Module 5: Patent and Patent Laws

Dr Ashwathanarayana R
Department of Genetics
Dayanand Sagar University, Bangalore
PATENT AND PATENT SYSTEM
• The patent is a monopoly right given to inventor in exchange for the disclosure
of his invention, for the limited period. The definition itself states the main
objectives of the Patent System. The definition can be divided into three parts,
namely:
❖ Monopoly rights
❖ In return for disclosure
❖ Limited Period
• The patent is given to inventor so that no other person can use/make/sell his
invention.
• The right is given because the inventor is disclosing his work, the work for
which he has put efforts.
• The rights are given for limited period so that the inventor does not enjoy
unlimited rights over his inventions and the invention is available to the public.
PATENT AND PATENT SYSTEM
The objective of the patent law
➢ To encourage inventor: If a person puts efforts and resources in invention
something that can be patented, he should have a provision that stops others
from copying his work without his permission. If it happens he would get
motivated to research further.
➢ To protect Inventors’ interest: By protecting inventions the Law also protects
the goodwill and financial gains of the inventor. For e.g. if Patents are not
provided anyone can copy the formula of drugs and can sell it at cheaper rates.
This will affect the goodwill of the inventor in case the drug does not work, and
the inventor will also lose his market that will result in financial loss.
➢ Encourage Research and Development: If an inventor gets recognition for his
work and at the same time his work is protected also, he may get motivated for
further research. This will also motivate others to go in the field of research. All
this will finally result in the technical and financial growth of the society.
PATENT AND PATENT SYSTEM
Objective of the patent law
➢ To ensure Fair trade practices: By providing protection and monopoly rights
the law indirectly stimulates fair trade practices. If a businessman knows that he
will be facing legal action for copying others’ process or product, he may not
try to do so. This will help in controlling unfair competition.
➢ To encourage innovation by granting inventors a patent for their inventions. A
patent is a governmental grant to inventors of a right to exclude others from
making, using, offering for sale, or selling or importing to, the United States,
their invention.
➢ Be coherent and balanced: offering a fair level of protection to
inventors/applicants from all backgrounds and providing a fair balance between
the rights of inventors/applicants and third parties.
➢ Promote high quality patents by ensuring that patent protection is provided
only to inventions that are new, involve an inventive step and are capable of
industrial application.
PATENT AND PATENT SYSTEM
Objective of the patent law
➢ Provide legal certainty: Provide legal certainty to inventors/applicants
and third parties alike.

➢ To enjoy the exclusive rights over the invention

➢ The patent is ensure commercial returns to the inventor for the time and
money spend in generating new products.

➢ Support economic growth: enabling global patent rights to be acquired in

an efficient manner; promoting consistent results in multiple jurisdictions;
promoting innovation and competition.
PATENT AND PATENT SYSTEM
Basic principles of the patent law
• Firstly, the invention must be novel, meaning thereby that the Invention must
not be in existence.

• Secondly, the Invention must be non- obvious, i.e. the Invention must be a
significant improvement to the previous one; mere change in technology will
not give the right of the patent to the inventor.

• Thirdly, the invention must be useful in a Bonafede manner, meaning thereby

that the Invention must not be solely used in any illegal work and is useful to
the world in a Bonafede manner.
PATENT AND PATENT SYSTEM
Basic principles of the patent law
1. Non-prejudicial disclosures / grace period
• Inventors/applicants whose inventions have been disclosed prior to filing a
patent application should, in certain circumstances, be given an opportunity to
patent their invention
• Such circumstances should include breach of confidence or theft of information
2. Publication of applications
• The global publication regime should be formulated to provide a clear time
limit by which information about a potentially patented invention will be made
public
• The timing of publication should provide for prompt dissemination of
knowledge from all pending patent applications wherever filed
• Pending patent applications should be published promptly after the expiry of a
globally agreed timeframe.
PATENT AND PATENT SYSTEM
Basic principles of the patent law
2. Publication of applications
• The globally agreed timeframe should balance the interests of
inventors/applicants and those of third parties.
• Patent offices should be able to delay or suppress publication of a pending
application in exceptional circumstances
• Inventors/applicants should be able to request publication of an application
prior to the globally agreed timeframe if they wish, as long as the requirements
for publication under the applicable law are met.
3. Conflicting applications
• The grant of multiple patents for the same invention in the same jurisdiction
should be prevented
• The patent system should allow for the protection of incremental inventions
while ensuring that patent rights are not unjustifiably extended
PATENT AND PATENT SYSTEM
Basic principles of the patent law
3. Conflicting applications
• Any system which allows incremental inventions to be patented should: balance
the interests of inventors to protect incremental improvements on their own
inventions with the interests of third parties to operate in the same field;
promote innovation and competition.
4. Prior user rights
• A third party who has started using an invention in good faith prior to the filing
of a patent application for that invention by another party should have a right to
continue to use that invention
• The circumstances under which prior user rights arise, including the extent to
which they rely on actual use having taken place, should balance the interests of
third parties to protect their investments with the interests of the
inventor/applicant
PATENT AND PATENT SYSTEM
Basic principles of the patent law
5. Prior art
• Patents should only be granted for contributions that place in the hands of the
public information that had not been previously known

