Agricultural Technology

The protection of agricultural technology, and biotechnology in particular, is an important and contentious area of intellectual property.  Agricultural biotechnology, in its broadest interpretation, refers to the application of biotechnology to agricultural problems in order to increase crop yields, open up new growing environments, use less chemical pesticides, improve nutritional content and decrease energy consumption in growing and processing.[1]  Generally, these activities involve research and breeding to produce improved crops, and the innovators charge a premium price for such improved varieties, in order to recover the investment in making the improvements.  A key component of commercial innovative breeding is the ability to ensure that farmers must buy the improved seed each year, and not keep and replant seed from the past season. 

The highly-touted benefits of agricultural biotechnology are not readily accepted by everyone, though, and many have raised concerns ranging from possible increased use of herbicides to unintended effects stemming from the planting, use and consumption of genetically modified organisms.  Along with the rapid pace of technology innovation, a host of legal mechanisms for protecting the intellectual property rights in these agricultural biotechnology advances have developed.[2] 

Major changes in the legal regime surrounding agricultural biotechnology have occurred in recent decades, ranging from UPOV’s requirement that “[e]ach Contracting Party grant and protect breeders’ rights”[3] to the United States Supreme Court’s decision in Diamond v. Chakrabarty that genetically modified bacteria are “compositions of matter” or “manufacture” subject to patenting.[4]  This legal regime continues to evolve -- for example, the Canadian Supreme Court recently held that a genetically modified mouse, the so-called Harvard mouse or oncomouse, is not patentable subject matter; and in so holding noted that:  -The patenting of all plants and animals, and not just human beings, raises several concerns that are not appropriately dealt with in the [Canadian] Patent Act.”[5]  The impact of this decision on the Canadian agriculture market, on the international legal regime and other countries’ laws remains to be seen, but it illustrates that determining how intellectual property laws apply to agricultural biotechnology innovations relating to plants and animals presents high impact issues whose resolution requires significant professional expertise. 

Also, the enforcement of intellectual property licensing strategies by agricultural biotechnology companies has led to high profile court challenges against farmers, for example in the case of Monsanto v. Percy Schmeiser in Canada.[6]  Intellectual property concerns pervade even technical, non-legal measures to prevent farmers from re-using seed from past growing seasons, such as the so-called genetic use restriction (“Terminator”) technology.  Recently, a body of the Convention on Biological Diversity (described in the following section) notified WIPO and UPOV that there is a need to examine “the specific intellectual property implications of genetic use restriction technologies, particularly in respect of indigenous and local communities.”[7]  This communication notes that the potential impact of genetic use restrictions on smallholder farmers, indigenous and local communities and on farmers’ rights needs to be explored with an emphasis on the development of new legal mechanisms to cope with such restrictions.[8]  In addition, the World Trade Organization’s (“WTO”) TRIPS Council is currently reviewing Article 27.3(b), regarding patent protection for plant and animal inventions.[9]

New intellectual property management strategies have been developed recently.  The case of golden rice[10] involved the negotiation of a complex web of licenses to provide freedom to use the technology for humanitarian purposes.  The Collaborative Crop Research Program of the McKnight Foundation is requiring grantees to adopt intellectual property terms facilitating technology transfer to poor countries.[11]

The rapid changes that have been seen in agricultural biotechnology in recent years are likely to continue as genetic manipulation techniques open up new avenues for scientific research and new corporate business strategies confront farmers with the need to understand intellectual property rights.  Developing countries and farmers, therefore, have a need to understand how these new technologies will impact them and how the decisions regarding the management of intellectual property rights in these new technologies will affect them.

