Patentable and Non Patentable Inventions

Biotechnology patent guide

1. Assignment Enal Jain 12014 Msc. Part 1

Patentable and Non-Patentable
inventions
What is patent?
A patent is an exclusive right granted for an invention. In other
words, patent protection means that the invention cannot be commercially
made, used, distributed, imported, or sold by others without
the patent owner's consent. This grant provides the inventor exclusive
rights to the patented process, design, or invention for a designated period
in exchange for a comprehensive disclosure of the invention. They are a
form of incorporeal right. A patent is important because it can help
safeguard your invention. It can protect any product, design or process that
meets certain specifications according to its originality, practicality,
suitability, and utility. In most cases, a patent can protect an invention for
up to 20 years.
Patents expire because allowing them to last for too long places a
constraint on others who want to improve upon existing technology.
Current patent law allows inventors to recoup their investment and profit
from their invention without slowing down innovation. Eventually, patents
do expire. While a patent will remain in force for a period of time,
eventually it is considered to be no longer in effect. The patented invention
then becomes freely usable by others. Patent terms, if maintained
correctly, vary but generally go for up to 20 years. You can buy an expired
patent by performing a patent search through the USPTO website (more
on this later) and checking to see if the patent has expired. Once you find
a patent that has expired and you want to buy, you can go ahead and
contact the patent owner to negotiate purchasing the patent. The owner
of an abandoned patent application in the US can petition to have it
revived on the basis that the non-response causing the abandonment was

2. unintential. If it is not revived then you or anyone else could make, sell,
and import the invention. You can't file a patent that you think
are abandoned or expired.
Under U.S. patent law, you must file your patent application within one
year of the first offer to sell your invention, or within one year of your first
public use or disclosure of your invention.
Under U.S. patent law, an invention is patentable only if it meets the
following four requirements, which are discussed in more detail
below:
 The invention must be statutory (subject matter eligible)
 The invention must be new.
 The invention must be useful.
 The invention must be non-obvious

Who can apply for a patent in India?
An application for a Patent for an invention may be made by any of the
following persons either alone or jointly with any other person:

 The true and first inventor.
 True and first inventor‘s assignee.
 The legal representative of the deceased true and first inventor or
his/her assignee.



Patentable Inventions
Patentable subject matter
Under the Patent Act 1970, every invention must pass a two-step test in
order to be patentable – namely, it must not fall in any of the categories
specifically excluded under Section 3 of the Patent Act; and the well-known
three-pronged test of novelty, inventive step and industrial applicability.

3. Biotechnology inventions are important for human development. It is the
broad area of biology involving living systems and organisms to develop or
make products, or any technological application that uses biological
systems, living organisms, or derivatives thereof, to make or modify
products or processes for specific uses.

Thomas Jefferson the man behind the first Patent Act did not have even
slightest idea that the life forms can ever become a subject of Patent
protection. The most famous case of Diamond v Anand Chakrabarty where
a biochemist at GE developed a genetically modified organism that had the
ability to decompose crude oil. At first his patent application was rejected
which on further appeal was granted by the court with order stating "His
claim is not to a hitherto unknown natural phenomenon, but to a non-
naturally occurring manufacture or composition of matter-a product of
human ingenuity".




There are certain basic qualifying criteria for a patentable invention. The
invention must be:

i) Novelty
ii) Non-obvious (read inventive)
iii) Have industrial applicability
iv) Be an invention

i) Novelty
Inventions must be new. Sections 2(1)(l) and 2(1)(j) of the Patents Act
highlight the difference between a new invention and an invention. A ‘new
invention’ is defined as:
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 a patent application with complete specification, i.e., the
subject matter has not fallen in the public domain or that it does not form
part of the state of the art.
A thing may lack novelty if it is disclosed or made available in any shape or
form. Novelty may be lost if the thing is disclosed such that it is freely
accessible by anyone, whether or not someone actually accesses it. The

4. patent examination process will search public records pre-dating the filing
date of the patent for ANY reference that may include a description even
partially matching the contents of the patent.

