Center for Advanced Study & Research on Intellectual Property

 

CASRIP Newsletter - Spring 2007, Volume 14, Issue 2

Traditional Knowledge, Genetic Resources, and Biotech Patents
The Controversy and Possible Solutions

By Frank Shao-Fan Lu1

I. INTRODUCTION

Emerging biotechnology has greatly improved pharmaceutical, medical, and agricultural applications in just a few decades. Unlike the electronics industry, the biotechnology industry is a large investment, long return, high risk industry. Therefore, to effectively screen and locate target molecules or ingredients, which could be effective to treat certain diseases or produce insecticides, for example, the biotechnology industry has relied heavily on the traditional knowledge and genetic resources found in developing countries. It is estimated that in terms of pharmaceutical technology, which depends upon genetic resources, approximately 10 corporations hold 36% of the pharmaceutical market and 82% of the agrochemical market.2 This dependence has fundamentally altered the economic potential of both the traditional knowledge and genetic resources of developing countries.3

Traditional knowledge and genetic resources, which may be, but are not necessarily, derived from indigenous peoples, are two major resources that are used by the biotechnology industry to develop useful target molecules or ingredients. Many known cases, such as the Turmeric plant,4 Neem tree,5 Basmati rice,6 Maca plant,7 Guayami’s T-lymphotropic virus,8 Hagahai’s T-lymphotropic virus,9 and Rosy periwinkle,10 have shown the close relationship among traditional knowledge, genetic resources, and indigenous peoples.

Generally, the biotechnology industries that use traditional knowledge and genetic resources belong to developed countries, where intellectual property systems, especially the patent system, are well established. In contrast, traditional knowledge and genetic resources come mainly from developing countries, where the governments are usually reluctant to establish protective intellectual property systems.11 The close relationship among traditional knowledge, genetic resources, and indigenous peoples may result in part from the unequal distribution of global biodiversity.12 “As a general rule, the richness in biodiverse natural resources is inversely related to latitude.”13 In other words, developed countries, which are generally located in higher latitudes, own less biodiverse natural resources, i.e., they are biodiversity-poor. In contrast, developing countries, which are generally located in lower latitudes, own more biodiverse natural resources, i.e., they are biodiversity-rich.

Developed countries usually seek to maintain incentives for new innovations via a powerful and enforceable intellectual property system. Developing countries, however, view an intellectual property system as a tool for developed countries to gain free access to their abundant resources without sharing with any benefit.14 This, in turn, results in the controversy over traditional knowledge, genetic resources, and intellectual property.

The conflict between these regimes raises issues when the biotech companies of developed countries file patent applications based on traditional knowledge and genetic resources found in developing countries. Whether such applications should be entitled to patents protection relates to the definition of patentability under the patent law, particularly how to interpret the wording “the invention was known or used by others …before the invention thereof by the applicant for patent.”15 Another issue relates to the rights that developing countries may assert and thus request equitable compensation or benefit-sharing for the use of the traditional knowledge or genetic resources.16

Two treaties, the United Nations Convention on Biological Diversity (“CBD”) and the Trade-Related Aspects of Intellectual Property Rights (“TRIPS”), attempt to reconcile the disputes between developed and developing countries. However, they have generated much conflict and uncertainty in the appropriate protection for traditional knowledge or genetic resources.17

This paper introduces the problems and proposed solutions regarding patenting of traditional knowledge and genetic resources. Further, this paper discusses the inconsistency between TRIPS and the CBD, focusing on intellectual property rights, traditional knowledge and genetic resources, and provides some possible solutions to resolve the conflict between developed and developing countries.

II. TRADITIONAL KNOWLEDGE AND THE PATENT SYSTEM

The term “traditional knowledge” has been defined in Article 8(j) of the CBD as “knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity.”18 It may also include “knowledge, possessed by indigenous people, in one or more societies and in one or more forms, including, but is not limited to, art, dance and music, medicines and folk remedies, folk culture, biodiversity, knowledge and protection of plant varieties, handicrafts, designs, literature,” and “all local ecological, agricultural, or medical knowledge.”19

The patent system, one of the intellectual property regimes adopted by many countries, is a statutory monopoly granted for a limited period of time for inventions having commercial application.20 The primary purpose in establishing a patent system is to encourage innovation and disclosure of inventions so as to benefit society. Under the patent system, an inventor is required to disclose the content of his invention to the public, and is then given an exclusive right to exclude others from making and using the invention for a limited period of time as a reward for the disclosure. It is believed that such a patent system provides a means that can effectively stimulate innovation and reasonably protect intellectual property.

A. Conflict between Traditional Knowledge and the Patent System

As several patents duplicated from traditional knowledge, especially from pharmaceutical or agricultural knowledge, were granted in the past decade, several problems in the current patent system were exposed. The following are a few typical examples of patents granted on traditional knowledge.

1. Turmeric Plant

Turmeric is a plant that grows widely in India and Pakistan.21 In 1995, the United States Patent and Trademark Office (“USPTO”) granted United States Patent Number 5,401,504 for the use of turmeric in wound healing.22 The India Council for Scientific and Industrial Research (“CSIR”) challenged the validity of the patent on the ground that the patent was not novel23 by citing the prior art references in India proving that the healing properties of turmeric had been used for thousands of years in India.24 The patent was ultimately canceled because of these challenges.25

2. Neem Tree

The neem tree is native to the Indian sub-continent.26 Extracts from the Neem’s leaves have been used as a pesticide, medicine, and fertilizer for centuries.27 W. R. Grace, a United States Company, along with the United States Department of Agriculture, applied for a patent for neem as an anti-fungal product with the European Patent Office,28 and obtained EP436257 patent, titled “Method for controlling fungi on plants by the aid of a hydrophobic extracted neem oil.” The patent was eventually revoked as lacking novelty.29

3. Basmati Rice

Basmati is a particular class of rice, including at least 400 varieties, which are traditional in India and Pakistan.30 In 1997, RiceTec, a Texas company, obtained United States Patent Number 5,663,484, titled “Basmati rice lines and grains.”31 The CSIR challenged the validity of the patent because the plant varieties and grains claimed in the patent already existed as a staple in India, and the rice was already being imported to the United States.32 As a result of the re-examination application, RiceTec withdrew most of its claims and limited the rest of the claims.33

4. Maca Plant

Maca, a plant grown in the Andean Highlands,34 has long been valued for its ability to enhance fertility in humans and livestock.35 In 2001, Pure World, a United States company, obtained United States Patent Number 6,267,995, titled “Extract of Lepidium meyenii roots for pharmaceutical applications,” which related to an alcoholic solvent to isolate the maca’s active compounds.

Developing countries, often the biodiversity-rich countries or traditional-knowledge holders as described above, condemned the above behaviors of the Western companies as biopiracy, a type of thievery in which traditional knowledge from one country is patented in another, without permission or compensation. They urged that every country of the world should stop immoral piracies and respect traditional knowledge with justice.36

B. Problems with the Current Patent System when Applied to Traditional Knowledge

There are many problems with the current patent system when applied to traditional knowledge. To present a clear analysis of this topic, this paper will divide inventions regarding traditional knowledge into two subgroups: “inventions duplicated from traditional knowledge” and “inventions derived from traditional knowledge.” As used herein, “inventions duplicated from traditional knowledge” refers to original traditional knowledge itself, existing in the same status as in the country of origin for a long period of time. “Inventions derived from traditional knowledge,” on the other hand, refers to innovations or creations that are developed based on original traditional knowledge, involving new ideas or improvements that are not present in original traditional knowledge. In other words, “inventions derived from traditional knowledge” refers to the use of original traditional knowledge as a starting point for producing valuable pharmaceuticals, medicines, insecticides, etc.37

For example, a medicinal plant or herb in its natural or direct form that is already known or used by indigenous people or a community would belong to “inventions duplicated from traditional knowledge.” By contrast, if a scientist isolates the plant’s active substance that was never known or used in the isolated form by indigenous people or a community, the isolated substance would belong to “inventions derived from traditional knowledge.”

