Patents
8.19 In the recent publication of the draft human
genome by a for-profit company, Celera Genomics[65],
certain restrictions were placed on access to the raw data[66].
In contrast, the publicly funded effort to sequence the human
genome[67]
was predicated on the fact that the basic genetic information[68]
should be freely available in the public domain (see paragraph
8.14 above).
8.20 The position taken by the publicly funded consortium
was that patenting should be based on original discoveries derived
from the use of genetic information, in order to develop understanding
of gene or cell function or to make new pharmaceutical or other
products. There was wide support for this view among our witnesses
- including Dr Dexter (Q 102) and the Sanger Centre (p 88).
8.21 Dr Cheeseman explained that material that was
the subject of a patent application was published 18 months after
filing, so the information was available for use in making new
inventions. All patent applications had to satisfy the basic tests
for patentability, including being strictly new, not obvious over
what was already known and having some commercial/industrial use.
Discoveries were not patentable in themselves - something "new
and unexpected" had to be added. Dr Cheeseman noted that
patents did not give the holder any ownership of the invention
- rather, they prevented unauthorised commercial use of the patented
invention (Q 250(c)).
8.22 Dr Roses stated that GlaxoSmithKline fully supported
the European Directive on the Legal Protection of Biotechnological
Inventions[69]
and the ability to patent inventions based on isolated DNA sequences,
provided that the usual conditions for patentability were met.
Published patent applications were recognised as a valuable source
of technical information for making further inventions and discoveries.
Without the patent system, this information would not be readily
available to the public - and research, if conducted at all, would
be carried out under great secrecy. Dr Roses asserted that patent
law permitted non-commercial research on patented subject matter,
so pure research by academic institutions was not affected by
the existence of patents. Even in relation to commercial research,
it would often be possible to negotiate a license under the patent
- or challenge its validity. Third parties could also obtain dependent
patents to patent (and then licence) an improvement of a previously
patented invention or a new use for an already patented gene.
This was frequently encountered with pharmaceuticals and was in
principle no different in the genetics field (Q 250(c)).
8.23 A commentary in Nature[70],
by Professor Martin Bobrow of Cambridge University and Dr Sandy
Thomas of the Nuffield Council on Bioethics, noted the difficulties
surrounding the award of patents concerning genetic discoveries,
and the tendency to extend the patentability of biotechnology
to inventions for which thresholds of novelty, inventiveness and
utility had been lowered. They identified a failure of policy
in this area. While legal challenges to patents were available,
this route was often rejected by the private sector in favour
of individual licensing deals which were often quicker and cheaper
to achieve.
8.24 Dr Power indicated in supplementary evidence
that Pfizer pursued patent rights for inventions having the highest
value for drug discovery, for example, biological function of
proteins, screening reagents (such as novel enzymes and receptors)
and biomarkers identified from outcome studies and toxicological
prediction (Q 250(c)).
8.25 In written evidence, the Sanger Centre took
the view that the patenting of genes was reasonable where a significant
function had been directly established. However, the patent should
cover only the application of that function and natural extensions,
as opposed to patents which covered all possible but not yet envisaged
and speculative uses of a gene (p 88).
8.26 As far as secondary use of data was concerned,
scientists at the Sanger Centre believed that work that contained
a creative element could be rewarded - for example, information
derived from analysis and annotation that combined information
from multiple sources. This could allow recovery of the costs
of forming the data collection. However, the rights should not
be extended over others who reached similar conclusions independently.
In most cases, the most effective way to disseminate results of
publicly or charitably funded research was to write off the cost
of producing the data and place the resulting database in the
public domain (p 88).
Conclusions
8.27 In common with most of our witnesses, we do
not regard ownership of biological samples as a particularly useful
concept with respect to human genetic databases. We prefer the
notion of partnership between participants and researchers, for
medical advance and the benefit of others, including future generations.
8.28 Much of the research that we discussed in earlier
Chapters is of a basic nature funded in large measure from public
funds with some commendable support from the private sector (e.g.
the SNP Consortium). The results of that research are freely available
to all.
8.29 Building on these basic data to develop the
hoped-for new treatments will require substantial investment of
risk capital. The private sector will make that investment only
if it has the degree of protection afforded by patenting of inventions
and discoveries in order to turn them into products. The protection
given, however, should not be such as to stifle research progress.
In our view, patenting in the field of genetics is, in principle,
no different from that in other fields.
8.30 We strongly endorse
the position taken by the International Human Genome Sequencing
Consortium, the Sanger Centre, The Wellcome Trust and others that
insists that the primary genetic sequence data should be freely
available in the public domain. Patenting of intellectual property
should be based on innovations and original discovery from the
use of genetic information, in order to develop understanding
of gene or cell function or to make new pharmaceutical or other
products. We recommend that the Government should press, both
within Europe and more widely, for patent rights over genes to
continue to be granted only where a significant gene function
has been established, and to ensure that the patent should cover
only that function and direct extensions of it. Possible but not
yet envisaged and speculative uses of a gene should not be patentable.
8.31 As we have found during
the course of our Inquiry, a distinctive feature of genetics is
the rapid pace of change. For the future, we recommend that
the Government should monitor closely patenting practices in the
field of genetics and take steps as necessary to ensure that the
proper balance is maintained between protecting inventors' interests,
facilitating commercial development of ideas and allowing research
to flourish.
62 Relevant parts of which are, for convenience, reproduced
as QQ 250(a)-(d) on PP 54-57. Back
63
International Human Genome Sequencing Consortium. "Initial
sequencing and analysis of the human genome." Nature
2001; 409: 860-921. Back
64
In its Statement on Benefit Sharing, 9 April 2000. Back
65
J Craig Venter et al. "The sequence of the human genome."
Science 2001; 291: 1304-1351. Back
66
Marshall E. "Celera and Science spell out data access provisions."
Science 2001; 291: 1191. Back
67
International Human Genome Sequencing Consortium. "Initial
sequencing and analysis of the human genome." Nature
2001; 409: 860-921. Back
68
Including SNP data, as noted by Dr Cameron and Professor Ashburner
(p 110). Back
69
98/44/EC. Back
70
"Patents in a genetic age." Nature 2001; 409:763-764. Back