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MaataloustieteellinenAikakauskirja Vol. 61:405—414, 1989

Legal protection of plant biotechnological inventions

P.T. VANHALA, T. PEHU, H.G. GYLLENBERG Department

of

Microbiology, University

of

Helsinki,

SF00710 Helsinki, Finland

Abstract.Within biotechnology, plant production is regardedas oneofthemost promising adaptations.New plant breeding methodsareconsidered to better fulfiltherequirements set onpatentabilitythan thetraditional breeding methods. InEurope,aplant varietycanbepro- tected by special legislation. The present patent laws inEurope are not applied to plant biotechnologicalinventions. The United States has three systemsunder whichnewvarieties of plantsmaybe protected.Theseinclude The 1930PlantPatentAct,The 1970 PlantVariety Protection Act and The 1952 PatentStatute. Companies that have specializedinplantbreed- ingand organizations representing the industrial countries recommend improvements to the legal protection. On the otherhand,farmers and the developing countries areagainstbetter protection.

Indexwords: plantpatent,breeder’s rights

I. Introduction

Within biotechnology, plant production is regarded as oneof themostpromising adap- tations. Today, several typesof biotechnolog- ical breeding methodsare used in plant breed- ing. Thesenewmethodsareconsidered toful- fil better the requirementsseton patentabili- ty than the traditional breeding methods.

Against this background, extension of thepat- ent protection to coveralso newplant varie- ties has becomeatopic ofcurrent interest. Be- cause of the fast development of biotechno- logical breeding methods it has becomeneces- sarytoapplypatent legislation ina very flex-

ible way all overthe world. The trend seems to continue also in the future. Therefore,is- sues on legal protection of plant breeding methods are relatively problematic to deal with.

The purpose of this study is toreview the currentlegalstateof the plant breeder’s rights and patentlegislation in Western Europe and in the United States. The firstpart of the study examines international agreements and na- tionalpatent laws, the secondpart the need to further develop the legal rights from the viewpoints of different interest groups.

JOURNAL OF AGRICULTURALSCIENCEIN FINLAND

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The study isareview of literature collected from databanks (Dialog and Dimdi), interna- tionalagreementsand other juridical publica- tions.

2. The protection of plant varieties in international agreements 2.1. The Strasbourg Convention

Unification of European patent laws was started in the late 19505. Due to the problematicnatureof thetask,questionscon- cerning the patenting of plant varietieswere not discussed at the conference (Beier and Straus 1986). The negotiations led to the Strasbourg Convention whichwas signed in

1963.

Article 2 of the Conventionstatute:

“The Contracting States shall not be re- quired to grant patents for:

a.

b. Plantoranimal varietiesoressentially bi- ological processes for production of plants or animals; this provision does not apply to microbiological processes or the products thereof.”

This article has hadgreatsignificanceonthe patentprotection of plantvarieties,since it has been transferred as such to the European Patent Convention of 1973, appearing there asArticle53. Furthermore,the countries par- ticipating in the European Patent Convention have adopted this articlein thesame or essen- tially thesame form in their nationalpatent laws.

2.2. The UPOV Convention

When the inapplicability of patenting for plant variety protectionwasrecognized, a new protection procedurewascreated for that pur- pose. Itwas signedasthe UPOV Convention (UNION POUR LA PROTECTION DES OBTENTIONS VEGETATES) in 1961.

This convention aims to recognize and to secure the breeder’s rights regarding a new

plant variety (Article 1). Each contracting stateguarantees the breeder’s rights bygrant- ing a special title of protection (Article 2).

The holder of the privilege possesses the monopoly of commercial production, supply and trade of propagation material. Theterm

“propagation material”covers,bydefinition, the entire plant (Article 5). Because the pro- tection appliestopropagationmaterial, it does

not coverotherusesof plant materialorhar- vest. The convention permits the production of propagation material for the farmer’sown needs.

The plant variety, for which protection is sought, should be distinguishable from previ- ously knownvarieties, both morphologically and physiologically. The variety should be sufficiently homogeneous and stable in itses- sential characteristics through repeated propa- gation cycles (Article 6).

In principle, the breeder’s rights canbe ap- plied toall botanical genera and species (Ar- ticle 4). Yet,duetothe shortness ofresources for the study of varieties, each decides in- dependently whetherornota newplant fam- ily will be included within the scope of pro- tection. Further breeding of the protectedva- riety is permitted,asis thecasewithcommer- cial utilization of its results (Article 5).

