I. Introduction
Biopiracy is an accusation that has been leveled at multinational pharmaceutical and biotechnology corporations that engage in the practice of traveling to biologically-diverse third-world countries, accumulating traditional or indigenous knowledge about native wildlife, and patenting the "discoveries" as their own. This article will examine the validity of biopiracy claims and how some have reacted to suspicions of unscrupulous business practices.
II. Background
The Patent Act focuses on rewarding innovation in the useful arts to encourage the progress of science. One requirement for patent eligibility is proof that the invention be novel. If an invention was either known or used in this country, or patented or described in a printed publication in the US or a foreign country, then the subject matter of the patent application is considered to be "anticipated" as information already in the public domain, and not a scientific advancement. [1]
But what if the invention is known and used in a foreign nation, but not patented or described in a printed publication? Unlike the EU, the US patent system does not "[consider] evidence of foreign public use in assessing the validity of its patents." [2] This differs from patent practices in most other developed countries, and results in the US not recognizing undocumented traditional knowledge or ancient remedies as "prior art" within the meaning of the Patent Act. The loophole is the foundation for "biopiracy": a derogatory term for companies from the developed world that purport to "claim ownership of, free ride on, or otherwise take unfair advantage of, the genetic resources and traditional knowledge and technologies of developing countries." [3]
III. Pirates
In 1999, US Patent No. 5,900,240 was granted to Cromak Research Inc. in New Jersey for "discovering" the anti-diabetic properties of karela, jamun, and brinjal. [4] However, the useful properties of these compounds were already common knowledge in India and documented in several treatises. [5] The threat of losing more biological and medicinal heritage has prompted a $2 million effort in India to translate a wealth of over 100,000 traditional remedies from ancient texts in Sanskrit, Urdu, Persian, and Arabic into English, Japanese, French, German, and Spanish on a comprehensive database, encompassing almost 4000 years of knowledge. [6] Although a lobbyist from the pharmaceutical industry scoffed at the project as "a solution in search of a problem," the project director revealed that the "need for the database became apparent in 1995, when two Indian-born scientists in Mississippi were granted a US patent on the use of tumeric, a common spice, to heal wounds," a well-known use described in old Sanskrit texts. [7] The American Association for the Advancement of Science (AAAS), an international non-profit organization, has also developed a prior art database, allowing for "traditional knowledge holders who wish to place information in the public domain in order to preempt patenting by others." [8]
The indigenous are indignant because not only are they uncredited for the use of their traditional and sometimes sacred knowledge in the patents without permission, their developing country seldom sees a cent of the millions of dollars worth of profits that a success venture yields. Even when there is some minimal consideration given in exchange, the fairness of contracts drawn up between researchers and developing countries to provide the latter with some royalties is questionable due to the imbalance of bargaining power.
But not only are the rich getting richer, the poor are arguably getting poorer. A patent term can last up to 20 years of unchallenged monopoly. [9] In the case of the Enola Bean, a businessman from Colorado brought back a bag of dry, multicolored beans from a vacation to Mexico and planted several of them for their pleasing yellow shade. [10] After a few generations of cultivation for color consistency, he filed and won US patent 5,894,079 in 1999 for any bean that falls within a range of yellow on the color spectrum. [11] Immediately after his patent was granted, his company sent letters to all importers of Mexican yellow beans insisting on royalties, and filed several lawsuits against bean companies for noncompliance. [12] Although his patent was eventually overturned in 2005, the company had held a 6-year monopoly by virtue of its patent on a bean no genetically different from a yellow bean cultivar developed in Mexico in 1978. [13] The damage was done: US Customs had stopped many shipments at the US border, export sales dropped 90% among importers, thousands of native farmers in Mexico were damaged economically, and a pall fell over the bean industry. [14]
And as in the case of the Enola Bean, many cases on behalf of indigenous people are brought by third parties who may not have the resources of a multinational corporation. Even though the patent was eventually rejected, there is no mechanism in place for its victims to recover their losses. Bringing the US patent system in line with those of other developed nations and the goals of the Convention on Biological Diversity (Rio Treaty) may go a long way to check ruthless business practices and patent abuse. [15]
IV. Patents
The 1980 Supreme Court case Diamond v. Chakrabarty stood for the proposition that an inventor can patent "anything under the sun that is made by man" when the Court upheld a patent on an artificially-created bacterium engineered to mop up oil-spills. [16] In an opinion by Chief Justice Burger, the Court reasoned that the microorganism was not a naturally-occurring phenomenon, but "a product of human ingenuity . . . [and] patentable subject matter" under § 101 of the Patent Act. [17] Examples of patents granted under the broad umbrella of "anything under the sun made by man" include chemical compounds isolated from natural sources, and new plant varieties that exist after generations of extensively cultivating wild species to breed desired characteristics.
