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

~~~~~~~~~--~~-~.-~----~~~~-~~--~~-~~-~~.~~.-~~-~~.-~~---------.---.-----.------.------.--..-----.----.-.-

24.L.P. Meredith Lloyd Evans,Patenting of Transgenic Animals-An Industry View Point,

U.K.Bioted7nology Handbook, 4th Ed., (1993), p.44.

2S.lbid.

26.D;amond v Chakrabatty, 447 U.S. 303 (1980).

209

innoculum comprised of a carrier material floating on water such a s straw,

and the third claims to the bacteria itself. The patent examiner rejected

the claim for the bacteria on the ground that the bacteria was a living thing

and hence not patentable and also on the ground that microorganisms are

products of nature. Chakrabarty appealed and the decision of the Examiner

was upheld on the ground that living things are not patentable under 35 US

Congress 10 1 According t o the Board of Appeals, though the Congress

extended patent protection to asexually reproduced plants, S. 101 was not

intended to cover l ~ v i n g things such as laboratory created microorganisms.

The Court o f Cus toms and Pa ten t Appeal reversed th i s f i n d i n g in t h e

l i gh t of the d e c ~ s i o n in Bergy and c a m e t o t h e conc lus ion t h a t t h e

mere f ac t tha t mlc ro organisms are alive is without significance. The

Commissioner of Patents and Trademarks sought certiorari. The ques t ion

before t h e Supreme Cour t was t o c o n s i d e r whe the r mic ro o rgan i sm

constitutes a manufacture or composition within the meaning of the Statute

which s t a t e s tha t "Whoever inven t s o r d i scove r s any new and usefu l

process, machlne, manufacture or composition of matter, or any new and

useful improvement the reo f , may o b t a i n a p a t e n t t he re fo r , sub jec t t o

t h e cond i t ions and r equ i r emen t s of t h i s t i t le" . The Cour t r easoned

tha t t h e Congress had c l ea r ly exp la ined in enac t ing the P lan t Pa ten t

Act t ha t the work of the plant breeder in a id of nature was patentable.

Congress had also recognised that the distinction was not between living

210 and animate thing but between products of nature . whether living or not

and human made invent ions. The respondent 's microorganism was the

resu l t o f human made inven t ion . A c l a i m t o a newly discovered natu-

ral product wtll be valid if it i s distinct from t h e product a s found i n

nature. The distinction in this case lay in the fact that the pure substance

was medicinally useful whereas the crude extract was not. In cer ta in cases

a s i n t h e Chakraba r ty c l a im, t h e s t r a in o f t h e b a c t e r i a i t s e l f wil l b e

t h e commercial product. In such cases i t would be necessary t o per se

n claim protection for the microorganism.

Patents on the m~croorganisms are not usually held by the scientist who

makes the break, but by corporations. Biotechnology i s a sophisticated

system requiring precision instruments that are expensive. So i t wi l l not

be poss ib le for t h e sc i en t i s t t o d o e x p e r i m e n t s o n his own. Therefore

the corporations usually hold the patents on the microorganisms. A typical

example is the patent held by the General Electric Co. that has the patent

for the oil eatlng bacteria which was mutated by Dr.Chakrabarty. It i s Du

Pont Co. that has the patent for the Onco mouse and not the scientists a t

---.--.---------------+---------.--.-..---.-.-.--.--.--..-...----..-..--.----..-..-..--.-.--...-..-----..

27.Diamond v Chakrabarty, 447 U.S. 303 (1980).

211 lu

the Harvard

Peculiarities in Protecting Micro Organisms:

There a re cer ta in cha rac t e r i s t i c s a s soc ia t ed wi th b io technology t h a t

distinguish i t from other forms of patentable subject matter. Biological

29 i nven t ions a r e desc r ibed more in func t iona l te rms . Pa ten t l aw was

intended to satisfy the requirements of industrial technology. Industrial

technology 1s mechan~s t ic and an applicant for biotechnology patent finds

it difficult to s a t~s fy the requirements for obtaining patent protection. With

the advancement in biotechnological development, industrial property laws

were to be s u ~ t a b l y modified to match the needs of science and industry.

