Introduction

Biotechnology is the science of developing techniques for the application of

biological processes and organisms to the production of materials of use in
medicine and industry.

Viewed from one perspective, biotechnology is no more than an aspect of

chemistry in that the raw material of biotechnology and its products most
commonly DNA and polypeptides, or proteins, for which these DNA
sequences, or genes, code are merely chemicals, albeit that many of them
occur in nature.

Certain aspects of biotechnology law have become an especially controversial

area of patent law, especially so in Europe, and particularly so in relation to
patents on genes or on living organisms such as genetically modified
animals.

Much such controversy ignores the fact that the patent system has been
protecting inventions in this field for many years, for example in relation to
naturally occurring but newly discovered living organisms, such as certain
yeasts or microbes that have value as the source of medicinal products such as
antibiotics, and that many patents with claims to genes in them, are now so
old that they have now expired.

RDNA Technology -

The consequences of the development in the 1970’s of recombinant DNA

technology, a tool for genetic engineering have however posed problems for
the patent system.

Certain of these problems such as the ‘product of nature’ issue encountered

by attempts to patent material of natural origin, are inherent in any patent
system, and it is those with which this paper is primarily concerned.

In the latter part of the 19th century, new inventions in the field of art,
process, method or manner of manufacture, machinery, apparatus and other
substances produced by manufacturers were on the rise in India and inventors
became very interested in getting their inventions protected.

Inventors were much concerned about the enforcement of their inventions that
others should not copy or infringe their inventions. In this background the

British rulers enacted the first ever patent law in India, i.e., Indian Patents Act,
1911 to offer patent protection to the inventions. Later, in the light of changing
economic and political scenarios the Act was thought as not comprehensive
and outdated. After independence, there were moves to consolidate the patent
law by bringing up a new comprehensive legislation.

At last in 1970, the government enacted the Patents Act, 1970. The Act
highlights that an invention that satisfies universally accepted requirements of
patentability such as novelty, inventive step and industrial application is
patentable.

The act defines invention to mean ‘any new and useful art, process, method
or manner of manufacture, machine, apparatus or other articles produced
by a manufacturer and includes any new and useful improvement on any of
them’.

The Act does not specify the inventions which are patentable, but it illustrates
subject matters that are not patentable.

The Act however did not mention anything about biotechnology inventions and
the reason for such was that at that time the biotechnology industry was not
developed in India and was in a nascent stage the world over as well.

Once patents were granted for different biotechnology inventions in the US

as well as in the European Union the demand for adopting the same approach
gained significance throughout the world including India.

The judiciary has been responsible for the evolution of patent law on
biotechnology inventions in the US as well as in the European Union.

Following such intervention patent laws were suitably amended and efforts
were made to grant patents on biotechnological inventions.

This momentum set new trends in the history of patent law and influenced the
adoption of international conventions like Trade Related Intellectual Property
Rights (TRIPS).

The agreement states that patents shall be made available to all types of
inventions in all fields of science and technology. The agreement mandates
patenting of biotechnology inventions in the member states.

After ratifying TRIPS, India modified all its intellectual property laws including
patents law and started marching towards patenting of biotechnological
inventions.’
TRIPS And Indian Patent Law

India has amended the Patents Act, 1970, three times in a span of five years.
The first was in the year 1999, to give effect to the provisions of the TRIPS and
thereby meet the first deadline, and some of these provisions were made
retrospective from 1995.

The second amendment was made in 2002 and brought the Indian law in
substantial compliance with the Agreement.

The third amendment was brought about in December 2004, which came into
force from 1 January 2005 to make the Patents Act fully TRIPS compliant.

The deletion of Section 5 of the Indian Patents Act, 1970 was important to
allow product patents in the area of biotechnology, chemicals and
pharmaceuticals.

Article 27(1) of the TRIPS Agreement clearly states that patents should be
granted for inventions in any field of technology without discrimination,
subject to certain clauses.

This implies that biotechnological inventions are patentable subject matter.

The patenting of genes or DNA sequences is popular in the US, the EU and
Japan.

However, patenting of genes or DNA sequences per se was not allowed in India
until January 2005, but processes involving recombinant DNA technology to
produce proteins involving a gene or a DNA sequence was patentable subject
matter.

Product patents for DNA, RNA or genetic inventions are patentable subject
matter from January 2005 following the third amendment.

The basic criteria for a patent to be granted are novelty, non-obviousness

(inventive step) and utility. – NIU

Negative List – Section 3

For a patent to be granted in India it should not be covered in the negative

list in Section 3 which provides an extensive list of what are not inventions
under the Indian Patents Act.

The inventions related to DNA molecules or sequences must not be contrary

to public order and morality.
An important exclusion in Section 3 (c) of the Indian Patents Act is that the
discovery of an invention is not patentable subject matter.

