By Ivan Ojakol*
Abstract:
I will go about this essay in the following ways; I will start by defining what genetic engineering is, the purpose of patenting in this area and then will look at the patentability of the subject as far as intellectual property is concerned. I will state some of the genetic research tools and examples of patents that exist in this field and proceed to look at the criticisms and controversies entailed in the patentability of genetic engineering especially as far as morality is concerned. That will then lead me to my conclusion.
Genetic
engineering is basically concerned with tailoring the genes of an
organism so that the newly modified organism will have desired
characteristics. It is the direct human manipulation of an organism’s
genetic material in a way that does not occur under natural
conditions.
According
to John R. Rudolph in A
study of Issues Relating to the Patentability of Bio-Technological
Subject Matter,
It is
part of a broader subject called bio-technology
which can be defined as the synergistic union of biological life
sciences and the technologically based industrial arts. They are more
or less one and the same with genetic engineering.
This
field, because of the gulf in development and scientific research in
western countries vis-à-vis African ones is mainly active in the
west. It is a research intensive industry requiring highly trained
and dedicated scientists, expensive laboratories and manufacturing
facilities. That is why all or most of the authorities on the subject
originate from countries like the US, Canada and the United Kingdom
and these have had a profound effect on other countries.
Particular
international agreements like the TRIPS
(Trade Related Intellectual Property Rights) agreement, the European
Union Directive on the Enforcement of Intellectual Property Rights,
European Patent Convention 1973
and Paris
Convention
for the Protection of industrial Property (1883)
are
of great significance as far as this subject is concerned.
The
purpose of patents in bio-technology and genetic engineering is to
promote progress in science and technology. It holds the key to
tomorrow’s medicine. Through bio-technology and genetic
engineering, future doctors and medical people will have a plethora
of weapons to fight against disease, injury and age.
Patents
in this field stimulate innovation in bio-technology companies by
encouraging the dedication of people, capital, and time to the search
for a new drug. According
to Beth and Zei in Patenting
genes and genetic research tools: Good or bad for innovation, If
the search is successful, those who have invested will obtain a
substantial reward for taking the risk. This is in line with the
justification for intellectual property rights which is that people
should be entitled to the fruits of their labour or a reward for the
sweat of their brow.
The TRIPS Agreement under
Article
70 (9)
consolidates
this position where it provides for the protection of pharmaceutical
and agricultural chemical products, data submitted by the originator
which secured such authorization and this stops a second application
for authorization during the term of the exclusive marketing rights
even if the “follower” generic company generates its own data.
The
TRIPS agreement under
Article 27.3(b), provides
for the patentability of micro-organisms and essentially biological
processes for production of plants and animals.
The
European
Union Directive on the Enforcement of Intellectual Property Rights
under
Article
4, provides for the patentability of inventions which concern
microbiological or other technical process or product obtained by
such a process. It further provides under
Article 5 that
an isolated element from the human body or otherwise produced by
means of a technical process, including the sequence or partial
sequence of a gene may constitute a patentable invention.
In
the first case that granted a patent as far as bio-technology and
genetic engineering was concerned, Diamond
v Chakrabarty 447
U.S 303 (1980) where
an oil eating bacterium was found to be patentable; it was held that
an invention is patentable because it is a “non-naturally
occurring manufacture or composition of matter, a product of human
ingenuity having a distinctive name, character and use.”
In
Graham
v John Deere Co.
383
US, at 12-17.,
Mr.
Justice Douglas
reminded that the inventions most benefiting mankind are those that
“Push back the frontiers of chemistry, physics and the like.”
Patent
offices in the west have for years granted patents over genetic
material whether human or otherwise- whether a gene, DNA sequence,
EST as long as they meet the tests of novelty, non-obviousness and
utility or industrial application, they are patentable.
Patents must
fulfill the ultimate objective of encouraging the development of
genetic technologies into products for the public good. Through
that limited
monopoly of 20 years,
innovation is encouraged. Though it can also be argued on the other
side that this limited monopoly granted to patent holders allows them
to prevent others from independently investigating and offering new
products.
It is argued that when only one organization is able to
provide a particular clinical service, it becomes more difficult to
evaluate service or compare its quality with competing products. I
will address this in detail later in the essay.
The
requirements for registering bio-tech patents include;
Novelty:
The
invention must be novel. Novel means new. Section
10 of The
Industrial Properties Act, 2013
of Uganda states that an invention is new if it is not anticipated by
prior
art
or where a person who is highly skilled in the relevant area could
not derive the invention from a combination of prior disclosed art.