• The scope of prior art should be properly defined to ensure that the subject
matter for which exclusive rights are granted truly represents a contribution to,
and not an encroachment on, the public domain

• Subject to agreed exceptions, prior art should consist of all information that has
been made available to the public anywhere in the world before the earliest
effective filing date of the claimed invention
PATENT AND PATENT SYSTEM
What can be patented?
Sections 3 and 4 of the Indian Patents Act, 1970 clearly mentioned the exclusions
regarding what can be patented in India. There are certain criteria which have to be
fulfilled to obtain a patent in India. They are:
• Patent subject: The most important consideration is to determine whether the
Invention relates to a patent subject matter. Sections 3 and 4 of the Patents Act
list non-patentable subject matter. Unless the Invention comes under any
provision of Section 3 or 4, it means that it consists of a subject for a patent.
• Novelty: Innovation is an important criterion in determining the patent
potential of an invention. Under Section 2(l) of the Patent Act, a novelty or new
Invention is defined as “no invention or technology published in any document
before the date of filing of a patent application, anywhere in the country or the
world”. The complete specification, that is, the subject matter has not fallen into
the public domain or is not part of state of the art”.
PATENT AND PATENT SYSTEM
What can be patented?
• Inventive steps or non-clarity: Under Section 2(ja) of the Patents Act, an
inventive step is defined as “the characteristic of an invention that involves
technological advancement or is of economic importance or both, as
compared to existing knowledge, and invention not obvious to a person
skilled in the art.” This means that the invention should not be obvious to a
person skilled in the same field where the invention is concerned. It should
not be inventive and obvious for a person skilled in the same field.
• Capable of industrial application: Industrial applicability is defined in
Section 2 (ac) of the Patents Act as “the invention is capable of being made or
used in an industry”. This basically means that the Invention cannot exist in
the abstract. It must be capable of being applied in any industry, which means
that it must have practical utility in respect of patent.
PATENT AND PATENT SYSTEM
Rights of Patentee
• Right to exploit patent: A patentee has the exclusive right to make use,
exercise, sell or distribute the patented article or substance in India, or
to use or exercise the method or process if the patent is for a person.
This right can be exercised either by the patentee himself or by his
agent or licensees. The patentee’s rights are exercisable only during the
term of the patent.
• Right to grant license: The patentee has the discretion to transfer rights
or grant licenses or enter into some other arrangement for a
consideration. A license or an assignment must be in writing and
registered with the Controller of Patents, for it to be legitimate and
valid. The document assigning a patent is not admitted as evidence of
title of any person to a patent unless registered and this is applicable to
assignee not to the assignor.
PATENT AND PATENT SYSTEM
Rights of Patentee
• Right to Surrender: A patentee has the right to surrender his patent, but
before accepting the offer of surrender, a notice of surrender is given to
persons whose name is entered in the register as having an interest in the
patent and their objections, if any, considered. The application for
surrender is also published in the Official Gazette to enable interested
persons to oppose.

