Intellectual Property Rights

Assignment

Patentability of Biotechnology In India

MTECH (BIOTECHNOLOGY) 1ST SEM2014-2016

SUBMITTED TO: - SUBMITTED BY:-

Mrs. Bhavna RathiRENU RAWATMr. Puneet Kacker Roll No.: 1027Amity Institute of BiotechnologyShifali Pandey

Roll No.: 1021

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1. Introduction

Biotechnology is a culmination of human intervention and naturalprocesses. Biotechnology is not new but exists since ancienttimes and its progress has been witnessed through many centuries.The term “biotechnology” is defined broadly to include not onlythe old biotechnology such as the traditional method ofmanufacturing fermented products but also the new biotechnologyrepresented by genetic engineering and recombinant technology.

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

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

Earlier nobody thought that biotechnology could manipulate eitherplant or animal or human being and therefore none thought of theneed for evolving a comprehensive law on biotechnology forregulation. However, as biotechnology has progressed in variousgenerations at different times and this field mandated acomprehensive legal framework for proper regulation, TRIPSagreement provided protection and regulation of variousbiotechnology inventions as well. Under the patent regime around

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the world the significance of biotechnology and its inventionsare recognized and protected. The biotech inventions could bepatented following the patentability criteria; however thereexists complexity of manipulating of living forms hence needspecial attention.

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

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2. Evolution of Indian Patents Act

British rulers enacted the first ever patent law in India the ActVI of 1856 on protection of inventions based on the Britishpatent law of 1852. After several modifications in 1859, 1872 and1888, the consolidated Indian Patents and Designs Act, 1911wasenacted and offered patent protection to the inventions. In thelight of changing socio-politico scenarios in India there weremoves to consolidate the patent law by bringing up a newlegislation and the outcome is the enactment of Patents Act 1970.The Patents Act 1970 highlights the invention that satisfies theuniversally accepted requirements of patentability such asnovelty, inventive step and industrial application. The PatentsAct 1970 had undergone several amendments in 1999, 2002 andfinally the Patents (Amendment) Act 2005 (hereinafter referred toas the Patents Act) with introduction of product patents onsubstances capable of use as medicine, drug, or food could beobtained when India completed implementation of TRIPS requiredamendments to its Act. Further considerable changes have beenmade in the patenting procedure through the introduction ofPatent Rules, 2003 further amended in 2005 and 2006, resulting innew practice and procedure. The Patents Act does not specifywhich are patentable, but it illustrates subject matters that arenot patentable. The Patents Act enacted in 1970 does not mentionanything about biotechnology invention. Judicial pronouncementsin the US and EU and suitable intervention by judiciary led toamendments of patent laws in these countries as efforts were madeto grant patents to biotech inventions. The same approach gainedsignificance in India as well. India’s patent third laws wereamended in 2002 to explicitly include biochemical,biotechnological, and microbiological processes within thedefinition of potentially patentable chemical processes. However,the formal bio-guidance is the need of the hour as biotechnologyis gaining momentum in India. The requirement of submission ofworking of patents in India is another salient feature of theIndian Patents Act.

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This paper will discuss the effectiveness of patent protection toenhance biotechnology innovation in India. The paper furtheroverviews expanding biotechnology patenting activity in India andProvisions of India’s current patent laws particularly relevantto biotechnology inventions with the watershed judicial decisionsfor biotechnology patenting in India. .

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3. Biotechnology & Scope of Patent Law in India

Indian patent practice and jurisprudence with respect to thepatenting of biological materials are relatively new and thus notso well settled and/or uniform. There are several outstandingdeficiencies within the substantive law that needs addressing.Apart from narrow standards of patentability, biotech productsare faced with certain additional hurdles like mandatorydisclosure of biological material, prior approval from theBiodiversity Board and access & benefit issues under the IndianPatent regime.

While TRIPS does not allow exclusion of inventions that arenovel, non-obvious and industrially applicable en masse, theIndian law has a long list of exceptions to patentability:

a. TRIPS consistent - naturally Occurring components, animateor inanimate from biological material or their parts;process to obtain such components; isolation of livematerial, genetically modified or transgenic organism, cellparts; process for the isolation and modification;use/application of biological material;

b. TRIPS consistent - plants and animals as a whole or partsthereof; varieties of plants and animals, seeds, essentiallybiological processes of propagation;

c. Criteria not found in TRIPS – e.g., frivolous, simplecombination of known elements;

d. Criteria inconsistent with TRIPS – e.g., Inventions based onmethods of agriculture, horticulture; methods of business;methods for curative & prophylactic treatments; traditionalknowledge considered as not patentable.

