Why all the fuss about biotech/genomics patents?

The idea of patenting human genes has raised significant concerns in both the medical community and public at large. Many have questioned whether patents should be granted for human gene sequences under any circumstances. A British woman, upset by the granting of patents on human gene sequences, is trying to become the first person to patent herself. In a letter from the patent office, Donna MacLean’ was told that her application would be examined if she sent them the ?130 application fee. To obtain a patent an invention, the inventor must prove their invention is both novel and useful. In her patent application, Ms MacLean claimed she is both. “It has taken 30 years of hard labor for me to discover and invent myself, and now I wish to protect my invention from unauthorized exploitation, genetic or otherwise,” she wrote.

The debate concerning the patenting of gene sequences began in June 1991, when the NIH filed a patent application on 350 partial DNA sequences, which was followed by a February 1992 filing on 2,375 sequences. One aspect of the controversy apparently arises from the belief in certain public sectors that companies are effectively being given ownership to what already exists in nature. In this regard, the confusion apparently stems in part from an overly broad understanding of the meaning of “gene” in “gene patenting,” giving it its broader meaning as a mechanism of heredity.

By law, to be patented, a gene must be in a form that is different from the way it exists in nature, such as part of the human genome. That is, patents are not granted on genes as they exist in the human body. Once the sequence for the gene has been identified, however, other compositions which include that sequence can be patented. This is analogous to other “natural products” for which patents have been granted, including taxol which is isolated from the yew tree and rapamucin which is isolated from soil microbes. Thus, gene patents do not have any claims on the genes in people‚Äôs bodies. Rather, they provide property rights to isolated DNA sequences and the proteins expressed by those DNA sequences -individual genes removed from the natural context of the human body and rendered useful by crafting them in specific ways for medical use. These “genes,” in the context of patents, are artifacts made by the hand of man, and as such, they are subject to being patented.

Another facet of the debate concerns the suggestion that the patenting of genes will lead to the restraint of further use of new knowledge, in contrast to the goal of science which is to permit others to build from new knowledge. In many ways, this dispute can be distilled down to the question of where to achieve balance between the best way to protect investments in genomic research and the best way to distribute it. While patenting of fully characterized genes is considered valid by most researchers, the mere presence of many patent applications and granted patents based on partial sequences has created tremendous uncertainty in the biotechnology sector about freedom-to-operate in drug design and diagnostics when the role of a particular gene in disease is finally elucidated. Ultimately, it will fall to the courts to clarify what is and what isn’t patentable, though a generic decision may not be handed down for several more years. In the meantime, despite the application of new guidelines for determining the scope of patentability for claims based on partial sequences, the variability in the types of supporting data and the willingness of examiners to except post-filing evidence will continue to prevent the patent bar from offering any meaningful advice about the actual likelihood of a dominant patent being granted based on partial sequence data.