owning omega-3: monsanto and the invention of meat · 2020. 2. 29. · the cow, chicken or pig...

Farm Policy Journal|Vol.8No.1|AutumnQuarter2011

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OwningOmega-3:Monsantoand the Invention of MeatDr Matthew RimmerANU College of Law, Australian National University

InAugustof2010,AnnaSallehoftheScienceUnitoftheAustralianBroadcastingCorporationbrokeastoryaboutMonsantoseekingtopatenttheenhancementofmeat,includingomega-3fattyacids:

Enhanced pork is sparking debate over the ethics of placing patents on food. Patentapplicationscoveringtheenhancementofmeat,includingporkwithomega-3fattyacids,are stimulating debate over the ethics and legalities of claiming intellectual propertyoverfood.Monsantohasfiledpatentsthatcoverthefeedingofanimalssoybeans,whichhave been genetically modified by the company to contain stearidonic acid (SDA), aplant-derivedomega-3fattyacid...Omega-3shavebeenlinkedtoimprovedcardiovascularhealthandtherearemanycompaniesengineeringthemintofoodstuffs.Butthenewpatentapplicationshavetouchedarawnerveamongthosewhoseethemasanattemptbythecompanytoexertcontroloverthefoodchain.(Salleh2010)

ThisarticleprovidesacriticalevaluationofthecontroversyofMonsanto’spatentapplications,andthelargerissuesoverpatentingfood.ItfirstconsidersthepatentportfolioofMonsanto;thenatureofthepatentclaims;andtheexaminationoftheclaimsbypatentexaminers.Second,itexaminesthewithdrawalandrevisionofthepatentclaimsbyMonsantointhewakeofcriticismbypatentauthoritiesandthepublicdisquietoverthecontroversialapplication.Third,thisarticleconsidersthelargerpolicyissuesraisedbyMonsanto’spatentapplications–includingthepatentingofplants,animalsand foodstuffs.There isalsoaconsiderationof theimpactofpatentsupontheadministrationofhealthcare,competitionandresearch.

Monsanto and Its Patent PortfolioMonsantoisanagriculturalbiotechnologycompanybasedintheUnitedStates.Originally,thecompanywasfocusedontheproductionandmarketingofagriculturalchemicalsandherbicides.Astheresultoftheexpiryofpatentsonkeychemicals,thecompanyhasshifteditsfocustothefieldofbiotechnology.Inhisremarkstothe2010AnnualReport,HughGrant(2010),thechiefexecutiveofficer,President,andChairmanofMonsanto,envisagedthisfutureroleforthecompany:

Creating value for farmers around the world bydeveloping and delivering best-in-class seeds andtraitsisattheheartofourbusiness.OurcustomersareclearinwhattheywantfromMonsanto.Theywant

us to continue to invest in research and development (R&D)tohelpbringinnovativeapproachestothefarm.Theywantmore top-performinggermplasmand trait choices across geographies. They want a broadarrayofproductchoicesacrossallcrops.Andthey want us to price our products in a way that encourages trial and adoption.

Monsantohasbeenasignificantplayerinpatentlaw and agriculture. As well as developing extensivepatentportfoliosinarangeofsectors,thecompanyhasbeeninvolvedinanumberofkeytestcasessuchasthematterofIn Re Fisher onpatentutility(Rimmer2007);1thecaseofSchmeiser v Monsanto onpatentinfringement;2 abattleintheEuropeanCourtofJusticeovera

1 In re Fisher421F.3d1365(C.A.Fed.,2005).2 Monsanto Canada Inc. v. Schmeiser(2004)SCC34;2004

SCC34.


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soyabeanpatent;3 and disputes over technology user agreements.4 In this most recent patent application, Monsanto has once again tested the limitsofpatentlaws,withitspioneeringpatentsinrespectofSDAomega-3soybeans.

