PTO Rejection of the "Ayahuasca" Patent Claim, Backround & Analysis

By Glenn Wiser, November, 1999

1. Introduction

For centuries, shamans of indigenous tribes throughout the Amazon Basin have processed the bark of Banisteriopsis caapi, along with other rainforest plants, to produce a ceremonial drink known as "ayahuasca" or "yagé." The shamans use ayahuasca in religious and healing ceremonies to diagnose and treat illnesses, meet with spirits, and divine the future. According to tradition, ayahuasca—which means "vine of the soul" in the Quechua language—is prepared and administered only under the guidance of a shaman. Indigenous peoples have characterized the ayahuasca vine as a religious and cultural symbol analogous to the Christian cross or Eucharist.

On November 3, 1999, the United States Patent and Trademark Office (PTO) rejected a patent that Loren Miller, an American citizen, had obtained on a purported variety of B. caapi. Part 2 below briefly reviews the original patent.  Part 3 discusses the Request for Reexamination filed by the Center for International Environmental Law (CIEL), the Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA), and the Coalition for Amazonian Peoples and Their Environment (Amazon Coalition).  Part 4 reviews the PTO's Order Granting Request for Reexamination.  Part 5 analyzes the PTO’s Office Action in Reexamination that rejects the claim. Finally, Part 6 discusses the current status of the case and possible next steps.

Although the PTO ultimately rejected the patent on narrow grounds, the case has broader significance. It represents one of the very few times that indigenous peoples from developing countries have successfully challenged a U.S. patent that was based on materials and knowledge acquired from them. The case thus provides a signal to future patent applicants that indigenous peoples are prepared to protect their rights by using the law to strike down improperly granted patents.  It also  demonstrates that indigenous peoples' organizations, scientists, lawyers, and human rights activists from both the developing and developed worlds can work collectively to that end. 

However, because the case was decided on narrow grounds, it also suggests a need for the PTO to take broader action beyond this specific case.  In our view, the PTO should conduct a broader review of its treatment of prior art that exists in the form of traditional and informal knowledge of indigenous and local communities.  The PTO should also reconsider its willingness to grant patents that are inherently offensive to the religious beliefs of such communities and peoples.

2. The Ayahuasca Patent

Loren S. Miller obtained U.S. Plant Patent 5,751 on June 17, 1986. The patent granted Miller rights over a purported variety of the Amazonian vine, Banisteriopsis caapi, also known as ayahuasca. Miller dubbed his variety "Da Vine." The patent was granted on the basis of Miller's claim that Da Vine represented a new and unique variety of B. caapi, which was distinct from other forms primarily because of the color of its flower petals. Miller stated that he had obtained a cutting of the plant from a "domestic garden in the Amazon rain-forest of South America." He added that he was investigating the plant for its medicinal value.

The Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA), an umbrella group representing over 400 indigenous tribes of the region, discovered in 1994 that Miller had obtained his patent. Indigenous peoples were unable to fathom how a plant known and cultivated by them throughout the rainforest since time immemorial for religious and medicinal purposes could have been "discovered" and patented by an outsider. Learning that Miller intended to install a pharmaceutical laboratory in Ecuador to process ayahuasca and other plants, they further feared that a bilateral intellectual property reciprocity agreement on the verge of approval between the United States and Ecuador would force indigenous peoples of the Amazon to recognize Miller's proprietary rights over their sacred plant.

3. The Request for Reexamination

On behalf of COICA and the Amazon Coalition, CIEL filed a Request for Reexamination of U.S. Plant Patent 5,751 (the Request) on March 30, 1999.

The Request presented several arguments as to why Miller's patent failed to satisfy the requirements of the Plant Patent Act and accordingly deserved to be canceled. First, the Request explained that a review of the prior art revealed that Da Vine was neither distinct nor new. The medicinal and morphological characteristics on which the claim was based were well within the normal range of variation for individual plants of the species. Both the species and the characteristics described in the patent were widely known, not only in the scientific literature, but also in the systems of traditional knowledge of indigenous groups throughout the Amazon.

