Patenting and Biotechnology
Intellectual
property laws are complicated in the field of biotechnology patents. A biological or biotechnological patent is
given to an invention in the field of biology and it lawfully allows the patent
holder to exclude others from making, using, selling, or importing the
protected invention for a limited period of time. The scope and reach of
biological patents include biological technology and products, genetically
modified organisms, genetic material, etc, even though it vary among
jurisdictions. The patenting of substances or processes wholly or partially of
natural in origin is a subject of heavy debate.
A
few examples of patented biotechnological products and procedures that are
lifesaving are insulin, anti-cancer drugs, autoimmune
drugs, pasteurization, etc. It was in 1862, Louis Pasteur patented
pasteurization at the French Patent Office. Today this process is used
commercially by companies to improve shelf life of juice, beer, eggs, milk,
etc.
Patenting
scientific advancements in the field of biotechnology is an extremely
complicated process.
Biotechnology
patents fall under utility patents which is available for the invention or
discovery of a new and useful machine, manufacturing process, composition of
matter, or process or for improvements to an existing process that are
considered new and useful.
When
applying for a patent, the inventor must prove that their invention meets
certain eligibility requirements. In the United States, the US Patent &
Trademark Office set forth five elements for patentability. To qualify as a
patent, an invention must fall under subject-matter eligibility, have utility
and novelty, be non-obvious, and not have been previously disclosed.
In
Europe, the European Patent Office states the requisites as a patentable
invention can be a product, a process, or an apparatus and it “must be new,
industrially applicable, and involve an inventive step.”
In
Japan, the Japanese Patent Act requires that patented inventions must have
commercial potential. The “medical activities” such as methods of surgery,
therapy, and the diagnosis of human diseases cannot be patented.
In
India, Under the Patent Act 1970, every invention must pass a two-step test in
order to be patentable
1. It must not fall in any of the
categories specifically excluded under Section 3 of the Patent Act
2. It must pass the three-pronged test of
novelty, inventive step and industrial applicability.
These
are the category of nonpatentable inventions in India
(a) an invention which is frivolous or which
claims anything obviously contrary to well established natural laws
(b) an invention the primary or intended use
or commercial exploitation of which could be contrary public order or morality
or which causes serious prejudice to human, animal or plant life or health or
to the environment
(c) the mere discovery of a scientific
principle or the formulation of an abstract theory [or discovery of any living
thing or non-living substances occurring in nature
(d) the mere discovery of a new form of a
known substance which does not result in the enhancement of the known efficacy
of that substance or the mere discovery of any new property or new use for a
known substance or of the mere use of a known process, machine or apparatus
unless such known process results in a new product or employs at least one new
reactant. Explanation. -For the purposes of this clause, salts, esters, ethers,
polymorphs, metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives of known substance shall
be considered to be the same substance, unless they differ significantly in
properties with regard to efficacy
(e) a substance obtained by a mere admixture
resulting only in the aggregation of the properties of the components thereof
or a process for producing such substance
(f) the mere arrangement or re-arrangement
or duplication of known devices each functioning independently of one another
in a known way
(h) a method of agriculture or horticulture
(i) any process for the medicinal, surgical,
curative, prophylactic [diagnostic, therapeutic] or other treatment of human
beings or any process for a similar treatment of animals to render them free of
disease or to increase their economic value or that of their products
(j) 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
(k) a mathematical or business method or a computer programe per se or algorithms
(l) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions
(m) a mere scheme or rule or method of
performing mental act or method of playing game
(n) a presentation of information
(o) topography of integrated circuits
(p) an invention which in effect, is
traditional knowledge or which is an aggregation or duplication of known
properties of traditionally known component or components
Among
these, the following are the excluded biotechnology-related inventions,
Section
3(b) – inventions contrary to public morality
Section
3(c) – discoveries, things isolated from nature, plants and animals
Section
3(d) – new forms or uses of known substance
Section
3(e) – mere admixture
Section
3(i) – methods of treatment and diagnosis
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
Section
3(h) – agricultural or horticultural methods
Section 3 (k) - Computer programs per se and algorithms, mathematical methods
Section
3(p) – traditional knowledge
....................................................................................................................................................................
Other than
section 3, the following sections of the Patents Act, 1970 are also emphasised
in the context of patents in biotechnology and allied fields:
·
Section 2 (1) (j): Novelty, inventive step &
industrial applicability of products or processes,
·
Section 10 (4): Sufficiency of disclosure and
the best method of performing the invention
·
Section 10 (5): Unity of invention and clarity,
succinctness and support of the claims
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 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. The act was amended
in 2002 and “biochemical, biotechnological and microbiological processes” are
potentially patentable chemical processes.
Plants
and animals or their parts – including seeds, varieties and species – are
unpatentable. Biological processes for the production of plants or animals (plant
breeding and tissue culture techniques) are also unpatentable.
Although
genetically modified plants or seeds are not patentable in India, processes for
the genetic modification of plants are patentable. A sui generis system for protection for plant
varieties is available under the Protection of Plant Varieties and Farmers’
Rights Act 2001.
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.
A
mere change of form of a chemical substance with properties inherent to that
form would not qualify as enhancement of efficacy of a known substance. Physico-chemical properties such as better
flowability, processability, thermodynamic stability and lower hygroscopicity
have nothing to do with therapeutic efficacy.
The
mere discovery of any new property or new use of a known substance is also
unpatentable. Therefore, a second therapeutic effect of a known drug is
unpatentable. In Monsanto (2013) a claim for a method of producing heat, salt
and drought-tolerant transgenic plants using cold shock protein was rejected
under Section 3(d), since the cold-tolerant property of cold shock protein was
already known in the art.
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 and the synergism must be properly demonstrated by
providing experimental data.
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(i) unpatentable subject matter examples
·
Medicinal methods - A process of
administering medicines orally, through injection, topically or through a dermal
patch.
·
Surgical methods - A stitch-free incision
for cataract removal.
·
Curative methods - A method of cleaning
plaque from teeth.
·
Prophylactic methods - A method of
vaccination.
·
Diagnostic methods - Identification of the
nature of a medical illness by investigating its history and symptoms and
applying tests.
·
Therapeutic methods - Prevention and
treatment or cure of diseases.
·
Methods of treatment to render animals
free of disease or increase their economic value (or that of their products) - A
method of treating sheep for increasing wool yield.
The
cosmetic application of substances to the body, methods of operating a medical
device and the manufacture of artificial prostheses and taking measurements
thereof are potentially patentable. Diagnostic methods practised on a living
body are unpatentable; however, diagnostic methods carried out on tissues,
cells or biological fluid completely removed from the body can be patentable.
Dosage
forms, modes of administering medicine or kits designed for the treatment of a
disease that comprise nothing more than a dosage pattern are unpatentable.
Section 3(h) – agricultural or
horticultural methods
Methods
of agriculture or horticulture are unpatentable. 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.
For
example, a method of reducing mycotoxin contamination of a plant or harvested
plant material that involved treatment of seeds with the chemicals before
sowing or during sowing in the field for the plant cultivation process is
unpatentable.
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 India’s traditional knowledge in the country related to ayurveda, unani, siddha and yoga. The database is available in five languages (English, German, French, Japanese and Spanish) and assist the major patent offices around the world to carry out prior art searches.
References
https://www.wipo.int/patents/en/topics/biotechnology.html
https://www.iam-media.com/patenting-biotechnology-indian-scenario
https://indiankanoon.org/doc/874310/
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