PROTECTION OF MICROORGANISMS Epoch making: The concept or using organisms and living things as a technology has long roots. This is evtdent from the Babylonian tablet, which depicts stages in brewing. I he Sutner~ans too were brewing as many as 19 different 1 varieties of beer as early as third millennium B.C. Microorganisms are a diverse group of stmple life forms including protozoa's, algae, molds, 2 bacteria and i rruses The foundation of microbiology was established during the last half of the 19th century. In 1856. one Lille, industrialist approached Louis Pasteur to find a way out for the souring of wines and beers. Pasteur found that properly aged wlnes and beers contained spherical yeast while soured vintages and brews contained elongated yeast cells. Pasteur con- cluded that out of the two types of yeast cells, one produced alcohol while the other produced lactic acid. Pasteur reached the answer to the problem as to kill an) yeast cells still left after fermentation. I. John Elkington, The Gene Factory-inside the Genetic and Biotechnology Business Revolufion. Carroll and Graf Publishers Inc., New York, I* Ed., (1985), pl5 2. The New Encyclopedra Br~tanrca-Miwpedia Ready Reference, Chicago,Vol.B, (1997), p 101
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PROTECTION OF MICROORGANISMS
Epoch making:
The concept o r using organisms and living things as a technology has long
roots. This is evtdent from the Babylonian tablet, which depicts stages
in brewing. I he S u t n e r ~ a n s too were b rewing a s many a s 19 d i f f e ren t
1 var i e t i e s of beer a s ear ly a s third mil lennium B.C. Microorganisms are
a diverse group of stmple life forms including protozoa's, algae, molds,
2 bacteria and i rruses
The foundation of microbiology was established during the last half of the
19th century. In 1856. one Lille, industrialist approached Louis Pasteur to
find a way out for the souring of wines and beers. Pasteur found t h a t
p rope r ly aged wlnes and b e e r s c o n t a i n e d s p h e r i c a l y e a s t w h i l e
soured vintages and brews contained elongated yeast ce l l s . Pas teur con-
c luded that out of the two types o f yeas t c e l l s , one produced a l coho l
while the other produced lactic acid. Pasteur reached the answer to the
problem a s to k i l l a n ) yeas t c e l l s s t i l l l e f t a f t e r f e r m e n t a t i o n .
I. John Elkington, The Gene Factory-inside the Genetic and Biotechnology Business Revolufion. Carroll and Graf Publishers Inc., New York, I* Ed., (1985), pl5
2. The New Encyclopedra Br~tanrca-Miwpedia Ready Reference, Chicago,Vol.B, (1997), p 101
198
3 T h i s process is now known a s Pasteurization. The first patent dealing
with microbio logy was g ran ted t o Lou i s P a s t e u r t h a t was a c l a i m t o
a b io logica l ly pu re c u l t u r e o f a mic roorgan i sm, a yeas t c u l t u r e a s a
composi t ion of mat te r .
Research in the 20Ih century has uncove red m e a n s o f channe l l ing t h e
ac t iv i t i e s of many microorganisms t o bene f i t medic ine , indus t ry and
ag r i cu l tu re C h a r l e s Weizmann c o u l d d u r i n g World War 11, isolate a
particular bacterium tha t c o u l d p roduce bu ty l a l coho l and a c e t o n e i n
commerc ia l q u a n t i t ~ e s . T h e b a c t e r i a i nven ted was a new one and the
patent claim was for successfully employing the bacteria in a process for
the commerc~al product ion o f bu ty l a l coho l a n d hence was pa t en tab le
1 subjec t mat te r . The antibiotic industry was based upon the production
from selected strains of microorganisms. Molds are employed to produce
enzymes and anti-biotic, notably penicillin. Apart from antibiotics many
5 drugs are produced by fermentation of microorganism. Microorganisms are
3. John Elkington, The Gene factory-Inside the Genetic and Biotechnology Business Revolution, Carroll and Graf Publishers Inc. New York. 1* Ed. . (1985), p15
4. Guaranty Trust Co. v Unmn Wmnts Corp, 54 F.2d 400 as cited in lver P. Cooper, Biotech- nology and the Law, Vol. I, (1993). p. 2.3
5. Philip W. Grubb, Patents for Chemicals, Pharmaceuticals and Biotechnobgx Oxford, (1999) p. 225.
now used in the production of antibiotics l ike pencillin, cephalosporins
6 etc.
