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THE ICFAI UNIVERSITY, DEHRADUN

ICFAI LAW SCHOOL

TOPIC – BIOTECHNOLOGY PATENTING DIFFERENCE


BETWEEN USA AND INDIAN PERSPECTIVE

Submitted to: Ms. Ayushi Mittal Submitted by : Meghna Shukla (Assistant


Professor) Enrollment No. : 17FLICDDN01066

BBA LLB(hons), 3rd Year

Section : A

1
TABLE OF INDEX

S. No. TOPIC Page No.


1 Introduction 5
2 BIOTECHNOLOGY PATENTING -INDIAN 9
PERSPECTIVE
3 Monsanto case 11
4 BIOTECHNOLOGY PATENTING- U.S. 14
PERSPECTIVE
5 Challenges 17

2
TABLE OF CASES

S. No. CASES Page No.


1. J.D. Houvener, founder & CEO of Bold IP 8
2. Monsanto Technology v Controller General of 11
Patents
3. DIAMOND V. CHAKRABARTY 447 U.S. 303 13
(1980)

TABLE OF ABBREVIATIONS

3
Abbreviations Abbreviated Words
TRIPS Trade Related Aspects of Intellectual
Property Rights
DNA Deoxyribonucleic Acid
EU European Union
USPTO U.S. Patent and Trademark Office
IPAB Intellectual Property Appellate Board
IP Intellectual Property

INTRODUCTION

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Biotechnology is a culmination of human intervention and natural processes. Biotechnology is
not new but exists since ancient times and its progress has been witnessed through many
centuries. The term “biotechnology” is defined broadly to include not only the old
biotechnology such as the traditional method of manufacturing fermented products but also
the new biotechnology represented by genetic engineering and recombinant technology.

In earlier days fermentation technology was used to produce and preserve goods for a long
time. Biotechnology proved itself to be in the field of miracles when it produced genetically
modified or non-natural living organisms. Genetic engineering is capable of manipulating
living organisms and making such organisms to perform and function in a way different from
the natural ones.

Ever since a genetically engineered micro-organism was granted patent, the field of
biotechnology gained enormous significance and patents have been granted on genetically
engineered plant and human genetic material. Though evolution of patent law on
biotechnology dates back to seventh century, the global adoption of the patent system started
in Venice as the first patent law was enacted in 1494, which regarded as the foundation for the
world’s patent system. The requirements enshrined in the Venetian Statute such as utility,
novelty and non-obviousness are still the basis of modern patent law around the world.

Earlier nobody thought that biotechnology could manipulate either plant or animal or human
being and therefore none thought of the need for evolving a comprehensive law on
biotechnology for regulation. However, as biotechnology has progressed in various
generations at different times and this field mandated a comprehensive legal framework for
proper regulation, TRIPS agreement provided protection and regulation of various
biotechnology inventions as well. Under the patent regime around the world the significance
of biotechnology and its inventions are recognized and protected. The biotech inventions
could be patented following the patentability criteria; however there exists complexity of
manipulating of living forms hence need special attention.

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This paper will examine and analyze the effectiveness of TRIPS-level patent protection as an
incentive mechanism for enhanced biotechnology innovation in India and how to enhance
patent protection on novel biotechnology products by prosecuting the patent applications in an
articulate manner in the Indian Patent Office. The trend of filing biotechnological patents in
India has a steady growth as in 2008-09 the total filing was 1884, 2009-10 the total biotech
application is about 2700, however the highest filing recorded so far is 2774 in 2007.

Patents Are Crucial For Promoting Medical Progress


i i i i i i

Advances iin ithe ilife isciences iand ipharmaceutical isector ihave had an impact on life expectancy
i and i the i quality iof ilife. i Most i modern imedicines i are ibased i i i i i i i i

on biotechnology.
Hands iholding ian iinsulin ipen iOne iof ithe iearliest ibiomedical idocuments iwas iinsulin, ia ilife-
saving idrug ifor idiabetics. iOver ithe iyears imany iimproved iforms iof iinsulin ihave ibeen
i developed, iand ithis icontinuous iinnovation ihas ibeen isupported iby ipatents igranted ifor ithe inew
i compounds.

