Probiotics Patent trends in Food Tech Sector in India| International Patent Classification (IPC) for Probiotic Related Inventions

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PROBIOTICS
PATENTING TRENDS
IN INDIA

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PROBIOTICS PATENTING
TRENDS IN INDIA

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Probiotic literally means “for life.” The Joint
Food and Agriculture Organization/World Health
Organization defines probiotics as “live
microorganisms which, when administered in
adequate amounts, confer a health benefit on the
host.”
WHAT ARE
PROBIOTICS ?

Probiotics have been shown to have beneficial effects against various
diseases and disorders, most common are:
• Gastrointestinal disorders
• Allergies- Skin, respiratory, food
• Cardiovascular diseases
• Metabolic disorders like Diabetes
• Obesity and overweight
• Urinogenital infections
• Kidney disorders
• Neurological disorders.
BENEFITS Of
PROBIOTICS

DEVELOPMENT OF
MUCOSAL
BARRIER
PRODUCTION OF
SHORT-CHAIN
FATTY ACIDS
METABOLISM OF
BILE ACIDS
REDUCTION OF pH
IN LARGE BOWEL
SYNTHESIS OF
VITAMINS
IMMUNE SYSTEM
ACTIVATION
PROBIOTICS
BENEFITS

Fermented products with live organisms
have existed for centuries and were
developed because of the need to extend
the shelf-life of common and precious
commodities like dairy and became one of
the oldest forms of preservation.
HISTORY OF
PROBIOTICS

The ability of beneficial bacteria to transform
milk into a longer lasting food was recorded as
far back as 6,000 years ago. Long before the
existence of microorganisms was even known or
recognized, fermented products were used
therapeutically, to treat colds, fevers, and
ailments of the gastrointestinal tract such as
constipation and diarrhea.
HISTORY OF
PROBIOTICS

Russian scientist and Nobel laureate Élie Metchnikoff,
beginning of the 20th century suggested that it would be
possible to modify the gut flora and to replace harmful
microbes with useful microbes. Metchnikoff, at that time a
professor at the Pasteur Institute in Paris, proposed the
hypothesis that the ageing process results for the activity
of putrefactive (proteolytic) microbes producing toxic
substances (phenols, ammonia) in the large bowel.
HISTORY OF
PROBIOTICS

According to Metchnikoff, these compounds were
responsible for what he called "intestinal auto-
intoxication", which caused the physical changes
associated with old age.
HISTORY OF
PROBIOTICS

Milk Fermented with lactic-acid bacteria
inhibited the growth of proteolytic bacteria
because of the low pH produced by the
fermentation of lactose. Metchnikoff had also
observed that certain rural populations in
Europe, for example, in Bulgaria and the
Russian steppes who lived largely on milk
fermented by lactic-acid bacteria were
exceptionally long lived.
HISTORY OF
PROBIOTICS

Metchnikoff proposed that consumption of
fermented milk would "seed" the intestine with
harmless lactic-acid bacteria and decrease the
intestinal pH and that this would suppress the
growth of proteolytic bacteria. Metchnikoff
himself introduced in his diet sour
milk fermented with the bacteria he called
"Bulgarian Bacillus" and found his health
benefited.
HISTORY OF
PROBIOTICS

● Persian tradition asserts that the biblical patriarch Abraham owed
his longevity to a diet of fermented milk.
● Later, Tissier found that bifidobacteria are dominant in the gut
flora of breast-fed babies and he observed clinical benefits from
treating diarrhea in infants with bifidobacteria. The claimed effect
was bifidobacterial displacement of proteolytic bacteria causing the
disease.
HISTORY OF
PROBIOTICS