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e. New requirement: not found in TRIPS - New use of a knownsubstance considered non-patentable. Salts, Esters, ethers,Polymorphs, Metabolites, Pure form, Particle size, Isomers,mixtures of isomers, complexes, composition, derivatives tooare considered non-patentable ‘unless they differsignificantly in properties with regard to efficacy’ or ifthey ‘do not result in the enhancement of known efficacy ofthe substance’.

f. New requirement: not found in TRIPS - mere admixture – e.g.,root-nodule bacteria of leguminous plants, use incombination does not improve natural functioning;

g. New requirement: not found in TRIPS - additional disclosureof source and origin biological materials for grant ofpatent (Further amendments to section 25 (j) & Section 64(p) of 1970 Act - non disclosure of origin and source ofbiomaterial - widens the scope of grounds for opposition andrevocation)

h. Restriction on scope of Patentability - Encompassing bio-chemical bio- technological and micro-biological processesin chemical processes by way of explanation for the purposeof product patent.

Its pertinent to mention that in order to give effect to TRIPSArticle 27(3) (b), a sui generis law Protection of Plant Variety andFarmer’s Rights Act 2001 has been passed to provide for effectivesystem for protection of the rights of plant breeders (PBRs) andfarmers and to encourage the development of new varieties ofplants.

The Indian Patents Act does not describe, in an inclusive manner,what is patentable. Rather, Section 3 includes a list ofinventions considered not patentable. In respect of biotechnologyinventions, the  Indian Patents  Act 1970 as amended till datespecifies  under  Section 3(a) to 3(e), 3(h) to 3(j) and3(p), inventions  that  will  not  be considered as a patentable

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subject  matter   in  India. However, Clauses 3(c) to 3(d), 3(i)to 3(j) and 3(p) are important in the context of patentability ofbiotechnological inventions. Clause 3(c) states that “The merediscovery of a scientific principle or the formulation of anabstract   theory or discovery of any living thing or nonlivingsubstances occurring in nature” will not be considered aspatentable invention. This provision of non-patentability iscommon to patent laws of other countries. The Clause 3(j) statesthat “Plants and animals in whole or any part thereof other thanmicroorganisms including seeds, varieties and species andessential biological processes for production or propagationof plants and animals as non-patentable invention”. Thisprovision differs from  the patent   laws of  countries  like the US,   the European Union,  and Japan,  who follow  liberal patent  standards and where patents are also granted togenetically modified organisms and plant  varieties.  Thisexception of non-patentability is allowed as per TRIPS Agreementprovided member countries provide alternate effectivesystem for protection of plant varieties (sui generis system).

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4. A summary overview on biotechnology patenting activity inIndia

Though inventions in this biotechnology category filed weremostly of the foreign origin but there was considerable increasein Indian applications. Inventions were mostly in the field ofrecombinant DNA molecule, recombinant vaccine, monoclonalantibodies, recombinant therapeutic molecules, diagnostic kits,stem cells, recombinant vectors, Isolated Nucleic acid encoding agene, Method of preparation of recombinant hormones, DNA relatedinventions such as preparing plasmids, vectors etc, bioleaching,biotransformation, biological treatment of waste, gene andsomatic cell therapy, pluripotent stem cells derived fromregenerative tissue, recombinant microbes expressing chimeric HIVprotein, regulation of cell mediated immune response, recombinantinterleukin IL-18 inhibitors, plastid transformation vectors,Waste water and sewage treatment using microorganism, conjugatevaccine against cholera and tetanus, peptide based immunotherapyfor atherosclerosis, mixed cell gene therapy, bone regenerationby gene therapy and treatment of flower.

As, in other jurisdictions, in India too, the subject matterclaimed as the invention, must be new, non-obvious, industriallyapplicable and requires sufficient disclosure. When the existenceof a new compound or element in nature is discovered, one can notobtain a patent on it because the form as it exists in nature isnot new. Further to translate the discovery into a patentablesubject matter, the discovered component must be substantiallychanged through human intervention into a form in which it doesnot occur in nature, or employed in a process resulting intotechnical advancement and/or economic significance.

Following are some instances of non patentable subject matter perse; however fulfilling certain criteria like functions thebiotechnological inventions are patentable.

I. Non-patentable inventions

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A. Ordre public and morality exception - Section 3 (b)- . Asper the section an invention

would not be patentable if it is immoral oragainst public order, harmful to human, animal or plant life or harmful to environment.

