BIODIVERSITY MYSTERY THEATRE SPECIAL
Prologue: As the world awaits the resolution of problems created years ago by the granting of patents on living organisms and their pieces and products, questions of access and benefit sharing persist: how to avoid biopiracy and ensure justice for those whose biological materials and traditional knowledge may be part of other people's research aspirations and patent applications.
BIODIVERSITY MYSTERY THEATRE
. . . featuring an international cast of characters
. . . in real-life tales drawn . . . once again . . . from the United States Patent and Trademark Office.
Today, . . . "Biopiracy in Progress?"
In its first season, Biodiversity Mystery Theatre introduced readers to investigator Jay McGown, who, aided by editor Freida Morris and translator Alexandra Curi, tracked down a series of suspicious research projects suggestive of biopiracy and crying for investigation. (1)
Today, several investigations later, McGown returns to his old biopiracy hunting grounds.
SAME OLD, SAME OLD
Mid-November, 2004. Jay McGown is at his computer, rummaging through the website of the U.S. Patent and Trademark Office (USPTO). McGown surfs onto the webpage with information about U.S. patent applications: <http://www.uspto.gov/patft/index.html> .
As he looks at the right-hand side of the webpage, the side labelled "Published Applications", McGown clicks "Quick Search" and finds himself wondering whether anything has really changed in the bioacquisition business over the years. "How long ago was it," he wonders, "that Madagascar got nothing of the 200 million in profits made from its rosy periwinkle?" He is thinking about the plant which produced vincristine and vinblastine, important drugs in the fight against childhood leukemia.
When the "Query" page <http://appft1.uspto.gov/netahtml/PTO/search-bool.html> comes into view, he decides to see how rosy periwinkle is doing these days. Jay enters " vincristine" in the "term 1" box, leaves everything else as it is, and punches "Search".
The search results indicate 4906 patent applications, from 2001-2004, using the word "vincristine".
"4906! Too many to check today, " he says to himself, going back to the "Query" page.
"I wonder if any of them even mentions Madagascar."
Jay enters "Madagascar" in the "term 1" box. As he waits for the results to appear, he remembers a time when it wasn't so easy to do what he is doing now, a time when the USPTO did not publish patent applications. "Back in the old days, we had to wait until a U.S. patent was issued," he recalls. "Today, we can get information about patent applications BEFORE a patent has been issued. That gives us a little traction in the race against biopirates. We can sometimes find the trail before the patent has issued." (2)
The Madagascar search results come up. There are 81 of them. McGown sighs and checks them all.
Hit number 51 proves doubly interesting.
"It wasn't just the rosy periwinkle they took from Madagascar," Jay mutters as he emails Freida Morris the patent application number and three cryptic words . . . "Biopiracy in progress?"
PATENT APPLICATION NUMBER 20030092729 (3)
On the surface, 20030092729 looks like many other patent application. For those concerned about potential biopiracy, (4) the interest begins in paragraphs 0031 and 0032:
"In accordance with an important feature of the present invention, extremely potent novel tropane alkaloid aromatic esters . . . were obtained from a chloroform-soluble extract derived from the roots of Erythroxylum pervillei Baillon (Erythroxylaceae). . . collected in Madagascar. This plant is known locally as "Tsivano" and has several folkloric uses, including as a fish poison, and to treat abdominal pain and tumors. . . Certain species from the plant genus Erythroxylum (family Erythroxylaceae) are used in traditional medicine to treat amenorrhea, hemorrhage, kidney disorders, influenza, sinusitis, upset stomach, and to combat fatigue, the feeling of hunger, and as stimulants. . ."
The patent application mentions a plant collected in Madagascar but does not appear to contain any evidence of permission for the plant's removal and further development. There is no mention of a contract with the country or the people in the region from which the plant. . . or the related traditional knowledge. . . was taken. Nowhere is there any mention of a certificate of origin of the kind that many of the nations of the Global South are clamoring for in the access and benefit sharing discussions of the Convention on Biological Diversity. (5)
Lack of mention, of course, does not necessarily mean that those who submitted 20030092729 did anything wrong. U.S. patent law does not require "inventors" to include in their patent applications copies of certificates of origin or access agreements related to biological materials mentioned in their applications. In the case of 20030092729, there may not have been any access agreement at all. It is not even clear what Madagascar law at the time may have required of those who originally collected the 20030092729 materials.
Paragraph 0066 of the application indicates, "The roots of E. pervillei were collected in a southern semiarid region of Madagascar in October 1992. A voucher specimen (A00362) is deposited in the John G. Searle Herbarium, Field Museum of Natural History, Chicago, Ill."
The plant was collected in 1992, a little after the Convention on Biological Diversity (CBD) was opened for signatures. (6) Not that that matters much. Although the CBD affirms that "States have sovereign rights over their own biological resources," Madagascar did not ratify the CBD treaty until 1996. The U.S. has never ratified the treaty. And whatever the parties to the CBD may someday require of each other in the way of access agreements, it is difficult to see how they can make their requirements apply to non-parties or to biological materials acquired before the CBD came into force . . . materials like the "Erythroxylum pervillei Baillon (Erythroxylaceae)" . . . the material mentioned in U.S. Patent Application Number 20030092729.
BIOPIRACY IN PROGRESS?
So where does that leave the patent application Jay McGown discovered? Were the biological materials it mentioned gained through some violation of law or some ethical indiscretion or were they gained through the best collection practices of the time? Did anyone involved in the acquisition even consider the problems (and profits) related to subsequent uses of the materials? Under what agreements, if any, did the materials come into the hands of those who submitted patent application 2003009279?
In an earlier Biodiversity Mystery Theatre, we warned that:
-- Mention of the name of a person or a project . . .should NOT imply that biopiracy has been committed or is being alleged. Mention. . . should only suggest that further questions MAY be in order. It is always wise to check further.