1. Inventions Duplicated from Traditional Knowledge

With respect to inventions duplicated from traditional knowledge, there are many conflicts between the nature of traditional knowledge and the current patent system.

(a) Essence of the existing patent system

The patent system operates based on the concept of individual ownership wherein an individual who creates a useful invention is given an exclusive right to own that invention. However, traditional knowledge is a heritage communal in nature, which is not owned by any individual.38 In addition, the exclusive right granted in a patent system is deemed as an incentive to create. The production of traditional knowledge, however, does not need to be “incentivized” because it already exists.39 Since traditional knowledge has been handed down through the generations, there is no reason to protect it for a limited period of time by patent laws.40 Therefore, the concept of individual ownership in the patent system is completely unsuitable to traditional knowledge.

(b) Patentability under the existing patent system

There are limitations on patent protection for inventions duplicated from traditional knowledge. To be patentable, an invention must be novel. Anything already in the public domain is not considered novel.41 Since traditional knowledge generally has been public within society for centuries, an invention duplicated from traditional knowledge falls within the public domain,42 and thus is not novel. Therefore, it is theoretically impossible to protect such inventions within the existing patent system.

However, in practice, because much traditional knowledge is in an oral form or recorded in an ancient language, and there are no readily available sources or databases on traditional knowledge,43 it is difficult for patent examiners in one country to research whether public knowledge about an idea already exists in another country. Even though patents that are not truly novel can eventually be revoked, traditional knowledge holders do not have the opportunity to check the validation of all of the issued patents. Moreover, it would be unfair to make traditional knowledge holders suffer through a long and expensive legal procedure for an unjustified patents.

In addition, the prior art in most countries is defined to include everything that has been made available to the public everywhere in the world by any means; however, in some countries, such as the United States, non-written disclosures, such as oral knowledge, or uses outside their territories, are not eligible to be considered prior art, and thus do not constitute a bar to patentability.44 In the United States, for example, prior foreign activity anticipates a United States patent only when the foreign activity is in a tangible, accessible form, such as a published document or a patent; however, prior foreign knowledge, use, and invention are all excluded even if they are considered to be close in relation to a United States patent application.45 Such a result can be unfair because no one should obtain a patent by merely placing in one country what is already known in another.46

2. Inventions derived from traditional knowledge

With respect to inventions derived from traditional knowledge, many conflicts and arguments are involved as well. Since such inventions may involve new features that are not known, used, or disclosed by the traditional knowledge (i.e. the prior art), the inventions are novel, and thus can be granted as patents under the current patent system if other requirements are satisfied. There is nothing suspect under current patent laws about granting protection to truly novel inventions, even if one of the inputs of traditional knowledge is in the public domain.47

In reality, the patentability of such inventions actually favors developed countries rather than developing countries from which much traditional knowledge was generated. Because developing countries generally have lower levels of technology and fewer financial resources than developed ones, it is difficult for developing countries to compete with developed countries in high-tech industries and to survive in an expensive patent system. Today, however, more and more western high-tech companies have noted the value of traditional knowledge. They use traditional knowledge to develop valuable products, and get patents for the products. For example, many western pharmaceutical companies have attempted to isolate active ingredients from a medicinal plant that is already used by indigenous peoples and then developed a commercialized medicine. Once the medicine is patented, it may result in high-priced products and services on the market, and result in the loss of economic profit for indigenous peoples.

In this case, it is clear that the traditional knowledge is of critical importance in the identification and development of the medicine because the active ingredient may very likely never have been isolated without the knowledge of the existence of a particular plant and its medical use.48 However, the real creators of the traditional knowledge themselves not only seldom share the enormous financial gains on the patent,49 but even must pay the patent owner for the patented product and services.50

This paper acknowledges the patentability, i.e., novelty, inventive step, and utility, of patent applications in this category since pharmaceutical companies use traditional knowledge as a starting point, and they usually have to further investigate to purify or isolate the active ingredient, requiring large investments. However, the result seems unfair to developed countries in which the traditional knowledge was generated.

C. Possible Solutions to Resolve the Conflicts between Traditional Knowledge and the Patent System

Several possible solutions have been raised to reform the current patent rules so as to cease biopiracy patents and to resolve the conflicts between traditional knowledge and the patent system.

1. New Disclosure Requirement

Most industrialized countries currently have similar disclosure requirements in their patent systems.51 In the United States, for example, an applicant is required to disclose an invention sufficiently to enable one skilled in the art to make and use the invention without undue experimentation.52 The applicant, however, is not necessarily required to disclose the source or the legal provenance of the materials that were used to make the invention.53

A number of developing, biodiversity-rich countries have insisted that international patent law should be modified to permit national laws to require patent applicants to disclose in their patent applications, the origin of biological resources and proof of prior informed consent of the use of traditional knowledge.54 If an applicant fails to meet this new disclosure requirement, sanctions may include the rejection of a patent application or the invalidation of any resulting patent.55 Many developing countries believe that the new disclosure requirement could prevent biopiracy and promote respect for indigenous and traditional knowledge.56 Some countries, especially developed countries such as the United States, however, have challenged the implementation of such a requirement on the grounds that in many cases the inventors do not know the origin of the biological materials used in their inventions, and the introduction of this new requirement would seriously burden and slow down the administration procedures leading to granting a patent.57

The debate of the disclosure requirement between developed countries and developing countries remains violent.58 This is also an important proposal that could reconcile the conflict between TRIPS and the CBD, which will be addressed in Part IV of this paper.

2. Novelty Requirement

The novelty requirement, particularly the establishment of prior art, in many countries’ patent laws is also similar. For example, European Patent Convention Article 54(2) states that “[t]he state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way.” Further, Japanese Patent Law Article 29(a) stipulates that “inventions which were publicly known in Japan or elsewhere” may not obtain a patent. Article 22 of Taiwanese Patent Act similarly states that an invention that “has become known to the public” may not obtain a patent. Clearly, in Europe and Japan, two representatives of developed jurisdictions, non-written disclosures including public knowledge and use, regardless of the origin, can be a novelty bar to patentability. Indeed, the European Patent Office revoked W. R. Grace’s EP436257 patent on the neem tree on the ground of foreign, i.e., Indian public use of the neem tree.59

However, as mentioned above, some unjustified patents have resulted from a narrow definition of prior art in certain countries, such as the United States, in which Patent Law Section 102(a) stipulates that “the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country” may not obtain a patent. Namely, non-written disclosures in foreign countries are not part of the prior art and thus will not constitute a bar to patentability.60

Professor Vandana Shiva, an environmental biologist and activist on behalf of traditional knowledge in India, has criticized that global recognition of patents without global recognition of prior art is a recipe for biopiracy.61 In support of Professor Shiva’s opinion, a universal definition of prior art has been incorporated into the most recent revision of the Substantive Patent Law Treaty (“SPLT”)62 that is being developed under the World Intellectual Property Organization (“WIPO”) for harmonizing substantive aspects of national patent laws. The SPLT in its current form would define prior art as “all information which has been made public anywhere in the world in any form … before the priority date of the claimed invention.”63 It is obvious that harmonization of the definition of prior art in patent laws all over the world is a good way to avoid granting such unjustified patents.

Fortunately, the United States Patent Reform Act of 2005, which makes some concessions to the novelty requirement, has been introduced in Congress.64 According to the draft, Section 102(a) relating to conditions for patentability (novelty) would be amended to state “[a] patent for a claimed invention may not be obtained if (1) the claimed invention was patented, described in a printed publication, or otherwise publicly known.” Optimistically, it might be the result of harmonization of patent law in the United States with that in other countries. As mentioned above, the harmonized definition of prior art may have certain positive effects on deferring biopiracy patents.