B. Discovery of living things or non living substances innature - Section 3 (c)

C. Plants and animals in whole or any parts thereof otherthan micro-organisms but including seeds, varieties andspecies - Section 3 (j)

D. Essentially biological processes for the production orpropagation of plants and animals– Section 3 (j)

E. Any Process for the medicinal, surgical, curative,prophylactic, diagnostic or therapeutic or othertreatment of human beings or animals to render them freeof disease or to increase their economic value or that oftheir products – Section 3(i)

F. New use or new property of known substance – Section 3(d)G. Methods of agriculture or horticulture – Section 3(h)H. Traditional knowledge – Section 3(p)

II. Patentable inventions

A. The MPPP regards claims to ‘genetically modified GeneSequence/Amino Acid Sequence, a method of expressing thesequence, an antibody against the protein/sequence, a kitcontaining such antibody/sequence as having a singleinventive concept and capable of being granted a patent

B. Gene sequences, DNA sequences without having disclosedtheir functions are not patentable for lack of inventivestep and industrial application

C. Living entities of artificial origin such as micro-organism, vaccines are patentable

D. Biological material such as rDNA, plasmids are patentableprovided they are produced by substantive humanintervention

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E. Processes for producing chemical and biologicalsubstances using microorganisms including lower plantsand animals are patentable

F. Modified Microorganism & process thereforG. Process for modification/ isolation of microbes. H. Isolated nucleic acids encoding gene, first time

isolation of a molecule; novel peptides, novel peptideanalogs, proteins, vaccines, antibodies, recombinant:DNA, RNA, Amino Acids, antibodies, primers, recombinantoligonucleotides and primers, genes and process therefor;DNA related inventions such as preparing plasmids,vectors etc.; composition/formulation thereof.

I. Cell lines-A cell line is patentable if artificiallyproduced.

J. Hybridoma technology: patents are also allowed onhybridoma technology, but not on protoplast fusion.

K. rDNA, cDNA, r-RNA, r-antibodies a. Expressed sequence tag’s, or ESTs, are smallfragments of genetic

material b. obtained by reverse transcriptions of messengerRNA (mRNA) from

expressed c. genes. The gene sequence, or expressed sequencetags (ESTs), can be

patented if it d. has a use, such as if it works as a probe.

L. Bioprobes, biosensorsM. Diagnostic/Equipment kits, Research Tools N. Methods of enzyme Purification.O. Environment cleaning using biological materials such as

solid or liquid waste P. (industrial/domestic) treatment, water treatment,

mitigation of air pollution, bio- Q. RemediationR. Treatment of plants.

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5. Biotechnology Patent Prosecution: Guidelines & BasicConsiderations

There is no formal bio-guidance as of yet with regard tobiotechnological patent application. Some reference in Manual ofPatent Practice and Procedure (MPPP) is there and guidelines withregard biotechnological inventions are inconsistent andinadequate. Pertinently there is no mention of word gene or DNAin Patents Act, 1970, nonetheless, MPPP serves as an informalwritten guidance for the examiners/Practitioners and is not abinding document. The biological material such as recombinantDNA, Plasmids and processes of manufacturing thereof arepatentable provided they are produced by substantive humanintervention. Gene sequences, DNA sequences without havingdisclosed their functions are not patentable for lack ofinventive step and industrial application.

Further, MPPP provides that the processes for cloning humanbeings or animals, processes for modifying the germ line, geneticidentity of human beings or animals, uses of human or animalembryos for any purpose are not patentable as they are againstpublic order and morality.

During prosecution, the establishment of the biological functionof a biotech invention, it is preferable to include biologicalexperimental data / efficacy data – both in vitro as well as in vivoto support the efficacy of a claimed invention over the priorart. Furthermore, an isolated but not modified living entity isnot substantially different from the form in which it existed inthe nature are non patentable under sec 3(c). However, mereisolation of a living thing or a part thereof from its naturalenvironment without a modification by genetic engineering orotherwise that improves properties or increases efficacy of theclaimed invention over the existing form or a biological materialor a part thereof is isolated in the desired form from itsnatural environment, such material is no longer a living thingoccurring in nature as envisaged in s. 3(c) of the Patents Act.

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Additionally, quite often the material obtained by the process ofisolation is in a raw state and thus needs to be processedfurther e.g. purified by physical or chemical treatment to renderit industrially applicable. It can therefore be argued that theisolated material is not necessarily a “merely discovered livingthing”. First time isolation of a component from biologicalmaterial is patentable.

If sequences of biologics included with claims, to obtainbroadest possible protection, it might not be prudent to includesuch specific references to SEQ IDs in the main claim. However,in the event that compliance with such a requirement is mandatoryduring the final stage of the prosecution of an application, sucha reference could then be merged in the main claim, as broadly aspossible in order to secure the eventual acceptance of such anapplication. The specific sequence IDs of the genetic materialbeing claimed must have been described sufficiently in theaccompanying description so as to enable a person skilled in theart to identify and work upon such material (submission of SEQ IDin electronic as well as in form is also mandatory). Otherwise,insufficient disclosure as well as enablement objections could beraised. Additionally, the reference to more than one SEQ IDsrequires establishing unequivocally that more than one sequenceof IDs is so correlated with another that they constitute a singleinventive concept.