• Right to sue for infringement: The patentee has a right to institute

proceedings for infringement of the patent in a District Court having
jurisdiction to try the suit.
PATENT AND PATENT SYSTEM
Obligations of patentee
• Government use of patents: A patented invention may be used or even acquired by
the Government, for its use only; it is to be understood that the Government may also
restrict or prohibit the usage of the patent under specific circumstances. In case of a
patent in respect of any medicine or drug, it may be imported by the Government for its
own use or for distribution in any dispensary, hospital or other medical institution run
by or on behalf of the Government. The aforesaid use can be made without the consent
of the patentee or payment of any royalties. Apart from this, the Government may also
sell the article manufactured by patented process on royalties or may also require a
patent on paying suitable compensation.
• Compulsory licenses: If the patent is not worked satisfactorily to meet the reasonable
requirements of the public, at a reasonable price, the Controller may grant compulsory
licenses to any applicant to work the patent. A compulsory license is a provision under
the Indian Patent Act which grants power to the Government to mandate a generic drug
maker to manufacture inexpensive medicine in public interest even as a patent in the
product is valid. Compulsory licenses may also be obtained in respect of related patents
where one patent cannot be worked without using the related patent.
PATENT AND PATENT SYSTEM
Obligations of patentee
• Revocation of patent: A patent may be revoked in cases where there has been
no work or unsatisfactory result to the demand of the public in respect of the
patented invention.
• Invention for defense purposes: Such patents may be subject to certain secrecy
provisions, i.e. publication of the Invention may be restricted or prohibited by
directions of Controller. Upon continuance of such order or prohibition of
publication or communication of patented Invention, the application is debarred
for using it, and the Central Government might use it on payment of royalties to
the applicant.
• Restored Patents: Once lapsed, a patent may be restored, provided that few
limitations are imposed on the right of the patentee. When the infringement was
made between the period of the date of infringement and the date of the
advertisement of the application for reinstatement, the patent has no authority to
take action for infringement.
PATENT AND PATENT SYSTEM
General requirements of patent
1. The innovation is patentable subject matter
➢ Patentable
▪ New products such as toys, appliances, tools, medical devices,
pharmaceutical drugs
▪ New process, such as a manufacturing process or an industrial method or
process
▪ Software, Business methods
▪ Some types of biological materials
➢ Not patentable
▪ Artistic creations, Mathematical algorithms or models
▪ Abstract intellectual or mental concepts or processes
▪ Plans or schemes
▪ Principles or theories
PATENT AND PATENT SYSTEM
General requirements of patent
2. The innovation is new (called 'novelty')
➢ You cannot patent something that is already publicly known, as it would be
unfair to confer the economic benefits of a patent in relation to something that
is already publicly known. The test of 'novelty' is assessed as at the date you file
your application for the patent.
➢ For this reason, if you intend to disclose your product, process or invention to
someone, it is critical that you have a confidentiality agreement signed
beforehand.
3. The innovation is inventive
➢ This requirement of an inventive step relates to the 'obviousness' of the new
product, process or invention. If it is 'obvious' to a skilled person, it is not
patentable.
PATENT AND PATENT SYSTEM
General requirements of patent
4. The innovation is useful (called 'utility’)
• This requirement does not relate to whether the new product, process or
invention is 'useful' in terms of whether or not someone would buy it. Instead, it
relates to whether the invention is capable of being made in accordance with the
claims and information in the patent.
• From April 2013, there has been a requirement to disclose a specific, substantial
and credible use for the invention in the patent specification.
5. The innovation must not have prior use
➢ If you have been selling the product, using the process in your business, or if
you have licensed it, this prior use disqualifies it from being patentable.
PATENT AND PATENT SYSTEM
Procedure of Patent
1. Disclosure of the invention: The first step is to disclose your invention to a
professional. This is done by signing a non-disclosure agreement. One must
submit all known facts about their invention and not miss anything.
2. Search for patentability: Usually, a professional charges a fee for this step
which is approximately INR 10,000 to INR 20,000. At this stage, the
professional will conduct a thorough investigation to obtain prior evidence in
all possible databases. They will also prepare a patentability report based on the
invention
3. Decision to apply for a patent: After a detailed examination of the (possibly)
existing history of the invention, one can decide whether they want to proceed
with the patent application. It must be noted that the invention must be
compared to existing prior artworks to qualify for a patent. Therefore, it must
be 'technically advanced' or 'economically significant' or both on an existing
work of art.
PATENT AND PATENT SYSTEM
Procedure of Patent
4. Patent Drafting: An application can be prepared by either the inventor or a
professional. A fee between INR 20,000 and INR 30,000 is to be paid to a
professional. This is one of the most important steps in the whole process and
requires technical and legal knowledge.
5. Filing the patent application: One can submit the patent application in the
prescribed manner using the appropriate forms, subject to a fee of INR 1,600 or
INR 4,000 or 8,000 depending on the type of application. These are payable for
filing the patent application with the Patent Office. If a request is not submitted
for an early publication, the patent application will be published within 18
months.
6. Request for examination: This is the step where the applicant is required to
request the Indian patent office to examine the patent application, within 48
hours and the request for examination fees ranges from INR 4,000 to INR
20,000.
PATENT AND PATENT SYSTEM
Procedure of Patent
7. Responding to Objections: This step thoroughly examines the draft and report
that will be presented to the Patent Office officials. In this step, the inventor has
the opportunity to apply their novelty or inventive step to any other work of art
found during the appraisal.

8. Granting of the patent: If the application meets all the prescribed

requirements; it will be released for grant and will be announced by a published
magazine.