Microorganisms also produce various important enzymes and are used as
I
growth promoters such as vitamin B-12. Genetic engineering has helped
to transform certain microorganisms t o d e v e l o p subs t ances usefu l t o
8 mankind . Microorganisms a r e b e i n g increasingly used in agriculture
as bio fertilizers.The enzymes are being uti l ised for removing skin from 9
hydes, in producing artificial rennet, for cheese making and clearing beer.
In cheese making the pas teur ized mi lk i s innoculated wi th f e r m e n t i n g
microorganisms and r enne t which p romote cu rd l ing . T h e f e rmen t ing
microorganisms car ry out t h e a n a e r o b i c conversion of lactose to lactic
acid. The type of organisms used depends on the variety of cheese and on
10 the production process. Enzymes though chemica l s a r e der ived f rom
B.S.V.Gupte, Micmnpnisms in th8 Pharmaceutical Industry,in Suman Sahai ed., Microorganisms and l ~ ~ u a l PmPropecty Rights, Gene Campaign,(l998), p.6.
7.lbid.
8.Robert C. Collins. William H. Francis, Ceses 8 Materials on Patent Law. lnduding Trade Secrets, Copyrights, Tmdemarks, West Publishing Company, (1995) p. 516
9.Robert Bud, The Uses of Lib- A History of Biotechndogy, Cambr i i University Press, (1993), p 17
1O.Encydopaedia Britennica,Vol. 19, p.392.
organisms. Enzymes were used in detergent industry and competed with
chemica l p roduc t s . O t t o Rohm pa ten ted a n enzyme p repa ra t ion f o r
I 1 1 washing in 19 1 3 . Thus biotechnology as the basis of many industrial
I and biotechnological inventions has great commercial importance,
I Promises of Biotechnology:
I The branch of technology concerned wi th the forms of indus t r ia l pro-
i duc t ion t h a t use m ~ c r o o r g a n i s m s a n d t h e i r b i o l o g i c a l p r o c e s s i s
I known a s b ~ o t e c h n o l o g y . Bio technology i s a technology based on t h e
I use of other Irving things. Like all other inventions, biological invent ions
also require t h e ~nte l lec tua l creativity of the plant breeder o r industrial
1 microbiologist. Industrial microbiology utilizes microorganisms as base I 12
products in many industries. The term biotechnology was coined a s early
13 / as the year of the Russian Revolution in 1917. The Organ iza t ion fo r I
Economic Co-ope ra t ion and Deve lopmen t de f ines b io technology
11. Robert Bud, The Uses of U@- A History of Botechndogy, Cambridge University Press, (1993), P 108
12. lver P. Cooper, Botei3nology and the Lsw, Vol.1, (1993),p 1.
13. Robert Bud, 0p.d. n. I I, p 1
201
a s t h e app l i ca t ion o f s c i e n t i f i c a n d eng inee r ing
process ing of m a t e r i a l s by b io log ica l agen t s t o \ I
services. The concep t o f b io sugges t s na tu ra l and , human cont ro l over na tu re .
- .-
Biotechnology, in the sense of genetic manipulation, has been practiced
by man for many hundreds of years. It has been used successfully by plant
b reede r s i n d e v e l o p ~ n g schemes fo r c ros s ing p lan ts t o in t roduce and
ma in ta in des i r ab le t r a i t s in va r ious c r o p s s u c h a s whea t o r ma ize .
Bake r s and beverage producers have used yeast, a fungus, for leavening
dough and for fermentation. Today, the practice of biotechnology is far
more powerful, with p romis~ng applications in diverse industries ranging
from pharmaceuticals. agr~cul ture and nutrition to environmental cleanup.
Some examples of widely known p roduc t s made wi th t h e use of b io -
technology inc lude rnsu l in , human growth hormone, home pregnancy
tests, tests for diagnosing human immunodeficiency virus (HIV), vaccine
against the Hepatitis B virus, and high-protein yielding corn.
The dramatic breakthroughs and future promises of biotechnology became
possible in the 1950's when scientists James Watson and Francis Crick
discovered the structure of DNA, or deoxyribonucleic acid. Ironically,
neither scientist seemed aware that their discovery would give birth to an
202
entire new generation of technology. Although most biologists thought genes
were made up of pro te ins , Watson and C r i c k were among t h o s e who
be l ieved DNA held t h e key. They were d e t e r m i n e d t o bu i ld a mode l
I4 of a DNA molecule. The discovery of DNA became the basis of a new,
promising industry that has led to significant breakthroughs in the ability
to improve human i ~ f e . DNA, known a s t h e u l t imate molecule of l i fe ,
con ta ins t h e c o d e s t h a t i n s t ruc t c e l l s t o grow, t o d i f f e r e n t i a t e i n t o
specialized structures, to duplicate, and t o respond to environmental
changes . D N A gu ides t h e s p e c i a l f u n c t i o n s o f c e l l s by d i r ec t ing t h e
synthes is of p ro te ins . A gene, which i s comprised of a specific section
of DNA, contains the special instructions the cell needs to synthesize pro-
teins. Proteins give llving organisms their unique characterist ics. Some
p ro te ins g ive t h e organism i t s s t ruc tu re ; o t h e r s m e d i a t e t h e many
biochemical react ions that occur within the body and are necessary for
o rgan i sms to func t ion . Af t e r World War I1 many be l i eved tha t mi -
c robio logy could offer humanity a way out o f starvation and disease.
