kenstauffer

Can Gene's be Patented?

16 posts in this topic

What kind of property rights should a drug company be allowed when they discover a gene (humans or otherwise)?

Can a company patent the gene, or just the process used to manufacture the gene?

Share this post


Link to post
Share on other sites

I think that a drug company could not patent a gene, it already exist. They haven't at this point created anything new. But, they could patent a new/mutated gene, such as the genes in golden rice. In golden rice the company has advanced this item by enhancing it. For all the research and resources put into this product they should be able to patent the mutated gene.

I also think they should be able to patent the technology created to duplicate an already existing gene, such as the ones needed to create a new pancreas.

Ray K

Share this post


Link to post
Share on other sites
What kind of property rights should a drug company be allowed when they discover a gene (humans or otherwise)?

Can a company patent the gene, or just the process used to manufacture the gene?

The standard answer is that you cannot patent laws of nature, natural phenomena or abstract ideas. If you can create a gene, it is patentable, as is the process for manufacturing it. Gene fragments have been patented: it's not clear to me what was patented and how it passed basic patentability muster -- possibly they are all manufactured. The oil-eating bacterium was the breakthrough legal ase, as far as I know, and it was manufactured, not naturally occurring.

Share this post


Link to post
Share on other sites

The way I understand it, you cannot patent the Human Genome, for example, but you can copyright the book that discusses it. That's a subtle difference, but an important one.

Share this post


Link to post
Share on other sites
What kind of property rights should a drug company be allowed when they discover a gene (humans or otherwise)?

Can a company patent the gene, or just the process used to manufacture the gene?

That looks like a terrific question for our Law Expert, Professor Adam Mossoff.

Share this post


Link to post
Share on other sites

Ayn Rand, when talking about patents and copyrights in CUI mentioned that you cannot patent a discovery, only an invention.

A scientific of philosophical discovery, which identifies a law of nature, a principle, or a fact of reality not previoulsy known, cannot be the exclusive property of th discoverer because: (a) he did not create it, and (B) if he cares to make h is discovery public, claiming it to be true, he cannot demand that men continue to pursue or practice falsehoods except by his permission.

Can you create new genes? THAT would be a really awesome invention!

Share this post


Link to post
Share on other sites
Ayn Rand, when talking about patents and copyrights in CUI mentioned that you cannot patent a discovery, only an invention.

Can you create new genes?  THAT would be a really awesome invention!

It's been done. I'll provide a link to an article on it when I have the time.

Share this post


Link to post
Share on other sites

JMeganSnow

One can create a new gene called recombinant DNA by combining the genetic information of two or more sources. Typically, scientists and students use a plasmid, which is a circular ring of bacterial DNA, then cut off a section and put it back together with some DNA from another source. For example, they might use a length of DNA which signals the creation of insulin, then add it to the plasmid. After it reproduces, the bacterial cell may be able to produce insulin for treatments.

Recombinant DNA can be used to create antibodies, proteins (like insulin) and is being used in yeast cells to produce interferon. Also, there is the potential to soon be able to replace defective DNA with healthy ones, like is needed for those with cystic fibrosis (a genetic disorder).

Here is an example of a cystic fibrosis study undergoing clinical trials:

Link

Pertaining to law: These genes are artificially created and therefore have never existed in nature, which makes them inventions.

Share this post


Link to post
Share on other sites
Can you create new genes?  THAT would be a really awesome invention!

Yes, it would be awesome, but unfortunately we do not yet have the biotechnology to create a new gene in the laboratory. What has been done so far is to exchange segments of already existing genes, which itself has great promise of applications in many fields. Clever techniques have been developed to combine small pieces of strands from different sources in the hope of expanding the range of resulting properties. But actually creating a new gene is still a ways off.

Share this post


Link to post
Share on other sites
One can create a new gene called recombinant DNA by combining the genetic information of two or more sources. Typically, scientists and students use a plasmid, which is a circular ring of bacterial DNA, then cut off a section and put it back together with some DNA from another source. For example, they might use a length of DNA which signals the creation of insulin, then add it to the plasmid. After it reproduces, the bacterial cell may be able to produce insulin for treatments.

This sort of technique severely limits the effectual number of recombined genes. However, there is a wonderful method developed for in vitro recombination (known in the category of "DNA shuffling") that generates truly diverse gene libraries. The tests reported in the original paper a few years ago were spectacular, though admittedly I have not kept up this technology (a quick look shows the paper has been cited 61 times since I read it, so indeed the technology may have been enhanced). See DNA shuffling method for generating highly recombined genes and evolved enzymes, W.M. Coco, et al., Nature Biotechnology, V. 19, No. 4, pp. 354-359, April 2001.