The requirement of filing a specification has to be satisfied in the c a s e of

microorganisms as we l l . An a p p l i c a t i o n r e l a t e d t o t h e p roduc t ion

by gene t i c englneerlng of a polypeptide called interleukin-3 believed to

con t ro l immune r e sponse in mammals . I t was he ld t h a t t h e c o r r e c t

approach was to c o n s ~ d e r the description and claims in the specif icat ion

in t h e eyes o f a sk i l l ed man in t h e a r t . Though t h e a p p l i c a n t need

28. Dr. Naresh Kumar, Sniffing Paradigms of industrial MMicbio/ogy, in Suman Sahai ed., Micmofganisms and lntettedual Property Rights, Gene Campaign,(lSBB), p.21.

29. Brad Sherman et. a/ . , The Question of Patenting Life, Perspedms on Intellectual hpeop , Vo1.4, Sweet 8 Maxwell, (1998), p.110.

212

not have to restrict his claims t o the specific embodiment described, but

the width of ' the claim must be properly supported by the description of

the invent ion i n the spec i f i ca t ion . To d e c i d e whe the r t h e c l a ims a r e

suppor t ed bv the desc r ip t ion i t i s necessa ry t o a sce r t a in what i s t h e

invent ion that I S specified in the claims and then t o compare that with the

30 invention w h ~ c h has been described in the specification. The r equ i r e -

ment o f enab l ing wr i t ten desc r ip t ion inco rpora t ed in a l m o s t a l l t h e

national patent laws was impracticable in the case of microorganisms. The

description however made will not enable the skilled person to reproduce

the invention A straln is not of a f ixed structure and properties but is a

l i v ing system capab le o f a l t e r i n g i t s behav io r i n r e sponse t o envi -

ronmenta l changes Even i f a comple t e description were possible, this

would not en t i t l e the publ ic to possess t h e invent ion when t h e pa ten t

expired. A person wishing to make the invention will first have to obtain

the invention after search in nature, which might take years. Though this

concept proved wrong the skilled person would only be able to identify the

new strain and the description will not be sufficient to enable him to get

it. The House of Lords held that the patentee was not obliged to supply the

30. Schering Biotech Corp's Application, [1993] RPC 249.

213

The EPC recognised t h i s need a n d inc luded provis ions in the Rules to

this effect . l t was the EPC which first incorporated the provisions for the

31 deposit of the m~croorganisms. Microorganisms are patentable under EPC.

The depos i t r equ i r emen t o f t h e EPC s t a t e s t h a t t h e c u l t u r e must be

depos i t ed on t h e f i l i n g da te . T h e a p p l i c a t i o n shou ld a l s o provide

the d e t a i l s o f the c h a r a c t e r i s t i c s of mic roorgan i sm. T h e Rules a l s o

r equ i r e tha t t h e c u l t u r e is made a v a i l a b l e t o a person only o n a n

understanding that the culture will be made available to a third person

only on an undertaking that it will be used only for experimental purposes

32 until the patent application is refused or withdrawn.

The Rule regarding deposit is applicable only t o the cases, which involve

the use of a microorganism which is not available to the public and which

cannot be described in a manner sufficient to enable the skilled man to

carry out the invention. The EPC requires the deposit of the culture of the

m i c r o o r g a n ~ s m in a r ecogn i sed depos i to ry i n s t i t u t i o n . T h e r e l evan t

i n f o r m a t i o n o f t h e c h a r a c t e r i s t i c s o f t h e m i c r o o r g a n i s m

---.-----------.-------------------------------------------------------------------------------------- 3lEPC. Art 53(b)

32. Ibid. Rule 28

214 should be made a v a ~ l a b l e in t h e a p p l i c a t i o n . T h e depository in s t i t u -

t ion and the f i l e number of the c u l t u r e d e p o s i t s h o u l d be g iven in

t h e application. The deposi ted c u l t u r e mus t be made a v a i l a b l e upon

reques t f rom t h e depos i tory in s t i t u t ion f rom t h e d a t e o f pub l i ca t ion

of the a p p l i c . a t ~ o n . The deposit of the microorganism must be made in

the appropriate p lace T h e d i f f i cu l ty a r o s e w h e n t h e depos i t in t h e

in s t i t u t ion of the count ry conce rned was cons ide red a s s a t i s f a c t o r y

only in the r e spec t ive count ry . Th i s d i f f i cu l ty was o v e r c o m e by t h e

signing of the Budapest Treaty concerning the deposit o f a microorganism

Necessity for deposit and Budapest Treaty :

The Budapest treaty was entered i n t o by t h e c o n t r a c t i n g S t a t e s fo r t h e

in t e rna t iona l r e c o g n ~ t l o n o f t h e deposit o f microorganisms for patent

33 procedure. T h e Treaty provides for re -deposit, if a strain becomes non-

viable on storage and a l so p re sc r ibes a min imum pe r iod o f 30 yea r s

34 f rom t h e o r i y ~ n a l d e p o s i t . T h e depos i to ry i n s t i t u t i o n must have

acont inuous existence and should accept for deposit microorganisms and

should examine their v ~ a b i l i t y a n d s t o r e t h e m . T h e Treaty r equ i r e s t h e

.1__.__1__1..1111____--I--.-------1---.----------.------.---.----------.----------------------------------

I 33.6udapest Treaty, Art 1

depos i t to be accompan ied by a wr i t t en s t a t e m e n t s t a t i n g t h a t t h e

depos i t is made under t h e t reaty, the name and address of the depositor

and the details of the conditions necessary for the cultivation of the mi-

croorganism. for its storage and for testing i ts viability.