Therefore, the question of whether a DNA sequence is a discovery or an

invention must be addressed first.

This is based on an assumption that genes are naturally occurring, these are
discoveries, and not inventions.

There are no case laws in India regarding discovery.

In Europe also ‘discoveries’ are not patentable subject matter. There are not
many case laws in Europe either. The EC has however, issued directives and
guidelines regarding discoveries.

The guidelines and rules of the European Patent Office clarify that DNA or
gene sequences are patentable subject matter as these are considered
synthetic molecules isolated from the organisms and characterized and
produced as recombinant molecules or synthetic molecules containing the
information as in the natural genes.

The position in the US regarding discovery is different as compared to India

and Europe.

Under the US law, Section 101 reads “Whoever invents or discovers and new
and useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent there for, subject to
the conditions and requirements of this title.”

Funk Brothers seed Vs. Kalo inculant Co.

In the case of Funk Brothers Seed Co v Kalo Inoculant Co, the patent
involved a process for inoculating leguminous plants with strains of naturally
occurring bacteria to allow the plants to fix nitrogen from the air.

Wherein the Court laid down that, the claimed inventions are a ‘discovery of
the phenomena of nature’, and therefore genes should not be patentable. A
gene is not an ‘invention.’ However, while the Court never explicitly overrules
Funk Brothers, it limited its holding in a subsequent decision.

Diamnond V. Chakrobarty

In Diamond v Chakrabarty, the Court held that bacteria, which had been
genetically modified to degrade oil, could be patented. The distinguishing
factor in Chakrabarty, as compared to Funk Brothers, appeared to be that in
Chakrabarty, the bacteria had been altered by human intervention,
furthermore the bacteria was considered to be an invention as it had two
energy generating plasmids which is quite different and uncommon for the
existing bacteria.

The Court in this case stated that a gene isolated for patenting is not
altered in the same way as the bacteria in Chakrabarty, but it is purified
and amplified.

The court has never answered whether this distinction is sufficient to qualify a
human gene as patentable subject matter. However, the 35 USC 101, is the
pertinent statute which allows grant of a patent to a person who ‘invents or
discovers’ a new and useful composition of matter, among other things.
Thus, an inventor’s discovery of a gene can be the basis for a patent on the
genetic composition isolated from its natural state and processed through
purifying steps that separate the gene from other molecules naturally
associated with it.

Patentable Subject Matter In India

Product and process -
The biotechnology industry is devoted to the development of commercially
valuable therapeutic, biochemical and pharmaceutical products and
processes among others.

Many of these products and processes revolve around the manipulation of

DNA molecules and their encoded proteins.

In the last thirty years, great strides have been made in the field of
biotechnology and particularly recombinant DNA research.

However with this progress has come a degree of uncertainty regarding the
obviousness of certain biotechnological inventions. For example, methods of
cloning genes and shuttling them between organisms have become common
place.

The ready availability of these methods coupled with the central dogma of
molecular biology, i.e., DNA is transcribed into RNA which in turn is
translated into functional or structural protein molecules, has created a
somewhat muddled legal structure.

In India only inventions are patentable but not discoveries. There is a clear
distinction between inventions and discoveries as the law specifies that only
inventions constitute patentable subject matter. The Indian patent law does
not provide for subjects that are not patentable, instead it does provide what
is not patentable. Indian patent law provides for an illustrative list where it
has mentioned the subjects that are not patentable. Any subject matter,
which does not fall within the purview of the illustrated list, does constitute
a patentable subject matter. The list has been updated and modified to comply
with the provisions of the TRIPS Agreement.

However, microorganisms and such other inventions of biotechnology, both

products as well as processes, do constitute patentable subject matter.

India has amended its patent law in 2002 to bring life and living beings
created through biotechnology within the purview of patentable subject
matter.

The term chemical process is redefined through amendments to include

biochemical, biotechnological and microbiological process. As per the
modified definition of the chemical process it is implied that biotechnological
processes and products of such processes are unambiguously patentable.
However, there are no decided case laws in India on the patentability of
biotechnological inventions.

After the Chakrabarty decision in the US, throughout the world living beings
were recognized as patentable subject matter.

The TRIPS provisions of the WTO Agreement make it mandatory to the

member countries to provide protection in the area of living materials for the
new plant varieties and for new micro organisms.

The member countries can decide as to whether to grant protection for other
living things or not. In the case of grant of protection for new Plant Varieties
the TRIPS provides two options for the member countries namely either to
grant the protection by way of patents or to have a separate legislation called
sui generis system.

India has opted for a sui generis system for the grant of protection for new
plant varieties.

Micro Organisms – Section 3(j) of Patent Act

The legal framework of patenting microorganisms in most countries was that
though they are not specifically excluded from patentability,
microorganisms were not granted patent protection on the ground that it was
contrary to natural laws.