9. Renewal of the patent: A patent is usually valid for 20 years. After a period of
20 years, the owner must renew the patent in exchange for a small fee.
PATENT AND PATENT SYSTEM
Biotechnological inventions and patent Law
• Biotechnology is the process of modifying the living organisms in such a way that
they become more productive for the humans. The recent trends in biotechnology
techniques i.e. recommendations DNA, cell fusion, and monoclonal antibody
technology have raised fundamental social and moral questions and created
problems in intellectual property rights.
• Over the last 25 years, the sector of biotechnological inventions has experienced
growth. It is an extremely dynamic area wherein there have been constant
innovations. One of the most important sectors in biotechnology is DNA.
Scientists have been able to use the DNA of some living organisms and cloned the
same.
• Article 27 of TRIPS discusses about the agreed international norms on
patentability of the inventions. It states that any product or process shall be
patentable if the said product or process is new, involves an inventive step and has
industrial application.
PATENT AND PATENT SYSTEM
Biotechnological inventions and patent Law
• Article 27 of TRIPS discusses about the agreed international norms on
patentability of the inventions. It states that any product or process shall be
patentable if the said product or process is new, involves an inventive step and has
industrial application. This criterion is same in all countries that are signatories of
the TRIPS Agreement.
• According to Article 27.2, inventions against public order or morality or which
would cause serious prejudice to the plant, animal and human health and life can
be excluded from patentability provided that such exclusion is not made merely
because the exploitation is prohibited by their law.
• According to Article 27.3, therapeutic, diagnostic and surgical methods as well as
plants and animals except microorganism cannot be patented. Also, it has been
agreed that the protection may be extended to the plant varieties through a sui
generis system or patent etc.
PATENT AND PATENT SYSTEM
Biotechnological inventions and patent Law
To be a patentable invention in India, the requirement of novelty, inventive step and
industrial application must be met. Also, it should not fall within the criteria mentioned in
Section 3 and 4 of the Patents Act, 1970. In case of biotech patents, the following inventions
are excluded from patentability:
1. An invention would not be patentable if it is immoral or against public order, harmful to human,
animal or plant life or harmful to environment.
2. Discovery of living things or non-living substances in nature
3. Plants and animals in whole or any parts thereof other than micro-organisms but including seeds,
varieties and species.
4. Essentially biological processes for the production or propagation of plants and animals.
5. Any Process for the medicinal, surgical, curative, prophylactic, diagnostic or therapeutic or other
treatment of human beings or animals to render them free of disease or to increase their
economic value or that of their products.
6. New use or new property of known substance.
7. Methods of agriculture or horticulture and Traditional knowledge
PATENT AND PATENT SYSTEM
Biotechnological inventions and patent Law
A. Patenting of Genetically modified Microorganisms
• Section 3(c) of the Patents Act, 1970 precludes patenting of discovery of any
living thing or non- living substance occurring in nature. This means an isolated
naturally occurring gene is not patentable but a genetically modified gene would
be considered as patentable if it is new and inventive having industrial
application.
• As per Section 3(j) Plants and animals in ‘whole’ or ‘any part thereof’ is not
patentable. Although, microorganisms are excluded from non-patentability list, a
conjoined reading with Section 3 (c) of the Patents Act, 1970 implies that only
modified microorganisms, which do not constitute discovery of living thing
occurring in nature, are patentable subject matter under the Act.
• Besides the claims on Plants and animals in ‘whole’ or ‘any part thereof’ the
claims relating to essentially biological processes of growing plants, germination
of seeds, of development stages of plants and animals are objected under
Section 3 (j) of the Patents Act, 1970.
PATENT AND PATENT SYSTEM
Biotechnological inventions and patent Law
B. Patenting Animal Cloning
• Section 3(j) precludes patenting of biological processes for production or
propagation of plants and animals. Further, as per Section 3(b) of the Patents
Act, 1970, the invention must not be contrary to public order, morality or causes
serious prejudice to human, animal or plant life or health or to the environment.