It is decreed by Article 2 of the Convention thatacontractingstatemayprotect avariety ofa certain familyorspecies, either bya pat- entorby the breeder’s rights, but notby both.

With the membership of the United States in 1978Article37 was included in the Conven- tion. This article permits double protection in instances where both forms of protection have been granted before a state has joined the Convention, which was the case with the United States.

2.3. TheEuropeanPatent Convention (EPC) 2.3.1. Patentability

Articles 52 and 83 of the European Patent Conventionpresent alist of criteria ofpatent- ability of an invention(Anon. 1981).

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These are as follows:

1. inventive step 2. industrial application 3. novelty

4. repeatability

Clause 2 in Article 52 determines the in- stanceswhenpatents cannotbe granted. These areeither abstractornon-technical bycharac-

ter. According to the GUIDELINES FOR EXAMINATION IN THE EPO (European Patent Organisation) 1987, Article 52 pre- sumes an inventionto be both concrete and technical by nature(Anon 1985). A plant va- riety does not meetthese criteria because it is difficult toencompass the concept of variety intoaconcretedefinition. In thecaseof plant material, however, this kind of definition is possible. In versely, theconcepts of plant va- riety and plant material are difficult to con- ceive as technicalby nature.

AccordingtoArticle 57,aninventionmust be consideredassusceptible of industrial ap- plication if itcanbe madeorused in any kind of industry, including agriculture. The Guide- lines of the EPO suggest that “industry”

should be understood in abroad sense.

The requirement of repeatability is pre- sented in Article 83. It states that an inven- tion can be carriedout by the person skilled in the art on the basis ofthepatent applica- tion. As for plant varietiesorplant material, the requirement of repeatability canbemet by a deposit practice defined in the Budapest Treaty.Thistreaty concernsthe international acknowledgement of the micro-organism de- posit practice. The EPC decrees that a pa- tented micro-organism must be deposited in an internationally acknowledged deposit in- stitute (EPC RULE 28). Some institutes have agreed on the acceptance of plant cell culti- vations and seeds to be deposited as micro- organism (Anon. 1986).

Article53a excludes frompatent protection inventions which could becontrary to“ordre public” ormorality. By thecorrect interpre- tation of this point the granting of ethically questionable patents can be prevented.

Article 53b excludes frompatentprotection plant varieties and essentially biological processes used for theproduction of plants.

Thegreatest controversyofpatentprotection of plants rises from thispoint. Because Arti- cle 53b uses the two concepts of plant and plant variety, they must be regarded as dif- ferent in bearing (Lommi

1987

a).

2.3.2. Plant variety

The rule of excluding plant varieties from

patent protection conforms with the prereq- uisites of patentability, because theconceptof plant variety lacksaprecise definition. A plant variety is generally defined on the basis of three features, i.e. distinguishability, unifor- mity and stability. In the decision known as T49/83 CIBA GEIGY the Technical Board of the Appeals of the EPO defines the distinc- tion between plant variety and other plant ma- terial.Thereby aplant variety is “a multiplic- ity of plants whicharelargely thesamein their characteristics and remain the same within specific tolerances after every propagationor every propagation cycle”.

Experts in this field tend to support the patentability of plants oncondition that this claim doesnotdirectlyconcernplant varieties.

In its decision (T49/83 CIBA GEIGY) the Eu- ropean Patent Office made a statementthat the items excluded frompatentprotectionare plant varieties solely, not plants in general.

The decision was made in association the EP Application 10588, where the following claims were presented:

“Claim 13: Propagating material for culti- vated plants, created withan oxime derivative according to Formula 1 in Claim 1.

Claim 14: Propagation material according to Claim 13, characterized in that it consists of seed.”

It was decreed in the decision that propa- gation material treated with a chemical is patentable with the restriction that the claim does not concern a spectic plant variety.

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2.3.3. The essentially biological process The EPC deniespatent protection for the essentially biological processes used for the production of plants. It isto be noted that in thiscontext thetermplant is used instead of plant variety. This leadstothe conclusion that the rule which denies patent protection for plant varieties does not cover plants in gen- eral.

