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Patents, traditional knowledge, and the USPTO
Clearing up some misconceptions in order to stop biopiracy
These days we often hear how knowledge used for centuries by indigenous communities
is being patented by corporations. Pharmaceutical companies are often called
“biopirates,” accused of stealing indigenous traditional knowledge,
and the United States Patent and Trademark Office (USPTO) is often blamed for
not taking measures to better protect this knowledge. According to article 15(1)(c)
of the International Covenant on Economic, Social, and Cultural Rights, everyone
has the right “to benefit from the protection of the moral and material
interests resulting from any scientific, literary or artistic production of
which he [or she] is the author.” This is the most relevant statement in
international human rights law regarding the issue of biopiracy, as it affirms
the right to intellectual property protection. Although the Covenant has not
yet been ratified by the United States, article 15 (1) (c) sets forth the internationally
accepted human rights standard. Based on this standard, the moral and material
interests resulting from indigenous communities’ centuries-old scientific
discoveries are entitled to protection. Understanding how the patent system
works in the United States helps to identify aspects of the patent regime inhibiting
efforts to protect traditional ecological knowledge.
One obstacle in the patent system is the definition of novelty. Novelty is
not defined in U.S. patent law according to the common understanding of the
word. In U.S. patent law, an invention is novel if it was not used, known, or
sold in the United States or previously patented or described in a printed publication
in the United States or a foreign territory one year prior to the date of a
patent application. All the materials under this definition (references to prior
publications, uses, or sales) are referred to as “prior art.” Because
most traditional knowledge originates outside the United States, it must therefore
be described in a printed publication in order to be recognized by the USPTO.
However, traditional knowledge is typically documented culturally through practice
and oral history and not according to USPTO guidelines.
A textbook example is the neem plant. The plant is native to India,
where it has been used for centuries by traditional farmers as a pesticide.
Traditional knowledge holders in India did not document this use because it
was considered common knowledge. Subsequently, various patents have been approved
in the United States for the use of the neem plant as a pesticide. The
patent applications were deemed novel by the USPTO because, despite prior use
by Indian farmers, no printed documentation existed. In contrast, the European
Patent Office accepts oral descriptions as prior art and rejected the neem
patent based on oral testimony from Indian farmers. Even when prior art capable
of disproving novelty exists in the United States, patents based on traditional
knowledge have still been approved. For example, it is widely known and documented
that the maca plant, native to the Andes, has been used by indigenous
communities to increase fertility for livestock reproduction. Maca by
itself was not patented in the United States to increase fertility, but instead
a combination of maca and velvet deer antler was patented. The combination
of these two plants, despite individually documented traditional uses, was not
published in written form; therefore, the USPTO was legally bound to approve
the patent.
Another obstacle in the patenting system is the patent approval process at
the USPTO. According to the U.S. Constitution, patents stimulate scientific
progress, which benefits society by rewarding innovation and discovery. The
job of patent examiners is simply to determine whether innovations and discoveries
meet the criteria for novelty. If so, they issue the patent. But the patent
examiners have a heavy workload. They must examine claims, review supporting
data and analysis, and conduct a thorough prior art search of existing relevant
documentation within a matter of hours. Patent examiners do not purposely overlook
prior art or ignore indigenous traditional knowledge, as commonly alleged by
traditional knowledge holders and their advocates. Examiners perform the most
thorough search they can, given limited resources and time restrictions. The
issue facing the examiners is access to resources that document traditional
knowledge in order to establish prior art. If examiners cannot find written
documentation in the short amount of time available to review the application,
the patent application is approved by default. This guideline for novelty does
not address all the realities of prior art, particularly with respect to traditional
knowledge. It is important to note that the criteria for issuing patents come
from laws passed by the U.S. Congress. They are not in-house USPTO guidelines.
To change the patent system, it is necessary to change the law.
In an effort to improve the ability of the current patent system to recognize
traditional knowledge as prior art, a project of the Science and Human Rights
Program documents traditional knowledge according to USPTO guidelines. The Traditional
Ecological Knowledge Prior Art Database, or TEK*PAD, is available online at
http://ip.aaas.org/tekpad. While the
project addresses one major obstacle to protecting traditional ecological knowledge,
several obstacles remain. Inconsistencies between traditional knowledge, the
definition of novelty in U.S. patent law, the demands placed on patent examiners,
and the lack of legislative interest in changing the law are all issues that
should be addressed in order to make the patent system more sensitive to traditional
practices, better able to reward true novelty, and more consistent with basic
human rights standards.
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