E lmer Gaden and Car l Goren Heden w e r e t h e p r i m e mover s t o use
b io technology fo r good. In 1956 Shukuro Kinosh i t a and h i s team -~_-__.~_-___.___.----~~--~~---~---------------------------.--*------------------------------.--- 14. J. D. Watson, F. H C. Cr~ck, A Structure forl)eoxynbose N u d a i c A d , in Nature. Vol. 171,
(1953),p. 737.
203
showed how to produce glutamic acid from bacteria. In the subsequent
decade a new industry producing amino ac id emerged with Japan in t h e
I 5 fo re f ron t . The potential value o f biotechnology products has helped
companies to over come the cost o f innovation mainly in pharmacology.
The single drug zantac used t o c o m b a t u l ce r s enab led manufac tu re r
16 g laxo t o become a major co rpora t ion . T h e advance o f science and
biotechnology has brought a b o u t t h e gene t i ca l ly man ipu la t ed micro-
organisms.
Asexual r ep roduc t ion is main ly a s a r e s u l t o f errors in r ep l i ca t ion
process .Mutants w ~ t h desired characteristics can be isolated by sub jec t -
i ng the bac ter ia to envi ronmenta l cond i t ions favour ing t h e bac te r i a .
The organisms can be subjected to mutagenic agents and the f requency of
the mutat ion can be Increased thus d iscover ing new microorganisms.
Apart f rom muta t ion , new microorganisms can be ob ta ined by
1LRobert Bud, The Uses of Life- History of Biotechndogy, Cambridge University Press,(l993). p.17.
16. /bid., p 191
. *
204 17
conjuc t ion . t ransduct ion e t c .
Viruses , chromosomes and p lasmids car ry genes . These genes c a n be
i so l a t ed and man ipu la t ed and used t o c o n f e r des i r ed p rope r t i e s t o
t r ans fe ree organisms. Thus genetic manipulation using different carriers
and r ep l i ca t~ng agents are being used by the industrial micro biologist t o
produce new and novel super strains and organisms having desirable at-
t r i bu te s . Cu l tu re s of microorganisms a r e ob ta ined f rom so i l , water ,
rott ing vegetables and the like. Natural microbial colonies can be detected
by a variety of techniques. Microbiological i nven t ions invo lve the use
o f a new s t r a in o f microorganism to produce a known compound more
efficiently. I t I S possible that the new microorganism was isolated from
the soil or produced in the laboratory. T h e novel p roduc t ob ta ined by
ustng the new m~croorganism can be patented subject to the requi rements
of patent law. But scientist would prefer t o patent the new microorganism
itself rather than patenting the product. Genetically modified s t r a ins o f
microorganisms could be patented. Multi national corporations hold most
of the pa t en t s on the mic roorgan i sms of Ind ian o r ig in . Even d u r i n g
the pre- independence period anyone wanting to import a microorganism
17. lver P. Cooper, Biotechndogy and the Law, Vol.1, (1993), p. 1.2.
205
had t o o b t a ~ n a c e r t i f i c a t e f rom t h e Head o f t h e Depar tmen t of P l an t
Pathology, C A R 1 T h e Advanced C e n t r e o f B iosys t ema t i c s formed by
the National Herbarrum, The Bureau o f Microbial Diversity established
under the ICAR and the other germplasm collection centers help in net
18 working the m ~ c r o b l a l divers i ty . Though i t i s d i f f icu l t t o s t o p bio-
piracy it will be possible to cap it by laws which will have a deterrent
effect. The revolut~on in patenting of microbiological inventions emerged
in 1949 with the historic deposit o f a microorganism's sample with the
then northern reg~onal research labora tory of the US Department of Ag-
r i cu l tu re . The microorganism depos i t ed was Dr. Duggar ' s micro-
19 organism used t o make chlorotetracycl ine.
