By SARITHA RAI
Published: August 25, 2001
A Texas company's attempt to patent a type of basmati rice became a touchstone for anti-globalization protest in the 1990's. But the long-simmering issue was largely settled this week, when the United States granted a narrower patent to the company, Ricetec of Alvin, Tex.
The United States originally granted the patent in 1997, touching a nerve in India, leading to a challenge by the Indian government and igniting demonstrations against what was termed a piracy of emerging nations' indigenous products.
After this week's decision, the Indian government said it saw no reason for further dispute. The new patent is limited to a few variants of the rice and will not hamper export of its own basmati product, the government concluded.
Still, scientists in India are complaining about future problems while evaluating the impact, and opposition politicians are agitating for further action.
The protests in the late 1990's were led by Vandana Shiva, who called Ricetec's claim to basmati rice absurd. She termed the limited scope of the final patent largely a success. But, she warned, ''the battle against Ricetec is just the beginning of India's battle against bio-piracy and theft of indigenous plant wealth.''
For most Indians, the basmati controversy went beyond the economic impact of one product. Basmati, an aromatic rice used in virtually every Indian kitchen, is considered a national heritage. The long-grain rice, whose grains remain petal-soft and separate after cooking, grows in the Punjab region in the north, and across the border in Pakistan.
In 1997, the United States initially granted a broad basmati patent to Ricetec, which developed several strains of rice marketed under various names as similar to basmati. Of the 20 claims made by the company, most related to the rice plant, with others covering the grain and farming methods.
The American decision created an uproar as bitter Indians expressed frustration that successive governments had let India lose claim to basmati, which had never been trademarked. India and its rival Pakistan said they would fight the patent, calling it a threat to the economic survival of thousands of farmers in the subcontinent. More than 50,000 people demonstrated in front of the United Sates Embassy against the patent.
At the World Trade Organization conference in Seattle, India protested the agreement on trade-related intellectual property rights, which had led to a spate of patents for western companies, including for basmati rice. Another coalition denounced the basmati rice patent at the Seattle meeting, and called on W.T.O. members to accept that the rights of farmers and communities precede intellectual property rights.
At the Summit of the Americas in Quebec, activists protested against the prospect of intellectual property protection that would work to the advantage of multinationals involved in genetic engineering of agricultural products -- like basmati developed over hundreds of years -- at the expense of small farmers in developing countries.
For years, India largely ignored any claim or legal protection for growers and marketers of basmati. A bill has been introduced to recognize produce as belonging to a specific geographical area, but it is still pending before a panel of the Parliament. Given that basmati is not patented by geographic location even within India, the country's international patent appeal appears weak.
For over two decades ''basmati'' has been used in the United States to describe long-grain aromatic rice grown domestically. This usage went unchallenged by India, so much so that the patent claims were under the plea of ''long usage'' provided for in trade-related intellectual property rights.
The premium grain stacked up in American supermarkets under brand names like Calmati, which comes from California, and Texmati and Kasmati, which are marketed by Ricetec.
Indian basmati exporters dismiss these varieties as basmati imitations. The distinct aroma and the texture of basmati comes from the Indian soil irrigated by waters from the Himalayan rivers, they say.
India urged the United States Patent and Trade Office in April 2000 to re-examine certain Ricetec claims that India felt posed a threat to Indian basmati exports to the United States. In hundreds of pages of scientific evidence, India argued that its basmati varieties already had the characteristics claimed as unique by Ricetec.
India protested Ricetec's claim to the term basmati, and insisted that the appellation should be reserved for rice grown in a specific region in India. The argument is much like the one that has been used successfully to limit Champagne to France and Scotch whiskey to Scotland.
Ricetec subsequently withdrew some 15 claims. The American patent office just issued a patent on the claims dealing with three strains of the rice developed by the company.
While the government said it was satisfied, opposition politicians stalled proceedings in the Indian Parliament demanding that the government challenge the patent.
On Tuesday, the commerce minister, Digvijay Singh, tried to pacify members of Parliament, saying Ricetec had received only a varietal patent so it could sell its rice as a superior strain of basmati. India could also develop its own different strains of basmati, he said.
Ms. Shiva, the protester, saw the narrowing of the patent as a significant accomplishment. ''What remains is a farmers' battle, because Ricetec's strains have been bred from traditional Indian and Pakistani basmati varieties,'' she said. Activists will continue to urge the government to pursue a trademark battle for the basmati name.
But scientists, including Dr. S. A. Siddiq of the Indian Council of Agricultural Research, remain skeptical about India's ability to thwart piracy of traditional basmati strains. ''India exports a million tons of basmati a year, and India is complacent because the Ricetec patent does not hinder that,'' Dr. Siddiq said.
The issue goes beyond mere protection of trade and export of the rice. ''The basmati patent came so suddenly that India has just woken up to the threat to its traditional plant wealth,'' Dr. Siddiq said. ''We have to get our laws in place.''
Ms. Shiva says that allowing multinational companies to patent indigenous produce and knowledge is a theft and has resulted in the revoking of a European patent for the traditional Indian neem tree. Patent fights are on for medicinal turmeric and tamarind.
''Granting exclusive patent rights amounts to stealing economic options of daily survival from the developing world,'' Ms. Shiva said.
The Mayacoba Bean is a case of biopiracy, where Larry Procter, a Colorado executive in the bean industry cultivated yellow beans he bought in Mexico on vacation for which he received a US patent two years later on all yellow beans of this variety. Larry’s company, Pod-Ners, admits that its Enola bean, (named after Larry Proctor’s wife), is a descendant of the traditional Mexican bean from the Andes, the Mayacoba, but that it has a better yellow color and a more consistent shape. By obtaining a patent and a U.S. Plant Variety Protection Certificate, he secured what amounted to a legal monopoly over yellow beans sold in the United States. Under the terms of the patent, he can therefore sue anyone in the United States who sells or grows a bean that he considered to be his particular shade of yellow. Procter also profits from yellow beans imported from Mexico by imposing on them a six cent-per-pound royalty. As a result, both farmers in the United States and particularly in Northern Mexico have suffered great economic hardship. The case has stimulated great debate over whether traditional knowledge and/or genetic resources should be patentable in the first place. As the number of patents filed by large corporations for native crops increases, activists become more concerned about the adverse effects of these patents on developing countries and particularly indigenous people.
