Patenting: Basics and history

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

IP Type	Protects	Typical Microbiology Example
Patent	New inventions (products/processes)	A novel genetically modified bacterial strain or fermentation process
Copyright	Original literary/artistic expression	A published research paper or lab manual
Trademark	Brand names, logos, symbols	A branded probiotic supplement name
Trade Secret	Confidential business information	An undisclosed growth medium formula
Plant Variety Protection	New plant varieties	A genetically improved crop variety

 

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.

Criteria	Legal Meaning	Example in Microbiology
1. Novelty	The invention must be entirely new - not published, publicly displayed, or commercially used anywhere in world prior to filing date (no prior art).	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.
2. Inventive Step (Non-Obviousness)	The invention must have a feature that would not be obvious to a Person Having Ordinary Skill in the Art.	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.
3. Industrial Applicability (Utility)	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.
4. Sufficiency of Disclosure (Enablement)	Must describe the invention clearly enough for another skilled person to replicate it.	Written description alone is insufficient for a living organism, hence deposition of the strain in a cultural repository to be done.

 

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	Milestone
1474	Venetian Patent Statute — world's first patent system
1623	Statute of Monopolies (UK) — restricts patents to new manufactures
1790	US Patent Act — novelty & utility examination established
1873	Pasteur's yeast patent — an anomaly under the Product of Nature era
1970	Indian Patents Act — process patents only for food/drugs/chemicals
1977	Budapest Treaty — international deposit system for microorganisms
1980	Diamond v. Chakrabarty — living, man-made microorganisms ruled patentable
1994	TRIPS Agreement — WTO members required to protect microorganism patents
2002/2005	India amends Patents Act to comply with TRIPS
2013	AMP v. Myriad Genetics — isolated natural DNA - unpatentable

 

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)

Region	Depository Authority
USA	American Type Culture Collection (ATCC)
Germany	DSMZ (Deutsche Sammlung von Mikroorganismen und Zellkulturen)
UK	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

 

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.