However, the scope of such prior art is restricted in the bill by the language “reasonable and effective accessibility requirement.”65 Specifically, the requirement provides that “(i) subject matter is reasonably accessible if persons of ordinary skill in the art to which the subject matter pertains are able to gain access to the subject matter without resort to undue efforts; and (ii) subject matter is effectively accessible if persons of ordinary skill in the art to which the subject matter pertains are able to comprehend the content of the subject matter without resort to undue efforts.” The ambiguous wordings, such as “reasonably accessible,” “undue efforts,” and “comprehend the content,” will open the restrictions to wide interpretation. Consequently, whether traditional knowledge can be deemed as prior art to bar the patent application will possibly remain open to question.

3. Database of Traditional Knowledge

As afore-mentioned, one cause that contributes to biopiracy patents is the lack of formal documentation of traditional knowledge.66 If there is no existing documentation of traditional knowledge in a printed publication, patent offices often consider claims based on traditional knowledge as “novel.”67 It is also difficult for the patent examiners to find an eligible “prior art” to disqualify the patent application. To prevent the issuance of biopiracy patents, one suggested establishing a database containing traditional knowledge.68 Some non-government organizations (“NGOs”) have already created databases with the purpose of documenting public domain traditional knowledge for patent offices.69

For example, the American Association for the Advancement of Science’s Science and Human Rights Program has created a database, Traditional Ecological Knowledge Prior Art Database (“T.E.K.*P.A.D.”), which currently archives more than 30,000 records of traditional knowledge and is accessible via the Internet for patent examiner use.70 Also, in Ecuador, a NGO has established a database of more than 8,000 entries related to traditional knowledge from six indigenous peoples.71 In addition, WIPO is currently compiling an on-line, searchable database of biodiversity-related Access and Benefit-Sharing Agreements, with a particular emphasis on the intellectual property aspects of such agreements.72 Considering that thousands of United States patents regarding medicinal plants are from India, currently a database is being constructed at the National Institute of Science, Communication, and Information Resources in India, and the database is called the Traditional Knowledge Digital Library.73

If the novelty requirement in such countries where only written disclosure in foreign countries is considered to be part of the prior art is unable to be amended in the future, the establishment of databases of traditional knowledge will be a useful and powerful way to avoid granting unjustified patents relating to traditional knowledge. However, there are still other practical issues that need to be resolved, such as the basis of user fees, valuation of the information collected, possible claims of intellectual property over the databases themselves and the recovery of the operational costs of these databases.74

III. GENETIC RESOURCES AND THE PATENT SYSTEM

Another issue that relates to traditional knowledge or indigenous peoples is the patenting of gene sequences and gene products (“genetic resources”). The scope of traditional knowledge and genetic resources may overlap, for example, if the active ingredient is purified or isolated from the biological resources via traditional knowledge in the specific community. Sometimes, however, they are distinguishable. For example, when scientists independently and randomly screen the flora or fauna in a region, especially in developing countries, without any information regarding traditional knowledge, and then identify a specific molecule that is effective for treating diseases, the issue raised just relates to the exploitation of genetic resources, i.e., bio-exploiting, rather than traditional knowledge as discussed above.

The genetic resources of indigenous peoples are another example. Possibly due to the pure lineage, scientists have started to research the genetic resources of indigenous peoples to find the causes of hereditary diseases. The understanding of the mechanisms that cause diseases can help find the gene products or design molecules that maybe effective for treating the diseases. The Human Genome Diversity Project, which aims to collect genetic samples from hundreds of ethnic groups around the world,75 is a representative example. Similar research is found in Iceland76 and Taiwan77 where the indigenous peoples are fighting against the patenting of their own genetic resources.

A. Conflict between Genetic Resources and the Patent System

As several patents duplicated from genetic resources of indigenous peoples were granted in the past decade, several issues have arisen, especially in the current patent system. The following are typical examples of patents on genetic resources.

1. Guayami’s T-Lymphotropic Virus

Guayami is an indigenous group in Panama. The United States Department of Commerce filed a patent application titled “Human T-lymphotropic virus type 2 from Guayami Indians in Panama,” and then published as PCT application WO92/08784 in 1992. This patent relates to a human T-lymphocyte line (a cell line) infected with a HTLV-II virus from the Guayami Indians of Panama. This patent was the first isolation of HTLV-II from a defined non-intravenous drug-using population. This patent, however, was withdrawn due to protests from Guayami leadership and numerous public interest groups.78

2. Hagahai’s T-Lymphotropic Virus

Similar to Guayami’s case, scientists successfully cultured and isolated a novel T-lymphotropic virus from the blood of the Hagahai people in Papua New Guinea.79 The United States Department of Health filed a patent application titled “Papua New Guinea human T-lymphotropic virus,” which was then granted as United States Patent number 5,397,696.

Although the issues are somewhat different from those of traditional knowledge, developing countries argue that it is still unfair to them because, via the patent system, developed countries have monopoly power on the genetic resources of indigenous peoples in developing countries. This results in, to some extent, the reduction of sovereignty over their genetic resources. Another concern is based on the moral or ethical issue relating to monopolization of common heritage of mankind, commercialization of life, and human dignity.80 Therefore, in addition to the issues described in traditional knowledge, a main issue relating to the patenting of genetic resources focuses on whether the genetic resources are suitable subject matter to be patented. Other issues such as sovereignty over genetic resources and benefit sharing will be discussed in Part IV.

B. Problems with Patents on Living Forms

After the Diamond v. Chakrabarty decision made by the United States Supreme Court in 1980,81 in which the Supreme Court held that the patent law did not preclude patents on living organisms and the subject matter included “anything under the sun that is made by man,” the biotech patents took off, which facilitated several breakthroughs in the biotech industry.82

However, this statement causes a misunderstanding that all biological material taken from human beings can constitute a patentable invention provided there is a human-made aspect to it. Opponents argue that it is due to the lax test for patenting biological material in Diamond v. Chakrabarty,83 which results in harm to the genetic resources of developing countries. Moreover, some groups try to add a “higher threshold” to the patentability to biotech inventions.84

C. Patentability of Biotech Inventions

TRIPS generally requires new, inventive step, and industrial application for all field of technology.85 In addition, TRIPS requires members to provide protection for inventions in all fields of technology, including microorganisms, non-biological processes, and microbiological processes.86 It is believed that novelty and non-obviousness requirements can apply to any patent in any field of technology. The third requirement is utility. In Brenner v. Manson,87 the court required that the stated utility of a claimed invention must be credible, specific and substantial. For any inventions, a verbal statement of utility in the specification should be taken by the USPTO as satisfying the requirement under 35 U.S.C. Section 101 unless there is a reason for one skilled in the art to question the truth of the statement of utility.88 The specific and substantial utility requirement undoubtedly should be applied to any patent in any field of technology.

In addition to the three requirements described above, the written description and enablement requirements are two more patentability requirements that profoundly affect the biotech inventions due to complexity and unpredictability of the biological materials in the invention. To satisfy the written description requirement, the patent specification must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the claimed invention.89

The current five patentability requirements in the United States play a role in avoiding patent abuse in genetic resources. In contrast, these requirements provide a suitable threshold to protect the innovations in the biotech industry. The prerequisite we have to acknowledge is the patent system is a useful and powerful way to provide incentives to develop medicines that are beneficial to the public interest of human beings. Therefore, it seems not necessary to elevate the higher threshold of the patentability of biotech inventions at this moment.