Biodiversity

In 1992, the United Nations Conference on Environment and Development convened in Rio de Janeiro and created two international agreements -- the climate change framework, and the Convention on Biological Diversity.[12]  Generally, the CBD “established sovereign national rights over biological resources and committed member countries to conserve them, develop them sustainably, and share the benefits resulting from their use.”[13]  Although the CBD has now been signed by at least 168 countries,[14] significant debate surrounded its passage and still plagues the implementation of the CBD today.[15] 

Over the centuries, many samples of unique genetic resources have been taken from their original country of origin to collections in industrialized nations.  Many unique biological resources have yet to be catalogued or even discovered.  These resources, which are concentrated in developing countries of high biodiversity, remain in demand as sources of leads for new products, or for scientific collections.[16]  This demand has led many biodiversity-rich developing countries to exercise their rights over biological resources established by the CBD by enacting national laws and rules to protect their resources.[17]  The extension of developing country national laws to require informed consent and benefit sharing as preconditions to access to biological resources has resulted in contractual arrangements between biodiversity source countries and biotechnology and pharmaceutical corporations seeking access to the biological resources.  These agreements are variously referred to as either biodiversity prospecting agreements or access and benefit sharing agreements. 

While this national legislation relating to biological resources and biodiversity prospecting agreements is intended to protect these countries’ rights to their biological resources, it has also added new legal complexities with which developing countries must cope.  Intellectual property experts have not been extensively involved in the establishment of such rules, with the result that they are of limited practicality.[18]  Developing countries, therefore, have a need for professional legal advice regarding the passage and implementation of effective laws, the formation and execution of appropriate biodiversity prospecting agreements, and also their enforcement in the event of a breach.  Countries may also require assistance to enforce permitting laws in the event that a company engages in biopiracy – the taking of biological resources without the requisite permissions and agreements. 

While some biodiversity prospecting agreements may be fairly straightforward contracts, many provide negotiated royalty payments in exchange for access and sample collection, and other agreements involve complex negotiations regarding the sharing and value of locally-acquired and/or pre-existing indigenous knowledge regarding a developing country’s biological resources.[19]  Source countries may place a high value on these contracts in monetary, environmental, and political terms.  Thus, ensuring that such countries have legal representation that can adequately and appropriately handle the intellectual property issues that arise in the context of biodiversity prospecting agreements, such as licenses for patent, trademark, and trade secret/ know-how rights, and material transfer agreements, is crucial.

Traditional Knowledge

For the past two years, WIPO’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (the “WIPO Committee”) has been examining the existing intellectual property mechanisms that could be used to protect traditional knowledge and debating the development of a sui generis system for protection of traditional knowledge.[20]  WIPO Members have indicated that depending on the country involved, a wide range of intellectual property laws may be available to protect traditional knowledge, ranging from patent to trademark to copyright to trade secret.[21]  For instance, both Australia and Canada can cite to examples where existing copyright laws were used to protect traditional knowledge and creations of Aboriginal peoples.[22]  On the other hand, several Members indicated that they either had adopted sui generis systems to protect traditional knowledge or intended to adopt a sui generis system of protection.[23]  Significantly, in response to an inquiry about the existence of legislation providing for special measures “to assist traditional knowledge holders to acquire, exercise, manage and enforce their rights,” the vast majority of Members “stated that there are no special measures in place to assist traditional knowledge holders handling their intellectual property matters.”[24]  Moreover, a number of Committee Members have expressed concerns that traditional knowledge does not always easily fit into or fulfill the criteria to qualify for protection under existing intellectual property laws.[25]  Thus, the European Community and its Member States, for example, have expressed their support for continued study of whether patent applications should disclose the origin of traditional knowledge where appropriate and for the development of an international sui generis model for the legal protection of traditional knowledge.[26]  This issue is just now coming under discussion in the European Community but not yet extensively in the United States.

Given the WIPO Committee’s findings regarding the current state of protection for traditional knowledge, it is clear that developing countries desiring to help protect traditional knowledge face a daunting challenge.  In recognition of this fact, the Committee has designed a series of workshops and consultations with local and indigenous communities in developing countries.[27]  In order either to determine whether and how traditional knowledge may be protected by existing intellectual property laws or to develop a sui generis system of protection, a substantial amount of work must be done.  For either of these endeavors, there is a need for the expertise of an intellectual property professional who has significant experience with finding, interpreting, and applying for example, copyright and trademark laws, to practical, real-life situations to achieve results desired by a specific person or group.  Developing countries could gain valuable insights from the experiences of these professionals, who could also be of great assistance in shaping existing or developing new laws to protect traditional knowledge.  This need may be particularly great, for example, in developing countries which export crafts and natural products, and those where tourism plays a significant role in the country’s economy. 