The essentially technical processes of plant production are patentable. In the Guidelines for Examination in the EPO, the essentially biological and the essentially technical processes are delineated. According to the guidelines, the amount of technical interven- tion by manis adecisive factor. If such inter- vention playsasignificant role in theoutcome, the process wouldnot be excluded. Thereby, a process of treating a plant to improve its properties or to improve its growth, e.g. a method of prunninga tree,wouldnot be an essentially biological process. Although a biological process isinvolved, theessence of the invention is technical.

The classical breeding methods based on crossbreeding and selectioncannot, according totheinstructions, be patented, whereas those using biotechnical processes are patentable since all these procedures require technical in- tervention by man. Similarly, most of these processes can be classified as chemical.

2.3.4. The microbiological method

According to the EPC, a patent can be granted to a microbiological process or the products thereof. Biotechnical plant breeding processes are eithermacro- or microbiologi- cal bynature,and it isnoteasytodistinguish between thetwo.The problems of distinction can be illustrated by the EP Application

122791 in which claims are presented for:

a DNA shuttle vector comprising T- DNA...

a method for genetically modifying plant ce11...

a plant, a plant tissue, or a plant cell produced accordingto the claimed meth- od.

Both the nationalpatent laws and the in- ternationalagreements have been avoiding the

definition of thetermmicro-organism. In the internationalpatentclassification(C 12,Note 2) items suchasviruses, undifferentiated plant and animal cells and protozoa are also in- cluded in the concept of micro-organism (Anon 1985). In The Guidelines for Exami-

nation in theEPO, microbiological processes include in additionto technical processes us- ing micro-organisms also processes for the productionofnewmicro-organisms, e.g. gene technological processes. The absence of defi- nition of the terminology from patent legis- lation has ledtothe practice of using theterm

“microbiological process” to signify the DNA-techniques and protoplast fusions alongside with microinjections and other gene technological processes (Beier and Straus

1986).

3. Plant varietyprotection in national patent laws

3.1. The United States

The United States has threesystems under which new varieties of plants may be pro- tected:

The 1930 Plant Patent Act (PPA) The 1970 Plant Variety Protection Act (PVPA)

The 1952 Patent Statute The Plant Patent Act (PPA) (35 USC 161 164)

The PPAgrants patentprotection forasex- ually propagated plant varieties (Sec. 161).

The Act wasconfinedtoasexual propagation only, becauseatthat time itwasbelieved ade-

quate uniformity and stability canbe main- tained only by this reproduction method. Pa- tentsarealso granted for discoveries that are made from the uncultivatedstate.

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The requirements of the PPA concerning novelties and distinction are in conformity with the General Patent Statute. However, Sec. 162 decrees that, as to description, the requirements of Sec. 112 do notcoverplant patent applications. A description of theva- riety as complete as is reasonable is consid- ered sufficient. Deposit of propagation ma- terial is notrequired. The applicationcannot contain more than one claim, which should concernthe varietytobe patented (Sec. 162).

A granted plant patentprohibits others from asexually reproducing the plant.

The number of granted plant patents rises toabout6000 atpresent, withanincrease of about400 patentsper year (Van Horn 1987).

The Plant Variety Protection Act (PVPA) (7 USC 2321—2583)

Growing interest in the protection of plant varieties propagated from seeds led to the enactmentof the Plant Variety Protection Act in 1970. This Act provides protection similar to thepatent protection for sexually propa- gated plant varieties. With theentranceof the USA into the UPOV Convention in 1980, this was amended to conform with the UPOV.

The plant breeder’s rights have now been granted for about 2000 plant varieties in the USA, while the number ofnew casesis about 200 per year (Van Horn 1987).

The Patent Statute (35 USC 101)

The United States’ Patent Statutedecrees, in Clause 101, that patent protection can be granted for any newand useful process, ma- chine, manufacture, orcomposition of mat- ter, or any useful improvement thereof. No industrial application of the invention is not required,noris its technical characterempha- sized the way it is in Europe.

Apatent caseEX PARTE HIBBERD 1985 extended the General Patent Statute tocover also plant varieties that are subject to the PVPA. The item discussedwas a variety of maize which produced high quantities oftryp- tophan. Cell lines with high quantities oftryp- tophan were selected and regenerated into

whole plants. The claimsweremade forseeds, cell lines and plants (Hibbertd 1985). The claim concerning the plant was as follows:

Claim 249: “A maize plant capable of producing seed having an endogenous free tryptophancontent ofat least about one-tenth milligram per gram dry seed weight, wherein the seed is capable of germination intoa plant capable of producing seed having an en- dogenous tryptophancontentofatleast about one-tenth milligram per gram dry seed weight.”