The IDA has to test the viability of the microorganism deposited with i t a t

35 reasonable intervals or a t any time on the request o f the depositor. The

international depository institutions are those institutions that satisfy the

requirements set out rn the Budapest treaty. Inorder to qualify forthe status

of Internatronal Depository Authority, the institution must be located on

the te r r i to rv of the C o n t r a c t i n g S t a t e s a n d mus t have a con t inuous

ex i s t ence and s h o u l d accep t fo r d e p o s i t any o r c e r t a i n k inds of mi -

36 c roorgan i sms , and e x a m i n e t h e i r v i ab i l i t y a n d s t o r e t h e m . Mak ing

ava i l ab le o f the depos i t ed c u l t u r e i s made in o rde r t o sa t i s fy and

supplement t h e publ ica t ion of the description. The amended provisions

of the EPC states that t h e c u l t u r e o f t h e microorganism sha l l b e made

37 ava i l ab le only to an e x p e r t nomina ted by the requester. The expert

35.Budapest Treaty Regulation, Rule 10

36.Budapest Treaty. Art 6

37. EPC, Rule 28(4)

can be either nom~na ted be fo re t h e a p p l i c a t i o n h a s been r e fused o r

wi thdrawn

A written description of a novel microorganism will not aid a scientist

un less the microorganism i s ava i l ab le th rough a p u b l i c depos i ta ry .

Commerc ia l f l rms are unlikely to deposit microorganisms in a deposi-

to ry unless adequa te pa t en t p ro tec t ion i s p rov ided . Trade s e c r e t s

will inh ib i t Cree f low of knowledge , a s t h e new microorganisms wil l

not be made ava i l ab le t o t h e s c i e n t i f i c communi ty . A t r a d e s e c r e t

gives the possessor an advantage by keeping it secret. A patent protection

to contrast will last only for a limited time but is enforceable against all

others. It is posslble to keep process secret and the fermentation industry

38 i s now d i s c o u r a g ~ n g the f r e e f l o w o f i n fo rma t ion . Almost a l l t h e

pharmaceutical compan ies d o not pa t en t t h e i r most e f f i c i e n t s t r a i n .

Though the f ~ r s t and second genera t ion of s t ra ins is patented, the strain

39 that gives maximum productivity is kept as a trade secret. The difference

between a trade secret and a patent is that a trade secret if kept secret can

38. lver P Cooper, B~ootechnology and the Law, Vol.1, (1993), p. 1-16

39.Dr. Naresh Kumar, Shfling Paradigms of Industrial Microbiology, in Suman Sahai ed , Micmrganisms and intellectual Property Rights, Gene Campaign,(1998), p.21

217

be enjoyed by the owner/ holder exclusively forever. But once i t becomes

open i t cannot be protected. On the other hand a patent grants protection

for a term and one has the right to exclude others during this period.

In inventions relating to molecular biology, i t will be the applicant who

has first isolated and cloned the genes. The genes will then be expressed

in transformed cells in order t o satisfy the description requirement, the

application should describe step by step how the gene was isolated. The

specification should also discuss how the desired protein is purified and

changed into useful products.

A patent a p p l ~ c a t ~ o n can be rejected on grounds of inoperability and lack

of enablement. lnoperability is distinct from lack of enablement. If the

inventor has to rely on materials not stated in the specification in-order t o

work the inven t~on , the disclosure is not an enabling one. On the other

hand if the lnventlon cannot be made to work the rejection should be for

inoperability

In the case of a microorganism usually the organism will be made by one

group of skilled persons while it will be utilised by another. For example

a microorgan~srn though made by a molecular biologist will be used either

by an e c o l o g ~ s t or by a chemist developing drug. Therefore the how to

make disclosure should be addressed to the molecular b io logis t and how

218 t o use d i sc losu re t o an env i ronmen t eng inee r .