Oflate,Monsantohasbeenengagedinextensiveresearchanddevelopment(R&D)inrespectofstearadonicacid(SDA)omega-3soybeans:

Monsanto researchers are developing SDA (stearadonic acid) omega-3 soybeans that resultin an improved soybean oil containing enhancedlevelsofomega-3s.Workingwithfoodcompanies,Monsanto is looking to incorporate these oils in many foods, including beverages and snack bars.Researchersdiscoveredtheremayalsobebenefitsto livestock consuming the omega-3 soybean oilaswell.Monsantoemployeesstudiedtheeffectonchickens, pigs, fish and cows (all raised for theirmeat)consumingSDAomega-3throughtheirsoymealfeed(theseanimalsareregularlyfedsoymeal/soyproteintoday).Earlystudiesshowaftereatingfeed with the omega-3 soybean oil, the animalshave more omega-3s in their system, improvinganimal health similarly to humans. And, as a result of increasedomega-3 levels in these animals, theomega-3scanbepassedontoconsumerswhoeatthecow,chickenorpigmeat.(Monsanto2010)

MonsantohasbeenassiduouslybuildingaportfolioofpatentsrelatingtoSDAomega-3soybeans.Asof2010,therewere22patentfamilies–withfilingsinarangeofcountries.Sixofthesepatentfamiliesrelatedtoanimalsandanimalby-products.Sixpatentfamiliescoveranimalfeed.FiveofthesepatentfamiliesrelatedtotheuseofSDAoilinfoodelements.Fivepatentfamiliesfocusedonthegeneticelements,whichallowtheproductionofSDAinsoybeans.Onepatentfamilyconcernedthetransformationevent.Fivepatentfamiliesrelatedtoindustrialusesoftheoilandoilapplications.

In2009,MonsantoTechnologyLLCfiledapatentapplicationunderthePatentCo-operationTreatyfor‘methodsoffeedingpigsandproductscomprisingbeneficialfattyacids’(Hartnelletal.2008).Thepatentapplicationdescribesthefieldoftheinventionthus:‘Theinventionrelatestothe

3 Monsanto Technology LLC v. Cefetra BV and Others(2010),C-428/08,EuropeanCourtofJustice.

4 Monsanto v. McFarling363F.3d1663(2004).

enhancementofdesirablecharacteristicsinpigsand/orporkproductsthroughtheincorporationofbeneficialfattyacidsinanimalfeedorinanimalfeedsupplements’.Theapplicationelaborates:‘Morespecifically,itrelatestomethodsofproductionandprocessingofporkproductscompromisingpolyunsaturatedfattyacidsincludingstearidonicacid’.

Theabstractoftheinventiongivesasenseofthebreadthofthepatent:

Thepresentinventionprovidesforimprovedporkproducts for human consumption andmethods ofproducing such pork products by incorporatinghealthy lipids containing stearidonic acid into swine feed products. Furthermore, the present inventionprovidesmethods for producing said products. Inoneembodimentof the invention, ananimalmaybefedfeedcomprisingatransgenicplantproduct.Inotherembodimentsoftheinvention,porkmeatproducts for human consumption, such meatproducts comprising SDA, EPA, and DHA aredisclosed.Infurtherembodimentsoftheinvention,porkproductscomprisingnovelfattyacidprofilesaredisclosed.(Hartnelletal.2008)

Thepatentapplicationdescribesthefieldoftheinventionthus:‘Theinventionrelatestotheenhancementofdesirablecharacteristicsinpigsand/orporkproductsthroughtheincorporationofbeneficialfattyacidsinanimalfeedorinanimalfeedsupplements’.Theapplicationelaborates:


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‘Morespecifically,itrelatestomethodsofproductionandprocessingofporkproductscompromisingpolyunsaturatedfattyacidsincludingstearidonicacid.’

Thescopeandbreadthofprotectionaffordedbyapatentisdeterminedbyitsclaims.Thescholars,Lionel Bently and Brad Sherman, emphasise that ‘theprimaryfunctionoftheclaimsistosetoutthescopeofthelegalprotectionconferredbythepatent’(2009,pp.263–364).Thepaircomment:

A number of different rules and proceduresregulate the form that claims ought to take. Ata general level, the contents of the claims mustcomply with the substantive requirements forpatentability:namely, subjectmatter, novelty, andnon-obviousness.Theclaimsmustalsodefine thematter forwhich protection is sought in terms ofthetechnicalfeaturesoftheinvention,beclearandconcise,besupportedbythedescription,andrelatetooneinvention,oragroupofinventionsthatareso linked as to form a single inventive concept.(Bently&Sherman2009,p.368)

BentlyandShermanreflectthatpatentclaimsareahighlyspecialisedlegaldiscoursedesignedtobereadbypatentattorneys,examiners,judges,andscientists:

Aswellasbeingwrittenforspecialists,thedraftingandreadingofclaimsbuildsuponwell-established

and sophisticated techniques and procedures that makethemdifficultfortheuninitiatedtounderstand.(Bently&Sherman2009,p.365)

Inmyopinion,themajorclaimsinMonsanto’sinitialpatentapplicationwerebreathtaking.Claim1isfora:

[P]orkproductforhumanconsumptioncomprisingstearidonic acid andwherein the concentrationofsaidSDAisatleast0.05gper100goffatintheporkproductandwhereinaportionofsaidSDAisincorporatedinthetissuesofsaidpigaftersaidpigisprovidedafeedcompositioncontainingSD.

Claims2to17providevariationsonthefirstclaim.Claim18relatesto

[T]he pork product of claim 1wherein said porkproduct is selected from the group consisting ofbacon,ham,porkloin,porkribs,porksteaks,lard,pork rinds, or other pork products.

Claims19to33offerfurthervariationsonclaim18.Claim34isfora‘methodofproducing pigs comprising providing a nutritious compositioncomprisingstearidonicacid(SDA)asafeedsourceforsaidpigs’.Claim35providesthatsucha‘nutritiouscompositioncomprisesseedsselectedfromthegroupconsistingofsoybeans,safflower,sunflower,canola,andcorn’.Claim46concernsa‘porkmeatproductforhuman consumption comprising stearidonic acid andeicosapentaenoicacid’.Claim70concernsa:

[S]wine feed comprising (a) stearidonic acid; (b)gamma linolenic acid (GLA); (c) additional feedcomponentswhereinsaidswinefeedcomprisesatleastabout0.10%stearidonicacidandabout0.07%GLA, wherein the ratio of SDA/GLA is at leastabout1.3.

Thepatentapplicationhas89claimsintotal.

Forapatenttobevalid,anapplicantmustestablishthattheinventioncanbeclassifiedaspatentablesubjectmatter.Furthermore,theapplicant must demonstrate that the invention is novel and displays an inventive step according toapersonskilledintheart,atthetimeoffiling.Moreover, an applicant must show that the inventionhasutilityorindustrialapplicability.

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Theinternationalpreliminarypatentabilityreportbythepatentexaminer,KevinRooney,oftheEuropeanPatentOfficewasquitecriticalofthepatentapplicationputforwardbyMonsanto(Patentscope2010).Onthecriteriaofnovelty,theexaminerwasoftheviewthatonlypatentclaims51–69displayednovelty.Hewasoftheviewthatclaims1–57and70–89lackednoveltybecausetheyhadbeenanticipatedbyarangeofdocumentsandpatents(Dazaetal.2007;Kang&Park2007;Guil-Guerrero2007;Kriese,etal.2004;Wilson,etal.2002;Arhancetetal.2006;CSIROandtheUniversityofTasmania2007).Onthecriteriaofaninventivestep,Rooneywasoftheviewthatnoneoftheclaimswerevalid.However,onthecriteriaofutilityorindustrialapplicability,Rooneywassatisfiedthatthepatentssatisfiedsuchcriteria.

Withdrawal of Patent ClaimsIn response to the international search report and the written opinion, Monsanto made amendments tothepatentapplicationonthe6July2010.Claims1–89werereplacedbyamendedclaims1–32.Claims34–45wererenumberedasclaims1–12.Claims70–89hadbeenrenumberedasclaims13–32.Suchclaimsrelatetothefeedsourceforpigs.Monsantohadabandonedclaims1–33and46–69.Thisamountstoasignificantreductioninthescopeandthebreadthofthepatent application.

Inapressrelease,Monsanto(2010)explainedthewithdrawalofsomeclaimsandtherevisionofotherclaims.Itisworthwhilequotingextensivelyfromthispressreleasetoensurethatthecompany’spositioninthecontroversyisfairlypresented.