Itwas decided in the course of the process that, although this invention belongs within the scope of the PVPA, normal patenting practice may be applied. Consequently, a patent was granted to this invention (US 4581847).

3.2. The nationalpatent laws in Europe The Strasbourg Convention, which took shape through negotiations onthe conformi- tyofpatent legislation, didnotexclude plant varieties from patent protection. Instead, it left thematter to be decided in each country

separately. Among the contracting states, FRG, France, Belgium and Spain have decid- ed for the patentability of plant varieties that are not included in their national legislation on breeder’s rights (Straus 1987). Conse- quently, patents have been granted in West Germany for thehybridto tomatoandpota- to (DE2842197) and for the tetraploidcamo- mile (DE 3423207).

The definitions of patentable inventionsare uniform in the Scandinavianpatentlegislation on the lines included in the Strasbourg Con- vention. The Scandinavian countriesactinac- cordance with the patenting practices of the EPO, amending their decrees only when the decrees of the EPC are amended (Lommi

1987

b).

Finland and Norway are in principle more freetointerpret of thepresent patent legisla- tion,because they havenotsigned the UPOV Convention. In thiscase,plants appearto be patentable, presuming thatthey meetthe other

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requirements of patentability andarenotclas- sified as plantvarieties (Hjelt 1987).

4. The need to improve plant variety protection

4.1 The plant breeder’s viewpoint

Plant breeders using the traditional breed- ing methods appear tobe satisfied with the breeder’s rights and the protection provided by them. The right tofurther breed is partic- ularly emphasized by the breeders.

The attitude of small breeding companies is cautiously positive towards improving the plant variety protection by patenting. A pat- ent would provide better protection than the breeder’s rights. Byasingle application, pat- entprotectioncanbe sought for several differ- ent varieties and parts of plants. Moreover, it is less costlyto apply for a patentthan for breeder’s rights, at least in the United States (Lesser 1986a).

Statistics from 1980 show that in the United States the number ofnew wheat,soybean and cottonvarieties introduced annually was3—6 times higher after the enforcement of the breeder’s rights than before (Berland and Lewontin 1986). Private investment in plant breeding was also tripled in ten years since 1970,the year of enforcement of the breeder’s rights(Barton 1982). Hence, the number of newplant varieties launchedtothe market will beaugmentedwith the protection of varieties.

Yet, the real value of breeding work cannot be estimated by thisfact, because the varie- ties introduced by private companies tendto resemble each other closely in their charac- teristics. Plant breeders fear that such cos- metic breeding would increase ifpatents are granted for plant varieties. Judging by the ef- fects of the breeder’s rights, this is tobe ex- pected (Lesser

1986

b).

The patenting of plant varieties would pre- vent the free use of a protected variety for plant breeding. Breeders using the traditional methods stand for the viewpoint that plant varieties should remain free for utilization in

plant breeding, regardless of the methods by which they have been produced (Masten-

broek 1985). Accordingto this view,acertain

gene, for example, could be patented, but when transferred into aplant, patent protec- tion no longer would be applicable (Dickson

1985).

A more positive view in the question of patentability of plant varieties is taken by those breeders who apply biotechnological breeding methods. They claim that the special characteristicsof the biotechnological breed- ing methods are notadequately appreciated in the protection policy based on the breed- er’s rights. This is duetothe factthat, at the time the breeder’s rights were enacted, these techniqueswere not known. Breeders find it unjust that the results of the work demand- ing great investment should remain free for any utilization. For example, when plant va- riety witha certain resistance is developed, protection is sought for all varieties produced by thesame invention, i.e. the gene causing theresistance. However, this protectioncan- not be provided by the breeder’s rights.

In most countries where the legal position of plant breeders has been improved, plant breeding is mostly practiced by privatecom- panies. The patenting of plant varieties would leadto the disappearance of unprotectedvar- ieties from the market. It is suspected that varieties created by public meansmighteven- tually fall into private patenting (Barton

1982). It is an alarming prospect for plant breeders that the generalization ofbiotechno- logical breeding methods, together with the tightening protection of plantvarieties, might lead to the concentration of all plant breed- ing activity into the hands of large companies (Dickson 1985).