A. Types of Objections Raised under First Examination ReportObjections relating to non compliance of criteria forpatentability such as lack of novelty and/or obviousness;community/folklore knowledge available, non-sufficientdisclosure; non-compliance of Biological Diversity Actrequirements; lack of functional aspects and information requiredunder Section 8 of the Act

B. Few Examples of Objections Raised GenerallyA. Claims do not sufficiently define the invention;B. Distinguishing features as compared to prior art given

are not clear;

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C. Disclosure is insufficient;D. SEQ should be filed in electronic form;E. Claims fall under section 3(i);F. Claims fall under section 3(j).G. Obtaining permission from NBAH. Disclosure of deposition of biological material used in

the inventionI. Invention that falls under 2(1)(j)J. Use claims (generally not considered).

C. Some examples of allowed claims in biotech inventions

1. Micro-organism per se:-A recombinant microorganism, which is amicroorganism having ability to produce 16-positionhydroxyl macrolide compounds represented by the formula(I): (wherein R represents a hydrogen atom or hydroxylgroup), and, which comprises: (a) DNA encoding wholly orpartially a polypeptide participating in biosynthesis ofthe macrolide compounds represented by the formula (II)

2. Nucleic Acid Molecule:-A nucleic acid molecule comprising asequence of nucleotides that encodes an HPV31 L1 proteinas set forth in SEQ ID No. 4, the nucleic acid comprisingsequence of nucleotides as set forth in SEQ ID NO: 2 orSEQ ID NO. 3 wherein the sequence being codon-optimizedfor high level expression in a yeast

3. Protein:-A sublingually highly effective hypoglycaemicpolypeptide-k, from seeds of Momordica charantia L. (bittergourd), prepared by a process which comprises, splittingthe seeds of Momordica Charantia L (bitter gourd) washingthoroughly the splitted seeds with water to removecontaminants, treating the splitted seeds with solventconsisting of hexane and acetone (3:1), grinding the saidseeds to obtain powder, treating the said powder of seedswith, hexane and acetone solvents (3:1), dissolving theresidual mass in aqueous acetone (water and acetone80:20), adjusting pH upto 9.5 by adding ammoniumhydroxide, separating the supernatant kyer from the

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mixture, treating the supernatant layer with sulphuricacid by adjusting the pH upto 3 to obtain the flocculentprecipitate of polypeptide-k.

4. Cell Line:-A method of producing human oral cancer cell linewhich comprises:

a. Subjecting oral squamous cell carcinoma from the floor ofmouth to the step of biopsy in Hanks Balanced SaltSolution (HBSS) as a buffer supplemented with antibiotics(Penicillin and streptomycin) and amphotericin B;

b. Cutting the treated tissue of step (a) into smallerpieces;

c. Washing the cut tissues with solution of antibiotics;d. The washed tissues being introduced into tissue culture

flasks having a medium comprising DMEM and media 199 in aratio of 2:1 supplemented with fetal bovine serum (FBS)and growth supplements such as herein described to allowthe growth of cells comprising fibroblast cells whichgrow earlier than the epithelial cells;

e. Removing the fibroblasts cells from the culture to obtaina cell line comprising essentially of epithelial cells.

D. Some examples of rejected claims in biotech inventions1. Claims related to Methods for identifying tumors that are

responsive to treatment with anti-ErbB2 antibodies Afterdetermination that the patient suffers from cancer (suchas, Castration- Resistant Prostate Cancer-CRPC or ovariancancer) that is positive for HER2 phosphorylation, thepatient will receive a loading dose of 840 mg of rhuMAb2C4 on day 1 of cycle 1 (first 21-day treatment period),followed by 420 mg on day 1 of each subsequent 21-daycycle, as continuous intravenous infusion. Applicantsubmitted that improvement lies in new amounts of rhuMAb(420 and 840 mg) The controller refused the applicationunder section 3(d) (new use of known substance) as beingdosage and 3(i) method of treatment that the said MAb arealready known as described in the description.

2. Invention related to a method for in vitro production ofisolated langerhans islets endocrine cells free from

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fibroblasts so as to be suitable for transplantation. Theprocess discloses the steps of culturing andproliferation the cells and back and forth aspiration toseparate fibroblast from the cells, which will be capableof differentiating into insulin producing, cells

The applicant argued the case on following grounds: That the process is novel and has utility as fibroblast freelangerhans islets are useful in the enhanced production ofinsulin to control diabetes. Kolkata High Court has already allowed patenting of a substancecontaining living organisms. Indian Patent law does not bar the grant patent for suchinventionThe Controller refused the application under section 15 on thefollowing grounds:

1. The end product of the process is nothing but a cluster ofcells or piece of tissues of human body. 2. The invention claimed is not patentable under section 3(I) asa method of treatment of human being, since langerhans islets arefreshly taken from the body of patient in order to treat them toremove fibroblast so as to increase secretion of insulin. 3. The principles laid down in Kolkata High Court are notapplicable as the end product of the process of present inventionare not commercial entity and cannot be passed on from one personto another upon the transaction of purchase or sale.

