BT14 804(A) BIO ETHICS AND INTELLECTUAL PROPERTY RIGHTS (set 1)

Part A

1. Define Bio ethics?

2. What are transgenic plants?
3. What is Intellectual Property Rights?
4. What is Patent?
5. What is Copyright?
6. What is e-Filing?
7. What are the following IPRS covered under TRIPS?
8. Explain about TRIPS?
9. What are the biotechnological inventions that can be patented?
10. Explain about plant breeders rights?

Part B

1) Detail about the risks and ethical issues in biotechnology ?

Or
2) Explain in detail about human genome project and its ethical issues?

3) Discuss about copyright in detail?

Or

4) Explain the patent and filing procedures?

5) Detail about patent infringement?

Or

6) Discuss about the WIPO?

7) Explain how to measure the quality cost?

Or

8) Discuss about ISO 9000?

 ANSWER KEY
Part A

1.The discipline dealing with the ethical implications of biological research and applications
especially in medicine. Bioethics includes the study of what is right and wrong in new
discoveries and techniques in biology, such as genetic engineering and the transplantation of
organs. Bioethicists are concerned with the ethical questions that arise in the relationships
among life sciences, biotechnology, medicine, politics, law, and philosophy. It also includes
the study of the more commonplace questions of values which arise in primary care and other
branches of medicine.

2.(ans) Transgenic plants are crops which have been genetically modified with genes from
another organism to make the plants more agriculturally productive. Transgenic plants are
only those with genes from other species, whereas genetically modified plants can have both
new genes and a re-arrangement of the genes already found in the plant. Traditional breeding
methods are one form of genetic modification. Transgenic plants have been developed for a
variety of reasons: longer shelf life, disease resistance, herbicide resistance, pest resistance,
and improved product quality.

3. (ans) Intellectual property rights (IPR) can be defined as the rights given to people over the
creation of their minds. They usually give the creator an exclusive right over the use of
his/her creations for a certain period of time. Intellectual property (IP) refers to creations of
the mind: inventions, literary and artistic works, and symbols, names, images, and designs
used in commerce.

4.(ans) Patent is a grant for an invention by the Government to the inventor in exchange for
full disclosure of the invention. A patent is an exclusive right granted by law to applicants /
assignees to make use of and exploit their inventions for a limited period of time (generally
20 years from filing). The patent holder has the legal right to exclude others from
commercially exploiting his invention for the duration of this period. In return for exclusive
rights, the applicant is obliged to disclose the invention to the public in a manner that enables
others, skilled in the art, to replicate the invention. The patent system is designed to balance
the interests of applicants / assignees (exclusive rights) and the interests of society (disclosure
of invention).
5.(ans) Copyright is the set of exclusive rights granted to the author or creator of an original
work, including the right to copy, distribute and adapt the work. Copyright lasts for a certain
time period after which the work is said to enter the public domain. Copyright gives
protection for the expression of an idea and not for the idea itself. For example, many authors
write textbooks on physics covering various aspects like mechanics, heat, optics etc. Even
though these topics are covered in several books by different authors, each author will have a
copyright on the book written by him / her, provided the book is not a copy of some other
book published earlier.

6.(ans) E-filing is a service provided by the Intellectual Property Office, India in order to
enable customers to apply for a patent on-line allowing from the User’s browser for the User
to:
• Complete an electronic application form
• Provide the associated attachments
• Complete the necessary payment details

7. (ans) The following Intellectual Property Rights are covered under the TRIPS –
1) Copyright;
2) Geographical indications;
3) Industrial designs;
4) integrated circuit layout-designs;
5) Patents;
6) New plant varieties;
7) Trademarks;
8) Undisclosed or confidential information.

8(ans) The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an
international agreement administered by the World Trade Organization (WTO) that sets
down minimum standards for many forms of intellectual property (IP) regulation as applied
to nationals of other WTO Members. It was negotiated at the end of the Uruguay Round of
the General Agreement on Tariffs and Trade (GATT) in 1994.
The TRIPS agreement introduced intellectual property law into the international trading
system for the first time and remains the most comprehensive international agreement on
intellectual property to date.
9(ans) Patents are often granted for products such as polypeptides, nucleic acids, cell lines,
vectors, gene delivery systems, microorganisms, genetically modified plants and animals,
antibodies, vaccines and pharmaceuticals; and methods such as diagnostic assays, screening
methods, purification protocols, sequencing protocols and cell culture techniques.

10(ans) Plant Breeders’ Rights are also a form of intellectual property which is specifically
designed to protect new plant varieties. The right as defined by UPOV is, an exclusive right
over the commercial production and marketing of the reproductive or vegetative propagating
material of the protected variety. These rights are assigned to the breeder of a new variety of
plant which gives him/her exclusive control over it; be it seeds, flowers, fruits, foliage or the
like. Protection of Plant Varieties and Farmers Rights Act was framed in India in the year
2001 to grant rights to the farmers as well as the breeders.