• The most serious issue with animal cloning is the adverse health effects as they
have been observed in sheep and the other mammals that have been cloned.
These include an increase in birth size and a number of defects in important
organs such as the liver, brains and heart. Besides these there has been
premature aging and problems with the immune system.
PATENT AND PATENT SYSTEM
Biotechnological inventions and patent Law
C. Patenting Stem Cells
• Section 3(j) of the Patents Act 1970 states that ‘plants and animals in whole or
any part thereof other than micro-organisms but including seeds, varieties and
species and essentially biological processes for production or propagation of
plants and animals’ are not patentable.
• Stem cells are considered to fall under the phrase ‘any part thereof’ and hence
are excluded from patentability. However, in vitro methods of differentiating,
isolating/purifying and culturing of stem cells may qualify as patentable subject
matter, provided it is novel, involves an inventive step and has industrial
applicability.
• In addition, Stem cells invention may also be objected under Section 3(b) of the
Act, which states that an invention, the primary or intended use or commercial
exploitation of which could be contrary public order or morality or which cause
serious prejudice to human, animal or plant life or health or to the environment,
are not inventions.
PATENT AND PATENT SYSTEM
Biotechnological inventions and patent Law
D. Patenting Genetically Modified Seeds
• The Patents Act, 1970 prohibits any patent on plants, plant varieties or seeds, but
it does not exclude man made gene sequences that are present in Genetically
Modified Seeds. Under the Protection of Plant Variety and Farmers Right Act,
2001, the creation of a new plant variety, which may include its propagating
material i.e. the seeds and includes within its ambit transgenic varieties is
protected.
• However the Patents Act, 1970 permits biotech companies to patent their
artificially engineered genes and use them to create transgenic seeds in a lab
and selling the same. Seeds can’t be patented in India. This is because a patent
is an exclusive right granted to an inventor to prevent others from making, using,
producing, selling and distributing the patented invention. A patent on seeds
would prevent farmers from saving and exchanging seeds.
PATENT AND PATENT SYSTEM
Biotechnological inventions and patent Law
The following sections of the Patents Act, 1970 are emphasized in the context
of examination of applications in biotechnology and allied fields:
1. Section 2 (1) (j): Novelty, inventive step & industrial applicability of products or
processes,
2. Section 3 (b): Inventions contrary to morality or which cause serious prejudice to
human, animal or plant life or health or environment,
3. Section 3 (c): Discovery of any living thing or non-living substance occurring in
nature
4. Section 3 (d): Mere discovery of new form of known substance which does not
result in enhancement of known efficacy or mere discovery of any new property
or new use for a known substance,
5. Section 3 (e): Mere admixture resulting only in aggregation of the properties,
6. Section 3 (h): Method of agriculture and horticulture
PATENT AND PATENT SYSTEM
Biotechnological inventions and patent Law
The following sections of the Patents Act, 1970 are emphasized in the context
of examination of applications in biotechnology and allied fields:
7. Section 3 (i): Method of treatment and diagnosis,
8. Section 3 (j): Plants and animals in whole or any part thereof other than
microorganisms, but including seeds, varieties and species, and essentially
biological processes,
9. Section 3 (k): Computer programs per se and algorithms, mathematical
methods,
10. Section 3 (p): Inventions which are in effect traditional knowledge,
11. Section 10 (4): Sufficiency of disclosure and the best method of performing the
invention, and
12. Section 10 (5): Unity of invention and clarity, succinctness and support of the
claims.
PATENT AND PATENT SYSTEM
LEGAL DEVELOPMENT OF PATENT LAW
• India has a well-established judicial system to work out an effective intellectual
property (IP) ecosystem. Based on feedback from stakeholders, the government
has taken several initiatives to create awareness and inculcate a culture of
innovation in India.
• During the year, the IP offices have been radically transformed through numerous
initiatives, which have contributed tremendously to the understanding of IP and
easing the patenting system to make it more user-friendly. Some of the
developments that happened in 2017 are discussed herein.
• One of the significant achievements has been to conduct various awareness
programmes to make IP-related issues understandable, and imparting knowledge
to various sectors including universities, industries and the general public.
• In this regard, the Modernization and Strengthening of Intellectual Property Office
(MSIPO) scheme has been floated by the Department of Industrial Policy and
Promotion (DIPP).
PATENT AND PATENT SYSTEM
LEGAL DEVELOPMENT OF PATENT LAW
1. Trademark law brought at par with international practices
• To bring Indian trademarks law in line with international practices and to ensure
implementation of India's commitments under the TRIPS Agreement, India
replaced the Trade and Merchandise Marks Act, 1958, with the Trade Marks Act,
1999. Some changes under the 1999 Act are as follows:
• Service marks, for the first time, made protectable through registration.
• The definition of "trade mark" now includes graphic representations, shapes,
packaging and combinations of colors, thereby widening IPR protection.
• The procedure for registration of trademarks expedited by removing the earlier
system of Part A and B registration. In addition, only a single application need
now be filed for registration of a trademark in different classes. The 1999 Act also
provides for the classification in conformity with recognized International
Classification of Goods and Services.
• The period of registration and renewal has been increased from seven to ten
years.
PATENT AND PATENT SYSTEM
LEGAL DEVELOPMENT OF PATENT LAW
2. Protection to Geographical Indications Provided
• India has enacted the Geographical Indications of Goods (Registration and
Protection) Act, 1999 (the GIG Act). The GIG Act provides for registration and
better protection of geographical indications relating to goods to help identify the
place of origin of goods, quality, reputation and other distinctive characteristics of
these goods. The GIG Act now helps in protecting unique.
• Indian products linked to some geographical region of India, such as Basmati
Rice, Darjeerling Tea, Alphonso Mangoes, Malabar Pepper, Cardamom and
Hyderabad Grapes, which are all well known in the international market. For
many years, these products have been exported on a regular basis,
demonstrating India's reputation of high quality of these products and, therefore,
require such protection. Under the GIG Act, assignment of geographical
indications is prohibited, being public property. The GIG Act helps prevent
geographical indications of goods becoming generic which may otherwise lead to
a loss of distinctiveness and consequently loss of protection.
PATENT AND PATENT SYSTEM
LEGAL DEVELOPMENT OF PATENT LAW
3. Copyright Law Modified
• The 2012 amendments in copyright law, which were made to make Indian
copyright law compliant with the WIPO Copyright Treaty (WCT) and WIPO
Performances and Phonograms Treaty, introduced technological protection
measures, ensured that fair use survives in the digital era by providing special fair
use provisions, made many author-friendly amendments, special provisions for
disabled, amendments facilitating access to works and other amendments
special provisions for disabled, amendments facilitating access to works and
other amendments to streamline copyright administration.
• The Government is considering further amendments to the Indian Copyright Act
to help deter continuing piracy. Future amendments would provide for greater
deterrents against infringement through more effective legislative and
administrative frameworks. These amendments would also offer the police wider
powers to conduct secret raids, seize and destroy infringing products, provide
faster criminal proceedings and increased punishment for piracy.
PATENT AND PATENT SYSTEM
LEGAL DEVELOPMENT OF PATENT LAW
4. Patents Law more aligned with TRIPS
• Modifications in Indian patent laws have been made in accordance with TRIPS by
widening the list of inventions not patentable, incorporating greater rights of the
patentee, reversing the burden of proof in an infringement suit on process patents and
creating a uniform period of patent protection of twenty years for all categories of
invention.
• During 2014, the Indian Patent Office released guidelines pertaining to issuance of
pharmaceutical patents. These guidelines primarily incorporate features of various court
decisions so as to assist the Patent Office in establishing uniform standards of patent
grant/examination. These guidelines are expected to bring in uniformity with regard to
examinations of the patent applications across all Patent Offices in India and by different
responsible officers.
• Indian Patent (Amendment) Rules 2014 recently introduced a third category of applicant
being of "small entity", and provided procedural rules for governing the same.
Furthermore, the fee for basic patent filing have been revised due to the introduction of
the e-filing system of patents wherein the rates for e-filing are lower than those involved
in physical filing.
PATENT AND PATENT SYSTEM
LEGAL DEVELOPMENT OF PATENT LAW
5. Protection for Plant Varieties and Rights of Farmers established
• India, in giving effect to the provisions of the TRIPS Agreement, enacted the
Protection of Plant Varieties and Farmers Rights Act, 2001, to provide for the
establishment of an effective system for protection of plant varieties.

