Many developing countries are attempting to promote legislations to protect BD and TK.

The Indian Biodiversity Act, 2002

It focuses on the rights of the state and monopoly IP rights such as patents. The implication is that most property rights will be in the hands of the state and private companies. The Act addresses basic concerns of access to collection and utilization of biological resources and knowledge by foreigners and sharing of benefits arising out of such access. The Act provides for National Biodiversity Authority (NBA) which will grant approvals for access, subject to conditions, that ensure equitable sharing of benefits. The main intent of this legislation is to protect India’s BD and associated knowledge systems against their use by individuals/organizations without sharing the benefits arising out of such use and also to check biopiracy. The legislation provides for a federal management structure with the NBA at the apex and the BD management committees at local community level. These are to consult each other in taking decisions relating to the use of biological resources/related knowledge within their jurisdiction. The NBA under 36(5) and 62 sections of the Biodiversity Act, 2002 has drafted the Biological Diversity Rules, 2009 for the protection, conservation and effective management of TK.

Indian Patent (2nd Amendment) Act, 2002

This amendment to the 1970 Act inserted Section 3(p), according to which “an invention, which is in effect traditional knowledge or which is aggregation or duplication of known properties of traditionally known component or components is not patentable.” This is of significance to medicinal plant related TK as it cannot be patented. This will thus rule out international filing of patents on Indian medicinal plants by a single international application under the Patent Cooperation Treaty (PCT).

In this context it is to be mentioned that the IP rights policy of the Kerala government released in 2008 proposes adoption of the concept of “knowledge commons” and “commons license” for protection of TK. It seeks to put all TK into the realm of “knowledge of commons” distinguishing this from the public domain.

Another amendment of importance is the deletion of subsection (g) from Section 3 – list of non-patentable inventions. Thus, earlier, before the amendment, “a method or process of testing applicable during the process of manufacture for rendering the machine, apparatus or other equipment more efficient or for the improvement or restoration of the existing machine, apparatus or other equipment or for the improvement or control of manufacture” was non-patentable.

Deletion of this section is of significance to the pharma sector in the following ways:

• It broadens the scope of patentability to include the testing methods or processes that are being developed in support of manufacture in the pharmaceutical industry.
• Newer methods of standardization of phytoconstituents and/or herbal formulations including classical and non-classical herbal drugs could be patented.
• Newer herbal drug formulations, if shown to be much more efficacious than the existing ones, could come under this category for patentability.

This amendment thus encourages newer herbal drug development and also novel analytical methods for standardization of classical and non-classical herbal drugs. Such newer methods of standardization shall enable several of our traditional Ayurvedic, Siddha and Unani drugs to be filed as even ethical drugs. With the booming global herbal drug trade, our vast BD and wealth of TK on medicinal herbs has to be rightly and assertively utilized in developing newer ethical herbal drugs.

Section 10 of the 2^nd amendment Act deals with contents of specification of a patent. According to this provision, “the applicant must disclose the source and geographical origin of any biological material deposited in lieu of a description.” Indication of geographic origin shall facilitate verification of prior art on the medicinal plant or biological material. This will serve as a check on biopiracy.

Section 25 of the 2^nd amendment Act deals with opposition to the grant of a patent. This has been amended allowing for opposition to be filed on the ground that “complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention.”