6. Patentability of Biological Material(s)(The Enablement Requirement in the Disclosure)

Mandatory disclosure is required in patent application of sourceand geographical origin of biological material used in invention- Sec.10 (4) (d) of Indian Patents Act, 2005. In case of patentapplications involving biological material such as DNA, arecombinant vector, or cells or invention related to genes thatmay not be described in such a way as to satisfy the enablementand best mode requirements and if such material is not available

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to the public, submission and/or deposition of biologicalmaterial to an International Depository Authority (IDA) under theBudapest treaty is required if adequate disclosure is notpossible - Sec.10 (4) (ii). The disclosure is mandatory if anyspecific material imparting the specific property is required towork the invention.

In case the material such as proteins/peptides/amino acidsprepared synthetically can substitute the live material to workthe invention appropriate submissions may help to overcome theobjection. The law also provides for pre-grant opposition andrevocation of granted patents of grounds of non-disclosure orwrongful disclosure of source or geographical origin ofbiological resources and traditional knowledge - Sec. 25(1) &Sec. 64

The Microbial Type Culture Collection (MTCC) at the Institute ofMicrobial Technology (IMTECH) in Chandigarh is the IDA in India.However the scope of this IDA is limited because it is notequipped to accept deposits of “cell lines, cyanobacteria,viruses etc. Biological deposits of such materials wouldpresumably need to be made in IDAs located outside of India,resulting in increased cost and administrative complexity fordomestic biotechnology firms.

National Biodiversity Authority’s prior approval is required foraccessing biological material by foreigners/NRIs (Sec. 3) as wellas before seeking patent based on biological material and TKobtained from India Sec 6(1) of Biodiversity Act 2002

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7. Patentability of Micro-organism (s)

Guidelines were formulated for examination of the patentapplications involving micro-organisms from the point of view ofsubstantial human intervention and utility.

Microbiological inventions include new products, processes, usesand compositions involving biological materials. These inventionscover methods to isolate and obtain new organisms, improve theircharacter, modify them and find their new and improved uses.

Patenting of new micro-organisms is based on their differenceswith the characteristics & uses of micro-organisms as availablein the prior art. Known micro-organisms are restricted to newuses, wherever patent law permits such a protection. The same isthe case with genetically modified micro-organisms. Genes andgene products are treated similar to chemical compositions.

In the Dimminaco AG vs. Controller of Patents, the Calcutta High Court heldin 2002 that a patent on a micro-organism is valid. The courtruled that the Act did not preclude a living end product frombeing patented. As a result, a large number of patents have beengranted to microorganisms since then

Universally, as practiced by most patent offices, new micro-organisms isolated for the first time from the naturalsurrounding can only be patented if they differ in character fromthe known micro-organisms and find a new or improved use orfunction. Claims to micro-organisms have been allowed on thegrounds that they are the products of micro-biological processes.

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8. Patent law and Conservation of Biological Diversity (CBD)

India enacted the Biological Diversity Act to address the issuesof prior informed consent, disclosure and access and benefitsharing. This Act primarily aims at regulating access tobiological resources and associated traditional knowledge so asto ensure equitable sharing of benefits arising out of their use.

All matters relating to requests for access by foreignindividuals, a non-resident Indian, institutions or companies( that are not incorporated or registered in India; orincorporated or registered in India with foreign participation inits share capital or management), and all matters relating totransfer of results of research to any foreigner is dealt with bythe NBA.  Section 3 provides that all foreign national requireapproval from NBA for obtaining Biological Resources or knowledgeassociated with it and Section 4 provides that Indianindividuals/entities to seek approval before transferringknowledge / research and material relating to any biologicalresources (occurring in or obtained from India)   to foreignindividuals, non-resident Indians, institutions or companies( that are not incorporated or registered in India; orincorporated or registered in India with foreign participation inits share capital or management). NBA, may consult theBiodiversity Management Committees (BMC) or any other expertcommittee constituted for this purpose and thereafter grantapproval under Section 19 subject to such terms and conditions itmay deem fit.

In case of Collaborative projects (covered by Section 5 ofBiological Diversity Act) that are either approved by theGovernment or conforms to the policy guidelines formulated by theGovernment, no further approval is required from NBA.