D. Issues Related to the Genetic Resources and Indigenous Peoples

The patents on the genetic resources from the Guayami and Hagahai groups as described above give rise to some ethical inquiries.90 These might relate to moral or ethical questions mainly because the indigenous peoples were involved. Objectively speaking, however, is it actually an issue just to use the genetic resources of indigenous peoples?

Undoubtedly, indigenous people would disagree that their genetic resources are the same as non-indigenous genetic resources. Actually, the higher purity of the genetic composition of indigenous people who have not intermarried is one of the features that scientists rely upon. Thus, certain indigenous groups would like to claim that their genetic resources are worth more than those of non-indigenous people.

However, although there is no precise statistic, if human beings are divided into two categories, indigenous peoples and non-indigenous peoples, this author believes that large proportions of human gene-relating patents are derived from non-indigenous peoples. In this regard, non-indigenous peoples seem to have a claim to benefit sharing because they have suffered from the loss of control of their genes.

Arguably, the world may become worse if both indigenous peoples and non-indigenous peoples claim benefit sharing when human genes are patented. Accordingly, the issue of patents on human genetic resources should not specifically relate to indigenous peoples or non-indigenous peoples. Instead, recognizing the importance of the public interest in health, incentives are necessary for scientists or pharmaceutical companies to investigate and develop various medications, such as gene therapy, anti-sense DNA, and antibodies, via human genetic resources, whether they come from indigenous peoples or non-indigenous peoples. In this regard, the issues related to the genetic resources should turn to the above-mentioned patentability requirements and prior informed consent91 as one of the features specified in paragraph 5, Article 12 of the CBD, which will be further discussed in Part IV.

IV. RELATIONS AND CONFLICTS BETWEEN TRIPS AND THE CBD

TRIPS and CBD are two treaties that touch the overlap area between intellectual property remedies and the protection of traditional knowledge and genetic resources. Both treaties, however, have generated conflict and uncertainty in the appropriate methods for traditional knowledge and genetic resources.

A. The Private Intellectual Property Rights Conferred by TRIPS

Article 27, Paragraph 1 states that “[s]ubject to the provisions of paragraphs 2 and 3, patents shall be available 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.” Paragraph 3 further states that members may exclude from patentability: (b) plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.

From Article 27, Paragraph 3(b), a conclusion can be inferred that the WTO members must provide protection for microorganisms, non-biological processes, and microbiological processes.92 Combined together, Article 27 of TRIPS provides that patents in all fields of technology, including living forms, but excluding certain conditions, shall be available for any invention. The use of traditional knowledge and genetic resource from developing countries for purifying or isolating an effective ingredient or developing or modifying a molecule most likely will fall within the scope of material protected by TRIPS. In other words, since a large portion of inventions at issue are derived from, but may not be duplicated from, traditional knowledge and genetic resources from developing countries, as described in Part II of this paper, it is clear that WTO members should provide patent protection for such inventions under TRIPS.

Developing countries are unwilling to grant monopoly power of patent right to the patent holders; however, mostly belonging to developed countries since their resources are depleted but they get nothing through the mechanism established by TRIPS.93 However, if developing countries do not try to strengthen their intellectual property rights by complying with TRIPS, they will face the threat of trade sanctions.94

B. The Principles of the CBD

The principles of the CBD, as Article 1 states, aim at the conservation of biological diversity, the sustainable use of biological diversity components, and, last but not least, the fair and equitable sharing of benefits arising from the utilization of genetic resources. The CBD also recognizes that states have the sovereignty over their biological resources, and thus have the sovereign right to exploit their own resources, including genetic resources.95

The access to genetic resources through a more transparent form, specifically via prior informed consent, in patent applications is a key point that Article 15 of the CBD attempts to regulate. The mutually-agreed terms or prior informed consent may be regarded as an efficient instrument by developing countries to confront the aggression of intellectual property rights of developed countries.

In addition to the access to genetic resources, benefit-sharing is another requirement conferred by the CBD to protect developing countries and achieve the goal of conservation and sustainable use of genetic resources. Specifically, Article 15 requires that sharing be provided in a “fair and equitable” way. The wording, however, might lead to different interpretation by developing and developed countries.

C. What are the Conflicts between TRIPS and the CBD?

On the one hand, the World Trade Organization (“WTO”) Agreement on TRIPS grants private, intellectual property rights for genetic resources, especially unauthorized appropriations of genetic resources. On the other hand, the United Nations’ CBD provides resource countries with principles of control over their genetic resources. Importantly, the CBD has no enforcement mechanisms and, up to now, the United States is not a party to the CBD. The two international treaties appear to have literal conflicts.96

However, does the grant of a patent indeed conflict with the sovereignty over the biological resources? Section 271(a) of the United States Patent Law states that “[e]xcept as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.”97 Therefore, what the patent law grants to a patentee are the exclusive rights to make, use, offer to sell, or sell the patented product or process. The ownership of the patented product, in contrast, is never converted to a patentee by the grant of a patent right.

For example, a patent that isolates and claims a novel compound that natively exists in a potato and is useful in treating lung cancer does not mean that all of the potatoes belong to the patentee and that people cannot use the potatoes any more. Instead, in this case, only if the alleged infringer makes, uses, offers to sell, or sells the specific compound to treat lung cancer without authority would this action constitute infringement liability.98 As a further assumption, if the potatoes are grown in a certain country and the country issues the patent to a company, clearly, it does not mean that the government loses the sovereignty over all of the potatoes in that country. Further, the government can actually establish a variety of measures to control the production, transaction, or management of the potatoes. This may be useful as a bargaining counter in negotiation with the patentee, which will be discussed in Part V.

The conduct of pharmaceutical companies from developed countries can be divided into two phases: one is bio-exploiting, which includes using and researching the genetic resources from developed countries (“bio-exploiting phase”), and the other is filing and obtaining a patent (“patent phase”). In the bio-exploiting phase, the company’s conduct may be in violation of the CBD if the company does not obtain permission to use the genetic resources.99 In the patent phase, however, since the grant of the patent will not deprive the country of its sovereignty over particular resources, the issue relating to the CBD should be focused on the sharing of the benefits arising from the utilization of genetic resources, which will be discussed in Part V.

D. Reconciliation between TRIPS and the CBD

Although developing countries are reluctant to provide TRIPS-compliant intellectual property protection, especially to those who misappropriate their genetic resources, they have the obligation to implement such an intellectual property system since most developing countries are members of the WTO. However, if both sides are at enmity with each other based upon the CBD and TRIPS, respectively, it is not a benefit to either society. Because there is inconsistency between the CBD and TRIPS, the WTO Ministerial Conference has instructed the TRIPS Council to examine the relationship of both treaties in terms of the protection of traditional knowledge.100 This is an important first step toward reconciliation between CBD and TRIPS provisions.101

Several solutions have been proposed to reconcile the inconsistencies between the two treaties, including prior informed consent as the fourth patentability requirement, strengthened benefit sharing, technology transfer, and monetary compensation. However, there is still a long way to go for developing and developed countries to reach a consensus. Undoubtedly, the patent system is a powerful, albeit not the only, tool to provide incentives for innovation, which encourages industries to invest and develop, for example, new drugs to protect the public interest. If there is a common view to acknowledge the importance of intellectual property rights, especially patent rights, the remaining controversies, mainly benefit sharing, may be easier to resolve.

For the greater public interest, it would be best to reach a solution in which developing countries receive benefits due to the contribution of their traditional knowledge and genetic resources, and the companies of developed countries have incentives to further develop processes and products that could be useful to the public interest.