Thecompanystressedthat‘Monsantodidnotinventmeat’andthat‘Monsantodoesnotintendtotakeownershipoflivestockorfishortosellcompany-brandedmilk,meatoreggsenrichedwithomega-3stoconsumers.’Explainingthemotivationsbehindfilingthepatents,Monsantonoted:‘Thecompanyrecognisesthatwhilemanyseethisasapositivestepinfindingnewwaystoget essential nutrients in our diets, it also raises somequestions.’Thecompanyobserved:

Monsantodecidedtoapplyforpatentsbasedonthishealthbenefittoprotecttheresearchers’discovery.Ifthepatentisgranted,Monsantodoesnotintendtogetinvolvedinlivestockorfishproductionorsellcompany-brandedmilk,meatoreggsenrichedwithomega-3s directly to consumers. (Media release,Monsanto2010)

Monsantonoted:‘Wemadethisclaimtoensuresomeoneelsewouldn’tfileapatentclaimonthederivedbenefitresultingfromomega-3animalfeed(includingMonsanto’simprovedsoybean)’.Thecompanyobserved:

Ifsomeoneelsefiledapatentonanotherstepoftheprocess(includingthemeatitself),itcould‘block’theuseofMonsanto’sSDAomega-3soybeansfrombeingusedinanimalfeed,simplybyvirtueofthethirdpartyhavingtheirend-useapplicationonfile.

Thecompanynoted:‘TheMonsantoapplicationsserveasofficialnoticeofwhatMonsantoscientists are working on to others in the private andpublicsectors.’Monsantostressedthatthe‘disclosureofexactlywhatMonsantoresearchersinvented is necessary to protect new technological advances.’

Discussingthewithdrawalofthepatentclaims,Monsanto emphasised that it had repudiated any claims in respect to animals and their meat:

Sincetheinitialpatentfilings,Monsantohastakenstepstowithdrawthespecificclaimsinthepatent


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applications relating to animals and their meat. Therehasn’tbeenanychangeinthederivedbenefitswe expect from our SDA omega-3 soybeans, butbecausetheearlierapplicationdisclosedtheanimalandmeatbenefits,nooneelsecannowclaimtheseas their invention. It also makes it clear Monsanto has no plans to take ownership of or sell company-branded omega-3 enriched meat.

The company said:

Monsanto is currently looking at ways to accomplish public disclosureof companydiscoverieswithouthaving tofilepatentapplications, so in the future

patent applications won’t include these derivedbenefittypesofclaims.

It noted:

The company and employees also want livestock andfoodproducerstobefreetodevelopproductsthat canmake the benefits of this enhanced feedavailabletobothanimalsandhumans.

Monsantostressedthatitskeyobjectiveunderpatentlawwastoprotectthesoybeanfeedthatithad developed. The company also seems to have leftopenthewaytomakepatentclaimsaboutanimal health.

Thisintriguingpressreleasecouldbereadinanumberofdifferentways–dependingonone’spolitical position and ideological persuasion.

Thepressreleasecouldbereadatfacevalue,andtakenasagoodfaithaccountofMonsanto’sactions.Themessagecouldbealternativelyreadas a coded mea culpa–anadmissionbythecompanythatithadoverreacheditselfwiththeextensive patent claims, and had retreated to a more cautious position. Rivals and competitors couldbemoresuspiciousaboutthepressrelease,seeingitasbraggadocioonthepartofMonsanto.Notwithstanding the withdrawal and revision ofthepatentclaims,certainenvironmentalgroupsremainedunconvinced.LauraKellyofGreenpeacewasreportedtobeconcernedthat,eveniftheydonotclaimownershipofthemeat,Monsanto might still claim royalties on meat productsalesproducedusingtheirtransgenicfeed(Salleh2010).

Policy ThemesThis individual controversy has erupted against thebackgroundofalarger,rolling,policydebateaboutintellectualpropertyandbiotechnology(Rimmer2008).Monsanto’spatentapplicationsraiseanumberoflargerpolicythemesabouttheownershipofplants,animalsandfood.Thepatentapplicationsalsohighlightmeta-questionsabouttheimpactofpatentlawuponpatientcare,healthcare and competition.

First, the patent applications raise questions aboutpatentingplants.Therehavebeenanumberofchallengestothegrantofpatentsinrelationtoagriculture.InthecaseofDiamond v. Chakrabarty,themajorityoftheSupremeCourtoftheUnitedStatesrecognisedthatthePlant Patent Act 1930(US),thePlant Variety Protection Act 1970(US),andthegeneralregimeofutilitypatentscouldco-existalongsideoneanother.5 In thecaseofJEM Ag Supply Inc v. Pioneer Hi-Bred International Inc.,themajorityoftheSupremeCourtoftheUnitedStatesheldthatutilitypatentscouldbegrantedinrespectofplants–aswellasplantpatentsandplantbreeders’rights.6 In thecaseofSchmeiser v. Monsanto, McLachlin J andFishJoftheSupremeCourtofCanadaemphasised:‘UnderthepresentAct,aninvention

5 Diamond v. Chakrabarty447US303(1980).6 JEM Ag Supply Inc v. Pioneer Hi-Bred International Inc534

US124(2001).