Part B

1(ans) Risks and ethical issues in biotechnology

An essential element in the ethical evaluation of biotechnology is the analysis of the possible
harms and their likelihood of occurring, weighing these risks against the probable benefits.
Since biotechnology encompasses a wide variety of biological methods and techniques in a
wide variety of circumstances, the analysis of the risks and benefits will be highly contextual,
depending upon the peculiarities of each specific application. For instance, the use of
genetically engineered bacteria to produce insulin in a commercial laboratory is quite
different from the release of genetically engineered bacteria into the natural environment.
Conditions can be controlled in the laboratory and, with appropriate safety measures, the
modified bacteria can be prevented from escaping. But the release of a genetically engineered
species into the environment poses additional risks depending on the viability of the
organism, the nature of its genetic modification, and the purpose for which it is introduced.
This discussion will be confined to the principles that may apply to the ethical evaluation of
biotechnology in general, recognizing that the ethical evaluation of each particular
intervention will depend upon its specific circumstances.
Adequate assessment of the risks of releasing a genetically modified species into the
environment entails a thorough knowledge of the ecology of the environment and how the
modified species will interact with other species. Proposals for the introduction of genetically
modified species into the environment have been criticized on the grounds that there is
insufficient ecological knowledge and that, in general, the science of predictive ecology is
underfunded and poorly understood.

Even in individual species, it is difficult to predict the health effects of inserting foreign DNA
into an organism or otherwise modifying the expression of genes it already contains. A
number of deleterious pleiotropic effects (where one gene can effect several traits) have been
shown to occur in genetically modified species. In fact, the only way to determine these
effects is through experiments upon individual organisms, a fact not lost upon animal welfare
advocates. Evaluation of the effects of genetic engineering on individual organisms can be
conducted in the safety of the lab, but the impacts of releasing genetically modified
organisms into the environment may be very difficult to measure or model experimentally.
Ultimately, the safety of transgenic organisms can only be evaluated through careful study of
their release into the environment, with the consequent risk that we will discover a cascade of
harmful effects on the environment only after it is too late to stop the spread of the organism.

The ecology of environments is highly complex and relational. Individual species can play a
variety of roles within an environment and the effects of a change in a species can be highly
unpredictable. The problem is not simply inadequate knowledge but rather the complexity of
ecological systems. Complex systems, in general, may be highly nonlinear, meaning that
there may be little or no correlation between incremental changes in a system and how it
behaves. In mathematical models of complex systems, the effects of changes in a system are,
in principle, unpredictable. The only way to discover these effects is to observe how the
system behaves upon the introduction of a specific change. Modifications to a system can
have no effect, an incremental effect, or revolutionary effects.

To the extent that ecological, and more generally, organic systems are complex and
nonlinear, modifications of them will, in principle, be unpredictable. Since adequate risk
assessment depends upon prediction and quantification of risk, the effects of the introduction
of new or modified species into an ecosystem may not be adequately quantifiable or
manageable, making each such introduction truly experimental. The lessons learned from the
endangered species program are valuable in this context. Biologists have learned that in order
to save a species, it is necessary to save its habitat. The complexity of ecological systems
makes it very difficult to identify specific causes of environmental change, and since one may
not be able to anticipate specific changes, it is possible that scientific observation will fail to
detect them. Without the development of a much richer general science of ecology, and
specific ecological studies of the environments into which biotechnology is introduced,
adequate risk assessment may be impossible. It follows, then, that in the absence of adequate
ecological study before biotechnological interventions take place, and in the absence of a
commitment to long-term study after they have been introduced, the ethical evaluation of
risks and benefits is incomplete. Proceeding on the basis of inadequate study may be
unethical.
One especially troubling risk of the introduction of genetically engineered species into the
environment is the possibility that the modified genes will cross to other species. This
problem is most characteristic of plants and microbes, especially bacteria. It is also possible
that genetically modified viruses may target unexpected species, spreading either deleterious
or beneficial genes in unexpected ways. A related risk is the short generation time and
potentially rapid evolution of microbes. If a genetically altered microbe persists in the
environment, it is possible that it may evolve in unforeseen ways, producing unforeseen
effects. In addition to the unpredictability associated with introducing new or modified
species into the environment, harmful effects may be irremediable. Once a genetic
modification has hopped to another species, there is little that biologists can do to effectively
contain the spread of the gene. Once disrupted in this fashion, the ecological balance may be
irrevocably altered, to the detriment of the ecosystem and its associated benefits to humans.
One promising method for protecting marine environments against the adverse consequences
of introducing genetically modified species of fish has been to limit the reproductive
capabilities of the fish. In this way, adverse ecological impacts may be reversed by
discontinuing the release of the modified species.

2(ans) The Human Genome Project

The Human Genome Project (HGP) is an international effort, coordinated by the United
States Department of Energy and National Institutes of Health, that aims to determine the
sequence of every nucleotide in the human genome and to identify all the genes contained
within the genome. Formally started in 1990, the project was intended to complete the
working reference genome by 2005 but technical advances have decreased the timeframe to
13 years.

The genome itself, at six billion nucleotides long, is far too big to sequence as a whole. The
initial approach was to break it into pieces, determine the order of the pieces, and then to
determine the nucleotide sequence for each piece. A private company split from the public
project, however, and began sequencing DNA segments in order to patent them. This forced
the HGP to change its approach to match that of the private company and to provide the
nucleotide sequence of the pieces before knowing the order of the pieces. The statement by
President Clinton and Prime Minister Blair 26 June 2000 announced not only the virtual
completion of the sequencing of the pieces, but also a truce between the private and public
projects. To obtain a reference copy of the human genome that is 99.99% accurate, and with
all the pieces in order, will take another three or so years. Various groups around the world
have been working on individual chromosomes and the sequencing of these is at different
stages of completion. Chromosome 21, with the exception of three gaps 30,000 nucleotides in
length, has already been completed to the final standard. Because this chromosome is
implicated in Down syndrome, some researchers had begun to sequence it before the start of
the Human Genome Project.

