Patenting: Basics and history
Intellectual Property (IP) refers to
creations of human intellect (inventions, literary and artistic works, designs,
symbols, etc.) for which law grants exclusive rights to creator or owner,
usually for a defined period of time.
In life sciences, IP allows a
research input (often years of work and large amount of money) to be recovered
commercially.
In microbiology, IP protection
secures commercial and research rights of scientists and institutions on:
- Engineered microbial strains
- Industrial fermentation protocols and
bioprocess optimisations
- Diagnostic kits based on antigens or
nucleic acid probes
- Novel biological compounds —
antibiotics, enzymes, biosurfactants, vaccines
The Main Categories of Intellectual
Property
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IP Type
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Protects
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Typical Microbiology Example
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Patent
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New inventions (products/processes)
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A novel genetically modified
bacterial strain or fermentation process
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Copyright
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Original literary/artistic
expression
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A published research paper or lab
manual
|
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Trademark
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Brand names, logos, symbols
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A branded probiotic supplement name
|
|
Trade Secret
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Confidential business information
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An undisclosed growth medium
formula
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Plant Variety Protection
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New plant varieties
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A genetically improved crop variety
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Patent
A patent is an exclusive right
granted by a sovereign government to an inventor for a limited period (typically
20 years from the date of filing). During this period, third parties cannot
make, use, or sell the patented product or process without the consent of the
patent holder.
A patent granted in one country
(e.g., India) is valid only within that country's jurisdiction. An inventor
wanting protection in multiple countries must file separately in each or apply
in multiple countries as per the Patent Cooperation Treaty.
To qualify for a patent, any
biological invention or microbiological process must fulfil three legal
requirements, and also it is to be fully disclosed in the patent application.
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Criteria
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Legal Meaning
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Example in Microbiology
|
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1. Novelty
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The invention must be entirely new -
not published, publicly displayed, or commercially used anywhere in world
prior to filing date (no prior art).
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A wild-type soil bacterium isolated
directly from nature - NOT novel.
A genetically altered microbe
carrying a foreign plasmid which provides it a new metabolic activity - novel.
|
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2. Inventive Step (Non-Obviousness)
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The invention must have a feature
that would not be obvious to a Person Having Ordinary Skill in the Art.
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Merely mixing different media
components in a known fermentation technique is obvious.
Engineering a novel synthetic
promoter that raises antibiotic yield ten-fold is non-obvious.
|
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3. Industrial Applicability
(Utility)
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The invention must be capable of
being made or used in an industry and must produce a tangible, practical
utility.
|
A modified bacterial strain must
serve a practical function such as bioremediation, toxin degradation, or
therapeutic protein expression.
Just serving and satisfying
academic curiosity not enough.
|
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4. Sufficiency of Disclosure
(Enablement)
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Must describe the invention clearly
enough for another skilled person to replicate it.
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Written description alone is
insufficient for a living organism, hence deposition of the strain in a
cultural repository to be done.
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History of Patent Law
Venetian Patent Statute (1474): The
world’s first official patent system. It gave inventors in Venice exclusive
rights to inventions.
Statute of Monopolies (1623,
England): As per this, the King was stopped from handing out unfair monopolies.
It limited giving patents only to true original creations.
US Patent Act (1790): Set up
America's patent review system, stating that inventions must be both new and
useful. This model became the blueprint for modern patent offices around the
world.
History of Patents in Microbiology
For over a century, patent offices
around the world operated under the Product of Nature doctrine. Product of
Nature doctrine states that living organisms are products of nature and cannot
be patented. Only human-made machines, chemicals, and mechanical processes were
considered eligible for protection as a patent.
Louis Pasteur (1873): US Patent No. 141,072 was granted
to Louis Pasteur for an 'Improvement in Brewing Beer and Ale'. This patent
included a claim on a living yeast culture free from harmful germs. Even though
he was granted a patent on a living organism, patent offices treated this as a
rare exception. For the next hundred years, patents on living things remained rejected.