Section 3(j) of the Patents Act allows for patents for microorganisms. It is
worded in the form of an exception to an exception. The permissibility of
patenting microorganisms was considered in Dimminaco AG v Controller of
Patents and Designs, a case which involved an invention relating to a
process for preparation of infectious Bursitis vaccine for protecting poultry.

The Assistant Controller of Patents and Designs rejected the application on the
ground that it did not constitute an invention under S 2(1)(j) of the Patents
Act, holding that the process of preparing the vaccine which contains a
living virus cannot be considered as ‘manufacture’ under the old definition of
invention.

The Assistant Controller further held that the vaccine with living organisms
cannot be considered a substance. An inanimate object can be described as a
thing or item but not as a living one.

Microorganisms cannot be considered an inanimate substance as it cannot be

converted physically or chemically to any other product. On an appeal
preferred under S 116 of the Patents Act to the Calcutta High Court, the court
took into account the practice of the Patent Office in granting patents for end
products containing living virus and quashed the order of the Controller and
directed the reconsideration of the patent application.

The case was decided under the provisions of the Patents Act before the
Patents (Amendment) Act 2002 came into force. The said Amendment
introduces S 3(j) which allows patents for microorganisms. The decision in
the Dimminaco case considers the practice of the Patent Office in granting
patents for end products containing living virus and arrives at its conclusion
to allow patents for microorganisms on the basis of such practice.

The controversial question pertains to how microorganisms are to be defined.

By a broader definition, it will include any microscopic organism.

A narrower definition of the word would limit the definition to only

unicellular organisms. The narrow definition of microorganism confines the
application of the definition to organisms such as viruses, algae, bacteria,
fungi and protozoa. It would exclude cell lines, genes and gene sequences.

Since the TRIPS Agreement approves patents for microorganisms, member

countries of the WTO have shown a tendency to expand the scope of the
microorganism and microbiological process to include genetic material and
plants and animals.

However, the TRIPS Agreement does not define the term ‘microorganisms’,
leaving the member countries with the necessary flexibility to decide the kinds
of microorganisms that will be entitled to protection. The Patent Office is
unlikely to grant protection for microorganisms which are living entities of
living origin.
Conclusion

A steady progression of case law marks the way by which patent protection has
been expanded to include living organisms. While formal patent law is about
500 years old, it is only in the past 130 years that it has begun to enter the
area of biotechnology. The first step in the expansion of patent law turned out
to be something of a false start. In 1873, Louis Pasteur received a patent for
his claim to a yeast free from organic germs of disease, as an article of
manufacture. This was the first patent on a microorganism and the first patent
on a living organism. It took over 100 years for the next patent on a
microorganism to be granted.

In 1980, the US Supreme Court ruled in Diamond v Chakraborty that living

organisms are patentable so long as they fit within the definition of
‘invention’ in the patent legislation.

Chakraborty’s application for a patent on a genetically modified organism

had been rejected by the US PTO on the grounds that living organisms were
not patentable.

Ultimately, the US Supreme Court, in a 5/4 split decision, reversed this policy
and found that ‘anything under the Sun made by man’ is patentable.

In its decision, the Court adopted expansive interpretations of the terms

‘manufacture’ and ‘composition of matter’ in the definition of invention.

Patents are a form of reward for human ingenuity in the form of monopoly
rights.

Biotechnology inventions, a result of human ingenuity to the biological

processes too deserve patent protection.

The law relating to patenting of biotechnology inventions could be traced to the

Supreme Court of America. In 1980 in the Chakrabarty case, the Supreme
Court of America had laid the foundation for the evolution of biotech patent
law.

Indeed the Chakrabarty decision had a great impact on the traditional patent
laws, which were against patenting living beings. The decision opened the
doors for the patenting of living beings and signaled a new era in the history of
the patent law.

However, the ethical and moral standards of society objects to the patenting of
living beings. Almost all religious groups are against patenting of living beings,
but the same is not being considered in the light of the enormous potential of
living beings fetching benefits to the society.

Living beings are considered as the creation of God and patenting of the same
is considered unethical and immoral.

The approach is that human beings cannot create living beings and cannot
own living beings through patents.

Morally speaking, a living beings life cannot be monopolized and living

beings cannot be treated as market commodities through patents.
Patenting living beings amounts to slavery and such is against the dignity of
living beings.

The law relating to morals and ethics has strong foundations in Europe and
India when compared to the USA. While European and Indian patent laws have
specific statutory provisions relating to morality and public order in
determining patentability of a gene based invention, the US patent law does
not have any such provisions.

Gene Base invention -

So the chances of a gene based invention being rejected based on moral and
ethical concerns is very high in Europe and India when compared to the USA.
The general public play a very important role in defining patent principles
based on their perception of morality in granting patents on biotechnology
and specifically gene based inventions.

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