[*PG69]THE AYAHUASCA PATENT REVOCATION: RAISING QUESTIONS ABOUT CURRENT U.S. PATENT POLICY

Leanne M. Fecteau*

Abstract:  This Note explores the discriminatory effect of U.S. patent law and policy on indigenous communities in developing countries. For years, Western researchers have relied upon local people to point them to useful regional plants and animals so that they could then isolate, develop and patent the chemical compounds found in the organisms. Yet, the U.S. patent system does not recognize or value the traditional knowledge of indigenous groups regarding their regional biodiversity. Rather, the researchers who isolate the compounds can obtain a patent with no recognition for the indigenous knowledge upon which they relied. Recently, the World Trade Organization has succeeded at globalizing Western intellectual property systems through international treaties. These efforts have met with significant resistance in several developing countries. The controversy over the ayahuasca patent is one example of developing countries’ opposition to Western-style intellectual property rights. By implementing the suggestions described in this Note, the United States could ensure that indigenous knowledge would be recognized and thus could avoid future controversies like the one surrounding the ayahuasca patent.

Introduction

In 1986, Loren Miller, an American scientist and entrepreneur, obtained a U.S. patent on a strain of the ayahuasca vine.1 Ayahuasca, a vine native to the Amazon Rain Forest, has been used by healers and religious leaders throughout the Amazon for generations.2 For hundreds of years, shamans have used ayahuasca to treat sicknesses, contact spirits, and foresee the future.3 Many indigenous Amazon tribes also view the plant as a sacred symbol of their religion.4

[*PG70] Several years after its issuance, tribal leaders learned of Miller’s patent.5 They were understandably angry and incredulous that a foreigner had patented a plant that they had been using and worshiping for hundreds of years.6 Voicing his countrymen’s frustration, Antonio Jacanamijoy, the leader of a council representing more than 400 indigenous tribes and groups in South America, stated, “[o]ur ancestors learned the knowledge of this medicine and we are the owners of this knowledge.”7 In 1999, Jacanimijoy’s council applied for and obtained a rejection of the ayahuasca patent from the U.S. Patent and Trademark Office.8 The controversy over the patent generated considerable hostility between the United States and Ecuador and eventually led Ecuador’s legislature to forgo signing a bilateral intellectual property rights agreement with the United States.9

The ayahuasca patent and the controversy it evoked is quite typical of the issues facing the biotechnology industry.10 Today, researchers from the United States travel to distant, resource-rich regions of the world, such as the Amazon, for the express purpose of gleaning scientific knowledge from indigenous populations regarding the var[*PG71]ied uses of local plants and animals.11 These researchers are free to return to their countries with their plant or animal samples, isolate a chemical compound, and subsequently obtain a patent.12 Protected by their patents, the researchers are not bound to share in the profits from their patented items with the indigenous tribes from whom they gained the critical knowledge.13 This activity has come to be known as “biopiracy.”14

Biopiracy has been on the rise ever since a 1980 U.S. Supreme Court decision held that people could patent biological living organisms.15 In response, many developing countries have enacted legislation designed to protect their natural resources, often by drastically cutting foreign-researchers’ access to some of the most diverse eco-systems in the world.16

Exacerbating the situation, the United States does not recognize prior foreign use of an “invention” as a bar to obtaining a patent unless such foreign use has been published and is available for all to find.17 In contrast, prior domestic use of an “invention” is enough, without publication, to preclude issuance of a patent.18 This differing treatment of domestic and foreign use dates back to a time when inventors in this country likely would not have known that an invention [*PG72]that was new in the United States was in fact common knowledge elsewhere.19 With modern technological and communications advances, the foreign use exclusion has come under increased criticism.20 Unlike in previous centuries, the ease of international travel and research today makes prior foreign use of an invention accessible to U.S. researchers.21

Since most of the world’s remaining biodiversity is concentrated in underdeveloped southern countries, such as Brazil and India, increasing protectionism on the part of these developing nations could significantly impair research regarding the fight against diseases.22 This result is not in anyone’s best interest.23 In order to reverse this protectionist trend, the United States and other developed nations should consider ways to reform domestic patent laws as well as international patent treaties to reflect more accurately the needs of developing countries and their indigenous populations.

Part I of this Note will discuss the current U.S. patent law regarding prior foreign use or knowledge. In particular, Part I will discuss how the current U.S. policy discriminates against developing nations and their indigenous populations by failing to value traditional knowledge. Part II will then illustrate the detrimental effect U.S. policy has on developing countries by offering a more detailed description of the ayahuasca patent controversy. Finally, Part III will suggest ways to reform current U.S. patent policy. In particular, Part III argues that the U.S. should: (1) enforce the public policy and morality aspects of current patent law so that morally offensive patents are not issued; (2) alter its current patent law to recognize prior foreign use as a bar to issuance of a patent; and (3) urge reform of the Agreement on Trade-Related Aspects of Intellectual Property Rights, so that, like the United Nations Framework Convention on Biological Diversity, it would seek a more equal distribution of the benefits de[*PG73]rived from biodiversity between developed and developing nations. This Note concludes that, by implementing the three measures mentioned above, the United States would improve considerably its relations with resource-rich developing nations. It further concludes that these measures would help to ensure that biologically diverse ecosystems and traditional knowledge systems are preserved so that they continue to be available in the future as a source for the discovery and development of new pharmaceutical and agricultural products.

