INTELLECTUAL PROPERTY LAW – I

COMPARATIVE ANALYSIS - BIO TECH PATENTS &

PATENTABILITY OF LIFE FORMS.

NAME: HAFSA MZ
REG. NO: 21LUL11012
CLASS: III YEAR
6TH SEM B.A., LL.B (HONS)

INTRODUCTION:
The term "Intellectual Property Rights" (IPR) refers to the legal protections afforded to
creative works such as inventions, musical compositions, designs, logos, and other
commercial images. The goal of these safeguards is to encourage innovation and originality
by giving artists and inventors complete control over their works while also setting standards
for fair competition.
Biotechnology is a term used in the life science industries to indicate the uses, and methods
involving, living organisms for making new useful products, which could include new
varieties of living organisms. Biotechnology plays an important role in the field of medicine
food, Fertilizer, energy and protection of environment, Biotechnology concerns living
organisms such as plants, animals and microorganisms as well as non-living biological
material such as seeds, cells, enzymes, plasmids and the like.
PREREQUISITES FOR PATENT
The Indian Patent Act of 1970 established the criteria for any technique or product to qualify
for a patent:
1. Inventive step- For a product or technique to qualify for a patent in India, it must be
novel and involve an inventive step.
2. Capable of industrial application- It is possible to patent an innovation in India that
relates to a good or a method that is applicable to the industry.
3. Novelty- This means that prior to the date of the application, the invention must not
have been disclosed to the public, not even by the inventor.

PATENTABILITY OF LIFE FORMS

Biotechnology has a vital role in covering and touching lives in various aspects.
Biotechnology in recent years has created unprecedented opportunities not only for
humankind but also for industries research & development. It has become the world’s fastest
growing technology. The pharmaceutical and agricultural sectors in India, a developing
nation, are built in part on advanced biotechnology.
PATENTABLE SUBJECT MATTER IN BIOTECHNOLOGY
1. Microorganisms:
 Patents can be granted for new and non-obvious microorganisms, such as genetically
engineered bacteria used for industrial processes (e.g., insulin production).
2. Genetic Material:
 Isolated DNA sequences, genes, and recombinant DNA can be patented if they meet
the criteria of novelty, non-obviousness, and utility. However, naturally occurring
sequences as found in nature are cannot patentable.
3. Biotechnological Processes:
 Processes involving the manipulation of biological materials, such as methods of gene
editing, cloning, and tissue culture techniques, are patentable.
4. Pharmaceuticals:
 Biologically-derived drugs, vaccines, and other medical treatments can be patented.
This includes both the products themselves and the processes for making them.
CASE LAWS
In the year 1980 a case of immense importance to the course of industrial microbiology was
decided in the United states court of custom & patent appeals in brief the court ruled that the
live human made microorganism is patentable.
In landmark case of Diamond v. Chakrabarty signaled a shift in the law.
Claims to the invention were on three grounds.
A. Process claims for the method of producing the bacteria.
B. Claims for an inoculum comprising an inert carrier and the bacterium.
C. Claims to the bacteria themselves

In another case, the emphasis changed from determining if genetic material is naturally
occurring to determining whether innovation is occurring, which allowed for more expansive
patentability.
The case of Harvard College v. Canada [5], 2002 SCC 76 (CanLII), [2002] 4 SCR 45,
which brought up the controversial issue of patenting higher living things, showed how
important it is to submit thorough patent applications that meet strict invention standards. The
term "manufacturing" was likewise broadened in the case of American Fruit Growers Inc.
v. Brogdex Co. [6], 283 U.S. 1 (1931) to include not just conventional manufacturing
techniques but also the transformation of raw materials, including live creatures, into finished
products.
Procedure for patenting Biotechnological Products
 1. Firstly microorganisms by themselves are not patentable, being products of nature and
living things however they are patentable as part of a useful process that is when they
are included along with the chemical or an inert material with which jointly, they fulfil a
useful purpose
2. A new Organism produced by genetic engineering shall constitute composition of matter
3. The patenting of microbiological process places on the patentee the obligation of
depositing the culture in a recognised culture collection they may deposited at the
World Health Organization WHO or any other culture depository of such invention
4. Where a. Microbiologist inventor is an employee, the patent is usually assigned to the
employer unless some agreement is reached between them to the contrary the patent for
the oil consuming pseudomonas discussed earlier went to the General Electric company
not its employee
5. In certain circumstances it may be prudent not to patent the invention at all but to
maintain the discovery as a trade secret
TRIPS – LEGAL FRAMEWORK
In reference to the patentability of biotechnological inventions, the Patents (Amendment) Act,
2002, provided substantial changes to Indian patent law. The law met the requirement of
Article 27.3(b) of the TRIPS Agreement by specifically providing for the patentability of
microorganisms.
The TRIPS Agreement, to which India is a party as a member of the World Trade
Organisation (WTO), mandates that biotechnological inventions, including plant varieties,
receive some level of protection
Challenges and Controversies in Biotech Patents and the Patentability of Life Forms
1. Ethical Issues
Moral concerns about genetic engineering and modifying life forms. Ethical debates about
treating living organisms and human genes as property.
2. Access and Equity
Patents can lead to expensive biotech products and medicines, limiting access.
3. Biodiversity and Biopiracy
- Patenting genetic resources without fair compensation (biopiracy).
4 Legal and Regulatory Challenges
- Jurisdictional Variability: Differences in patent laws across countries complicate
international protection.
5. Societal and Economic Impacts
- R&D Impact: Patents can stimulate investment but also restrict collaborative research.
CONCLUSION
The biotechnology industry has contributed significantly to developments in patent laws.
Because it involves the patenting of living things, biotechnology patenting raises complex
concerns. Indian patent laws address this issue of patentability in this field without breaching
the TRIPS Agreement. Biotech patents are crucial for fostering innovation in biotechnology,
offering protection for novel and useful inventions.