V. EXAMINATION OF CURRENT AND POSSIBLE SOLUTIONS TO THE CONTROVERSIES BETWEEN CBD AND TRIPS

A. Prior Informed Consent

1. Functions of Prior Informed Consent

Developing countries have proposed a new patentability requirement, which requires the disclosure of origin as evidence of prior informed consent.102 Prior informed consent, from the developing countries’ perspective, can play a role not only in permitting the bio-exploiting, but also in ensuring equitable benefit sharing. Another advantage of proof of prior informed consent is to prevent issuing of patents that relate to biopiracy,103 provided that proof of prior informed consent is a patentability requirement.

The United States, however, argues that the new patentability requirement would have a significant negative impact on the patent system.104 The first reason is that prior informed consent cannot prevent the misappropriation of traditional knowledge or genetic resources from developing countries because this requirement cannot guarantee that the companies from developed countries obtain prior informed consent before filing patent applications.105 However, if TRIPS had added prior informed consent as the fourth patentability requirement, its members would have the obligation to adopt and amend their laws, and then to follow this new patent system. In this regard, if a patent applicant misappropriates the traditional knowledge or genetic resources, and cannot provide the proof of prior informed consent, the application should not be granted as a patent, or the patent should be invalidated.

The United States further asserts that the desirable objectives should be achieved by mutual contract, rather than by proof of prior informed consent.106 This argument is also unpersuasive. If the goal is to ensure the equitable sharing of benefits, as stated in the CBD, a contract is a viable, but not the only, way to bound two parties to the contractual terms and obligations. Specifically, the requirements stipulated in international treaties (e.g. prior informed consent as the fourth patentability requirement) could strengthen the enforcement of benefit sharing. For example, if there are both an international treaty and a contract, developing countries may utilize WTO arbitration or national litigation to protect their benefits if companies from developed countries violate the terms of the contract. The dual protections will not clash with, but complement, each other.

The third argument of the United States is that prior informed consent will overburden the patent office with the burdensome duty to examine the validity of prior informed consent and to interpret foreign laws.107 However, prior informed consent could be evaluated as a formalistic requirement, rather than a substantial requirement. That is to say, the patent examiners would not be required to determine such validity, but rather to confirm the submission of prior informed consent.108 The validity of prior informed consent would be determined by a court if disputes occur in the future. Therefore, prior informed consent would not worsen the insufficient resources or the capability of patent offices and would not increase the cost of the existing patent system. This design of prior informed consent may thus be a way to reconcile the controversy between the CBD and TRIPS.

As another aspect of prior informed consent, a standard form could be incorporated into TRIPS as a minimum requirement. The contracting members may then add other conditions or restrictions based upon the standard form. For example, it could be redesigned, according to the standard form, to contain both prior informed consent and a contract. The agent, which has the authority and obligation to investigate and then issue prior informed consent, could also be arranged in advance, for example, by the Department of Agriculture or the Patent Office of the respective country.

The United States also alleges that “the real problem is the general lack of benefit-sharing infrastructures in developing provider countries.”109 In deed, the form of benefit-sharing, as will be discussed later in this Part, may vary greatly, including but not limited to, monetary compensation, training scientists, building factory to produce pharmaceuticals, and building graduate schools to educate students, to name a few. This argument merely shows the need for benefit sharing for developing countries that provide traditional knowledge and genetic resources.

The United States’ final argument about prior informed consent is that uncertainties to the patent system would increase the costs and decrease the investment in innovative companies. This concern is valid because the patent system is a useful tool to provide incentives to companies for further investment in research. If the dispute regarding prior informed consent results in the invalidation of a patent, the companies’ worry may be reasonable. In view of this, it is better to make prior informed consent easy to obtain. Further, if the traditional knowledge or genetic resources involve several countries, it would be preferable to make prior informed consent from any one of the countries sufficient to meet the new patentability requirement, so that the uncertainties of the patent and the costs of the company could be lowered.

2. Potential Problems of Prior Informed Consent

In addition to the above-mentioned arguments of the United States, several potential problems might involve prior informed consent as a new patentability requirement.

The first problem is that it is difficult to determine which kind of invention needs a prior informed consent. It is believed that major portions of inventions are made according to the previous knowledge in the form of, for example, scientific articles, experimental reports, or patents. In practice, after a scientist reports that a molecule may be effective in treating cancer, many more studies that focus on the modifications of the molecule or other applications or improvements in the production process will be initiated, either by the scientist or others. The latter inventions may be termed “derivative inventions” or reinventions.110

For example, the patent on the neem tree, as described above, has been issued for its anti-fungal effect with the European Patent Office.111 However, if searching in the United States patent collection database just by the keyword “neem” in the “title” field, the result shows that there are 37 patents in which the patent title contains “neem.”112 Most of the patents still relate to the pesticide or fungicide function.

Are all of the derivative inventions required to submit the proof of prior informed consent if the proof becomes a new patentability requirement? What if an invention uses a neem-derivative product as a male contraceptive,113 which might have never been known by indigenous peoples in India? Other inventions focus on improving the stability of neem extract,114 or on the manufacturing process of large scale recovery.115 Do these inventions require the same standard as one that is “really” derived from the traditional knowledge of developing countries? These questions reveal the difficulty in defining the scope of prior informed consent.

On the one hand, if the scope is too narrow, the goal of benefit-sharing is not easy to achieve because many of the latter inventions would assert that their works were indirect to the traditional knowledge. On the other hand, if the scope is too broad, the uncertainties of the patent will increase if lack of prior informed consent could result in the invalidation of the patent. Also, patent applicants might technically bypass the requirement if they feel that it is too strict or burdensome. For example, they would use the molecular formula instead of the keyword “neem” throughout the patent specification so that the patent is less likely to be found in relation to neem.

As to genetic resources, especially from indigenous people, the second problem might be how to define the scope of the genetic resources. For example, mixed marriages and immigration could make the problem more complex. One Hagahai man whose clan has lived in Papua New Guinea over hundreds of years, for instance, immigrates to the United States. After a couple of years he becomes a citizen of the United States. A novel antibody found in his body is proved to be effective in treating human Acquired Immune Deficiency Syndrome (AIDS). Does Papua New Guinea or the United States government have the right to the genetic resources according to the CBD? Further, for example, if he marries a Chinese woman and then has a baby whose certain gene segment has potential for treating Huntington’s chorea. In this case, which government would have the right to the genetic resources?

This problem presents the difficulty in determining which government has “sovereignty” over the genetic resources under the CBD. For a simple case like a specific plant species located only within the territory of a country, it is easy to determine who has authority to issue prior informed consent. However, for a complex case like that described above, or with animals or fish that may migrate within a broad area belonging to several countries, to establish a standard which can apply to all cases is a very demanding challenge.

These scenarios exemplify that several countries may have sovereignty over the genetic resources. If prior informed consent comes from any of the countries is sufficient to meet the new patentability requirement, this could lead to “forum shopping.” That is to say, if one of these countries has lax control for issuing prior informed consent, or its conditions (for example, government fees, tax, etc.) are less than those of other countries, patent applicants will apply prior informed consent from this country. However, if prior informed consent from all the involved countries is required, it will indeed overburden patent applicants with the heavy duty to obtain all of prior informed consents.

This problem will result because rare biological resources are located only within the territory of a single country. Developing countries commonly use Rosy periwinkle as an example to protest against the unfair benefit-sharing of developed countries. In the 1960s, Eli Lilly, a United States company, developed alkaloids from Rosy periwinkle from Madagascar. The alkaloids have anti-cancer properties and Eli Lilly obtained patents on the materials. Most significantly, Eli Lilly earned several hundred million dollars from the resulting drug; however, Madagascar was paid nothing at all.116 Scholars think Rosy periwinkle “represents an extreme example of the biotechnology trade gone awry.”117

Actually, although Rosy periwinkle is native to Madagascar, it grows throughout the tropics.118 If in this case only genetic resources, rather than traditional knowledge, were involved, the problem, as mentioned above, then turns into whether companies have to obtain prior informed consent from all the related countries, and more importantly, whether companies have to share their benefits with all the related countries. If developing countries insist that all the related countries have rights to share in the benefits, it will become a nightmare for developed countries, and it is believed that the progress of the development medications will be seriously impeded. In an assumption that Rosy periwinkle is later found in Miami, the southernmost city in America, does the issue change? The problem reveals the importance of prior informed consent as a proposed patentability requirement – specifically, how prior informed consent can work to balance the patent system and the benefit-sharing?