Disclosures may be made in many different ways such as:

 A published paper or written article

 An abstract for a conference paper/poster sent to a conference
organiser

 A thesis on a shelf in a university library,the internet (eg web-site)
poster sessions at conferences ,an oral presentation (including
slides) at a conference/seminar

 Emails

 Informal conversation

 Providing a sample to someone

Some forms of communication may not be considered "disclosures", for
example:
 Speaking on site with colleagues/employees of the same organisation
as the inventor

 Meeting with others under circumstances of acknowledged
confidentiality (preferably in writing)

 Theses held under moratorium

 Submitted papers for publication and grant applications provided that
recipients and referees/reviewers are made aware of the need to
observe confidentiality.

ii) Non-obvious (read inventive)
Inventions must be inventive or "non-obvious". The patent must describe
an invention that is not obvious to a person "skilled in the art" from the
entire/collective body of publicly available knowledge ("prior art") existing at

5. the date the patent application was filed. This is usually the most
contentious issue in determining patentability. Technical advance means
some feature of the invention is having advancement which is technical in
nature as compared to the existing knowledge

iii) Have Industrial Applicability
This must be discernible from the patent application as filed, ie there must
be a clear utility for the invention, eg, to solve an existing problem, however
simple. 'Discernible' means more than mere speculation or guessing and in
certain jurisdictions, such as the USA, it is strongly advisable that an
industrial utility allegation in the description is backed up by experimental
work that points to that perceivable industrial utility.
Section2(1)(ac) capable of industrial application”, in relation to an invention,
means that the invention is capable of being made or used in an industry;

Industrial application means invention is capable of being made or used in
any kind of industry. This is also known as usefulness, a patented invention
should be able to be produced on a large scale that is it could be created,
used and repeated.

iv) Be an Invention
An idea, a discovery or an observation is NOT PATENTABLE by itself eg,
an explanation of what is happening in a particular chemical pathway is not
enough. Although an invention may be founded on a discovery, the
discovery itself is not patentable. A discovery may lead to a patentable
invention if the discovery is accompanied by a description of how the
discovery is used to form an invention that has a perceivable industrial
applicability. The employment of the discovery that forms the basis of the
invention must be clearly described. This is usually done in the examples
section of the patent application. Similar considerations apply to ideas for
inventions in as much as the idea has to be supported in the patent
application by work that shows that the idea has a technical rather than
merely theoretical basis. Patent Offices exclude mere ideas, discoveries
and various other items from patentability.

Biotechnology Patent and India
Patent Act in India was enacted in 1856. It has been modified several times
since then; one major amendment being in 1970 which satisfied the
international norms of patentability covering novelty, inventive step and

6. industrial application. But this version had nothing specific concerning
Biotechnology invention and protection. At the same time, since the patent
offices and courts in US and EU were seeing increasing number of biotech
inventions and patent application, the demand for amendment of Indian
Patent Act to introduce biotech patentability gained voice in India. The
amendment came in 2002 to explicitly include biochemical,
biotechnological and microbiological processes within the definition of
potentially patentable process.

Genetically modified multicellular organisms including plants, animals,
human beings and their parts are excluded from patentability in India.
Gene sequences and DNA sequences having disclosed functions are
considered patentable in India.

Why consider patenting?
As the world moves from an economy based on industry to one based on
information, protecting ideas becomes increasingly important. This follows
from the fact that ideas, when captured and passed on as information, can
be transferred from one place to another much more easily and quickly
than physical objects. It also follows from the fact that the economic value
of information is greatest when it relates to an idea, rather than a fact about
a physical object, such as a manufacturing plant or commercial product.
Because information about ideas is so valuable and so easy to obtain and
use, protecting ideas becomes a paramount concern.
There is still much debate about the relative merits of legally protecting
scientific discoveries and inventions versus their free and unencumbered
disclosure and use. On the one hand, legally protecting discoveries and
inventions through patents provides an incentive for researchers and
businesses to undertake scientific inquiry in the hopes of a financial benefit
in return. Likewise, when one inventor patents one solution to a particular
problem, it highlights that problem and provides an incentive for
competitors to find other solutions, thus bringing new products to the
market rapidly. On the other hand, permitting an inventor or company to
exclude others from making and using an invention can result in higher
costs for consumers or a delay in advances in a field covered by a patent

7. because of a lack of advancement by the patent holder. Of course,
regardless of the merits of a patenting system, one may always choose to
attempt to maintain an invention secret from the world in order to achieve
an advantage in the market. But such a strategy often backfires when the
secret is lost and others are able to use it without having to compensate the
original inventor. For companies, patenting is by far the more attractive
choice because it enables the companies to profit from the ideas of their
employees. In these times of tight budgets and financial accountability,
pursuing patent protection for scientific discoveries and inventions is also
important for academic researchers, as patents can generate prestige and
income for the institute and for individual researchers.

Patentable biotechnological inventions
 Methods for producing or analysing 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.
 An invention relating to plants and animals can be patented, if the
implementability of the invention is not limited to a certain plant
variety or animal breed. Even a microbiological procedure and
products of such a procedure, for example plants and animals, can
be patented.