THE SBMATE PATENT:
AMERICAN INGENUITY OR LOOTING OF A TANZANIAN RESOURCE?
April 10, 2011
Today’s pirates don’t come with eye patches and daggers clenched in their teeth, but with sharp suits and claiming intellectual property rights. So those rich countries which take seeds away from their poorer neighbors and then try to patent them are guilty of theftplain and simple: biopirates by another name.
National and international regulation of all areas of bioscience must strike a
balance between promoting innovation and addressing public concerns.
– British BioIndustry Association
I. THE SBMATE CONTROVERSY
Issued on September 1, 2009, the U.S. Patent for the sorghum aluminum tolerance
gene, SbMATE, is assigned to the United States of America and the Brazilian
Agricultural Research Corporation.3 This patent is notable because it has enormous
commercial potential,4 yet its ownership and scope are controversial. In fact, critics believe that the SbMATE patent is a “biopiracy” patent, in which biological material from a developing country was used to develop a patent without creating any ownership rights for the developing country.5 It is argued that the SbMATE gene comes from a Tanzanian farmers’ variety of sorghum and, furthermore, that the SbMATE patent will harm Tanzanians.6 At the very least, the SbMATE patent story demonstrates the complexity of both patentable subject matter and biopiracy determinations.
B. The Importance of the SbMATE Gene and the SbMATE Patent
The SbMATE gene used in the SbMATE patent was developed from sorghum, which is a type of domesticated grass.8 Sorghum is important in agriculture, and is considered the fifth most important cereal crop grown in the world,9 as certain varieties
of sorghum are used to make food products and food items.10 Sorghum is also a notably hardy crop, as it may be grown with limited water and generally without the application of fertilizer or other food inputs. Because of these features, sorghum is generally grown in harsh environments where other crops grow or yield poorly.
Sorghum is particularly important to the developing world in Asia and Africa
because it is an vital food staple that, along with millet, is “the principle source of energy, protein, vitamins and minerals for millions of the poorest people . . .” In fact, sorghum is referred to as a “course grain” or a “poor people’s crop” because it is consumed mostly by disadvantaged groups.
The demand for sorghum is not as high as it might be because removing the pericarp, or hull, requires a lot of manual labor. Furthermore, sorghum flour “may have taste, texture, and consistency characteristics that are less appealing than those of maize or wheat flours.” Because of such problems, sorghum is not usually traded on international markets.
The SbMATE gene that is found in some varieties of sorghum is particularly desirable because it enables plants to grow in aluminum-rich soil, which is normally toxic to crops.18 As noted in the patent for SbMATE, aluminum toxicity “is a primary limitation for crop production in developing countries,” and “reduces food security in parts of the world where it is most tenuous.” Crops such as wheat, rice, and maize are unable to grow in aluminum-rich soil because aluminum in such soil takes a chemical form that is toxic to them. This toxicity both “stunts the growth of crop plant roots and inhibits the uptake of key minerals.” In contrast, the SbMATE gene allows crops to neutralize the toxic effects of aluminum at their root tips, so that crops with the gene can grow normally.
The inventors of the SbMATE patent also believe that the SbMATE gene can help prevent phosphorus deficiency, which limits crop production in such soils and is
associated with acidic soils.23 It is believed that a transporter like SbMATE “can
facilitate the efflux of citric acid from roots [and may] significantly increase the ability of crop plants to acquire [phosphate] from acid soils . . . ."
The U.S. patent application for SbMATE was filed on May 17, 2007, and was assigned to both the United States of America, as represented by the Secretary of Agriculture, and the Brazilian Agricultural Research Corporation. The inventors of the patent were listed as government researchers from the U.S. Department of Agriculture, the Brazilian Agricultural Research Foundation (Embrapa), and Texas A&M
University. The Patent Cooperation Treaty (PCT) application for the SbMATE patent
was filed almost a year later on May 9, 2008, and the applicants listed on it were similar to those listed on the U.S. patent, although the PCT Application also included The Texas A & M University System for all countries except the U.S.
National phase processing for the PCT application was requested for Australia and the European Patent Office. Tanzania was not mentioned anywhere in either the U.S. patent or the PCT application.
The inventors of the U.S. patent stated that “the single locus …identified as
controlling aluminum tolerance … [was] developed from two highly [aluminum] tolerant
sorghum cultivars.” These cultivars are listed as SC283 and a recombinant inbred
population created from SC283.32 When the patent inventors described the research done with these cultivars, they cited to findings in a 2004 research paper by some of the patent’s listed inventors.
The authors of this research paper worked for institutions such as the U.S.
Department of Agriculture, Cornell University, Texas A & M University, and the
Brazilian Agricultural Research Foundation (Embrapa). The research paper stated that
the authors used two Al tolerant sorghum inbred lines, SC283 and SC566-14.35 The
paper further stated that the SC283 line was collected in Tanzania, while the SC566 line was collected in Nigeria. The SC283 Tanzanian sorghum line mentioned in the paper is a relatively common Tanzanian farmers’ variety of sorghum that is also known internationally as either IS7173 or Msumbji.
C. Expectations for the SbMATE Patent
Among other claims, the SbMATE patent claims isolated and recombinant DNA sequences, a transgenic seed and plant, and a method of producing the genetically
transformed plant.38 Both the U.S. patent and the PCT application state that “SbMATE
can work across species to enhance tolerance to [aluminum] in other important crops
grown in localities worldwide.”
More specifically, it is stated in the patent that the SbMATE patent technology
can be used to create genetically modified versions of crops such as maize, wheat, and rice, so that these crops may also grow in aluminum rich and acidic soils. As the inventors of the SbMATE patent noted, aluminum toxicity is “the primary limitation for crop production in developing countries, including 38% of the farmland in Southeast Asia, 31% in Latin America, and 20% of the arable lands in East Asia and Sub-Saharan Africa.” Because of this potential to increase crop growth in so many areas, there has been commercial interest in licensing the SbMATE patent. For example, both Dow Chemical and Oji Paper, Japan’s second largest paper products producer, have sought to license SbMATE.