Other ipatented imedical iinventions ihave iprovided ibreakthroughs iin iDNA ifingerprinting,
i paternity itesting iand iblood itransfusions, iwhere ipatented itests ito icheck idonated iblood ifor ithe
i presence i of i deadly iviruses ihave iimproved i patient isafety.

Many ianti-cancer idrugs ibased ion ipatented ihuman igene isequences iare iprolonging ithe ilives iof
i cancer ipatients, isuch ias iHerceptin ifor ibreast icancer iand iAvastin, ifor icolon iand iother cancer.
i Humira, ia ipatented imedicament ibased ion ihuman igene isequences iused ito itreat i i

i diseases isuch ias iarthritis, iwas ithe iworld's ibest-selling imedicine iin i2014. iEight i auto-immune
i i i

i 10 ibest-selling imedicaments iwere ibiological iin iorigin iand icovered iby ipatents. out of the top

It iis ienormously iexpensive iand itime-consuming ito idevelop ia inew idrug iand iobtain imarket
i approval, iand ithe inecessary ifunds iare ilargely iprovided iby iventure icapital isupplied iby
i investors.

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Drug icompanies iwould inot ibe iable ito ifund icostly iclinical itrials iand iresearch iwithout ibeing
i able ito iclaim iexclusive irights ito irecoup ithese iinvestments. iPatents iare ialso ian ieffective ibarrier
i to iillicit icopying iof imedicines iand ithe ihealth irisks iassociated iwith iunauthorized icopycat
i versions.

A idoctor ivisits ia ichild ipatient iin ihospital iPatents iconstitute ia ilimited iexclusive iright ionly:
i Once ithe ipatent ihas iexpired i(after ia imaximum iof i20 iyears), ithe iinvention ifalls iin ithe ipublic
i domain iand ican ibe iused iby ianyone iwithout ipaying iroyalties. iNational iauthorities iwork iwith
i pharmaceutical icompanies ito inegotiate ilower iprices ifor imedical iproducts, iand iafter ithe ipatent
i has iexpired, i cheaper igeneric icopies i may ienter ithe i market.

The ipatent isystem ialso icreates itransparency: iPatent iapplications iare ipublished 18 months after
i filing, iso ithey idisclose idetailed iinformation i about ithe ilatest technical i i i

i i
improvements.

Patentability requirements
i

Biotechnology ipatents ifall iunder ithe iscope iof iutility ipatents. iA iutility ipatent iis iavailable ifor ian
i invention ior idiscovery iof ia inew iand iuseful imachine, imanufacturing iprocess, icomposition iof
i matter, ior iprocess. iThis itype iof ipatent iis ialso iavailable ifor iimprovements ito ia iprocess that are
i i
i considered inew i and i useful.

Despite ithe icritical irole ithat ibiotechnology iplays iin isaving, iimproving, iand iextending human
i life, ithere iis ian iextremely icomplicated iprocess ibehind ithe iwork iof ipatenting i i i

i ideas i and i advancements. these scientific

When ian iinventor iapplies ifor ia ipatent, ithey imust idemonstrate ithat itheir icreation imeets icertain
i eligibility irequirements. iFor iexample, iin ithe iUnited iStates, ithe iUS iPatent i& iTrademark iOffice
i set iforth ifive ielements ifor ipatentability. iTo iqualify, ian iinvention imust ifall iunder isubject-
matter ieligibility, ihave iutility, inovelty, ibe inon-obvious, iand inot ihave ibeen ipreviously
i disclosed.

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Then, iin iEurope, ithe iEuropean iPatent iOffice istates ithat ia ipatentable iinvention can be a
i product, ia iprocess ior ian iapparatus. iTo ibe ieligible ifor ia ipatent, i“it imust i i i i i i

i applicable iand i involve ian iinventive istep.” be new, industrially

When imembers iof idifferent iEU imember istates iapply ifor ipatents iwith ithe iEuropean iPatent
i Office, itheir ipatent ireceives inational ivalidation iin ieach istate ithat iis ia iparty ito ithe iEuropean
i Patent iConvention. iArticle i2 iof ithe iconvention istates ithat i“a iEuropean ipatent ishall, iin ieach iof
i the icontracting istates ifor iwhich iit iis igranted, ihave ithe ieffect iof iand ibe isubject ito ithe isame
i conditions ias ia inational ipatent igranted iby ithat istate, iunless iotherwise iprovided iin ithe
i European iPatent i Convention.”