 The Patent Offices treat transgenic plants and transgenic animals as
complex chemical compositions. For example, if the insertion of a
foreign gene into a known organism produces a novel and non-
obvious transgenic organism, then that organism is novel and
potentially patentable. Transgenic plants and animals are generally
claimed by reference to a parent plant or animal, and the new gene
which has been inserted into it.

8.  Medicines can be patented in the same way as any chemical product’

 DNA and proteins are treated by the Patent Offices as chemical
entities. If they are claimed in isolated or purified form, then that form
will be novel over the forms that are present in the organism from
which they are obtained. Patents may also be granted for artificial
DNA constructs such as cDNA and geneticallyengineered proteins.
The patent application must give details of the use of the new gene or
protein

 If the invention is based on the identification of a new gene or
polypeptide, then patent claims to vectors or plasmids comprising the
claimed genes and host cells comprising such vectors/plasmids will
generally be allowed in the same patent application.

 There are several ways to claim antibodies in patent applications:
these range from purely functional definitions based on the antibody’s
binding affinity, through to defining the complete heavy and light
chain amino acid sequences of the antibodies. Increasingly, the
Patent Offices are requiring more structural (i.e. sequence)
information in the patent claims as it becomes more recognised that
small changes to the antibody’s sequence can have profound effects
on its properties.

 If the new micro-organism is derived from a known one (for example,
a plant gene has been inserted into a known E. coli bacterium), then
a method of making the new micro-organism can probably
adequately be described − in words − in the patent application. An
example of a claim to such a bacterium is the following: 1. An E. coli
mutant which contains genes encoding proteins [X and Y], wherein
the mutant is capable of producing ethanol.

 Biotech inventions are often incorporated into medical devices and
hence, if appropriate, it is important to include a claim to such a
device in the patent application.

9. Policy Framework In India
To promote research and development in the field of biotechnology, the
government of India set up a dedicated Department of Biotechnology within
the Ministry of Science and Technology. The DBT has established a
“Biotechnology Patent Facilitation Cell (BPFC)” which is a single
window awareness-cum-facilitation mechanism aiming at creating
awareness and understanding about IPRs (especially patents) among the
scientists and researchers
15
.
The Ministry of Science and Technology has also issued the guidelines
called “Instructions for Technology Transfer and Intellectual Property
Rights” with a view to encourage intellectual property protection of
inventions done by scientists, research institutions and universities in
projects which are funded by the Department of Science and Technology,
Department of Biotechnology, Department of Scientific and Industrial
Research and Department of Ocean Development.
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One of the interesting
features of this guideline is that the owner institution(s) has been directed
to set aside at least 25% of the revenue generated from IPR, to create
a Patent Facilitating Fund. The fund shall be utilized by the owner for
updating inventions, filing new patent applications and protecting the IP
rights against infringement and for building competency in the area of IPR
and related issues. The 2019-20 interim budget saw an allocation of INR
5,321 crore to the Department of Science and Technology (of which, the
Department of Biotechnology is a part). This allocation is INR 207 crore
more than the allocation made in the 2018-19 Budget.

10. Non patentable 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.
Acts regarding non patentable biotechnological
inventions
 Section 3 (b) - . As per the section 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
 Discovery of living things or non- living substances in nature - Section
3 (c)
 Plants and animals in whole or any parts thereof other than micro-
organisms but including seeds, varieties and species - Section 3 (j)
Essentially biological processes for the production or propagation of plants
and animals– Section 3 (j)
 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 – Section 3(i)
 Methods of agriculture or horticulture – Section 3(h)
 Traditional knowledge – Section 3(p)

Section 3(b) – inventions contrary to public morality
Inventions for which the primary or intended use or commercial exploitation
is contrary to public order or morality or which cause serious prejudice to
human, animal or plant life or health or to the environment are
unpatentable. Examples include genetic modification of animals which

11. results in suffering of the modified animal without any substantial medical
or other benefit, and inventions causing adverse environmental impact.



Section 3(c) – discoveries, things isolated from nature, plants and animals
Discoveries of living things or non-living substances occurring in nature are
not patentable subject matter. Thus, micro-organisms isolated from nature
and DNA, RNA or proteins isolated from living organisms are unpatentable.
Although naturally occurring micro-organisms are unpatentable, genetically
modified micro-organisms and vaccines are patentable, subject to other
requirements. Synergistic compositions of new or known micro-organisms
can also be patentable, as can processes for isolating such substances

Section 3(d) – new forms or uses of known substance
A new form of a known substance is unpatentable unless it differs
significantly in properties with regard to the known efficacy. This provision
essentially prevents the evergreening of patents through trivial
modifications or incremental innovations. However, its interpretation has
been the source of polarising debate among legal professionals,
academics, non-governmental organisations and pharmaceutical
companies.