Patents were granted for
microbiological processes (for example - fermentation method for producing
penicillin) and for purified microbial metabolites (such as an isolated
antibiotic compound), but not for the living microorganisms. The organism was
treated as a natural entity, only the man-made process built around it, or the
purified chemical extracted from it, was patentable.
As genetic engineering techniques
advanced in 1970s, scientists began creating microorganisms having significant
industrial value, but did not exist previously in nature.
|
Year
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Milestone
|
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1474
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Venetian Patent Statute — world's
first patent system
|
|
1623
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Statute of Monopolies (UK) —
restricts patents to new manufactures
|
|
1790
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US Patent Act — novelty &
utility examination established
|
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1873
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Pasteur's yeast patent — an anomaly
under the Product of Nature era
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1970
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Indian Patents Act — process
patents only for food/drugs/chemicals
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1977
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Budapest Treaty — international
deposit system for microorganisms
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1980
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Diamond v. Chakrabarty — living,
man-made microorganisms ruled patentable
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1994
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TRIPS Agreement — WTO members
required to protect microorganism patents
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2002/2005
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India amends Patents Act to comply
with TRIPS
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2013
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AMP v. Myriad Genetics — isolated
natural DNA - unpatentable
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Two biotechnological inventions and
court decisions on these became landmarks on patenting life.
1. In 1972, Dr. Ananda Mohan
Chakrabarty, who was a microbiologist working at General Electric at USA, filed
a patent application for a novel, genetically engineered bacterium derived from
Pseudomonas putida. This bacterium carried multiple plasmids encoding
catabolic (breakdown) pathways for distinct components of crude oil (camphor,
octane, xylene, and naphthalene). This
engineered bacterium was capable of using crude oil as a nutrient, making it
useful for cleaning up oil spills through bioremediation. The US Patent and Trademark Office (USPTO)
examiner was willing to allow two categories of claims: the process used to
produce the bacteria and the combination of an inert carrier material together
with the bacteria, but they rejected the claim on the bacterium itself, since microorganisms
are products of nature and thus a non-patentable subject matter. Chakrabarty appealed, and in 1980, the US
Supreme Court ruled in Chakrabarty's favour and stated that patentable subject
matter includes anything under the sun made by man. The bacterium in question was not a naturally
occurring organism but a product of human ingenuity, possessing a distinctive character
and use different from anything found in nature.
This ruling opened the door to the modern
biotechnology industry - recombinant organisms, engineered cell lines, and
genetically modified plants and animals are all now patentable.
2. Myriad Genetics in US, isolated the
BRCA1 and BRCA2 genes (linked to high risks for breast and ovarian cancer) and
secured US patents covering the isolated DNA sequences. When a coalition led by
the Association for Molecular Pathology (AMP) challenged these patents, the US
Supreme Court rejected the patent. Court
ruled a firm boundary between discovering a natural product and creating a true
human invention. The Court ruled in 2013 that simply isolating naturally
occurring human DNA from the genome does not make it patentable. Because the
genetic code itself remains unchanged, isolated BRCA1 and BRCA2 genes are
unpatentable as they are products of nature.
So, in simpler terms, isolating a
wild bacterium, or a wild-type gene, from an environmental sample without any
genetic modification does not make it patentable — it remains a product of
nature. However, complementary DNA (cDNA), synthetic gene constructs, and other
laboratory-modified sequences remain patentable, because they involve human
intervention.
Key International Treaties Governing
Biological Patents
WIPO - The World Intellectual
Property Organisation (WIPO) is the United Nations agency that serves the
world’s innovators and creators, ensuring that their ideas are protected and
reach the market and improve lives everywhere.
It officially began operations on April 26, 1970 and headquarters is
located in Geneva, Switzerland.
The World Trade Organization (WTO) is
the only global group that handles rules for trade between countries. It
started on January 1, 1995, and located in Geneva, Switzerland.