Patentability issues around biological materials


i i i i

“An iexaminer iis igoing ito itry ito ireject ia ibiotechnology iapplication iby isaying ithat ithe iscientist’s
i invention iis imerely ia icreation iof inature. iThey iwill iargue ithat ia iscientist imade ian iobvious
i variant iof iwhat iorganically ioccurs iin inature. iThis iis iineligible ifor ia ipatent. iThis iis iespecially ia
i problem iwhen i it i comes i toi geneticallyimodified iorganisms, itissues iand icells,”1

In iterms iof inovelty, ithe icomplication ifor ia ibiotechnologist iis idemonstrating ithat itheir icreation
i is ia i‘new’ iprocess irather ithan imerely ia inatural ione. iThe iprocess ialso iinvolves ihaving an
i
i inventor idemonstrate ithat i their iinvention iis i the i first iin ithe iworld ito ido iits ispecified i action.

While iany iinvention iin ithe ifield iof itechnology ican ifeasibly be eligible for a patent, the
i patentability iof i biological imaterials iis ioften ia isource iof i i i i i i i

controversy.
Some iargue ithat isuch ibiological imaterials iare imere idiscoveries, iand itherefore inot ipatentable.
i Others iargue ithat icertain ibiological imaterials iare iman-made iinventions, iand iare itherefore
i patentable.

Another isource iof icomplexity iregarding biotechnological inventions results from the fact that
i i i i i i i
i biological imaterial iis icapable iof ireproducing iitself. iThe ipotential ifor ithis ishift iinvokes iseveral
i complications, ias ione ican iimagine. iFor iexample, ia ibiological imaterial imay ibe ipatented ias iit iis

1 J.D. Houvener, founder & CEO of Bold IP.


i i i i i i i i

8
i one imoment, ibut imight ichange ior imorph ithe inext imoment. iThis iwould beg the question of
i whether ithe i patent icovers ithe i shift ior istops ipoint iblank iat i the i invention i i i i i

pre-shift.

BIOTECHNOLOGY PATENTING -INDIAN PERSPECTIVE

i i i

Evolution of Indian Patents Act


British rulers enacted the first ever patent law in India the Act VI of 1856 on protection of
inventions based on the British patent law of 1852. After several modifications in 1859, 1872
and 1888, the consolidated Indian Patents and Designs Act, 1911was enacted and offered
patent protection to the inventions. In the light of changing socio-politico scenarios in India
there were moves to consolidate the patent law by bringing up a new legislation and the
outcome is the enactment of Patents Act 1970. The Patents Act 1970 highlights the invention
that satisfies the universally accepted requirements of patentability such as novelty, inventive
step and industrial application. The Patents Act 1970 had undergone several amendments in
1999, 2002 and finally the Patents (Amendment) Act 2005 (hereinafter referred to as the
Patents Act) with introduction of product patents on substances capable of use as medicine,
drug, or food could be obtained when India completed implementation of TRIPS required
amendments to its Act. Further considerable changes have been made in the patenting
procedure through the introduction of Patent Rules, 2003 further amended in 2005 and 2006,
resulting in new practice and procedure. The Patents Act does not specify which are
patentable, but it illustrates subject matters that are not patentable. The Patents Act enacted in
1970 does not mention anything about biotechnology invention. Judicial pronouncements in
the US and EU and suitable intervention by judiciary led to amendments of patent laws in
these countries as efforts were made to grant patents to biotech inventions. The same approach
gained significance in India as well. India’s patent third laws were amended in 2002 to
explicitly include biochemical, biotechnological, and microbiological processes within the
definition of potentially patentable chemical processes. However, the formal bio-guidance is
the need of the hour as biotechnology is gaining momentum in India. The requirement of
submission of working of patents in India is another salient feature of the Indian Patents Act.

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This paper will discuss the effectiveness of patent protection to enhance biotechnology
innovation in India. The paper further overviews expanding biotechnology patenting activity
in India and Provisions of India’s current patent laws particularly relevant to biotechnology
inventions with the watershed judicial decisions for biotechnology patenting in India.