Companies depos i t s t r a ins t o mee t t h e spec i f i ca t ions c l a imed in t h e

pa ten t but will wi thhold t h e h igh y i e ld ing s t r a i n .

Anlnvent ion for whlch the pa t en t was c l a i m e d cons i s t ed o f t h e c u l -

t i va t ion o f ce r t a ln s t r a i n s o f a known m i c r o organism wi th a v i ew

t o t h e production of a new antibiotic. The claims extended both to the

method of productron and to the antibiotic itself. T h e t a sk o f f ind ing

h i the r to u n i d e n t ~ f i e d s t r a i n s o f microorganisms existing in the natural

state from w h ~ c h useful new antibodies can be prepared ca l l s for the

exercise of technical proficiency and practice. The r e su l t o f success in

it is a new product useful to humanity which does not exist in nature. If

such research i s t o be e n c o u r a g e d i n a c o m p e t i t i v e society, t h e

monetary rewards of success must be assured to those who undertake the

expense. An inventron for which the patent was claimed cons i s t ed t h e

cu l t i va t ion of ce r t a in s t r a ins o f a known microorganism wi th a v iew

t o t h e p r o d u c t ~ o n o f a new antibiotic.The claims extended both to the

method of production and to the a n t i b i o t i c i t s e l f . T h e microorganism

exis ted in nature i n very many strains,and even a skilled researcher might

not findthose relled upon by the appl icants a s the s tar t ing point of their

p r o c e s s . T h e m r c r o o r g a n i s m d e p o s i t e d b y C y a n a m i d w a s

219

a very weak straln The American Cyanamid wasordered t o fu rn i sh any

l icencee who reques ted i t , wi th v i ab le S. au reo fac ines c u l t u r e s t h a t

40 were handed over t o Pf izer . A fully genotyped organism can be de-

s c r i b e d by mere ly s t a t i n g i t s g e n o t y p e b a s e pa i r by p a i r .

Depos i t ion of m ~ c r o o r g a n i s m s i s a h a r d f a c t t o be a c c e p t e d by t h e

s c i e n t i f i c communt ty a s i t e n a b l e s a c o m p e t i t o r t o s t a r t w i th t h e

research work immediately.

Microorganisms are normally deposited in culture collection a s a means

of supplementing specification. The requirement is widely followed and

is intended to s a t ~ s f y the statutory requirement that the specification must

instruct persons skilled in the art o f manner and process of making the

inven t ion . 'l 'hus t h e r equ i r emen t c a n be c a l l e d a s a r ep roduc ib i l i t y

requi rement Cu l tu re c o l l e c t i o n s d a t e s b a c k t o 1900 when t h e Kra l

41 co l l ec t ion was e s t ab l i shed in P rague . In t h e U.S. t h e r e a r e t h r e e

cu l tu re collections recognised a s In te rna t iona l Depos i ta ry Authori-

t i e s under the Budapes t t rea ty . T h e Agr i cu l tu ra l Resea rch Se rv ice

40. American Cyanam~d Co. (Dann's) Patent . [1971]RPC 425.

41lver P Cooper. Biotechnology and the Law, Vol.1. (1993), p.552.22.

220 depository i n the United States contributed much t o the development of

penicillin. It was rn 1949 that the PTO directed the deposit of mic roor -

ganism in a cu l tu re co l l ec t ion t o compensa te fo r the inadequac ie s o f

the written desc r ip t~on . The first deposit of a microorganism was made

on July 8, 1949 when Parke Davis Co. deposited a culture of streptomyces

42 Venezuela w ~ t h the American type culture collection.

In the United States there are rules of practice that states how a deposit o f

a biological materlal has to be made. The deposit shall be regarded as

acceptable only when made in accordance with the regulations. Deposit

ofa biological material is not necessary when the biological material used

43 are known and readily available to the public. An original deposit o f

t h e biological m a t e r i a l has t o b e made w h i l e t h e a p p l i c a t i o n i s

44 pending. The Rule also makes provision for replacement, if the deposited

45 mater ia l has become con tamina ted . T h e depos i t o f t h e b io log ica l

42.lver P. Cooper, B~otecbndopy and the Law, Vol.1, (1993), p.5-52.22.