In a nutshell, a patent will be barred if the invention was invented
by another at least one year prior to the patent filing date or if
the inventor or another had publically used or offered it for sale
more than one year prior to the patent filing date. In Chiron
Corp v Organon [1994] FSR 202,
the inventive step lay in using the expression screening in an
unconventional manner to identify a protein.
Non-obviousness
or
inventive step:
The
Industrial Properties Act, 2013
(under
section 11) of
Uganda states that an invention is new if it is not anticipated by
prior art relevant to the application claiming inventions it would
not have been obvious to a person skilled in the art.
A patent will
not be granted if the differences between the subject matter sought
to be protected and the prior art renders the subject matter as a
whole obvious at the time the invention was made to a person having
ordinary skill in the art. When determining obviousness, the law
attempts to look through the lenses
of a person skilled in the art of invention.
For instance, although a new function or use for a known protein may
not be obvious to everyone, but obvious to a trained biologist who is
cognizant of all that had been reported in the literature about the
particular protein, then the patent cannot be granted in such a case.
So the fact that nucleic and amino acid sequencing are well known
does not mean that novel sequences discovered using these standard
procedures are “obvious”
and thus unpatentable. The relevant inquiry is obvious in view of
well-known structures.
Utility
or industrial application:
Section
12 of The
Industrial Properties Act states
that
“An
invention shall be industrially applicable if according to its
nature, it can be made or used in any kind of industry
including….medicine...”
The
new process, machine or manufacture must be useful. The patent
specification must provide at least one practical use for the
invention. The United
States Patents and Trademarks Office
has set forth a three-pronged test; the utility must be “specific,
substantial and credible”
For
example, U.S
patent no. 6 6,025,154
to human genome sciences claims polynucleotides encoding a human
G-protein chemokine receptor designated as HDGNR10. The patent
specification points out that compounds such as soluble form HDGNR10
which inhibit the activation of membrane bound HDGNR10 receptor may
be employed to treat “allergy, atherogenesis, malignancy,
histamine, anaphylaxis, among others.
Disclosure
is paramount when registering a patent and is statutorily provided
for. The
European Union Directive on the Enforcement of Intellectual Property
Rights
under
Article 5 (2), states
that the industrial application of a sequenced or partial sequence of
a gene must be disclosed in the patent application. In
the case of Biogen
v Medeva [1996] 3 IPR 438,
it was held that claims 1 and 2 of the Biogen European Convention
were invalid since the claims were drafted in very wide terms.
Written
description:
The
inventor must describe the invention in sufficient detail to
demonstrate that, at the time the patent was filed, he or she was in
full possession of the invention. In Regents
of California v Eli
Lilly&
Co.,
the court invalidated a species claim to “human insulin c DNA,”
where the only nucleic acid sequence specification described in the
patent specification was obtained from a rat. Court held that an
adequate written description of DNA…requires a precise definition
such as by structure, formula, chemical name or physical properties.
Enablement:
This
is meant to ensure that a person having ordinary skill in the art is
will be able to make and use the invention after reading the patent
specification. For some materials that are difficult to enable
through a written description, a deposit of the materials in an
appropriate repository is required.
This position is in line with
section
16 (1) (a) of the
Industrial
Properties Act, 2013 of
Uganda that states that where an invention involves a
micro-biological process, the invention shall only be regarded
disclosed if a culture of the micro-organism has been deposited with
a depository institution not later than the date of filing the
application.
For example, the necessary enablement for a novel SNP
associated with Alzheimer’s-a team of researchers analyze the
genomic DNA from a population of Alzheimer’s patients and discover
that the DNA from many of these patients contains a novel SNP that is
not present in genomic DNA from subjects that do not have Alzheimer’s
and do not have a family history of it.
What must be disclosed in the
patent application to support these claims is that particular SNP as
well as sequences that hybridize the SNP as
per Patenting
genes and Genetic Research Tools: Good or bad for innovation?
By Beth E. Arnold and Eva Ogielska-Zei.
Best
mode:
To
satisfy the best-mode requirement, the inventor must disclose the
optimal way to practice the invention, if such a way is in fact known
at the time of filing.
Definiteness:
This
requirement obliges the patent applicant to draft one or more claims
particularly pointing out and distinctly claiming the subject matter
that the applicant regards as his invention. A person skilled in the
art ought to be able to decipher the boundaries of the claimed
invention from the claim language.
However, a number of claims are
still being issued with the broader “comprising” language for
example claims to nucleic acid sequences can in theory be broadly
drafted to cover not only the particular nucleic acid but any nucleic
acid that “comprises” it.