The final problem relating to prior informed consent is when companies obtain the samples from non-profit gene banks such as the Consultative Group on International Agricultural Research (“CGIAR”),119 American Type Culture Collection (“ATCC”),120 GenBank (the NIH genetic sequence database; an annotated collection of all publicly available DNA sequences),121 or the Protein Data Bank (maintained by the Research Collaboratory for Structural Bioinformatics (“RCSB”)),122 rather than obtaining the samples directly from fields within the boundaries of developing countries.

In the emerging bio-informatics era, much research screening of potential molecules or compounds can be done only by analyzing and comparing gene or protein databases. Such databases provide the primary sequences, secondary or tertiary structures of millions of genes and proteins, many of which, however, may not record the source of origin. Moreover, these kinds of work are more likely to be classified as “derivative inventions,” as defined above, because they are made in accordance with the current knowledge. Under this situation, it seems difficult to require prior informed consent. Therefore, there will be a loophole that could result in biopiracy.123

B. Monetary Compensation

Monetary compensation is the fastest and most direct way of benefit sharing, and it may, at least in part, alleviate poverty in developing countries. In fact, some indigenous peoples were angry that they have yet to obtain any benefit after they have experienced invasive testing.124 However, monetary compensation may not be the best option for indigenous peoples or developing countries.125

Although this is a simple and effective method of benefit sharing, there are still numerous problems with monetary compensation. The first problem is which party is eligible for the compensation. The national governments may be qualified because the CBD recognizes that governments have sovereignty over biological resources within their territories. However, some inventions made by companies of developed countries are derived from traditional knowledge known by indigenous peoples in a certain region. The indigenous peoples may assert their rights under this situation. Actually, Maori, indigenous people in New Zealand, have lodged a claim against the New Zealand Government that the indigenous flora and fauna of Aotearoa remain vested with Maori tribes, rather than with the Government.126

Another issue accompanied with monetary compensation is how much “fair and equitable” is. Since the biotechnology industry is a huge investment, long return, and high risk industry, it is hard for those companies to provide compensation at the early stage of bio-exploitation. One general monetary compensation form is royalties calculated in accordance with the sales of the commercial products. However, since the possibility of success in developing drugs that are approved by Food and Drug Administration (“FDA”) is low, developing countries may get frustrated if the benefit-sharing program depends entirely on the sales of the drugs. Therefore, a feasible way of benefit-sharing may combine monetary compensation with other solutions, such as technology transfer, as described below.

C. Technology Transfer

Technology transfer from developed countries to developing countries as a way of benefit sharing has induced positive and negative opinions. Proponents believe that technology transfer can increase the knowledge supplied in patents and necessary know-how to developing countries. In contrast, opponents argue that the monopoly power of foreign patents impedes the use of new technologies by developing countries.127

Article 66 of TRIPS imposes an obligation on developed countries to provide incentives for their companies to transfer technology to developing countries so that developing countries may establish a sound technological base. The provision commits developed countries to use best efforts in identifying measures to encourage technology transfer and to promote the building of technological capacities of both developing and less-developed countries.128

Similarly, Article 15, Paragraph 7 of the CBD specifies that technology transfer is an invaluable instrument for the effective implement of the CBD.129

A significant example of technology transfer is the agreement between Merck Pharmaceuticals and Costa Rica’s Institutio Nacional de Biodiversidad (“InBio”).130 InBio agreed to provide 2,000 genetic samples to Merck over a two-year period. Merck paid InBio $1,135,000 for taxonomic activity, scientific training, and acquiring equipment for specimen collection. In addition, Merck also employed local scientists for bio-exploiting activities.131

Although the efforts to transfer technology to developing countries have largely amounted to nil,132 objectively speaking, technology transfer is the best way to radically free developing countries from poverty if the program is implemented for a long term. In a broad sense, technology transfer may include various forms such as training scientists, building factories to produce pharmaceuticals, and building graduate schools to educate students, as shown in the InBio case. By implementing technology transfer, developing countries can learn the new knowledge, the operation of facilities, and the management of business, thus promoting quality of human resources and technology level of the countries. Finally, developing countries may have opportunities to catch up with developed ones via technology transfer.

D. Trade Secret

Some scholars believe that traditional knowledge may be protected through a different intellectual property right, trade secret.133 This author, however, respectfully disagrees.

Traditional knowledge may meet the definition of trade secret in that it affords “an actual or potential economic advantage over others.”134 However, one of the requirements to protect trade secrets is a reasonable effort to maintain secrecy,135 which means that the current operation of traditional knowledge may not qualify. For example, few, if any, laws have been enacted to prohibit the holders of traditional knowledge from releasing the secret. Specifically, Professor Jim Chen has asserted that traditional knowledge “already lies in a public domain of sorts…”136 The public disclosure of traditional knowledge destroys the “secret,” and thus ends trade secret protection forever.

Furthermore, trade secret is also not a suitable means to protect traditional knowledge such as traditional knowledge that relates to the application of certain plants to certain diseases. With these kinds of final products, it is not difficult to analyze the effective ingredients by reverse engineering or by independent research, which is not considered an improper means.137 In this regard, once the product has commercially been marketed the risk of losing protection increases.

E. Moral Rights

Moral rights are also not suitable to protect traditional knowledge and genetic resources. Unlike real property rights, it is hard to distinguish whether the certain traditional knowledge belongs only to one person. For example, one herbal medicine used in a tribe for hundreds of years was initially one person’s (or a small group of people’s) own achievement. Most cases of genetic resources face s similar situation in that scientists usually gather samples from more than one person.138 Thus, the applicability of the moral rights to traditional knowledge and genetic resources is difficult to specify. Therefore, it seems that moral rights do not work in the protection of traditional knowledge and genetic resources.

F. Compulsory Licensing

One possible solution to balance the patent rights owned by developed countries and the public interests of developing countries might be the use of compulsory licensing, which has already been stipulated in TRIPS. The notion of compulsory licensing is that in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use, WTO members may allow for other uses of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government. Under this situation, the requirement of reasonable commercial terms and conditions may be waived.139

Similar provisions have been enacted in the patent laws of several countries, including Japan,140 Taiwan,141 and China.142 Through the mechanism of compulsory licensing, developing countries can make sure that the quantities and/or prices of pharmaceuticals that are used for public interest or welfare are satisfactory. It is the primary object for developing countries to have enough and/or affordable life-saving drugs. However, the prerequisite is that such developing countries have to establish a TRIPS-compliant patent system.

Although the case is rare and may not relate to traditional knowledge or genetic resources, a recent example of compulsory licensing occurred in Taiwan in 2005. To resist the serious threat of bird flu, on December 8, 2005, the Taiwanese Intellectual Property Office mandated compulsory licensing of Taiwanese Patent Number 129988, which relates to the preparation of Oseltamivir, due to the insufficiency of drug supplies.143 The patentee, Gilead Science, Inc., is a company located in California.

If compulsory licensing is combined with foreign direct investment (“FDI”), developing countries may not only resolve the problem of the insufficiency of drugs, but also promote the local technology level. Foreign direct investment is a useful and powerful way to promote the technical and economical levels of developing countries. Developing countries then may have opportunities to free themselves from poverty and stride forward toward developed countries through a combination of compulsory licensing with foreign direct investment. One advantage of developing countries is cheap labor, which is an incentive to companies in developed countries. Therefore, it is not impossible to implement such a combination of compulsory licensing with foreign direct investment, but the prerequisite is still that developing countries have to strengthen the protection of intellectual property rights.

