Biotechnology patent guide

1. Assignment Enal Jain 12014 Msc. Part 1
Patentable and Non-Patentable
inventions
What is patent?
A patentis an exclusive right granted for an invention. In other
words, patentprotection means that the invention cannot be commercially
made, used, distributed, imported,or sold by others without
the patentowner'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 patentis important because it can help
safeguard your invention. It can protectany product, designor process that
meets certain specifications according to its originality, practicality,
suitability, and utility. In most cases,a patentcan protectan 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 patentwill remain in force for a period of time,
eventually it is considered to be no longer in effect.The patented invention
then becomes freelyusable by others. Patentterms, if maintained
correctly, vary but generally go forup to 20 years. You can buy an expired
patentby performing a patentsearch through the USPTO website (more
on this later) and checking to see if the patenthas expired.Once you find
a patentthat has expired and you want to buy, you can go ahead and
contact the patentowner to negotiate purchasingthe patent.The owner
of an abandoned patentapplication 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'tfile a patentthat you think
are abandoned or expired.
Under U.S. patentlaw, you must file your patentapplication within one
year of the first offerto sell your invention, or within one year of your first
public use or disclosure of your invention.
Under U.S. patentlaw, an invention is patentable only if it meets the
following four requirements,which are discussedin more detail
below:
 The invention must be statutory (subjectmatter 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 fora 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
specificallyexcluded under Section 3 of the Patent Act; and the well-known
three-pronged test of novelty, inventive step and industrial applicability.

3. Biotechnologyinventions are important for human development.It is the
broad area of biology involving living systems and organisms to develop or
make products,or any technologicalapplication that uses biological
systems,living organisms,or derivatives thereof, to make or modify
products or processes forspecificuses.
Thomas Jeffersonthe man behind the first Patent Act did not have even
slightest idea that the life forms can ever become a subjectof Patent
protection.The mostfamous case of Diamond v Anand Chakrabarty where
a biochemistat GE developeda genetically modified organism that had the
ability to decomposecrude 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 compositionof matter-a productof
human ingenuity".
There are certain basic qualifying criteria fora 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 differencebetweena new invention and an invention. A ‘new
invention’ is defined as:
any invention or technology which has not been anticipated by publication
in any documentor used in the country or elsewhere in the world before the
date of filing of a patent application with complete specification,i.e., the
subjectmatter 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 disclosedor made available in any shape or
form. Novelty may be lost if the thing is disclosed such that it is freely
accessibleby anyone, whether or not someone actually accessesit. The

