The previous section has indicated various approaches that can be followed for the patent protection of TRM, and suggested that countries have, under current international rules, considerable freedom to determine the scope of such patenting. In section IV.C below, the implications of different policy options are discussed in more detail. Little is known as to the extent to which patenting of TRM-related inventions occurs in practice. Such patenting has steadily increased in China, with more than 12.000 patents applied in relation to TCM during 1999-2001 (Yongfeng, 2002).
A recent study by Barsh (2001) presents interesting information on the US record with regard to patents derived from ethnomedicine (see Table 4). Fifty-five such patents were granted during the period 1995-2001,118 most of them originating from “tribal” knowledge, followed by Chinese, Euro-folk and Ayurvedic medicine.
118 During the same period, nearly 50.000 patents were granted for pharmaceuticals in the U.S..
The majority of patents (58 per cent) claim a new therapeutic application or form of delivery of a known active component of a traditional medicinal plant or compound, while in other cases claims apparently cover the already customary use of plants, or an isolated or synthesized form of certain compounds. This suggests that patent claims tend to concentrate on the use of certain compounds, rather than on the latter as such. In any case, and though more detailed analysis would be necessary, these data seem to confirm the expressed concerns regarding the appropriation of TRM knowledge under the patent system.
Other interesting observations provided by Table 4 is that most patents (50 of 55) were obtained by small pharmaceutical companies, small producers of botanicals and herbal supplements, universities, and individual researchers. However, only 7 were granted to applicants from developing countries (5 to individuals or universities and one to a large company in India). Big pharmaceutical and cosmetic companies accounted for nine percent of the identified patents. A majority of the patents of traditional/indigenous origin built upon research in Amazonia (7 of 24), tropical Africa (5 of 24), and Central America (3 of 24). Two originated in Australia and only one in North America. No more than three or four of the 55 patents in Table 4 were based on the applicant’s own field research; the rest had drawn their inspiration from articles by others in academic journals, which they cited.
Table 4
U.S. Patents Derived from Ethnomedicine, 1995-2001
Sources |
|
Tribal |
Chinese |
Ayurvedic |
Euro-folk |
Totals |
Assignee |
Big Pharma |
1 |
- |
1 |
- |
2 |
| |
Big Cosmetic |
3 |
- |
- |
- |
3 |
| |
Smallpharma |
6 |
2 |
3 |
1 |
12 |
| |
Botanical |
2 |
3 |
- |
8 |
13 |
| |
University |
7 |
5 |
- |
1 |
13 |
| |
Individual |
5 |
3 |
3 |
1 |
12 |
Claims |
Customary use |
6 |
2 |
3 |
- |
11 |
| |
Isolation/synthesis |
7 |
4 |
- |
1 |
12 |
| |
Novel use/delivery |
11 |
7 |
4 |
10 |
32 |
Totals |
|
24 |
13 |
7 |
11 |
55 |
Source: Barsh, 2001.
A comparison with data in Table 2 suggests that while academics and institutions from developing countries are active in publishing information about TRM, they are mush less active than their counterparts in developed countries in applying for patents on TRM-related products and uses.
It is also interesting to note that in many cases a large variety of patents were obtained in relation to the same natural product, as illustrated by the one hundred-plus patents relating to the neem tree. Another telling example is provided by patents concerning taxol (taxus brevifolia), which include different product and processes, as well as uses (see Table 5).
Table 5
Patents over taxol in the U.S.
Subject matter |
No. of Patents |
Synthesis/semi-synthesis/preparation/process of production of taxol its derivatives |
106 |
Taxol products-formulations/compounds/derivatives/composition and intermediates |
3 |
Extraction/isolation/purification |
21 |
New uses/methods of treatments/method of administration/doses |
16 |
Structure - activity relationship |
2 |
Other miscellaneous areas including plant patent or patents on agents for drug resistance |
6 |
Source: Karki, 2000, p. 209.
In sum, while much of TRM is not novel, a significant number of patents have been obtained on TRM knowledge and related products, both on TRM that can accurately and not so accurately be described as truly novel in the sense demanded by an appropriate application of novelty standards. Typically, several patents are applied for and obtained around a single commercially promising TRM-based product (including processes and uses). Applicants are generally companies or researchers from developed countries. While a growing number of patents is being acquired by applicants from developing countries, they still lag significantly behind their counterparts in the developed world in their propensity to patent.