Pertaining to law: These genes are artificially created and therefore have never existed in nature, which makes them inventions.

Interesting. I would not agree with that, but I am far from an expert on law, so my opinion hardly matters. Though "create" as it usually used in the field of biotechnology refers to a literal creation of a gene in the lab (not yet done), rather than the exchange of segments.

Share this post


Link to post
Share on other sites
Interesting. I would not agree with that, but I am far from an expert on law, so my opinion hardly matters. Though "create" as it usually used in the field of biotechnology refers to a literal creation of a gene in the lab (not yet done), rather than the exchange of segments.

Does the term "gene" refer to the entire DNA/RNA strand, or just to those segments? If the term only refers to those segments and all you're doing is exchanging them, then I agree with Mr. Speicher. However, if the term refers to the entire end product (would chromasome be a the right word?) then you are creating something that didn't exist before in nature by combining the natural elements available to you, in which case it is an invention.

Perhaps the question here depends on what the product is actually considered to be.

Share this post


Link to post
Share on other sites
Does the term "gene" refer to the entire DNA/RNA strand, or just to those segments?

Traditionally (1960s) "gene" was defined strictly in molecular terms, a portion of the DNA that produced an RNA molecule, but now the term generally refers to any DNA sequence that transcribes (constructs a messenger RNA molecule) as a single unit and encodes a single set of polypeptide chains (the structural element of a protein). The problem is that there exists a multiplicity ot techniques by which segments are formed and integrated, but all essentially depend on physical processes which to us right now appear random. Some people, like myself, would put such an "invention" in scare quotes, but your mileage may vary. It is a complicated issue because it combines science, technology, and law, and what may be considered as purposeful action is not necessarily agreed upon.

Share this post


Link to post
Share on other sites

Genes have been patented in great numbers. I don't however think that it's a justifiable practice.

A naturally occuring gene (currently there are no others, as far as I know) is just that: a product of nature. No human creativity went into the DNA sequence which comprises the gene. To discover that sequence is fundamentally no different than discovering any other fact of nature, scientifically. One can argue that the *means* used to discover the sequences ought to be potentially patentable, say a certain kind of gene sequencing device - but not the knowledge so derived.

What should be patentable are new drugs which, say, interact with a given gene or its products (genes code for proteins.) Those *are* new products of the human mind.

I think what shows the big mistake of permitting genes to be patented is the fact that a company can stop the development of new drugs which target, say, a gene coding for a defective protein that causes cancer or sickle-cell anemia, etc. This has already happened.

A patent holder is under no legal obligation to license the patent to anybody else. A patent is fundamentally an obstructive tool that permits the holder, for a certain time, to treat the subject of the patent as his intellectual property, which he can choose to license, or not, under any terms he pleases. That is proper, if the subject of the patent is in fact some new creation. Patenting drug X that targets breast cancer is logical and necessary for a drug company. But to make it impossible for any other company to develop drugs Y,Z, etc. against the natural fact of breast cancer, is completely unjustified in my view - yet that is exactly the situation if a company holds a patent on a gene responsible for causing breast cancer.

Share this post


Link to post
Share on other sites

I think I agree, now, with PhilO. It is distressing to think that patents, which are intended to protect inventors, are now used either by the government or by researchers as a bludgeon against them.

In CUI (which I just read) didn't Ayn Rand comment to the effect that many inventors are beginning to rely on secrecy to protect their ideas?

Share this post


Link to post
Share on other sites
Genes have been patented in great numbers. I don't however think that it's a justifiable practice.

A naturally occuring gene (currently there are no others, as far as I know) is just that: a product of nature. No human creativity went into the DNA sequence which comprises the gene. To discover that sequence is fundamentally no different than discovering any other fact of nature, scientifically. One can argue that the *means* used to discover the sequences ought to be potentially patentable, say a certain kind of gene sequencing device - but not the knowledge so derived.

What should be patentable are new drugs which, say, interact with a given gene or its products (genes code for proteins.) Those *are* new products of the human mind.

Yes, but there is an in between issue in regard to genes. The situation discussed in previous posts was not that of simply sequencing, but rather combining segments from differing genes, by ever more complex and sophisticated means, in order to create a gene with properties that are not seen in nature.

Share this post


Link to post
Share on other sites

A gene created by recombining other elements would arguably be a creative product of the human mind. As Ayn Rand observed (I remember being especially impressed when I first read it), human creativity actually amounts to rearranging the existing elements of reality. I think that would apply even if the elements were large segments of natural genes - it wouldn't have to be at the level of a completely new sequence of bases.

However, currently, natural gene sequences with no human modifications have in fact been patented - that's part of what I was criticizing in my earlier post.

Share this post


Link to post
Share on other sites