Unlike some other countries, such as Great Britain and Japan, Canada has had no formal
national human genome program and for this reason was not included in the announcement as
a partner. Despite this, Canadian scientists have contributed to the HGP, for example through
the sequencing of genes and ethics studies. The Government of Canada has contributed to
this research; in the year 2000 budget, Genome Canada was allotted $160 million for five
centres of genome science research in Canada.

One of the most significant aspects of the HGP is that it reverses the way in which science is
normally done. Usually, researchers approach a specific problem and then try to find its
causes, among which might be the DNA sequence of a gene or genes. The HGP will yield the
order of the nucleotides in the human genome, and identify putative genes, but will not
identify their functions. It will take many years, if not decades, before the gene products are
identified and many more years to understand how they interact with each other and the
environment in developmental, biochemical and physiological processes.
The HGP has also involved the determination of the nucleotide sequence for the genomes of
other organisms, many of which have been used as laboratory models and so have many well
understood biochemical pathways and physiologies. Since their genomes have many
similarities to the human genome, knowing their sequences will help to identify genes and the
function of genes in the human genome.

Ethical, Legal and Social Implications of the Human Genome Project

From the beginning, it has been understood that the Human Genome Project will have
profound ethical, legal and social (ELS) implications; thus, between 3 and 5% of its budget
has been devoted to the study of ELS issues. Ethical issues are generally defined as those
raising questions concerning what is moral or right. Legal issues are those concerning the
protections that laws or regulations should provide. Social issues are concerned with how
events may affect society as a whole and individuals in society. Clearly, these aspects of the
HGP and its possible outcomes are not independent of each other.

Many of the ELS implications are not new. The gene for Huntington’s disease was
discovered in 1993, after a ten-year search following the localization of the gene to
chromosome 4 in 1983. A test for the disease was developed soon after. Many of the
questions currently being addressed by the ELS issues program of the HGP have, therefore,
been familiar for many years to families afflicted with Huntington’s. As a result of the HGP,
however, society as a whole will have to deal much more frequently with issues arising from
knowledge of the human genome. Moreover, the implications may be less clear in the case of
genes identified for diseases that have strong environmental aspects and involve interaction
with many other genes.

3(ans) Copyright

Copyright is the set of exclusive rights granted to the author or creator of an original work,
including the right to copy, distribute and adapt the work. Copyright lasts for a certain time
period after which the work is said to enter the public domain. Copyright gives protection for
the expression of an idea and not for the idea itself. For example, many authors write
textbooks on physics covering various aspects like mechanics, heat, optics etc. Even though
these topics are covered in several books by different authors, each author will have a
copyright on the book written by him / her, provided the book is not a copy of some other
book published earlier. Copyright ensures certain minimum safeguards of the rights of
authors over their creations, thereby protecting and rewarding creativity. Creativity being the
keystone of progress, no civilized society can afford to ignore the basic requirement of
encouraging the same. Economic and social development of a society is dependent on
creativity. The protection provided by copyright to the efforts of writers, artists, designers,
dramatists, musicians, architects and producers of sound recordings, cinematograph films and
computer software, creates an atmosphere conducive to creativity, which induces them to
create more and motivates others to create.

Copyright law in India

The Copyright Act of 1957, The Copyright Rules, 1958 and the International Copyright
Order, 1999 governs the copyright protection in India. It came into effect from January 1958.
The Act has been amended in 1983, 1984, 1992, 1994 and 1999. Before the Act of 1957,
copyright protection was governed by the Copyright Act of 1914 which was the extension of
British Copyright Act, 1911.
The Copyright Act, 1957 consists of 79 sections under 15 chapters while the Copyright
Rules, 1958 consists of 28 rules under 9 chapters and 2 schedules.

Meaning of copyright
According to Section 14 of the Act, “copyright” means the exclusive right subject to the
provisions of this Act, to do or authorise the doing of any of the following acts in respect of a
work or any substantial part thereof, namely:-
(a) in the case of a literary, dramatic or musical work, not being a computer programme, -
(i) to reproduce the work in any material form including the storing of it in any medium
by electronic means;
(ii) to issue copies of the work to the public not being copies already in circulation;
(iii) to perform the work in public, or communicate it to the public;
(iv) to make any cinematograph film or sound recording in respect of the work;
(v) to make any translation of the work;
(vi) to make any adaptation of the work;
(vii) to do, in relation to a translation or an adaptation of the work, any of the acts
specified in relation to the work in sub-clauses (i) to (vi);

(b) in the case of a computer programme,-

(i) to do any of the acts specified in clause (a);
(ii) to sell or give on commercial rental or offer for sale or for commercial rental any
copy of the computer programme:
Provided that such commercial rental does not apply in respect of computer programmes
where the programme itself is not the essential object of the rental.

(c) in the case of an artistic work,-

(i) to reproduce the work in any material form including depiction in three dimensions of a
two dimensional work or in two dimensions of a three dimensional work;
(ii) to communicate the work to the public;
(iii) to issue copies of the work to the public not being copies already in circulation;
(iv) to include the work in any cinematograph film;
(v) to make any adaptation of the work;
(vi) to do in relation to an adaptation of the work any of the acts specified in relation to the
work in sub-clauses (i) to (iv);

(d) In the case of cinematograph film, -

(i) to make a copy of the film, including a photograph of any image forming part thereof;
(ii) to sell or give on hire, or offer for sale or hire, any copy of the film, regardless of
whether such copy has been sold or given on hire on earlier occasions;
(iii) to communicate the film to the public;

(e) In the case of sound recording, -

(i) to make any other sound recording embodying it;
(ii) to sell or give on hire, or offer for sale or hire, any copy of the sound recording
regardless of whether such copy has been sold or given on hire on earlier occasions;
(iii) to communicate the sound recording to the public.

