Biotechs: Patenting Nature
Mar 22 2000
Can something that exists in nature be patented? This is one of the big questions in medicine today, for if a company can patent a gene, what's to stop it from patenting human DNA or a substance in the periodic table of elements? Human Genome Sciences [HGSI] released fantastic information last month about the identification of a genetic sequence that lowers susceptibility to the HIV virus. Yesterday, however, some errors in the gene patent were pointed out, bringing the issue into the spotlight.
The bottom line is that patents in this arena must be specific. Broad attempts to patent genetic information will be denied or will not stand up under legal challenge or scientific scrutiny. In Human Genome's case, we believe the registration will be upheld because it is specific as to the function of the gene, and such patents are constantly being refined to strengthen their position.
Since a gene is not something that a scientist creates, should it be patentable--and are such patents enforceable? Gene, or a genetic fragment, can be patented under certain circumstances. If you gather the sequence of a portion of DNA and submit it to the patent office, you will be politely informed that you have nothing of substance. However, if you find a fragment of a gene that you wish to use to test for a specific disease, you have a pretty good shot at approval. So what's the difference?
In order to receive a patent, you must not only indicate a genetic sequence but also go the extra mile towards identifying the function of that gene. That's much harder than it sounds, as a single gene may be only a single component of a disease process.
Here's how the patent process works: first, a genetic fragment thought to be involved in a biologic function is identified. Attempting to patent a genetic fragment may tip your hand to competitors, though, so it behooves you to identify the entire gene involved. And even that will not protect you entirely until you identify the precise function of the gene.
To strengthen the patent, scientists must go beyond the gene and identify the protein that the gene produces. From there, pharmaceutical composition must be identified, the usage of the medication specified, and the manufacturing process detailed. Each of these steps builds upon the other and helps strengthen the patent position.
In the case of naturally occurring substances such as insulin, it is imperative to focus on the manufacturing process in order to differentiate your insulin product from another. In many cases, the process by which the drug is derived is more important than the drug itself.
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