Patent Law

Is protection of TK under the Patent Law possible? First, one must determine whether TK is patentable subject matter, that is, a creation of technical concepts by utilizing the rules of nature. Then, one must determine whether the TK meets the requirements of novelty, inventive step, and industrial applicability.

According to TRIPs, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application (TRIPS Article 27). Those applicable products made from TK or processes of TK should not be excluded from this provision.

Some scientific inventions are not applicable and hence not patentable, such as mathematical equations. TK is not different. Much TK is not associated with physical materials; these inventions may not be patented.

Essentially biological processes for the production of plants and animals of indigenous peoples or farmers may also not be patented.

Novelty is one of the criteria for patentability of an invention. Much TK has been documented and published, and is seen as prior art, which may be used as evidence precluding patentability. On the contrary, TK that remains undisclosed to the outside world does not lose its novelty, even if it has existed for many centuries. Modern inventions of a big company should be considered novel as long as it has not been published before the time of application, notwithstanding that the inventions were invented twenty years ago.

Many inventions can be patented, but only if they can be repeated independently of the participating persons. Modern technologies that are based on the reductionistic approach meet the criteria of repeatability more easily than TK, which is of a holistic nature, since it often requires the same environment in which it was created to achieve the same

functions. Modern inventions that are based on TK are more repeatable because so many factors that form TK have been excluded during the invention process.

The level of repeatability required by the patent protection is somehow lowered after that patent covered biological invention. For example, in the system of plant breeders’ rights, a sui generis patent law, requires the variety to be both uniform and stable. That means that one should be able to reproduce the variety repeatedly. However, while the self-pollinated species require a higher level of uniformity and stability, cross-pollinated species do not.

The level of the inventive step (sometimes called “non-obviousness”) required varies in the patent systems of different countries. Minor improvements of prior patented invention sometimes can obtain patents.

Many new formulas of traditional Chinese medicines have been patented now in China.⁹

Some scholars believe that patent protection of TK is inappropriate, and that people should not obtain patent protection on TK at all. Two methods can prevent the patenting of TK. Firstly exclude TK itself from protection entirely. Secondly include TK as prior technology, ensuring that patent offices compare TK with patent applications during the patent examination. If the country takes the second approach, these countries could require for the applicant for a patent based on TK to submit with the application the authorization of the TK holders.¹⁰ Countries could adopt the “absolute novelty” in the patent examination procedure, and require the inclusion of TK published or disclosed publicly prior to the application as prior technology. Countries should demand a higher inventive step requirement when examining patents related to TK, in order to prevent applications that are simply based on TK from becoming patents. These are all ways that prevent people from copying another’s TK and applying for a patent.¹¹

However, this is not to say that anything related to TK is not patentable. TK-based inventions, which meet the requirements of

9 Chen, K.J. (Editor-in-Chief) 1997 Chinese Patent Medicines. (English Translation) Hunan Science &

Technology Press, 1997.

10 Wen-Yin Chen 1994 The Feasibility Study of Traditional Knowledge Protection Under Patent System, CHENCHI L. J., 78:189-90.

11 Brett, N. 2002 Australia Patent Law Changes. http://ficpi.org/newsletters/50/AUreform.html.

novelty, inventive step, and industrial applicability, are still patentable.

Many countries have enacted legislation requiring TK owners to consent to the TK-related parts, for the TK-based invention to be patentable.

Without the consent of the TK owners, some laws require the patent authorities to reject the application.¹²

For example, in the Andean Community on a Common Industrial Property Regime Decision 486 (Decision 486) Article 26 states that applications for patents shall be filed with the competent national office and shall contain:¹³

a), a copy of the contract for access, if the products or processes for which a patent application is being filed were obtained or developed from genetic resources or byproducts originating in one of the Member Countries;

b), if applicable, a copy of the document that certifies the license or authorization to use the traditional knowledge of indigenous, African American, or local communities in the Member Countries where the products or processes whose protection is being requested was obtained or developed on the basis of the knowledge originating in any one of the Member Countries, pursuant to the provisions of Decision 391 and its effective amendments and regulations;

c), the certificate of deposit of the biological material, if applicable; and, d), a copy of the document attesting to the transfer of the patent right by the inventor to the applicant or assignee.

Thus, anyone (including inventors or pharmaceutical multinational companies) wishing to access those resources must file an application and sign an access contract with the suppliers.

Moreover, the Andean Community on a Common Industrial Property Regime Decision 391 (Decision 391) creates provisions for access contracts:

The State and the applicant requesting the access may enter into access contracts (Decision 391 Article 32).

The terms of the access contract must be in keeping with the

12 supra note 2, p. 76.

13 Ruiz, M. 2002 The Andean Community’s New Industrial Property Regime: Creating Synergies between the CBD and Intellectual Property Rights, BRIDGES, 4(9).

http://www.iprsonline.org/ictsd/docs/RuizBridgesYear4N9NovDec2000.pdf.

provisions of this Decision and Member Country national legislation (Decision 391 Article 33).

The access contract shall bear in mind the rights and interests of the suppliers of genetic resources and their by-products, the biological resources that contain them and the intangible component as applicable, in accordance with the corresponding contracts (Decision 391 Article 34).

When access is requested to genetic resources or their by-products with an intangible component, the access contract shall incorporate, as an integral part of that contract, an annex stipulating the fair and equitable distribution of the profits from use of that component (Decision 391 Article 35).¹⁴

The competent national authority may, either ex officio or at the request of a party, and at any time, declare a patent null and void (Decision 486 Article 75).

In conclusion, countries could use the system under Decision 486 to ensure that t hey fulfill the general principles under the CBD.¹⁵