Classes of works for which copyright protection is available

Indian Copyright Act affords separate and exclusive copyright protection to the following 7
Clauses of work:
1. Original Literary Work
2. Original Dramatic Work
3. Original Musical Work
4. Original Artistic Work
5. Cinematograph Films
6. Sound recording
7. Computer Programme
Copyright will not subsist in any cinematograph film if a substantial part of the film is an
infringement of the copyright in any other work or in any sound recording made in respect of
literary, dramatic or musical work, if in making the sound recording, copyright in such work
has been infringed. In case of work of architecture, copyright will subsist only in the artistic
character and design and will not extend to processes or methods of construction.

Ownership of Copyright

The author of the work will be the first owner of the copyright in the following instances:
i. In the case of a literary, dramatic or artistic work made by the author in the course of his
employment by the proprietor of a newspaper, magazine or similar periodical under a
contract of service or apprenticeship, for the purpose of publication in a newspaper, magazine
or similar periodical, the said proprietor will, in the absence of any agreement to the contrary,
be the first owner of the copyright in the work in so far as the copyright relates to the
publication of the work in any newspaper, magazine or similar periodical, or to the
reproduction of the work for the purpose of its being so published, but in all other respects the
author will be the first owner of the copyright in the work.
ii. In the case of a photograph taken, or a painting or portrait drawn, or an engraving or a
cinematograph film made, for valuable consideration at the instance of any person, such
person will, in the absence of any agreement to the contrary, be the first owner of the
copyright therein.
iii. In the case of a work made in the course of the author’s employment under a contract of
service or apprenticeship, the employer will, in the absence of any agreement to the contrary,
be the first owner of the copyright therein.
iv. In the case of any address or speech delivered in public, the person who has delivered
such address or speech or if such person has delivered such address or speech on behalf of
any other person, such other person will be the first owner of the copyright therein not
withstanding that the person who delivers such address or speech, or, as the case may be, the
person on whose behalf such address or speech is delivered, is employed by any other person
who arranges such address or speech or on whose behalf or premises such address or speech
is delivered.
v. In the case of a government work, government in the absence of any agreement to the
contrary, will be the first owner of the copyright therein.

4(ans) Patent
Patent is a grant for an invention by the Government to the inventor in exchange for full
disclosure of the invention. A patent is an exclusive right granted by law to applicants /
assignees to make use of and exploit their inventions for a limited period of time (generally
20 years from filing). The patent holder has the legal right to exclude others from
commercially exploiting his invention for the duration of this period. In return for exclusive
rights, the applicant is obliged to disclose the invention to the public in a manner that enables
others, skilled in the art, to replicate the invention. The patent system is designed to balance
the interests of applicants / assignees (exclusive rights) and the interests of society (disclosure
of invention).
Meaning of ‘Invention’ under Patent Law
Sec.2(1)(J) - Invention” means a new product or process involving an inventive step and
capable of industrial application
What is not an ‘Invention’?
According to Sec 3 of the Patent Act, 1970
• Frivolous inventions
• Inventions contrary to well established natural laws
• Commercial exploitation or primary use of inventions, which is contrary to public order or
morality which causes serious prejudice to health or human, animal, plant life or to the
environment
• Mere Discovery of a Scientific Principle or
• Formulation of an Abstract Theory or
• Discovery of any living thing or
• Discovery of non–living substance occurring in nature
What can be patented?
Any invention concerning with composition, construction or manufacture of a substance, of
an article or of an apparatus or an industrial type of process.
What cannot be patented?
Inventions falling within Section 20(1) of the Atomic Energy Act, 1962
Patent System In India
The Patent System in India is governed by the Patents Act, 1970 as amended by the Patents
(Amendment) Act, 2005 and the Patents Rules, 2003, as amended by the Patents
(Amendment) Rules 2006 effective from 05-05-2006.

Administration
Patent system in India is administered under the superintendence of the Controller General of
Patents, Designs, Trademarks and Geographical Indications.
The Office of the Controller General functions under the Department of Industrial Policy and
Promotion, Ministry of Commerce and Industry. There are four patent offices in India. The
Head Office is located at Kolkata and other Patent Offices are located at Delhi, Mumbai and
Chennai. The Controller General delegates his powers to Sr. Joint Controller, Joint
Controllers, Deputy Controllers and Assistant Controllers. Examiners of patents in each
office discharge their duties according to the direction of the Controllers.
The Patent Information system (PIS) at Nagpur has been functioning as patent information
base for the users. The PIS maintains a comprehensive collection of patent specification and
patent related literature, on a world-wide basis and provides technological information
contained in patent or patent related literature through search services and patent copy supply
services to various users of R&D establishments, Government offices, private industries,
business, inventors and other users within India.

Hierarchy of Officers in Patent office

• Controller General of Patents, Designs, Trademarks & GI
• Examiners of Patents & Designs
• Assistant Controller of Patents & Designs
• Deputy Controller of Patents & Designs
• Joint Controller of Patents & Designs
• Senior Joint Controller of Patents & Designs

Types Of Patent Applications

1) Ordinary Application
2) Application for Patent of Addition (granted for Improvement or Modification of the
already patented invention, for an unexpired term of the main patent).
3) Divisional Application (in case of plurality of inventions disclosed in the main
application).
4) Convention application, claiming priority date on the basis of filing in Convention
Countries.
5) National Phase Application under PCT.