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inthedomainofagricultureisasdeservingofprotectionasaninventioninthedomainofmechanicalscience’.7 In Grain Pool of Western Australia v. Commonwealth,theHighCourtofAustralia held that the intellectual property power oftheAustralianConstitutionsupportedboththepatentregimeandtheplantbreeder’srightssystem.8TheEuropeanPatentOfficehasbeenconsideringthemeritsofpatentsbeinggrantedinrespectoffoodssuchasbroccoliandtomatoes.9

Notwithstandingtheprecedentsofsuperiorcourts,anumberoffarmers’collectives,environmentalgroups,andanti-biotechnologygroupshavecampaignedforpatentsonplantstoberevokedandprohibited.

Second, the patent applications highlight issues concerningpatentinganimals.InthecaseofMartek Biosciences Corporation v. Nutrinova Inc.,theUnitedStatesCourtofAppealsfortheFederalCircuitconsideredapatentinfringementactionrelatedtoomega-3.10Allassertedclaimsofthepatentweredirectedtomethodsforachievinghighconcentrationsofomega-3HUFAinan‘animal.’GarjarsaJoftheCourtofAppealsfortheFederalCircuitdiscussedthedefinitionofan‘animal’inthepatentclaims:

Underourprecedent,because thepatentdoesnotclearlydisclaimcoverageofhumans, itwouldbeerroneous to limit the claims to certain types ofanimals that the inventor anticipated would prove usefulintheinvention.Thatisespeciallytrueinthepresentcasebecausethepatentexpresslydefinestheclaimterm‘animal’broadlyenoughtoencompasshumansanddisclosesusesoftheclaimedinventionapplicabletohumans.11

7 Monsanto Canada Inc. v. Schmeiser(2004)2004SCC34.8 Grain Pool of Western Australia v. Commonwealth(2000)46

IPR515.9 State of Israel – Ministry of Agriculture v. Unilever T1242/06

–3.3.04(4April2008),EPOBoardsofAppealDecision,http://legal.european-patent-office.org/dg3/biblio/t061242ex1.htm;currentlyunderreviewbytheEnlargedBoardofAppeals.ThepatentinquestionisSchaffer,A(1998),‘Methodforbreedingtomatoeshavingreducedwatercontentandproductofthemethod’,EuropeanPatentApplicationNo.00940724.

10 Martek Biosciences Corporation v. Nutrinova Inc.579F.3d1363(2009).

11 Ibidat1382.

GajarsaJheld:‘Theproperconstructionfortheclaim term “animal” is the one explicitly provided bythepatentee:“anyorganismbelongingtothekingdomAnimalia,”whichincludeshumans.’12 In dissent, Lourie and Rader JJ dissented:

Having examined the use of the term ‘animal’ intheclaimsandthespecificationofthe‘244patent,I believe it is clear that one of ordinary skill inthe art would conclude that, despite the purported definitioninthespecification,theterm‘animal’inthe claims cannot include humans.13

Third, the patent applications tap into the controversyaboutpatentingfood.AnnaShihnotesthat‘patentingfoodproductsandfood-processingtechniquesisnotnew,orevenuncommon’(Shih2002).Shereflects:

Patenting food products and food-processingtechniques is not new, or even uncommon. The US PatentandTrademarkOffice(USPTO)hasanentirecategoryinitspatentclassificationsystemdevotedto food-related patents. Class 426, entitled ‘Foodor Edible Material: Products, Compositions, andProducts’,includesoverfivehundredsub-categoriescoveringeveryaspectoffoodandfoodprocessing,suchasbakedorpuffedready-to-eatbreakfastcereal(subclass621) and food-fryingmethods (subclass438).GiventhebreadthofClass426andthevaluethat many companies place on patents, nearly every fooditeminasupermarketorfast-foodrestaurantcouldconceivablyincorporateatleastonepatentedinvention in itscreation,and thepatentscouldbedirectedtothefoodproductitself,additivesinthefoodproduct,themannerinwhichitisprocessed,or even the machinery used in the processing. (Shih2002)