● During an outbreak of shigellosis in 1917, German professor Alfred Nissle
isolated a strain of E. coli from the feces of a soldier who was not affected
by the disease. Nissle used the Escherichia coli Nissle 1917 strain in acute
gastrointestinal infectious Salmonellosis and Shigellosis.
● In 1920, Rettger demonstrated that Metchnikoff's "Bulgarian Bacillus",
later called Lactobacillus delbrueckii subsp. bulgaricus, could not live in
the human intestine. Metchnikoff's theory was disputable (at this stage) and
people doubted his theory of longevity.
HISTORY OF
PROBIOTICS

● After Metchnikoff's death in 1916, the centre of activity moved to the
United States. It was reasoned that bacteria originating from the gut
were more likely to produce the desired effect in the gut, and in 1935
certain strains of Lactobacillus acidophilus were found to be very
active when implanted in the human digestive tract.
● In early 1930’s, in Japan, Minoru Shirota a researcher at the
Faculty of Medicine at Kyoto University developed a fermented milk
product called Yakult.
HISTORY OF
PROBIOTICS

● The term "probiotics" was first introduced in 1953 by Werner
Kollath. Contrasting antibiotics, probiotics were defined as microbially
derived factors that stimulate the growth of other microorganisms. In
1989, Roy Fuller suggested a definition of probiotics that has been
widely used: "A live microbial feed supplement which beneficially
affects the host animal by improving its intestinal microbial
balance". Fuller's definition emphasizes the requirement of viability for
probiotics and introduces the aspect of a beneficial effect on the host.
HISTORY OF
PROBIOTICS

In the following decades,
intestinal lactic acid bacterial
species with purported health
beneficial properties have been
introduced as probiotics,
including Lactobacillus
rhamnosus, Lactobacillus casei,
and Lactobacillus johnsonii.
HISTORY OF
PROBIOTICS
Lactobacillus johnsonii

Inventions in the field of probiotics include-
❖ Method for isolating/extracting/conditioning/modifying live
micro-organisms including various strains of bacteria and
yeast
❖ New strains of bacteria and yeast
❖ Compositions/formulations/products comprising micro-
organisms
❖ Use of probiotics
PATENTABLE
SUBJECT MATTER

CRITERIA FOR
PATENTABILITY
The relevant sections of the Patent Act applicable for
ascertaining patentability of probiotic related
invention are:
Section 3(c): 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.

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Section 3(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 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.
CRITERIA FOR
PATENTABILITY

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CRITERIA FOR
PATENTABILITY
Section 3(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;

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CRITERIA FOR
PATENTABILITY
Section 3(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;

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CRITERIA FOR
PATENTABILITY
Section 3(p): an invention which, in effect, is
traditional knowledge of which is an aggregation or
duplication of known properties of additionally known
component or components.

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PROBIOTIC PRODUCTS
AVAILABLE IN INDIA

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PROBIOTICS – AN INDIAN
SCENARIO
Within the functional foods, probiotics is the rapidly expanding, active
arena. In probiotic revolution, India can play a key role as being the
largest producer of milk and having world’s highest cattle
population. Indian probiotic industry is in its infancy stage and presently
accounts for only a small fraction i.e. less than 1% of the total world
market turnover in the probiotic industry. But Probiotic industry is
evolving at a steady pace with conditions set for tremendous growth in
near future.

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SCENARIO
India is emerging as a major probiotic market of the future with annual growth
rate of 22.6% until 2015 with a handful of players in Indian probiotic industry
are Amul, Mother Dairy, Yakult Danone and Nestle along with other minor
players operating in different regions in their own capacities. With their advent,
the Indian probiotic market turnover is expected to reach $8 million by the year
2015. Probiotics in India generally comes in two forms, milk and fermented
milk products with the former occupying 62% of the market share and the latter
having 38% marketshare (Indian consumer survey, 2010). Source:
ProbioticIndia

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SCENARIO
Amul was the first to make a dent at National level with its probiotic ice
creams prolife in February, 2007. Amul, on the other hand, having tasted success
in the probiotics category with its ice cream introduced probiotic lassi. Probiotic
products contribute to 10% to its ice-cream sales and 25 per cent of its Dahi
(Indian yoghurt) sales. Mother Dairy has the largest milk (liquid/unprocessed)
plants in Asia selling more than 25 lakh liters of milk per day. b-Activ
Probiotic Dahi, b-Activ Probiotic Lassi, b- Activ Curd and Nutrifit
(Strawberry and Mango) are the company’s probiotic products. Probiotic
products are contributing to 15% of the turnover of their fresh dairy products.