Moreover, concerns regarding the role of intellectual property also exist with regard to the protection of folklore.  For example, China has expressed to WIPO its concerns relating to whether and how national folklore, such as traditional operas, music, performing skills, and literary and artistic works, can be protected.[28]  To this end, the WIPO Committee is also studying various expressions of folklore and experiences with the legal protection of expressions of folklore.[29]  As with traditional knowledge, developing countries have a great need for assistance in addressing the issue of whether intellectual property can protect some expressions of folklore with legal strategies and measures that can be implemented and deployed to fulfill the intended goals of preserving existing cultural diversity and stimulating a rich creative process as new folklore is produced.

Health Care

The AIDS epidemic is one of the greatest challenges facing every nation in the world today.  This is especially the case for the developing countries of Sub-Saharan Africa,[30] where the challenges go well beyond the scientific problem of devising a treatment to the formidable task of obtaining affordable versions of any treatments.[31]  Many have argued that the absence of affordable treatments can be traced to the deadly combination of Sub-Saharan Africa’s poverty, poor infrastructure, lack of ability to administer and monitor a pharmaceutical treatment regime and, more controversially, to strong patents under the intellectual property laws required by the TRIPS agreement.  The counter-argument is that the innovations arising under a strong patent regime are the only hope, over the long run, for new cures for AIDS and other diseases. One way to resolve this debate between populist and economic views involves the practical use of intellectual property strategies on a case-by-case basis.[32]

TRIPS requires its members to award “patents . . . for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”[33]  Article 70(8) of TRIPS sets forth procedures for establishing “patent protection for pharmaceutical and agricultural chemical products.”[34]  Developing countries have attempted to avoid the drug-restrictive effects of patents in developed countries and their own by relying on the TRIPS parallel importation and compulsory licensing measures,[35] but these strategies have met with only limited success. In November 2001, WTO members concluded the Doha Development Agenda (the “Doha Declaration”), an agreement on patents and access to medicines.  Unfortunately, the Doha Declaration did not fully resolve the problem of developing countries’ access to medicines.[36] 

In December 2002, in face of disagreement over the extent to which the Doha Declaration would give developing countries flexibility to override patent rights in the importation of essential medicines for health crises, the United States announced its own pledge “to permit [developing countries] to override patents on drugs produced outside their countries in order to fight HIV/AIDS, malaria, tuberculosis, and other types of infectious epidemics.”[37]  In addition, the United States urged other nations to join in this “moratorium” of not challenging “any WTO member that breaks WTO rules to export drugs produced under compulsory license to a country in need.”[38]  The United States also stated that it “will implement the Doha Declaration by pledging not to challenge any WTO Member that breaks WTO rules to export drugs produced under compulsory license to a country in need.”[39]  The announcement concluded that:  -[U]nder current WTO rules, products produced under compulsory license generally cannot be exported to other WTO Members. The U.S. solution is intended to eliminate this export restriction so medicine can be supplied to countries most in need that cannot manufacture their own pharmaceuticals.”[40]

Developing countries need professional assistance to develop strategies to cope with the restrictions of TRIPS and the Doha Declaration.  For example, invoking compulsory licensing laws might require input from intellectual property professionals. 