-- Many of the researchers who seek biological materials may either work for or get grants from institutions and agencies that have ethical protocols about bioprospecting. It is worth investigating whether the institutional ethical requirements are enforced and/or stringent enough to avoid problems of biopiracy. It is always wise to check further.
Unfortunately, 20030092729 begs more questions than it answers about the biological materials described in paragraphs 0031, 0032, and 0066. Only further investigation. . . hopefully carried out by those whose biodiversity was the subject of desire . . . can answer those questions.
(1) Earlier Biodiversity Mystery Theatre scripts can be accessed at <http://www.edmonds-institute.org>.
(2) According to the USPTO website:
"A member of the public cannot obtain direct physical access to any pending published (original) application, but may obtain a copy of the papers in the application file as follows:
"On-line: Patent application publications are available electronically on the USPTO website, at http://www.uspto.gov/patft/index.html. A copy of a patent application publication, a patent application file contents or a particular paper within the file contents of a patent application that was published under 35 U.S.C. 122(b) may be requested electronically at http://ebiz1.uspto.gov/oems25p/index.html with authorization to charge the appropriate fee to a deposit account or credit card.
"By mail: A copy of a patent application publication, a patent application file contents or a particular paper within the file contents of an patent application that was published under 35 U.S.C. 122(b) may be requested by mail. Address correspondence to the United States Patent and Trademark Office, Office of Public Records, PO Box 1450, Alexandria, Virginia 22313-1450. The request must include the application's publication number and payment of the appropriate fee.
"By facsimile: A copy of a patent application publication, a patent application file contents or a particular paper within the file contents of an patent application that was published under 35 U.S.C. 122(b) may be requested by facsimile, with a credit card, electronic fund transfer, or deposit account authorization for the appropriate fee. The FAX number is (703) 305-8759.
"By telephone:A copy of a patent application publication, a patent application file contents or a particular paper within the file contents of an patent application that was published under 35 U.S.C. 122(b) may be placed by telephone, with a credit card, electronic fund transfer, or deposit account authorization for the appropriate fee. The telephone number is (703) 305-8716.
"In person: The file contents of a pending application that was published as a patent application publication will not be given to a member of the public without a power to inspect. If the application is abandoned, the entire application (except in the situation where the publication was a redacted publication) is available to the public for inspection and for making copies through the File Information Unit (FIU). The FIU is located in Crystal Plaza Three, Room 1D01. The telephone number of the FIU is (703)308-2733."
Further, the USPTO website explains, members of the public can obtain Status Information About Published or Patented Applications:
"On- Line: For published and patented applications, status information may easily be obtained using the Patent Application Information Retrieval (PAIR) system. Access the PAIR system through the USPTO Electronic Business Center available at http://www.uspto.gov/ebc/.
"By telephone: Third parties should not call the Office to inquire as to the status of a published application other than to inquire if the application is still pending. To see if the application is still pending, third parties may call the FIU at (703) 308-2733."
Note: callers from outside the U.S. should add the prefix "001" to the phone and fax numbers indicated.
(3) The full patent application for United States Patent Application 20030092729, "Tropane alkaloid multidrug resistance inhibitors from Erythroxylum pervillei and use of the same", was available on the USPTO website as of November 23, 2004. If difficulties are encountered in accessing a copy, contact the Edmonds Institute, <email@example.com>.
(4) As was mentioned in an earlier Biodiversity Mystery Theatre, "Concerns about biopiracy derive from concern for biodiversity itself and concern for the rights of those who own or steward biodiversity and the traditional knowledge related to it. Thus in every case where biodiversity and/or traditional knowledge is being accessed, the biopirate hunter asks whether the researcher (or company employee or ethnobotanist or whoever is the seeker) has discerned who are the owners/stewards of the sought-after biodiversity or knowledge. Has the researcher obtained prior informed consent from those who have the right to give prior informed consent for the access to and use of this material or knowledge? How has the researcher determined that those he is dealing with indeed are the owners/stewards? Is there anyone who would disagree with the researcher's determination of ownership or stewardship? What evidence is there of the rightful owners/stewards' grant of prior informed consent to the research? Is there a contract? Under what circumstances was it signed? Who advised the owners/stewards of their rights under alien intellectual property systems? What benefits will flow back to the stewards/owners? If they said "no" to the research, were their wishes respected? What agreements about subsequent patents and patent royalties have been made? What restrictions have the local peoples/owners/stewards put on the amount, use and development of whatever diversity or knowledge may be extracted or shared? Are there any time restrictions related to access? Is there an up-front payment to the owners/stewards (or their communities) or just a series of small payments should the researcher or subsequent persons create a (later-developed) viable commercial product from the biodiversity ? Who is doing the bookkeeping on the deal, if anyone? Will the owner/stewards be included in the list of authors of any related publications and patents? How will disputes over the arrangement be dealt with? Can the owners/stewards call the deal off and if so, how? . . . These are but a few of the questions to keep in mind when scanning databases with an intention to monitor for biopiracy."
(5) For details about past discussions and current negotiations related to Access and Benefit Sharing, see the CBD webpage <http://www.biodiv.org/programmes/socio-eco/benefit/> .
(6) The Convention on Biological Diversity was opened for signatures at the United Nations Conference on Environment and Development in Rio de Janeiro on June 2, 1992. It entered into force December 29, 1993.
BIODIVERSITY MYSTERY THEATRE is produced by the Edmonds Institute, a public interest, non-profit concerned with issues related to environment and technology. Known for its work on biodiversity, the Institute was incorporated in 1995 and is a 501(c)(3) organization under the rules of the US Internal Revenue Service.
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