While the SbMATE gene has enormous commercial potential,43 widespread commercial use is years away. In the meantime, there is a lingering concern that such
biological patents will “threaten the ability of developing countries to build their own industries, and feed and treat their people.” Opponents of patents like SbMATE argue that developing countries must pay a high price for patented products that are reintroduced into their countries while simultaneously being unable to use “intellectual property framework to protect against the piracy of their own indigenous and local resources and knowledge.”
Defenders of Tanzania’s rights to the SbMATE gene are upset that, while the SC283 line of sorghum was used to isolate the SbMATE gene, no rights to the gene or related patents were conferred to Tanzania. The SC283 variety of sorghum is not the
only aluminum tolerant variety of sorghum; there are aluminum tolerant sorghums from
other areas of Africa as well, such as the Nigerian SC566-14 line mentioned in the
research paper. Some critics further argue that genes from sorghum varieties
originating from Ethiopia, Sudan, and Uganda are also “encompassed” by the U.S.
patent. Still, the possible “theft” of Tanzania’s rights to the SbMATE is written about the most.
II. GENERAL PROBLEM OF DEVELOPED COUNTRIES & COMPANIES PATENTING “INVENTIONS” INDIGENOUS TO DEVELOPING COUNTRIES
A. Historical Perspective
The term “biopiracy” is somewhat ambiguous. The term is most often used today
to describe “when multinational corporations profit from the medicinal and agricultural uses of plants known to indigenous or native societies and fail to compensate those communities,” but the term can also apply when more developed nations or societies are the “pirates,” or when profiting occurs from new uses of non-indigenous plants.
Currently, biopiracy is most likely to occur when “knowledge is patented by ‘expatriate scientists and resident inventors with access to industrial country patent offices,’” although biopiracy can occur in many other ways as well.
The World Intellectual Property Organization (WIPO) considers biopiracy to be both a trade abuse and a threat to biodiversity. There is a concern that taking a country’s indigenous plants without its permission undermines its statehood, as “the
undoubted powers of states to regulate access to and the use of plant life forms within their domains has always remained an inherent aspect of statehood.”56 The number of “takings” involved underscores the seriousness of the problem. For example, one study found that by 1996 the base compound in most of the top 150 plant-derived pharmaceuticals corresponded with traditional medical knowledge. 57
Furthermore, there is a very real concern that biopiracy “delegitimizes the profound intellectual input of local farmers onto the improvement of plants.”58
Accusations of “biopiracy patents” are not new.59 The following examples of natural rubber, rosy periwinkle, and the Enola Bean Patent demonstrate how the term biopiracy is applied to different types of situations and has evolved throughout history. 60
These are only a few examples of the larger cultural clash that can result over the
exploitation of non-indigenous plant material. At its core, biopiracy “encapsulates a strong moral and ethical dimension, which is entrenched on the demise of cultural
linkages between communities and their assets, from which communities have contributed in nurturing and sustaining their assets.”
Authors often use the story of natural rubber as a famous example of possible
biopiracy, although the alleged taking does not include the taking of traditional
knowledge. 62 In the mid–1800s natural rubber was produced primarily from wild trees in the Amazon basin.63 During the Industrial Revolution, the value of this raw rubber grew as demand for it in Europe and North America rapidly increased.64 By 1876, Brazil controlled ninety-five percent of the global trade,65 and its Amazon River cities became “the centers of an extremely lucrative, near-global monopoly.” 66
To overcome the Brazilian monopoly, the British Royal Botanical Gardens sent a
botanist to collect Amazon seeds.67 The botanist collected over 70,000 rubber tree
seeds,68 which were used to establish rubber plantations in the British colony of Ceylon and other plantations in South East Asia.69 These British plantations “broke” the Brazilian monopoly on natural rubber,70 which eventually collapsed.71
This rubber “piracy” is still remembered in some parts of Brazil today.72
The story of rosy periwinkle (Catharanthus roseus) is another example of alleged
biopiracy. The plant is found in Madagascar, and is the source of the two powerful
cancer fighting drugs vincristine and vinblastine.73 Both drugs were isolated, tested, and marketed by Eli Lilly beginning in the 1950s and, eventually, vincristine generated substantial profits for the company. 74 Madagascar did not profit from the development or sale of either of the drugs, while many authors have argued it should have.75
However, there is another perspective on the rosy periwinkle biopiracy story.