Developing countries have many other needs relating to health care for which intellectual property is relevant.  For example, another organization has identified “the need for good management of IP in health R&D” as part of a broad-based plan to improve public health in developing countries.[41]  In addition, complex intellectual property issues limit the ability of public-private partnerships to address the existing health research funding imbalance (the so-called “10/90 gap”).[42]  These sophisticated strategic alliances for research, production, and delivery of health products and services involve licensing and ownership of patents, trade secrets, and trademarks.  In sum, expanded intellectual property assistance should help to resolve the immediate need for access to affordable medicines, and the longer term need for sustainable management of innovation in public health, as global society seeks to find an equitable balance between the public health needs of today and of tomorrow.[43]

Technology Transfer and the Environment

Developing countries are essential players in environmental conservation.  It has been recognized that transfer of technologies between countries should emphasize the transfer of environmentally sound technologies.  For example, the Intergovernmental Panel on Climate Change (“IPCC”) has identified national governments and certain international agreements as key elements of an effective, environmentally-sound technology transfer system.[44]  Transfer of renewable energy sources, and low greenhouse gas emitting engines and generators are initiatives promoted by Global Environment Fund under the auspices of the IPCC.  Transfer of these and other technologies that reduce pollution to land and water or reduce consumption of natural resources may require skilled intellectual property negotiators to effectuate. 

As efforts to ensure environmentally-sound technology transfer continue to grow, developing countries will increasingly be called upon to navigate thickets of intellectual property rights in order to license and access the relevant technologies.  Countries may need to conform their policies and regulations accordingly.  As such, developing countries could benefit greatly by having access to professional assistance from intellectual property professionals experienced in technology transfer.

Open-Source, Internet Access, and Information Technologies

As access to and reliance on Internet resources increases worldwide, including in developing countries, concerns about fair and equal access to these resources are also increasing.  Organizations such as Open Source,[45] IP Justice,[46] the Electronic Frontier Foundation,[47] the Global Internet Liberation Campaign,[48] and The Digital Divide Network[49] have highlighted the public interest need for legal advice and representation in this evolving arena.  Current concerns include building of a global public domain of open source materials, copyright law, and privacy, to name just a few.[50]  The focus of these efforts has naturally followed the growth pattern of the Internet, with the primary historical focus being on the United States, Europe, and parts of Asia. 

As access to the Internet become more globalized, so do concerns about access and fair use.  Attempts to analogize Internet issues to locally relevant statutes or norms can lead to complicated and unpredictable legal scenarios for people in areas were the law of the Internet is still in a nascent stage, or when those same people are confronted with international treaties or laws of foreign nations regarding open source materials, access, privacy, and censorship.  Professionals experienced in these intellectual property issues can help address the public interest needs for information access.

Science and Technology

Academic and public research institutions in developing countries require assistance in technology transfer. PIIPA can help organizations build capacity by identifying IP professionals who can participate in establishing organizational policies and agreements. PIIPA is collaborating with other professional organizations involved in capacity-building for research institutions. PIIPA volunteers can also help handle specific projects such as license negotiation or patent prosecution.

[1]               See Michael A. Gollin, At the Crossroads: Intellectual Property Rights and Agricultural Biotechnology, at 1, Third Asia-Pacific Conference on Agricultural Biotechnology:  Issues and Choices, Thailand, 1996 (paper on file with author).

[2]               For a discussion of these various mechanisms in the United States and elsewhere in the world see Neil D. Hamilton, Who Owns Dinner:  Evolving Legal Mechanisms for Ownership of Plant Genetic Resources, 28 Tulsa L.J. 587, 590 (1993).

[3]               UPOV, supra note 3, art. 2.

[4]               447 U.S. 303 (1980).

[5]                 Commissioner of Patents v. President and Fellows of Harvard College, (Can.), No. 28155, 12/5/02.

[6]               See, e.g., http://www.percyschmeiser.com (last visited March 14, 2003).

[7]               See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/12, at Annex p. 7.

[8]               See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/12, at Annex p. 7.

[9]               See WTO TRIPS Council Document No. IP/C/W/273/Rev.1 (available at http://www.wto.org/english/tratop_e/trips_e/intel6_e.htm) (last visited March 6, 2003).

