Unit-1

1INTELLECTUAL PROPERTY IN BIOTECHNOLOGY

Biotechnology is a term used by those in the life sciences industry to indicate
the use of, and methods involving, living organisms or their products for
making new useful products, which could include new varieties of living
organisms. This defnition is quite broad, but that is an accurate refection of
the technical range associated with the feld. The term Life Sciences
Industry, itself, can indicate a wide range of entities from a pharmaceutical
manufacturer, to a farmer, to a food processor or medical diagnostics
company.
Even in the strictest sense, biotechnology is not a new feld and throughout
human history, biotechnology assets have been generated through human
ingenuity. Biotechnology has been used in the form of fermentative
processes to manufacture beer, bread, wine and cheese for generations. The
Egyptians used yeasts in bread and winemaking around !""" B.#. Till today,
we use microorganisms to produce many products in the food and
pharmaceutical industries. Turning biotechnology inventions into protected
intellectual property, with concomitant intellectual property rights, has also
been happening for over a century. $ouis %asteur was granted a &rench
patent in '()* for yeast clones that he had isolated from mi+tures of yeast
species. ,e had a -... %atent, which was issued in '(/0, entitled,
12mprovement in Brewing Beer and 3le4. This covered a new method of
making beer and ale 5with the process we now call pasteurization6 and also
involved the production of cultures of particular yeast species.
.ince then protection of products isolated from living materials and methods
to produce them became quite commonplace, Biotechnological inventions
may have a very signifcant e7ect on our future, in particular in the felds of
medicine, food, energy and protection of the environment.
8enerally, Biotechnology concerns living organisms, such as plants, animals
and microorganisms, as well as nonliving biological material, such as seed,
cells, en9ymes, plasmids 5which are used in genetic engineering6 and the
like. Biotechnological inventions fall into three categories. They are the
processes for the creation or modifcation of living organisms and biological
material, the results of such processes, and the use of such results.
2n more recent times, as a result of scientifc discoveries, it has become
possible to develop biological processes which manipulate living organisms.
These processes may be entirely controlled by man. The most notable
e+amples of such processes occur in the artifcial modifcation of genes
5genetic engineering6. These processes are able to change the material
determining the hereditary characteristics of living organisms, and thus it is
possible to create modifed organisms which have certain desirable features.
&or e+ample, the microorganism created by #hakrabarty 5an inventor in the
-nited .tates of 3merica6 is able to absorb oil pollution from oceans and
rivers. 2t was the sub:ect of a landmark decision of the .upreme #ourt of the
-nited .tates of 3merica, when the microorganism created by #hakrabarty
was recogni9ed as patentable.
8enetic engineering processes are also used in the modifcation of micro
organisms for the production of new medicines. Biotechnology is e+pected to
lead to important breakthroughs in medicine which may be e7ective in
combating diseases such as cancer and 32;.. 2t may also lead to new
opportunities for obtaining food and energy, and may provide solutions to
the problems of pollution of the environment.
Traditionally, in scientifc circles, the concept of invention was generally
limited to the felds of physics and chemistry because living organisms were
considered to be outside the scope of technology. ,owever, with the
possibility of controlling and describing processes in the feld of
biotechnology, the concept of invention will have to be enlarged to cover
biotechnological inventions. If it is possible to control a biotechnological
process and to describe such a process in a way that experts in the feld can
carry out on the basis of the description, then an invention in the feld of
biotechnology has been made.
To protect such developments in biotechnology feld di7erent intellectual
property protection tools can be used. These may include patents for
inventions, trademarks for identifying products, copyright for various data
bases or their presentation, geographical indications for plant varieties with
specifc geographical origins.
2n order to streamline the patents of microorganisms, a convention for
international recognition of the deposit of microorganisms for purposes of
patenting was established in '<//.
2n this -nit we will be discussing the issues related with intellectual property
protection in case of biotechnology area. =ou will be learning various tools of
intellectual property protection used in the feld. .ince this is an emerging
feld, di7erent countries are attempting to create mechanisms for tackling
the biotechnology related issues of intellectual property. >e will briefy
discuss about these e7orts citing some typical e+amples.
Objectives
3fter studying this unit, you should be able to?
e+plain the specifc obstacles arising in biotechnology 2%@ %rotectionA
describe various intellectual property rights related to biotechnologyA
e+plain the protection mechanisms for 2%@ in biotechnologyA
#ite e+amples of mechanisms evolved by di7erent countries to address
biotechnology 2%@ issuesA and
e+plain the important features of Budapest treaty.
NEED FOR IPR PROTECTION IN BIOTECHNOLOGY
3s in other felds of technology, there is a need for legal protection in respect
of biotechnological inventions. .uch inventions are creations of the human
mind :ust as much as other inventions, and typically they are the result of
substantial research and inventive e7ort and investment in sophisticated
laboratories. Typically, enterprises engaged in research only make
investments if legal protection is available for the results of their research.
Thus, there is an obvious need for the protection of biotechnological
inventions :ust like inventions in any other technology feld. This is not only
in the interest of inventors and their employers, but also in the public
interest in order to promote technological progress.
$egal protection of inventions is normally e7ected through the grant of
patents or other titles for the protection of inventions. ,owever, inventors in
the feld of biotechnology are faced with several obstacles when seeking
protection for their inventions. These obstacles do not e+ist to the same
degree in other areas of technology.
The frst obstacle is the problem of whether there really is an invention
rather than a discovery. 2f, for e+ample, a microorganism as yet unknown is
isolated by a sophisticated process, it may be argued that such a micro
organism is not an invention but is a scientifc discovery. The counter
argument would be that the isolation requires an important human
intervention using a highly sophisticated process, and therefore the result is
a solution of a technical problem. 2t may also be argued that the isolated
microorganism is not di7erent from a chemical substance e+tracted from
nature, which is patentable sub:ect matter.
The second obstacle is the e+istence of e+press legislative provisions that
e+clude certain categories of biotechnological inventions from patent
protection, in particular, in view of public order and morality. Those
provisions have their origin in developments which took place in Europe, but
have also infuenced countries outside Europe.
3lthough not all questions have been answered yet at the international level,
a number of legal issues with respect to patent protection for
biotechnological inventions have been addressed by the T@2%. 3greement
and the E# ;irective on the $egal %rotection of Biotechnological 2nventions.
EXISTING PROTECTION
2n general, a biotechnological invention is not di7erent from other inventions
with respect to its protection under patents. 3rticle B/.' of the T@2%.
3greement requires that patents be available in all felds of technology,
provided that they are new, involve an inventive step and are capable of
industrial application. ,owever, 3rticle B/.B enables a Cember to e+clude
from patentability inventions whose commercial e+ploitation may be contrary
to public order or morality. &urther, 3rticle B/.0 also allows Cembers to
e+clude from patentability plants and animals other than microorganisms,
and essentially biological processes for the production of plants or animals
other than nonbiological and microbiological processes.
2n Europe, the E# ;irective <(D!! on the $egal %rotection of Biotechnological
2nventions, which entered into force on Euly 0", '<<(, has harmoni9ed the
rules concerning patent protection for biotechnological inventions. 2t provides
that biological material which is isolated from its natural environment or
produced by means of a technical process may be the sub:ect of a
patentable invention even if it previously occurred in nature. 2t however
e+cludes from patentability plant and animal varieties and essentially
biological processes for the production of plants or animals. 3s regards public
order and morality, it provides a none+haustive list of inventions which
should be considered nonpatentable. These are processes for cloning human
beings, processes for modifying the germ line genetic identity of human
beings, uses of human embryos for industrial or commercial purposes and
processes for modifying the genetic identity of animals which are likely to
cause them su7ering without any substantial medical beneft to man or
animal, and also animals resulting from such processes.
#oncerning protection of plant varieties, 3rticle B/.05b6 of the T@2%.
3greement provides that plant varieties shall be protected either by patents
or by an e7ective sui generis system or by any combination thereof. The
special system of protection for plant varieties is di7erent from patent
protection in respect of the conditions for protection and the protected acts.
The special nature of this system is demonstrated by the fact that an
international convention was concluded for the protection of new varieties of
plants which is administered by a special organi9ation, namely the
2nternational -nion for the %rotection of Few Garieties of %lants 5-%HG6.
DIFFERENT TYPES OF IPRs IN BIOTECHNOLOGY
&or some, it seemed a new era was ushered in with the advent of gene
sequencing and the intellectual property assets derived from techniques
associated with the manipulation of ;F3. %erhaps the public only began to
be concerned about biotechnology inventions when patents were granted to
claims involving ;F3 sequences. %rotection of this new type of biotechnology
asset can be traced to the invention involving ;F3 isolated from frogs and
bacteria using genetic engineering methods invented by ,erbert Boyer and
.tanley #ohen
%eople have long considered plant seed and animal breeding stocks to be
property. #ommercial seed companies, with which we are familiar, are
commercial enterprises based on the production and selling of human
selected plant germplasm. There are many ways of protecting this type of
asset but the methods by which plant materials can be bred or reproduced or
genetically changed can also represent intellectual property assets.
2n some nations, you can protect these types of assets with a patent, but
that might not be the only mode. The -... Board of 3ppeals ruled in '<(*
that new plant varieties were inventions that could be granted intellectual
property rights with the grant of a patent. The records of breeding trials,
records of e+periments involving the e7ects of di7erent fertili9ers also
represent assets that involve creative ideas and the hand of man. Therefore,
they too can be considered intellectual property assets and can have 2%@s
associated with them.

Biotechnology inventions in the field of medicine, notably therapeutic methods, such as a new
type of laser surgery to correct visual acuity or diagnostic methods used in the treatment of
diseases or methods of surgery are inventions that can be protected by patents in some nations,
whilst in other countries patent protection can be controversial. Article 52(4) of the uropean
!atent "onvention provides that methods for treatment of the human or animal body by surgery
or therapy or diagnostic methods practiced on the human or animal body shall not be regarded as
patentable sub#ect matter.
,owever the case law with regard to the way, in which this regulation is
interpreted, is quite comple+ and can be confusing. 3 fne distinction has
been put forward, in which the European %atent HIce Technical Board of
3ppeal has made a list of what is necessary for an invention to be called a
diagnostic method. This includes?
recording case history and results of testsA
comparing the test data with normal valuesA
recording any deviationsA and
attributing the deviation to a particular clinical situation.
3ll of these steps must be included or this is not a diagnostic method, but
instead might be called, for e+ample, a data acquisition or data processing
method. This data acquisition or data processing might itself be in the realm
of patentable sub:ect matter.
$n addition to legal considerations, contemplation of whether therapeutic methods should be
afforded restricted or e%clusive distribution is an ethical dilemma in some societies.
3lso legal requirements for performing a search to determine novelty or non
obviousness may vary between international agreement regulations, such as
those for %atent #ooperation Treaty 5%#T6 applications and those of national
patent oIces. This may also impact on the way in which patent prosecution
regulations are applied to therapeutic types of inventions.
%atent protection is available for diagnostic and therapeutic inventions,
mainly in the -... ,owever, regarding diagnostic methods, European case
law indicates that the defnition of a diagnostic method has been challenged,
successfully, in the courts.
$f we consider other, less obvious assets, produced as a result of more recent biotechnology
investigations, (many involving practicing inventions), we see that a vast amount of information
is being produced& records from drug efficacy clinical trials, information from nucleic acid
se'uencing studies or dose(response studies. )his information is fuelling the production of large
databases. )hese databases can be collections of information, or a database in which people have
organi*ed and annotated information. )his information can be protected, 'uite apart from the
underlying invention. )hese annotated databases are especially central to stimulate the useful
application of this information for industrial purposes and to allow pharmaceutical companies
and seed companies to pass stiff regulatory hurdles. +uch databases can represent a very valuable
intellectual property asset. !rotection of such an asset, in a manner that also encourages
distribution of the information, re'uires both legal and technical s,ill.
Te+t in a scientifc report or patent, pictures or drawings, records in a
notebook, seeds stored in a gene bank, hybridomas in the incubator can all
be put into a form that allows another person to make and use these
improvements. Hften however, there are intellectual property assets that
may be diIcult to capture in a traditional mode. Hne of these is what we
often term, knowhow. Jnowhow is usually an intellectual property asset
that is transferred by having the inventor show another person what has
been invented. 2t consists often of those small details that allow the
invention to work, an e+perience not too di7erent from having someone
show you a cooking technique, such as creaming the butter in a cake recipe,
rather than trying to fgure it out from reading a description in a cookbook.
%utting together a legal description of such an asset requires good drafting
skills.
.o, intellectual property assets in the feld of biotechnology can be
categori9ed in many ways?
a new method of isolating a pharmaceutically active compound from a
plantA
a new compound created by employing a microbiological process method
to synthesi9e an organic dye, 5such as indigo previously only available
from eukaryotic plants6A
a database of information, for e+ample on growth characteristics of mai9e
varieties in .ub.aharan 3fricaA
plant or animal varieties produced as a result of biotechnologyA
secondary information? products, compositions, applied methods,
databases, techniques, scientifc articles, scientifc knowhow,
manufacturing methods, computer programs for annotating sequences,
feld trial data, clinical trial data, geographical names associated with
particular products that result from biotechnology processes.
BASIC INSTRUMENTS TO PROTECT BIOTECHNOLOGY IP ASSETS
)he instruments most often associated with the protection of biotechnology associated
intellectual assets are&
%atents 5utility, design, innovationDpetty6A
Trade secretA
#opyrightA
TrademarkA
%lant patentA
%lant breederKs rightA and
8eographic indication.
2f the asset is an invention then it would be very routine to fle for patet
protection for this asset in almost any country 5or most countries or a
selection of countries6 in the world. Then after making sure that your
application meets the legal requirements in the country5ies6 where you have
fled, and after an e+amination of the claims, you will be granted a patent.
This enables you to prevent others 5for the term of the grant6 from making,
using or selling your invention in the country where the patent is issued,
unless they obtain a license from you.
But, because you must disclose the best mode of practicing your invention,
at the time the patent application is fled, people can then read about, look
at, and handle your invention. That is, your invention can be inspected,
perhaps even literally touched. &or e+ample, if your invention had been a

plasmid or a seed, it may be possible for others to germinate and grow the
invention, without a license, as long as the invention is not used or made in
the way it is protected in the patent claims. =ou may not wish this to happen
as it could give ideas to potential competitors.
,ence, alternatively you could choose to keep the invention a t!a"e sec!et,
by not telling anyone 5unless they had signed a confdentiality or non
disclosure agreement6. =ou could also license this type of trade secret, under
the conditions of a confdentiality agreement. >ith the trade secret route
there is no public disclosure, unless you choose to do so or someone violates
a contract.
=our records, written down during your e+periments can be c#p$!i%&te"
and the copyright can also be registered. @egistration is not necessary to
obtain copyright protection, but registration may make it easier to enforce
your copyright. Then you might also choose to name your invention and
t!a"e'a!( the name.
.ometimes it can be more problematical to protect your asset. This can be
due to an inherent characteristic of your asset, such as trying to protect
(#)*&#) to something more recogni9able than knowhow but that still
presents diIculties. 3n e+ample of this would be a variation in the legal
standard of what constitutes patentable sub:ect matter, due to a di7erence
in the laws or regulations between countries.
!rotection of databases presents a good e%ample of legal differences in regulations. -nder -.+.
law and in many other places, with the e%ception of the uropean -nion (-), databases are
generally protected by copyright, as compilations. a compilation being the collection and
assembling of data or other materials into a fi%ed mode.