43.37 C.F.R. Sec.1 802

22 1

material has to be for a term of a t least thirty years and a t least 5 years

46 a f t e r the most recent reques t fo r a sample . Pub l i c has t o be gran ted

access to the deposited sample when the patent is granted but the request

47 for the sample must be in writing and should identify the requesting party.

Cont rovers~es also surrounded the t ime when the deposit has to be made

In re Lundak was a claim to a n immortal B. cell l ine itself. On the date of

application the cell line was available at three places by the members of

the faculty of the University of California. The cell line was deposited

with the IDA only at a later date. The question was whether the non de-

posit of the cell l ~ n e with an independent depository a t the date of patent

application was material or not. The three fold requirements for granting

a patent are whether at the t ime the appl icat ion i s f i led, i t i s fully

capableof b e ~ n g reduced t o p rac t i ce , whe the r d u r i n g t h e pendancy

o f the a p p l i c a t ~ o n , the examine r wi l l be a b l e t o eva lua te t h e c l a imed

inven t ion a s new. non obvious, whether a t issuance one of ordinary

skillwill be able to make use of the claimed invention. It was heId that the

46. Budapest Treaty Regulation, Rufe 9.1

47. /bid Rule 11 3(a)

222

availability of the cell line with three members o f the faculty itself proves

that it is fully capab le of be ing r educed t o p rac t i ce . I t was a l s o he ld

tha t i t was not mate r i a l whe the r t h e s a m p l e o f t h e ce l l l i n e r e s ided

48 in t h e hands of an independent depository or not. The Rules regarding

I deposit also accepted this view that the original deposit may be made ei-

49 ther a t the date of application or during i ts pendency.

Another issue w h ~ c h arose was whether a deposit with the authority is

enough to sa t~s fy the enablement requirement or should the public be given

access to i t The deposit of an organism on condition that distribution of

the organism should be with held t i l l a United States patent is issued was

considered as valid. The microorganism need not be made available to

the public at the time of fi l ing of the application. The Budapest Treaty

provides tha t the IDA may fu rn i sh s a m p l e s t o the gene ra l pub l i c i f

the request 1s on the prescribedform. Authorization from the depositor i s

50 not necessary in such cases. A request for a sample must be in writing

48. In re Lundak. 227 USPQ 90 (Fed. Cir. 1985)

49.37C.FR Sec 1.804

5O.Budapest Treaty Regulation, Rule 11 (3) (a)

223 51

and shou ld s t a t e t h e a c c e s s i o n number g iven t o t h e depos i to r . T h e

Indus t r ia l property office has to certify that the certified party has a right

to the samples The Industrial property office will automatically certify

the request if the requester calls attention t o the patent number and the

passage refers to the deposit. All restrictions on availability to the public

of the b io log~ca l material so deposited will h e removed on the grant of

the patent. 'I he only exception i s those required by law or regulation for

5 2 safety and p u b l ~ c health.

Use of an Independent depos i tory would minimize the opportunity for

intentional or negligent mishanhandling of the depos i t ed ma te r i a l . Bes t

mode requirement insisted by U.S. patent law make sure that the inventor

does not keep the best as a trade secret.

The Pa ten t Co-ope ra t ion Trea ty a l s o s t a t e s t h e manner i n wh ich t h e

in t e rna t iona l app l i ca t ion s h o u l d r e fe r t o t h e d e p o s i t i n g o f a micro-

53 organism in a c u l t u r e c o l l e c t i o n . An applicant who fails to deposit

51 .Budapest Treaty Regulat~on. Rule l l(4) (c)

52.37C.F.RSec 1 808

53.PCT, Rule 13

224

according to the Rules will have to abide by the national laws. The Treaty

requlres ~ n d ~ c a t ~ n g the name and address of the depository institution and

the date of d e p o s ~ t of the microorganism and also the accession number

54 given to the d e p o s ~ t by that institution.

55 The TRIPS Agreement r e q u i r e s t h e p a t e n t i n g of mic roorgan i sms .

Ind ia has to enac t l eg i s l a t ive measu res des igned t o b r ing i t s l ega l

f ramework i n compitance with theTRIPS obligations.

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54. PCT, Rule 13 3

55.TRIPS Agreement. Arl. 27(3)(b)