What Is Not Patentable In India?


i i i i i

 Section i3 i(b) i- i. iAs iper ithe isection ian iinvention iwould inot ibe ipatentable iif iit iis iimmoral
i or iagainst ipublic iorder, iharmful ito ihuman, ianimal ior iplant ilife ior iharmful ito
i environment
 Discovery iof iliving ithings ior inon- iliving isubstances iin inature i- iSection i3 i(c)
 Plants iand ianimals iin iwhole ior iany iparts ithereof iother ithan imicro-organisms ibut
i including i seeds, i varieties iand ispecies i- iSection i3 i(j)
 Essentially ibiological iprocesses ifor ithe iproduction ior ipropagation iof iplants iand
i animals– iSection i3 i (j)
 Any iProcess ifor ithe imedicinal, isurgical, icurative, iprophylactic, idiagnostic ior
i therapeutic ior iother itreatment iof ihuman ibeings ior ianimals ito irender ithem ifree of
i
i disease ior ito iincrease i their i economic ivalue ior ithat iof itheir iproducts i– iSection i 3(i)
 Methods iof iagriculture ior i horticulture i– i Section i3(h)
 Traditional iknowledge i– iSection i3(p)

Monsanto case

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The case of Monsanto Technology v Controller General of Patents2 brought this particular
aspect into focus before the IPAB3 last July. Although the appeal filed by Monsanto against
the patent office’s decision was eventually rejected by the IPAB, the patent office’s decision is
extremely significant in that it interprets the expression “essentially biological processes”.
The Indian Patent Office had refused the grant of a patent to Monsanto for an invention
described as “a method of producing a transgenic plant with increased heat tolerancesalt
tolerance, or drought tolerance” based on the following key grounds:

1. That the subject matter of claims was considered to lack inventive step in view of
prior art documents cited in the office action;
2. That the claims in the application were not considered to qualify as an invention.
The reason offered for rejection was that the structure and function of a cold shock
protein was disclosed in the cited prior art, and was, therefore, obvious to a person
skilled in the art to make a transgenic plant
3. The claimed invention was considered un-patentable as it was regarded as a mere
application of an already known cold shock protein in producing cold stress tolerant
plants as well as plants tolerant to heat, salt and drought conditions; and
4. Last but not least, it was held that the claims in the Monsanto patent application fell
under the proscription of Section 3(j) of the Patent Act. The primary reason offered for
rejection under this ground was that the claims related to “essentially biological
processes” of regeneration and selection, which in turn included growing of plants in
specific stress conditions.

Dissatisfied by the controller’s decision, Monsanto filed an appeal before the IPAB.
Considering the matter after hearing both parties, the board upheld the decision of the Indian
Patent Office on the first three grounds listed above but, significantly, overruled the patent
office’s findings on Section 3(j). The IPAB affirmed that the claimed method of the case
being considered included an act of human intervention on a plant cell and produced in that
plant cell some changes, which took it outside the proscription of Section 3(j).

i Patenting of Micro-organisms and Cells


i i i i
22013

3 Indian Intellectual Property Appellate Board

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The ifirst isuccessful idirected iinsertion iof irecombinant iDNA4 iinto ia ihost imicro-organism
i took iplace iin i1973, iand isince ithen iscientists irealized ithe ihuge ipotential iinvolved in
i directing icellular imachinery ito idevelop inew iand iimproved iproducts iand iprocesses. i i

i of ithese iproducts iwere imicro-organisms ior icells. iHence iwith ithe idevelopment iof
Many
i the

i recombinant iDNA itechnology, ithe ipotential iof ipatenting ithe iliving iorganism iresulting
i from i the i technology iarose.