Fow there has been variation in the past with regard to a test as to the
amount of creativity that has gone into the construction of the database that
has to be satisfed before formal protection can be obtained. !reativity is
related to the way in which the data has been selected and arranged. The
only protection you may be able to provide your database that fails this
creativity test is to keep the information confdential as a t!a"e sec!et.
Even in situations where a database is protected by copyright, the underlying
data is not automatically granted copyright protection in its own right.
,owever, the underlying data itself may already be protected by copyright,
e.g. in a database that is a compilation of video images of cell reaction in
response to a particular treatment, the images themselves may be protected
by copyright.
The limited protection available to databases in some countries has
prompted owners of these types of assets to seek additional protection for
databases and for the use of the data contained in the database, by making
databases available only under contract or a license agreement. 3n
enforceable contract could prohibit the end user from making data e+tracted
from the database available to third parties or from incorporating such data
into another database.
,owever, in some European countries, all databases are immediately
protected by "atabase !i%&ts as soon as they are f+ed or the data are set
down. $aws enacted in response to the European ;atabase directive set out
two types of protectionA '6 protection that is similar to copyright protection
regarding the particular selection or arrangement of the contents, and B6 a
sui generis protection against the e+traction or reuse of substantial portions
of the database contents. 3ll countries that are members of the E- have now
enacted such legislation.
$iving materials present another set of issues in relation to biotechnology
and intellectual property. %rotection of an intellectual property asset as
represented by living plant material has always been a comple+ issue.
&armers have always saved seed and traded their supplies in barter or
money for goods, if the demand was there. ;omesticated hybrid mai9e has
long been protected by keeping information about the parental lines as a
t!a"e sec!et. This is clearly an important issue for plant breeders.
$nitially plant breeders in the -nited +tates of America turned to the -.+. !atent /ffice for
protection and indeed the !atent /ffice collected information on agriculture and even distributed
seeds as early as 0123. )his was apparently burdensome and confusing to patent e%aminers
accustomed to loo,ing at the novelty and utility of farm machinery or gearbo%es. $n 0425, the
-.+. created a special form of protection (that e%ists to this day in the -.+. and other countries
such as the 6epublic of 7orea), called a plant patent. )his created a special form of protection
that is usually limited to ase%ually reproduced varieties of plants. ("uriously, and depending
upon the regulations for a particular country, such patents cannot be granted to new varieties of
plants that form edible tubers such as potato plants and 8erusalem articho,es).
2nterestingly, this type of patent contains only one claim, in which the patent
owner claims the plant, based on a new characteristic that the plant e+hibits.
This claim is substantiated by a drawing, a photograph or information that
clearly illustrates the new characteristic. The plant is not grown in trials, nor
is there a requirement for enablement associated with this type of patent.
3nother type of protection that can be formally sought for plants is a p+at
b!ee"e!,s !i%&t -PBR.. ,istorically, the Fetherlands granted a very limited
e+clusive right for breeders of agriculturally important species to market the
frst generation of certifed seed, and also an e+clusive right to market
propagating material of other species, in the BreedersK Hrdinance of '<!'.
3lso in 8ermany, after many years of limited protection for breeders based
upon seed certifcation, the $aw on the %rotection of Garieties and the .eeds
of #ultivated %lants of '<*0 gave breeders the e+clusive right to produce
seed of their varieties for the purposes of the seed trade and to o7er for sale
and market such seed. .ome patents were granted in some 8erman states
but the likelihood of securing patent protection for plant varieties was not
generally considered to be suIcient to constitute an e7ective incentive for
plant breeders.
%B@ is usually obtained in accordance with plant variety protection
regulations that involve growing the plant for which protection is sought to
see if the plant is distinct from e+isting varieties of the same species. Tests
also involve propagation of the variety to ensure that the variety is uniform
when multiplied and that with propagation the varietal plants e+hibit a
stability that is inherited. 3s you may have reali9ed from these requirements
obtaining a %B@ can often take quite a long period of time, due to the
verifcation process that involves growing and multiplying the material in
question. =ou have already learnt in the last -nit that the 2nternational -nion
for the %rotection of Few Garieties of %lants 5-%HG6 is an intergovernmental
organi9ation with headquarters in 8eneva 5.wit9erland6 that administers the
2nternational #onvention for the %rotection of Few Garieties of %lants, with
the ob:ective to protect new varieties of plants by %B@. 2n a limited number
of countries, such as Eapan and the -..., new varieties of plants or animals
can also be protected by seeking a /ti+it$ patet. 2n these situations the
e+aminers make decisions about the patentability of B* a plant variety
invention using the same procedures as with other categories of utility
patent applications. The basis for allowance of claims is utility, novelty, and
nonobviousness. The plant material itself is not tested, nor is it handled in
any way. ,owever, a deposit of material at a certifed biological material
depository may be a legal requirement.
3 name, associated with a biotechnology intellectual property asset can
receive t!a"e'a!( protection. The legal requirements for this type of
protection are usually not sub:ect to a great deal of interpretation. Hften this
type of protection will prove to be an e+cellent marketing tool that may meet
the desired goal of protection in a more timely manner than seeking patent
protection or a plant breederKs certifcate. By trade marking the name of a
new plant variety, you can prevent others from using that name in the same
wayA an e+ample is the Cadeleine
L
strawberry. Hther trademarks found in
association with biotechnology assets can be names of laboratory machinery
for e+ample, .F%streamM, a system used for identifying single nucleotide
polymorphisms 5.F%Ks6 in genomic ;F3s harvested from organisms. 3
trademark thus has the quality of establishing intellectual property rights
associated with this type of name or logo asset.
The fling of a "esi% patet can be an option to consider for the protection
of a biotechnology asset where the design, for a piece of equipment such as
a tractor, a ;F3 analy9er or a ;F3 chip, be it either ornamental or functional
is unique. The acceptable format for this type of application is usually quite
formali9ed and applicants are advised to follow %atent HIce instructions to
the letter to avoid re:ection problems.
2n some countries, such as 3ustralia, an inventor can apply for a patent
called an i#vati# patet. >ith this type of application there is no formal
e+amination of the claims, unless it is requested by the applicant or
contested after the patent has issued. 2n addition, the term of the patent is
much shorter, ( years as compared to the usual B"year coverage period for
utility applications. 2n Thailand and some other countries it is possible to get
protection for an invention using the pett$ patet system. -nder this
system, the inventive step or the uniqueness associated with an invention is
not e+amined. The time period that such a patent is in force is also reduced.
Ge#%!ap&ic i"icati# is a category of intellectual property asset
protection that is seeing increasing use in the agricultural and food industry
sectors of the life sciences industry. #urrently, this type of protection is
sought for particular varieties that have a strong association with a particular
geographical region and allow producers in that region to e+ert a type of
quality control over their asset. 3 famous e+ample is the term, champagne,
which is registered as a geographic indicator for the type of fermented
beverage made using a certain type of grape that is grown in a certain
region of &rance. The unique favour of this wine is associated both with the
grape species, the fermenting microorganisms, and with the conditions
under which the grapes are grown.
3 particular category of biotechnological inventions, concerning micro
organisms 5either the processes for obtaining a microorganism or the micro
organism itself, or the particular use of a microorganism6 is governed by
special provisions. >e will discuss about these in the ne+t section.
Trademark law
The Trade Carks 3ct, '<<< replaces the Trade and Cerchandise Carks 3ct,
'<*(. The 3ct is a consolidated e7ort to bring the law at par with
international practices. These changes were envisaged by 2ndia well before it
signed the 8eneral 3greement on Trade and Tari7 583TT6 and the Trade
@elated 2ntellectual %roperty @ights 5T@2%.6.
&or the frst time the new 3ct will protect service marks, and the scope of
other terms has been e+panded in tune with international practices. 3 brief
analysis of the e+panded terms is mentioned herein. The service sector,
including information technology, B%H services, hotels, hospitals, airlines and
advertisement agencies, can now protect their marks as service marks.
>ellknown trademarks without registration or use are now protected in
2ndia. 2ndia recently made certain changes to its trademarks law to
harmonise it with the requirements of T@2%.. To fulfl its obligations under
T@2%., 2ndia enacted a new trademarks law N the Trade Carks 3ct, '<<<,
which di7erentiates between wellknown trademarks and trademarks
generally. .pecial treatment and rights are envisaged for wellknown
trademarks under the '<<< 3ct.
3n important feature of the '<<< 3ct is the recognition and protection of
wellknown trademarks. The '<<< 3ct deals elaborately with facts to be
considered and methods to be adopted by the @egistrar of Trade Carks
5@egistrar6 in protecting a wellknown trademark against copying of such
marks by others, whether the proprietor is an 2ndian or a foreign company,
and at the same time protecting the interests of bona fde proprietors.
The provisions of the '<<< 3ct are not to be seen as totally new as similar
results are achieved under e+isting law N the Trade and Cerchandise Carks
3ct, '<*(, and the practice followed by 2ndian courts in various decided
cases. The determination of a wellknown trademark should be based on the
knowledge or recognition of that trademark in the relevant section of the
public, including knowledge in 2ndia obtained as a result of promotion of the
trademark.
The question of whether a trademark is known to or recognised by the
relevant section of the public is to be determined after taking into
consideration the following facts?
the number of actual or potential consumers of the goods or servicesA
the number of persons involved in the channels of distribution of the goods
or servicesA
the business circle dealing with the goods or services, to which that mark
applies.
>here a trademark is determined to be wellknown in at least one relevant
section of the public in 2ndia by any court or @egistrar, the @egistrar would
consider that trademark as a wellknown trademark for registration under
the '<<< 3ct.
the duration, e+tent and geographical area of any use of that trademarkA
the duration, e+tent and geographical area of any promotion of the
trademark, including advertising or publicity and presentation, at fairs or
e+hibitions of the goods or services to which the trademark appliesA
the duration and geographical area of any registration of or any publication
for registration of that trademark under the '<<< 3ct to the e+tent they
refect the use or recognition of the trademarkA and
the record of successful enforcement of rights in that trademark, in particular
the e+tent to which the trademark has been recognised as a wellknown
trademark by any court or registrar under that record.
The above list is not e+haustive and any other relevant fact in determining
whether the trademark in question has become wellknown is to be taken
into account.
2t will also be seen that it is not a single factor but the totality of the
circumstances that establish and determine whether or not a particular
trademark is wellknown.
There are new provisions of additional remedy against criminal o7ence,
which has now been made a cognisable o7ence.
3n 2ntellectual %roperty 3ppellate Board has now been constituted to hear
appeals on the decisions of the @egistrar.
The authority to register a certifcation trademark now vests with the
@egistrar under the new 3ct and the validity of @egistration has been
increased from seven years to '" years. The concept of collective trademark
has been introduced. #ollective trademark means trademark distinguishing
the goods or services of members of an association of persons 5not being a
partnership6 as proprietorship from those of others. The scope of
infringement has been widened.
2ntellectual property is probably an entityOs most valuable asset and it is
important to clearly identify it. 2t may be a name on your front door, a
graphic design, or invention.
&ailure to protect it, or to do so early enough, may put your business at risk.
2dentify and value your 2% assets and ensure they are itemised in your
business plan.
Copyright Law
#opyright $aw in 2ndia is governed by the C#p$!i%&t Act, which was
enacted in '<*/. -nder copyright 3ct, #opyright is proprietary right although
vests in the author of the work. Hn the creation of the work, the author
receives e+clusive right, use or e+ploit the work as well as prevent the
authors from using or e+ploit the work. .pecifcally, the copyright lists the
following as protected work?
'. $iterary work
B. Cusical work
0. ;ramatic work
!. 3rtistic work
*. #inematographer work
). 3udio TapeA and
/. #omputer .oftware
The #opyright 3mendment 53mendment 3ct6 passed in the year '<(!
defnes and permit computer program Pas literary work that includes tables,
compilation and program that is to say programs record on any discs, tape,
perforated media or other. The information storage device which is if fed into
or located in computer, any information. The originality of the work is to be
proved by the author since the author of the work must be able to prove that
the work was frst published or displayed or performed. The #opyright act
defnes infringement as in the 3ct permitted only by the author of the work
which is done by the person without permission of the author. =es, .oftware
in 2ndia can be protected against piracy. The 3ct provides for registration of
the work but various pronouncements by various courts have held that the
registration under the #opyright 3ct is not mandatory. %iracy of the #opyright
has been protected under .ection *' of the 3ct. That it is desirable that the
.oftware registration is made with the @egistrar of #opyright Few ;elhi. &or
obtaining registration of the .oftware one as statutory right which can be
protected and enforced through %olice or #ourts which has been e7ective
enforcement by the %olice by raiding the premises of the infringers. The ne+t
query asked by you ishow can one enforce licensing its software in 2ndia.
The statute permits licensing of the work as that of assignment provision of
the #opyright 3ct, the author is permitted to license one or more rights or
interest in work 2n the statute contains a list or di7erent type of licensing
including the following?
'. E+clusive license
B. B. Fone+clusive $icense
0. 0. $icense from a Eoint Hwner
!. $icense without considerationA and
*. 2mplied $icense.
Hnly restriction placed in that creation of the license is that the agreement
of license has to be in writing and has to be e+ecuted by the $icensee
5owner of the work6. 2n addition to allowing the author of the work to take
action to permit his or moral rights in the work. There are three types of
remedies for infringement of the work by any authori9ed persons in 2ndia?
'. Hwner 3ssignee
B. . E+clusive $icensee or legatees of the work may initiate a lawsuit
claiming infringement of the copyright.
0. The %lainti7 in such suit may name ;efendant, the person to copyright
infringement act, the person to permit a place to be used to infringe the
copyright and persons who sells or o7ers to soil any product which
infringes copyright. The lawsuit can be fled in any ;istrict or ,igh #ourt
but to be fled within years from the date of infringement. Conetary
damages can be recovered. ;elivery has been all infringing copyright
work and in:unctive reliefs are appropriate. &orm of remedy for
infringement provided by the #opyright 3ct is imprisonment of criminal
fnes and sanction including a term of imprisonment for any person that
infringes a protected work.
COPYRIGHTS IN INDIA
-nder $ndian law, registration or any other formality is not re'uired either for ac'uiring
copyright or for enforcing it in an infringement action. $n other words, registration is not a
prere'uisite or a condition precedent for securing copyright protection in $ndia. $t only has
evidentiary value in showing that the person mentioned in the 6egister is the actual
author9owner. $ndia is a signatory to the -niversal "opyright "onvention and the Berne
"onvention
LEGISLATION
$ndia:s copyright law, laid down in the $ndian "opyright Act, 045;, fully reflects the Berne
"onvention on "opyrights, to which $ndian is a party. Additionally, $ndia is party to the <eneva
"onvention for the !rotection of 6ights of !roducers of !honograms and to the -niversal
"opyright "onvention. $ndia is also an active member of the =orld $ntellectual !roperty
/rgani*ation (=$!/), <eneva and ->+"/.
)he copyright law has been amended periodically to ,eep pace with changing re'uirements. )he
latest amendment to the copyright law which came into force in ?ay 0445, has ushered in
comprehensive changes and brought the copyright law in line with new developments in satellite
broadcasting, computer software and digital technology. )he amended law has made provisions
for the first time, to protect performers: rights as envisaged in the 6ome "onvention.
+everal measures have been adopted to strengthen and streamline the enforcement of copyrights.