Despite concerns about the improper treatment of Madagascar, it is not clear if rosy
periwinkle is native to Madagascar or just first described there.76 Furthermore, while rosy periwinkle may have originated in Madagascar, it was naturalized in other parts of the world long before Eli Lilly studied it, and the first specimens used by Eli Lilly actually came from India.77 Today the rosy periwinkle is truly an international plant, as it is cultivated on all six continents and is integrated into folk healing traditions in countries as diverse as England, Vietnam, and Dominica.78
Also, while “indigenous and peasant communities strongly suggested bioactivity,”
the flower’s use as the source of a cancer drug was previously unknown and was
expensive for Eli Lilly to discover.79 Therefore, while numerous authors once argued
that Madagascar was unfairly denied revenues from Eli Lilly’s drugs, the rosy periwinkle story is now considered, “a weak case for those who argue that the pharmaceutical industry has reaped great profits by exploiting the ethnobotanical knowledge of particular nations . . . .”80
The Enola Bean Patent
A more recent example of possible biopiracy is the Enola bean. The alleged
“theft” of an indigenous resource began when an American executive, Larry Proctor,
traveled to Mexico and brought back a bag of yellow colored beans.81 In April of 1999, after two years of a selective breeding program using the beans, Proctor obtained a patent on the resulting beans.82 Proctor stated that these patented beans had a distinctively yellow color that held true across generations, and he named them Enola beans after his wife.83 While it was admitted that the Enola bean is a descendent from the traditional Mexican bean Mayacoba,84 it was argued that the Enola bean is unique.85
In Mexico, farmers have grown yellow colored beans since the Aztecs, and
agronomists registered the Mayacoba bean as a variety of the yellow bean in 1978.86
By the time of the Enola patent, Mexican farmers were exporting yellow beans, including Mayacoba, to the U.S., and annual sales in the U.S. were reported at about $50 million dollars.87
After the Enola bean patent was issued, Proctor monitored imports of Mexican
yellow beans.88 He believed that Mexican farmers were possibly infringing on the Enola patent by selling yellow beans to companies in the United States, and he stated that Mexican farmers were likely raising Enola beans and selling them as Mayacoba.89 At the request of his company, U.S. Customs officials stopped bean shipments from Mexico to search for any beans with the same color as Enola beans.90
Proctor also monitored U.S. sales of yellow beans. He filed suit against sixteen
small U.S. bean seed companies that sold Mexican yellow beans for infringing on the
Enola patent, also accusing them of illegally growing and selling Enola beans.91
Furthermore, he charged licensing fees of up to six cents a pound for the right to sell yellow beans in the United States.92 All of these actions had a large effect on the Mexican yellow bean industry.93 After the Enola bean patent was issued, Mexican export sales of yellow beans dropped over ninety percent, which had a severe economic impact on farmers in northern Mexico.94
The Enola bean patent was most controversial because a number of organizations
believed that the patent was improvidently granted.95 These organizations maintained
that despite its consistent yellow coloration, the Enola bean failed to meet the basic patent requirement of novelty over Mexican yellow beans and, therefore, the Enola bean was unpatentable.96
Less than a year after the Enola bean patent was issued, the Colombia-based
International Center for Tropical Agriculture (CIAT), with support from the Food and
Agriculture Association, filed a request for reexamination of the Enola bean patent.97
CIAT claimed it that maintained “some 260 bean samples with yellow seeds, and six
accessions [that were] ‘substantially identical’ to claims made in Proctor’s patent.”98
After several years of re-examinations, the U.S. Patent and Trademark Association
revoked the Enola Patent in April of 2008.99 Despite the ultimate invalidation of the Enola bean patent, opponents of the patent believe that the invalidation took too long to occur, and allowed “the owner of a flagrantly unjust patent to legally monopolize markets and destroy competition for close to half the 20-year patent term.”100 This inability of the U.S. patent system to quickly invalidate an improvidently granted patent is often cited as a failure of the U.S. patent system, and a concern for future “biopiracy patents.”101
Perhaps because the Enola bean patent is so often cited as a “biopiracy,” a few authors have wrote adamant defenses of the Enola bean patent while its validity was being determined.102
B. Acquiring a U.S. Patent
Patent law in the United States is grounded in the United States Constitution,
which gives Congress the power “to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their
respecting Writings and Discoveries.”103
A patent grant gives the owner the right to exclude others “from making, using,
offering to sell, or selling the invention within the United States, or importing the invention into the United States.”104 In other words, the United States provides the inventor the right to exclude others from the invention for a limited period of time, so that the inventor has an economic incentive to disclose her invention; furthermore, in exchange for a patent, the inventor provides the public with the knowledge of how to create the invention in her patent application.105
Section 101 of the Patent Act defines patentable subject matter as:
Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefore, subject to the
conditions and requirements of this title. 106
The Supreme Court has determined that the wide language of this section means
that “Congress plainly contemplated that the patent laws be given wide scope.” 107
While the patent laws do give “a wide scope” as to what is patentable, there are limits, and the court has provided three specific exceptions.108 Laws of nature, physical phenomena, and abstract ideas are not patentable.109 The Court has noted that while these exceptions are not clearly stated in the text, “these exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years.”110
Determinations of patentability can be subtle and sometimes appear contradictory.
For instance, while discoveries that are “only some of the handiwork of nature” have
been held not patentable,111 a bacterium was held patentable because it had
“markedly different characteristics from any found in nature” and had “the potential for significant utility.”112 Even if a discovery meets the requirements of § 101 of the Patent Act, in order for it “to receive patent protection, [it] must be novel, § 102, nonobvious, § 103, and fully and particularly described,
§ 112.”113 These requirements are thought to “serve a critical role in adjusting the tension . . . between stimulating innovation by protecting inventors and impeding progress by granting patents when not justified by statutory design.” 114
Still, the United States’ patent law has been criticized for impeding progress by
not sufficiently recognizing already existing traditional knowledge known in other
countries. United States patent law explicitly prohibits the patenting of an invention when another inventor has already “patented or described [the invention] in a printed publication in this or a foreign country,” however, United States patent laws only prohibit the patenting of an “invention known or used by others in this country.”115 Therefore, United States patent law does not explicitly prohibit the patenting of an invention known or used by others in a foreign country and, subsequently, has been criticized for not recognizing other countries’ traditional knowledge that has not been published.116 Still, the United States has policy reasons for using this language.117 However, this omission of non-recorded knowledge of inventions known in other countries is different from what most other countries require.118 Additionally, arguments that controversial patents are
valid because previous knowledge of the invention in a foreign country was not published incite further criticism of United States patent law.119
As outlined below, United States patents for genes, plants, and seeds are also
controversial,120 but U.S. patent law has developed in such a way that all three are
currently patentable in at least some form. However, as outlined below, there have been challenges to the future patentability of genes, plants, and seeds, and such challenges have implications for future controversies that are similar to the SbMATE controversy.
U.S. Plant Patents
The United States Plant Patent Act of 1930121 introduced a type of patent
specifically for plants known as a “plant patent.”122 These patents protect developers of new varieties of asexual propagated plants,123 such as apple trees and rose bushes.124
Because plant patents can only be issued for asexually-propagated plants, they are limited in scope. Furthermore, the patent rights derived from such patents are limited to “plants that are asexually reproduced from the patentee’s plants . . . [so that] independent creation is a valid defense.”125 Allowing independent creation as a valid defense against patent infringement is an unusual limitation on the rights of the patent holder, as most patent holders can pursue infringement actions against anyone who uses the patented invention, even if the alleged infringer created the invention independently.