In i1980, iin ithe iDiamond iv. iChakrabarty iruling, ithe iSupreme Court of US ruled that a living
i i i i i i i
i micro iorganism icould ibe ipatented. iChakrabarty ihad ideveloped ia igenetically imodified
i bacterium icapable iof ibreaking idown ithe imultiple icomponents iof icrude ioil. iSince ithis iproperty
i was inot ipossessed iby iany inaturally ioccurring ibacteria, ithe iinvention iwas ithought ito ihave
i significant ivalue. iIt iwas iheld ithat ia inon-naturally ioccurring imanufacture iwas ia iproduct iof
i human iingenuity. iDNA icompounds ihaving inaturally ioccurring isequences iare ieligible ifor
i patenting iwhen iisolated ifrom itheir inatural istate iand iwhen iit imeets ithe istatutory icriteria ifor
i patentability. iHence iby ia i5-4 iruling iit iwas iheld ithat ia ilive, ihuman imade imicro-organism iis ia
i patentable isubject imatter iunder isection i101 ias ia imanufacture ior icomposition. iThe ifact ithat
i biotechnology iwas i not i predicted ias ia ibranch iof iscience iwhen ithe icongress i enacted isection i101
i does inot i arrive i at i the i conclusionithat imicro-organisms i are inot ia ipatentable isubject imatter iuntil
i the i congress i expressly i authorizesisuch iprotection.

Post Chakrabarty trends


i i

The iChakrabarty idecisions5 iand ithe isubsequent iactions ienacted iby ithe iUS icongress
i provided igreat ieconomic istimulus ito ithe ipatenting iof imicro-organisms iand icells, iand iin
i turn iprovided istimulus ito ithe igrowth iof ithe ibiotechnological iindustry iin ithe i1980's.
i However, iincreased ipatenting iof ibiotechnological iinventions ihas iled ito i litigation irelated i to
i patent iinfringement iissues. iThe ipatent ilitigation iis ionly ilikely ito iincrease iin ifuture
4

5DIAMOND V. CHAKRABARTY 447 U.S. 303 (1980)

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i considering ithe ioverlapping iof ipatent iclaims, ithe ihigh ivalue iof iproducts, iproblem iof iprior
i publication iand ithe ifact ithat imany icompanies iare ipursuing ithe isame iproduct. iThe iincrease
iin ithe ipatent iclaims ileads ito ithe iinability iof ithe ipatent ioffices ito iprocess ithe
ibiotechnological iinventions i in ia itimely imanner. iTurnover iamongst ithe ipatent examiners,

i luring ithem i to i the iprivate isectors iby ioffering ihigher ipay ietc iare ireasons i i delay iin i the
ii

i reviewing iof i patents. for the

Patenting of Transgenic Animals


i i i

The ifirst ianimal ipatent iwas iissued iin iApril, i1988 ito iHarvard iUniversity ifor ia iparticular
itype iof imammal, inamely ithe iHarvard ioncomouse, igenetically iengineered ito iobtain ia
icancer- icausing igene. iThe ioncomouse ihas ibeen igenetically iengineered ito icarry
i

a
i particular itype iof igene icalled ias ithe ioncogene iwhich imakes iit isusceptible ito icancer iand
ihence imakes iit iideal ifor icancer iresearch. iSubsequently ithe iUSPTO iannounced ithat iit
iwould iconsider inon-naturally ioccurring inon-human, imulti-cellular iorganisms, iincluding

i animals ito ibe ipatentable i subject imatter iunder i its i laws.

Most iof ithe ianimal ipatents ihave ibeen igranted ito itransgenic ianimals iproduced iby
i recombinant iDNA ior igenetic iengineering. iTransgenic ianimals ihave iDNA iwhich ihas been
i modified iby iadding iDNA ifrom ianother isource iother ithan ithe iparental igermplasm, i i

i from idifferent ianimals i or i humans. usually

Moral Issues
i

It iis itrue ithat inecessity ipropels iany iinvention. iIn ithis inew iera iour inecessities are increasing
i fuelling iinventions ibut iagain iit iis iour iresponsibility ito iprotect iour irights i i i

too.
1. Organ iTransplantation i- iOrgan itransplantation iis ia ibig imoral iissue ifor ibiological ibased
i invention. iIt ipossess ia ibig imoral iissues. iThe ibiological iinvention ifacilitate ithe iorgan
i transplantation iis iopposed iby inumerous iintellectual ibased ion ireligious ifaith. iAlso iit iis
i anticipated i by i some i that i itimay igive irise ito iillegal iHuman itrafficking.