)hese include the setting up of a "opyright nforcement Advisory "ouncil, training programs
for enforcement officers and setting up special police cells to deal with cases relating to
infringement of copyrights.
Copyr!"t #Amendment$ A%t& '(()
+ince we last reported, developments have ta,en place in the field of copyright law. )he
"opyright (Amendment) Act, 0444 came into force with effect from ?ay 05, 0445 and some of
the salient features thereof are listed below&
(i) A comprehensive definition for @computer programme@ (absent in the previous Act) reading as
follows has been introduced &
"computer programme" means a set of instructions expressed in words, codes, schemes or in any
other form, including a machine readable medium capable of causing a computer to perform a
particular task or achieve a particular result"
As under the earlier Act, computer programmes continue to be treated as @literary wor,s@. )he
definition of @literary wor,s@ under the new Act includes "computer programmes, tables and
compilations including computer data bases".
(ii) $n relation to any literary, dramatic, musical or artistic wor, which is computer(generated, the
person who causes the wor, to be created is the @author@.
(iii) A new offence has been added in the Act for ,nowing use of infringing copy of computer
programme prescribing imprisonment for a term which shall not be less than ; days but which
may e%tend to 2 years and with fine ranging from 6s 55,555 (-+ A 0,555 appro%.) to 6s 255,555
(-+ A 3,555 appro%.) Bowever, where the computer programme has not been used for gain or in
the course of trade or business the court may not impose any sentence of imprisonment and may
instead only impose a fine up to -+ A 0,555.
(iv) )he definition of @communication to the public@ has been amplified (
"communication to the public" means making any work available for being seen or heard or
otherwise enjoyed by the public directly or by any means of display or diffusion other than by
issuing copies of such work regardless of whether any member of the public actually sees, hears
or otherwise enjoys the work so made available."
$n an e%planation to this definition, it has been clarified that communication through satellite or
cable or any other means of simultaneous communication to more than one household or place of
residence including residential rooms of any hotel or hostel shall be deemed to be
communication to the public.
(v) very @broadcasting organisation@ has been conferred with a special right ,nown as
@broadcast reproduction right@ which shall subsist until 25 years from the beginning of the
calendar year ne%t following the year in which the broadcast is made. )he Act stipulates that
certain acts, which when done without the licence of the owner of such right, shall be deemed to
have infringed such right.
(vi) )he Act specifies certain acts which do not constitute infringement of copyright the
important one being "the making of copies or adaptation of a computer programme by the lawful
possessor of a copy of such computer programme, from such copy i! in order to utilise the
computer programme for the purpose for which it was supplied" or ii! to make back-up copies
purely as a temporary protection against loss, destruction or damage in order only to utilise the
computer programme for the purpose for which it was supplied".
Copyr!"t #Amendment$ A%t& '(((
An amendment to the "opyright Act, 045;, the "opyright (Amendment) Act, 0444 has recently
come into force. $n compliance with Article 04 of )6$!+ it e%tends copyright protection to
performers from the present twenty(five years to at least fifty years computed from the end of the
calendar year in which the performance too, place. $t further empowers the <overnment to
e%tend the provisions of the "opyright Act to broadcasts and performances made in other
countries provided those countries e%tend similar protection to broadcasts and performances
made in $ndia.
$n terms of the $nternational "opyright /rder, 0440 (promulgated by the $ndian <overnment)
@foreign wor,s@ first published in a country which is a member of either of the
"onventions would be accorded the same copyright protection in $ndia as $ndian wor,s
without undergoing any formalities. )his is on the assumption that the home country
accords @national treatment@ to $ndian wor,s, i.e., recognises the criterion of reciprocity.
)his has led to a somewhat peculiar situation in the $ndian "opyright 6egistry. $f an
application for registration of copyright is filed by an applicant who is a member of either
of the "onventions, the 6egistry is inclined to return the application on the ground that
since copyright protection would be afforded to the applicant automatically, there is no
need for registration therefore. $t appears that in the process the 6egistry is trying to
reduce its paper wor,. )hus, in case of infringement, the applicant can rely on the
copyright registration certificate issued by his home country and on the basis thereof
enforce his rights in $ndia through the $nternational "opyright /rder, 1991.
TRIPS0 STANDARDS CONCERNING TRADEMAR1S
%art 22 of the T@2%. 3greement provides minimum standards concerning the
availability, scope and use of intellectual property rights. This %art contains
eight sections relating, respectively, to copyright and related rights,
trademarks, geographical indications, industrial designs, patents, layout
designs 5topographies6 of integrated circuits, protection of undisclosed
information and control of anticompetitive practices in contractual licenses
5the latter sub:ect is not contained in the defnition of intellectual property of
3rticle '.B6.
T!a"e'a!(s
The essential elements of the standards concerning the availability, scope
and use of trademark rights include the following?
any sign capable of distinguishing the goods or services of one
undertaking from those of other undertakings 5thus including service
marks6 shall be eligible for registration as a trademark 53rticle '*.'6A
registrability may be conditional upon visual perceptibility and, for signs
which are not inherently distinctive, on distinctiveness acquired through
use 53rticle '*.'6A
registrability may be conditional upon use 53rticle '*.B6, but use may not
be a condition for fling and an application may not be refused solely on
the ground that intended use has not taken place within three years of the
fling date 53rticle '*.06A
the nature of the goods or services to which a trademark is to be applied
may not be an obstacle to the registration of the mark 53rticle '*.!6A
Cembers shall publish each trademark and a7ord a reasonable
opportunity for petitions to cancel the registration, and may a7ord an
opportunity to oppose the registration 53rticle '*.*6A
the rights conferred by registration shall include the e+clusive right to
prevent third parties from using identical or similar signs for identical or
similar goods or services, where such use would result in a likelihood of
confusion, the latter to be presumed where the goods or services are
identical 53rticle ').'6, sub:ect to certain allowable e+ceptions such as the
fair use of descriptive terms 53rticle '/6A
certain rights are provided for the owners of wellknown trademarks and
service marks 53rticle ').B and ').06A
the term of initial registration and renewals shall be no less than seven
years, renewable indefnitely 53rticle '(6A
if a showing of use is required for the maintenance of a registration, the
registration may be cancelled only after an uninterrupted period of at
least three years of nonuse, unless valid reasons for nonuse are shown
53rticle '<.'6A
certain restrictions on use are not permitted 53rticle B"6A
compulsory licensing of trademarks is not permitted 53rticle B'6A
trademarks may be assigned with or without the transfer of the business
to which the trademark belongs 53rticle B'6.
Ge#%!ap&ica+ I"icati#s
The essential elements of the standards concerning the availability, scope
and use of rights involving geographical indications include the following?
geographical indications are defned as indications which identify a
product as originating in the territory of a Cember, or a region or locality
in that territory, where a given quality, reputation or other characteristic
of the product is essentially attributable to its geographical origin 53rticle
BB.'6A
Cembers must provide the legal means for interested parties to prevent
the use of indications that misleadingly indicate or suggest that a good
originates in a geographical area other than the true place of origin
53rticle BB.B5a66A
Cembers shall refuse or invalidate the registration of a trademark which
consists of a misleading indication 53rticle BB.06, and provide means to
prevent any use which constitutes an act of unfair competition within the
meaning of 3rticle '"
bis
of the %aris #onvention 53rticle BB.B5b66A
protection shall be applicable against a geographical indication which is
literally true but misleading 53rticle BB.!6 and, in the case of wines or
spirits, even where the true origin of the goods is indicated or the
geographical indication is used in translation or accompanied by
e+pressions such as kind, type, style, imitation or the like 53rticle B0.'6A
protection is not required in respect of a geographical indication of
another Cember which is identical with the common name for goods or
services, or, for products of the vine, which is identical with the customary
name of a grape variety e+isting in the territory of that Cember as of the
date of entry into force of the >TH 3greement 53rticle B!.)6A
there is no obligation to protect geographical indications which are not or
cease to be protected in their country of origin, or which have fallen into
disuse in that country 53rticle B!.<6A
guidelines are provided for additional protection for geographical
indications for wines and spirits 53rticle B06, including concurrent
protection of homonymous geographical indications for wines 53rticle
B0.06, certain e+ceptions to substantive rights such as prior rights 53rticle
B!.!6 and the right to use personal names 53rticle B!.(6, and time limits
for registration in certain cases 53rticle B!./6A
in order to facilitate the protection of geographical indications for wines,
negotiations are to be undertaken in the T@2%. #ouncil, concerning the
establishment of a multilateral system of notifcation and registration of
geographical indications for wines, which would be e7ective for those
Cembers participating in the system 53rticle B0.!6.
&or provisions relating to enforcement of intellectual property rights and
maintenance and dispute settlement under T@2%., you may refer back to
section ).* and ).) of -nit ), Codule B.
%aris #onvention signed in '((0, came into e7ect on Euly /, '((!. 2t was
subsequently revised in '<"" at Brussels, in '<'' at >ashington, in '<B*
at the ,ague, in '<0! at $ondon, in '<*( at $isbon and in '<)/ at
.tockholm.
The convention touches on the issue of the use of marks in 3rticle *# 5'6,
5B6 and 506.
3rticle ) at the convention establishes the important principle of the
independence of trademarks in the di7erent countries of the -nion.
The convention obliges a member country to refuse or cancel the
registration and to prohibit the use of a trademark that is liable to create
confusion with another trademark already wellknown in that member
country.
The convention also makes provisions for collective marks, industrial
designs, trade names, appellation of origin and unfair competition.
T@2%. agreement covers #opyrights and @elated @ights, Trademarks,
8eographical 2ndications, 2ndustrial ;esigns, %atents, $ayout ;esigns of
2#s and -ndisclosed 2nformation under 2%@ sub:ect matter. 2t also provides
for control of anticompetitive practices in contractual agreements.
T"e TRIPS a!reement * +,lt on t"e prn%ple* o- Par* and Bern Con.enton*
U NIT / INTELLECTUAL PROPERTY RIGHTS THE INDIAN SCENARIO
INTRODUCTION
The tradition of scholarship and intellectual creativity in 2ndia goes back to a
few millennia. =et the concept of 2ntellectual %roperty @ights in the modern
sense is rather new and would appear to have no cultural moorings or
sanction in our country. The history of intellectual property rights in 2ndia
backed by enforceable legal provisions scarcely goes back to '*" years.
Objectives
3fter studying this unit you will?
know the history of 2% legislation in 2ndiaA
have an overview of the 2% $aw in 2ndiaA
know 2% $aws enacted by 2ndiaA and
know 2nternational 2% Treaties where 2ndia is a member.
HISTORY OF IP LEGISLATION
Patets
The frst 2ndian statute on patents was passed in '(*) granting some
e+clusive rights to inventors for '! years. 2t had to be reenacted with some
modifcation as the 3ct of '(*<. 2t granted to inventors of Qnew manufactureK
e+clusive rights to make, sell and use the invention in 2ndia, or to authorise
some one to do so. 2ts scope was e+panded to include designs, under Qthe
new manufactureK in the %atents and ;esigns %rotection 3ct '(/B. Then
came the 2nventions and ;esigns 3ct of '(((, and later the 2ndian %atents
and ;esigns 3ct '<'', 5which was modelled largely on the British %atents
and ;esigns 3ct '<"/6. 3fter independence in '<!/, the 8overnment felt the
need for a more e7ective patent legislation. The e+isting situation with
regard to patents was reviewed by two e+pert committees? one, headed by
Eustice @a:agopal 2yengar, and another headed by Bakshi Tek #hand. 2t was
revealed that the CF#s, who owned <"R of all patents in 2ndia, had misused
patents largely to ensure a protected market in 2ndia for their products,
denying availability of many essential goods to people at competitive prices.
The %atents Bill following the reports of these #ommittees was debated for a
decade when fnally the 2ndian %atents 3ct '</" was enacted. 2t was highly
acclaimed by, amongst others, -F#T3;, as a most progressive patent law
and inspired similar legislation in many developing countries. 2t clearly
codifed inventions that could not be patented, permitted patenting of only
process, not products, of manufacture in the felds of food, drugs and
medicines and substances produced by chemical processes. The term of
patent was in the case of process relating to food, medicines and drug, *
years from the sealing of the patent or / years from the date of patent
whichever was earlierA in case of other process patents, it was '! yearsA it
had provision for Qlicences of rightK and compulsory licensing in some
circumstancesA it provided for use of inventions for government purposes,
acquisition of invention by #entral 8overnment and revocation of patents in
public interest.
&ollowing 2ndiaKs membership of the >TH and her obligations under the
T@2%. 3greement, the 2ndian %atents 3ct '</", was amended by %atents
53mendment6 3ct '<<< and %atents 53mendment6 3ct B""B, which came into
force on Cay B, B""0. The %rovisions of the present 3ct are in line with the
T@2%. 3greement.
T!a"e'a!(s
Fo specifc legislation e+isted on trademark before '<!". ,owever,
remedies for violation of trademark were available under the 2ndian %enal
#ode '()" and .pecifc @elief 3ct, '(//. The Trade Carks 3ct, '<!" was
replaced by the Trade and Cerchandise Carks 3ct, '<*(, which has now been
repealed and replaced by the Trade Carks 3ct, '<<<.
Desi%s
;esigns continued to be governed by the provisions of the 2ndian %atents and
;esigns 3ct, '<'', until the ;esigns 3ct, B""" was passed.
C#p$!i%&t
2n matters of #opyright the English #opyright 3ct, '(!B was deemed
applicable to 2ndia, though it was never e+pressly declared to be so. The
application of the #opyright 3ct, '<'' of England was e+tended to 2ndia as a
British dominion. The 2ndian #opyright 3ct, '<'! introduced criminal
sanctions for infringement and continued till the copyright act '<*/ came
into force on B'.'.'<*(. This was necessitated as much by the changed
status of 2ndia as an independent nation as by the advancement of
technology of reproduction and communication. The 3ct had several original
featuresA registration of copyright was voluntaryA an administrative
machinery for registration of copyright was establishedA the government was
empowered to protect copyright of citi9ens from other countries. 2t has been
amended since then in '<(0, '<<B, '<<!, and '<<< S the last one, after 2ndia
ratifed the T@2%. 3greement as a member of the >TH.
Besides these four principal felds for intellectual property protection,
namely, patents, trademarks, industrial designs and copyright, 2ndia has
enacted the 2% laws for geographical indications of goods, protection of plant
varieties and farmersK rights, semiconductor 2# layout designs, information
technology, and biodiversity.
O2ER2IE3 OF IP LA3 IN INDIA
The 2ndian $aw to grant and regulate protection of intellectual property in
various felds of 2% has now been aligned to the requirements and provisions
as visualised under the T@2%. 3greement of the >TH.
=ou will study the details of the individual 3cts dealing with specifc 2%
instruments S patents, copyright, trademarks, industrial designs etc. S in
relevant -nits. ,ere we will refer to some general features, specially those
pertaining to the administration and enforcement of 2%@s in 2ndia, that defne
2% $aws in 2ndia.
45456T&e I"ia Patet La)
The law relating to patents is laid down in the 2ndian %atents 3ct 5'</"6 as
amended by %atents 53mendment6 3ct, '<<< and %atents 53mendment6 3ct,
B""B. .ome of the more signifcant changes introduced by these
amendments in the original 3ct of '</" are as follows?
There is no restriction now on 2ndians applying for patents abroad.
The defnition of term QinventionK is fully consistent with the T@2%.
3greement, and includes both products and processes in all felds of
technology. Before amendment only methods or processes of
manufacture relating to food, medicines and drugs were patentable.