• The 2001 Act recognizes and protects the rights of farmers for their contributions
made in conserving, improving and making available plant genetic resources for
the development of new plant varieties.

• A variety that conforms to the criteria of novelty, distinctiveness, uniformity and

stability is registrable under law. The 2001 Act provides for a total eighteen years
protection for trees and vines and fifteen years for other plants.
PATENT AND PATENT SYSTEM
LEGAL DEVELOPMENT OF PATENT LAW
6. New Designs Law
• India enacted a separate law for the protection of copyrights in an industrial
design. The Designs Act, 2000 repealed the earlier Designs Act, 1911.
• The new law protects proprietors of novel or original designs and enforces those
rights against infringers. The new law incorporates the definition of the term
"original" to specify what is a registrable design.
• In relation to a design, the term "original" includes designs, which though old in
themselves, are new in their application. Any design which is new or original, not
previously published in any country, whether India or outside India, and which is
not contrary to public order or morality is registrable under the Act.
• The new Act amplified the definitions of "article" and "design" to bring them in
conformity with internationally accepted definitions for providing wider protection.
PATENT AND PATENT SYSTEM
LEGAL DEVELOPMENT OF PATENT LAW
7. Integrated Circuits Provisions adopted
• In compliance with obligations under the TRIPS Agreement, India has enacted
the Semiconductor Integrated Circuits Layout-Design Act, 2000. This Act provides
for registration of original, inherently distinctive and not yet exploited layout-
designs. Any misuse of a registered layout-design can be prevented by way of an
infringement action. The Act provides a term of protection for 10 years.
• Although the Indian IP laws are still in the stages of development but the same
are very much in conformity with the international IP laws as India is a signatory
to international conventions and treaties including Paris Convention for the
Protection of Industrial Property, Berne Convention on Copyright and TRIPS
Agreement.
• Generally, other than period of protection available and the time and cost taken to
register an IP, there are but a few major differences between Indian and
European IP laws and even those primarily relate to less significant procedural
aspects.
PATENT AND PATENT SYSTEM
Patentable biotechnological inventions
• Biotechnology patents fall under the scope of
utility patents. A utility patent is available for the
invention or discovery of a new and useful
machine, manufacturing process, composition
of matter, or process.
• This type of patent is also available for
improvements to an existing process that are
considered new and useful.
• When an inventor applies for a patent, they
must demonstrate that their creation meets
certain eligibility requirements.
• To qualify, an invention must fall under subject-
matter eligibility, have utility and novelty, be non-
obvious, and not have been previously
disclosed.
PATENT AND PATENT SYSTEM
Patentable biotechnological inventions
• Methods for producing or analyzing proteins and their use in an analysis method
or in a medicinal product.
• Proteins, DNA sequences, microorganisms and constituents of the human body
(for example, cells) which already exist in nature, if they are isolated from their
natural environment or produced by a technical procedure, and have not been
described previously.
• A gene, which is isolated and given a new task as a medicinal product or
diagnostic tool.
• Genetically modified products, such as plants and animals.
• microorganisms and microbiological processes are patentable subject matter.
Genetically modified multicellular organisms including plants, animals, human
beings and their parts are excluded from patentability in India.
PATENT AND PATENT SYSTEM
Non-patentable biotechnological inventions
• Pure discoveries, such as discovered but not isolated or further described parts
of animals, plants or microorganisms.