I.  Current U.S. Patent Law and Policy

A.  Requirements for Patentability

In order to receive a patent under U.S. law, an individual must demonstrate the (1) novelty; (2) non-obviousness; and (3) utility of her invention.24 Although these are useful measures for determining whether an inventor deserves an exclusive property right, as presently applied, these criteria result in discrimination toward indigenous groups in developing nations.25

1.  Novelty

Federal law requires that, in order to obtain a patent on an invention or discovery, the invention or discovery must be new.26 Section 102(a) of the Patent Act provides that a person can obtain a patent unless “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, before the invention thereof by the applicant for patent.”27 Thus, an important goal of the U.S. Patent Act is to distinguish claimed inventions from prior inventions to ensure that patents are only granted for products and processes that are actually new.28 When deciding whether or not to issue a patent, patent examiners look to [*PG74]the existence of any prior art references.29 Prior art references include: prior inventions, patents, patent applications, and publications discussing prior inventions.30 The specific types of prior art references upon which the Patent and Trademark Office (PTO) relies are listed in 35 U.S.C.  102.31 In particular,  102(a) identifies four categories of prior art references that preclude issuance of a patent: (1) prior knowledge of the invention by others in the United States; (2) prior use of the invention in the United States; (3) prior patent of the invention in any country; and (4) the printed publication of the invention in any country.32

As  102(a) demonstrates, prior use or knowledge of an invention in this country is enough to preclude issuance of a patent, while the same prior use or knowledge in a foreign country has no effect on patentability.33 The reason for this apparent double standard is that, historically, U.S. patent laws have based prior art references on accessibility.34 In other words, the use or knowledge of a prior invention, must be accessible to the public in this country.35 While foreign publications or patents meet this criteria, unpublished foreign use or knowledge do not.36 This distinction has the effect of discriminating against indigenous populations in foreign countries because their traditional knowledge is rarely published.37 Furthermore, such a distinction is not useful in the bio-piracy arena: biopirates who “discover” new species of plants and animals are able to pass the novelty requirement, even though indigenous people have often led them to the “new” species and imparted to them information about its traditional use.38 Thus, by granting patents in this type of situation, U.S. [*PG75]patent law seems to violate the very goals that underpin the novelty requirement.39

2.  Non-Obviousness

In addition to the novelty requirement,  103 of the Patent Act also requires that an invention or discovery be non-obvious in order to be patentable.40 The non-obviousness requirement precludes any invention that would have been obvious at the time of invention to a person with ordinary skill in the particular art.41

As under the novelty requirement, the prior art relied upon to determine whether an invention is obvious would not cover prior knowledge or use in a foreign country.42 As a result, the “person with ordinary skill in the particular art” would not include a member of an indigenous population in a foreign country.43 Therefore, the non-obviousness requirement discriminates against indigenous persons in the same way as the novelty requirement.44 In addition, this effect on indigenous persons is often exacerbated when the invention involves chemical compounds because indigenous use of a plant does not require isolation of the chemical compounds that make up the plant.45 If prior art references show that a compound likely contains certain [*PG76]qualities, patent applicants must rebut the presumption of obviousness.46

A common method of rebutting the presumption is to show that the new compound displays “unexpectedly improved properties.”47 Because plants are made up of biochemical compounds, the isolation of these compounds must prove that the new genetic configuration displays “unexpected properties.”48 Therefore, it is nearly impossible for indigenous groups to obtain patents on their own innovations because their unprocessed uses of medicinal plants would be considered obvious.49 Furthermore, indigenous communities have no means and no need to improve the chemical compounds of plants in order to meet the non-obviousness requirement.50 Unlike Western research companies, indigenous peoples have no need to isolate compounds for mass marketing; rather, they rely on these plants mainly for local subsistence.51

3.  Utility

The third major requirement for patentability is utility.52 As the term suggests, the utility requirement mandates that an invention or discovery must be useful in order to be patented.53 This requirement is set out in 101 of the Patent Act, and is based on Article I, Section 8 of the U.S. Constitution, which grants Congress the power to promote the progress of science and the useful arts.54 The utility requirement is a relatively easy one for a patent applicant to fulfill: an invention can be quite trivial, but if it has any fathomable use it will generally pass the utility requirement.55 In fact, even if an invention is inferior to a prior invention that serves the same purpose it can still be patented.56

The only kinds of inventions or discoveries that have been precluded from patentability on the grounds of non-utility are those for [*PG77]purposes deemed illegal or immoral.57 For example, any invention useful only in committing a crime or fraud, such as a method of counterfeiting currency, could be unpatentable for public policy reasons.58

B.  Current U.S. International Patent Policy

In addition to maintaining domestic patent laws that discriminate against foreign indigenous knowledge, the United States also supports international agreements which impose traditional Western patent systems on less-developed, resource-rich countries.59 One such agreement involving intellectual property rights is the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), a result of the Uruguay Round of trade agreements.60 While fully supporting TRIPS, the United States has failed to ratify the 1992 Convention on Biological Diversity (Biodiversity Convention) which, unlike TRIPS, lists the sharing of benefits arising from the use of traditional knowledge as a goal.61

1.  TRIPS

The goal of TRIPS is to “reduce distortions and impediments to international trade [by] taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade . . . .”62 [*PG78]In short, the agreement requires that signatory nations adopt intellectual property legislation that conforms to the treaty’s provisions.63