Second, Da Vine, like other forms of the species B. caapi, could not be patented under the explicit terms of the Plant Patent Act because it is "found in an uncultivated state." Finally, the requesters argued that issuance of the patent did not meet the public policy and morality aspects of the Patent Act, which preclude awarding a patent on a plant that is sacred to indigenous peoples throughout the Amazon region and has been used and revered in their cultures for many generations.

4. The PTO’s Order Granting Reexamination

The PTO granted the Reexamination Request on May 28, 1999, agreeing that the Request raised "substantial new questions of patentability." The PTO based its decision on CIEL's arguments that Miller’s plant was similar or identical in physical appearance to other specimens of B. caapi found in U.S. herbarium collections. This was apparently the first time the PTO had considered the question whether the concept of prior art included mounted herbarium specimen sheets.

The narrow decision avoided the question of whether the knowledge and use of a plant by generations of indigenous peoples should constitute prior art under the patent rules. The PTO also declined to consider whether the patent conflicted with public policy and morality aspects of the Patent Act’s utility requirement.

Additionally, the PTO determined that two specimen sheets accessioned by major herbaria more than a year before the Da Vine patent was filed—but after the filing of an earlier application that was subsequently abandoned—were not "bona fide prior art references."  However, the only publication that Miller relied upon to establish the putative difference of his plant was also published after the earlier application date.  This inconsistent treatment could allow patent applicants to "grandfather" the effective cutoff date for prior art by abandoning an application in favor of a new one, and then supporting their new claims by picking favorable prior art while ignoring unfavorable prior art.

5. The Order Rejecting Miller’s Patent Claim

A. Narrow basis for rejection

The PTO rejected Miller’s patent claim in an Office Action dated November 3, 1999.  The rejection was made on the narrowest grounds possible, under the statutory bar of 35 U.S.C. § 102(b).  Section 102(b) prohibits, inter alia, the issuance of a patent when the invention was patented or described in a printed publication more than one year prior to the date of patent application.

The rejection noted that the accessioned specimen sheets from the Field Museum in Chicago (offered as Reexamination Request Exhibits 1 and 2) contain specimens of B. caapi whose major defining feature is flower color indistinguishable from that of Da Vine. These sheets were known and available in the United States more than one year prior to the filing of Miller's patent application. Because Da Vine’s major defining characteristic was its flower color, the PTO concluded that it could see no patentable distinctions between Da Vine and the plants mounted in the specimen sheets. Accordingly, Da Vine failed the § 102(b) statutory bar.

B. Herbarium specimen sheets recognized as "printed publications"

By permitting § 102(b)’s statutory bar to be met by these specimen sheets, the PTO confirmed in its rejection that such sheets qualify as "printed publications" for the purpose of determining a plant's patentability. To the best of our knowledge, this is the first time the PTO has adopted this interpretation of prior art publications. However, the interpretation is a logical extension of earlier decisions that recognized as printed publications single copies of doctoral dissertations cataloged in university libraries, and single copies of grant proposals indexed and publicly available on file with the National Science Foundation.

C. Other exhibits not considered

The PTO declined to consider any references offered by the reexamination requesters beyond those that specifically addressed the physical characteristics Miller had claimed as the basis for Da Vine’s patentability. These references included a monograph by ethnobotanist Richard Schultes that included a scientific description of B. caapi, exhibits describing the phenomenon of plasticity in plants, and a Declaration by Dr. William Anderson of the University of Michigan explaining why Da Vine could not reasonably be differentiated from other forms of B. caapi.

The PTO admitted that these references were not considered during the original prosecution of Miller’s application, and that an examiner would have found them important in deciding whether or not Da Vine was within the previously described range of variability of the species and thus patentably distinct from other forms of B. caapi. However, the PTO concluded that none of the references could defeat or adversely affect Da Vine’s patentability, because it believed that they did not speak directly to whether the defining characteristics claimed for Da Vine were distinct or novel.