How is a patent obtained?

 File an application for patent
 With one of the patent offices based on territorial jurisdiction of the place of office or
residence of the applicant /agent
 Pay the required fee
 Information concerning application form and details of fee available at
www.ipindia.nic.in
 Guidelines for applicants also available on this website
The Patent Office then
- Conducts searches to ascertain the prerequisites
- Publishes the application
- Conducts in-depth examination
- Raises objection to the application
- Grants the patent

5(ans) patent infringement

A patent owner has the right to exclude all others from using the patented invention, and any
one who practices the invention without the owner’s consent,infringes his rights. By exactly
following the details as revealed in a patent you would infringe on a patent, unless what you
do is exempted as being an experimental or research use. But copying from a patent is not the
only way for a business to violate a
patent. In fact, whether knowingly or unknowingly if you have incorporated a patented
invention or practiced or incorporated an invention sufficiently similar to a patented
invention, then you may be also hauled up for patent infringement. A patent owner can
legally stop your business from using the patent, and also sue for damages. In many
situations, an injunction may be equally or more costly than any potential damages levied by
a court in due course. This may happen when you have a big inventory that must be destroyed
and the retooling costs for modifying your production process.
So, technically speaking, patent infringement means others have entered a prohibited space
defined by one of the claims in your patent. As we discussed earlier, a patent provides its
owner with the right to prevent or stop others from making, using, selling or importing the
patented product without the owner’s permission for a period of 20 years calculated from
filing date of the earliest relevant patent application. Therefore, the original patent owner or
his assignee may enforce his right in a patent. If a product in question physically has or
perform all of elements contained in your patent’s broadest claim, then it would infringe your
patent and you can take legal action against its manufacturer or
distributor or retailer. Let’s look at a simple case:

If you come across your competitor’s patent

If you come across a new or improved product of your competitor that is protected by a
patent, then you may have no option but to deal with it especially if it is relatively easy for
your competitor to find out that your product is infringing his patent, the competitor is known
to take prompt legal action on
discovering infringement, and the competitor has access to a good patent lawyer. Firstly,
carefully go through the competitor’s patent and the relevant prior art to determine whether
your product would actually violate the patent rights of the competitor. If yes, then examine
whether it is possible for your company to invent around such a patent easily and quickly by,
for example, eliminating some essential element or replacing an essential element by other
elements with a different function. The basic legal test for infringement of a patent is whether
your product uses every element of a granted claim in the patent. If you manage to develop a
product that does not include at least one of the claimed elements of the competitor’s patent,
then you have not infringed it. In fact, you may
instead have a better product, which may ultimately dominate the marketplace, and, of
course, a patentable invention of your own. If you cannot find an element that you can
eliminate in a competitor’s patent, try to find an element that may be changed to function
differently even though it may be the structurally the same or equivalent. If you cannot design
around the patented invention, then examine whether you have some key strength or assets
that your competitor would like to have
access to, so that you may be able to leverage it to enter into a strategic business partnership
or an arm’s length licensing arrangement with such a competitor. If you don’t even have this
option then be prudent and do not risk introducing such a product in the market. If the patent
owner does nothing about the violation of his patent right in the marketplace, competitors
will sooner or later attempt to make similar or identical products. In some cases, competitors
may benefit from economies of scale,
greater market access, or access to cheaper primary resources, and therefore be able to make
a similar or identical product at a cheaper price, putting heavy pressure on the innovator of
the original product. On occasions, this may erode only profits or drive the original innovator
out of business because, usually, the duplicated product may dominate the market and attract
customers more than the original one.

6(ans) WIPO
The World Intellectual Property Organization (WIPO) is one of the 17 specialized agencies
of the United Nations, located in Geneva, Switzerland. The Organization has External Offices
at Rio de Janeiro in Brazil, Tokyo in Japan, Singapore and New York. The mission of WIPO
is to promote innovation and creativity for the economic, social and cultural development of
all countries, through a balanced and effective international intellectual property system. The
origin of WIPO goes back to 1883 and 1886 when the Paris Convention for the Protection of
Industrial Property and the Berne Convention for the Protection of Literary and Artistic
Works, respectively, were concluded. Both Conventions provided for the establishment of an
international bureau. The two bureaus were united in 1893 and, in 1970, were replaced by the
World Intellectual Property Organization, by virtue of the WIPO Convention. The WIPO
Convention, the constituent instrument of the World Intellectual Property Organization
(WIPO), was signed at Stockholm on July 14, 1967, entered into force in 1970 and was
amended in 1979. WIPO is an intergovernmental organization that became in 1974 one of the
specialized agencies of the United Nations system of organizations. WIPO currently has 185
Member States, and 68 intergovernmental organizations (IGOs) and 232 International non-
governmental organizations (NGOs) and 63 National NGOs that are accredited as observers
at WIPO meetings.
The core tasks of WIPO are:
 working with Member States to support a balanced evolution of international IP law
 administering treaties
 assisting governments and organizations in developing the policies, structures and
skills needed to harness the potential of IP for economic development
 servicing global registration systems for trademarks, industrial designs and
appellations of origin and a global filing system for patents
  delivering arbitration, mediation and other dispute resolution services
 promoting respect for IP
 providing a forum for informed debate and for the sharing of IP knowledge
 identifying IP-based solutions that can help confront global challenges and
maximize the benefits of the IP system for all

How WIPO works?