The provisions to which signatory nations must conform mirror the U.S. Patent Act’s requirements of novelty, non-obviousness, and utility.64 The agreement further states that a newly created World Trade Organization Council (WTO) for TRIPS will monitor compliance with TRIPS’ terms and oversee disputes between Member States.65 To date, the WTO’s dispute resolution process has been successfully used to resolve patent enforcement problems before trade sanctions were imposed.66 For instance, in 1997, both India and Pakistan had failed to comply with the requirement of enacting a system of intellectual property laws.67 This is because each of these countries has until 2005 to pass patent legislation that conforms with TRIPS.68 [*PG79]In the interim, TRIPS requires these countries to set up “mailbox” systems for holding patent applications until passage of new legislation.69 After these countries enact a permanent patent system that is in compliance with TRIPS requirements, the applications in the “mailbox” will receive priority dates as of the dates that they were originally submitted.70 The failure of India and Pakistan to comply with TRIPS’ “mailbox” requirement led the United States to file dispute resolution proceedings with the WTO against each country.71 The proceeding against Pakistan resulted in a settlement requiring Pakistan to pass an ordinance creating a “mailbox” system.72 The United States dropped its complaint when Pakistan complied with this requirement in 1997.73 The case against India was resolved by the WTO Appellate Body, which upheld a panel ruling in favor of the United States.74 As a result, the Indian government promulgated a temporary ordinance to meet its “mailbox” rule obligations.75 In 1999, despite significant domestic opposition, India passed permanent legislation entitled the Patents (Amendment) Act, which updated India’s patent system in order to cover pharmaceutical and agricultural chemical products.76

[*PG80] In creating a system granting patents on agricultural and pharmaceutical products, India was complying with article 27 of TRIPS.77 Article 27 states that signatory countries must protect property rights in genetic plant resources “either by patents or by an effective sui generis system or by any combination thereof.”78 However, many peo[*PG81]ple in developing countries that have signed TRIPS are critical of assigning property rights in plant resources.79 This requirement does not take into account the differing cultural perspectives of indigenous groups in member states regarding the commodification of biological resources.80 In particular, it disregards the contributions of indigenous groups in discovering and nurturing the medicinal and agricultural uses of plants over the centuries.81

Historically, international law has allowed sovereign nations control over all persons and things within their territory, which means that lesser developed nations could act to protect the cultural knowledge of their people.82 However, these countries were economically pressured by developed countries to sign TRIPS, which prevents them from passing protectionist laws.83 Many lesser developed nations succumbed to this pressure as a means of equalizing their economies with those of developed nations at the expense of their indigenous populations who consider their cultural knowledge as community, rather than private, property.84

TRIPS has effectively resulted in continued exploitation of indigenous knowledge.85 Some scholars have referred to this exploitation as a form of modern-day imperialism.86 In this regard, article 27 of the TRIPS Agreement is in direct opposition to the goals of the Biodiversity Convention.87

[*PG82]2.  The Biodiversity Convention

The United Nations Framework Convention on Biological Diversity, concluded in 1992 in Rio de Janeiro, endeavors to conserve the world’s biological resources and to forward sustainable development.88 Unlike TRIPS, the Biodiversity Convention recognizes and acknowledges the value of indigenous knowledge of regional biological resources.89 Article 8(j) of the Convention states that respect and preservation should extend to “innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity . . . .”90 In addition, article 9 of the Convention urges nations to include indigenous and local communities in the conservation and sustainable use of biological diversity.91 In so doing, the Biodiversity Convention recognizes, for the first time in an international treaty, the important role played by indigenous populations in the gathering and preservation of cultural knowledge regarding regional biodiversity.92

Despite its laudable goals, the Biodiversity Convention has been criticized for investing in the governments of developing nations rather than in local communities, the sovereign right to control access to biodiversity located within their borders.93 In these nations, the result has been a great incentive for prospecting agreements between governments and foreign researchers.94 Prospecting agreements “provide a means by which the global community can turn local governments and peoples into biodiversity stakeholders, thus creating a viable economic alternative to competing ecologically destructive sources of income.”95 However, prospecting will not fulfill the goals of the Biodiversity Convention unless each agreement provides compensation to the indigenous and local groups who have preserved their [*PG83]traditional knowledge.96 Presently, the goal of the Biodiversity Convention to ensure that the contributions of indigenous populations are respected is thwarted in that the holders of traditional knowledge are still exploited.97 The only difference is that the exploitation under the Biodiversity Convention is by their own governments.98

Another roadblock to the success of the Biodiversity Convention is the failure of the United States to ratify it.99 Since its inception, the United States has been critical of the Biodiversity Convention because it would impair American intellectual property rights.100 The State Department voiced the United States’ concerns about the Convention in 1992, stating that it focused on intellectual property rights “as a constraint to the transfer of technology rather than as a prerequisite.”101

The Clinton Administration eventually signed the Biodiversity Convention in 1993, but only after considerable lobbying efforts by pharmaceutical and biotechnology firms.102 These firms had changed their position from opposition of the Biodiversity Convention to promotion of it, due to fear that continued opposition would exclude U.S. companies from opportunities to explore genetic resources in developing countries and preclude U.S. involvement in future negotiations interpreting the exact meaning of the Convention.103 After signing the Biodiversity Convention, Clinton stated that future legislation ratifying the Convention would illustrate the White House’s interpretation and would highlight the United States’ concern that the Convention fails to protect intellectual property rights.104 However, Congress never took up the issue of the Convention and has yet to ratify it.105

[*PG84] Despite the Biodiversity Convention’s flaws, its underlying assumption that indigenous communities should share in the profits of inventions resulting from their traditional knowledge is a valid one.106 The failure of the U.S. Congress to ratify the Biodiversity Convention is yet another way in which U.S. patent policy fails to acknowledge the value of indigenous cultural knowledge. The real life discriminatory effect of U.S. patent law and U.S. international patent policy is well illustrated by the controversy surrounding the ayahuasca patent.