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SCENARIO
Nestle NESVITA was India’s first Dahi with Probiotics – For Healthy Digestion.
Yakult Danone India Pvt Ltd (YDIPL) is a 50:50 joint venture between Japan’s
Yakult Honsha and The French- Danone Group and is offering Yakult, a probiotic
drink made from fermented milk, Lactobacillus and some sugar. The entry of
Yakult is expected to increase the visibility and growth of probiotic category in India.
Major players in the probiotics drug market in India include companies like Ranbaxy
(Binifit), Dr. Reddy's Laboratories, which has four probiotic brands, Zydus
Cadila, Unichem, JB Chem, and Glaxo SmithKline. While probiotics in the form of
drugs are widely accepted, probiotic foods are still viewed with scepticism.

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PROBIOTICS – GLOBAL
SCENARIO
Knowledge in probiotic continues to expand on daily basis.
The progressive interest in ‘these magic bugs’ has grown
enormously during the last few years due to their protective
role in the gut to keep our gut healthy and fit. Probiotics have
gained tremendous popularity amongst individuals searching
for alternative and “natural” means to promote intestinal
health.

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SCENARIO
The growth of probiotic products in the developed world has been quite
amazing. According to a new market research report, 'Probiotics Market’
(2009-2014), published by Markets and Markets, the global probiotics
market is expected to be worth US $ 31.1 bn by 2015 with the Europe and
Asia accounting for nearly 42 and 30% of the total revenues respectively.
Europe forms the largest market for probiotics with an estimated $13.5
billion by 2014. Asia is the second largest segment, growing at with an
estimated CAGR of 11.2% to reach $9.0 billion by 2014.

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SCENARIO
A Frost and Sullivan study estimates that the probiotic ingredient market in the US was $450
million in 2010. Probiotics, with a market of $3.23 billion is a large part of Japanese
functional foods. The Japanese spent $126 per person per year on functional foods and
it is higher than other countries including US ($67.9), Europe ($51.2) and Asia ($3.20).
According to Euromonitor International’s packaged food data, in 2000, pro/prebiotic
yogurt (both drinking and spoonable combined) accounted for one-quarter of global
yogurt sales by value. A decade later, in 2010, it accounted for one-third. global value for
sales of probiotic dietary supplements almost tripled, amounting to US$2.2 billion in 2010,
thereby, further suggesting that probiotics are spreading like wildfire around the globe.

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SCENARIO
Normalization of the properties of unbalanced indigenous microflora of the
intestinal tract by ingestion of specific strains of the healthy microflora forms the
rationale of probiotic therapy. It is now well recognized that probiotics hold great
promise and have the prospects to serve as candidate biotherapeutics in the
management of inflammatory metabolic disorders including cardiovascular diseases
such as atherosclerosis, hypertension and stroke etc. So many food companies are
expanding their market profile to the most promising growth markets for probiotics.
Some of the probiotic products available worldwide are presented in the following
table.