WIPO’s Member States determine the strategic direction and activities of the Organization.
They meet in the Assemblies, committees and working groups. The WIPO Secretariat, or
International Bureau, is based in Geneva. WIPO staff, drawn from more than 90 countries,
includes experts in diverse areas of IP law and practice, as well as specialists in public policy,
economics, administration and IT. The respective divisions of the Secretariat are responsible
for coordinating the meetings of Member States and implementing their decisions; for
administering the international IP registration systems; for developing and executing the
programs designed to achieve WIPO’s goals; and for providing a repository of IP expertise to
assist its members. It has to present a program and a budget every 2 years about performance
measures, budget planning for all the events of the organization which requires member state
approval.It is a self financing organization and its funds are majorly used for organizing
events. WIPO Arbitration and Mediation Centre was created in 1994 for the settlement of
international commercial disputes arising between private parties located in Geneva,
Switzerland and it has an office in Singapore
WIPO’s Goals

The strategic goals defined in WIPO’s revised Program and Budget for 2008/09 are:
 A balanced evolution of the international normative framework for IP
 Provision of premier global IP services Facilitating the use of IP for development
 Coordination and development of global IP infrastructure
 World reference source for IP information and analysis
 International cooperation on building respect for IP
 Addressing IP in relation to global policy issues
 A responsive communications interface between WIPO, its Member States and all
Stakeholders
 An efficient administrative and financial support structure to enable WIPO to
deliver its programs
 7(ans) Diamond vs Chakrabarty case

A person who eats cornflakes at breakfast, puts on a cotton shirt, or takes a vitamin C
supplement to ward off a cold almost certainly benefits from the US Supreme Court’s 1980
decision in Diamond v. Chakrabarty.1 It has been 25 years since this landmark decision, in
which the Supreme Court held that a live, man-made microorganism is patentable subject
matter under Section 101 of the US Patent Act.2
Chakrabarty is not well known outside the intellectual property community--the average
person probably has never even heard the name. Yet Chakrabarty has affected the lives of
virtually everyone in the United States, having contributed to a revolution in biotechnology
that has resulted in the issuance of thousands of patents, the formation of hundreds of new
companies, and the development of thousands of bioengineered plants and food products.
In Chakrabarty, the US Patent and Trademark Office (PTO) rejected claims to a
genetically engineered bacterium on the ground that living organisms are not
patentable. The Supreme Court disagreed, deciding by a five-to-four majority that a
patent may be obtained on “anything under the sun that is made by man.”3 The
Supreme Court decision opened the floodgates for protection of biotechnology-related
inventions and helped spark the growth of an industry that no one, regardless of his or
her moral or philosophical views, can deny is capable of modern-day miracles.

The Proceedings before the PTO and the Lower Court

Chakrabarty began with a patent application filed in 1972 by microbiologist Ananda
Chakrabarty on an invention for treating oil spills. Scientists in the petrochemical industry
had long been aware of the potential of certain strains of bacteria to metabolize and degrade
hydrocarbon compounds into simpler, harmless substances that could serve as a food source
for aquatic life. Because no single strain of bacteria was capable of
metabolizing all the different hydrocarbon compounds present in crude oil, however, prior
methods had to rely on a mixture of bacterial strains, each of which acted on a different set of
hydrocarbon components. Unfortunately, not all the bacterial strains in the mixture could
thrive in the various environmental conditions existing in the area of an oil spill, so that when
a mixture of bacterial strains was used, only some of the bacteria survived long enough to
attack the spill.
The key discovery in Chakrabarty’s research was that “plasmids” control the oil degradation
abilities of certain bacteria. Plasmids are transmittable, non-nuclear segments of DNA.
Chakrabarty developed a process by which multiple plasmids capable of degrading different
hydrocarbon components could be incorporated within a particularly “hardy” single
bacterium. This genetically engineered bacterium was capable of breaking down oil spills at a
much faster rate than naturally occurring bacteria. As importantly, it was not affected by
varying environmental conditions.
Chakrabarty’s 1972 patent application contained three groups of claims directed to
1. The method of producing the bacterium
2. An inoculum composed of a carrier material and the bacterium
3. The genetically engineered bacterium itself
The patent examiner allowed the first two groups but rejected the claims directed to the
bacterium as unpatentable under 35 U.S.C. § 101. On appeal at the PTO, the Board of Patent
Appeals and Interferences affirmed the examiner’s rejection. The Court of Customs and
Patent Appeals reversed the Board’s decision, however, ruling that living organisms are
patentable subject matter.4 The PTO then filed a petition for writ of certiorari to the Supreme
Court.

The Supreme Court Decision

The Supreme Court heard the Chakrabarty case in March 1980. Deputy Solicitor General
Lawrence Wallace argued on behalf of the PTO. Edward McKie, William Schuyler, and Dale
Hoscheit of Schuyler, Birch, McKie & Beckett represented Chakrabarty.5
The question before the Court was whether the claimed microorganism constituted a
“manufacture” or “composition of matter” within the meaning of the US Patent Act.
Reviewing the broad congressional mandate regarding patentable subject matter, the Supreme
Court concluded that it did and asserted the principle for which Chakrabarty is best known:
that “anything under the sun that is made by man” is eligible for patenting.