[10]             Rice was engineered to include genetic material from daffodils causing vitamin A production.  The resulting varieties have been as heavily praised by the biotechnology industry, see http://www.isaaa.org/kc/, GM Crops—rice– golden rice (last visited March 14, 2003), as they have been criticized by the anti-genetic engineering movement, see http://www.grain.org/publications/delusion-en.cfm (last visited March 14, 2003).

[11]             See http://www.mcknight.org/science/cropresearch.asp.

[12]             Rio Declaration on Environment and Development, adopted June 14, 1992, 31 I.L.M. 874, 880 (1992) (princ. 22) [hereinafter “Rio Declaration”].

[13]             See Michael A. Gollin, New Rules for Natural Products Research, 17 Nature Biotechnology 921 (1999).

[14]             See http://www.biodiv.org/world/parties.asp (last updated on December 13, 2002).

[15]             See Sarah A. Laird & Kerry ten Kate, Biodiversity Prospecting: The Commercial Use of Genetic Resources and Best Practice in Benefit Sharing, in Biodiversity and Traditional Knowledge 241, 243 (Sarah A. Laird ed., 2002).

[16]             See Sarah A. Laird & Kerry ten Kate, Biodiversity Prospecting: The Commercial Use of Genetic Resources and Best Practice in Benefit Sharing, in Biodiversity and Traditional Knowledge 241, 241-42 (Sarah A. Laird ed., 2002).

[17]             See Michael A. Gollin, New Rules for Natural Products Research, 17 Nature Biotechnology 921 (1999).

[18]                 Anecdotal evidence suggests that the extremely restrictive model of regulation enacted in the Philippines in Executive Order 247 (available at http://www.elaw.org/resources/text.asp?ID=257) has resulted in widespread bypassing of the procedures by plant researchers.

[19]             Perhaps the most famous example of a developing country providing more than just access to biological resources is Costa Rica’s National Institute of Biodiversity (“InBio”), which conducts its own commercial collections in protected areas and possesses a reliable information system on those collections.  See, e.g.,  Charles V. Barber, Lyle Glowka & Antonio G. M. La Vina, Developing and Implementing National Measures for Genetic Resources Access Regulation and Benefit Sharing, in Biodiversity and Traditional Knowledge 363, 371-74 (Sarah A. Laird ed., 2002).

[20]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/7 & 3/8.

[21]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/7, at 3-6; see also IPGRTKF/IC/4/7 (reporting further responses to questionnaire on existing protection for traditional knowledge from the Fourth Session of the Committee).

[22]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/7, at 4-5.

[23]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/7, at 6 (noting that Brazil, Costa Rica, Guatemala, Panama, the Philippines, Samoa, Sweden and Venezuela all indicated that had some type of special protection for traditional knowledge, and that Ecuador, New Zealand, Papua New Guinea, Peru, Solomon Islands, Tanzania, Tonga, Trinidad and Tobago and Viet Nam all indicated they intended to adopt such a system in the future).

[24]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/7, at 9.

[25]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/7, at 10-11.

[26]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/16, at 4-5.

[27]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/4/12, at 3-4.

[28]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/14, at 1-2.

[29]             See WIPO IG-IPGRTKF, supra note 5, at WIPO/GRTKF/IC/3/10 & 3/11.

[30]             In 2000, it was estimated that since the AIDS epidemic began, over 15 million Africans have died from AIDS and almost 25 million Sub-Saharan Africans are infected with HIV/AIDS.  World Bank Press Release, “World Bank Steps Up Fight Against AIDS in Africa,” dated Sept. 14, 2000.

[31]             See World Health Organization Essential Drugs and Medicines Policy (noting that 50 percent of the population in developing countries lack access to essential drugs and that 50-90 percent of drugs in developing countries are paid for out-of-pocket, which places the heaviest burden on the poor) (available at www.who.int/medicines).

[32]             Michael A. Gollin, “Sustainable Innovation for Public Health,” FDLI Update Magazine, January 2002 (available at http://www.venable.com/publication.cfm?publication_type_ID=2&publication_ID=816).