Section 3(i) – methods of treatment and diagnosis
The act does not prevent patenting of pharmaceuticals and medical
devices. Thus, medicinal compounds, drugs, formulations, stents, surgical
sutures and staplers are patentable. However, Section 3(i) precludes from
patentability any process for the medicinal, surgical, curative, prophylactic,
diagnostic, therapeutic or other treatment of human beings; or any
treatment of animals which renders them free of disease or increases their
economic value (or that of their products)

Section 3(e) – mere admixture
The mere admixture of two or more previously known substances is
unpatentable, unless it is shown that the combinative effect of such
substances is more than the sum of their individual effects. In other words,
such a combination should result in a synergistic effect. The synergism
must be properly demonstrated in the complete specification by providing
appropriate experimental data.

12. Section 3(h) – agricultural or horticultural methods
Methods of agriculture or horticulture are unpatentable. In
1785/KOLNP/2009 the IPO referred to the dictionary definition of both
terms and observed that agriculture and horticulture are processes
involving multiple steps, such as preparation of soil, sowing, applying
manure and fertilisers, irrigation, protection from pests and weeds,
harvesting and storage. The application claimed:

A method of combating harmful insects and/or phytopathogenic fungi,
which comprises contacting said harmful insects and/or phytopathogenic
fungi, their habit, breeding ground, food supply, plant, seed, soil, area,
material or environment in which the harmful insects and/or
phytopathogenic fungi are growing or may grow, or the materials, plants,
seeds, soils, surfaces or spaces to be protected from attack or infestation
by said harmful insects and/or phytopathogenic fungi with an effective
amount of an agrochemical formulation as claimed in any of claims 1 to 6.

Section 3(p) – traditional knowledge
An invention which is essentially traditional knowledge or which is an
aggregation or duplication of the known properties of a traditionally known
component or components is specifically excluded from patentability. India
has developed the Traditional Knowledge Digital Library (TKDL), providing
information on traditional knowledge in the country related to ayurveda,
unani, siddha and yoga. The database is designed to assist the major
patent offices around the world to carry out prior art searches.


Deposition of biological material
Under Section 10(4) and rule 13 (8)of the Patent Act, an applicant must
deposit the biological material mentioned in the specification if it is
unavailable to the public and cannot be described adequately as per the
provisions of the act. The material must be deposited with an international
depository authority under the Budapest Treaty.

The international depository authorities in India are the Microbial Culture
Collection, Pune and Microbial Type Culture Collection and Gene Bank,
Chandigarh. It is the duty of the applicant to give information w.r.t biological
material used in specification.

13. Time period - The deposit must be made no later than the filing date of the
patent application in India. Mentioning of the deposit must be made in the
specification within the prescribed period (i.e. three months from the filing
date).

Sequence listing
Sequence listing is the most important part of any bilological invention. It
pertains to the listing of nucleotides and amino acids. The details of
nucleotides and/or amino acids shall be filed in electronic form. However,
the fee with respect to the equivalent number of pages shall be payable. In
the case of Biotechnology related inventions, relevant numbers of the
sequence listing shall be mentioned at appropriate place in the
specification. Sequence listing should also be given in electronic form.

Why are biotechnology inventions difficult to patent?
Researchers who have biological inventions are often surprised by the
difficulties they encounter when trying to patent their inventions, compared
with the experience of their counterparts in the fields of electronics and
mechanics. These difficulties arise because a higher standard of scrutiny is
applied to inventions in biotechnology because they are more complex and
unpredictable (see below) [4]. For example, for patents including the
sequences of genes or proteins, the current policy of the US Patent and
Trademark Office is to require disclosure of "a representative number of
examples" of homologs, either from the same organism or from different
organisms, of the gene or protein before a patent generically covering it will
be issued [5]. Although the European Patent Office does not officially have
such a policy, in cases in which the essence of the invention is the
achievement of a technical effect, it is often necessary to provide a
sufficient number of examples to show that the effect can be achieved in
most - if not all - instances of the use of the invention in a particular field.
For example, if one wished to patent an antibody for use in detecting all
cancer cells, one would probably need to provide examples showing that
the antibody could detect a variety of different cancer cells, including solid
tumor cells, and lymphoma cells, and leukemia cells.

14. Patent offices invariably justify their higher standard of scrutiny for
biotechnology inventions by asserting that biological systems are complex
and unpredictable and that complex and unpredictable technologies should
require a greater amount of data and disclosure. Although this assertion
might be an inaccurate generalization, one must continually be mindful of
the policy before and during the patenting process in order to improve the
likelihood of obtaining a patent with commercial value.