The list of items that are not to count as inventions for grant of patents
has been modifed to include e+clusions permitted by the T@2%.
3greement. Earlier an invention was not patentable if its primary or
intended use would be Qcontrary to law or morality or in:urious to public
health.K Fow it will not be considered an invention if its Qprimary or
intended use or commercial e+ploitationK could be Qcontrary to public
order or morality or which causes serious pre:udice to human, animal or
plant life or health or to the environment. 3lso Qdiscovery of any living
thing or nonliving substance occurring in natureK is not regarded as an
invention under the amended 3ct.
The rights of the patentee have been brought in line with the provisions of
the T@2%. 3greement, as necessitated by changes permitting product
patents.
@eversal of burden of proof when infringement of a process patent occurs
has been included in accordance with the T@2%. 3greement. 2t is now for
the defendant to prove that the process being used by him is di7erent
from the patented process alleged to be infringed.
The term of patent is now uniform B" years as required by the T@2%..
Earlier, for a process patent, relating to an item of food, medicine or drug
it was fve years from the date of sealing of the patent or seven years
from the date of application whichever period was shorter, and fourteen
years from the date of patent in respect of any other invention.
The provision of licenses of right has been omitted and compulsory
licensing brought in line with T@2%..
%rovisions for e+clusive marketing rights have been included.
%rovisions for parallel import of patented products have been included.
%rotection of biodiversity and traditional knowledge, under Qinventions not
patentableK category.
The 3ct makes the #ontroller 8eneral of %atents, ;esigns and Trade marks
appointed under the Trade Carks 3ct, '<<< as the controller of %atents with
powers of a civil court.
Indan Copyr!"t Law
The #opyright 3ct, '<*/, as amended in '<<< governs the copyright law in
2ndia. 2t came into force on Eanuary '*, B""". 2t has established a copyright
oIce, under the immediate control of the @egistrar of #opyrights, to
facilitate registration of copyright. 2t has also established a #opyright Board
5#B6 with @egistrar of copyrights as its .ecretary. The #B is meant to hear
and settle certain kinds of disputes arising under the 3ct.
The 3ct defnes various categories of works in which copyright subsists, and
has inter alia, provisions for determination of frst ownership of copyright, the
scope of rights conferredA assignment and licensing of copyrightA compulsory
licensing and the circumstances in which it could be grantedA performing
rights of societiesA broadcasting rightsA authors special rightsA international
copyrights. The 3ct sets out in detail what constitutes infringement and
what does notA civil and criminal remedies against infringement and
remedies against threat of legal proceedings without any ground.
The 2ndian copyright law is in conformity with the provisions of the T@2%.
3greement of the >TH. 2t is also in line with the provisions of the Berne
#onvention for the %rotection of $iterary and 3rtistic >orks 5Brussel Te+t,
'<!(6, and the -niversal #opyright #onvention 5'<*B6A 2ndia is a member of
both conventions.
I"ia T!a"e Ma!( La)
The Trade Carks 3ct, '<<< lays down the law governing trade marks in 2ndia.
2t e+tends the scope of protection by registration of trade marks to services,
besides goods. 2t provides for a single register and simplifes the procedure
for registration. 2t recognises well known marks as a distinct category, and
provides for registration of collective marks, owned by an association of
persons. 2t frmly discourages persons tempted to e+ploit other persons
good name in business through false or misleading means.
The #ontroller8eneral of %atents, ;esigns and Trade Carks is the @egistrar
of Trade Carks. The act establishes an appellate board with the same
powers as are vested in a civil courtA any proceedings before the Board are
deemed as :udicial proceedings.
.everal measures have been taken to simplify trade mark law and
procedure, o7er better protection and make enforcement more e7ective, e.g.
a single application for registration in more than one classA increasing the
term of protection from / years to '" yearsA enhancing punishment to bring
it at par with the copyright lawA making trade mark o7ences cognisable.
Indan De*!n* Law
The ;esigns 3ct B""" lays down the law for protection of industrial designs
in 2ndia. The #ontroller8eneral of %atents, ;esigns and Trade Carks is the
#ontroller of ;esigns.
The 3ct inter alia defnes QoriginalK and enlarges the scope of defnitions of
QarticleK and QdesignKA it spells out what designs shall not be registered, brings
in the internationally followed system of classifcation in place of the 2ndian
system, provides for restoration of lapsed designs and maintaining the
register of designs on computerA the two year period of secrecy of a
registered design is revoked and any document for transfer of right in a
registered design is required to be compulsorily registered. Core grounds
have been added for cancellation of registration and cancellation
proceedings are to be initiated before the #ontroller of ;esigns instead of a
,igh #ourt. 2nfringement attracts heavier penaltiesA the initial period of
registration is enhanced from * years to '" years, e+tendable by a further
period of * years. 2t provides for control of anticompetitive practices in
contractual licences. 3ppeal against an order of the control lies to the ,igh
#ourt.
Appea+ Mec&ais'
2n keeping with its status as a ma:or, vibrant economy, and as an active
contributor in the realm of knowledge and creativity, 2ndia, though a
relatively late comer in the 2% game, has strong 2% $aws and e7ective
enforcement of 2%@s. 3ll the 3cts dealing with 2% in its various forms are
aligned to the T@2%. 3greement making appropriate use of fe+ibilities
available under the T@2%.. They are fully alive to the role of 2%@s in growth
and development consistent with societal and environmental concerns.
3ll the 2% $aws provide for 5i6 a fully empowered administrative machinery to
grant and register claims for 2%@s in a fair and transparent manner, 5ii6 a
mechanism for appeal against administrative decisions if necessary, and 5iii6
a procedure for legal enforcement of 2%@s.
%atents and industrial designs are required to be registered under the
relevant 3cts to claim any legal protection of 2%@s. ,owever, copyright and
trademarks 5in 2ndia6 have no such requirement. Their registration is
voluntary, but in case of legal disputes, registration carries distinct
advantages. 3s copying, counterfeiting and forgery have become easy and
rampant and economic consequences of infringing a copyright or using a
brand name 5trademark6 in an unfair way may be huge, it is advisable to get
the copyright and trademark duly registered.
The provision of appeal against a decisionDorder of the highest controlling
authority is only fair and necessary under a sound legal system. The appeal
earlier used to lie with a ,igh #ourt of appropriate :urisdiction. ,owever, the
domain of 2% being highly specialised, which was often unfamiliar to a ,igh
#ourt :udge, the need of a specialist member on the reviewing bench was
always felt. &urther the disposal of an appeal in a ,igh #ourt was time
consuming and involved high cost of litigation.
,aving regard to these considerations, the Trade Carks 3ct, '<<<,
established an 3ppellate Board 53B6 having advocates who have been active
in the feld of Trade Carks for '" years. 3 bench of the 3ppellate Board will
consist of a Eudicial Cember and a Technical Cember. The bench will sit at a
place decided by the #entral 8overnment.
The 3ppellate Board for trade marks is also the appellate authority under the
%atents 3ct, '</", as amended by the %atents 53mendment6 3ct, B""B. 2t is
also the 3ppellate Board for geographical indications. The Technical Cember
of the 3B for patents cases is a person e+perienced in patent law to consider
appeals against the decision of #ontroller. ,e is a person who has been
#ontroller, or has e+ercised his functions, for * years, or he should be an
3dvocate practising law relating to patents and designs for '" years. 3
bench of the 3ppellate Board consists of one :udicial member and one
technical member.
The 3ppellate Board sits in the following cities? 3hmedabad, #hennai, ;elhi,
Cumbai, Jolkata. The Board f+es its own procedure, place and time of
sittings.
%ursuing a case before a trade mark 3ppellate Board or the #opyright Board
5which can also have sittings all over 2ndia6 can be frustrating and diIcult
e+perience.
The procedure for appeal in the case of copyright is di7erent. The appeal
against a decision of the @egistrar of #opyrights lies with the #opyright
Board. The #opyright Board, constituted by the #entral 8overnment,
consists of a #hairman who is or has been or has the qualifcations to be a
:udge of ,igh #ourt, and two to fourteen members. The @egistrar of
#opyrights is the secretary of the Board. 3 further appeal against the
decision of the #opyright Board lies with the ,igh #ourt of appropriate
:urisdiction.
-nder the ;esigns 3ct, B""", the appeal against a decision of the #ontroller
of ;esigns lies with the ,igh #ourt. The .emiconductor 2ntegrated #ircuits
$ayout ;esigns 3ct, B""", provides for a $ayout ;esign 3ppellate Board,
and an appeal against its decision lies with the ,igh #ourt. The appellate
authority under the %rotection of %lant Garieties and &armersK @ights 3ct
B""', is the %lant Garieties %rotection 3ppellate Tribunal. The Biological
;iversity 3ct B""B provides for a appeal against the orders of the national
biodiversity authority or a state biodiversity board, to the ,igh #ourt. The
2nformation Technology 3ct provides for appeal to a cyber 3ppellate Tribunal
against one order of the #ontroller of #ertifying 3uthority or an ad:ucating
oIcer.
Thus, the situation in respect of appeal related to various kinds of 2%@s may
do with some streamlining.
The diversity of appellate authorities and procedures for di7erent 2%@s seems
unnecessary. There could be a case to have only one 2ntellectual %roperty
3ppellate Tribunal to hear appeals cases of all category of 2%@s. The Tribunal
and its benches may also shed the roving character and have f+ed places for
hearings to make it easy, convenient and less costly for litigants to pursue
their cases.
IP ACTS ENACTED BY INDIA
2ndia has enacted the following 2% 3cts?
'. The %atents 3ct, '</", as amended by the %atents 53mendment6 3ct,
'<<<, and the %atents 53mendment6 3ct, B""B
B. The #opyright 3ct, '<*/ as amended in '<<<
0. The Trade marks 3ct, '<<<
!. The ;esigns 3ct, B"""
*. The 8eographical 2ndications of 8oods 5@egistration and %rotection6 3ct,
'<<<
). The %rotection of %lant Garieties and &armers @ights 3ct, B""'
/. 2ntegrated #ircuit $ayout ;esigns 3ct, B"""
(. The Biological ;iversity 3ct, B""B
/01 2A3OR INTERNATIONAL TREATIES SIGNED BY INDIA
'. The #onvention Establishing the >orld 2ntellectual %roperty Hrganisation
B. The %aris #onvention for the %rotection of 2ndustrial %roperty
0. The Berne #onvention for the %rotection of $iterary and 3rtistic works
!. The %atent #ooperation Treaty
*. The 8eneva #onvention for the %rotection of %roducers of %honograms
3gainst -nauthorised ;uplication of their %honograms.
). The Budapest Treaty on the 2nternational @ecognition of the ;eposit of
Cicro organisms for the %urposes of %atent %rocedure
/. The -niversal #onvention of #opyrights
3 brief history of 2% legislation in 2ndia is given. 3n overview of the current 2%
$aw in four principal kinds of 2% vi9. patents, copyrights, trade marks and
designs, is given pointing to some salient features that make the 2%
provisions in 2ndia tougher and in conformity with its international
obligations. E+isting 3cts giving 2% laws in various categories of 2% have been
listed, as also ma:or international treaties which 2ndia has signed.
Unit 2
What are patents? What are the requirements of patentability?
Can software be patented?
A0 Ba%k!ro,nd4
A patent is a form of industrial property which may be broadly described as a monopoly right
conferred by the state to an inventor to industrially and commercially e%ploit his invention at the
cost of ma,ing a complete disclosure of the details of his invention. A patent is thus a statutory
privilege granted by the <overnment to an inventor, and to other persons deriving their rights
from the inventor, for a fi%ed period of years, to e%clude other persons from manufacturing,
using or selling a patented product, or from utilising a patented method or process. At the
e%piration of the period of the patent, the patented invention is available to the general public or
as it is sometimes put, falls into the public domain.
B0 O+5e%t o- Patent Law4
$n the case of #ishawanath $rasad %adhey &hyam v. 'industan (etal )ndustries
1
, the ape% court
outlined the ob#ectives of patent law as under&
C*+,he object of patent law is to encourage scientific research, new technology and industrial
progress. -rant of exclusive privilege to own, use or sell the method or the product patented for
a limited period stimulates mew inventions of commercial utility. +he price of the grant of
monopoly is the disclosure of the invention at the $atent .ffice, which after expiry of the fixed
period of monopoly, passes into the public domain.D
C0 Re6,rement* o- Patenta+lty4
A patent confers a statutory privilege on an inventor i.e. that there is no common law of patents.
2

As seen above, $ndia became a signatory to the )6$!+ Agreement in 0445 and as such was
'
#ishwanath
bound to embody the principles contained therein into its domestic intellectual property
legislation.
7eeping in mind its obligations under )6$!+, the !atents Act, 04;5 came to substantially
amended in 2552 and again in 2555. $n light of the )6$!+ Agreement, the !atent Act, 04;5
prescribes that an invention must satisfy the trinity re'uirements of novelty, innovativeness and
usefulness in order to receive a patent under the Act.
.
i. +est 1/ +rinity re0uirements/
As stated above, $ndia as a signatory to )6$!+, has adopted the trinity re'uirements as specified
therein in order to ascertain the patentability of an invention. Before considering these
re'uirements in detail and whether the invention satisfies these re'uirements, let us consider
some pertinent definitions under the Act.
patent/ patent means a patent for any invention granted under this 1ct
2
invention/ invention means a new product or process involving an inventive step and capable of
industrial application
2
inventive step& a feature of an invention that involves technical advance as compared to the
existing knowledge or having economic significance or both and that makes the invention not
obvious to a person skilled in the art
3

capable of industrial application/ capable of being made or used in an industry
4
B
+ection 2(0) (m) of the Act.
2
4
.
5
new invention& any invention or technology which has not been anticipated by publication in any
document or used in the country or elsewhere in the world before the date of filing of patent
application with complete specification, i.e. the subject matter has not fallen in public domain or
that it does not form part of the state of the art
5
)herefore, the criteria for an invention to be patentable are,
(0) novelty
(2) inventive step
(2) utility
1. 6ovelty/
)he first ingredient for an invention is that it must be new product or a new process. >ovelty
means what is new and original, never seen or done before. An invention is ta,en to be new if it
does not form a part of the state(of(the(art. $n order to be patentable, the new sub#ect must
involve invention over what is old. $t is not essential that the invention should be anything
comple% or complicated. $t must merely be of such nature that it involves a technical advance as
compared to the existing knowledge. As observed by "otton E8 in #lakey 7 8o. v. 9athem 7
8o.
;
C+o be new in the patent sense, the novelty must be shown in the invention. )t is not enough that
the purpose is new or that there is novelty in the application, so that the article produced is in
that sense new. +here must be novelty in the mode of application.D
$n view of this principle, the "ourt of Appeal in ngland in :omento v (entomore
;
denied patent
rights to a designer of an improved design of a ball(point pen, on the grounds that the inventor
himself had published a description of ma,ing ball point pens and had made two pens
3
;
1
embodying the invention available to the members of the public before filing the patent
application.
<. )nventive step/
As seen above, an Cinventive step= is one which ma,es the invention Cnon-obvious to a person
skilled in the art=. $n other words, if the invention is obvious to the person s,illed in the art, it
cannot be said to involve an inventive step. After the Amendment in 2555, the definition of
inventive step has been enlarged to include economic significance of the invention as well.