In 1970, the United States Plant Variety Protection Act126 (“PVPA”) established
plant variety protection certificates issued by the United States Department of
Agriculture.127 These certificates give developers of new varieties of seed-propagated plants patent-like rights, although they cannot be granted for first generation hybrid plants.128 The certificates confer to a breeder the right to prevent others from selling, reproducing, importing, or exporting a plant, and the right to stop others from producing a hybrid or different variety of the plant.129 They provide protection for slightly longer than a patent; plant variety protection certificates provide protection for twenty years from the date of issuance, instead of the standard patent protection term of twenty years from the date of filing.130 The certificates are limited in scope because there is an
exception from infringement liability for experimentation using a protected variety.131
Also, farmers may legally save seeds from protected varieties and use these seeds in the production of crops without infringement.132
In 1985 in Ex parte Hibberd,133 the Board of Patent Appeals and Interferences
held that a variety of maize was patentable, despite initial rejections that the subject matter was beyond the scope of 35 U.S.C. § 101 and ought to be protected under the Plant Patent Act or the Plant Variety Protection Act.134 Since this case was decided, it has been cited for the proposition that utility patents can be issued on plants, in spite of other intellectual property protections available to inventors of such plants by the Plant Patent Act and the Plant Variety Protection Act.135
Subsequently, in 2001, in J.E.M. Ag Supply v. Pioneer Hi-Bred International,136
the Supreme Court affirmed the patentability of sexually reproducing hybrid plants, even if they are not genetically modified.137 In J.E.M, the Supreme Court also held that breeders had the right to obtain “dual protection” for new breeds of plants under both the PVPA and the Patent Act.138
These cases are significant. They increased the methods of protection available
for some types of plants, and gave some inventors a range of options not generally
available to patent holders. While most inventions can only be protected by a single
patent, transgenic plant holders can chose to apply for multiple patents or to not use any patents.
Generally, inventors prefer to protect transgenic plants with utility patents
because “the utility patent can apply to the method used to engineer a plant, the genetic sequences that are inserted, and the plant that results.”139 In contrast, plant patents protect “only a single plant or genome”140 and do not provide protection against independently created plants.141 Also, while plant patents and plant variety protection certificates can prevent only the unlawful proliferation of a variety and cannot prevent the use of plant materials for breeding purposes, utility patents can both prevent seed increases by reproduction of the same variety and protect breeders from unauthorized use of protected plant varieties for breeding and research.142 The same plant may be protected by both a utility patent and a plant patent,143 and a plant variety protection certificate.144
U.S. Gene Patents
Patents on genes are not generally allowed until a DNA product has been isolated
and purified.145 Patents on such isolated and purified products prevent others from
“mak[ing], us[ing], offer[ing] to sell, or sell[ing] [patented genes] within the United States, or import[ing] [patented genes] into the United States.”146
Biotechnology companies argue that genes, plants and seeds should be patentable so that companies will have enough confidence to invest the time and money necessary to develop such products.147
Still, a recent district court ruling held patents for isolated DNA containing breast cancer susceptibility genes invalid.148 This district court noted that “[i]n light of DNA’s unique qualities as a physical embodiment of information, none of the structural differences . . . between native . . . DNA and the isolated . . . DNA claimed in the patentsin-suit render the claimed DNA ‘markedly different,’”149 and that “the time may come when the use of DNA for molecular and diagnostic purposes may not require purification.”150 The district court further noted that “Supreme Court precedent has established that products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product.”151
This decision has led to questions about other patents on human genes, which has
led to doubt about a larger number of U.S. patents, as over 40,000 patents on 2,000
human genes are said to exist.152 The language of the decision also questions the
patentability of other types of genes, as much of the logic regarding the patentability of human genes applies to the patentability of genes in general.153
The district court’s decision has been criticized for relying on older cases and
failing to cite relevant Federal Circuit cases.154 However, the decision may be indicative of a new trend. Soon after the decision, the Department of Justice submitted a friend-of-the-court brief that contradicted the long-standing stance of the PTO and stated that genes should not be eligible for patents because they are a product of nature.155
Ultimately, the patentability of genes remains a controversial subject.156 Despite
its brief, the government suggested that changing gene patent laws “would have limited impact on the biotechnology industry because man-made manipulations of DNA, like methods to create genetically modified crops . . . could still be patented.”157
C. International Patent Law
International patent law has been significantly influenced by the U.S. Supreme
Court decision in Diamond v. Chakrabarty,158 which held that a live, human-made microorganism is patentable subject matter.159 International gene and plant patenting has also been affected by international trade and patent harmonization agreements, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the General Agreement on Trade and Tariffs (GATT), and the North American Free Trade Agreement (NAFTA).160 In both the developed and developing countries that signed these agreements, “genes . . . are considered patentable material if they meet general patent criteria and are demonstrated to be new creations (e.g., artificial genes) or are isolated from nature and identified . . . and shown to have a particular function and use.”161
While TRIPS does not require plant patents, it specifically requires the protection
of plant varieties “either by patents or by an effective sui generis system or by any combination thereof.”162 The term “sui generis” is not well defined and its meaning is debated.163 It is generally thought that it “enables member countries to design their own system of protection for plant varieties” if they do not issue plant patents; however, it is not clear what is sufficient to qualify as a “sui generis system.”164
The TRIPS agreement also did not define “invention.” The United Nations has
noted that this exclusion allows WTO “member countries relatively free to draw the line between patentable ‘discoveries’ and actual inventions in the patent field,”165 thereby preserving some autonomy for WTO member countries as they implement their patent laws.
