Patenting our human heritage
A two part series
Prof Ames Dhai
Part one: The threats posed by patenting DNA
Patenting in biotechnology has been subject to increasing public scrutiny as
a result of the profound changes in the way research in the life sciences has
become commercialised. This has resulted in immense ethical and legal
controversy.
Numerous human DNA sequence patents have been granted to date but it is
questionable as to whether these achieve either the goal of stimulation of
innovation for the public good and or rewarding people for useful new
inventions.
Patent offices have tended to be generous in granting patents in relation to
DNA sequences and many of the patents are broad in scope because a successful
patent holder for a DNA sequence will in effect obtain broad protection on all
uses of the DNA and often on the proteins that the DNA produces. In addition,
patents have been granted when the usual criteria for inventiveness and utility
have been inappropriately and weakly applied.
In awarding patents for DNA sequences, patent offices fail to take into
account that DNA is a naturally occurring phenomenon and hence, scientific
knowledge concerning the DNA is not eligible for patenting.
What is also not considered is that DNA sequences, unlike other patentable
chemicals, carry the body's information as to how proteins are to be
constructed. It is questionable as to whether this type of information can
properly be patented.
Patent offices have taken into consideration that cloning techniques have
been used to create artificial molecules that carry the same genetic information
as found naturally in the human body. The base sequences would not be
identifiable were the genes not isolated and cloned. This would satisfy the
patents' criteria for inventiveness. However, with the increasing availability
of the human genome sequence over recent years, cloning techniques are no longer
necessary to identify the DNA sequences of genes. DNA sequences can now be
identified from computer databases and therefore the inventiveness criteria for
patenting will not be satisfied. Scientific knowledge about DNA sequences is no
longer dependant on the construction and analysis of an artificial molecule.
Other arguments against patenting of genetic materials are:
* Patents of partial and uncharacterized DNA sequences will reward those who
make routine discoveries but penalize those who determine their biological
function or application.
* Patents could impede the development of diagnostics and therapeutics by
third parties because of the costs associated with using patented research data.
* Patent stacking may follow. A single genomic sequence may be patented in
several ways. High royalty costs could discourage product development; costs
that will be passed on to the consumer.
* Companies may work on developing a product and find that new patents have
been granted along the way for that product. Unexpected licensing costs and
possible infringement penalties may follow.
* Costs are incurred for paying for patent licensing, and also for
determining what patents apply, and who has rights to downstream products.
* Private biotechnology companies that hold certain patents can monopolize
certain gene tech markets.
* Patent filings are replacing journal articles as places for public
disclosure. As a result, our body of knowledge is reduced.
* Following a discovery, patent application and first publication generally
occur relatively quickly and at around the same time (applications must precede
publication to retain international rights). Although physicians may adopt the
test, and it may be accepted within the standard of care, the patent itself will
not issue for close to two years or more. When the patent finally is awarded,
laboratories that have adopted the test may be faced with licensing fees,
royalty payments, or, in the extreme case, a prohibition on performing the test.
* Potential restrictions on research: there may be a monopoly on research
resources (blood and other clinical tissue samples). Widespread clinical use and
observation, which are necessary for medical advances, may be inhibited.
External study and the validation of the patentee's research and clinical
services may be inhibited. There could be an imposition of stifling
reach-through conditions on licensees and of unethical constraints on the
performance of research by others.
* Patents clearly raise concerns about conflicts of interests. Laboratories
may engage in unwarranted promotion, including direct patient marketing.
Individual clinicians or researchers may overuse tests in which they have
financial interests, and may be overly aggressive in soliciting research
subjects.
* Patents may reduce access to services including testing services. Single
service providers may refuse medical insurance reimbursements or require
prepayments from patients. Monopoly rents, or excess profits attributable to the
patent, will be extracted from those able to pay, to the detriment of those
patients effectively priced out of testing by the monopolist.
* Exclusive service providers will interfere with the practice of medicine.
Direct patient marketing may undermine provider education, and it may well
undermine standards calling for adequate patient education and counseling
surrounding genetic testing services.
* Disease gene patents have the very real ability to prescribe nationwide
medical practices and to dictate the medical standard of care. Patents may grant
them the ability of dictating what kind of tests may be done, or limiting the
conditions for which testing may be done. This is an unacceptable outcome of
medical process patenting and again highlights the fundamental incompatibility
between diagnostics process patents and medical care.
* Patent holders are being allowed to patent a part of nature - a basic
constituent of life; this allows one organism to own part or all of another
organism.
That the human genome is our common heritage is an idea that has been
championed by various organisations including UNESCO which declared "the
Human Genome underlies that fundamental unity of all members of the human family
… The human genome in its natural state shall not give rise to financial
gains."
The Medical Research Council of South Africa equates the patenting of human
genes and proteins) to "biopiracy" and states that this is foremost a
commercial issue where profit becomes the incentive for research and
development. It questions whether the price paid to the contribution of
knowledge is not too high. Apart from concerns over the transactional costs of
patenting human biological material, there is another response to such
patenting, which posits that the human body cannot be the subject of property
rights. Objections are based on human rights theories related to human integrity
and dignity, and religious and spiritual values and beliefs. At the heart of the
objection is a concern that human beings should not be objectified. For a patent
to be eligible, the invention must not be contrary to morality or ordre public.
Hence, patents should not be granted for inventions the publication or
exploitation of which would go against the mores of society. Patenting of
genetically engineered plants and animals as well as the patenting of human
genes falls foul of this.
Read part TWO
More information:
Prof Ames Dhai is the Head, Bioethics, Medical Law and Research Ethics at the
University of KwaZulu Natal, South Africa.
dhai@webmail.co.za
Public understanding of Biotechnology website www.pub.ac.za
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