• Plant varieties and animal breeds. For a definition of plant variety, see chapter 1,
section 3 of the Act on the Protection of Plant Breeders' Rights.

• Inventions that are contrary to public order or morality, which society regards as
unethical and unacceptable. For example, it is not possible to patent a method for
reproductive human cloning as it is contrary to public order and morality. Here
you can find more information on biotechnology and ethics.
PATENT AND PATENT SYSTEM
Non-patentable biotechnological inventions
• Living elements of the characteristic root, for example, creatures, plants, in entire
or any parts thereof, plant assortments, seeds, species, qualities also, smaller
scale living beings.
• Any procedure of assembling or generation identifying with such living
substances.
• Any strategy for treatment, for example, therapeutic, careful, therapeutic,
prophylactic indicative also, remedial, of people or creatures or on the other hand
different medications of comparable nature.
• Any living substance of fake beginning, for example, transgenic creatures and
plants, or any part thereof.
• Natural materials, for example, organs, tissues, cells, infections and all the way
toward getting them ready. Basically natural procedures for the creation of plants
and creatures, for example, a technique for intersection or reproducing.
PATENT AND PATENT SYSTEM
Patent Protection in biotechnology
Legal provisions and government policies for biotech patent
Biotechnology Patent Facilitation Cell (BPFC) :The Department of Biotechnology
works under the Ministry of Science & Technology and provides services in the
areas of research, infrastructure, generation of human resources, popularization of
biotechnology, promotion of biotech industries, and establishing centers of
excellence. The BPFC was formed with the aim to provide an awareness cum
facilitation mechanism to create awareness about IPRs among scientists and
researchers and further to provide patent facilities to biologists and biotechnologists
in the country for filing Indian and foreign patents on a sustained basis.
National Research Development Council(NRDC): It was established by the
Government of India with the primary objective to promote, develop and
commercialize the technologies, inventions, patents, processes emanating from
various R&D institutions or universities and is presently working under the
Department of Scientific & Industrial Research
PATENT AND PATENT SYSTEM
Patent Protection in biotechnology
Remedies for Patent Infringement
Patent infringement lawsuits can result in significantly higher losses than other
types of lawsuits. Some laws, such as the Patent Act, allow plaintiffs to recover
damages.
Monetary Relief: Monetary relief in the form of compensatory damages is available
to prevent patent infringement:
1. Indemnity compensation – A patent owner may have lost profits for infringement
when they established the value of the patent.
2. Increased damage – Up to three times, compensation charges can be charged
in cases of will or violation of will.
3. The time period for damages – The right to damages can be claimed only after
the date when the patent was issued and only 6 years before the infringement
claim is filed.
PATENT AND PATENT SYSTEM
Patent Protection in biotechnology
Remedies for Patent Infringement
Patent infringement is the illegal manufacture or usage of an invention or
improvement of someone else’s invention or subject matter who owns a patent
issued by the Government, without taking the owner’s consent either by consent,
license or waiver. Several remedies are available to patent owners in the event of
an infringement. Measures available in patent infringement litigation may include
monetary relief, equal relief and costs, and attorneys’ fees.
Equitable relief: Orders are issued by the court to prevent a person from doing
anything or Act. Injections are available in two forms:
1. Preliminary injunction – Orders made in the initial stage of lawsuits or lawsuits
that prevent parties from doing an act that is in dispute (such as making a patent
product)
2. Permanent injunction – A final order of a court which permanently ceases
certain activities or takes various other actions.
PATENT AND PATENT SYSTEM
Patenting Living organisms
• Biological diversity is undergoing a dangerous wave of privatization under the
label of Intellectual Property Rights, through the patenting of plants, animals,
genes and smaller parts of DNA. A biological patent is a patent relating to an
invention in biology.
• Patents were historically developed to ensure that the inventors could get the
financial return and benefits deriving out of the use of their inventions. Patents
are guarantees given by government that provide an inventor with exclusive
rights to use, sell or manufacture for a set period of time. (20 years in India).
• Earlier living organisms were always considered as discoveries of nature and
unpatentable. But in 1980, in the land mark case of Diamond v/s Chakrabarty,
the U.S Supreme Court ruled that the living organism, a bacterium that could
digest crude oil in oil spils, could be patented. The court observed that patents
can only be granted when living products could be seen as human-made
inventions.
PATENT AND PATENT SYSTEM
Patenting Living organisms
• On the other hand it must also be seen that patenting of genes of organisms
deprive farmers of their generations-old rights to freely replant and exchange
seeds, community resources and knowledge because this allows industries and
individuals to take control and exploit generic material as exclusive private
property that can be sold or withheld from framers, breeders, scientists and