[33]             TRIPS, supra note 1, art. 27(1).

[34]             TRIPS, supra note 1, art. 70(8).

[35]             See Carlos M. Correa, Intellectual Property Rights, the WTO and Developing Countries: The TRIPS Agreement and Policy Options (Zed Books 2000), pp. 42-44.

[36]             For an overview and access to the relevant legal documents involved in the debate over TRIPS and the provision of pharmaceuticals to developing countries, including the latest materials relating to the Doha Declaration see the website for the World Trade Organization (“WTO”) (available at http://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm) (last visited March 6, 2003).

[37]             Office of the United States Trade Representative, U.S. Announces Interim Plan to Help Poor Countries fight HIV/AIDS and other Health Crises in Absence of WTO Consensus, dated Dec. 20, 2002 (available at http://www.ustr.gov/releases/2002/12/02-119.htm) (last visited March 5, 2003).

[38]             Office of the United States Trade Representative, U.S. Announces Interim Plan to Help Poor Countries fight HIV/AIDS and other Health Crises in Absence of WTO Consensus, dated Dec. 20, 2002 (available at http://www.ustr.gov/releases/2002/12/02-119.htm) (last visited March 5, 2003).

[39]             Office of the United States Trade Representative, U.S. Announces Interim Plan to Help Poor Countries fight HIV/AIDS and other Health Crises in Absence of WTO Consensus, dated Dec. 20, 2002 (noting that under the WTO rules countries are free to resort to compulsory licensing to override a patent, in certain situations, to allow for production of the item in the domestic market) (available at http://www.ustr.gov/releases/2002/12/02-119.htm) (last visited March 5, 2003).

[40]             Office of the United States Trade Representative, U.S. Announces Interim Plan to Help Poor Countries fight HIV/AIDS and other Health Crises in Absence of WTO Consensus, dated Dec. 20, 2002 (available at http://www.ustr.gov/releases/2002/12/02-119.htm) (last visited March 5, 2003).

[41]             See Mission Statement of Centre for the Management of IP in Health R&D (“MIHR”) (available at http://www.mihr.org/mission.htm) (last visited March 5, 2003).  MIHR defines its goals as:  -To define effective licensing practices for public sector management of IP so that new and improved products can become more readily available to the poor in developing countries.  To promote the development of new norms for licensing and other management of IP.   To become an international mechanism for effective exchange of information in the rapidly evolving field of IP management in health research.  To deliver training to increase capacity in IP management for health technology R&D in developed and developing countries.  To promote coordination and synergy in public sector product R&D.”  See id.

[42]             See The Global Forum for Health Research, Press Release 10/90 Report on Health Research 2000:  Narrowing the 10/90 Gap in Health Research, dated May 2, 2000 (“Less than 10% of the estimated US$56 billion spent annually on health research by the public and private sectors is devoted to diseases or conditions that account for 90% of the global burden of disease.”) (available at http://www.globalforumhealth.org/non_compliant_pages/report00/presserelease.htm) (last visited March 5, 2003); see also Initiative on Public-Private Partnerships for Health Mission Statement (available at http://www.ippph.org/presentation/affich_mission.cfm?chap=4&sous_chap=0) (last visited March 5, 2003).

[43]  See Michael A. Gollin, Sustainable Innovation for Public Health, FDLI Update Magazine January/February 2002 (available at http://www.venable.com/publication.cfm?publication_type_ID=2&publication_ID=816).

[44]             See IPCC Special Report on Methodological and Technological Issues in Technology Transfer (available at http://www.ipcc.ch/activity/srtt-out.htm) (last visited March 6, 2003).

[45]  See http://www.opensource.org.

[46]  See http://www.ipjustice.org/.

[47] See http://www.eff.org/.

[48] See http://www.gilc.org/. 

[49] See http://www.digitalopportunity.org/features/success_stories/.

[50]  The range of concerns even extends into international criminal law.  See International Treaty on Cyber Crime, http://www.tilj.com/content/litigationarticle10110001.htm.