II.  The Ayahuasca Patent

As described above, upon learning of Loren Miller’s patent on ayahuasca, many indigenous tribes of South America organized to oppose the patent on the ground that the vine was a sacred religious symbol and a known medicinal herb.107 This effort by the indigenous tribesmen and their attorneys proved very successful, and on November 3, 1999, the United States Patent and Trademark Office (PTO) ultimately rejected Miller’s patent.108 This section will describe in more detail the history of this patent and its eventual revocation.

A.  Issuance of the Patent

In 1974, a tribe in Ecuador gave Loren Miller samples of a local ayahuasca vine.109 In return for the plants, Miller claims to have built a school for the tribe’s people.110 Upon returning to the United States, Miller cultivated the plant in Hawaii and developed a stable variety that was eligible for a patent.111 He then formed a small company, International Plant Medicine, to investigate whether the plant had any useful purpose.112

In 1986, Miller obtained a plant patent on his ayahuasca, which he called “Da Vine.”113 In his patent application, he stated merely that he had originally obtained the ayahuasca from a “domestic garden in the Amazon rain-forest of South America.”114 He claimed that Da Vine [*PG85]represented a new and unique variety of ayahuasca distinct from other forms primarily because of the color of its flower petals.115

In 1994, the Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) discovered that Miller had obtained a patent on ayahuasca.116 Perplexed at the idea of an outsider “discovering” a plant that had been used by their ancestors since ancient times, some tribes in Ecuador reacted in a hostile fashion.117 One coalition actually issued a threat of bodily harm to Miller should he ever return to the Amazon Basin.118 This threat, in turn, led the United States to cancel all aid to the indigenous tribal group.119 COICA also learned that Miller intended to build a pharmaceutical laboratory in Ecuador to process ayahuasca.120 This discovery prompted fear among COICA members that a bilateral intellectual property reciprocity agreement being forged between the United States and Ecuador would force indigenous peoples to recognize Miller’s proprietary rights over a plant which they viewed as sacred.121

B.  PTO Re-Examination of the Ayahuasca Patent

COICA and the Amazon Coalition both decided that the best way to assert tribal rights to their cultural knowledge and their sacred plant was to object formally to Miller’s patent.122 The tribal organizations set out to use the U.S. patent law as a tool in their fight.123 They began working with attorneys at the Center for International Environmental Law (CIEL) to prepare a Request for Re-examination of the patent.124

Attorneys from CIEL filed the Request for Reexamination of the ayahuasca patent on March 30, 1999.125 In their Request, they argued [*PG86]that prior art revealed that Da Vine was not, in fact, distinct or new, thus failing the Patent Act’s requirement of novelty.126 Miller’s patent application described ayahuasca as it was already illustrated in scientific literature and known by indigenous Amazonian peoples.127 The CIEL attorneys further argued that the Da Vine patent violated the Plant Patent Act because the vine is “found in an uncultivated state.”128 Lastly, the attorneys charged that the patent on ayahuasca violated the Patent Act’s utility requirement because issuing a patent on a plant that is sacred to indigenous peoples violates notions of public policy and morality.129

On May 28, 1999, based on the fact that Da Vine was identical to other specimens of ayahuasca found in U.S. herbarium collections, the PTO granted the Reexamination Request.130 In November 1999, after reviewing the facts, the PTO ordered the rejection of Miller’s patent on the narrow ground that the same plant had been described in herbarium sheets in Chicago’s Field Museum over a year prior to Miller’s application.131

By revoking the ayahuasca patent on these narrow grounds, the PTO failed to address the more significant issues of whether the prior use by indigenous tribes or the fact that the plant was a sacred religious symbol precluded issuance of the patent.132 In the absence of any attempt by Congress or the U.S. PTO to address the issues raised by the ayahuasca patent, many developing nations have enacted laws making it more difficult for researchers from developed nations to study indigenous plants and animals for possible medicinal value.133 [*PG87]In particular, the ayahuasca patent controversy has led Ecuador to reject a proposed bilateral intellectual property rights agreement with the United States.134 Ecuador was likely on its way to signing the agreement prior to this controversy.135 As the ayahuasca controversy demonstrates, U.S. patent policy (and policies of other developed nations) inevitably leads to international conflict and protectionist response from developing nations. As a result, the resources of developing nations are often effectively cut off from the world, to the detriment of nations on both sides of the dispute. In order to effectively prevent similar reaction from developing nations in the future, the time is ripe to re-evaluate and reform U.S. patent policy.

