COMMENTARY© 2010 Nature America, Inc. All rights reserved.Note: Supplementary information is available on theNature Biotechnology website.ACKNOWLEDGMENTSResearch in our laboratory is funded by MICINN(Ministry of Science and Innovation), Spain(BFU2007-61413); European Union Framework 6Program – The Pharma-Planta Integrated Project LSH-2002-1.2.5-2; European Union Framework 7 Program-SmartCell Integrated Project 222716; European UnionFramework 7 European Research Council IDEASAdvanced Grant (to P.C.) Program-BIOFORCE;Acciones Complementarias (MICINN) BIO2005-24826-E. Centre CONSOLIDER on Agrigenomicsfunded by MICINN, Spain.COMPETING INTERESTS STATEMENTThe authors declare no competing financial interests.1. James, C. International Service for the Acquisition ofAgri-biotech Applications Brief No 37 (ISAAA, Ithaca,NY, USA, 2008).2. Brookes, G. & Barfoot, P. Co-existence in North AmericanAgriculture: Can GM Crops Be Grown with Conventionaland Organic Crops? (PG Economics Ltd., Dorchester,UK; 2004).3. Devos, Y. et al. Agron. Sustain. Dev. 29, 11–30 (2009).4. Sanvido, O. et al. Transgenic Res. 17, 317–335(2008).5. European Commission. Off. J. Eur. Commun. L189,36–47 (2003).6. Brookes, G. Coexistence of GM and Non-GM Crops.Current Experience and Key Principles (PG EconomicsLtd., Dorchester, UK; 2004).7. Kalaitzandonakes, N. in Proceedings to the SecondInternational Conference on Co-existence BetweenGM and non-GM-based Agricultural Supply Chains,Montpellier, France, November 14–15, 2005 (ed.Messéan, A.) 29–30 (Agropolis Productions, 2005).8. Ramessar, K., Capell, T., Twyman, R.M., Quemada, H.& Christou, P. Nat. Biotechnol. 26, 975–978 (2008).9. Ramessar, K., Capell, T., Twyman, R.M., Quemada, H.& Christou, P. Mol. Breed. 23, 99–112 (2009).10. European Commission. Off. J. Evr. Commun. L268,24–28 (2003).11. Abbott, A. & Schiermeier, Q. Nature 450, 928–929(2007).12. Asociación Profesional de Empresas Productoras deSemillas Selectas (APROSE). Guía 2007 de BuenasPrácticas para el Cultivo de maíz Bt. (AsociaciónProfesional de Empresas Productoras de SemillasSelectas, Madrid, Spain; 2007).13. Corti-Varela, J. in Proceedings to the 2 nd AnnualCambridge Conference on Regulation, Inspection andImprovement, Cambridge, UK, September 11–12,2007. 14. Binimelis, R. J. Agric. Environ. Ethics 21, 437–457(2008).15. Beckmann, V., Soregaroli, C. & Wesseler, J. Am. J. Agric.Econ. 88, 1193–1199 (2006).16. EuropaBio. EU Court rejects Austrian biotech ban—supportsright to choose biotech crops (EuropaBio, Brussels) (14 September 2007).17. Messean, A., Angevin, F., Gomez-Barbero, M., Menard,K. & Rodriguez Cerezo, E. in Technical Report Series ofthe Joint Research Center of the European Commission(Institute for Prospective Technological Studies, Sevilla,Spain; 2006). 18. Aylor, D.E. Agric. For. Meteorol. 123, 125–133(2004).19. Devos, Y., Reheul, D. & de Schrijver, A. Environ.Biosafety Res. 4, 71–87 (2005).20. Paterniani, E. & Stort, A.C. Euphytica 23, 129–134(1974).21. Brookes, G. et al. GM Maize: Pollen Movement andCrop Co-existence. (PG Economics Ltd., Dorchester,UK; 2004).22. Luna, V.S. et al. Crop Sci. 41, 1551–1557 (2001).23. Cruz de Carvalho, P. (coordinator). Coexistência EntreCulturas Geneticamente Modificadas e Outros Modosde Produção Agrícola. Relatórios de Acompanhamento.(Ministério da Agricultura, do DesenvolvimentoRural e das Pescas/Direcção-Geral de Agricultura eDesenvolvimento Rural, Lisbon, 2009). 24. Scientific Committee on Plants (SCP). Opinion ofthe Scientific Committee on Plants Concerning theAdventitious Presence of GM Seeds in ConventionalSeeds (European Commission, Brussels, Belgium;2001).136 volume 28 number 2 february 2010 nature biotechnology
patentsChanging the rules of the game: addressing theconflict between free access to scientific discoveryand intellectual property rightsMiriam BentwichA provisional patented paper application procedure could promote earlier disclosure of novel scientific knowledge.