For flora such as bacterial or fungal strains habitant fromreserved and protected forests, notified sanctuaries and nationalparks are regulated by Indian Forest Act, 1927 and WildlifeProtection Act, 1972. The Indian Forest Act and Forest

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(Conservation) Act deal with management of forests andconservation of forest land respectively. Wildlife (Protection)Act is for the protection of wild animals, birds and plants, andbasically aims at protecting, propagating or developing wildlifeor its environs through national parks, sanctuaries etc. Inaddition, the Act has a provision to prohibit picking anduprooting etc. of specified plants.

In the Biological Diversity Act, ‘Biological resources’ meanplants, animals and micro-organisms, their genetic material andby-products with actual or potential use or value. Human geneticmaterial is outside the purview. However, extracts of bacterialand fungal strains and all value added products are notencompassed in the definition of ‘biological resources’ and thusdo not require approval of the NBA. The Indian collaboratingcompany of a foreign entity is only required to give priorintimation to the concerned State Biodiversity Board aboutobtaining such material for commercial purposes. The fees payablefor export permits will be regulated by EXIM policies. Pleasenote that additional permission is required from the DirectorGeneral of Foreign Trade for import and export of certainbiological material.

The Biological Diversity Act forbids an application for any IPRin or outside India without prior approval of NBA. The Gatekeeping for this is envisaged at several stages: 1) Section 6(1) provides that prior approval of NBA is

necessary before applying for any kind of IPRs (in oroutside India)based on any research or information on abiological resource obtained from India.Such approval, however, is not required where IPR rightsrelating to protection of plant varieties are applied for[Section 6(3)]. This is because in such cases, it is thePlant Varieties and Farmers' Rights Authority, establishedunder the Protection of Plant Varieties and Farmers' RightsAct, 2001, which grants the right and determines the benefitsharing. This Authority, in turn, endorses the grant ofright to NBA;

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2) In case of Patents, one can procure such approval after thepublication of the patent application and before the grantof patent.

3) In case of assignment of IP rights to third persons, thepersons who have been granted approval for access tobiological resource and associated knowledge may transferthe same by taking approval from NBA.

While granting such permission, the NBA is most likely to imposebenefit sharing conditions such as monetary benefit like royalty,joint ventures, technology transfer product development. Theparameters involved for payment of such compensation are extentof use, sustainability aspect, impact and expected outcomelevels, short term and long term benefits etc.

NBA drafted new guidelines on access and benefits sharingparticularly on International Regime on Access and BenefitSharing; Evolving sui generis system for the protection ofTraditional Knowledge and Amendments to the Biological DiversityAct, 2002 and Biological Diversity Rules, 2004 and opened forpublic hearing. The final draft is yet to be released.

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9. Patent law and Traditional Knowledge

The TRIPS Agreement has some provisions having limitedapplication to the protection of Traditional Knowledge. Theobligation to protect geographical indications can be used toprotect traditional knowledge if associated with the indicationused for production and sale of goods. It is made clear that agiven quality, reputation or other characteristics of the goodsessentially attributable to its geographical origin are to beconsidered in identifying the geographical indications forprotection.

India’s current Patents Act includes several provisions aimed attraditional knowledge outside the realm of patenting. Section3(p) excludes from patentability “an invention which, in effect,is traditional knowledge or which is an aggregation orduplication of known properties of traditionally known componentor components.” This exclusion is but one of several provisionsinserted into the new Act in an effort to prevent the exercise ofproprietary rights in India’s genetic resources and indigenousknowledge. As mentioned above, the Act’s disclosure requirementsmandate inclusion of the source and geographical origin ofbiological material used in the claimed invention, and interestedparties may oppose or petition to revoke an Indian patent on theground that the invention claimed therein is anticipated “havingregard to the knowledge, oral or otherwise, available within anylocal or indigenous community in India or elsewhere . . .

The government of India has granted the EPO &USPTO, access to itsTraditional Knowledge Digital Library (TKDL). The European PatentOffice, for instance, has set aside its original intention togrant patents in at least two cases, while 33 applications werewithdrawn by the applicants themselves. Council of Scientific &Industrial Research claims that around 400 applications pendingin various other patent offices have also been similarlychallenged. Loaded with ancient medical knowledge, the onlinedatabase contains translations of manuscripts and textbooks in

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five languages (500-5000 year old texts on Ayurvedic cure &herbal remedies are documented), including English. Access to the30-million-page database helps to correctly examine patentapplications relating to traditional knowledge. With the TKDL,examiners have improved access to background information at anearly stage of patent examination. Prominent cases of patentdisputes include a US patent on the wound-healing properties ofturmeric (revoked in 1997) as well as an anti-fungal product fromthe Indian Neem tree (revoked in 2008). Both herbal practiceswere evidence of traditional knowledge and the patents wererescinded. In both instances, the Indian government needed toprove that the patented methods were not novel and were based ontraditional knowledge. The process to challenge the grantedpatents proved lengthy and cumbersome as some traditionalknowledge had only been documented in Sanskrit or other ancientwritings and thus required extensive translation. Agreements withregard to TKDL with offices in Japan and New Zealand are roundthe corner.