III.  Suggestions for Reform of U.S. Patent Laws

In order to avoid the ill effects of biopiracy that are demonstrated by the ayahuasca controversy, the United States should reform its patent policy in three distinct ways. First, the PTO should give greater consideration to the morality component of the utility requirement when deliberating an invention’s patentability.136 For instance, Loren Miller’s patent should have been refused on the basis that it was immoral to grant a property right in a religious symbol.137 Second, the United States should recognize foreign prior use as a prior art under the Patent Act’s novelty requirement.138 Such recognition would prevent biopirates like Loren Miller from claiming an exclusive patent right over plants which have been used by indigenous populations for centuries.139 Furthermore, recognizing prior foreign use would likely help to convince underdeveloped nations to stop restricting researcher access to their diverse ecosystems.140 Finally, the United States and other signatory nations should reject TRIPS, as it presently reads, in favor of a reformed treaty which provides a more [*PG88]equitable distribution of the rights over, and benefits deriving from, the world’s biodiversity.141 To that end, the United States should support an effort to integrate some of the goals of the 1992 Rio Biodiversity Convention into the TRIPS agreement.142

A.  Enforcing the Morality Component of the U.S. Patent Act

1.  Genesis and Rebirth of the Patent Act’s Morality Component

There is sufficient ground in the development of the utility requirement to expand its morality component to include things like religious symbols.143 The history of the morality component of the utility requirement can be traced to an 1817 Massachusetts case authored by Justice Joseph Story.144 In that case, Lowell v. Lewis, the court found that an invention relating to the construction of water pumps satisfied the utility requirement of the Patent Act.145 The court reached its decision by concluding, “[a]ll that the law requires is, that the invention should not be frivolous or injurious to the well-being, good policy, or sound morals of society. The word ‘useful,’ therefore, is incorporated into the act in contradistinction to mischievous or immoral.”146 Thus, from its inception, the utility requirement drew its meaning, in part, from a reliance on morality.147

Following the Lowell decision, other courts in the nineteenth and early twentieth centuries generally struck down patents on the basis of immorality in two types of cases.148 First, courts struck down inven[*PG89]tions used to defraud buyers.149 Second, courts denied patents for items useful for gambling or similarly immoral activity.150

Since early in the twentieth century, federal courts have stopped applying the moral utility doctrine to reject patent applications.151 Many scholars argue that this is based on the fact that moral norms can change over the course of only a few years and that the PTO is not institutionally equipped to make moral judgments.152 Rather, it is argued, the PTO should limit itself to deciding issues of novelty.153 Since the middle of this century, the courts have done just that.154

However, with the recent explosion of the biotechnology industry and the moral questions this explosion has raised, the moral utility doctrine is experiencing a re-birth, both in the United States and abroad.155 In particular, the PTO has recently issued an advisory citing Lowell and the moral utility doctrine, as did the federal circuit court in Tol-O-Matic, Inc. v. Proma Product-Und Marketing Gesellschaft, m.b.H.156 Additionally, the European Union has used a form of the moral utility doctrine as a means of rejecting immoral or destructive patents.157 Finally, article 27(2) of the TRIPS Agreement allows for the barring of [*PG90]patent protection if “commercial exploitation” of an invention would harm public policy or morality.158

2.  The Revived Morality Component in Action: Recent Decisions and Legislation

a.  Human-Animal Chimera

One instance of the recent revival of the morality component of the U.S. Patent Act’s utility requirement involved a proposed patent on a human animal chimera.159 A human animal chimera is a genetically engineered creature composed of some human and some animal cells.160 In December of 1997, Dr. Stuart Newman, a cellular biologist at New York Medical College, and Jeremy Rifkin, a biotechnology activist opposed to the patenting of life forms, applied for a patent on the production of human-animal chimeras that could be up to fifty percent human.161 The co-applicants hoped either to forestall other scientists from creating human-animal chimeras for the twenty-year term of a patent or that the PTO would reject the patent due to the moral questions such a creature would raise.162

As it turned out, the PTO quickly issued an advisory opinion to the media stating that it would likely reject the patent.163 In particular, the PTO stated that it would not “issue a patent for an invention of incredible or specious utility or for inventions whose utilization is not adequately disclosed in the application.”164 While this sentence, taken alone, merely illustrates the PTO’s intention to question the proposed utility of the invention, the advisory went on to state that, “the courts have interpreted the utility requirement to exclude inventions deemed to be ‘injurious to the wellbeing, good policy, or good morals [*PG91]of society.’”165 This language is quoted directly from Justice Story’s opinion in Lowell.166 By citing the moral utility doctrine illustrated in Lowell, the PTO intimated that it would consider the morality of patenting a life form.167 This indication was contrary to earlier federal court decisions that upheld patents on transgenic animals including animals with human genes or organs.168

In relying on Lowell, the PTO was following the recent example of the U.S. Circuit Court of Appeals.169 In Tol-O-Matic v. Proma Product-Und Marketing Gesellschaft, a 1991 decision, the court upheld a patent on a rodless piston-cylinder.170 In arriving at its opinion, the court noted that 35 U.S.C.  101 has “been interpreted to exclude inventions deemed to be immoral.”171 Although neither party argued that the rodless piston-cylinder was immoral, the court went on to cite the Lowell opinion extensively in upholding the patent.172 It has been suggested that the willingness of the Federal Circuit to cite to such a controversial doctrine in a setting where the morality argument was not even raised indicates that the courts may be preparing to invoke the doctrine with greater frequency in the future.173

Ultimately, the PTO did reject the human-animal chimera patent in June of 1999, in part because the invention “embraces” a human being and is, therefore, unpatentable on the longstanding policy of the PTO that human beings are not patentable.174 However, the PTO [*PG92]did not say in the holding why other animals injected with human genetic material do not embrace a human being.175 Thus, the holding that a being that is fifty percent human is too human to be patentable appears to be, in part, a rejection of a patent based on moral questionability.176

