As discussed in The Supreme Court Reviews Myriad's Gene Patents, the justices have agreed to tackle the issue of patenting human genes, at least in the context of the challenge to Myriad's patents on the BRCA cancer genes. However, what does patenting a human gene actually mean? Actually, natural genes cannot be patented so what do companies really have claims on and what rights does this give them? It turns out this is not so clear. Although patents have been awarded for genes, the rights grant by these documents remains somewhat murky.
DNA: The Chemical with the Codes
Genes are made up of DNA which is a chemical with a unique structure that encodes information. It is somewhat of a special chemical in that way. DNA can be thought of a chain made of four different chemical links: adenine (A), cytosine (C), guanine (G),and thymine (T). The order of the chemical links, known as nucleotides bases, define a code that is used to make all the proteins in the body that run the chemical reactions for life.
It is the particular order in which hundreds of these four chemical bases are linked together along a stretch of DNA that makes each gene different, like different sequences of the 26 letters in the alphabet make different words. Different genes have almost the same chemical composition. It is not the chemical nature of DNA that makes genes, it is the information encoded in the way the chemical components are ordered that is the gene. As James Watson, one of the co-discoverers of the structure of DNA, says, "The myopic viewpoint thinks of a human gene as merely another chemical compound, composed of various bases and sugars. But history and science teach us otherwise. A human gene, which is a product of nature, is useful because it conveys vital information."
This unique nature of DNA as information is what makes the patent issue so difficult. Patents are meant to provide companies with either the rights to something they make or process they use to make it. Natural products can't be patented but innovative ways to isolate them can be, and so can ways to make or synthesize copies of natural products. Unique or specialized chemicals made in the lab that include DNA components would be typical material for patents. However, since natural genes are not unique chemically, what's there to patent?
The Difficulty in Patenting Genes
Researchers spend a lot of time and money to work out what different gene variations affect diseases or other traits. Companies, in exchange for this investment, reasonably want some protection to develop products they can market and sell without interference or competition for at least a while. This exclusive right to some product or process is the purpose of a patent. However, the most essential and useful characteristic of a gene is simply the order of the chemical DNA bases it contains, or the simple fact that one base is sometimes different or mutated in some people with a certain trait. Since these natural characteristics cannot be patented, what can the company patent?
One typical patent approach for unpatentable natural chemicals is to patent the method used to isolate or make the chemical in the laboratory. However, since the chemistry of DNA is essentially standard across all animals, laboratory techniques to identify, isolate, copy, and otherwise manipulate it are mostly common knowledge to anyone trained in biology. In other words, there is very little to patent in terms of an innovative method to isolate and identify a specific gene. Of course, new general techniques to work with and analyze DNA are developed and patented all the time for research, but they apply to most any DNA, not just one specific gene. So, what's left to patent when specific gene variations are found associated with diseases?
Patenting Isolated DNA Molecules
As the blog for the Biotechnology Industry Organization (BIO), points out, gene patents typically claim rights to preparations that contain isolated DNA molecules for the gene which are configured differently than they are in nature. In fact, DNA in its natural state is not very efficiently organized. The evolutionary process produced sort of a mess and pieces of genes are not neatly arranged in normal DNA. There are a whole list of biological steps required to decode a gene.
Making copies or mimics of a natural genes requires shuffling around pieces of DNA and combining them together with other pieces of DNA to make a non-natural construct. Isolated DNA molecules that have been prepared in this manner enable researchers to work with them to find out about what the gene does. Also, these isolated DNA molecules often become part of diagnostic test kits as references to compare with patient samples. As the BIO blog notes, since these isolated gene preparations are not exactly equivalent to the gene's DNA in its natural state, it is these preparations that companies patent.
As mentioned above, though, the techniques to prepare constructs incorporating isolated genes are mostly standard, so other labs can make them for the same gene too. What's more, the isolated DNA preparations will often be different between different labs. There are many ways to make these DNA constructions. So, does a company's patent on one isolated DNA molecule for a gene also cover other constructions of the same gene too, even if they are in different configurations? How expansive can the company make the claims of their patent for an isolated DNA molecule?
Can a Company Claim to Own the Gene?
As the BIO blog note goes on to explain, a company also cannot just patent any isolated gene. To get a patent, the application has to include some information about what the gene does and would be useful for. This additional criteria helps ensure patent rights focus on a specific application, for example a test for a disease, or sensitivity to a drug. So, if others find a different use for the gene, it is possible they could also get a different patent on another use for the same DNA.
However, in practice, this requirement to include information about what the gene is useful for also gives patent holders a claim on all rights to use the gene for that particular use. In other words, if a company such as Myriad has rights to two isolated DNA sequences corresponding to genes that are associated with breast cancer, they might argue that anyone doing any research on how these genes affect breast cancer infringe on their patent. In fact, this is precisely how Myriad's lawsuit started. Researchers working on the BRCA genes Myriad patented were angry when Myriad sent them legal notices to stop their work.
The Crux of Gene Patenting
The question really, then, is how extensive are patent rights on DNA sequences made in the laboratory that mimic unpatentable natural genes. The term 'gene' is not as precise as chemical. A chemical is unique but a gene, as described above, really describes the information a DNA molecule contains. Yet, gene patents are modeled on patents of other biological molecules and chemicals. Maybe, this isn't a good approach.
In fact, DNA can come in many configurations and still have similar functions or effects. Are two isolated DNA molecules in different configurations with almost identical function, the same genes or different genes? Does a company own just the specific isolated version of the gene they made for the patent? If so, the patent wouldn't really provide any protection. On the other hand, should the patent claims provide protection so broad that the company owns all rights to any isolated laboratory-made mimic of the natural gene? If so, it would be very difficult for other researchers to investigate how the gene works.
It is these questions that have pushed this case to the highest court in the US. Let's see where they decide to draw the lines between the two extremes.(Published: January 14, 2013)