One of the biggest misconceptions about biological patents is that they are granted for a naturally-occurring organism itself. In truth, patent law bars ownership of any phenomena already in the public domain such as laws of nature, abstract ideas, or creatures found in the wild. [18] Some practices reviled as biopiracy may actually be research building on an existing base of scientific knowledge, as opposed to merely taking credit for what is already out there. The Rio Treaty (which the US has not yet ratified) extends the sovereignty of nations over their biodiversity as chattel with property rights flowing from ownership [19], but "a single sample of a rare rainforest plant can be transformed . . . into a lucrative drug or plant variety, and the physical means ordinarily used to confine chattels can scarcely stem the outward flow of information and wealth." [20]
The difference may be the thin line between the genetic marker or chemical makeup or breedable traits of a biological specimen that gives it its useful properties, and the "tribal lore" that composes the distilled knowledge developed through years of traditional use. [21] The two are arguably distinct. It's akin to the difference between knowing the folklore of chicken soup being good for a cold, and knowing the exact chemical formula of the active ingredient in chicken soup for the purpose of selling a viable version in pill form. If the subject matter was obtained by honest means, should any new discoveries that are legitimately patentable as scientific innovations truly need to be credited to a vaguer, sometimes unverified body of local knowledge that set the inventor on his journey?
One US scientist doing research in Brazil has been detained on charges of biopiracy that his colleagues have characterized as thinly-veiled xenophobia and stifling of scientific inquiry. [22] Both foreign and Brazilian scientists have suffered severe administrative delays to their work due to the Brazilian government's strict policies as a result of a history of unauthorized takings and the absence of the royalties they feel are owed to them. [23] But money is only part of the equation. The pharmacy industry may be worth billions, but the result is companies engaged in fierce competition to find the next breakthrough cure for AIDS, cancer, and other ailments in a race to the Patents Office. The Patent Act allows a limited monopoly as reward for patent-holders, and the system brings new research into the world for the benefit of a greater number of people.
And the fact is that pharmaceutical companies, in the hopes of getting a big return, spend an average $802 million and 12 years of research and development to bring a new drug to market. [24] Not every endeavor bears fruit, and projects are often discarded along the way. Multinational companies are capable of million-dollar investments and providing availability of treatment to the world.
V. Conclusion
Biopiracy is a harsh term that is too quickly applied in some cases. While abuses of patent law exist and should be subjected to strict measures, it seems unreasonable to insist that legitimate discoveries based on traditional knowledge and subject matter freely given should be encumbered by a grant of royalties based on information in the (limited) public domain. The Rio Treaty has placed the burden on countries to determine how they will exercise their property rights in biodiversity, and they have the option to open their borders to inventor-scientists, negotiate for a better deal with pharmaceutical corporations, or bar them completely. The US Patent Act as written will not recognize foreign use alone as prior art, but future renditions may pull it more in line with the current practices of EU nations.
[1] See 35 U.S.C. § 102(a) (2000).
[2] Jim Chen, There's No Such Thing as Biopiracy . . . And It's a Good Thing Too, 36 McGeorge L. Rev. 1, 32 (2005), available at http://ssrn.com/abstract=781824.
[3] Graham Dutfield, What is Biopiracy?, Queen Mary Intell. Prop. Research Inst. (2004), available at http://www.canmexworkshop.com/documents/papers/I.3.pdf.
[4] Vandana Shiva, The US Patent System Legalizes Theft and Biopiracy, http://www.organicconsumers.org/Patent/uspatsys.cfm (last visited Oct. 19, 2007).
[5] Id.
[6] John Lancaster, India Digitizes Age-Old Wisdom, Washington Post, Jan. 18, 2006, http://www.washingtonpost.com/wp-dyn/content/article/2006/01/07/AR2006010701042_pf.html.
[7] Id.
[8] American Association for the Advancement of Science, Traditional Knowledge Prior Art Database, http://shr.aaas.org/tek/tekpad.htm (last visited Oct. 19, 2007) (describing the Traditional Knowledge Prior Art Database, or T.E.K. *P.A.D).
[9] See generally 35 U.S.C. § 154(a)(2) (2000).
[10] Danielle Goldberg, Jack and the Enola Bean (Dec. 2003), http://www.american.edu/TED/enola-bean.htm
[11] Id.
[12] Id.
[13] Id.; ETC Group, Whatever Happened to the Enola Bean Patent Challenge? (Dec. 2005), available at http://www.etcgroup.org/upload/publication/pdf_file/41.
[14] Goldberg, supra note 10.
[15] The Convention also addressed concerns that biopiracy would have effects on natural selection that harm delicate ecosystems. The arguments for and against the theory are not addressed in this article.
[16] Diamond v. Chakrabarty, 44 U.S. 303 (1980).
[17] Id. at 309.
[18] See generally 35 U.S.C. § 101 (2000).
[19] Sudhir D. Ghatnekar & Mandar S. Ghatnekar, Bio-prospecting or Bio-piracy?, Indian Express, Feb. 8, 1999, http://www.expressindia.com/news/fe/daily/19990208/fec08011.html.
[20] Chen, supra note 2, at 21.
[21] Id.
[22] Larry Rohter, In Brazil, A Conviction on Biopiracy Charges Angers Scientists, Int’l Herald Tribune, Aug. 29, 2007, http://www.iht.com/articles/2007/08/29/healthscience/snbiopiracy.php.
[23] Id.
[24] Pills, Patients, and Profits: In Search of a Cure, http://www.bbc.co.uk/worldservice/specials/1718_pills/page2.shtml (last visited Oct. 19, 2007).