Dr. Newman and Mr. Rifkin, the human-animal chimera patent applicants, have already filed an appeal of the PTO decision rejecting their patent, in hopes that the case will eventually reach the Supreme Court for a long-awaited limitation of the holding of Diamond v. Chakrobarty, which upheld a patent on a genetically-altered bacterium.177 It was that case that led to the inevitable patents of genetically-engineered animals.178 The United States courts and the PTO have re-opened the door for using the moral utility doctrine to reject immoral patents.179 This positive step could make patents like the one on ayahuasca less likely to be upheld.180

b.  The European Union’s Use of Morality Determinations to Bar Patents

In addition to the progress made in the United States in resurrecting the moral utility doctrine, the European Union has employed a similar doctrine.181 In July 1998, the European Parliament and the Council of the European Union issued a directive expressly allowing patents on genetically engineered plant and animal species, but forbidding biotechnological applications that “would be contrary to ordre public or morality.”182

The term “ordre public” derives from French law and is similar to the notion of public policy.183 However, “ordre public” encompasses a few separate and distinct ideas that are not covered by the Anglo-[*PG93]American doctrine of public policy.184 First, according to the doctrine of ordre public, judges have some discretion to bar enforcement of contracts which they find to offend public order.185 Second, there are statutory requirements within the ordre public which limit private contracts.186 Finally, the notion of ordre public can be used to bar application of a foreign law which would normally apply, on the basis that the foreign law “would sanction conduct that offends against the forum’s concept of fundamental norms.”187

In 1998, the European Parliament and the Council of the European Union issued a directive on the legal protection of biotechnological inventions.188 Included in the directive was an article making unpatentable inventions whose “commercial exploitation would be contrary to ordre public or morality.189 That article lists human cloning, commercialization of human embryos, and modifying the genetic makeup of animals in ways likely to cause them suffering without any apparent benefit as examples of inventions which would be rejected on the basis of offending morality or being contrary to ordre public.190

At this point, it is unclear whether Europe’s new patent laws will have any effect on U.S. domestic policy.191 However, this is an area in which the United States has been lagging behind in legislation.192 Therefore, it is very possible that Congress and the National Bioethics Advisory Commission (NBAC) could look to Europe in formulating U.S. policy.193 But, regardless of Europe’s effect on U.S. domestic policy regarding biotechnology, its provision against granting patents on [*PG94]inventions which are contrary to “ordre public or morality” has already been included in the TRIPS agreement.194

c.  Article 27(2) of the TRIPS Agreement

Finally, like the European Union and the United States, TRIPS has placed greater emphasis on morality.195 The Agreement on Trade-Related Aspects of Intellectual Property, in article 27(2), provides that states may exclude an invention from patent protection if prevention of “commercial exploitation” of that invention in their territory is “necessary” in order to “protect ordre public or morality.”196 This provision allows that if prevention of “commercial exploitation” of an invention is “necessary” to protect “the ordre public or morality,” and if exclusion of the invention from patentability is the only way to prevent its commercial exploitation, then the state may bar the patent.197 Thus, under article 27(2), states may only exclude an invention from patentability on the basis of ordre public where granting a patent would result in commercial exploitation of the invention, and that such commercialization would offend the state’s concept of fundamental norms.198

The inclusion of this clause in the TRIPS Agreement has led to some speculation that it creates a loophole in the requirement that Member States create adequate systems for protecting intellectual property rights.199 Some scholars argue that this clause could especially hinder the goal that Member States protect technology.200 However, the application of the clause by Member States is limited in that patent protection can only be denied if preventing commercial exploitation of an invention is necessary to protect ordre public or morality.201

[*PG95] By allowing Member States to exclude patent protection on certain inventions for public policy reasons, article 27(2) of the TRIPS Agreement is in line with the morality component of the utility requirement of the U.S. Patent Act.202 The inclusion of morality considerations in determining an invention’s patentability, therefore, comports with both domestic law and an international treaty.203 Therefore, by applying a morality test in determining whether a patent should issue, U.S. courts and the U.S. PTO would be applying the Patent Act correctly and would not be violating the TRIPS Agreement.204

B.  Foreign Prior Use

In addition to expanding the application of the morality component, the United States should also reconsider the exclusion of foreign prior use as a bar to granting a patent.205 In particular, under the novelty requirement of the Patent Act, the United States should recognize foreign prior use in the form of traditional knowledge as a prior art reference.206

1.  Recognizing Traditional Knowledge as Prior Art Is Consistent with the Mission of U.S. Intellectual Property Law

In recognizing cultural knowledge as a prior art reference the U.S. Patent Act would remain consistent with its underlying purpose of granting property rights in new and useful inventions.207 In the United States, intellectual property law has its basis in the U.S. Constitution, which states that “[t]he Congress shall have Power . . . [t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”208 The award of patents for inventions is one means of fulfilling the mission of promoting the progress [*PG96]of science and useful arts.209 However, financially rewarding inventors by granting exclusive patent rights is only one means of progressing science and the useful arts, it is not an end in itself.210 Another important means of promoting innovation is by way of the patent application and publication process itself.211 Patent applications disclose to the public the basis for inventions.212 By acknowledging the prior art used, inventors can at once recognize their predecessors and provide a complete view of the inventive process relied upon by future inventors.213 Such acknowledgment is just given that indigenous people often facilitate the ability of transnational corporations to access these substances by helping a corporations’ researchers to identify the natural sources of various compounds.214

The Center for International Environmental Law, whose attorneys successfully challenged the ayahuasca patent on behalf of COICA, argues that the disclosure of traditional knowledge that forms part of the prior art promotes the progress of science and the useful arts in two ways.215 First, it would recognize the holders of cultural knowledge of local biological resources, providing incentive for continued use and maintenance of indigenous knowledge systems.216 Such an incentive could work to slow the rapid loss of traditional knowledge due to cultural assimilation and the destruction of local biological resources.217 Second, by encouraging the maintenance of traditional knowledge systems through positive incentives, a reformed U.S. Patent Act would induce knowledge holders to continue the traditional practices which have helped to maintain high levels of biodiversity in their regions over many centuries.218

