Patenting

Dr. Fazli Wahid

COMSATS Institute of Information Technology, Abbottabad

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What is a patent and what is patentable?

A patent may be described as a monopoly granted by a

government to an inventor, such that only the inventor may exploit the
invention/innovation for a fixed period of time (up to 20 years).
In return, the inventor makes available a detailed technical
description of the invention/innovation so that, when the monopoly
period has expired, it may be exploited by others without the
inventor’sn permission.
A patent, therefore, encourages innovation by promoting research
and development.
It can also be regarded as a physical asset, which can be sold or
licensed to third parties for cash.
Patents also represent a unique source of technical information
regarding the patented product.

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What is a patent and what is patentable?

The philosophy underlining patent law is fairly similar throughout

the world.
Thus, although there is no worldwide patenting office, patent
practice in different world regions is often quite similar.
This is fortuitous, as there is a growing tendency towards world
harmonization of patent law, fuelled by multinational trade
agreements.
In order to be considered patentable, an invention/innovation must
satisfy several criteria, the most important four of which are:
novelty
non-obviousness
sufficiency of disclosure
utility

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Patenting in biotechnology

Many products of nature (e.g. specific antibiotics,

microorganisms, proteins, etc.) have been successfully patented.
It might be argued that simply to find any substance naturally
occurring on the earth is categorized as a discovery and would be un-
patentable because it lacks true novelty or any inventive step.
However, if you enrich, purify or modify a product of nature such
that you make available the substance for the first time in an
industrially useful format, that product/process is generally
patentable.
In other words, patenting is possible if the ‘hand of man’ has
played an obvious part in developing the product.

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Patenting in biotechnology

In the USA, purity alone often facilitates patenting of a product

of nature.
The US Patent and Trademark Office (PTO) recognizes purity as
a change in form of the natural material.
For example, although vitamin B12 was a known product of nature
for many years, it was only available in the form of a crude liver
extract, which was of no use therapeutically.
Development of a suitable production (fermentation) and
purification protocol allowed production of pure, crystalline vitamin
B12 which could be used clinically.
On this basis, a product patent was granted in the USA.

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Patenting in biotechnology

Using the same logic, the PTO has granted patents, for example,
for pure cultures of specific microorganisms and for medically
important proteins (e.g. Factor VIII purified from blood and EPO
purified from urine).
Rapid technological advances in the biological sciences raises
complex patenting issues, and patenting law as applied to modern
biotechnology is still evolving.
In the late 1980s, the PTO confirmed they would consider issuing
patents for non-human multicellular organisms, including
animals.
The first transgenic animal was patented in 1988 by Harvard
University.
The ‘Harvard mouse’ carried a gene that made it more susceptible
to cancer and, hence, more sensitive in detecting possible
carcinogens.

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Patenting in biotechnology

Another area of biotechnology patent law relates to the patenting of

genes and DNA sequences.
Thus far, patents have been issued for some human genes, largely on
the basis of the use of their cloned products (e.g. EPO and tPA “tissue
plasminogen activator”).
A consensus has emerged that patent protection should only be
considered for nucleotide sequences that can be used for specific
purposes, e.g. for a sequence that can serve as a diagnostic marker or
that codes for a protein product of medical value.
This appears to be a reasonably approach, as it balances issues of
public interest with encouraging innovation in the area.
The issue of patenting genetic material or transgenic plants/animals
remains a contentious one.
The debate is not confined to technical and legal argument: ethical
and political issues, including public opinion, also impinge on the
decision-making process.

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Patenting in biotechnology
The increasing technical complexity and sophistication of the
biological principles/processes upon which biotechnological innovations
are based also render resolution of legal patenting issues more difficult.
A major step in clarifying European Union (EU)-wide law with
regard to patenting in biotechnology stems from the introduction of
the 1998 European Patent Directive.
This directive (EU law) confirms that biological material (e.g.
specific cells, proteins, genes, nucleotide sequences, antibiotics, etc.) that
previously existed in nature are potentially patentable.
However, in order actually to be patentable, they must
(a) be isolated/purified from their natural environment and/or be
produced via a technical process (e.g. rDNA technology in the case of
recombinant proteins) and

(b) they must conform to the general patentability principles regarding

novelty, non-obviousness, utility and sufficiency of disclosure.

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Patenting in biotechnology
The ‘utility’ condition, therefore, in effect prevents patenting of
gene/genome sequences of unknown function.
The directive also prohibits the possibility of patenting inventions
if their exploitation would be contrary to public order or morality.
Thus, it is not possible to patent:
the human body;
the cloning of humans;
the use of human embryos for commercial purposes;
modifying germ line identity in humans;
modifying the genetic complement of an animal if the modifications
cause suffering without resultant substantial medical benefits to the
animal/to humans.

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COMSATS Institute of Information Technology, Abbottabad

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