Microbial system IS aregenerable system. They demand only low energy
and have a h ~ g h degree o f e f f ic iency . The pos i t i ve a spec t o f a mi-
croorganlsm ls that it is possible t o introduce desired character is t ic i n t o
a microorganrsm S o rndus t r i e s wi l l now be s h i f t i n g towards
18. Dr.Anupam Venna, Microorganisms in Agffiultum, in Suman Sahai ed.,Micmoqanisms and Intellectual Property R&hts, Gene Carnpaign,(1998), p.28.
19. Albert P. Hallurn, Patenting The Results of Genetic Research : An Overview, in David W. Plant et. a/., ed. Banbury Repart 10- Patenting @Life Foms, (1982), p.68.
206 20
microbia l t e c h n ~ q u e s
Inves to r s expec t a r e tu rn fo r t h e i r i nves tmen t . Wi thout monopoly
p ro tec t ion research and deve lopmen t o f t r ansgen ic a n i m a l s and i t s
products cannot be achieved. The quid pro quo for patent monopoly is the
benefit derived by the society. An organism which i s only a laboratory
cur ios i ty and useful only in research is not patenable.
I Challenges in Patenting Microorganisms:
The challenge f a c ~ n g us now is whether a new living strain of microor-
ganism is itself patentable. The Patent Act 1977 of UK and the EPC does
not exc lude such pa ten t ing . Exc lus ion o f p lan t and an ima l va r i e t i e s
spec i f ica l ly , from the provis ion imports in the general presumption that
m i c r o b i o l o y ~ c a l process o r the p roduc t t h e r e o f a r e not e x c l u d e d .
The British Patent Office and the EPO grant patents for microorganisms.
The TRIPS Agreement now o b l i g e s t h e members o f WTO t o g r a n t
2 1 pa ten t protection fo r mic roorgan i sms . T h e l ega l f r a m e work of
20. Dr. Naresh Kumar, W n g Paradigms of lndustriel MMmobidopy, in Suman Sahai ed, Micmorganisms and irttellectual Property Rights. Gene Campaign,(l998), p.17.
21.TRIPS Agreement, Art. 27
207
pa ten t ing m ~ c r o o r g a n i s m s in mos t c o u n t r i e s i s t h a t though they a r e
not s p e c i f ~ c a l l v excluded from patentabil i ty, microorganisms were not
granted patent protection on the ground that i t was contrary to natural
2 2 l aws . In U S, mic rob ia l c u l t u r e s c o u l d g a i n p ro tec t ion e i t h e r by
obtaining u t ~ l i t y patent or by plant patent. A plant patent can be ob ta ined
only by satisfying the description r equ i r emen t . T h e difficulty of adequate
description of micro organisms necessitated the need for exploration of
utility patents for micro organisms. Utility patents in biotechnology can
be classified as product patents, process patents and use patents. Product
patents cover nutrient media, organisms, cultures etc. Process patents cover
fermentation methods, methods of cultivating or altering organisms. Use
patents cover new methods of using previously known compounds. Utility
patents can be o b t a ~ n e d only by satisfying the statutory conditions.
The purpose of patent law is t o promote the progress of useful arts and
when any useful result is attained the result should he considered as an
23 advance in the art and should be granted a patent protection. The Patent
Act of U . K . does not express ly e x c l u d e l i v i n g o rgan i sms , bu t
22. Brain C. Reid. Cases on Patents, (1988), p.21.
23.Parkerv Flook. 437 US. 584 (1978),
I
208
microorganisms were not regarded as a manner of manufacture. It was only
a manner of manufacture that qualified for protection under the U.K.Act.
But the Unlted States PTO has been g ran t ing p a t e n t s on l i f e f rom t h e
p a s t . Gene constructs and genetically manipulated microorganisms are
2 4 a l so pa t en ted . Gene s e q u e n c e s f r o m whoop ing cough ( p e r t u s s i s )
25 bacter ia , gene sequences related t o house mite allergens are examples.
In 1980 the U S . Supreme Court granted patent for a man made microor-
26 ganism. Chakrabarty filed a patent application for a live, human made
genetically engineered bac te r i a c a p a b l e of b reak ing down mul t ip l e
components of c rude o i l . The claim of Chakrabarty was for a bacterium
from the genus Pseudomonas containing therein at least two stable energy
genera t ing p lasmlds , e a c h of t h e s a i d p l a smids provid ing a s e p a r a t e
hydrocarbon degradative pathway. Any other bacteria did not posses s
thiscapabili ty The patent claims of Chakrabarty was of three types, pro-
cess claims for the method of producing the bacteria, claims for an