2.  The Exclusion of Foreign Prior Use as a Prior Art Is Outdated and Should Be Eliminated from the Patent Act

Given that the foreign prior use exclusion comes out of a nineteenth century legislation, the United States should reconsider the [*PG97]continued utility of its application in the modern world.219 Exclusion of foreign prior use as a prior art first appeared in U.S. law in the Patent Act of 1836.220 The 1836 Act required that prior knowledge, use or invention by others be “in this country” in order to bar issuance of a patent.221 This exclusion of foreign prior knowledge, use or invention as a prior art remains in the Patent Act today.222 Thus, while foreign patents and printed publications are considered prior art and preclude subsequent patent of the same invention in the United States, the existence of foreign traditional knowledge, which is rarely printed, does not preclude issuance of a U.S. patent.223 As illustrated by the ayahuasca patent, the exclusion of prior foreign use as a prior art makes it difficult for a foreign litigant to defeat a plant patent.224

The exclusion of foreign prior knowledge, use or invention as a prior art has been under attack for at least thirty years.225 The President’s Commission on the Patent System’s 1966 Report to the U.S. Congress recommended that  102’s geographical distinction be abolished so that foreign knowledge, use and sale would be included as prior art.226 As scholars have argued, enacting this recommendation [*PG98]would improve global patent protection in three distinct ways.227 First, it would prevent the PTO from granting U.S. patents on inventions which would be unpatentable abroad because of long use or sale there.228 Second, eliminating  102’s geographical distinction would further conform U.S. patent law with current European patent laws, thus promoting acceptance of a common definition of prior art.229 And third, it would lead to the establishment of international scientific data banks, eliminating one of the barriers to the useful exchange of search results among national patent offices around the world.230

The final and strongest reason to eliminate  102’s geographical distinction is that, due to increased international communications, travel and trade, the distinction has become unnecessary.231 Today, the ease and frequency of researcher access to foreign indigenous knowledge point to the falseness of the foreign prior use distinctions.232 The ayahuasca case illustrates this idea well. As discussed above, Loren Miller traveled to Ecuador where indigenous people gave him samples of ayahuasca, a vine which they had been using for religious and healing purposes for generations.233 Because he obtained this information outside of the United States, his subsequent patent application was not required to contain any acknowledgment of the traditional knowledge supplied by the indigenous tribespeople.234 Due to the increased ease of traveling to other countries and the frequency with which researchers go to developing nations to find specimens of plants used in traditional medicine, information gathered in foreign countries, whether previously published or not, should be credited as prior art under the Patent Act.235

[*PG99]C.  Reconciling the TRIPS Agreement with the Biodiversity Convention

Finally, working to reconcile TRIPS with the goals of the Biodiversity Convention could help to promote a more equal sharing of profits from products developed from indigenous sources of knowledge.236 As discussed above, article 27 of the TRIPS Agreement requires Member States to protect property rights in microorganisms, non-biological and microbiological processes, and plants by either a patent system or a sui generis system.237 In contrast, article 3 of the Biodiversity Convention recognizes that “[s]tates have . . . the sovereign right to exploit their own resources pursuant to their own environmental policies . . . .”238 Despite the differing requirements of the two treaties regarding intellectual property protection, it is possible to reconcile the goals of both.239

The purpose of the TRIPS Agreement is to reduce distortions and impediments to international trade by protecting intellectual property rights on a global level.240 Whereas, the ultimate purpose of the Biodiversity Convention is to prevent the depletion of the Earth’s biodiversity and ensure the equitable sharing of the benefits arising out of the use of genetic resources.241 To this end, the Convention recognizes that sovereign nations have the autonomy to enact protective measures to conserve their biodiversity.242 It further provides that nations can protect both the indigenous knowledge of their people and the biological resources within their borders.243 Finally, in contrast to TRIPS, the Biodiversity Convention recognizes that knowledge deserving of intellectual property protection can be held by communities, not just private individuals.244 As India has argued to the WTO, [*PG100]the TRIPS Agreement should be reviewed with an eye to recognizing these points of the Biodiversity Convention.245

First, the WTO should review TRIPS’ failure to require that biotechnology patent applications disclose the geographical source of the biological resources and the indigenous knowledge used in the inventive process.246 Presently, TRIPS requires only that the inventor disclose his invention such that a person skilled in the art could utilize it.247 In this way, TRIPS’ disclosure requirements are similar to the patent laws of developed countries, which were, for the most part, written with an eye to mechanical and chemical patents.248 TRIPS should be amended to recognize that biotechnological inventions require additional disclosure requirements.249 By including in article 29 a requirement that biotechnological patent applicants disclose the biological source and the indigenous knowledge utilized in the invention, the WTO would take a step toward reconciling TRIPS with the goals of the Biodiversity Convention.250 Such a disclosure to the public would give countries the opportunity to review patent applications and file any claims before the patent is granted.251

Second, the TRIPS Agreement should be amended to recognize that biological resources and indigenous knowledge are often inseparable.252 To this end, TRIPS should oblige inventors to share the benefits derived from inventions with the communities from whence the biological resources and indigenous knowledge came.253 This could be accomplished through the use of Material Transfer Agreements where the inventor is using biological resources from a developing country and a Transfer of Information Agreement where the invention is based on indigenous knowledge.254 Thus, recognition of both biological resources gathered and indigenous knowledge used would allow for compensation of the holders of such resources and knowledge.255