4. patent examination process will search public records pre-dating the filing
date of the patent for ANY reference that may include a descriptioneven
partially matching the contents of the patent.
Disclosures may be made in many differentways such as:
 A published paper or written article
 An abstract for a conference paper/postersent to a conference
organiser
 A thesis on a shelf in a university library,the internet (eg web-site)
postersessions at conferences ,an oral presentation (including
slides)at a conference/seminar
 Emails
 Informal conversation
 Providing a sample to someone
Some forms of communicationmay not be considered "disclosures",for
example:
 Speaking on site with colleagues/employees ofthe 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/reviewersare 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 descriptionis 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 discoveryor 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
discoveryitself is not patentable. A discoverymay lead to a patentable
invention if the discoveryis accompanied by a descriptionof how the
discoveryis used to form an invention that has a perceivable industrial
applicability. The employmentof the discoverythat forms the basis of the
invention must be clearly described.This is usually done in the examples
sectionof 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 Officesexclude 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 severaltimes
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
Biotechnologyinvention and protection.At the same time, since the patent
officesand 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,
biotechnologicaland microbiologicalprocesseswithin the definition of
potentially patentable process.
Genetically modifiedmulticellular organisms including plants, animals,
human beings and their parts are excluded from patentability in India.
Gene sequencesand DNA sequences having disclosedfunctions are
considered patentable in India.
Why consider patenting?
As the world moves from an economybased 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 commercialproduct.
Because information about ideas is so valuable and so easy to obtain and
use, protecting ideas becomesa paramount concern.
There is still much debate about the relative merits of legally protecting
scientific discoveriesand 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 secretfrom the world in order to achieve
an advantage in the market. But such a strategy oftenbackfires when the
secretis 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 profitfrom the ideas of their
employees.In these times of tight budgets and financial accountability,
pursuing patent protectionfor 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 microbiologicalprocedure and
products of such a procedure,forexample plants and animals, can
be patented.
 The Patent Offices treat transgenic plants and transgenic animals as
complexchemical compositions.Forexample, if the insertion of a
foreigngene 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 presentin 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/plasmidswill
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 Officesare requiring more structural (i.e. sequence)
information in the patent claims as it becomesmore recognisedthat
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.
 Biotechinventions 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 developmentin the field of biotechnology,the
government of India set up a dedicated Departmentof Biotechnologywithin
the Ministry of Science and Technology.The DBT has established a
“BiotechnologyPatentFacilitation Cell (BPFC)” which is a single
window awareness-cum-facilitation mechanism aiming at creating
awareness and understanding about IPRs (especiallypatents) among the
scientists and researchers15
.
The Ministry of Science and Technologyhas also issued the guidelines
called “Instructions for TechnologyTransferand Intellectual Property
Rights” with a view to encourage intellectual propertyprotectionof
inventions done by scientists,research institutions and universities in
projects which are funded by the Department of Science and Technology,
Department of Biotechnology,Departmentof Scientific and Industrial
Researchand Department of Ocean Development.16
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 PatentFacilitating 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 competencyin the area of IPR
and related issues. The 2019-20 interim budget saw an allocation of INR
5,321 crore to the Departmentof Science and Technology (of which, the
Department of Biotechnologyis 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 discoveredbut not isolated or further
describedparts of animals, plants or microorganisms.
 Plant varieties and animal breeds.For a definition of plant variety,
see chapter 1, section3 of the Act on the Protectionof 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 biotechnologyand ethics.
Acts regarding non patentable biotechnological
inventions
 Section3 (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
 Discoveryof 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 - Section3 (j)
Essentially biological processes forthe productionor propagation of plants
and animals– Section 3 (j)
 Any Process forthe 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 – Section3(i)
 Methods of agriculture or horticulture – Section3(h)
 Traditional knowledge – Section 3(p)
Section3(b) – inventions contrary to public morality
Inventions for which the primary or intended use or commercialexploitation
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 modificationof animals which

11. results in suffering of the modifiedanimal without any substantial medical
or other benefit,and inventions causing adverse environmental impact.
Section3(c) – discoveries,things isolated from nature, plants and animals
Discoveries of living things or non-living substances occurring in nature are
not patentable subjectmatter. 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, subjectto other
requirements.Synergistic compositions of new or known micro-organisms
can also be patentable, as can processes forisolating such substances
Section3(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.
Section3(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)
Section3(e) – mere admixture
The mere admixture of two or more previously known substances is
unpatentable, unless it is shown that the combinative effectof 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 properlydemonstrated in the complete specificationby providing
appropriate experimental data.

12. Section3(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, protectionfrom pests and weeds,
harvesting and storage.The application claimed:
A method of combating harmful insects and/or phytopathogenic fungi,
which comprisescontacting 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 agrochemicalformulation as claimed in any of claims 1 to 6.
Section3(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
componentor components is specificallyexcluded 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 assistthe major
patent officesaround 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
depositthe biologicalmaterial mentioned in the specificationif it is
unavailable to the public and cannot be describedadequately as per the
provisions of the act. The material must be depositedwith an international
depositoryauthority under the BudapestTreaty.
The international depositoryauthorities in India are the Microbial Culture
Collection,Pune and Microbial Type Culture Collectionand 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 depositmust be made no later than the filing date of the
patent application in India. Mentioning of the depositmust be made in the
specificationwithin the prescribedperiod (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 respectto the equivalent number of pages shall be payable. In
the case of Biotechnologyrelated 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 biologicalinventions are oftensurprised 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 biotechnologybecause they are more complexand
unpredictable (see below) [4]. For example, for patents including the
sequences ofgenes 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 doesnot officiallyhave
such a policy, in cases in which the essence ofthe invention is the
achievement of a technical effect,it is oftennecessary to provide a
sufficientnumber of examples to show that the effectcan 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 detecta variety of differentcancer cells, including solid
tumor cells, and lymphoma cells, and leukemia cells.

14. Patent officesinvariably justify their higher standard of scrutiny for
biotechnologyinventions by asserting that biologicalsystems are complex
and unpredictable and that complexand 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 processin order to improve the
likelihood of obtaining a patent with commercialvalue.