Some
genetic research tools include; a wide range of laboratory assays,
reagents and processes including informatics algorithms.
However,
genetic engineering and bio-technology patents have raised a lot of
dust and controversy over the years including questions of morality;
Further
more, Source
book on Intellectual Property Law by
Peter j. Groves also state that scientists
among them noble laureates are quoted suggesting that genetic
research may pose a serious threat to the human race.
Concerns
have been raised over the patentability of human genetic material,
through public protests and international statements from
politicians. For example, the June 2000 statement by French Minister
Elizabeth Gulgou, that human genetic patents violate French ethical
norms. This points to the politically charged nature of the
gene-patenting debate.
Even
international bodies have raised this concern like the 1997
UNESCO
Declaration on the
Human
Genome and Human Rights
states that the human genome in its natural state shall not give rise
to financial gains.
The
critics of bio-tech patents posit that the European Union Directive
and TRIPS Agreement are designed to allow all categories of patents.
They are neo-colonial instruments used by the west to impose their
policies on Africa and the under developed world.
The
opponents argue that the human experience cannot be commoditized.
That gene-patenting is a gross violation of human life. That it is
unethical and contrary to basic human rights as it creates
unnecessary suffering in animals and is contrary to public order and
morality. In
Why bio-tech patents are patently Absurd-Scientific Briefing on TRIPS
and related issues,
The
hit or miss technologies associated with many of the inventions are
inherently hazardous to human life and bio-diversity.
The
European Patent Convention under
Article 54 (2)
stipulates that a method of treating the human body by surgery or
therapy or of diagnosis practiced on the human or animal body is
unpatentable. The TRIPS Agreement under
Article 6 also
excludes from patenting, commercial exploitation contrary to “ordre
public or morality” such as human cloning, use of embryos for
industrial or commercial purposes and modifications of animals
causing substantial medical benefit.
The
opponents of gene-patents contend that they all involve biological
processes not under the control of scientists. That they cannot be
regarded as innovations but expropriations from life. That they
involve acts of plagiarism of indigenous knowledge. It has been
labeled “bio-piracy”
Notwithstanding
this strong opposition to the granting of gene-patents, the European
Patents Office and other areas in the west continue to grant
controversial patents. Mainly basing on the argument of economics, in
other words, this is an impetus for private investment. Companies
invest as much as $800m in research.
The decision of the Canadian
Court of Appeal in the Onco-mouse
(1990)
EPOR 4 and (1case
is a good example of how public policy and morality are not
considered. In that case, the patent application seeking a patent on
a genetically modified mouse was first rejected, on appeal; the Court
held that it is the legislature to decide the policy issue and not
the patent office.
Some
of the most controversial patents are;
Stem
cells which can be isolated from embryos, fetuses, newborns and
adults. The most controversial aspect of this is the therapeutic
human cloning which involves using nuclear transplant cloning to
create a human embryo. The UK became the first country in 2001 to
approve of such procedure.
Patents
of genes of plants. There are 229
patents on rice; the diet of the world’s poorest. This has affected
farmers’ rights to create new varieties or to preserve existing
ones. This has adverse effects on food security in Africa.
These
patents have also jeopardized the entire health system of countries
that depend on indigenous medicine. These patented drugs are even
very expensive for poor countries to afford.
In
conclusion,
I posit and contend that despite the major short comings of
gene-patenting, it should not be done away with; rather there is need
for greater enforcement of the regulatory mechanisms so that humanity
does not lose its soul to capitalism and commercialism.
Books and references for further reading
Statutes:
TRIPS
Agreement
European
Patents Convention, 1973.
European
Union Directive on the Enforcement of Intellectual Property Rights.
Industrial
Properties Act, 2013.
1997
UNESCO Declaration on the Human Genome and Human Rights.
Books:
Peter
J. Groves; Source
book
on Intellectual Property Law;
Cavendish Publishing Limited, 1997.
Others:
John
R. Rudolph; A
study of issues Relating to patentabilty of bio-technological subject
matter.
Gowling, Strathy & Henderson.
Timothy
Caulfield, E. Richard Gold and Mildred K. Cho; patenting
human genetic material: refocusing the debate
Dr.
Mae-Wan Ho; Why Bio-tech Patents are Patently Absurd-Scientific
Briefing on TRIPS and related issues. Institute of Science in society
London House, 24 Old Gloucester St. London WCIN 3 AL, UK.
* Ivan Ojakol is the President of the Uganda Christian University Law Society.