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Active Players in
Probiotics in India
1. Chr. Hansen (India) Pvt. Ltd.
2. Danone foods & beverages (India) Pvt. Ltd.
3. Mother Dairy fruits and vegetables private limited
4. Micrbax(India) ltd.
5. Nestle India ltd.
6. Yakult Danone India Pvt ltd.
7. Zytex Biotech Pvt. Ltd.
8. Shree Additives Pharma and Foods Limited

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APPLICABLE
WIPO CLASSES
Applicable international classes(IPC) for probiotic related
Inventions :
A23C A23L A23K A47G
A61K A61L A61M A61P
Other related classes :
C12N C12P C12Q C12R

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APPLICABLE
WIPO CLASSES
Applicable international classes(IPC) for probiotic related
Inventions :
A23L1/30 C12N11/10 A61K35/74
A61K35/66 A47G21/18

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APPLICABLE Cooperative
Patent Classification (CPC)
CLASSES
Applicable Cooperative Patent Classification(CPC) for probiotic
related Inventions :
A61K36/064 A23L1/0032 C12N1/20
A61K35/744 A47G21/183 C12N1/16
A23L1/3014 A61K35/747 C12N11/02

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SECTION A -
HUMAN
NECESSITIES

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INTERNATIONAL PATENT
CLASSIFICATION (IPC):A23
FOODS OR FOODSTUFFS; THEIR TREATMENT,
NOT COVERED BY OTHER CLASSES

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DAIRY PRODUCTS, e.g. MILK, BUTTER, CHEESE; MILK OR
CHEESE SUBSTITUTES; MAKING THEREOF (obtaining protein
compositions for foodstuffs A23J 1/00; preparation of peptides, e.
g. of proteins, in general C07K 1/00)
INTERNATIONAL
PATENT
CLASSIFICATION (IPC):
A23C

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GRANTED PATENT IN INTERNATIONAL
PATENT CLASSIFICATION (IPC) Class : A23C
No. Application No. Patent No. Title of Invention
Date of Filing
(National)
1 1359/MUMNP/2010 260159 Stable nutritional powder 25/06/2010
2 245/MUMNP/2009 258316 Polyphenol/peptide composition and use thereof for promoting gastric health 2/2/2009
3 480/DEL/2006 258152 A method for the estimation of multi residue in milk & milk products 22/02/2006
4 1078/DEL/2006 257783 "a process for the preparation of low cholesterol ghee". 27/04/2006
5 5536/DELNP/2006 257376 "a water or milk based liquid product comprising living micro-organisms". 22/09/2006
6 3653/CHENP/2006 257233 An apparatus for the evaporative cooling of a liquid product 3/10/2006
7 2685/DELNP/2007 257203 Infant formula comprising beta serum or / and fraction obtained from beta serum 11/4/2007
8 1403/MUMNP/2008 257124 A self-stable beverage composition 7/7/2008
9 1181/DEL/2007 257068 Process for manufacture of spray dried cheddar flavour base/concentrate 1/6/2007
10 1362/CHENP/2007 257045 Fermented food material comprising receptor ligand 3/4/2007
11 4435/CHENP/2006 254520 Enzymatic process for obtaining increased yield of lactobionic acid 1/12/2006
12 97/KOLNP/2007 253828
Food ingredients and food products treated with an oxidoreductase and methods for preparing
such food ingredients and food products 8/1/2007
13 1617/MUM/2007 253269 Lecithinisation process for preparation of milk based powder bevarage with micronutrients 24/08/2007
14 2180/MUM/2007 253078
A process for the perparation of novel molecular dispersions of lipophilic nutrients and a product
obtained thereof 1/11/2007
15 2834/KOLNP/2008 252856 Method for producing fermented milk using novel lactic acid bacteria 11/7/2008