Nonetheless, there remains controversy over patentingfoodandediblematerial.Absurdpatents–suchasJ.M.SmuckerCompany’sUnitedStates.PatentNumber6,004,596onthe‘SealedCrustlessSandwich’–haveattractedire(Kretchman&Geske1997).High-mindedcriticsareconcernedabouttheimpactofintellectualpropertyonfoodsecurity,particularlyinlightofclimatechange,urbanisation,andthegrowthintheworldpopulation(Patel2007).OliverdeSchutter(2009),thespecialUnitedNationsRapporteurontherighttofood,hascalledforflexibleexceptionstopatentrightsandplantbreeders’rights–suchas

12 Ibidat1382.13 Ibidat1385.


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abroadexperimentalusedefence;farmers’rightscompulsorylicensing,crownuseandacquisition;andcompetitionregulation.Hemaintainsthatsuch measures are particularly important when dealingwithfoodshortages,faminesandpricevolatility.

ThepatentapplicationsofMonsantotappedintothislargercontroversy.GreenpeaceAustralia’sLauraKellyobserved:‘Asacommunityweneedtodecidewhetherwewantourmostbasicfoodstobeownedbychemicalcompanies’(Salleh2010).

Fourth,giventhefocusuponthehealthbenefitsofomega-3,thepatentapplicationsraiselargerissuesabouttheimpactofpatentlawuponaccessto healthcare. In the United States, there has beenmuchcontroversyoverMyriadGenetics’patentsoverBRCA1andBRCA2.InresponsetoachallengetothevalidityofthepatentsbytheAmericanCivilLibertiesUnion,SweetJexpressed reservations in a United States District Courtabouttakingabroadapproachtopatentablesubjectmatter.14Thejudgewasparticularlyconcernedabouttheimpactofgenepatentsupon patient care, medical research, and the administrationofhealthcare:

TheresolutionoftheissuespresentedtothisCourtdeeply concerns breast cancer patients, medicalprofessionals, researchers, caregivers, advocacygroups, existing gene patent holders and their investors, and those seeking to advance publichealth.15

Thejudgeheld:

The claims-in-suit directed to ‘isolated DNA’containing human BRCA1/2genesequencesreflecttheUSPTO’spracticeofgrantingpatentsonDNAsequences so long as those sequences are claimed in the form of ‘isolated DNA.’ This practice ispremisedontheviewthatDNAshouldbetreatednodifferentlyfromanyotherchemicalcompound,and that its purification from the body, usingwell-known techniques, renders it patentable bytransforming it into somethingdistinctly different

14 Association for Molecular Pathology v. United States Patent and Trademark Office, Myriad Genetics, and the directors of the University of Utah Research Foundation2010WL1233416(S.D.N.Y.).

15 Ibid.

in character. Many, however, including scientists in the fields ofmolecular biology and genomics,haveconsideredthispracticea‘lawyer’strick’thatcircumventstheprohibitionsonthedirectpatentingof theDNA in our bodies butwhich, in practice,reaches the same result. The resolution of thesemotions isbasedupon long recognizedprinciplesofmolecularbiologyandgenetics:DNArepresentsthephysicalembodimentofbiologicalinformation,distinct in its essential characteristics from anyotherchemicalfoundinnature.ItisconcludedthatDNA’sexistenceinan‘isolated’formaltersneitherthisfundamentalqualityofDNAasitexistsinthebodynortheinformationitencodes.Therefore,thepatentsatissuedirectedto‘isolatedDNA’containingsequences found in nature are unsustainable as amatteroflawandaredeemedunpatentablesubjectmatterunder35U.S.C.§101.16

TherearegravedoubtsastowhetherthedecisionisconsistentwiththebroadapproachtakentopatentablesubjectmatterinpreviousprecedentsofsuperiorcourtsintheUnitedStates.Thematteris currently under appeal in the United States CourtofAppealsfortheFederalCircuit.