The Immediate Aftermath

The Chakrabarty patent was not the first US patent to issue on a living organism. The PTO
had granted patents on single-cell organisms on several occasions dating back to 1873, when
Louis Pasteur obtained a patent (US Patent No. 141,072) on a purified yeast cell. It was only
after Chakrabarty, however, that the PTO clarified what had been an inconsistent approach to
patenting living organisms. This clarification came in Ex Parte Allen,6 when the Board of
Patent Appeals and Interferences reversed the examiner’s rejection of claims for genetically
engineered oysters as unpatentable because it found “no evidence that the claimed polyploid
oysters occur naturally without the intervention of man.”7
Shortly after Ex Parte Allen was decided, the PTO issued a statement on April 7, 1988,
announcing that “[t]he Patent and Trademark Office now considers non-naturally occurring
non-human multicellular living organisms, including animals, to be patentable subject matter
within the scope of 35 U.S.C. 101.”8 Almost exactly one year later, on April 12, 1988, the
PTO issued the first patent for a transgenic animal, commonly known as the “Harvard
Mouse” (US Patent No. 4,736,866).

The Post-Chakrabarty World

At the time Chakrabarty was decided, biotechnology was a newly developing field. No one
could have foreseen in 1980 the phenomenal pace at which new biotechnology advances
would develop. Neither could anyone have predicted the exponential growth in the number of
patent applications and issued patents on biotechnology-related inventions that would occur
over the next 25 years.
By virtually every measurable factor, the biotechnology industry has literally exploded in
the 25 years since Chakrabarty. According to data compiled by Ernst & Young:9
• As of December 31, 2003, there were 1,473 biotechnology companies in the United
States; the US biotechnology industry employed 198,300 people; and the US revenues for
the biotechnology industry had increased from $8 billion in 1992 to $39.2 billion.
• In 2003 alone, the US biotechnology industry spent $17.9 billion on research and
development.
• As of mid-March 2004, the total value, or market capitalization, of the 314 publicly held
biotechnology companies had risen to $311 billion as compared to $45 billion in 1994.
The number of patent applications and issued patents on biotechnology-related inventions
also has risen dramatically since Chakrabarty. Data complied by the Biotechnology Industry
Organization, based in Washington, DC, shows that the number of biotechnology patents
granted by the PTO rose from 2,160 in 1989 to 7,763 in 2002. Since 1998, that total has aver-
aged over 7,000 patents each year.10
The biotechnology patents issued over the last 25 years have covered a wide range of
technologies and products from medicine and diagnostics for treating diseases to agriculture
and environmental products for feeding the world’s growing population and safeguarding the
environment. Some of the significant biotechnology patents to issue since the Chakrabarty
decision are discussed below.

The Harvard Mouse

Among the most fascinating developments in the post-Chakrabarty world is the “Harvard
Mouse,” developed by Harvard University researchers Phillip Leder and Timothy Stewart.
US Patent No. 4,736,866 received a great deal of attention when it was issued in April 1988,
because it was the first US patent to issue for a transgenic animal (i.e., an animal created by
injecting genes from another species into a fertilized animal egg and then surgically
implanting the egg into the mother). The injected genes were oncogenes that triggered cancer
growth, making the “oncomouse” a particularly valuable tool for testing the effects of cancer-
fighting drugs and suspected carcinogens.11
Since the Harvard Mouse patent was issued in 1988, hundreds of other patents pertaining
to transgenic animals have been issued in the United States, including patents to chickens
(US Patent No. 5,656,479), cows (US Patent No. 5,750,176), dogs (US Patent No.
6,498,791), mice (US Patent No. 6,552,246), monkeys (US Patent No. 5,489,524), pigs (US
Patent No. 6,498,285), rabbits (US Patent No. 5,675,063), rats (US Patent No. 5,489,742),
and sheep (US Patent No. 5,763,739). The Harvard Mouse is also patented in Europe and
Japan. However, not all countries have been willing to join the United States in allowing
patents on higher life forms. Canada, for example, has refused to patent transgenic animals.
The Supreme Court of Canada ruled in December 2002 that the Harvard Mouse is not patent-
able subject matter within the scope of the Canadian Patent Act.

The Polymerase Chain Reaction

The polymerase chain reaction (PCR)--the subject of US Patent Nos. 4,683,195, 4,683,202, and
4,965,188, issued in 1987 and 1990--has been hailed as one of the most important scientific technologies to
be developed in the last hundred years. Euphemistically referred to as a copying machine for DNA, PCR is
a technique for amplifying, detecting, and cloning DNA sequences. Using this process, scientists can take a
tiny fragment of DNA and generate an unlimited number of copies in just a few hours.
In the short time since its invention, PCR has revolutionized drug research and medical diagnostics,
aiding scientists in detecting hereditary diseases, identifying viruses, and mapping the human genome.
The process has become critical in the forensic science of genetic fingerprinting, where initial samples
often are too small to test. PCR has even been used successfully to analyze ancient DNA from sources
ranging from Egyptian mummies to a 40,000-year-old mammoth.

Genetically Engineered Crops

 US Patent Nos. 4,940,835 and 5,188,642 are two key patents in the area of genetically engineered crops.
Issued to Dilip Shah of the Monsanto Company on July 10, 1990, and February 23, 1993, these patents are
directed to a technique for genetically altering plant seeds so that the plants are resistant to glyphosate-
containing herbicides. These herbicides can then be safely applied in crop fields to selectively kill and
control weeds without also killing the crops.Other gene-altering techniques also are in use today to
increase the nutritional content of some foods and the resistance of crops to particular insects.

Thanks to biotechnology, the future has literally come to the dinner table. By some estimates,
more than 70 percent of processed foods sold in the United States today contain some
biotechnology products. In 2004, the US Department of Agriculture reported that genetically
altered soybeans accounted for 85 percent of the soybeans grown in this country and that
genetically altered corn accounted for 45 percent of the US corn crop.