)he test to ascertain whether an invention involves an inventive step is e%pressed in 'alsbury
9aws of >ngland as& Cwas it for practical purposes obvious to the skilled worker, in the field
concerned, in the state of knowledge existing at the date of the patent to be found in the
literature then available to him, that he should or would make the invention the subject of the
claim concerned.D $n other words, the 'uestion to be answered in determining inventive step is
C?ould a non-inventive mind have thought of the alleged invention@D $f the answer is Cno=, then
the invention is non(obvious. $f the patent claimed merely includes the development of some
e%isting trade, in the sense that it is a development as would suggest itself to an ordinary person
s,illed in the art, it would fail the test of non(obviousness.
$n order to ascertain whether an invention subscribes to the re'uirements of an Cinventive step=, a
two pronged approach may be adopted. Firstly, ascertaining what was the state of the art before
the relevant date of the complete specification filed pursuant to an application for a patent, and
secondly having regard to the state of the art, ascertaining whether the alleged inventive step
would have been obvious to a person s,illed in the art.
4
i. &tate of $rior 1rt
For an invention to be #udged as novel, the disclosed information should not be available in the
Cprior art=. )his means that there should not be any prior disclosure of any information contained
<
?olnlyc,e A.B. v !rocter and <amble 0444 6!" 44. Boechst "elanese "orp. v B.! "hemicals 044; F+6 54;,
532.
in the application for patent (anywhere in the public domain, either written or in any other form,
or in any language) before the date on which the application is first filed i.e. the Cpriority dateD.
Although the term Cprior art= has not been defined under the $ndian !atents Act, it shall be
determined by the provisions of section 02 read with the provisions of sections 24 to 24 of the
Act.
)he following has been indicated as Cprior artD vide the Act
05
&
(a) anticipation by publication before the date of the filing of the application in any of the
specification filed in pursuance of application for patent in $ndia on or after the 0st day of
8anuary 0402.
(b) anticipation by publication made before the date of filing of the application in any of the
documents in any country.
(c) claim in any claim of any other complete specification filed in $ndia which is filed before
the application but published after said application.
(d) anticipation having regard to the ,nowledge, oral or otherwise, available within any local
or indigenous community in $ndia or elsewhere.
From the above it is clear that in order for an invention to be anticipated by virtue of a patent, the
patent must have been granted in $ndia alone.
00
)hus, a patent granted in any other country would
not constitute Cprior artD for the purposes of the Act.
02
Bowever, if the patent is anticipated by
publication, it is irrelevant whether the publication occurred in $ndia or elsewhere.
An invention is not considered Cnew= if the claimed invention is publicly ,nown or publicly used
in $ndia before the priority date.
02
As observed by the +upreme "ourt in (onsanto&
C$ublicly known does not mean that it must be published in a document, although not found in a
book, it may form a part of the common knowledge among the public concerned. )t also does not
'"
''
'B
'0
mean that it should be widely used to the knowledge of the consumer. )t is sufficient if it is known
to persons who are engaged in the pursuit of knowledge of the patented product or process,
either as men of science or men of commerce or as consumers.D
04
)he +upreme "ourt in #ishwanath $rasad=s case observed that prior public ,nowledge of the
alleged invention would dis'ualify the grant of a patent. !ublications concerning the invention
whether through word of mouth or through boo,s or media would, therefore nullify any
subse'uent attempt to secure a patent.
ii. .bviousness to a person skilled in the art/
A s,illed person would be a person who Chas experience of the field in 0uestion and he may be
one who have available assistants who would carry out tests=.
05
$n order to pass the test of
obviousness, the prior art referred above must be of such nature as to inform the s,illed person as
to how the invention derived from the prior art is to be performed. $n other words, the person
s,illed in the art must have the necessary information (through the prior art) to ta,e the inventive
step in 'uestion.
03
$n determining whether an invention involves an Cinventive stepD and is Cnon-obviousD, the
supervening policy of patent law vi*. to reward and encourage invention without inhibiting
improvements of e%isting technologies by others must be ,ept in mind. Although no absolutely
uniform test for determination of inventive step can be formulated, certain broad criteria can be
indicated, whether the invention was publicly ,nown, used or practiced before or at the date of
the patentG $f the answer is positive, it shall negate inventive step.
'!
'*
')
A structured approach to determine obviousness consisting of four steps was e%pounded in
?indsurfing )nternational v +abur (arine
1A
/
a. $dentify the inventive concept in the suit
b. 7eep in mind a normally s,illed, but unimaginative person having common general
,nowledge of the concerned art as at the priority date will be the date from which the
ob#ector to the patent would allege inventive step was obvious
c. )hrough the spectacles of the aforesaid s,illed person identify differences, if any,
between the matter cited as being ,nown or used and the alleged invention.
d. Finally, without considering the alleged invention, consider whether the differences
would see to the aforesaid s,illed person such as leading obviously to the alleged
invention or that a degree of invention would be necessary to obtain the invention.
$n #ishwanth $rasad=s case, the ape% court reiterated the above test and suggested three
alternative conceptions of the same&
a. ?hether the alleged invention lies so much out of the track of what was known before as
not natural to suggest itself to a person thinking on the subject, it must not be the obvious
or natural suggestion of what was previously known"
b. 'ad the document been placed in the hands of a competent draftsman, or engineer, as
distinguished from a mere artisan!, endowed with the common general knowledge at the
Bpriority date=, who was faced with the problem solved by the patentee, but without
knowledge of the patented invention, would he have said, this gives me what ) want@
0;
c. ?as it for practical purposes obvious to a skilled worker n the field concerned, in the
state of knowledge existing at the date of the patent, to find in literature then available to
him" that he would or should make the invention the subject of the claim concerned.
2. Utility/
$t is pertinent to note that utility was not a re'uirement for patentability under the !atents and
Hesigns Act, 0400. $n #ishwanath $rasad=s case, the +upreme "ourt recognised utility as one of
the grounds on which a patent can be revo,ed. )he usefulness of an alleged invention depends
not on whether by following the directions in the complete specification all the results not
necessary for commercial success can be obtained, but on whether by such directions the effects
that the application9patentee professed to produce could be obtained. )he usefulness of the
invention is to be #udged, by the reference to the state of things at the date of filing of the patent
application, if the invention was then useful, the fact that subse'uent improvement have replaced
the patented invention render it obsolete and commercially of no value, does not invalidate the
patent.
)hus, novelty, non(obviousness, industrial applicability and utility form the essential
re'uirements of patentability. )hese conditions have been universally accepted as the essential
prere'uisites of patentability.
D0 Patenta+lty o- Comp,ter So-tware4
$t is a well(established proposition that computer programs
01
are copyrightable sub#ect(matter,
#ust li,e any other literary wor,.
04
Eoading a program into computer memory, saving the program
or running it without authority may infringe copyright. ?a,ing an arrangement or altered version
of the program or converting it into or out of one computer language or code into a different
computer language or code is also an infringement. Article 05 of the )rade 6elated $ntellectual
!roperty 6ights Agreement ()6$!s) e%pressly provides that computer programs, whether in
'(
'<
source code or ob#ect code shall be protected as literary wor,s under the Berne "onvention,
04;0.
Hespite protection afforded to computer software through copyright law, it is submitted that
copyright protection is not always ideal. !roblems arise when, in a particular invention, software
and hardware co(e%ist. =ould, in such circumstances, copyright protection e%tend to the
invention itselfG )hat seems unli,ely, as copyrights being restricted to literary and artistic wor,s
cannot be held to e%tend to machines. Bence, some amount of protection is conferred
+ection 2 of the Act contains a list of Cwhat are not inventionsD.
4
$f the CinventionD for which the
patent is sought falls within the provisions of +ection 2, no patent would be granted, even if it
otherwise satisfies the re'uirements of patentability outlined above.
+ection 2(,) of the Act prescribes&
Bmathematical or business method or a computer program per se algorithms"=
+ection 2 (,) of the Act thus clearly lays down that computer programmes are not patentable.
25

Bowever, this was not always the case. )he provisions concerning patentability of software have
been amended a number of times. )he original unamended Act did not e%clude e%plicitly patents
for computer related inventions, as computer technology at that point of time was relatively
un,nown, but the definition of the term CinventionD
3
itself e%cluded patents for computer
programmes.
A ma#or amendment was introduced in +ection 2 with respect to the patentability of computer
programs through the !atents (Amendment) /rdinance on Hecember 2;, 2554. )he /rdinance
split the sub(section 2, into two( sub(section 2(,) and 2(,a). )he e%cluded sub#ect matters as
originally contained in +ub(section 2(,) were provided in the new +ub(section 2(,a). )hey
included Ca mathematical method or a business method or algorithms=. )he amended +ection
2(,) read as follows&
Bk! a computer programme per se other than its technical application to industry or a
combination with hardware.=
B"

)he ,ey e%pressions contained in the above amendment are Ctechnical application to industryD
and Ccombination with hardwareD. )he legislative intent behind these words was clear. $f an
invention is directed at computer software having technical application to industry or coupled to
hardware I then it is patentable.
;
)he law as it stands now however reverts to the original
position of e%cluding computer program per se from patentability.
From the above discussion it follows that if a patent is sought only for the software tools
20
i.e. a
patent is sought only for a computer program per se, then a patent would not be available for the
invention, as it would be hit by the provisions of +ection 2 (,) elucidated above. Bowever, if the
patent is sought for a combination of software and hardware, then it would not be a computer
application per se, and hence might be patentable.
22
As observed in -ales= case&
C1lthough those instructions are not patentable as such, that is not the end of the matter.
8omputer instructions may represent, for instance, a technical process. ?hat is recorded in the
instructions may be the means for carrying out a technical process with the aid of a computer. )n
such a case the process is not barred from patentability by reason of the use of a computer as a
medium by which it is carried out.=
1

Analogy may also be drawn to the Ciamond v. Ciehr
D
, where the -+ +upreme "ourt granted a
patent for a rubber curing process controlled by software as the patent was for the Crubber curing
process and not the computer software per se.D
From the above, it may be concluded that in ascertaining the patentability of an invention, the
invention must be loo,ed at a whole. A claim directed to a technical process which process is
carried out under the control of a program (whether by means of hardware or software), cannot
be regarded as relating to a computer program per se. An invention consisting of a combination
of hardware and software may be considered patentable, if it satisfies the other re'uirements
prescribed by the Act.
Unt /
INTRODUCTION
20
BB

The remedies in cases of infringement of intellectual property rights are
available through action in three channels? civil procedure, criminal
procedure and administrative procedure. 2n addition to these there are
always technological measures that the owner of 2% can employ to minimise,
if not eliminate, the possibilities of infringement of his 2%@s, and detect the
incidence of infringement. The T@2%. 3greement, %art 222 53rticle !' to )'6
deals with the enforcement of intellectual property rights. Cembers of the
>TH have the general obligation to provide under their law enforcement
procedures to permit e7ective action against any act of infringement of 2%@s.
The remedies should be e+peditious and deterrent to further infringements.
The procedures should not create barriers to legitimate trade and provide for
safeguards against their abuseA they should be fair and equitable and not
unduly costly or comple+A there should be no unreasonable time limits or
undue delays. The last two qualifcations are important because the
e7ectiveness of the 2%@ depends on whether they could be speedily enforced
and with low cost. The T@2%. also lays down other requirements for
enforcement process? right to be heard and give evidenceA right to have a
prompt, reasoned, written decisionA :udicial review, written notice of claims,
legal representationA protection of confdential informationA discovery of
information held by the other partyA and indemnifcation against abuse of
enforcement procedure.
O+5e%t.e*
3fter studying this unit, you should be able to?
understand the actionoptions available to an owner of 2%@ aggrieved by
infringementA
know some special evidential aspects in cases of infringement of patents
and trademarksA and
know the remedies available under di7erent options.
CI7IL PROCEEDINGS
The three issues that need to be considered are?
>ho could initiate proceedings in a case of infringement of industrial
property 5the plainti76T
3gainst whom the proceedings can be initiated 5the defendant6T
>hich court will have the :urisdiction to try the case 5the #ourt6T
3&# ca Iitiate P!#cee"i%s7
#learly the owner of the 2%@ is the aggrieved party if infringement of his 2%@
takes place and he is to initiate the proceedings as the plainti7. 2f the 2% is a
patent or a trademark an e+clusive licensee also can initiate proceedings.
T&e De8e"at
=ou have read in the previous -nit what constitutes infringement in the case
of a specifc category of 2%. 3 person who commits an act of infringement
becomes the QdefendantK, if the plainti7 brings infringement proceedings for
such an act of infringement. 3dditionally, anyone else who may :oin the
infringer in a common design to perpetrate the act of infringement will also
be :ointly liable to be sued. The liability is, however, to be :udged in relation
to the territorial :urisdiction. 2f a person, outside the :urisdiction of a
countryKs courts, supplies a protected article to a party again outside the
:urisdiction, he is not guilty of infringement. But if he is working in a common
design with a person who resides within the :urisdiction and commits the
infringing act, the frst person in this case :ointly shows the liability with the
infringer.
2f an employee attracts tortuous liability, his employer is also vicariously
liable for torts. ,owever, a person, commissioning work from an independent
contractor does not carry such vicarious liability.
T&e C#/!t
Fational laws clearly specify, the court which will be competent and have
:urisdiction in relation to a case of infringement. The issue of :urisdiction
becomes comple+ in cases involving international aspects in a case of
infringement.
3n interesting question relating to enforcement of 2%@ in the conte+t of global
commerce pertains to the legal :urisdiction of a court where the case for a
violation of 2%@ should be initiated. The diIculty arises when the parties to
litigation belong to di7erent countries. .uch situations are becoming quite
common as technological capabilities advance, globalisation becomes
universal and ecommerce becomes common. ;i7erent countries have
di7erent laws. The course, outcome and costs of litigation may signifcantly
depend on where the case is contested. Fovell, a -. computer software
frm, sued its distributor in .outh Jorea, in a court in -tah, -.3 for
infringement of copyright and trademark though the cause of action arose in
the @epublic of Jorea.
Besides $! laws, redressal can in certain cases be available under common law liability for
economic torts, particularly passing off and in#urious falsehoods.
Civi+ P!#ce"/!e
3 #ivil #ourt can provide a wide range of relief in a case of infringement of
property. The relief can be in the form of an in:unction, or damages or
account of profts, or otherwise 5other relief6.
2n:unction is a prohibitory relief to stop the infringement. The court may
direct the defendant not to do certain acts. .uch direction may come at the
end of a trial in which the complaint of the owner of the 2% that his rights
have been violated has been upheld. 2n such case the in:unction is called
fnal. ,owever, in a civil action, there can also be an interim, interlocutory
in:unction, which is meant not to enforce an established right but to maintain
the status quo till the proceedings are complete. 2nterlocutory in:unction
makes the 2%@ regime very e7ective.
;amages are meant to compensate the owner of the 2% for the loss in money
terms su7ered by him due to infringement of the 2%@.
Q3ccountsK relates to the account of net profts earned by the defendant
5infringer6 due to infringement. 2f there are no profts, there is no award of
Q3ccounts of %roftK as relief. The account of proft is not a punishment, it
only aims to deny the infringer un:ust enrichment at the cost of the owner 5or
licensee6 of the 2%@. ;amages and 3ccounts are alternative remediesA the
plainti7 can choose only one of them, not both.
#ivil action can o7er remedies also for acts which are themselves not
infringement but may be preparatory for completing the infringing act e.g.
supplying part for illegally making a patented invention, or consequential to
an illegal act e.g. importing or marketing infringing goods. 2n such
QsecondaryK acts the liability is dependent to a great degree on whether the
defendant knew that infringing goods were involved.