Still, many WTO member countries have changed their patent laws to conform to
the TRIPS agreement because, as member countries, they are bound to adhere to
TRIPS.166 For example, prior to joining TRIPS, the Indian patent system followed the
1970 Indian Patent Act, which prevented patent claims for “substances intended for use, or capable as being used as food or medicine or drug.”167 This patent exception was broad and the Indian Patent Act defined food as “any article of nourishment.”168
However, the India patent system changed after India joined WIPO and had to comply
with the TRIPS agreement. Patents are now granted for seeds, plants, micro-organisms, cells and even [genetically modified] organisms and animals.”169 Similarly, it is argued that prior to Australia, Canada, and Ireland joining WIPO, attempts by agribusiness to introduce legislation similar to TRIPS were rebuffed in all three countries.170
In fact, Australian patent laws have changed to such an extent that, like the U.S,
Australia now allows inventors to patent individual plant varieties.171 While plant
varieties are not patentable in many European countries, a plant characterized by a
particularly gene, instead of by its genome, is patentable in most of Europe.172
Furthermore, in much of Europe, transgenic plants are patentable only if they are not restricted to a specific plant variety but represent a broader plant grouping.173 In the past, developing countries have responded with attempts “to restrict and even prohibit the patenting of plants.”174
The issuance of intellectual property rights over genetic material in native species
has been defended for two reasons. It has been argued that:
[i]n addition to more fairly distributing the gains from recombinant genetic
products based on those species, it . . . also gives[s] developing countries
an incentive to protect rainforests and other genetically rich areas . . . the
granting of property rights over a resource can be expected to lead to more
efficient use of a resource.175
In 1993, the landmark Convention for Biological Diversity (CBD) Treaty went into force, which attempted to address global biodiversity conservation.176 The CBD
Treaty is dedicated to the objectives of conservation of biological diversity, sustainable use of the components of biological diversity, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.177 This third objective acknowledges the concerns of developing countries, and the CBD Treaty “recognizes the sovereign rights of states to determine through national legislation the conditions for access to the biological resources in their territories.”178
Recently, developing countries have attempted to alter the TRIPS patent requirements in order to address biopiracy concerns, although these attempts are unlikely to be successful.179 One recently proposed amendment suggested a requirement that patent applications that “use or are based upon genetic resources or traditional knowledge disclose the source, as well as the country of source.”180
Another proposed amendment to TRIPS would require that patent applications “must include evidence of prior informed consent of any materials used from another country and satisfaction of the [Convention of Biological Diversity] mandate that access to genetic resources be subject to prior informed consent . . . .”181
Neither of these amendments is likely to be successful for many reasons, including the fact that amendments to TRIPS require broad consensus among WTO members, and that such proposals have little support among Western countries.182
Developing countries have attempted more local reform as well. Against a movement toward broader international intellectual property regimes, developing countries have implemented national systems to regulate use of their own indigenous plants and knowledge. For example, in 1999 the Indian government created an online database of documented traditional knowledge in response to concerns that traditional knowledge was being “misappropriated in the form of patents on non-original innovations.”183 The government specifically cites concerns about patents on inventions that use Indian plants such as basmati rice, hoodia, and kava, and the government’s desire to prevent such “bio-prospecting” patents in the future.184 It is hoped the database will break “the format and language barrier and mak[e traditional knowledge] accessible to patent examiners at International Patent Offices for the purpose of carrying out search and examination.”185
SbMATE and the African Perspective
In spite of the ongoing controversy regarding the patentability of genes and
plants, at least some of the claims in the SbMATE patent are likely to remain valid even if gene patents and general plant patents are held invalid. The SbMATE patent claims include not only isolated and recombinant DNA sequences and a transgenic seed and plant, but also a method of producing the genetically transformed plant.186 Such transgenic organisms and methods for their production are unlikely to be invalidated as unpatentable subject matter.187
The continued patentability of transgenic organisms and methods of their production is discouraging to many Africans. Africans are concerned that biopiracy is costing Africa a lot of benefits.188 There is a general sentiment that “the existing system
of intellectual property rights and patents does not accommodate non-western systems of knowledge ownership and access.”189 There is also a concern that the system treats “knowledge as a commodity owned by an individual or company with the goal of trade.”
Furthermore, there is concern among “scholars, activists, and indigenous peoples  that the patent system has not been sensitive to the dignity, rights and worldviews of indigenous and traditional people.”190
Western intellectual property protections have been criticized because developing
countries must pay a high price for patented products that are reintroduced into their countries while simultaneously being unable to use the “intellectual property framework to protect against the piracy of their own indigenous and local resources and knowledge.”191 Patents are accused of reflecting “the arrogance of Western
civilization.”192 Another complaint is that the “creativity, ingenuity and invention which an efficient patent system should nurture and encourage is being undermined by patents that are creating patent thickets so dense that they are adding costs to medical and scientific research and, in some instances, hindering it all together.”193
In 2000, in response to such concerns and in accordance with the CBD Treaty, the
African Union formally endorsed legislation that sought to protect biological resources “including agricultural genetic resources by requiring, among other things, that ‘any access to any biological resources . . . shall be subject to application’ and refused to recognize any patent for life forms of biological processes.”194 This legislation, known as the Law on the Rights of Local Communities, Farmers, Breeders and Access, attempts to “provide a framework for the recognition of the innovative and creative efforts of African societies.” 195
The law still exists as a model law, although it has not been formally adopted.196
This type of model law is unlikely to be adopted in African countries, such as Tanzania, because they are members of the World Trade Organization197 and, therefore, must adhere to minimum intellectual property standards under TRIPS.198
Still, there is an ongoing concern that patents that claim living organisms and
genes, such as the SbMATE patent, are patents for discoveries of nature, and as such
should not be patentable.199 It is argued that the TRIPS requirement of a minimum,
uniformly applicable intellectual property standard, “is a reflection of the trends in economic globalization, which promotes a private profit oriented approach within an economic and proprietary framework” that will result in “dire consequences for countries in the South.”200 Additionally, critics argue that the TRIPS requirement “of patenting of life forms and biodiversity will erode the sovereign power of  Third World [countries]”, such as Tanzania, “to their resources and will generate ethical problems to the patenting of life.” 201