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2. Biological iWeapons i- iBiological iweapons iare ithe imost idreaded iones itoday, ifar imore
i dangerous ithan inuclear, ichemical ior iconventional iweapons. iDiscussion ion ithis iissue iis
i most icrucial.
3. Bioinformatics- iIt iis ia imethology iof ibiological istudies iimplemented iwith ithe ihelp iof
i computer iprogramme. iIt iis igenerally iused ifor igene iidentification iand iprediction iof
i upcoming idiseases. iMany ibelieve ithat ithis icould ibring ilegal iturmoil iin ithe isociety.
i Also iit imay ihamper ithe i natural iliving iof ihumans.

BIOTECHNOLOGY PATENTING- U.S. PERSPECTIVE


i i i

The ibiotechnology iindustry iis ivital ito ihuman iprogress iand iAmerica’s ieconomy. iThe isector
i depends iheavily ion ithe iincentive iprovided iby ipatents ito irationalize ithe ienormous irisk of
i investing iin i life i science iR&D. iThese irisks ipay ioff ifor isociety iby igenerating isolutions i that i

i diagnose, iprevent, iand itreat idiseases iand idisorders; iimprove ihuman ihealth iand iifood
help
i production; iand iprovide igreater ienergy isecurity, iwater idevelopment, iand ienvironmental
i protection. iThese iaccomplishments, imoreover, icreate iwell-paying ijobs iand idrive iglobal
i competitiveness.

Despite ithese ipositive iattributes, iquestions iand icontroversies iare iemerging iat ithe inexus iof
i biotechnology iand iour ipatent isystem. iThese ichallenges iwill ihave isignificant iimpact on a wide
i array iof iscientific idisciplines, iincluding imolecular ibiology, biotechnology, i i i

i genetics, iand ibioinformatics. iIndeed, ithese iare isectors iin iwhich


i ithe iUnited iiStates
embryology,
ihas ia

i comparative iadvantage ithat imust ibe imaintained. iHow iwell isociety iaddresses ithese iissues iwill
i significantly iinfluence i the i state iof iour ieconomy iand icreative icapacities ifor iyears ito icome.

The ibasis iof ithe iAmerican ipatent isystem iis ifound iin iArticle iI, iSection i8 iof ithe iU.S.
iConstitution, iwhich iempowers iCongress i“to ipromote ithe iProgress iof iScience iand
i i

useful arts,
i by isecuring ifor ilimited iTimes ito i… iInventors ithe iexclusive iRight ito itheir i… iDiscoveries.”
i Congress ienacted ithe ifirst ipatent istatute iin i1790 iand iamended it in 1793. The 1793
i amendment idefined, iwhat iwas ipatentable: i“any inew iand i i i machine,
i i i
i

manufacture,
i i
i

or
i composition iof imatter, ior iany inew ior iuseful i usefulithereof.”
art, 6
iJefferson's iphrasing

i remains iat ithe icore iof ithe iU.S. ipatent icode, iexcept
improvement
i i
i i i i

replacement of the 18th-century


for the

6Thomas Jefferson
i

14
i word i“art” iwith ithe imodern iequivalent i “process” i in i a i 1952 i congressional i overhaul i of i patent
i law.

This ichapter iaddresses iintellectual iproperty iissues iin ithe icontext iof igenomics iand iproteomics,
i focusing ion ipatent ilaw iand iinterpretation—specifically, ifields iof iactivity, iapplicable ilaw, iand
i limitations ion ilicensing iand ienforcement

What Is Patentable In U.S.?


i i i i

To ibe ipatentable isubject imatter iin iUSA, ian iinvention should be a process, machine,
i i i i i
i manufacture ior icomposition iof imatter ior iany iimprovement ithereof. iThere iare ithree ijudicially
i created iexclusions ito ipatentable isubject imatter iin iUSA. iThey iare iLaws iof inature, iphysical
i phenomena, iand iabstract iideas. iBiotechnology i(Biotech) iinventions i are i considered i to i be
i eligible isubjects ias i Compositions iof imatter i or i manufactures.