QHtherwiseK as a remedy is a general provision which authorises the court to
grant such other reliefs as it may deem necessary for complete redressal of
the complaint.
Q;elivery upK is a provision to make in:unction e7ective. The court ordering
in:unction may in its discretion order delivery up of infringing
articlesDdocuments for destruction by the defendant. 2f the case pertains to
the infringement of a trademark the equivalent order may require erasure of
trademark. 2n the case of a copyright work or an unregistered design, the
order may e+tend both to infringing copies and to the apparatus that is
specifcally designed to make them.
@ecourse to civil proceedings in cases of 2% infringements is on the rise. 2n
many cases, civil courts have awarded substantial damages. &or e+ample,
the award in the %olaroid vs. Eastman Jodak case was -. U(/0 million, and
in the .mith 2nternational vs. ,ughes Tools, -. UB"! million.
The civil procedure may come to the help of the owner of the 2%@ in securing
evidence of infringement through what is generally known as 3nton %iller
Hrder and Careva in:unction. These have already been discussed in -nit ',
.ection '.*. 3n 3nton %iller Hrder from a competent #ourt authorises a
plainti7, after a hearing in camera for pretrial relief in the form of a search
order of the defendantKs premises, with some safeguards for liberties and
prevention of abuse, for discovery of incrementing material or documents.
The Careva in:unction directs the defendant to retain the infringing material.
The e+perience with the enforcement of patent rights shows wide variation
from country to country in terms of comple+ity of the proceedings, duration
of a case in courts and the cost of litigation.
The patent infringement cases are full of technical comple+ities and receive
divergent interpretations at di7erent courts. The -.3 has established in '<(B
the -nited .tates #ourt of 3ppeals for the &ederal #ircuit to deal with the
issue of comple+ity in an attempt to provide uniform interpretation of patent
claims.
The present e7orts seek a negotiated resolution of the international
:urisdictional issue by adopting the ,ague #onvention on Eurisdiction and
&oreign Eudgments in #ivil and #ommercial Catters.
CRIMINAL PROCEEDINGS
The penalties for infringement in a criminal case are tougher than in civil
proceedings. #riminal penalties involve a real prospect of imprisonment for
a substantial term. Thus recourse to criminal proceedings, in a case of
infringement of 2%, can be more e7ective and have more of a Qdeterrent
valueK than a case under civil proceedings. ,owever, the standards to prove
a liability in a criminal action are more stringent than in a civil suit.
But a criminal suit has no immediate, pretrial, or interlocutory remedies like
in:unction or even remedies like permanent in:unction and damages. The
remedial action has to wait for the outcome of criminal proceedings. The
civil remedies have a greater appeal in business community than
punishment by state as in a criminal action.
The legal framework and guidelines provided under the T@2%. 3greement
aim at making enforcement of 2% in criminal proceedings more e7ective.
@ecourse to criminal proceedings in cases of violation of 2%@ is becoming
more popular. .everal countries have made criminal proceedings more
e7ective and pursue infringement of 2%@s with seriousness. 2n Calaysia,
Business .oftware 3lliance assists the government in fghting software
piracy. %enalties include imprisonment up to * years, #hina, ,ong Jong,
.ingapore, 2ndia are all on hot pursuit of counterfeiters and pirates.
Establishments raided include largely those producing autoparts, fake
medicines, music #;sDcassettes, books etc. and large stocks of counterfeit
and pirated goods have been sei9ed. 3n interesting development in the
administration of law pertaining to the violation of 2%@s is seen in Thailand.
3s the 2%@ law is highly comple+ and requires specifc knowledge for
competent interpretation, needing specially qualifed :udges, Thailand has
set up a #entral 2ntellectual %roperty and 2nternational Trade #ourt with
e+clusive :urisdiction in both #ivil and #riminal matters relating to
enforcement of 2%@s.
#riminal proceedings can be initiated by oIcers of the .tate.
ADMINISTRATI2E PROCEDURE
3part from court, administrative agencies can and do take e7ective steps in
case of violation of 2%@s. .uch action may include sei9ing infringing goods at
the borders by customs authoritiesA confscation of o7ending goods by e+cise
authoritiesA action by appropriate authorities to test quality and standards
etc. 3dministrative actions to stop infringement have high visibility.
#ustoms authorities play a notable role in administrative enforcement of 2%@s
at national borders by sei9ing infringing goods if the owner of the 2%@ notifes
the #ommissioner of #ustoms and E+cise that an incoming consignment is
violative of his 2%@, usually a copyright or a trademark, and needs to be
confscated to uphold his legal right. 2n B""', <* million counterfeit articles
were sei9ed at the E- borders. 3dministrative enforcement through sei9ure
at borders faces diIculty in several countries as customs authorities are
generally illequipped to handle 2% mattersA such matters may often not be
receiving high priority in customs policy. 3bsence of reliable databases to
support legal enforcement of 2%@s, particularly in trademarks, is an
impediment for quick action.
E2IDENTIAL ASPECTS
.ome evidential aspects relating to infringement of a patent and a trade
mark need to be noted.
Patet 9 I8!i%e'et
2f it is a product patent, the burden of proof lies on the plainti7. ,e has to
furnish evidence to convince the court that on a balance of probabilities the
defendant has infringed the patent.
2f it is a process patent for obtaining a product it is for the defendant to prove
the process he has been using to obtain an identical product is di7erent from
the patented process.
2t may be necessary, in view of the technical comple+ities involved in an
invention and the technical language used in specifcation and claims to call
e+perts, to give evidence, as to the state of art in a feld or the meaning of a
technical term, and whether in his opinion a skilled worker can carry out the
invention as described in the specifcation. ,owever, it is not for the e+pert
to say what the specifcation means or whether a particular step is obvious.
T!a"e'a!( I8!i%e'et
2f a challenge to a trademark has been mounted on the ground of non
use, or if the owner claims that the trademark has acquired
distinctiveness through use, the burden of proof lies with the proprietor of
the trademark.
@egistration of a trademark is prima facie evidence of its validity, as
regards its ownership.
Evidence may come from people in the trade 5wholesalers, retailers6,
e+perts, and even market surveys though they may not carry much
weight.

REMEDIES FOR INFRINGEMENT IN SPECIFIC IP INSTRUMENTS

Patets
@emedies available are? in:unction 5interlocutory as well as fnal6, damages
or account of profts, an order of delivery up, declaration of validity of patent
and the fact of its infringement by the defendant.
T!a"e'a!(s
@emedies are? in:unctions, damages or accounts, or otherwiseA as order of
delivery up which may be sub:ect to limitation of time.
I"/st!ia+ Desi%s
@emedies are normally in:unctions and damages. ,owever, damages may
not be awarded if the defendant succeeds in showing that he was not aware,
and had no reasonable ground for supposing that the design was registered.
2t may be noted that national laws may contain remedies against groundless
threats of infringement proceedings from the owner of the design by means
of advertisements, or publication of views, or circulars, or otherwise.
Se'ic#"/ct#! La$#/t*Desi% a" Ge#%!ap&ica+ I"icat#!
2nfringement attracts punishment with fne or imprisonment or both.
TECHNOLOGICAL MEASURES TO PRE2ENT AND DETECT
INFRINGEMENT
Besides the remedies and mechanism of 2% enforcement considered so far S
#ivil and #riminal %roceedings and 3dministrative %rocedures S which
envisaged active role of the government in enacting enabling legislation and
rules and regulations and in putting in place an e7ective institutional
infrastructure, the concerned owner can always devise or use technological
means to make counterfeiting and copying diIcult. This serves the owner of
the 2%@ by protecting his economic interest. 2t also tends to save the
customer from buying QfakeK goods 5and pirated copies of books, flms, music
cassettes, software programmes etc.6. .ince technology places a powerful
tool in the hands of counterfeiters and copiers, it can also be an apt means
to counter these e7orts. 2n any case, it could create measures to counter the
evil with speed as e7ecting change in national legislation, or developing
international understanding, is a slow and tedious process.
Technological means to counter infringement of 2%@s have acquired particular
importance since the advent and growth of internet, and in its wake, of e
commerce. To fght piracy in cyberspace, it is necessary to develop
technologies that make copying diIcult and easy of detection. Technological
means should increase the risks of the infringers? it should be diIcult for
them not to get caught and punishment should be heavy, that should serve
as an e7ective deterrent.
8overnments can help technological enforcement by providing legal
protection and e7ective remedies if someone tries to circumvent
technological measures which a rightholder employs for protection of 2% and
enforcement of 2%@s.
The more common technological methods deployed for 2%@ enforcement are
based on optical technology and electronic technology. They are briefy
discussed. .ome measures based on biotechnology and chemical technology
have also made their appearance.
,olograms are the most widely used optical measures. 3 hologram is a two
or threedimensional device which refects an image, sometimes associated
with some movement. #opying a hologram is very diIcult and costly.
.everal electronic devices are available e.g. the magnetic strip as the one on
a credit card which stores a large amount of coded data, readable with a
scannerA the smart card, incorporating a computer chip which can carry a
large amount of data upon accessA encryption, where electronic signal is
scrambled, but is readable through an authorised key.
Uit :
The B/"apest T!eat$ # t&e Ite!ati#a+ Rec#%iti# #8 t&e Dep#sit
#8 Mic!##!%ais's 8#! t&e P/!p#ses #8 Patet P!#ce"/!e, or
B/"apest T!eat$, is an international treaty signed in Budapest, ,ungary, on
3pril B(, '<//. 2t entered into force on 3ugust <, '<(", and was later
amended on .eptember B), '<(". The treaty is administered by the >orld
2ntellectual %roperty Hrgani9ation 5>2%H6.
3s of ;ecember B""(, /B countries were party to the Budapest Treaty.
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The
accession to the Treaty is open to .tates party to the %aris #onvention for the
%rotection of 2ndustrial %roperty of '((0. The 3frican @egional 2ndustrial
%roperty Hrgani9ation 53@2%H6, the Eurasian %atent Hrgani9ation 5E3%H6 and
the European %atent Hrganisation 5E%H6 have fled a declaration of
acceptance under 3rticle <5'65a6
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of the Treaty.
The treaty allows Pdeposits of microorganisms at an international depositary
authority to be recogni9ed for the purposes of patent procedureP.
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-sually,
in order to meet the legal requirement of suIciency of disclosure, patent
applications and patents must disclose in their description the sub:ectmatter
of the invention in a manner suIciently clear and complete to be carried out
by the person skilled in the art 5see also? reduction to practice6. >hen an
invention involves a microorganism, completely describing said invention in
the description to enable third parties to carry it out is usually impossible.
This is why, in the particular case of inventions involving microorganisms, a
deposit of biological material must be made in a recognised institution. The
Budapest Treaty ensures that an applicant, i.e. a person who applies for a
patent, needs not to deposit the biological material in all countries where
heDshe wants to obtain a patent. The applicant needs only to deposit the
biological material at one recognised institution, and this deposit will be
recognised in all countries party to the Budapest Treaty.
PATENTING OF MICRO*ORGANISMS
2n view of the fact that it is often diIcult, if not impossible, to suIciently
describe a new microorganism in a patent application, a system for
depositing microorganisms has been established. Thus, under the national
law of many countries, patentees are required to deposit with a recogni9ed
depositary institution a sample of the new microorganism, together with a
written description of the microorganism in the patent application.
The system of deposit of microorganisms is the sub:ect of the Budapest
Treaty on the 2nternational @ecognition of the ;eposit of Cicroorganisms for
the %urposes of %atent %rocedure, which provides for the setting up of
international depositary authorities with which microorganisms can be
deposited. This treaty is a special agreement under the %aris #onvention,
and it entered into force on 3ugust '<, '<(". The treaty is regulated by the
rules spelt out in the @egulations accompanying it. The complete te+t of the
Budapest Treaty is given in 3ppendi+ 3.
Bac(%!#/" t# t&e B/"apest T!eat$
;isclosure of the invention is a generally recogni9ed requirement for the
grant of patents. Formally, an invention is disclosed by means of a written
description. >here an invention involves a microorganism, or the use of a
microorganism, which is not available to the public, such a description is not
always suIcient for disclosure. That is why in the patent procedure of an
increasing number of countries it is necessary not only to fle a written
description but also to deposit, with a speciali9ed institution, a sample of the
microorganism. %atent oIces are not equipped to handle microorganisms,
whose preservation requires special e+pertise and equipment to keep them
viable, to protect them from contamination and to protect health or the
environment from contamination. .uch preservation is costly. The furnishing
of samples also requires speciali9ed e+pertise and equipment.
>hen protection is sought in several countries for an invention involving a
microorganism or the use of a microorganism, the comple+ and costly
procedures of the deposit of the microorganism might have to be repeated
in each of those countries. 2n order to eliminate or reduce such
multiplication, and to enable one deposit to serve the purpose of all the
deposits which would otherwise be necessary, the Budapest Treaty was
concluded.
I'p#!tat Feat/!es #8 t&e B/"apest T!eat$
The main provision of the Treaty is that a #ontracting .tate which allows or
requires the deposit of microorganisms for the purposes of patent procedure
must recogni9e, for such purposes, the deposit of a microorganism with any
international depositary authority 53rticle 05'6 5a66, irrespective of whether
such authority is on or outside the territory of the said .tate. 2n other words,
one deposit, with one international depositary authority, will suIce for the
purposes of patent procedure before the national patent oIces of all of the
#ontracting .tates and before any regional patent oIce 5e.g., the European
%atent HIce6.
>hat the Treaty calls an international depositary authority is a scientifc
institution, which is capable of storing microorganisms. This is typically a so
called culture collection. .uch an institution acquires the status of
international depositary authority through the furnishing, by one of the
#ontracting .tates on the territory of which it is located, of assurances to the
;irector 8eneral of >2%H to the e7ect that the said institution complies, and
will continue to comply, with certain requirements 53rticle )5'66 including,
that
it will be available, for the purposes of the deposit of microorganisms, to
any depositor 5person, frm, etc.6 under the same conditionsA
it will accept and store the deposited microorganismsA and
it will furnish samples thereof to anyone entitled to such samples but to
no one else.
The said assurances may be furnished also by certain intergovernmental
industrial property organi9ations 53rticle <5'6 5a66.
The @egulations contain detailed provisions on who is entitled, and when, to
receive samples of the deposited microorganism. The depositor himself has
a right to a sample at any time. ,e may authori9e any third party 5authority,
natural person, legal entity6 to ask for a sample and such a third party will
receive a sample upon producing such an authori9ation. 3ny interested
industrial property oIce to which the Treaty applies may ask for a sample
and will receive oneA an industrial property oIce will mainly be regarded as
interested where the microorganism is needed for the purposes of patent
procedure before the said oIce. 3ny other party may obtain a sample if, an
industrial property oIce to which the Treaty applies certifes that, under the
applicable law, such a party has the right to a sample of the given micro
organismA the elements of the certifcation are provided in detail to ensure
that the ma+imum e+tent of caution will be e+ercised by the industrial
property oIce before it issues a certifcation.