D. Narrow scope of protection under the Plant Patent Act

One of the most striking aspects of the rejection is that it is based on an exceedingly narrow interpretation of the scope of protection awarded by a U.S. plant patent. According to the rejection’s text, that protection extends only to "the single germplasm" contained in the patented plant and its asexually reproduced progeny. The Oxford American Dictionary defines "germplasm" as "the nuclear part of a germ cell by which hereditary characteristics are transmitted." The PTO's interpretation thus appears to permit a plant patent holder to enforce her patent only against others who attempt to market or use plants directly descended (by asexual reproduction) from the patented plant. The interpretation does not appear to allow plant patent protection against other plants with similar or even identical physical characteristics (i.e., plants of the same phenotype). Should a plant breeder independently develop or discover a plant variety with a physical appearance identical to a patented variety, the PTO’s interpretation would apparently preclude the patent holder from enforcing her patent against that plant breeder, unless the breeder had asexually developed his variety from the patented stock (so that it shared the same genotype).

Assuming the rejection’s text accurately reflects PTO policy, we can be confident that U.S. plant patents do not enable "bio-prospectors" to obtain any meaningful property rights over a species or naturally occurring variety of rainforest plant. Any awarded patent would likely be unenforceable—even in this country—against users of seemingly identical plants that did not share the same genotype.

E. Loophole for patenting wild plants

In the rejection, the PTO reiterated an interpretation of the law that effectively permits patenting of wild plants, in contravention to the Plant Patent Act. Our Request for Reexamination argued that the Act’s prohibition on patenting plants "found in an uncultivated state" logically extends to each individual member of the population of a variety that is found in both wild and cultivated states. If the statutory preclusion was triggered only when the individual specimen had been found in the wild by the patent applicant, a plant prospector could patent a previously un-described wild plant simply by having a third party dig a specimen up and transplant it to a location where it could be "cultivated." The prospector could then take a cutting of this "cultivated" plant, asexually reproduce it, and obtain a U.S. plant patent.

The PTO apparently believes this scenario satisfies the Plant Patent Act. It accepted at face value Miller’s assertion in his application that Da Vine had been "discovered growing in a domestic garden in the Amazon rain-forest of South America." In the PTO’s opinion, the origins of the plant and the question of whether it was identical to plants growing wild nearby were irrelevant to patentability.

Nevertheless, this scenario probably does not pose a meaningful threat to the rights of indigenous peoples to use or benefit from their living resources or knowledge, given the PTO's narrow interpretation of the scope of protection awarded by a U.S. plant patent, as discussed above.

6.  What Next? The Procedural Posture of the Case

The formal cancellation of the ayahuasca patent will not occur until the PTO issues a final certificate. That cannot happen until the expiration of a two-month period, during which time Miller has the opportunity to respond to the rejection of his claim. In this case, the two-month period will expire on January 3, 2000.

Miller is entitled by right to request that the PTO reconsider its decision. See 37 C.F.R. § 1.111. However, the burden of proof he must meet to win a reconsideration is probably insurmountable. A general allegation of error is insufficient. To prevail, Miller must: 1) distinctly and specifically point out the examiner’s alleged errors; 2) reply to every ground of the rejection of his claim; 3) point out why his claim is patentable over any references applied by the examiner; and 4) appear throughout the proceedings to be making a bona fide attempt to advance the reexamination proceeding to final action. See id.

If Miller fails to make a timely and appropriate response (i.e., one that meets the requirements specified above), then the PTO will issue a final certificate canceling the patent. See id. § 1.550(d), 1.570).

In the unlikely event that Miller subsequently wanted to continue pursuing the issue, he could appeal the final Office action to the Board of Patent Appeals and Interferences. The Board's decision could in turn be appealed to the U.S. Federal Circuit.

For more information, please contact info@ciel.org.

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