The WTO and WIPO work together to
manage global rules for intellectual property, such as patents and copyrights,
linked with international trade. While WIPO focuses on promoting intellectual
property protection globally, WTO enforces trade rules via the TRIPS Agreement.
1. The Budapest Treaty (1977)
Budapest Treaty is on the
International Recognition of Deposit of Microorganisms for Patent Procedure. Patent law requires that written disclosure should
be clear and complete enough for a person skilled in the art to reproduce the
invention. However, complex living microorganisms cannot always be fully
reproduced from a written description alone.
The Budapest Treaty allows a patent applicant to deposit a live culture
of the microorganism with an officially recognised culture collection, known as
an International Depository Authority (IDA), to satisfy the disclosure
requirement.
Key International Depository
Authorities (IDAs)
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Region
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Depository Authority
|
|
USA
|
American Type Culture Collection
(ATCC)
|
|
Germany
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DSMZ (Deutsche Sammlung von
Mikroorganismen und Zellkulturen)
|
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UK
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ECACC (European Collection of
Authenticated Cell Cultures)
|
|
India
|
MTCC — Microbial Type Culture
Collection and Gene Bank, Chandigarh
|
|
India
|
MCC / NCMR — Microbial Culture
Collection / National Centre for Microbial Resource, Pune
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2. The TRIPS Agreement (1994)
Agreement on Trade-Related Aspects of
Intellectual Property Rights, administered by the World Trade Organisation
(WTO).
Article 27.3(b) of TRIPS outlines
what member countries can and cannot exclude from patent protection regarding
living things. Countries can exclude plants
and animals and biological processes like traditional plant breeding or
cross-breeding. Countries must mandatorily allow patenting of Microorganisms
(e.g., bacteria, fungi, viruses) and microbiological and non-biological
processes (e.g., lab-engineered fermentation or genetic modification
techniques).
To belong to the WTO, a country had
to accept TRIPS. This forced member
nations, especially developing countries like India, to update their laws to
allow patents on microorganisms and microbiological processes, even if their
previous laws banned living patents entirely. TRIPS is the legal driver under
which India amended the Patents Act in 2002 and 2005.
3. The Paris Convention & PCT
(Patent Cooperation Treaty) administered by WIPO
This provided a procedural framework
for international patent filing. Paris
Convention (1883) provides the "Right of Priority," allowing
inventors 12 months after their first filing to apply in other countries while
locking in the original filing date. PCT
(1970) allowed a single "international application" to seek patent
protection simultaneously in over 150 countries.
4. The UPOV Convention (1961, revised
1991) by the International Union for the Protection of New Varieties of Plants
(UPOV)
As per this, plant varieties are
protected via Plant Breeders' Rights (PBRs / sui generis systems) rather
than standard utility patents and require the plant variety to be New,
Distinct, Uniform, and Stable.
5. Convention on Biological Diversity
(CBD, 1992) & Nagoya Protocol (2010) by United Nations Environment
Programme (UNEP)
CBD regulates access to natural
biological resources and prevents Biopiracy.
Researchers must get permission from the source country before
collecting biological material, and there should be mandatory fair sharing of
commercial/monetary benefits resulting from genetic resources or traditional
knowledge.
Patenting Framework in India (The
Indian Patents Act, 1970)
Indian Patents Act, 1970 allowed only
process patents for food, drugs, and chemicals. This was designed to encourage
a strong domestic generic drug industry by preventing foreign multinationals
from obtaining product-level monopolies on medicines in India. Product patents
for biologicals were excluded. Subsequent
amendments were driven by India's obligations under the WTO-TRIPS Agreement,
which India joined in 1995:
2002 Amendment: Introduced the
patentability of microorganisms, effective 20 May 2003.
2005 Amendment: Introduced product
patent protection across all fields of technology, including biotechnology and
pharmaceuticals.