InAustralia,therehasbeenongoingcontroversyovergenepatents.InNovember2010,theSenateCommunityAffairsReferenceCommitteereleased its long awaited report on gene patents. Themajorityofthecommitteerecommendedanumberofproceduralandsubstantivereformstoimprovethequalityofpatentsgranted–particularlyintheareaofbiotechnology.However,aminorityofthecommitteewereoftheviewthatthereshouldbeaprohibitionongenepatentsaltogether.Aprivatemembers’billhasbeenintroducedintoParliament,entitledthePatent Amendment (Human Genes and Biological Materials) Bill 2010(Cth).ThesponsorsincludetheLiberalPartymavericks,SenatorHeffernanandCoonan;GreensSenatorSiewert,andIndependent Nick Xenophon. The rather crudely draftedbillproposesabroadprohibition:

The following are not patentable inventions: (a)humanbeings,andthebiologicalprocessesfortheirgeneration; and (b) biologicalmaterials includingtheir components and derivatives, whether isolated or purified or not and however made, which areidenticalorsubstantiallyidenticaltosuchmaterialsas they exist in nature.

16 Ibid.

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ItisdoubtfulthatsuchabillwillwinthesupportofthemajorpartiesintheAustralianParliament.

Finally, the patent applications highlight questions ofpatentlawandcompetition.BinnieJoftheSupremeCourtofCanadahasemphasisedthatpatents have a strong impact upon competition in the marketplace:

The grant of a patentmonopoly for [20 years]…creates, and is intended to create, serious anti-competitiveeffects.Oncethesubjectmatterofthepatentisfencedinbytheclaims,otherstrespass(advertently or inadvertently) on the forbiddenterritory at their peril. The boundary is defendedby a considerable arsenal of remedies conferredby thePatent Act, includinganaccountingof theinfringer’s profits in an appropriate case. Patentlitigation is usually protracted and costly… There is in the meantime a chilling effect on otherresearchers. They will tend to invest their talents in less litigious areas. Parliament considered this chilling effect to be a worthwhile price for thedisclosureofa‘newanduseful’invention,bringinginto the public domain information that mightotherwiseremainatradesecret,butthereisnothingin the Act to suggest that Parliament was prepared toacceptthechillingeffectinexchangefornothingbutspeculation.17

Therewasaconcernexpressedbyanumberofrivalresearchersintoomega-3–includingCSIRO, the Pork Cooperative Research Centre, andAustralianPorkLimited–abouttheimpactofanypatentuponresearchandcompetitioninthisfield.Evenbypublishinganddisclosingitsresearchinthisfield,andmakingthismaterialpartofthepriorart,Monsantoperhapshopestofrustratetheabilityofitsrivalsandcompetitorstofilepatentsinthisfield.

TherivalsofMonsantoremainedscepticalofthevalidityofthepatentclaims,andwouldclaimthattheirresearchanticipatesthatoftheMissouriagriculturalbiotechnologycompany.ItiscertainlytruethatCSIROisasignificantcompetitortoMonsantointhefield,withpatentsofitsown(CSIROandtheUniversityofTasmania2007).AspartofitsFoodFuturesFlagship,CSIROhasbeenbusy,developingplantsthatproduceDocosahexaenoicacid(DHA),ahealthyomega-3

17 Apotex Inc. v. Wellcome Foundation Ltd.(2002)4S.C.R.153,2002SCC77.

oilcomponentthatisvitalforhumanhealthandnormallyonlyavailablefromfishsources.CSIRO(2010)claimsthatsuchresearchisanimportantsteptowards‘improvinghumannutrition’;‘reducingpressureondecliningfishresourcesworldwide’and‘providingAustraliangraingrowerswithnewhigh-valuecrops.’CSIROcomments:

Although it will be some years beforecommercialisation, crop plants capable ofproducingusefullevelsofDHAintheirownseedswould have many benefits. DHA enriched cropplants could provide consumers with cheaper and morevariedsourcesofDHA–particularlyvaluable

tothosewithfishallergiesorwho,becauseofcost,availability or choice, don’t have a high level offishconsumptionintheirdiet.DemandonnaturalfishstocksasasourceofDHAwouldbeless.FishinaquaculturecouldbefedDHAenrichedplants,rather thancontinuing touseotherfishas a feed,improvingthesustainabilityofaquaculturewithoutcompromisingquality.(CSIRO2010)

CSIROsuggeststhatomega-3oilsarewidelyrecognisedfortheirabilitytoreduce‘coronaryheartdiseaserisk’,‘type-2diabetes’,‘Alzheimersdisease’and‘asthma.’Moreover,CSIROhasbeenincreasingly willing to engage patent litigation,


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evenwithlargeUnitedStatescompanies–suchasin the dispute over its wireless technology.18

So,inthefuture,theremaywellbeprioritydisputesoverpatentapplicationsbetweenMonsanto and CSIRO.