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Date of Filing
(National)
16 2666/CHENP/2007 252330 Method for producing fractions of a milk composition 20/06/2007
17 3279/KOLNP/2006 251851 Cheese and methods of making such cheese 9/11/2006
18 150/CHENP/2006 249788 Powderous formulations of fat-soluble active ingredients 12/1/2006
19 3724/KOLNP/2006 249636 Acidic milk drink 11/12/2006
20 489/DEL/2004 249174 A process for the preparation of spray dried norbixin powder 16/03/2004
21 738/DEL/2005 248474 A process for corn flour biscuits 31/03/2005
22 1657/MUM/2008 247578 A process for deoiling liquid lecithin using rotating disc contactor 4/8/2008
23 2227/DEL/2005 245014 "a process for the preparation of processed cheese spread" 19/08/2005
24 745/DEL/2005 243804 A process for the preparation of a novel bio-curd 31/03/2005
25 1433/DEL/1999 243797 "process for the detection of synthetic milk" 2/11/1999
26 468/DEL/2004 240948 A packaging process for extension of shelf life of milk based products 16/03/2004
27 600/MUMNP/2007 239473 Carbonated protein drink and method of making 25/04/2007
28 IN/PCT/2002/1301/CHE 235254 Process for the preparation of milk powder 20/08/2002
29 155/MUMNP/2006 234855 Fermented food product comprising soy protein 8/2/2006
30 929/CHENP/2004 234584 A method for the preparation of a fermented dairy product 30/04/2004

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Date of Filing
(National)
31 842/DELNP/2006 234280 "a composition comprising a strain of lactic acid bacteria" 20/02/2006
32 3377/DELNP/2005 233464 "a method for treating dairy process stream" 28/07/2005
33 1809/DELNP/2005 233280 A beverage composition 3/5/2005
34 2626/CHENP/2005 229760 A nutritionally complete composition 13/10/2005
35 518/CHENP/2005 226665
A method for producing acid coagulation-resistant milk and increasing its calcium
absorbability and the milk 1/4/2005
36 2707/CHENP/2004 226363 Method for producing whey protein hydrolysate 30/11/2004
37 379/KOLNP/2003 225437 A dairy product and a mehtod for manufacturing thereof 1/4/2003
38 1193/CHENP/2003 224869 A method of increasing the solubility or dispersibility of a powder or a tablet 1/8/2003
39 963/CHENP/2004 223679 A method for producing a modified whey protein preparation 5/5/2004
40 1451/DELNP/2004 218049 "imitation cheese composition" 28/05/2004
41 2233/DELNP/2003 217544 "a mehtod for producing an imitation cheese composition" 22/12/2003
42 IN/PCT/2001/1474/CHE 216428 Shelf-stable calcium fortified milk and dairy products 23/10/2001
43 IN/PCT/2000/343/CHE 215934 An apparatus in an infusor for a liquid food product 4/9/2000
44 IN/PCT/2000/342/CHE 215933 An apparatus in an infusor for a liquid food product 4/9/2000
45 IN/PCT/2001/789/CHE 212338 A process for reducing free fatty acid present in an anhydrous liquid animal fat 7/6/2001

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Date of Filing
(National)
46 IN/PCT/2002/1972/CHE 209522
A process for preparation of a composition containing exogenous lactic bacteria strains
against actinomyces naeslundii related disease 29/11/2002
47 1250/MUM/2003 206340 A process for low carbohydrate sweetener 8/12/2003
48 607/MUM/2003 206338 An improved process of production of channa podo 11/6/2003
49 IN/PCT/2002/01178/KOL 203629 "nutritional mineral fortification of milk" 18/09/2002
50 IN/PCT/2002/141/CHE 201814 Foaming ingredient and powders containing it 25/01/2002
51 548/MAS/1997 196347 Method and device for dissolving 17/03/1997
52 41/MAS/1993 181165
A method of producing a soya drink possessing superior flavour and stcrage properties
on a rational industrial scale 25/02/1993

FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES,
NOT COVERED BY SUBCLASSES A21D OR A23B-A23J;
THEIR PREPARATION OR TREATMENT, e.g. COOKING,
MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL
TREATMENT (shaping or working, not fully covered by this
subclass, A23P); PRESERVATION OF FOODS OR
FOODSTUFFS, IN GENERAL (preservation of flour or dough for
baking A21D)
A23L

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FEEDING-STUFFS
SPECIALLY ADAPTED
FOR ANIMALS; METHODS
SPECIALLY ADAPTED
FOR PRODUCTION
THEREOF
IPC A23K

