The concept of patenting has been around for many centuries. The idea was to grant
monopoly to inventors in exchange for information that others could then use to
improve practices in science and the practical arts. Few will dispute the idea
that the patent system has been a force for good, but as we stand on the brink
of one of science's greatest achievements - the complete sequencing of the human
genome - the issue of how and when to assign patent rights to all manner of DNA
sequences threatens to throw the patent system into disarray.
Patents must satisfy four criteria: the innovation must be useful, novel, nonobvious,
and must be described in sufficient detail as to enable one skilled in the field
to use it for the stated purposes. Persons or companies filing for a patent submit
their application to the Patent and Trademark Office (USPTO) in the Department
of Commerce. Patents are good for 20 years upon the date of filing. Currently
over three million genome-related patent applications have been filed.
There are various areas in genetics for which patents are issued such as gene
fragments, SNPS, Gene Tests, and Proteins. The patenting of gene fragments has
already sparked controversy. Patenting fragments of minimal use generates problems
for someone trying to patent a larger fragment or gene that contains an already
patented sequence. This adds undue costs to the researcher and raises issues such
as will the 2nd inventor need to obtain a license from the first or patent without
the holder's permission. SNPs are variations that occur in the DNA when a single
nucleotide is altered and are of great value for research as they have a major
impact on how humans respond to disease. One can also patent Gene Tests which
help screen for genes responsible for a certain disease. Already the gene-based
diagnostic tests for cystic fibrosis and breast cancer have been of utmost beneficence
in developing new healthcare products. The test are usually patented by the owners
of the disease gene patent and each time the tests are administered by licensed
individuals, royalties are paid to the patent holders. Finally, patenting proteins
have been found very useful in pharmaceutics. Proteins are important in understanding
gene function which in turn can be used in designing new drugs.
Although many researchers find the concept of intellectual property as a hindrance
upon their freedom, there are many arguments in favor for gene patenting. Inevitably
the rewards for their discoveries can enable the inventors to further enhance
their research. Patents grant the right to exclude other competitors from using,
selling, and making the invention for a limited time (20 years). Wasteful duplication
of effort is prevented and researchers are forced to explore new and uncharted
territory. Also, secrecy is eliminated and the public is ensured access to the
new knowledge.
There are however the drawbacks which manifest controversies and arguments against
patenting in a genetic age. As mentioned above, patent of partial fragments reward
those who take advantage of the easiest step and penalize those who actually determine
the biological use and discover the larger picture. Patents interfere with the
therapeutic utilization by third parties due to the high costs with using patented
data. Patent stacking - allowing a single genomic sequence to be patented in several
ways (a gene, EST, SNP) may discourage product development due to high royalties.
Due to the secrecy of patent applications, other researchers working on the same
innovation will unknowingly lose money and be subject to possible infringement
penalties. Patent holders are being allowed to patent a part of nature which allows
one organism to own all or part of another organism. Private biotechs who own
certain patents can monopolize certain gene test markets. Finally, patent filings
are reducing the body of knowledge in literature by replacing journal articles.
Patent guidelines are getting more stringent as the patent office reconsidered
its utility guidelines for genes and tightened them somewhat in December 1999.
As we are awaiting the completion of the Human Genome Project in 2003, it is imperative
to refine the gaps and discrepancies that now exist in the patent system. As the
"Universal Declaration on the Human Genome Project" states in articles 1-4 the
human genome shall not give rise to financial gains and should be geared toward
human benefit. Inevitably, it is the general public who should gain from this
incredible innovation, and thus patents should be awarded with this in mind. Although
many issues and unavoidable debates will arise due to the delicacy of the matter,
I believe that by and large patents are generally positive things. In the larger
picture, they are necessary in order to protect the researchers and are means
of regulation. In the case of genetic patenting, it is the scope and number of
claims that has generated controversy - not the issue of patents themselves.