[*PG101] Finally, the WTO should amend TRIPS such that it would recognize the intellectual property rights of both individuals and communities.256 To this end, the WTO should evaluate implementing a system wherein traditional knowledge and contemporary innovations of indigenous communities could be protected under a system of intellectual property rights.257 The ability to patent such knowledge and innovation would provide a concrete means by which to achieve the benefit-sharing objective of the Biodiversity Convention.258 However, under current patent regimes, recognizing an indigenous community’s right to patent its cultural knowledge would prove difficult as most patent systems only award patents to individuals.259 One alternative to patenting traditional knowledge would be a system of geographical indications for products derived from traditional knowledge.260

TRIPS currently allows protection of geographic indications which it defines as “indications which identify a good as originating in the territory of a [WTO] Member, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin.”261 Geographical indications differ from patents in that their main purpose is not to reward innovation.262 Rather, they reward good will and reputation cultivated over many years by a group of producers.263 In addition, geographic indications are particularly well-suited to protecting traditional knowledge because they are communally based, as opposed to patents which reward individual effort and innovation.264 Geographic indicators are based upon collective traditions and decision-making and they protect and reward traditions while allowing for evolution.265

[*PG102] As TRIPS now reads, it does not extend either patent or geographic indication protection to the traditional knowledge of indigenous groups.266 Amending TRIPS to allow for such protection of common intellectual property could preserve the integrity of indigenous cultural knowledge, thereby allowing the survival of indigenous communities.267 Such an amendment would therefore bring TRIPS closer to being reconciled with the goals of the Biodiversity Convention.268

Conclusion

Shortly after the PTO issued its decision to overturn Loren Miller’s patent on ayahuasca, Mr. Miller declined to say whether he would appeal the PTO decision.269 He did, however, express that he could not comprehend what all of the fuss was about.270 He stated, “If this patent was causing any harm to the indigenous people I would have canceled it myself.”271 Miller went on to say, “I don’t care about the patent. It’s worthless. It’s useless, it’s just sitting in a drawer.”272 In his failure to comprehend the viewpoint of the indigenous tribes regarding ayahuasca, Miller personifies the U.S. perspective toward intellectual property rights in biological resources.

First, like most U.S. courts, Miller fails to recognize the moral harm in creating a property right in a sacred plant.273 Although courts have historically construed the Patent Act’s utility requirement to enjoin the issuance of patents that offend morality, the PTO and modern courts have largely failed to bar issuance of such patents.274 However, a few recent decisions in the biotechnology field have signaled a possible end to judicial reticence in this area.275 These indications, coupled with international legislation that recognizes morality exceptions to patent rights, has opened the door to a revival of the moral utility doctrine, which could provide a powerful argument for the [*PG103]barring of biological patents that are morally offensive to indigenous communities in developing countries.276 The United States should resolve to consider morality when determining whether a patent application passes the utility requirement.

Second, Miller’s disregard for the value of indigenous use and knowledge of ayahuasca reflects the U.S. Patent Act’s exclusion of prior foreign use as prior art.277 The U.S. patent system rewards exclusive property rights to individuals who create new, non-obvious and useful inventions.278 The Patent Act does not recognize foreign, indigenous use as prior art, nor does it recognize collective intellectual property rights in the form of indigenous communities’ traditional knowledge of local biological resources.279 Thus, the United States’ narrow definition of intellectual property rights not only precludes indigenous communities from reaping a share of the benefits of their traditional knowledge, but it encourages the appropriation of this knowledge by rewarding individuals who isolate useful chemical compounds from plants used by indigenous people.280 The United States should recognize the collective traditional knowledge and use of indigenous communities as prior art.281 Such an amendment to the Patent Act could improve U.S. relations with developing countries, encouraging them to allow researchers more open access to their biodiversity.282

Finally, through the TRIPS Agreement, the United States is ensuring that its intellectual property regime will become the universal norm.283 Over 130 countries have already signed TRIPS, thus promising to enact patent systems or sui generis systems that meet its requirements regarding the protection of individual property interests in plant resources.284 Like U.S. patent law, TRIPS only recognizes individual patent rights.285

[*PG104] As scholar, Vandana Shiva argues, the globalization of Western intellectual property rights will inevitably diminish the world’s biodiversity because Western intellectual property regimes place no value on the communal knowledge of indigenous societies.286 Shiva points out that it is the lifestyle of these indigenous groups that has sustained and nurtured their countries’ biodiversity.287 TRIPS-compliant patent laws will lead to the monopolization of the world’s biological resources and knowledge, shutting out the indigenous communities who sustain that biodiversity.288

Only by recognizing indigenous rights in their communal knowledge and biological resources will TRIPS ensure that the world’s biodiversity is sustained. To this end, the United States should work to reconcile TRIPS with the Biodiversity Convention, which recognizes communal property rights.289 The ayahuasca patent controversy well illustrates the diverging views of developed and developing countries regarding patents on biological products. Although, standing alone, Miller’s patent may seem harmless, it brought out fierce emotion from the indigenous people who felt that their very culture was being stolen.290 Such a reaction is not unique to the ayahuasca case, as evidenced by the reaction of indigenous communities to their countries’ compliance with TRIPS.291 The United States needs to change its domestic and international patent policies in order to address the claims of indigenous people to their biodiversity and traditional knowledge.

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