The improved protection has benefithed plant breeding companies. Private breeding activity in England had met with several difficulties before the enforcement of the law that guaranteed the breeder’s rights (Barton 1982). Previously the Government had a ma- jor role in the breeding activity, but the law

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411 has resulted in a significant rise in private

breeding activity (Aro 1977).

4.2. The seedproducer’s viewpoint It is necessary for the seed companytopro- duce seed of adequate quality at lowercosts than the farmer doesor, alternatively, prevent the farmer from using hisown harvestasseed.

Thiscanbe donebyproducing sterile seed in the manner of the hybrid varieties, or by patenting the seed. The absence ofpatent pro- tection has partlycontributedtothegreatrise in the use of hybrid varieties (Berland and Lewontin 1986).

Plant breeding and seed production usual- ly take place inseparateinstitutes. Where the breeder’s rights areapplied, the seed producer is obliged topay royalties tothe breeder for the right toutilize the variety. Thesecosts are transferredtothe seed price, tobe paid by the farmer.However, the market price of the seed must not exceed the limit after which it be- comes moreprofitable for the farmertopro- duce seed for his own needs.

After the enforcement of the breeder’s rights in England, many seed producerswent bankrupt. The new law forced themtoraise seed prices, whichcaused themdifficultiesin marketing the seed. Seed companies triedto evade the law by producing seed from the farmers own harvests, leaving the breeders without royalties. Plant breeders have made effortstopreventthis. InFrance, forinstance, plant breeders managed in 1985to enforce a law prohibiting this kind of activity (Berland and Lewontin 1986).

Seed producersare generally in favor of the extension ofpatent protection to cover also plant varieties. The American Seed Trade As- sociation (ASTA) supports the patenting of plants. It also supports the simultaneous ap- plication of patenting and breeder’s rights (Murphy 1987). Patenting is supported by the argument that it would prevent farmers from using their own harvest as seed. This, again, would accelerate the introduction of new varieties and promote breeding activity.

The concentration of seed production into afew large companies isa prevailing trend in the USA. In 1980,the large breeding compa- nieswereresponsible only for 20 %of allpat- ent applications concerning plants, but now anincreasing number of small companies are being fused into large ones (Barton 1982).

Yet,it is difficultto show whether this is due to general industrial trendsortothe improved protection of plant varieties.

Companies that haveactively invested in plant biotechnologyare increasingly purchas- ing seed companies as a meansof effectively launching new varieties to the market (Rosenqvist et ai. 1987). The heavy invest- ments give special weight to the demand for protection. In the United States, large seed companies have presented these demands for several years already (Lesser

1986

a). The

present European legislationseems to be in- adequate especially for the protection of plant varieties.

Companies applying biotechnological processes stand for the view that the breed- er’s rights do not in any circumstances pro- vide adequate protection for plant varieties in the field of biotechnology. The breeder’s rights are only applicable to the traditional breeding techniques for which theywereorigi- nally designed. The companies claim theright to decide independently on the form of pro- tection. Special dissatisfaction is aroused by the right for further breeding, because a mo- nopoly could easily be evaded by insignificant amendments in a variety.

5.3. The

farmer’s

viewpoint

Facing the improving variety protection, farmers are concerned about the rising seed prices. There is also the fear of the number of cultivated plant varietiestoreduceas a con- sequence of the protection. Large homogene- ousmonoculturesareespecially vulnerableto crop damage. The patenting arrangement wouldcause anempoverishment in the choice of varieties through the concentration of seed production. This process leadsto the loss of

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valuable genetic material through the disap- pearance of old varieties (Bell 1985).

4.4. The international situation

4.4.1. The industrial countries’ viewpoint The OECD report, BIOTECHNOLOGY AND PATENT PROTECTION 1985, sup- portsthe improvement of plant variety pro- tection by patenting. The report exhorts governments to seek possibilities for better protection of plants produced by the gene technological methods. It is further proposed that breeders be given the right to choose the form of protection between patenting and breeder’srights.

The WORLD INTELLECTUAL PROP- ERTY ORGANIZATION (WIPO) has de- lineated the present situation of protection policies within the field of biotechnical inven- tions. The results have motivatedalist of pos- sible solutions for the ambiguous points.

Thereby:

all biotechnological inventions should be considered patentable,

the patenting of plants should be possible atleastas farasplant varietiesarenotcon- cerned, and

the protection of living material should cover subsequent generations,too (Anon.