Non-Patentables - Section 3 of the
Indian Patents Act
Under Section 3 of the Indian Patents
Act, 1970, the law lists non-patentable inventions. Even if an innovation is
new, non-obvious, and useful, it cannot be granted a patent if it falls under
any of Section 3. Key subsections
relevant to microbiology, biotechnology, and biological sciences are listed
below
Section 3(b) - Contrary to Public
Order or Morality
"An invention the primary or
intended use or commercial exploitation of which could be contrary to public
order or morality or which causes serious prejudice to human, animal or plant
life or health or to the environment."
Excludes inventions that cause
serious prejudice to human, animal, or plant life or health, or to the
environment (e.g., human cloning, dangerous biological weapons, or unsafe
genetically modified microbes designed for environmental release)
Section 3(c) — Products of Nature
& Mere Discoveries
"The mere discovery of a
scientific principle or the formulation of an abstract theory or discovery of
any living thing or non-living substance occurring in nature."
You cannot patent something that
already exists in nature just because you found it first; mere discovery does
not qualify for a patent.
A wild-type bacterial strain isolated
directly from soil or water. Naturally occurring genes, plasmids, or viruses in
their wild state are non patentable but, Genetically modified, engineered, or
novel mutated strains are patentable.
Section 3(d) — Mere Discovery of New
Forms / Derivatives
"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..."
Modifying a known molecule or
biological compound (e.g., making a salt, polymorph, isomer, or derivative) is
not patentable unless you prove a significant increase in efficacy (usually
therapeutic efficacy).
Prevents "evergreening" of
patents on known microbial metabolites, antibiotics, or secondary metabolites
without proof of superior performance.
This provision became globally famous
through the Novartis Vs Union of India litigation concerning the cancer drug
imatinib/Glivec, where the Supreme Court of India denied a patent because the
new crystalline form did not show enhanced therapeutic efficacy.
Section 3(e) — Mere Admixtures
"A substance obtained by a mere
admixture resulting only in the aggregation of the properties of the components
thereof..."
Simply mixing two or more known
ingredients is not patentable if the result is just the sum of its parts.
A microbial consortium (biofertilizer
or biopesticide mix) combining known strains is unpatentable unless you
demonstrate a synergistic effect.
Section 3(i) — Diagnostic and
Medicinal Treatment Methods
"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..."
Methods of medical diagnosis,
therapy, or surgical procedures performed directly on the human or animal body
cannot be patented. A method for diagnosing a bacterial infection directly in a
patient is non-patentable, but diagnostic kits, reagents, primers, synthetic
probes, or in vitro assay compositions used outside the body are patentable.
Section 3(j) — Plants, Animals, and
Essential Biological Processes
"Plants and animals in whole or
any part thereof other than microorganisms but including seeds, varieties and
species and essentially biological processes for production or propagation of
plants and animals."
Whole plants, animals, seeds, tissue
cultures, and traditional cross-breeding techniques are barred from standard
patent protection, but Microorganisms are patentable.
Transgenic plants or animals, plant
seeds, cell cultures of whole plants/animals, or traditional selective breeding
steps are non-patentable
Microorganisms (bacteria, microalgae,
yeasts, fungi) and microbiological processes (e.g., optimized industrial
fermentation protocols) are patentable.
Section 3(p) — Traditional Knowledge
"An invention which in effect is
traditional knowledge or which is an aggregation or duplication of known
properties of traditionally known component or components."
Traditional Indian remedies, herbal
formulations, or traditional fermented food knowledge cannot be patented. Formulations or fermentation processes long
documented in traditional texts (e.g., ayurvedic preparations or traditional
fermented foods) are non-patentable.
Indian law additional requirements apart
from the above-mentioned Section 3 restrictions. These are
1. Disclosure & Budapest Deposit
Section 10(4) - biological strains must be deposited at an International
Depository Authority (IDA) on or before the filing date.
2. Mandatory Origin Disclosure - The
patent specification must state the source and geographical origin of any
biological material used.