© 2010 Nature America, Inc. All rights reserved.major constraint on the advancementA of scientific research in biotech is thegrowing barriers to free exchange of scientificknowledge associated with the increasednumber of patents linked to intellectualproperty rights (IPR). This matter, whichcan be tagged as the ‘secrecy threat’, has beenaddressed in numerous publications 1–7 , andcan be described as essentially revolvingaround two issues. One issue concerns thepossible reluctance of patent applicants andowners to fully disclose their acquired novelscientific knowledge through early and easilyaccessible scientific publications. The otherissue was broadly termed the “tragedy of theanticommons” by Eisenberg and Heller andhas been further developed by other scholars8–10 . It involves the possible constrainingof other scientists from using patented novelknowledge for further scientific research foreconomic reasons.Indeed, numerous empirical studies haveshown that scientists delay scientific publicationof research they expect to patent and arereluctant to freely share research results andmaterials with other scientists 11–15 . Otherstudies and judicial decisions have shownthat, contrary to its intended purpose 6,16,17 ,the patent system does not necessarily offera practical incentive for patent applicantsto disclose much information regardingtheir inventions in a comprehendible manner18–21 . In fact, the notion of prior art, socrucial in determining the eligibility of a patentapplication with respect to its novelty, atbest, significantly limits the grace period inMiriam Bentwich is in the Department ofPolitical Science, The Hebrew University,Mt. Scopus, Jerusalem, Israel.e-mail: mbentwich@gmail.comwhich potential patentees may publicly discloseinformation regarding their inventionbefore a corresponding patent application issubmitted 22–24 . Finally, additional case-inpointresearch illuminates instances such asthat of Myriad Genetics’ policy regarding itspatented breast cancer genes and their mutations,where patentees exploited their IPR toincrease their profits at the direct expense ofsharing novel scientific knowledge 10,25–27 .Admittedly, there have already been extensiveand contrasting attempts to address thechallenge at hand 3,28–30 , the bulk of whichrevolves around practical steps that may betaken to mitigate the secrecy threat and itsnegative consequences for scientific researchwithout deserting the patent system 20,31–33 .However, these practical steps appear to beflawed with respect to the two main concernsassociated with the secrecy threat.Thus, suggested practical measures againstthe tragedy of the anticommons, such aspatent pools and governmental compulsorylicensing for use of patents, lack a theoreticaljustification from an IPR advocate’s viewpoint.Meanwhile, other suggested practicalsteps, like extending the grace period for ‘selfprior art’ or using the US provisional patentapplication (PPA) option more extensively,could allow potential patentees to publishtheir scientific knowledge at an earlier stageand in a fuller manner. Yet these practicalsteps have so far neither obligated norstimulated potential patentees to do so inpractice.We present here an alternative and, wehope, more successful approach to tacklethe secrecy threat without undermining thepatent system. This is achieved by a revisedmandatory version of PPAs, designed for patentsin biotech and administered by leadingscientific journals, which would be officiallyrecognized by the US Patent and TrademarkOffice (USPTO) and subsequently by otherpatent offices as well.From optional PPAs to mandatory PPPAsSince 1995, the USPTO has offered theoption to submit provisional patent applications34 that are easier and substantiallycheaper to file than a full-fledged patentapplication 35–37 . Submitting a PPA is easierbecause, unlike regular patent applications,PPAs do not require the inclusion of the patent’sclaims, which define the extent of theprotection sought in a patent application indetailed technical terms. Additionally, PPAsdo not necessitate discussion of relevant priorart or use of applicable legal terms. Instead,PPAs need only adequately describe theinvention and its scope 38,39 . As a result, thistype of patent application lacks fundamentalingredients of any full-fledged patent application,and therefore, patents cannot evolvedirectly from PPAs.However, PPAs allow potential patenteesto secure an earlier valid ‘priority date’(that is, official filing date) for their futurepatented invention before the latter is fullyprepared, thereby decreasing the chances ofpossible competition over their inventions 36 .Such an advantage, though, is granted only iftwo conditions are met. First, the nonprovisionalpatent application must be submittedno later than 12 months past the filing dateof the PPA. Second, the provisional applicationmust adequately provide a writtendescription of the full scope of the inventionexplicated in the later full application 36,39 .Additionally, when these two conditions aremet, and a corresponding non-US patentapplication is submitted within 12 monthsnature biotechnology volume 28 number 2 february 2010 137
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