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CLASSIFICATION (IPC):IPC A47
FURNITURE; DOMESTIC ARTICLES OR
APPLIANCES; COFFEE MILLS; SPICE MILLS;
SUCTION CLEANERS in general

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HOUSEHOLD OR TABLE
EQUIPMENT (book-ends
A47B 65/00; knives B26B)
A47G

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Drinking straws or the
like (for therapeutic
purposes A61J 15/00)
A47G21/18

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A61
MEDICAL OR VETERINARY SCIENCE; HYGIENE

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PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET
PURPOSES (devices or methods specially adapted for bringing
pharmaceutical products into particular physical or administering
forms A61J 3/00; chemical aspects of, or use of materials for
deodorisation of air, for disinfection or sterilisation, or for
bandages, dressings, absorbent pads or surgical articles A61L;
soap compositions C11D)
CLASSIFICATION (IPC):IPC
A61K

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METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS
IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF
AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT
PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES,
DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES (preservation
of bodies or disinfecting characterised by the agent employed A01N;
preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical,
dental or toilet purposes A61K) [4]
A61L

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DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY
(introducing media into or onto the bodies of animals A61D 7/00; means for
inserting tampons A61F 13/26; devices for administering food or medicines
orally A61J; containers for collecting, storing or administering blood or medical
fluids A61J 1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR
TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of
surgical articles A61L; magnetotherapy using magnetic elements placed within
the body A61N 2/10); DEVICES FOR PRODUCING OR ENDING SLEEP OR
STUPOR
A61M

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SPECIFIC THERAPEUTIC ACTIVITY OF
CHEMICAL COMPOUNDS OR MEDICINAL
PREPARATIONS
A61P

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SECTION C -
CHEMISTRY;
METALLURGY

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C12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR;
MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC
ENGINEERING

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MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF (biocides,
pest repellents or attractants, or plant growth regulators containing
micro-organisms, viruses, microbial fungi, enzymes, fermentates, or
substances produced by, or extracted from, micro-organisms or animal
material A01N 63/00; medicinal preparations A61K; fertilisers C05F);
PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS;
MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological
testing media C12Q 1/00)
C12N

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FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A
DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE
OPTICAL ISOMERS FROM A RACEMIC MIXTURE (fermentation processes
to form a food composition A21, A23; compounds in general, see the relevant
compound class, e.g. C01, C07; brewing of beer C12C; producing vinegar
C12J; processes for producing enzymes C12N 9/00; DNA or RNA concerning
genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or
purification C12N 15/00)
C12P

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MEASURING OR TESTING PROCESSES INVOLVING
ENZYMES OR MICRO-ORGANISMS (immunoassay G01N
33/53); COMPOSITIONS OR TEST PAPERS THEREFOR;
PROCESSES OF PREPARING SUCH COMPOSITIONS;
CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL
OR ENZYMOLOGICAL PROCESSES [3]
C12Q

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INDEXING SCHEME ASSOCIATED WITH
SUBCLASSES C12C-C12Q OR C12S, RELATING
TO MICRO-ORGANISMS
C12R

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Important point for
patent applicant
❏ Before filing for patent, the patent applicants should ascertain,
that the subject matter in respect of which a patent is sought,
does not fall under section 3 of the Indian Patent Act.
❏ In India, deposition of the microorganism isolated/ conditioned/
extracted/modified should be submitted at MTCC Chandigarh
or Pune.
❏ It is advisable to follow guidelines released by Indian Patent
Office.

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This post is no way related to Indian Patent office (IPO) or any of its
subsidiaries. All the posts/comments are only for general information or use and
it should not be relied on as official notice. Every care has been taken to ensure
the accuracy of information furnished in this post, authors do not accept any
responsibility or liability for any damage or loss arising from the direct or indirect
use of the contents provided on this post. We can be reached at info [at]
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