Unfortunately, this model may have disadvantages to both developed and developing countries. Generally, the patented goods will have a higher price than if they were not patented.144 However, if the patentee licenses, either mutually or compulsorily, the patent to produce patented drugs in developing countries, the price of the patented drugs may not maintain as high as that in developed countries. This might lead to gray market leakage that is difficult to control in contracts due to the significant difference of price.145 Like parallel importation of genuine goods, the uncontrolled product distribution could cause profit loss to the patentee.

On the other hand, there is a limitation to compulsory licensing. According to the TRIPS Agreement Article 31(b), such practice of compulsory licensing “shall be restricted mainly to the purpose of satisfying the requirements of domestic market.” Namely, the output of such patented products can only satisfy the requirements of the market in that licensee country. Therefore, the yield may not reach an economical scale, which will make FDI reluctant to invest in factories to produce drugs.

VI. CONCLUSION

Biodiverse developing countries have significant traditional knowledge and genetic resources, much of which can induce and contribute to the research of new drugs. Developed countries own high technology which has the capability to screen and design various pharmaceuticals, which could be effective to save human lives. If developing and developed countries could cooperate in terms of, for example, bio-pharmaceuticals, it will be beneficial to the welfare of all human beings.

Of the possible solutions mentioned above, trade secrets and moral rights are not appropriate methods to protect traditional knowledge and genetic resources. Monetary compensation is the most direct way to share benefits; however, it only has a short-term affect on the developing countries. As one may expect, those governments or groups that receive the benefits may not use the money exclusively to improve or enhance the protection of the traditional knowledge and genetic resources. On the other hand, technology transfer has a positive, long-term affect on developing countries because their technological levels will increase by acquiring know-how from developed countries. Prior informed consent, which may facilitate benefit sharing, can run parallel with technology transfer to have a synergistic effect on the protection of the traditional knowledge and genetic resources. Finally, a new cooperation model combining compulsory licensing with foreign direct investment may also provide another approach to help achieve the goal. However, the above suggestions are standing under the structure of intellectual property rights, i.e., if the intellectual property rights did not exist, most of the solutions provided above would fail to achieve the desirable results. When the cooperation goes smoothly between developing and developed countries, the outcome will be advantageous to all.