III. THE “INTERNATIONAL SEED TREATY”
The International Treaty on Plant Genetic Resources for Food and Agriculture
(ITPGRFA),202 popularly known as the International Seed Treaty, and hereinafter
referred to as such, went into force in June of 2004.203 Its aims include:
[R]ecognizing the enormous contributions of farmers to the diversity of
crops that feed the world; establishing a global system to provide farmers, plant breeders and scientists with access to plant genetic materials; [and]
ensuring that recipients share benefits they derive from the use of these
genetic materials with the countries where they have been originated.204
The International Seed Treaty was fostered by the Food and Agricultural
Organization (FAO) of the United Nations, and the Treaty remains under its control.205
The FAO encouraged the Treaty because of “unease about intellectual property regimes
that reward formal breeders while ignoring the contributions . . . of farmers to the
development and conservation of the very plant genetic sources on which breeders
depend.”206 The FAO maintains that genetic resources have a lot of value and that in the last thirty years more than three-quarters of increased crop productivity is the result of breeding.207
The Treaty provides “a strong and elaborate shape to the concept of farmers’ rights.” Furthermore, the Treaty is consistent with the theory that “the ownership
approach is simply contrary to communities’ traditional ways of life, which promote the common ownership of their [traditional knowledge] associated with their seeds . . . .”208
The Treaty sets up a Multilateral System from which resources can be obtained
for use and conservation in research, breeding, and training.209 If a commercial product is developed using resources from the multilateral system and may not be used without restriction by others for further research and breeding, the Treaty provides for payment of an equitable share of the resulting monetary benefits.210
If a product is developed that others may use without restriction, payment is considered voluntary.211
Much of the Treaty is about the germoplasm collection of Consultative Group on
International Agricultural Research (CGIAR)’s Future Harvest Centers. This
germoplasm collection is thought to contain about 560,000 accessions of crop diversity and is considered invaluable because it contains diverse farmers’ landraces212 and local varieties, and they are held in trust for the international community.213 The treaty calls upon International Agricultural Research Centers (IARCs) of CGIAR to “sign agreements with the Governing Body with regard to such  collections.”214 A large amount of this material and other regional collections are placed into the International Network.215
Sorghum is included under the list of Food Crops covered by the treaty.216 It is
listed as a food crop that falls under the Multilateral System, which “include[s] all plant genetic resources for food and agriculture . . . that are under the management and control of the Contracting Parties and in the public domain.”217 The Treaty further states that “Contracting Parties also agree to encourage natural and legal persons within their jurisdiction who hold plant genetic resources for food and agriculture listed in [the Treaty] to include such plant genetic resources . . . in the Multilateral System.218
The International Seed Treaty came into effect on June 29, 2004, and there are
now 127 parties to the Treaty.219 Of the countries involved in the SbMATE controversy, Brazil was the first to sign the Treaty on June 10, 2002 and further ratified it on May 22, 2006.220 The United States of America was second to sign on November 1, 2002.221
Tanzania did not accede to the International Seed Treaty until April 30, 2004.222
The International Seed Treaty has been criticized because it does not clarify what
enforcement procedures will be used to ensure that farmers’ rights will be respected223 or even how benefits from the commercial use of the genetic materials will be shared.224
The treaty itself advocates arbitration between contracting parties for the settlement of disputes.225
IV. ANALYSIS TO DETERMINE IF THE UNITED STATES DID VIOLATE THE INTERNATIONAL SEED TREATY
Defenders of Tanzania’s right to the SbMATE patent contend that the patent and
attempts to license the patent contradict the goals of the treaty.226 Indeed one of the aims of the treaty is stated to be “ensuring that recipients share benefits they derive from the use of these genetic materials with the countries where they have been originated.”227
However, as has been noted by other authors, it is difficult to claim that the
SbMATE patent directly violated the International Seed Treaty. The SC283 sorghum
strain used in the invention of the SbMATE patent is available at a center, the
International Crop Research Institute for the Semi-Arid Tropics (ICRISAT), under the
label of Msumbiji or SB117.228 This center supplies germoplasm under agreement with
the FAO’s International Seed Treaty,229 so any material acquired through the center
would be subject to the International Seed Treaty’s rules. Therefore, if the researchers who invented the SbMATE patent innovation had used SC283 sorghum from the center, they would have broken the Treaty’s requirement that “recipients share benefits they derive from the use of these genetic materials with the countries where they have been originated.”230 The SbMATE patent would also have violated Article 12.3.d that “recipients shall not claim any intellectual property or other rights that limit the facilitated access to the plant genetic resources for food and agriculture, or their genetic parts or components . . . .”231
However, the ICRISAT center is unlikely to have been the source of the material
used to obtain the SbMATE patent. Instead, Texas A & M is thought to have held
samples of SC283 long before the International Seed Treaty was ratified, and there is no evidence that the Texas A & M sorghum line came from any Center subject to the
International Seed Treaty.232 Hence statements that “governments . . . ignore [the
International Seed Treaty] provisions, pillag[e] the coffers of CGIAR and sell them to Dow Chemical and other wealthy country concerns” 233 are inaccurate and misleading exaggerations.
While the International Seed Treaty predates both the U.S. patent and the PCT
application, neither falls under the authority of the International Seed Treaty, for neither encompasses material covered by the Treaty. However, it is worth noting that while the SbMATE patent and the PCT application may not directly violate the Treaty, they do appear to create the type of problem that the International Seed Treaty was designed to address.
As earlier noted, the FAO encouraged the Treaty because of “unease about
intellectual property regimes that reward formal breeders while ignoring the contributions. . . of farmers to the development and conservation of the very plant genetic sources on which breeders depend.”234 While statements such as, “permitting the SbMATE patent to stand and for the private sector to profit from it, would signal a new open hunting season on privatization of the vast collection of farmers’ varieties of food crops held by the CGIAR” are inaccurate, they do demonstrate how farmers in developing countries feel misled and unprotected by the Treaty.
There is a sentiment that “the genius of African farms is locked up in the vaults of
the CGIAR,”235 and that while the International Seed Treaty may not protect the plants used by Tanzanian farmers from being used to make the SbMATE patent, it should. At its center, biopiracy “encapsulates a strong moral and ethical dimension, which is entrenched on the demise of cultural linkages between communities and their assets, from which communities have contributed in nurturing and sustaining their assets.”236
Therefore, even if the SbMATE patent is proven not to violate the International Seed
Treaty, concerns about the SbMATE patent are likely to continue.