3. Biodiversity Compliance (Biological
Diversity Act 2002) - Patent applicants using Indian biological resources must
abide by the National Biodiversity Authority (NBA) for approval and satisfy
Access & Benefit Sharing rules.
Patent Application Process for
Microbiological Inventions
Filing a patent on a microbiological
invention follows the general patent prosecution process, with the crucial
addition of a strain deposit step.
Step 1: Invention & strain characterisation
Step 2: Deposition of the Strain in
an IDA
Step 3: Drafting the patent specification
- Provisional Specification — An optional initial filing and Complete
Specification within the statutory period of 12 months, with a detailed
technical description.
Step 4: Filing - National Route - Filing
directly with a single national patent office or the International Route (PCT)
- Filing via the Patent Cooperation Treaty to file one international
application in any of the 150+ countries.
Step 5: Examination, objections,
responses
Step 6: Grant for a term of 20 years
from the filing date.
Product Patents vs Process Patents
Product Patent: Protects the
invention itself, which might be the physical entity, such as a compound,
composition, device, or a specific genetically modified organism or cell line.
A product patent gives the broadest possible protection, because it covers the
product no matter how it is made. Even
if a third party later invents a completely different manufacturing route to
the same product, the product patent exists.
Process Patent: Protects only the
specific method or technique used to manufacture a product, not the resulting
product itself. If a third party can independently develop a different process
that arrives at the same end product, they do not infringe a process patent.
Biopiracy
Biopiracy is the appropriation,
patenting, or commercial exploitation of biological resources (plants,
microorganisms, genetic material) and/or the associated traditional knowledge
of indigenous or local communities. This
is typically done by foreign corporations or researchers, without adequate
consent, acknowledgement, or fair benefit-sharing with the communities or
countries of origin.
Biopiracy Controversies
1. Turmeric (Curcuma longa) Patent Case
(US Patent, 1995): The University of Mississippi Medical Centre was granted a
US patent on turmeric powder for wound healing. India's Council of Scientific
and Industrial Research (CSIR) challenged the patent, presenting ancient
Sanskrit texts and traditional Ayurvedic references documenting this use for
centuries. The US PTO revoked the patent in 1997.
2. Neem (Azadirachta indica)
Patent Case (European Patent, 1994): The European Patent Office granted a
patent for controlling fungal infections using neem oil. India opposed the
patent, showing that antifungal and pesticidal properties by Neem is part of
traditional Indian knowledge and centuries. European Patent Office revoked the
patent in 2005.
3. Basmati Rice Patent Case (US Patent,
1997): A US company was granted a patent covering rice grains that referenced
characteristics that are closely associated with basmati rice. India objected that
basmati's characteristics were the product of traditional and geographically
specific cultivation.
In direct response to cases like the
turmeric and neem patents, India established the Traditional Knowledge Digital
Library (TKDL) in 2001. This was a
collaborative project between the Council of Scientific and Industrial Research
(CSIR) and the Ministry of AYUSH (Ayurveda, Yoga, Unani, Siddha, Homoeopathy). TKDL systematically documents traditional
medicinal knowledge on Ayurveda, Unani, Siddha, and Yoga in digital format and
translated into five international languages (English, French, German,
Japanese, and Spanish). So, the TKDL is
made available to major patent offices so that examiners can check whether a
claim is already documented as traditional knowledge
References
https://www.wipo.int/treaties/en/ip/plt/
https://www.wipo.int/treaties/en/ip/tlt/
Yadav, M., Meenu, M., Sehrawat, N., & Sharma, A.
K. (2019). Intellectual property rights in microbiology. In H. B. Singh, A.
Jha, & C. Keswani (Eds.), Intellectual Property Issues in
Microbiology (pp. 79–93). Springer Nature Singapore.
Jeyaprakash, K. (2016). Intellectual property rights –
Role in biotechnology. International Journal of Current Microbiology and
Applied Sciences, Special Issue-3, 39–43.