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Footnotes

  1. Frank Shao-Fan Lu is an attorney-at-law and patent agent from Taiwan, and a student in the I.P. LL.M. Program at the University of Washington, School of Law.
  2. See Jonathan Curci, The New Challenges to International Patentability of Biotechnology: Legal Relations between the WTO Treaty on Trade-Related Aspects of Intellectual Property Rights and the Convention on Biological Diversity, 2 Int’l L. & Mgmt. Rev. 1, 25 (2005).
  3. See Greg K. Venbrux, When Two Worlds Collide: Ownership of Genetic Resources under the Convention on Biological Diversity and the Agreement on Trade-Related Aspects of Intellectual Property Rights, 9 Pgh J. Tech. L. & Pol’y 5, 1 (2005).
  4. See Shubha Ghosh, Traditional Knowledge, Patents, and the New Mercantilism (Part II), 85 J. Pat. & Trademark Off. Soc’y 885, 898 (2003).
  5. See id. at 910.
  6. See id. at 902.
  7. See Brendan I. Koerner, Maca, a Plant Grown in the Andean Highlands, Is Believed to Boost Male Potency. The Quechua Indians Cultivate It; a New Jersey Company Owns the Patent on It. The Americans Call the Work that Led to the Patent Bioprospecting. Others Say It’s Stealing, 2005-DEC Legal Aff. 48 (2005).
  8. See Marina L. Whelan, What, If Any, Are the Ethical Obligations of the U.S. Patent Office?: A Closer Look at the Biological Sampling of Indigenous Groups. 2006 Duke L. & Tech. Rev. 14, *10 (2006).
  9. See id. at *16.
  10. See Venbrux, supra note 2, at 7-8.
  11. See id. at 18-19. The reasons why developing countries are reluctant to set IP systems may be the increased prices for pharmaceutics and heavy costs for establishment of intellectual property mechanisms, both of which are not affordable to developing countries.
  12. See id. at 6.
  13. Id.
  14. See id. at 2.
  15. 35 U.S.C. § 102(a) (1972).
  16. See Whelan, supra note 7, at *8.
  17. See Curci, supra note 1, at 4.
  18. See Srividhya Ragavan, Protection of Traditional Knowledge, 2 Minn. Intell. Prop. Rev. 1, 60 (2001).
  19. See Matthew L.M. Fletcher, Theoretical Restrictions on the Sharing of Indigenous Biological Knowledge: Implications for Freedom of Speech in Tribal Law, 14-SPG KAN. J.L. & PUB. POL’Y 525, 527 (2005).
  20. See Ragavan, supra note 17, at 8.
  21. See Ghosh,, supra note 3, at 898.
  22. See id.
  23. See id. at 899.
  24. See Ragavan, supra note 17, at 11.
  25. See id.
  26. See Ghosh, supra note 3, at 910.
  27. See id.
  28. See Ragavan, supra note 17, at 12.
  29. See id.
  30. See Ghosh, supra note 3, at 902.
  31. See id.
  32. See id. at 905-906.
  33. See id.
  34. See Koerner, supra note 6, at 48.
  35. See E. Jane Gindin, Maca: Traditional knowledge, new world (Dec. 2002), available at http://www.american.edu/TED/maca.htm.
  36. See Koerner, supra note 6, at 48.
  37. See Dennis S. Karjala, Biotech Patents and Indigenous Peoples, 7 Minn. J. L. Sci. & Tech. 483, 485 (2006).
  38. See Fletcher, supra note 18, at 531.
  39. See Shubha Ghosh, Traditional Knowledge, Patents, and the New Mercantilism (Part I), 85 J. Pat. & Trademark Off. Soc’y 828 (2003).
  40. See Fletcher, supra note 18, at 531.
  41. See Ragavan, supra note 17, at 13.
  42. See id.
  43. See Mary Ann Liebert, Inc., EPO Takes Toward Blocking Patents on Traditional Medicines, 24 Biotechnology L. Rep. 445, 445 (2005).
  44. See Andrew R. Sommer, Trouble on the Commons: A Lockean Justification for Patent Law Harmonization, 87 J.Pat.& Trademark Off. Soc’y 141, 162 (2005).
  45. See Ragavan, supra note 17, at 14.
  46. See Ghosh, supra note 3, at 900.
  47. See id. at 901.
  48. See Nuno Pires De Carvalho, From The Shaman’s Hut to the Patent Office: in Search of a Trips-Consistent Requirement to Disclose the Origin of Genetic resources and Prior Informed Consent, 17 Wash.U. J.L. & Pol’y 111, 146 (2005).
  49. See Ragavan, supra note 17, at 7.
  50. See Ghosh, supra note 38, at 895.
  51. See Dominic Keating, Access to Genetic Resources And Equitable Benefit Sharing Through a New Disclosure Requirement in the Patent System: an Issue in Search of a Forum, 87 J. Pat. & Trademark Off. Soc’y 525, 526 (2005).
  52. See id.
  53. See id.
  54. See Carvalho, supra note 47, at 116.
  55. See Keating, supra note 50, at 526.
  56. See id, at 532.
  57. See Nuno Pires de Carvalho, Requiring Disclosure of the Origin of Genetic Resources and Prior Informed Consent in Patent Applications Without Infringing the TRIPS Agreement: the Problem and the Solution, 2 Wash. U. J.L. & Pol’y 371, 392 (2000).
  58. See Curci, supra note 1, at 34-39.
  59. See Jim Chen, There’s no Such Thing as Biopiracy…And It’s a Good Thing Too, 37 McGeorge L. Rev. 1, 29 (2006). Also see Ragavan, supra note 17, at 12.
  60. See Sommer, supra note 43, at 162.
  61. See Ghosh, supra note 3, at 900.
  62. See Sommer, supra note 43, at 163.
  63. Id.
  64. H.R. 2795, § 102(a) (2005); available at http://thomas.loc.gov/cgi-bin/query/z?c109:H.R.2795.
  65. Id. § 102(c).
  66. See Justin VanFleet (2003), available at http://www.worldethicsource.org/ viewMedia.php/prmTemplateID/5/prmID/942?PHPSESSID=a05af499a441b398114b38aa12c85482.
  67. See Id.
  68. See Erik B. Bluemel, Substance Without Process: Analyzing Trips Participatory Guarantees in Light of Protected Indigenous Rights, 86 J. Pat. & Trademark Off. Soc’y 671, 700 (2004).
  69. See VanFleet, supra note 65.
  70. See Id.
  71. See Bluemel, supra note 67, at 701.
  72. See http://www.wipo.int/tk/en/databases/contracts/index.html.
  73. See http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2006/07/08/BUG2RJRNS81.DTL&hw=india cures&sn=001&sc=1000.
  74. See GRAIN and Kalpavriksh, Traditional Knowledge of Biodiversity in Asia-Pacific, Problems of Piracy & Protection (Oct. 2002), available at http://www. grain.org/briefings/?id=97.
  75. See Whelan, supra note 7, at *5.
  76. See Mapping the Icelandic Genome, available at http://sunsite.berkeley.edu/biotech/iceland/.
  77. See S.C. Chen, Problems with Research on Genome of Indigenous Peoples, available at http://web.my8d.net/m5a07/volem014/wakeup1.htm.
  78. See Whelan, supra note 7, at *14.
  79. See id. at *17.
  80. See Karjala, supra note 36, at 510-516.
  81. See Diamond v. Chakrabarty, 447 U.S. 303 (1980).
  82. See Curci, supra note 1, at 1.
  83. See Whelan, supra note 7, at *19.
  84. See Curci, supra note 1, at 42.
  85. See TRIPS Agreement art. 27.1.
  86. See TRIPS Agreement art. 27.3(b).
  87. 383 U.S. 519 (1966).
  88. See John Richards, United States Patent Law and Practice with Special Reference to the Pharmaceutical and Biotechnology Industries: Utility Requirement, available at http://www.ladas.com/Patents /Biotechnology/USPharmPatentLaw/USPhar04.html
  89. See id.
  90. See Karjala, supra note 36, at 485.
  91. For example, in the case Moore v. Reagents of the Univ. of California, 793 P.2d 479 (Cal. 1990), the patient’s spleen cells were extracted during the therapy and used to develop a cell line that became a subject matter of a patent. The use of genetic resources is not limited to indigenous peoples or developing countries. Also see Karjala, supra note 36, at 495.
  92. See id., at 7.
  93. See Curci, supra note 1, at 4. Other reasons why developing countries are reluctant to provide intellectual property protection are the increased prices of medications and huge costs of establishing a TRIPS-compliant administration for intellectual property rights.
  94. See Venbrux, supra note 2, at 16.
  95. See Curci, supra note 1, at 11.
  96. See Curci, supra note 1, at 4.
  97. 35 U.S.C. § 271(a) (1994).
  98. The situation whether the infringement is held will depend on the claims in the patent. If the patent claims the novel compound only, the conduct which makes, uses, offers to sell, or sells the compound constitutes infringement, regardless of the purpose to which the compound is applied. However, if the patent claims the novel compound in treating lung cancer, the conduct which makes, uses, offers to sell, or sells the compound to the applications other than lung cancer may not be liable unless the doctrine of equivalent applies.
  99. See Convention on Biological Diversity, art. 15.
  100. See Curci, supra note 1, at 34.
  101. See id.
  102. See Curci, supra note 1, at 35.
  103. See id.
  104. See id.
  105. See id, at 36.
  106. See id.
  107. See id.
  108. See id, at 39.
  109. See id, at 37.
  110. Taiwanese Patent Act § 78.1 (2003).
  111. See European Patent No. 436257.
  112. See http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2F netahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=neem&FIELD1=TI&co1=AND&TERM2=&FIELD2=&d=PTXT. Last visited on November 29, 2006.
  113. For example, see United States Patent No. 5,501,855.
  114. For example, see United States Patent No. 5,736,145.
  115. For example, see United States Patent No. 6,545,167.
  116. See Venbrux, supra note 2, at 7-8.
  117. See id. at 8.
  118. See Chen, supra note 58, at 5.
  119. See Curci, supra note 1, at 18.
  120. See http://www.atcc.org/.
  121. See http://www.ncbi.nlm.nih.gov/Genbank/.
  122. See http://www.rcsb.org/pdb/home/home.do.
  123. See Curci, supra note 1, at 18.
  124. See Whelan, supra note 7, at *8.
  125. Sometimes they just reject the idea that live forms can be owned by a person or by a company. See Resisting on the Gene Raiders, available at http://www.rcsb.org/pdb/home/home.do.
  126. See id.
  127. See Karjala, supra note 36, at 519-520.
  128. See Venbrux, supra note 2, at 15.
  129. See Curci, supra note 1, at 12.
  130. See Venbrux, supra note 2, at 28.
  131. See id. at 29.
  132. See id. at 15.
  133. See Venbrux, supra note 2, at 26.
  134. See Chen, supra note 58, at 21.
  135. See Rockwell Graphic Systems, Inc. v. DEV Industries, Inc., 925 F.2d 174 (7th Cir. 1991).
  136. See Chen, supra note 58, at 22.
  137. Civil Code, § 3426.1(a). Also see Chicago Lock Co. v. Fanberg, 676 F.2d 400 (9th Cir. 1982).
  138. One exception is Moore case, which the hybridoma is derived from one person. See supra note 104.
  139. See TRIPS Agreement art. 31(b).
  140. See the public interest requirement in Japanese Patent Law, § 93(1) (1999), stating that: “[w]here the working of a patented invention is particularly necessary in the public interest, a person who intends to work the invention may request the patentee or the exclusive licensee to hold consultations on the grant of a non-exclusive license.”
  141. See the public welfare requirement in Taiwanese Patent Act, § 76 (2003), stating that: “[i]n order to cope with the national emergencies, or to make non-profit-seeking use of a patent for enhancement of public welfare, or in the case of an applicant’s failure to reach a licensing agreement with the patentee concerned under reasonable commercial terms and conditions within a considerable period of time, the Patent Authority may, upon an application, grant a right of compulsory licensing to the applicant to put the patented invention into practice; provided that such practicing shall be restricted mainly to the purpose of satisfying the requirements of the domestic market. However, if the application for compulsory licensing of a patent right covers semiconductor technology, such application may be allowed only if the proposed practicing is purposed for a non-profit-seeking use contemplated to enhance the public welfare.”
  142. See the public interest requirement in China Patent Law, § 49 (2000), stating that: “[w]here a national emergency or any extraordinary state of affairs occurs, or where the public interest so requires, the Patent Administration Department Under the State Council may grant a S to exploit the patent for invention or utility model.”
  143. See Department of Health v. Gilead Science, Inc. Chi-Fa-Ji No. 09418601140 (TIPO, 2005), available at http://www.tipo.gov.tw/attachment/tempUpload/539606478/審定書.pdf.
  144. See Karjala, supra note 36, at 520.
  145. See id. at 521.

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Last updated 4/27/2012