doctors.
• This also deters scientists from research in the areas that have been claimed as
patents, patents in science promote secrecy and hinder the exchange of
information and makes important products more expensive and less accessible,
and it also promotes unsustainable and inequitable agricultural products. This is
also seen as turning of life forms into commodities to be used for profit making as
patents ensure profits through monopolies.
PATENT AND PATENT SYSTEM
Patenting Living organisms
• The Human Genome Organization (HUGO) an international membership
organization of individual scientists has released a statement in favour of those
who have determined the biological functions or products of the genes, to patent
their work. A HUGO project currently aims to collect blood, hair and cell samples
from up to 7000 indigenous communities throughout the world, before these
people disappear as a result of increasing industrialization.
• Many indigenous groups are outraged that researches might patent genes
without the consent of communities of origin. A similar case has been seen where
cells from a human spleen have been granted patent to University of California
which was removed from the body of a leukemia patient. The value of this cell
was estimated over one billion dollars, but when the patient demanded the return
of his body part the California Supreme Court denied that he was no longer
entitled to it after it had been removed from his body.
PATENT AND PATENT SYSTEM
Patenting Living organisms
• A genetically engineered mouse has been patented as an invention in U.S, and became
the first animal to be considered as an invention. The mouse has been engineered for
susceptibility to cancer. Patents on living organisms are morally objectionable to many,
patenting organisms and their DNA promotes the concept that life is a commodity to be
exploited for profit.
• The Neem tree, which is a part of traditional Indian ayurvedic and tibetian medicine,
agriculture and household use, as well as being a symbol of “Gandhi’s favorite tee”. Its
usefulness is known throughout India. However, it is possible that Indian citizens will
soon be required to pay royalties on the products produced from the Neem, since a
patent has been granted to the U.S Company W.R Grace on a compound in the tree
(azadirachtin) for the production of a bio pesticide.
• Similarly in 2000, the U.S Corporation Ricetec attempted to patent certain hybrids of
basmati rice and semidwarf long-grain rice. The Indian government intervened and
several claims of the patent were invalidated. Meanwhile the European Commission has
agreed to protect basmati rice under its regulations pertaining to Geographical
Indications.
PATENT AND PATENT SYSTEM
Patenting Living organisms
• A genetically engineered mouse has been patented as an invention in U.S, and became
the first animal to be considered as an invention. The mouse has been engineered for
susceptibility to cancer. Patents on living organisms are morally objectionable to many,
patenting organisms and their DNA promotes the concept that life is a commodity to be
exploited for profit.
• The Neem tree, which is a part of traditional Indian ayurvedic and tibetian medicine,
agriculture and household use, as well as being a symbol of “Gandhi’s favorite tee”. Its
usefulness is known throughout India. However, it is possible that Indian citizens will
soon be required to pay royalties on the products produced from the Neem, since a
patent has been granted to the U.S Company W.R Grace on a compound in the tree
(azadirachtin) for the production of a bio pesticide.
• Similarly in 2000, the U.S Corporation Ricetec attempted to patent certain hybrids of
basmati rice and semidwarf long-grain rice. The Indian government intervened and
several claims of the patent were invalidated. Meanwhile the European Commission has
agreed to protect basmati rice under its regulations pertaining to Geographical
Indications.
PATENT AND PATENT SYSTEM
Patenting Living organisms
• The first patent for a human product was granted on March 20, 1906, for a purified
form of adrenaline. It was challenged and upheld in Parke-Davis v. Mulford. Judge
Hand argued that natural substances when they are purified are more useful than
the original natural substances.

• The 1970s marked the first time when scientists patented methods on their
biotechnological inventions with recombinant DNA. It wasn’t until 1980 that patents
for whole-scale living organisms were permitted.
• Food patent: An early example of a food patent is the patent granted to RiceTec
for basmati rice in 1997. In 1999, a patent was filed for a peanut butter and jelly
sandwich that was without crust. Agriculture giant Monsanto filed for a patent on
certain pig genes in 2004.
PATENT AND PATENT SYSTEM
Patenting Living organisms
• Gene patent: In 1978 University of California filed a patent application for the
cDNA encoding human growth hormone, which issued in 1982 as U.S. Patent
No. 4,363,877 and listed Howard M. Goodman, John Shine, and Peter H.
Seaborg as inventors.
• University of California licensed its patent to Lilly, leading to extended litigation
among University of California, Lilly, and Genentech; each of Lilly and Genentech
had introduced recombinant human growth hormone drugs, which were among
the first biotech drugs brought to market.
• A patent application for the isolated BRCA1 gene and cancer-promoting
mutations, as well as methods to diagnose the likelihood of getting breast cancer,
was filed by the University of Utah, National Institute of Environmental Health
Sciences (NIEHS) and Myriad Genetics in 1994