The iexclusion imost irelevant ifor ibiotech iinventions iis i‘Laws iof inature’ iexclusion. iUS iCourts
i have iconsistently iheld ithat ias iper ithe iexclusion ianything ithat inaturally iexists ior iis ia i‘product
i of inature’ iis inot ipatentable. iThe iquestion irelating ito ipatentability iof imicro-organisms ifirst
i came ibefore ithe iUS iSupreme iCourt iin iFunk iBros. iSeed iCo. iv. iKalo iInoculant iCo. iThe icase
iinvolved ian iinvention irelating ito ia imixed iculture iof iRhizobium ibacteria icapable iof
isimultaneously iinoculating ithe iseeds iof iplants ibelonging ito iseveral icross-inoculation igroups.

i The icourt iin ithis icase iheld ithat ithe imere iaggregation iof ispecies ifell ishort iof iinvention iwithin
i the imeaning iof ithe ipatent istatute ibecause ithe icombination iof ispecies iproduced ino inew
i bacteria iand ino ichange iin ithe isix ispecies iof ibacteria. iAs ithere iwas ino ichange iin ithe ispecies,
ithe icourt istated ithat iqualities iof ithe inon-inhibitive istrains iwere ithe iwork iof inature iand
itherefore inot i patentable i subject imatter.

Later, ithe iUS iSupreme iCourt iin iDiamond iv. iChakrabarty, ia ilandmark ibiotech icase, iobserved
i that ieverything iunder ithe isun imade iby iman iis ipatentable. iThe icase irelated ito ipatentability iof ia
i genetically imodified ipseudomonas ibacterium icapable iof idegrading ioil ispills iand ia iprocess iby
i which ifour idifferent iplasmids, icapable iof idegrading ifour idifferent ioil icomponents, icould be
i
i transferred ito iand imaintained istably iin ia isingle iPseudomonas ibacterium. iThe ipatent
i application irelating ito ithe ibacterium iwas irejected ion ithe iground ithat ithe ibacterium iwas ia
i product iof inature iand ithat iit iis ia iliving iorganism. iOn iappeal, ithe iUS iSupreme
i invention is patentable because it is

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i characteristics ifrom iany ifound iin inature. iThe iSupreme icourt ifurther istated ithat ithe itest ifor
i determining iwhether ian iinvention ifalls iwithin ithe iscope iof i‘Product iof inature’ iis iwhether ithe
i invention iin iquestion iinvolves ia ihand iof iman. iIf iyes, ithe iinvention iis inot product of nature or
i i i i
i naturally i existing. i If i No,iit iis inaturally iexisting iand itherefore inot i patentable.

As ithe ipseudomonas ibacterium iin ithe icase iinvolved ithe ihand iof iman iin iinserting ifour idifferent
i plasmids iinto iit, ithe icourt iheld ithat iit iwas inot inaturally iexisting iand itherefore ipatentable. iIt
i also istated ithat iliving iorganisms iwere inot iexcluded ifrom ithe iscope iof ipatentable isubject
i matter iin i USA.

After ithe iChakrabarty’s idecision iexpounded ithe iproduct iof inature idoctrine, ipatents ihave ibeen
i granted ito ivarious imulti-cellular iorganisms. iPatents iwere igranted ito ipolyploid ioysters,
i genetically imodified imice, irabbits iand iso ion. iFurthermore, iin iUSA, igene isequences, igene
i therapies iand isoon ihave ialso ibeen iheld ito ibe ipatentable isubject imatter. iWith irespect ito igene
i sequences, ithe iextent iof i their i patentability iis itoday ibefore ithe iCourt iof iAppeals ifor ithe iFederal
i Circuit, i which iis ithe i patent i appealsi courti iniUSA.

Though ithe iscope iof ipatentable isubject imatter iis ivery broad in USA, human beings are not
i i i i i i i
i considered ito ibe i patentable isubject imatter. iA ipatent iapplication ifiled iby iDr. iStuart iNewman iof
i New iYork iMedical iCollege icovering ifusion iof iembryonic ihuman iand ianimal icells ito icreate
i chimeras ifor imedical iresearch iwas irejected iby iUSPTO iand isuch irejection iwas ilater iapproved
i by ithe iCourt.

