmers unless you want to hear a long spiel. The big agricultural companies go to great lengths to enforce their patents on certain strains of seed (including hiring PIs to spy on farmers, blacklisting farmers, and suing them for saving seeds).

ewjordan 16y ago

Gene patents have not been a "problem" in the same way as software patents. 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.

kljensen 16y ago
The claims are not just on the sequences, but can be on uses of the sequences, combinations, whatever. This is why genes are be patented in some cases up to 25+ times. Each patent owner claimed something unique that passed the USPTO's tests for patentability.