1985).

4.4.2. The developing countries’ viewpoint There has beenstrongcriticismonthepart

of the developing countries against plant va- riety protection, in fear that it may promote

the monopoly of multinational companies on food production (Dixon 1985).

The UNITED NATIONS FOOD AND AGRICULTURAL ORGANIZATION (FAO) presentsthe viewpoint that seeds, along with other plant material, are a commonheritage ofmankind, and should thus be exploitable by anyone. The enforcement ofpatent pro- tection isassumed toreduce breeding activity

funded by public means which is the form of breeding activity that has the greatestbearing for the developing countries.

5. Results and conclusions

In the UnitedStates, where it is possible to protect aplant witha patent or the breeder’s rights, thepatentlaw is better adapted to the development of biotechnology than in Eu- rope. As farasEPC isconcerned, thepatent legislation stillseemsto be relatively unsettled.

The reformation process of legislation appears to besoslowthat, in thepresent situation,the interpretation of the law hasto be asflexible aspossible.

Efforts have been made to improve the patent protection of plant bya new interpre- tation of such legal expressionsas“a plantva- riety”, “a microbiological method” and “an essentially biological method”. For themo- ment,plant materialcanbe regardedpatent- able but, on the other hand, there are no precedentstoclarify thematter.Thereare no signs ofareform of the EPC in thenear fu- ture. However, it is most evident that the patenting of plants will become possible either by reinterpretation of the laworafter amend- ments.

Thegreatestweaknesses of the plant varie-

typrotection provided by the UPOVseamto be the right to further breed protected plant varieties and the farmer’s right tousehisown harvestas seed. It is evident that the number of UPOV members will notincrease in the fu- ture unless the protection provided by the Convention is improved. With increasing plant patenting the importance of the UPOV will diminish.

Two interest groups can be recognized:

companies specializing in plant breeding and organizations representing the industrialcoun- tries. They both recommend improvementsto the legal protection and stand for the libera- tion of plant patenting. The improvedprotec- tion is assumedto speed up researchas it in- creasesthe willingness toinvest in plant breed- ing.

412

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On the other hand, farmers in industrial countries and the developing countries are against the improvements of the plant breed- ers’ legal rights. Farmers fear for anincrease in seed prices as well asfor toomuch depen- denceonthe producer. The developingcoun- tries also feel suspicious about the multina- tional seed companies whose influence is ex-

pected to increase if plant patenting is made possible.

Acknowledgements.The authorsaremost grateful to Ms HelyLommi,The National Board of Patents and Registration,for critical reading of the manuscript and valuable comments and advice,aswellastoMs Sisko Knuth-Lehtola,ALKOLtd, Helsinki, Finland,forcon- sultation.

6. References

Anon, 1981. European Patent Convention. European Patent Office. 2nd Ed. Wila Verlag, Wilhelm Lampi.

Miinchen.328p.

1984.International Patent Classification.4th Ed. Vol- ume3.World Intellectual Property Organization. Carl Heymanns Verlag KG. Miinchen.

1985. Guidelinesfor the Examination in the EPO.

Guidelinesfor substantivexamination.Part C, Chap- ter4.3.5.

1986.Industrialpropertyprotectionof biotechnolog- ical inventions. Industrial Property. 25(6)253—274.

Aro,P.L. 1977.Kasvinjalostajanoikeudellisesta asemas- ta.Suomen lakimiesyhdistyksen julkaisusarja,A119, Vammalan Kirjapaino Oy, Vammala. 135s.

Barton, J. 1982.The International Breeder’s Rights Sys- tem and Crop Plant Innovation. Science 216(4)

1071 1075.

Beier, F.&Straus, J. 1986.Genetic Engineeringand In- dustrial Property. Industrial Property 86(11), 447—459.

Bell, R. 1985.Case Against Plant Patenting. Search16, 9—12.

Beriand, J.&Lewontin,R. 1986. Breeder’s Rightsand

Patentinglife forms. Nature 322, 785—787.

Dickson, D. 1985.Chemical GiantsPush for Patentson Plants. Science228,277 —280.

Dixon, B. 1985. Debate over plantpatents grow in Eu- rope. Biotechnology3, 855.