The Treaty and the @egulations contain provisions for?
a new deposit where no samples of the originally deposited micro
organism can be furnished 53rticle !6A
for the termination or limitation of the status of international depositary
authority at the will of the #ontracting .tates where the said authority
does not, or does not fully, comply with its assumed duties 53rticle (6,
transfer of all microorganisms deposited with an international depository
authority to another such authority if the former is about to cease
functioning as suchA
the content of the receipt that each international depositary authority is
required to give to the depositor for the deposited microorganismA
the testing of the viability of the deposited microorganisms and the
issuance of viability statementsA
the international depositary authority to charge a fee for each deposit, the
fee covering the minimum 0" years during which the deposited micro
organism must be storedA and
for a special status and a special role for certain intergovernmental
organi9ations.
Mai A"vata%es #8 t&e B/"apest T!eat$
The Budapest Treaty is primarily advantageous to the depositors who are
seeking patent protection in several countries. 2t will save them money
because, instead of depositing the microorganism in each and every country
in which they fle the patent application referring to that microorganism,
they can deposit it only once, with one depositary, with the consequence
that in all but one of the countries in which the protection is sought, the
costs pertaining to deposit are saved. 2n most cases, there will be at least
one international depositary authority in the country of the depositors, which
means that they will deal with an authority which is close to them, can deal
in their own language, can pay the fees in their own currency and they may
even know the depository from personal e+perience.
The security of the depositor is increased by the fact that, for an institution
to become an international depositary authority, solemn assurances as to
the seriousness and continued e+istence of that institution must be given.
.uch assurances must be given by a .tate or by an intergovernmental
organi9ation and they are addressed to all the member .tates of the
Budapest -nion. #onsequently, it may be e+pected that the assurances will
be strictly respected, all the more so since, if they are not so respected, the
member .tates may take away from the defaulting institution the status of
international depositary authority.
%lease remember that adherence to the Treaty entails no fnancial burden or
obligation for any 8overnment.
$et us now summari9e the points discussed in this unit.
-nit *
Bi#sa8et$? prevention of largescale loss of biological integrity, focusing
both on ecology and human health
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.
Biosafety is related to several felds
in ecology 5referring to imported life forms from beyond ecoregion borders6,
in agriculture 5reducing the risk of alien viral or transgenic genes, or prions
such as B.EDPCad#owP, reducing the risk of food bacterial contamination6
in medicine 5referring to organs or tissues from biological origin, or genetic
therapy products, virusA levels of lab containment protocols measured as ', B,
0, ! in rising order of danger6,
in chemistry 5i.e., nitrates in water, %#B levels a7ecting fertility6 and
in e+obiology 5i.e., F3.3Os policy for containing alien microbes that may e+ist
on space samples sometimes called Pbiosafety level *P6.
The international Biosafety %rotocol deals primarily with the agricultural
defnition but many advocacy groups seek to e+pand it to include post
genetic threats? new molecules, artifcial life forms, and even robots which
may compete directly in the natural food chain.
Biosafety in agriculture, chemistry, medicine, e+obiology and beyond will
likely require application of the precautionary principle, and a new defnition
focused on the biological nature of the threatened organism rather than the
nature of the threat.
>hen biological warfare or new, currently hypothetical, threats 5i.e., robots,
new artifcial bacteria6 are considered, biosafety precautions are generally
not suIcient. The new feld of biosecurity addresses these comple+ threats.
"iosafety level refers to the stringency of biocontainment precautions
deemed necessary by the #enters for ;isease #ontrol and %revention 5#;#6
for laboratory work with infectious materials.
Bi#c#tai'et
The concept of bi#c#tai'et, also called +ab#!at#!$ bi#sa8et$,
pertains to microbiology laboratories in which the physical containment of
highly pathogenic organisms 5bacteria6 or agents 5viruses6 is required,
usually by isolation in environmentally and biologically secure cabinets or
rooms, to prevent accidental infection of workers or release into the
surrounding community during scientifc research. The term
PbiocontainmentP was coined in '<(*
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, but the concept stretches back at
least to the '<!"s.
#rimary containment is the protection of personnel and the immediate
laboratory environment from e+posure to infectious agents and is provided
by good microbiological technique and the use of appropriate safety
equipment, such as biological safety cabinets. Secondary containment is the
protection of the environment e+ternal to the laboratory from e+posure to
infectious materials and is provided by a combination of facility design and
operational practices.
Biological safety cabinets 5B.#6 are fairly common devices designed to
provide e7ective primary biocontainment in laboratories working with highly
infectious agents. Three general levels and types have been devised 5#lass 2,
#lass 22, and #lass 2226.
Biosafety suites are suites of laboratory rooms which are essentially
equivalent to large #lass 222 cabinets in which positive pressure personnel
suits 5Pspace suitsP6 serve as the PoutsideP environment for workers.
E+amples include the biosafety suites at -.3C@22; at &ort ;etrick, Caryland
and the Ca+imum #ontainment &acility 5C#&6 of the #;# in 3tlanta, 8eorgia.
Bi#sa8et$ +eve+
3 bi#sa8et$ +eve+ is the level of the biocontainment precautions required to
isolate dangerous biological agents in an enclosed facility. The levels of
containment range from the lowest biosafety level ' to the highest at level !.
2n the -nited .tates, the #enters for ;isease #ontrol and %revention 5#;#6
have specifed these levels.
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2n the European -nion, the same biosafety
levels are defned in a directive.
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History
The frst prototype #lass 222 cabinet was fashioned in '<!0 by ,ubert Jaempf,
then a -... 3rmy soldier, under the direction of ;r. 3rnold 8. >edum,
;irector 5'<!!S)<6 of 2ndustrial ,ealth and .afety at the -nited .tates 3rmy
Biological >arfare $aboratories, &ort ;etrick, Caryland. Jaempf was tired of
his C% duties at ;etrick and was able to transfer to the sheet metal
department working with the contractor, the ,.J. &erguson #o.
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Hn '( 3pril '<**, fourteen representatives met in #amp ;etrick in &rederick,
Caryland. The meeting was to share knowledge and e+periences regarding
biosafety, chemical, radiological, and industrial safety issues that were
common to the operations at the three principal biological warfare 5B>6
laboratories of the -... 3rmy
V!WV*W
Because of the potential implication of the
work conducted at biological warfare laboratories, the conferences was
restricted to top level security clearances. Begininning in '<*/, these
conferences were planned to include nonclassifed sessions as well classifed
sessions to enable broader sharing of biological safety information. 2t was not
until '<)!, however, that conferences were held in a government installation
not associated with a biological warfare program.
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Hver the frst ten years, the biological safety conferences grew to include
representatives from all federal agencies that sponsored or conducted
research with pathogenic microorganisms. By '<)) it grew to include
representatives from universities, private laboratories, hospitals, and
industrial comple+es. Throughout the '</"s participations in the conferences
continued to grow, and by '<(0 discussions began considering the creation
of a formal organi9ation.
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The 3merican Biological .afety 3ssociation 53B.36 was oIcially established
in '<(!, and a constitution and bylaws were drafted in '<(!. 3s of B""(,
3B.3 has grown to include ',)"" members in its professional association.
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Rationale
Biocontainment can be classifed by the relative danger to the surrounding
environment as biological safety levels 5B.$6. 3s of B""), there are four
safety levels. These are called "SL$ through "SL%, with one anomalous level
"SL&ag for agricultural ha9ards between B.$0 and B.$!. ,igher numbers
indicate a greater risk to the e+ternal environment. See biological hazard.
3t the lowest level of biocontainment, the containment 9one may only be a
chemical fume hood. 3t the highest level the containment involves isolation
of the organism by means of building systems, sealed rooms, sealed
containers, personal isolation equipment commonly referred to as Pspace
suitsP and elaborate procedures for entering the room, and decontamination
procedures for leaving the room. 2n most cases this also includes high levels
of security for access to the facility, ensuring that only authori9ed personnel
may be admitted to any area that may have some e7ect on the quality of the
containment 9one. This is considered a hot 9one.
Levels
Biosafety level 1
This level is suitable for work involving wellcharacteri9ed agents not known
to consistently cause disease in healthy adult humans, and of minimal
potential ha9ard to laboratory personnel and the environment 5#;#,'<</6.
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2t includes several kinds of bacteria and viruses including canine hepatitis,
nonpathogenic 'scherichia coli, as well as some cell cultures and non
infectious bacteria. 3t this level precautions against the bioha9ardous
materials in question are minimal, most likely involving gloves and some sort
of facial protection. The laboratory is not necessarily separated from the
general traIc patterns in the building. >ork is generally conducted on open
bench tops using standard microbiological practices. -sually, contaminated
materials are left in open 5but separately indicated6 rubbish receptacles.
;econtamination procedures for this level are similar in most respects to
modern precautions against everyday microorganisms 5i.e., washing oneOs
hands with antibacterial soap, washing all e+posed surfaces of the lab with
disinfectants, etc.6. 2n a lab environment all materials used for cell andDor
bacteria cultures are decontaminated via autoclave. $aboratory personnel
have specifc training in the procedures conducted in the laboratory and are
supervised by a scientist with general training in microbiology or a related
science.
Biosafety level 2
This level is similar to Biosafety $evel ' and is suitable for work involving
agents of moderate potential ha9ard to personnel and the environment.
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2t
includes various bacteria and viruses that cause only mild disease to
humans, or are diIcult to contract via aerosol in a lab setting, such as !.
di(cile, hepatitis 3, B, and #, infuen9a 3, $yme disease, dengue fever,
Salmonella, mumps, measles, ,2G,
V(W
scrapie, C@.3, and G@.3. 8enetically
modifed organisms have also been classifed as level B organisms, even if
they pose no direct threat to humans. This designation is used to limit the
release of modifed organisms into the environment. 3pproval by the &;3 is
required to release these organisms. 3n e+ample is genetically modifed food
crops. B.$B di7ers from B.$' in that?
'. laboratory personnel have specifc training in handling pathogenic agents and
are directed by scientists with advanced trainingA
B. access to the laboratory is limited when work is being conductedA
0. e+treme precautions are taken with contaminated sharp itemsA and
!. certain procedures in which infectious aerosols or splashes may be created
are conducted in biological safety cabinets or other physical containment
equipment.
Biosafety level 3
This level is applicable to clinical, diagnostic, teaching, research, or
production facilities in which work is done with indigenous or e+otic agents
which may cause serious or potentially lethal disease after inhalation.
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2t
includes various bacteria and viruses that can cause severe to fatal disease
in humans, but for which vaccines or other treatment e+ist, such as
)ycobacterium tuberculosis, "acillus anthracis, >est File virus, Gene9uelan
equine encephalitis virus, Eastern equine encephalitis virus, ,endra virus,
.3@. coronavirus, Salmonella typhi, !oxiella burnetii, @ift Galley fever virus,
*ickettsia rickettsii, and yellow fever virus.
$aboratory personnel have specifc training in handling pathogenic and
potentially lethal agents, and are supervised by competent scientists who
are e+perienced in working with these agents. This is considered a neutral or
warm 9one.
3ll procedures involving the manipulation of infectious materials are
conducted within biological safety cabinets or other physical containment
devices, or by personnel wearing appropriate personal protective clothing
and equipment. The laboratory has special engineering and design features.
2t is recogni9ed, however, that some e+isting facilities may not have all the
facility features recommended for Biosafety $evel 0 5i.e., doubledoor access
9one and sealed penetrations6. 2n this circumstance, an acceptable level of
safety for the conduct of routine procedures, 5e.g., diagnostic procedures
involving the propagation of an agent for identifcation, typing, susceptibility
testing, etc.6, may be achieved in a biosafety level B facility, providing
'. the fltered e+haust air from the laboratory room is discharged to the
outdoors,
B. the ventilation to the laboratory is balanced to provide directional airfow into
the room,
0. access to the laboratory is restricted when work is in progress, and
!. the recommended .tandard Cicrobiological %ractices, .pecial %ractices, and
.afety Equipment for Biosafety $evel 0 are rigorously followed.
The decision to implement this modifcation of biosafety level 0
recommendations is made only by the laboratory director.
Biosafety level 4
The 8alveston Fational $aboratory B.$! lab on the #ampus of the -niversity of
Te+as Cedical Branch
This level is required for work with dangerous and e+otic agents that pose a
high individual risk of aerosoltransmitted laboratory infections, agents which
cause severe to fatal disease in humans for which vaccines or other
treatments are not available, such as Bolivian and 3rgentine hemorrhagic
fevers, Carburg virus, Ebola virus, $assa fever, #rimean#ongo hemorrhagic
fever, .mallpo+, and other various hemorrhagic diseases. >hen dealing with
biological ha9ards at this level the use of a ,a9mat suit and a selfcontained
o+ygen supply is mandatory. The entrance and e+it of a $evel &our biolab will
contain multiple showers, a vacuum room, an ultraviolet light room, and
other safety precautions designed to destroy all traces of the bioha9ard.
Cultiple airlocks are employed and are electronically secured to prevent both
doors opening at the same time. 3ll air and water service going to and
coming from a biosafety level ! lab will undergo similar decontamination
procedures to eliminate the possibility of an accidental release.
3gents with a close or identical antigenic relationship to Biosafety $evel !
agents are handled at this level until suIcient data is obtained either to
confrm continued work at this level, or to work with them at a lower level.
Cembers of the laboratory sta7 have specifc and thorough training in
handling e+tremely ha9ardous infectious agents and they understand the
primary and secondary containment functions of the standard and special
practices, the containment equipment, and the laboratory design
characteristics. They are supervised by qualifed scientists who are trained
and e+perienced in working with these agents. 3ccess to the laboratory is
strictly controlled by the laboratory director.
The facility is either in a separate building or in a controlled area within a
building, which is completely isolated from all other areas of the building. 3
specifc facility operations manual is prepared or adopted. Building protocols
for preventing contamination often use negatively pressuri9ed facilities,
which, if compromised, would severely inhibit the containment of an
outbreak of aerosol pathogens.
>ithin work areas of the facility, all activities are confned to #lass 222
biological safety cabinets, or #lass 22 biological safety cabinets used with one
piece positive pressure personnel suits ventilated by a life support system.
The Biosafety $evel ! laboratory has special engineering and design features
to prevent microorganisms from being disseminated into the environment.
The laboratory is kept at negative air pressure, so that air fows into the room
if the barrier is penetrated or breached. &urthermore, an airlock is used
during personnel entry and e+it.
ist of biosafety facilities
Na'e L#cati#
Leve+ Estab+is&e
"
Disc#ti/e
"
Desc!ipti#
Girology $aboratory
of the Xueensland
;epartment of
,ealth
3ustralia,
Xueensland,
#oopers
%lains
!
3ustralian 3nimal
,ealth $aboratory
3ustralia,
Gictoria,
8eelong
!
2nfectious ;iseases
-nit, .t.EohnOs
@esearch 2nstitute
2ndia,
Bangalore
0
3ll 2ndia 2nstitute of
Cedical .ciences
2ndia, Few
;elhi
'! '<<0
Hne of the
premier
research
institute Y
conducts
studies on
ma:or
pathogenic
organisms.
,as been
contributed in
discovering
novel strains
Y vaccines.
Fational E3$C3
2nstitute for $eprosy
Y Hther
Cycobacterial
;iseases
5F#E2$HC;6, 3gra
2ndia, 3gra 0 B""B This facility
deals with the
Cycobacterial
strains Y their
pathogenicity
Y
epidemiology.
Fational ,igh
.ecurity $aboratory
3ustralia,
Gictoria,
Forth
Celbourne
!
Fational ,igh
.ecurity
$aboratory
Hperates
under the
auspice of the
Gictoria
2nfectious
;iseases
@eference
$aboratory.