Inconclusion,thecontroversyoverMonsanto’spatentapplicationinrelationtoomega-3hasbeenresonantinthelargerpublicarenabecauseit has crystallised key issues over intellectual propertyandbiotechnology.Inparticular,itraisedquestionsaboutthepatentingofplants,animalsandfood;andtoucheduponissuesovertheaccessto healthcare, research and competition.

18 Intel v. CSIRO455F.3d1364,79U.S.P.Q.2d1508,C.A.Fed.(Cal.)(14July2006);Microsoft v. CSIRO2007WL4376104,E.D.Tex.;andCSIRO v. Buffalo Technology Inc. 542F.3d1363(2008).

ReferencesArhancet,Jetal.(2006),UnitedStatesPatent,2006/111578A1.

Bently,L,Sherman,B(2009),Intellectual Property Law: Third Edition,Oxford:OxfordUniversity Press.

CSIRO(2010),Omega-3 oils in grains,availableat:http://www.csiro.au/science/Omega-3-oils-in-grains.html

CSIROandtheUniversityofTasmania(2007),Feedstuffs for Aquaculture Comprising Stearidonic Acid,CanadianPatentNo.2,630,173.

Daza,A,Ruiz-Carrascal,J,Olivares,A,Menoyo,D,Lopez-Bote,CJ(2007),FattyacidsprofileofthesubcutaneousbackfatlayersfromIberianpigsraisedunderfree-rangeconditions,Food Science and Technology International,vol.13,issue2,p.135.

DeSchutter,O(2009),Seed policies and the right to food: enhancing agro biodiversity and encouraging innovation, United Nations General Assembly,A/64/170,21,availableat: http://www.ip-watch.org/weblog/wp-content/uploads/2009/11/n0942473.pdf

Grant,H(2010),Looking Ahead, Monsanto Annual Report,availableat:http://www.monsanto.com/investors/Pages/looking-ahead.aspx

Guil-Guerrero,JL(2007),StearidonicAcid(18:4n-3):Metabolism,nutritionalimportance,medical uses and natural sources, European Journal of Lipid Science and Technology, vol.109,p.1226.

Hartnell,G,Ursin,V,Lucas,D(2008),Methods of feeding pigs and products comprising beneficial fatty acids, World Intellectual Property Patent NumberWO2009/097403.


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About the AuthorDr Matthew Rimmer is an Australian Research Council Future Fellow, working on intellectual propertyandclimatechange.HeisanassociateprofessorattheANUCollegeofLaw,andanassociatedirectoroftheAustralianCentreforIntellectualPropertyinAgriculture(ACIPA).HeholdsaBA(Hons)andaUniversityMedalinliterature,andanLLB(Hons)fromtheAustralianNational University. Rimmer received a PhD in lawfromtheUniversityofNewSouthWalesforhisdissertationonThe Pirate Bazaar: The Social Life of Copyright Law.HeisamemberoftheANUClimateChangeInstitute,andadirectoroftheAustralianDigitalAlliance.Rimmerhaspublishedwidelyoncopyrightlawandinformationtechnology,patentlawandbiotechnology,accesstomedicines,cleantechnologies, and traditional knowledge. Rimmeristheauthorof Digital Copyright and the Consumer Revolution: Hands off my iPod (EdwardElgar,2007),andIntellectual Property and Biotechnology: Biological Inventions (EdwardElgar,2008).Heisalsotheco-editorofIncentives for Global Public Health: Patent Law and Access to Essential Medicines (CUP,2010).HisbookIntellectual Property and Climate Change: Inventing Clean TechnologieswillbepublishedbyEdwardElgarin2011.

Thisresearchprojecton‘PatentingOmega-3’hasbeensupportedbyanAustralianResearchCouncilDiscoveryProject,‘PromotingPlantInnovationinAustralia’(2009–11).

owning omega-3: monsanto and the invention of meat · 2020. 2. 29. · the cow, chicken or pig...

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