Hibberd 1985.USA, Board of Patent Appeals and In- terferences oftheUnited StatesPatentand Trademark Office. 227 USPQ443.

Hjelt,P. 1987.Patentoitavuus. Kemian ja biotekniikan patenttikysymykset, INSKO 9—lo. 12.

Lesser, W. 1986a.Patenting Seedsinthe United States of America: What to Expect. Industrial Property9, 49—57.

Lesser, W. 1986b. SeedPatent Forecast.Biotechnology 4, 783.

Lommi, H. 1987a. Miten Suomen patenttijärjestelmä soveltuu kasvi- jaeläinkeksintöjen suojaamiseen. Ke- mian ja biotekniikan patenttikysymykset, INSKO, 9.—10. 12.

—1987b,Selostus biotekniikan alan keksintöjen suojamuotojakäsittelevän asiantuntijakomitean ko- kouksesta Genevessä29. 6—3. 7.1987.5 p.

Mastenbroek, C. 1985.Plant breeder’s rights and pat- ent protectioninrelation tonewdevelopmentsinplant breeding. Zaadbelangen4, 10—15.

Murphy, C. 1987.National Board Debates Impact of Biotech Patentson Germplasm. Diversity 11, 10.

Rosenqvist,H.,Seppänen,P.&Törmälä, T. 1987.Kas- vibiotekniikan mahdollisuudet biotekniikassa. Kemia- Kerni 14(3),225—228.

Straus, J. 1987. Personal communication. Kemian ja biotekniikan patenttikysymykset, INSKO9.—10. 12.

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Ms received March20, 1989

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SELOSTUS

Kasvibiotekniikan oikeudellinen suoja P.T. Vanhala, T. Pehu, H.G. Gyllenberg

Helsingin yliopisto.

Mikrobiologianlaitos

Keksinnön ontäytettävä tietytehdot,jottasevoidaan patentoida.Patenttilain soveltamista kasveihin rajoittaa perussääntö, jonka mukaan keksinnön tulee olla sillä ta- vallakuvattu, ettäasiantuntijavoi kuvauksen perusteel- la toistaa keksinnön. Nykyäänkatsotaan, ettätällaista kuvausta ei voida antaa elävästä organismista. Tästä joh- tuenonkasvilajikkeille kehitetty oma, patenttia vastaa- va, UPOV-sopimuksessa määritelty suoja.

Yhtenä biotekniikan lupaavimpana sovelluksena pide- täänkasvintuotantoa. Kasvinjalostuksessa käytettävien bioteknisten jalostusmenetelmien katsotaantäyttävän pa- tentoinnille asetetut ehdot paremmin kuin perinteistenme- netelmien. Tämän perusteellaonvaadittu patenttisuojan laajentamistakoskemaan myös uusia kasvilajikkeita.

Euroopan patenttisopimuksen piirissä oikeuskäytäntö onvielä vakiintumaton. Lainsäädäntöprosessi vaikuttaa niin hitaalta,ettänykyistälakia joudutaan tulkitsemaan mahdollisimman väljästi. Tällä hetkellä kasvimateriaali näyttää patentoimiskelpoiselta, mutta asiaa selventävät

ennakkotapauksetpuuttuvat.

Yhdysvalloissa patenttilainsäädäntöon mukautunut biotekniikan kehitykseen paremmin kuin Euroopassa.Yh- dysvalloissaon mahdollista suojata kasvejatuotepaten- teilla ja valita suojan muodoksi patentti tai jalostajan- oikeudet.

UPOV;intarjoaman kasvilajikesuojan pahimpinaheik- kouksina pidetään jatkojalostusoikeutta ja viljelijän oikeutta käyttää satoaan siemenenä. Näiden oikeuksien katsotaan tarjoavan mahdollisuuksia suojan kiertämiseen.

Kasvinjalostustyötätekevät yritykset ja teollisuusmai- taedustavat järjestöt suosittelevat suojan parantamista.

Parantuneen suojan katsotaan vauhdittavan alan kehi- tystä. Sitävastoin viljelijät ja kehitysmaiden edustajat ovat kasvilajikesuojan parantamista vastaan. Viljelijät pelkää- vätsiementen kallistumista ja liiallista riippuvuutta sie- mentuottajasta. Kehitysmaissa epäilläänmonikansallis- ten yritystenvaikutusvallan kasvavan parantuneen laji- kesuojanmyötä.

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Viittaukset

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