A. Prior art & enablement

The TKDL allows examiners to compare patent applications withexisting traditional knowledge. New patent applications need todemonstrate significant improvements and inventiveness comparedto prior art in their field. If the medical use of an herb is atraditional practice, and thereby public knowledge, it isconsidered prior art under regulations.

If an applicant seeks to patent the medicinal use of an herblisted in the TKDL, examiners conduct a thorough investigation.In some cases this leads to a reduction of the scope of thepatent or its refusal.

However, the patent applicant may still be granted a patent on anew method for industrial-scale production of the activeingredient of the herb, for example, if this process is new andinventive (example-jeevani, a medicine based on the traditionalmedicinal knowledge, an extract of arogyappacha plant [Trichopuszeylanicusused] as immunomodulator as well as for energy andvitality). There are about 6 patents granted on jeevani and

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Tropical Botanical Garden and Research Institute (TBGRI), the patent holdershared the royalty through ABS with the local tribe)

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10. Biotech patent jurisprudence in IndiaA. Dimminaco A.G. v. Controller

In India there is no substantial case law development with regardto the biotechnology inventions in India as the industry is in aninfant stage. The leading biotechnology patent law decision ofthe Indian courts is the A.G. v. Controller of Patents, Designs &Trade Marks (in 2002), where for the first time, and utility of abiotech invention was demonstrated. The invention related to aprocess for preparation of infectious bursitis vaccine. Thevaccine was useful for protecting poultry against contagiousbursitis infection. Initially the Patent office rejected thepatent application on the ground that the claim did notconstitute an invention. But the utility of the invention was notdisputed. Although this decision was issued more than twentyyears after the U.S. Supreme Court’s decision in Diamond v.Chakrabarty, Indian commentators view it as epoch making as bythis decision, the court overturned a long-standing policy of theIndian Patent Office to refuse such process claims, thus openingthe door to biotechnology patenting in India much as theChakrabarty decision did in the United States.

The Assistant Controller of patent observed that “in India tilldate, no patent had been granted for any process of preparing aliving organism. In the Controller’s view, if such a processbecame patentable, “there will be further problems as foreignsophisticated technologies will have to be patented in India. TheAssistant Controller also contended that the framers of India’sPatents Act, 1970, had relied on the 1959 recommendation of thegovernment commissioned Iyengar Committee that “invention” shouldbe defined narrowly. Appellant Dimminaco countered that thePatent Office had not cited any anticipatory prior art againstthe claimed process, nor had it questioned the utility of theend-product vaccine. Therefore, the process should be held apatentable “manner of manufacture” coming within the Patent Act’senumerated categories of inventions. After summarizing theparties’ respective arguments, the Calcutta High Court consideredthe scope of “manner of manufacture” under section 2(i)(j) of the

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Patents Act, 1970, and noted that the word “manufacture” was notdefined in the Patents Act. In such cases, the court explained,the dictionary meaning of “manufacture” or its usage “in theparticular trade or business must be accepted. Further, in orderto decide whether a particular process of manufacture “ought tobe patented or not, “one of the most common tests is thevendibility test. This test is satisfied “if the inventionresults in the production of some vendible item something whichcan be passed on from one man to another upon the transactions ofpurchase and sale claimed method was a patentable inventionbecause the dictionary meaning of the word manufacture does notexclude the process of preparing a vendible commodity whichcontains a living substance. Where, as in this case, the PatentsAct, 1970, provided no definition of “manufacture,” then “thedictionary must be accepted. The Assistant Controller had legallyerred “by holding that merely because the end product contains alive virus, the process involved in bringing out the end productis not an invention.

In overturning the Assistant Controller’s decision, the courtheld that there was evidence that the Indian Patent Office hadalready granted a few biotechnology process patents producing aliving end product. The Assistant Controller had “not acted oncorrect principles” by rejecting Dimminaco’s application on theground that it could not be called a “manner of manufacture”because it involved a living virus in the end-product. The IndianPatent Office appears to have adopted Dimminaco’s teaching thatthe fact that an invention is living (or produces a livingproduct) does not automatically exclude it from patentability.The MPPP states that a “living entity of artificial origin suchas micro-organism, or vaccines are considered patentable,although higher life forms such as plants or multi-cellularanimals, whether of natural or artificial origin, are not.Moreover, biological material such as recombinant DNA, Plasmidsand processes of manufacturing thereof are patentable providedthey are produced by substantive human intervention. In addition,the processes relating to micro-organisms or producing chemicalsubstances using such micro-organisms are patentable.