Ethical concerns about patents, as well as concerns about the threat of patents to
biodiversity,237 are likely to continue in spite of the International Seed Treaty. Similar to the plant lines used in the SbMATE patent, any plant lines that have already been acquired will not be covered under the International Seed Treaty.238 Therefore, it is likely that there are other germoplasms that are listed among the 560,000 accessions of crop diversity available in CGIAR239 that were also acquired outside of the CGIAR regime and may be patented despite the International Seed Treaty.
In spite of these problems, the International Seed Treaty has been credited with
“providing access to, as well as the conservation and sustainable use of, plant genetic resources on the one hand and the fair and equitable sharing of benefits derived from their use on the other.” 240 Presumably the Treaty will become more important over time, as plants subject to the Treaty are used to develop further innovations in agriculture and medicine.
In the meantime, there are other proposed improvements to intellectual property
systems intended to provide additional protection for developing countries’ genetic
resources.241 For example, there are suggestions for developing more sui generis systems of intellectual property, which are thought to be a more “fair” way to protect genetic sequence rights.242 Another proposed improvement is having more developing countries adopt the Indian Traditional Knowledge Digital Library model, which lists online the known uses of indigenous plants by developing countries, to prevent the issuance of new patents for previously known uses of plants.243
In addition to the protection provided by proposed improvements to intellectual
property laws, it is hoped that over time intellectual property systems in both developing and developed countries will become more advanced so that they provide better and more clear protection of genetic resources in general.244 It is also hoped that intellectual property systems will be more effective at protecting developing countries’ rights, after there is an increased understanding in developing countries of how intellectual property systems work and more people are taught how to use such systems to their advantage.245
B. Lessons Learned
As the historical examples of “biopiracy” have shown, determinations of biopiracy are not easy, and intellectual property systems are generally not well suited for
making such determinations. In fact, patent systems in particular are not usually
designed to address problems of “theft” of indigenous resources, and systems that are designed to address such concerns are often distinct from intellectual property systems.
When alleged “biopiracy patents” occur, generally the problem is a failure to create
protections against the taking of indigenous material, the failure to adequately publicize traditional knowledge,247 or the failure to properly reward cultures for the use of their indigenous material. The problem is usually not that an intellectual property system granted a patent per se. For example, while the United States patent system may be criticized for allowing patents on inventions that are known, but not described in published material in foreign countries, generally in objectionable cases such knowledge is either known in the United States, published somewhere or fails to meet the nonobvious requirement.248 Therefore, most biopiracy analysis should be determined without implicating intellectual property systems, particularly patent systems, and should instead focus primarily on the original “taking” and use of indigenous material.
For example, in the case of the possible biopiracy of Brazilian natural rubber, no
intellectual property rights were involved, let alone patent rights.249 Still, many authors have argued that the rubber was “biopirated.” In the case of the Enola beans, a patent was issued in spite of biopiracy concerns, although it was eventually invalidated250 because the beans were considered obvious; intellectual property law does not reward inventions that are simply “takings.”251 Finally, in the case of the rosy periwinkle the “invention” was not taken directly from an indigenous country and was in fact novel, so the patent should be valid.252 Although the SbMATE patent involves a more obvious “taking” from an indigenous country than the rosy periwinkle did, the “invention” is also treated as a “novel” invention, and as such is considered patentable.
While there are increasingly greater protections for developing countries’ resources, disagreements similar to the SbMATE controversy will continue. Intellectual property law, particularly in the United States, has accepted genetically modified plants as novel and patentable inventions.253 While genetically modified plants may use traits from other plants, patents are granted to incentivize the work and skill that is required to create genetically modified plants and to incentivize the release of information to the public about how to create the genetically modified plant.254 Researchers already have strains of many plants from around the world and will undoubtedly use these plants to create genetically modified plants. Countries such as the United States will continue to
grant patents on these genetically modified plants as long as such patents conform to patent laws.
International intellectual property systems have largely followed the U.S. example
that living organisms are patentable.255 Like all other countries, developing countries are required to adopt WIPO intellectual property protection requirements if they wish to join the WTO.256 For better or worse, this mandate limits how developing countries may approach intellectual property.
While patent laws may change so that patents can no longer be granted for genes
and for some types of plants, patents that cover genetically modified plants, such as the SbMATE patent, are likely to continue. There are undoubtedly critics who believe that plants should never be patentable, critics who believe that intellectual property laws should not incentivize the creation of genetically modified plants, and critics who believe that patents should never be obtained on inventions that use material from a foreign country without the foreign country’s permission. However, most patent laws are created to incentivize broad innovation and are not designed to meet these particular objectives.
Furthermore, the International Seed Treaty was not designed to completely
address any of these concerns. The Treaty was never designed to encompass or address
all past takings, and it is not clear where in history “the biopiracy clock” should start.
Since plants such as the rosy periwinkle now exist throughout the globe,257 tracing their “theft” is impossible. Indeed, it is almost equally impossible to determine when all the strains of plants like SC283 sorghum were taken from their indigenous countries.
Moreover, any intellectual property system that does address these concerns will appear radically different from the system currently in place.
Under current intellectual property law, the SbMATE patent represents American
ingenuity, and not the “looting” of a Tanzanian resource. While the use of the SC283
sorghum line must appear to some Tanzanians much like the theft of the Elgin marbles
from Greece, there is no complete system in place to compensate developing countries
for any use of their indigenous plants in the creation of new patentable inventions. The International Seed Treaty attempts to remedy these problems in the future and reward those farmer cultures that developed useful plants like SC283 sorghum. It does not seek to correct all past “takings.” Therefore, the International Seed Treaty does not address potential problems caused by the SbMATE patent. In addition, for the foreseeable future patents accused of being “biopiracy patents,” such as the SbMATE patent, are likely to remain valid.