Many thousands of patents which assert rights over
DNA sequences have been granted to researchers across the public and private sector.
Many patents that assert rights over DNA sequences have already been granted but are of
doubtful validity. This talk will argue that in the future, the granting of patents that assert
rights over DNA sequences should become the exception rather than the norm.
To achieve this, the criteria already in place within existing patent systems for the
granting of patents, particularly the criterion of inventiveness, should be stringently
applied to applications for product patents which assert rights over DNA sequences for
use in diagnosis, for use as research tools, and in gene therapy. Only in the case of claims
for DNA sequences based on therapeutic proteins should patents to be broadly
acceptable, provided that they are narrowly defined.

Dr Sandy Thomas
Director, Nuffield Council on Bioethics
Ref. The ethics of patenting DNA can be downloaded from the Council’s website:
www.nuffieldbioethics.org
 

DNA fingerprinting based on highly variable minisatellites was accidentally
developed in 1984. Initially seen as an academic curiosity, it soon saw major
applications in kinship disputes and criminal investigations. Subsequent refinements
in DNA profiling and PCR-based DNA typing systems led to the development of
high throughput systems and the creation of major national DNA databases that are
already proving extraordinarily effective in the fight against crime.
DNA fingerprinting has also provided access to some of the most variable and
unstable loci in the human genome, allowing direct mechanistic studies of some
classes of human heritable mutation. This work, facilitated by direct analysis of
mutation in sperm, revealed the role that aberrant meiotic recombination plays in
driving repeat DNA instability at minisatellites.
The development of single sperm methods capable of detecting crossover and gene
conversion events at the sub-kilobase level of resolution has allowed us to explore
broader questions concerning recombination processes in humans and how these
impact on patterns of human DNA diversity. Evidence to date shows that meiotic
crossovers are far from randomly distributed in human chromosomes but instead
concentrate into very narrow hotspots that probably contain sites of recombination
initiation, and that these hotspots, which occasionally spawn minisatellites, can
profoundly influence haplotype structures in human populations.
Minisatellites provide efficient systems for monitoring germline mutation in humans
and animals, and have been used to study the effects of environmental agents such as
ionising radiation on heritable mutation. Repeat DNA instability in the mouse
germline is highly sensitive to radiation, with mutation induction occurring by an
enigmatic indirect process that can persist into subsequent generations. The situation
in humans is less clear, with some studies - for example on Chernobyl - providing
evidence for radiation-induced heritable mutation, and others showing no sign of
mutation induction.