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B. Speaking Roses International Inc. vs. Controller-General ofPatents And Anr.

The Petitioners, viz. Speaking Roses international Inc., had onSeptember 19, 2002, applied for a patent for “providing an imageon an Organic Product, being flowers”. Subsequently, they weregiven the First Examination Report (FER) as well as the SecondExamination Report (SER), both of which they had replied to andcomplied with. However, by an order the Respondent had rejectedsaid application on the following 5 major grounds. The firstground of rejection was that the application was in contraventionof Section 3(j) of the Patents Act, 1970. As per sub-clause (j),such exclusion extends to “Plants and animals in whole or anypart thereof other than micro-organisms but including seeds,varieties and species and essentially biological processes forproduction or propagation of plants and animals.” This sub-clausethus does not allow grant of patent for plants or for anybiological processes for production or propagation of plants. Thecourt held that the patent sought was not for any flowers ororganic products, but for providing an Image on an organicproduct. Hence it was not a plant that was being sought to bepatented. Furthermore, such image was to be created by amechanical process and not a biological one. Therefore, the claimdid not fall within the scope of the aforesaid Section3(j).

The second ground of objection was that 3 other inventors, hadbeen previously granted patents for identical purpose and inlight of that fact, the Petitioners’ claim lacked the necessaryinventive step to qualify for a patent. The Petitioners, however,argued that their product was substantially different from thoseof the patentees as the Petitioners, had been using a pad/rolleras a transfer medium, which resulted in no such damage. Again,another inventor marked the image by cutting and altering overthe surface of the flower by a computer-controlled laser beam,which caused alterations of the material of the organic productand subsequent quick deterioration. However, the Petitioners'process of pad printing did not cause any such alteration. Thecourt held that that the Petitioners were the first to have

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applied for the process they have claimed a patent for and hencethe requirements of inventive step and novelty stood satisfied.

The remaining 3 grounds of objection included the allegationsthat the Petitioners' claim does not sufficiently define theinvention, lack of clarity of the title of the patented productand the inconsistency of the title with the claims made by thePetitioners. Regarding these, the Court was of the opinion thatthe Petitioners intended to obtain a patent on the mechanicalprocess of imprinting the message by way of pad printing on anorganic product and the hence the title of their application,being for “Providing an image on an Organic Product”, appeared tobe precise, concise and definite. The court observed that thePetitioners’ illustrative explanation of the method appeared tobe in perfect consistency with their claim for a method patent asagainst a product patent. Moreover, the summary of the invention,provided by the Petitioners in the application, renders welldefined methods of the invention as the type of images to beimprinted upon specifically illustrated organic products and aclear object of the exercise in its entirety and the objectionwith regard to the title and claims inconsistency also met with asimilar fate.

The Court also held that the Petitioners do not require amendingtheir claims under such circumstances and refused to considerfurther objections of the Respondent regarding the feasibility ofexpanding the scope of the claim. At the end the court observedthat a patent application could not be rejected merely on theground that only one of the assignees of the patent had filed theapplication. Finally, the Court set aside the Respondent’s orderof rejection of the patent.

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11. Conclusion

As stated hereinbefore, the issues that relate to the patentingof biological material are relatively new to India. Standardizedpractice has yet to be satisfactorily established with respect topatenting or non-patenting of biological inventions. However, ifa claim of an invention is related to a novel and inventive andmodified genetic material, wherein such genetic material isidentified by its protein or amino acid sequences at least in thedescription and in the claims, such genetic material is capableof industrial application, then the Patent Office generallyaccepts such invention as patentable. Therefore, the inventionsare subject to the fulfillment of the relatively broad criteria.It is noteworthy to mention that the patenting of biologicalmaterial in India is still decided more often on a case-by-casebasis.

India’s post-TRIPS patent laws include several provisions thatmake biotechnology patenting more attractive as a basis forcompetitive advantage. The Dimminaco decision likewise signifiesgreater judicial and administrative appreciation of theimportance of biotechnology patenting. It is apparent from theallowable claims disclosed hereinbefore, that the biotech patentscan be obtained in diverse areas provided thedescription/enablement requirements be complied with andprosecuted articulately.

Furthermore, India being one of the bio-diversity rich countries,it would, thus, be prudent to

protect biotechnological inventions as that would help Indian biotechnology research to compete

globally. India needs to reap the due benefits from its rich bio-resources with an enabling

provision for patent protection in biotechnological innovations and inventions.

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