Primate Embryonic Stem Cells

US Patent No. 6,200,806 was issued on March 13, 2001, to University of Wisconsin’s James
Thomson for his method of isolating and sustaining embryonic stem cells in culture so that
the cell lines continue to proliferate in an undifferentiated state. Embryonic stem cells, unlike
other cell types, are “pluripotent,” meaning that they can develop into any organ or tissue
type. Thomson’s invention electrified developmental biologists, who saw the potential for
directing cell differentiation to generate any organ or tissue type desired. It also created
considerable controversy, as debates raged regarding the harvesting of stem cells from
aborted embryos. Swayed by the tremendous promise that stem cell research holds for the
treatment of such tragic diseases as Parkinson’s and Alzheimer’s, the US House of
Representatives passed HR 810 on May 24, 2005, expanding federal funding for embryonic
stem cell research. The Bush Administration is opposed to the bill, but lawmakers are
confident that there will be sufficient votes to overcome any Presidential veto.

Conclusion
It is impossible to know whether biotechnology research and development would have been
stunted had the Supreme Court ruled against the inventor in Chakrabarty. Yet, the decision in
Chakrabarty surely provided companies in the nascent biotechnology industry with the
needed incentives to invest in the production of new medical treatments and drug therapies,
new and better diagnostic tools, and stronger and more disease-resistant crops. It also
emboldened the industry to seek patent protection on an ever-broadening range of
technological advances. As biotechnology has progressed from the genetic manipulation of
microorganisms to transgenic animals and human gene sequences, some religious and public
interest groups who oppose the patenting of animal life forms on moral and ethical grounds
have raised objections. Yet, these issues have less to do with patent law than with defining
the appropriate ethical limits on scientific development. As stated by Chakrabarty’s counsel,
Dale Hoscheit:
The issue decided in Chakrabarty was a narrow one, but it led to the removal of
barriers to patents for a wide variety of biotechnological innovations. The patents for
these innovations are limited only by the skill of the individuals drafting the claims.
Although there are moral and ethical issues involved in the manufacture of living
things, patents themselves are not designed to address such issues. The role of the
Patent Office is to determine novelty and no obviousness; issues of morality and ethics
are best left to other organizations specifically tasked to deal with those issues.

8(ans) UPOV treaty

UPOV was established in 1961 by the International Convention for the Protection of New
Varieties of Plants (the “UPOV Convention”). The mission of UPOV is to provide and
promote an effective system of plant variety protection, with the aim of encouraging the
development of new varieties of plants, for the benefit of society. Most countries and
intergovernmental organizations which have introduced a plant variety protection (PVP)
system have chosen to base their system on the UPOV Convention in order to provide an
effective, internationally recognized system (see www.upov.int/members/en/). As of October
10, 2017, UPOV has 75 members (shown in green). Sixteen States and one intergovernmental
organization have initiated the procedure for acceding to the UPOV Convention and 23 States
and one intergovernmental organization have been in contact with the Office of the Union for
assistance in the development of laws based on the UPOV Convention .
The UPOV Convention provides the basis for UPOV members to encourage plant breeding
by granting breeders of new plant varieties an intellectual property right: the breeder’s right.
In order to obtain protection, the breeder needs to file individual applications with the
authorities of UPOV members entrusted with the task of granting breeders' rights

The UPOV Convention specifies the acts that require the breeder’s authorization in respect of
the propagating material of a protected variety and, under certain conditions, in respect of the
harvested material. Under the UPOV Convention, the breeder’s right is only granted where
the variety is
 (i) new,
(ii) distinct,
(iii) uniform,
(iv) stable and has a suitable denomination.

The breeder’s right does not extend to acts done

 privately and for non-commercial purposes,
 for experimental purposes and
 for the purpose of breeding other varieties.
A State or intergovernmental organization that wishes to become a UPOV member needs to
seek the advice of the UPOV Council in respect of the conformity of its laws with the
provisions of the UPOV Convention. This procedure leads, in itself, to a high degree of
harmony in those laws, thus facilitating cooperation between members in the implementation
of the system. Guidance documents on how to develop legislation and become a UPOV
member can be found at www.upov.int/upov_collection/en/. The legislation of UPOV
members can be consulted in UPOV Lex.
The UPOV Report on the Impact of Plant Variety Protection
(www.upov.int/about/en/pdf/353_upov_report.pdf)
demonstrated that in order to enjoy the full benefits which plant variety protection is able to
generate, both implementation of the UPOV Convention and membership of UPOV are
important. The introduction of the UPOV system of plant variety protection and UPOV
membership were found to be associated with:
(a) increased breeding activities,
(b) greater availability of improved varieties,
(c) increased number of new varieties,
(d) diversification of types of breeders (e.g. private breeders, researchers),
(e) increased number of foreign new varieties,
(f) encouraging the development of a new industry competitiveness on foreign
markets, and
(g) improved access to foreign plant varieties and enhanced domestic breeding
programs.
The effectiveness of the UPOV system of plant variety protection is enhanced by the
provision of guidance and information materials such as Explanatory Notes (“UPOV/EXN”
series), Information Documents (“UPOV/INF” series) (e.g. UPOV/INF/12 “Explanatory
Notes on Variety Denominations under the UPOV Convention”), the General Introduction to
the Examination of Distinctness, Uniformity and Stability and the Development of
Harmonized Descriptions of New Varieties of Plants, with its associated TGP documents, and
the “Guidelines for the Conduct of Tests for Distinctness, Uniformity and Stability”