Challenges

 ADMINISTRATIVE iCHALLENGES- iThe ipatent isystem iis iplagued iby ithe ifollowing
i three imajor iproblems ithat icreate iuncertainty iand ipile ion ihigher icosts ithat iencumber ithe
i biotech isector’s iability ito i maintain ia i high i rate iof iinnovation:

16
1. iPatent ibacklogs iand iapplication iprocessing idelays idue ito ithe iU.S. iPatent iand iTrademark
i Office’s i(USPTO’s) imushrooming iworkload, ithe iincreasing icomplexity iof ipatent iclaims, iand
i an iinability ito i recruit iand i retain i technically isavvy i examiners.

2. iPoor ipatent iquality, isuch ias ioverly ibroad ior iill-defined intellectual property (IP), which
i i i i
i adds iuncertainty iand i spawns iresource-sapping ilawsuits.

3. iExcessive ilitigation, iincluding ithe iactions iof ipatent itrolls icreated ito ibuy ipatents ifor the
i purpose iof iclaiming iinfringement iand iextracting ifees, irather ithan iusing iIP ito imarket i i

i goods. useful

 LEGAL iCHALLENGES- Four major legal challenges dominate the biotech patent
i i i i i i i i
i landscape:

1. iDefining iwhat idegree iof ialteration ito inaturally ioccurring imatter, isuch ias ia igene isequence, iis
i necessary ito iqualify ias ia ipatentable i“invention” iin ilight iof ithe iSupreme iCourt’s i2013
i Association i for i Molecular iPathology i v. iMyriad iGenetics, iInc. idecision.

2. iIdentifying iwhat iconstitutes ipatentable utility, novelty, unobviousness, and description of


i altered igenomic iand iproteomic i i i i i i

material. i

3. iClassifying iwhat constitutes patent infringement, particularly for academic research using
i patented genomic i i i i i i i i

i i
material.
4. Protecting IP rights, i particularlyi abroad.
i i i

 INNOVATION iCHALLENGES- iMeeting ifour imajor ichallenges iarising iat ithe


i intersection iof ibiotech iand ipatent ipolicy iwill ideeply iinfluence ithe ifertility iof ithe iU.S.
i innovation isystem:

1. iFinding ithe iinnovation isweet ispot iwhere igenuine iintellectual iproperty iis iduly iprotected,
i while istimulating ithe iopenness, ifreedom, iand icollaboration iupon iwhich ithe iscientific iprocess
i thrives.

2. iClarifying iwhat iqualifies ias ipure iresearch iversus icommercial ipursuit ifor purposes of patent
i i i
i infringement iindemnification.

17
3. iFostering ithe isharing iof ibiomedical idata ias ian iopen iplatform ito idrive iinnovation.

4. iReducing ipolicy iand ilegal iuncertainty, icreated iby ichanging ipatent istandards, in
i transparency iof ipatent iawards, iuneven iIP iprotection, itrolling iabuses, iand iprivacy i rules, i so i that
i the iinnovation i system ican i function imore iefficiently. i

 ETHICAL iCHALLENGES- iFour iethical ichallenges imust ibe iovercome ito imaintain ia
i vigorous ipace i of i biotechi development:

1. iAddressing ipublic iconcerns iregarding ithe ihuman alteration of genetic codes—the blueprints
i i i i i
i for ilife.

2. iCoping iwith iunintended iscientific, isocial, ienvironmental, iand ipublic ihealth iconsequences
i from iDNA imanipulation.

3. iMaking ilifesaving ibiomedicine iavailable ito ithose iwho ican’t iafford it while continuing to
i i i i
i incentivize iinnovation.

4. Protecting privacy of personal genomic information


i i i i i i

BIBLIOGRAPHY

1. https://www.labiotech.eu/features/biotechnology-patents-intellectual-property/
2. https://www.epo.org/news-issues/issues/biotechnology-patents.html
3. Biotechnology iPatenting iIN iIndia iand iRelated Issues Rajashree Sharma
i i i

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4. https://www.mondaq.com/india/x/758110/Patent/Biotechnology+Patent+And+Related+
Moral+Issues
5. https://www.remfry.com/wp-content/uploads/2017/11/challenges-patenting-essentially-
biological-processes-in-india-lsipr.pdf
6. https://notesforfree.com/2018/01/18/patent-case-brief-diamond-v-chakrabarty/
7. https://www.ncbi.nlm.nih.gov/books/NBK19867/
8. https://www.bananaip.com/ip-news-center/patentability-of-biotech-inventions-in-4/

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