#urtin -niversity of
Technology
3ustralia,
>estern
3ustralia,
Bentley
0
&undaZ[o Hswaldo
#ru9
Bra9il, @io
de Eaneiro
0
2t is unclear
whether this
facility
operates as a
B.$!. Bra9il
doesnOt have
any B.$!
facilities
Vcitation
neededW
-niversity of .[o
%aulo
Bra9il, .[o
%aulo
0
2t is unclear
whether this
facility
operates as a
B.$!. Bra9il
doesnOt have
any B.$!
facilities
Vcitation
neededW
2nstituto 3dolf $ut9 Bra9il 0
2nstituto Butantan Bra9il 0
British #olumbia #anada, 0 The British
#entre for ;isease
#ontrol
British
#olumbia
#olumbia
#entre for
;isease
#ontrol,
operates
three
biosafety
level 0 labs.
Fational
Cicrobiology
$aboratory
#anada,
Canitoba,
>innipeg
!
$ocated at the
#anadian
.cience
#entre for
,uman and
3nimal
,ealth, it is
:ointly
operated by
the %ublic
,ealth
3gency of
#anada and
the #anadian
&ood
2nspection
3gency.
#entre Fational de
Biologie
E+p\rimentale
#anada,
Xuebec,
$aval
0
$ocated at the
2nstitut
national de la
recherche
scientifque.
Gaccine and
2nfectious ;isease
Hrgani9ation 5G2;H6
#anada,
.askatchew
an,
.askatoon
B '</* FD3 -niversity of
.askatchewan
Os Gaccine and
2nfectious
;isease
Hrgani9ation
is a pre
eminent
research
institute
investigating
the
pathogenesis
of infectious
diseases and
the
development
of e7ective
therapeutic
and
prophylactic
methods to
control
infectious
diseases of
humans and
animals.
#anada,
Hntario,
Toronto
!
This facility
never opened
due to
community
opposition in
the '<<"s.
#enter of Biological
%rotection
#9ech
@epublic
!
$ocated at the
#entrum
biologick\
ochrany
T]chon^n
5#enter of
Biological
%rotection6
V<W
Fational 2nstitute
for ,ealth and
>elfare
&inland,
,ermanni,
,elsinki
0
;ocument
from Fational
2nstitute for
,ealth and
>elfare that
mentios the
facility.
V'"W
Fational 2nstitute
for ,ealth and
>elfare
&inland,
Tilkanm_ki,
,elsinki
0
;ocument
from Fational
2nstitute for
,ealth and
>elfare that
mentios the
facility.
V'"W
$aboratoire %! Eean
C\rieu+
&rance,
@h`ne
3lpes, $yon
! '<<<"0"*
Eean C\rieu+
laboratory is a
cooperation
between the
%asteur
2nstitute and
2F.E@C. Fote
that in &rance,
it is %! for
%athogen or
%rotection
level !.
V''W
#entre 2nternational
de @echerches
C\dicales de
&ranceville
8abon !
This facility is
operated by a
research
organi9ation
supported by
the &rench
government,
operates >est
3fricaOs only
B.$! lab.
V'BW
@obert Joch
2nstitute
8ermany,
Berlin
!
The facility
was licenced
for
construction
by #ity of
Berlin on
Fovember 0",
B""(.
Bernhard Focht
2nstitute for Tropical
8ermany, !
Cedicine ,amburg
%hilipps -niversity
of Carburg
8ermany,
Carburg
! B""(
The facility is
licenced to
work with
genetically
modifed
organisms
>ehrwissenschaftli
ches 2nstitut far
.chut9technologien
8ermany,
Cunster
0
&riedrich $oeber
2nstitute on 2sland
@iems
8ermany,
2sland @iems
! B"'"
;eals
especially
with virology
Evangelismos
8reece,
3thens
0 B""0
#rete -niversity,
%agne hospital,
#linical
bacteriology lab
8reece,
,eraklion
0 B""0
,igh .ecurity
3nimal ;isease
$aboratory 5,.3;$6
2ndia,
Bhopal
! '<<(
This facility
deals
especially to
9oonotic
organisms
and emerging
infectious
disease
threats.
2nstitute of Tropical
;isease 52T;6
2ndonesia,
East Eava,
.urabaya
0 B""(
Hperated by
2nstitute of
Tropical
;isease
3irlangga
-niversity,
Build
#ooperation
with Eapan.
39ienda
Hspedaliera
Hspedale $uigi
.acco
2taly,
$ombardy,
Cilano
!
3 university
hospital in
%olo
-niversitarioA
it contains
two special
vehicles for
transporting
infectious
persons.
2stituto Fa9ionale
Calattie 2nfettive
2taly, @ome,
@ome
!
This facility,
5trans.6
Fational
2nstitute of
2nfectious
;iseases,
operates
within the
$a99aro
.pallan9ani
,ospital.
2nstitute for Cedical
@esearch 52C@6,
Cinistry of ,ealth
Calaysia,
Juala
$umpur
0
This facility is
able to
conduct
research and
tests on
acarology,
bacteriology,
medical
entomology,
parasitology
and virology.
Fational 2nstitute
for 2nfectious
;iseases
Eapan,
Jantc, Tokyo
0 $ocated at
Fational
2nstitute for
2nfectious
;iseases,
;epartment
of Girology 2A
this lab has
the potential
of operating
as a B.$!,
however it is
limited to
perform work
on only B.$0
agents due to
opposition
from local
residents and
communities.
2nstitute of %hysical
and #hemical
@esearch
Eapan,
Jantc,
Tsukuba
This is a non
operating
B.$! facility.
Fetherlands
Fational 2nstitute
for %ublic ,ealth
and the
Environment 5@2GC6
Fetherlands,
Bilthoven
0 ! B""<
#urrently
under
construction,
it is planned
to be fnished
by the end of
B""<. 2t is
planned to
operate as a
B.$ 0 and a
B.$ ! facility.
>uhan 2nstitute of
Girology of the
#hinese 3cademy
of .ciences
%eopleOs
@epublic of
#hina,
,ubei,
>uhan
0 ! B"'" 5%!6 >uhan
2nstitute of
Girology
already hosts
a B.$0
laboratory. 3
distinct B.$!
facility is
currently
being built
based on %!
standards, the
original
technology for
confnement
developed by
&rance.
V'0WV'!W
2t
will be the
frst at level !
in #hina,
under the
direction of
.hi dhengli.
V'*W
.tate @esearch
#enter of Girology
and Biotechnology
GE#TH@
@ussia,
Fovosibirsk
Hblast,
Joltsovo
' !
2t is one of
two facilities
in the world
that oIcially
hold
smallpo+. The
other @ussian
B.$!
facilities have
been
dismantled.
;efence .cience
Hrgani9ation 5;.H6
.ingapore !
;efence
.cience
Hrgani9ation
goal is to
conduct
autopsies
during a
potential
deadly
epidemic
outbreak.
.ingapore
also has a
mobile B.$!
autopsy
facility,
perhaps the
only one of its
kind in the
world.
V')W
Fational 2nstitute
for #ommunicable
;iseases
.outh 3frica,
Eohannesbur
g
!
Fational
2nstitute for
#ommunicabl
e ;iseases of
.pecial
%athogens
-nit is one of
only two B.$
! facilities in
3frica but the
only suit
laboratory on
the continent.
Fational %ublic
,ealth $aboratory
5F%,$6, Cinistry of
,ealth
Calaysia,
.ungai
Buloh,
.elangor
0
The F%,$ is
established to
develop
laboratory
based
surveillance
systems for
infectious
diseases of
epidemic and
pandemic
potential as
part of an
early warning
system and
response
strategies for
outbreaks of
infectious
diseases.
.wedish 2nstitute
for 2nfectious
;isease #ontrol
.weden,
.olna
!
.wedish
2nstitute for
2nfectious
;isease
#ontrol is
.candinaviaOs
%! facility.
2nstitute of Girology
and
2mmunoprophyla+is
52G26
.wit9erland,
Cittelh_user
n
! B""/"B"'
This facility
only deals
with animal
diseases
which do not
transmit to
humans, and
is the only %!
facility where
complete
isolation suits
are not used.
,igh #ontainment
$aboratory ;;%.
5.i$ab6
.wit9erland,
.pie9
!
-nder
construction,
it will start
operations in
B"'". This
laboratory will
comply with
B.$!
standards.
%reventive Cedical
2nstitute of @H#
Cinistry of Fational
;efense
@epublic of
#hina
5Taiwan6
!
Jwenyang
$aboratory 5
6 #enter of
;isease #ontrol
@epublic of
#hina
5Taiwan6
!
%art of the
;epartment
of ,ealth
@epublic of
#hina.
,ealth %rotection
3gencyOs #entre for
2nfections
-nited
Jingdom,
#olindale
!
$ocated in the
Giral doonosis
unit.
Fational 2nstitute
for Cedical
@esearch
-nited
Jingdom,
$ondon
!
;efence .cience
and Technology
-nited
Jingdom,
!
$aboratory %orton ;own
-nited
Jingdom
!
-nder
construction.
#enters for ;isease
#ontrol and
%revention
-nited
.tates of
3merica,
8eorgia,
3tlanta
!
#urrently
operates in
two buildings.
Hne of two
facilities in
the world that
oIcially hold
smallpo+.
8eorge Cason
-niversity
Biomedical
@esearch
$aboratory
-nited
.tates of
3merica,
Girginia,
Canassas
0
This facility is
currently
under
construction
on a '"acre
site ad:acent
to 8eorge
Cason
-niversityOs
%rince >illiam
#ampus. 2t is
scheduled to
be fully
operational in
the .pring of
B"'".
8eorgia .tate
-niversity
-nited
.tates of
3merica,
8eorgia,
3tlanta
!
2s an older
design
Pglovebo+P
facility.
2ntegrated
@esearch &acility
-nited
.tates of
3merica,
Caryland,
&ort ;etrick
! -nder
construction.
This facility
will be
operated by
Fational
2nstitute of
3llergy and
2nfectious
;iseases
5F232;6, it is
planned to
begin
operating at
B""< at the
earliest.
Fational Biodefense
3nalysis and
#ountermeasures
#enter 5FB3##6
-nited
.tates of
3merica,
Caryland,
&ort ;etrick
!
-nder
construction,
it will be
operated for
the
;epartment
of ,omeland
.ecurity.
Fational 2nstitutes
of ,ealth 5F2,6
-nited
.tates of
3merica,
Caryland,
Bethesda
!
$ocated on
the F2,
#ampus, it
currently only
operates with
B.$0 agents.
-. 3rmy Cedical
@esearch 2nstitute
of 2nfectious
;iseases
5-.3C@22;6
-nited
.tates of
3merica,
Caryland,
&ort ;etrick
! Hld building
-. 3rmy Cedical
@esearch 2nstitute
of 2nfectious
;iseases
5-.3C@22;6
-nited
.tates of
3merica,
Caryland,
&ort ;etrick
!
Few building,
currently
under design
construction
Fational Emerging
2nfectious ;iseases
$aboratory 5FE2;$6
-nited
.tates of
3merica,
Cassachuset
ts, Boston
! -nder
construction
by Boston
-niversity,
building and
sta7 training
complete,
waiting for
regulatory
approval.
F232; @ocky
Countain
$aboratories
-nited
.tates of
3merica,
Contana,
,amilton
!
-nder
construction,
it is planned
to begin
operation in
B""< at the
earliest.
.tony Brook
-niversity #enters
for Colecular
Cedicine #enter for
2nfectious ;iseases
-nited
.tates of
3merica,
Few =ork,
.tony Brook
0 '<<<
Hperated by
.tate
-niversity of
Few =ork at
.tony Brook,
a B.$0
facility
studying
Borrelia
burgdorferi
5$yme
;isease6,
=ersinia pestis
5Bubonic
plague6 and
&rancisella
tularensis
5@abbit fever6
-niversity of
#incinnati
-nited
.tates of
3merica,
Hhio,
#incinnati
0
-niversity of
#incinnati
Cedical
.ciences
Building
Battelle Cemorial
2nstitute
-nited
.tates of
3merica,
Hhio, >est
0
Ee7erson
8alveston Fational
$aboratory,
Fational
Biocontainment
&acility
-nited
.tates of
3merica,
Te+as,
8alveston
!
Hpened in
B""(, facility
is operated by
the -niversity
of Te+as
Cedical
Branch.
V'/W
.hope $aboratory
-nited
.tates of
3merica,
Te+as,
8alveston
!
Hperated by
the -niversity
of Te+as
Cedical
Branch
5-TCB6.
.outhwest
&oundation for
Biomedical
@esearch
-nited
.tates of
3merica,
Te+as, .an
3ntonio
!
The only
privately
owned B.$!
lab in the -..
;ivision of
#onsolidated
$aboratory .ervices
-nited
.tates of
3merica,
Girginia,
@ichmond
!
This facility is
part of the
;epartment
of 8eneral
.ervices of
the
#ommonwealt
h of Girginia.
2t is so called
PsurgeP B.$!
capacity.
Fational Bio and
3gro;efense
&acility 5FB3&6
-nited
.tates of
3merica,
Jansas .tate
-niversity,
Canhattan,
Jansas
! &acility to be
operated by
the
;epartment
of ,omeland
.ecurity, and
replace the
%lum 2sland
3nimal
;isease
#enter.
%lanned to be
operational by
B"'!.
%lum 2sland 3nimal
;isease #enter
-nited
.tates of
3merica,
Few =ork,
%lum 2sland
0ag
&acility
scheduled to
be replaced
by the
Fational Bio
and 3gro
;efense
&acility.
@esearches
9oonotic
pathogens
only.
.aint $ouis
-niversity ;oisy
@esearch Building
-nited
.tates of
3merica,
Cissouri, .t.
$ouis
0
.aint $ouis
-niversityOs
new center
for biomedical
research.
Conkeypo+ is
the primary
B.$0 agent
studied.
-niversity of
#alifornia, Berkeley
-nited
.tates of
3merica,
#alifornia,
Berkeley
0 The -#
Berkeley B.$0
&acility is
currently
housed in a
single location
but will be
e+panded in
B"'' to
include a
second site
5in a building
under
construction6.
-niversity of
#alifornia, $os
3ngeles
-nited
.tates,
#alifornia,
$os 3ngeles
0
2nstituto Facional
de Tecnologia
3gropecuaria,
Buenos 3ires
3rgentina,
Buenos
3ires,
#astelar
03
2nstituto de
Girologia
5#2#Gy36
Geterinary @esearch
2nstitute 5G@26,
;epartment of
Geterinary .ervices
Calaysia,
2poh, %erak
0
This facility
created a
breakthrough
in identifying
the Fipah
virus, which is
classifed
internationally
as a B.$!
agent.
Popular culture
The beginning of the movie +utbreak 5'<<*6 walks the audience through
each biosafety level, giving e+amples of diseases in each categoryA
unfortunately, the diseases used are often incorrectly categori9ed, and
numerous egregious violations of biosafety level protocol are witnessed. The
introduction to the book ,he -ot .one is similar to the beginning of
+utbreak.
3 fctitious Biosafety $evel * is referenced in the video game %ariah, which
takes place in the year B*B". 2t is described by the protagonist Eack CasonN
a doctor with military training who works for a government organi9ation
called the Transgenic #ontrol #ommissionNas a biosafety protocol which
calls for the release of nuclear weapons in order to sterili9e a location where
it is believed that a hopelessly catastrophic disease outbreak is imminent.
The novel by Cichael #richton called The 3ndromeda .train references a
functionally identical biosafety protocol under the name of P;irective /'BP.