Patent protection of traditional knowledge and biological material

In December 2012, the Indian Patent Office (IPO) released guidelines for the processing of patent applications relating to traditional knowledge (TK) and biological material, reaffirming its commitment to protect TK.

Especially targeted are the ayurveda, siddha and unani systems of medicines. The IPO has been under fire for violating law relating to the protection of TK by granting patents for inventions related to TK and without following the due procedure. The recent guidelines have directly linked the Biological Diversity Act, 2002, with the Patents Act, 1970.

India joined the Convention on Biological Diversity (CBD) on February 18, 1994, becoming part of the movement to promote the conservation of biodiversity and the equitable sharing of benefits arising out of the use of genetic resources.

The Indian legislatures made specific provisions in the second amendment to the Indian Patents Act, 1970. Sub-clause (p) was added to Section 3 excluding the grant of a patent for inventions relating to TK.

Section 10 was also amended to make disclosure of the source and geographical origin of the genetic material used in the invention mandatory. Moreover, to protect the genetic material from unauthorised use and also to prevent TK from being patented, new grounds were introduced in Sections 25 and 64 relating to opposition and revocation, respectively.

Further, by way of the third amendment to the act, the application form for grant of patent was revised to make it binding on the applicant to attach the copy of the prior informed consent for the use of genetic material of Indian origin from the authority concerned so as to effectively enforce the obligation of prior informed consent and benefit-sharing envisaged under the CBD.

Despite having specific provisions in the patent statute, there was no strict implementation of them. Most of the applications filed and examined flouted the provisions of disclosing the source and geographical origin of the genetic material used in the invention. Prior permission from the National Biodiversity Authority (NBA) under Section 6 of the Biological Diversity Act, 2002 for the use of the biological resource was not required by the IPO.

In October 2012, the government of India exercised its powers conferred under Section 66 of the act to revoke Avesthagen’s patent IN252093, on the grounds that the patent or the mode in which it is exercised is prejudicial to the state or the public.

The recent guidelines seem to extend the government’s sentiments. They aim to provide strict procedures for the screening, allotment and examination of applications relating to TK so as to ensure that patents are not granted to inventions relating to TK.

Three-tier system

Once an application is filed, it will be identified, screened and classified as TK. Once screening is complete, applications will be assigned the appropriate IPO classification. During the allotment of the applications for examinations, if the screening and/or classification is found to be inappropriate, the group leader will re-screen or re-classify the application on the recommendation of the examiner/controller.

If the application is wrongly screened and classified as TK, the technical head will re-screen or re-classify the application on the recommendation of the group leader.

Specialised teams

The group leader will act as the controller of applications classified as TK. He will be responsible for ensuring that the provisions relating to the protection of TK and/or biological resources have been complied with. The group leader will identify one examiner in his group for dealing with all the applications relating to TK. The guidelines aim at developing specialised teams to deal with applications relating to TK.

Examination

It is now mandatory for the examiners to carry out a thorough search for patentability in the TK Digital Library (TKDL) and/or other databases. If a citation is made from the TKDL, a copy of it in English will be provided along with the examination report.

Assessment of novelty and inventive step

The new guidelines provide guiding principles for the assessment of the novelty and inventive step of inventions relating to TK.

According to the principles, inventions relating to extracts/alkaloids and/or isolation of active ingredients of plants, which are naturally/inherently present in plants, cannot be considered as novel and/or inventive, when the use of such plants is known as part of the teachings of TK.

“IF MULTIPLE INGREDIENTS ARE KNOWN TO HAVE THE SAME THERAPEUTIC ACTIVITY AS PER TRADITIONAL KNOWLEDGE, TAKING OUT ONE SINGLE COMPONENT CANNOT BE CONSIDERED AS INVENTIVE.”

The combination of plants with a known therapeutic effect with one or more plants with the same known therapeutic agents is considered to be an obvious combination. In case of combination products, it will be necessary to show super-additive or synergistic effect among the ingredients.

Discovering the optimum or workable ranges of traditionally-known ingredients by routine experimentation is not inventive. If multiple ingredients are known to have the same therapeutic activity as per TK, taking out one single component cannot be considered as inventive.

If individual ingredients are already known for the treatment of a disease as a part of TK, then a combination product comprising these known ingredients with one or more plants with the same known therapeutic effect would be more effective than each of the medicinal plants when applied separately.

Other relevant provisions

Patentability of inventions relating to TK will also be decided in view of Section 3, particularly:

Disclosure requirement

The applications relating to TK need to clearly and particularly disclose the invention, its operation and use and the method by which it has to be performed along with the best method of performing the invention, as required under Section 10(4) of the act.

It will be mandatory for the applicant to disclose the source and geographical origin of the biological material used in the invention.

Approval from NBA

The applicant is now required to furnish a declaration in the application for the grant of patent (Form 1) stating that the invention as disclosed in the specification uses biological material from India, and the necessary permission from the competent authority.

If the biological material is not from India, the specification will have to be amended and the country of origin of the biological material will have to be incorporated.

Therefore, no patent will be granted without the necessary permission from the NBA in cases where the invention uses biological material from India or the source and/or the origin of the biological material is India.

Impact

The guidelines have been widely criticised by the life sciences industry. The threshold for the assessment of novelty and inventive step has been raised considerably. This will seriously prejudice the filing of patent applications relating to TK and use of biological material. It is often said that TK is dynamic in nature and it evolves with time and technology. Original research fills the gap in TK. Therefore, if the bar of assessment of patentability is raised, it will seriously discourage invention in this area.

Further, obtaining prior approval from NBA is a cumbersome requirement. The guidelines have failed to establish a correlation between the nature of the invention and the source of the biological material.

However, we are yet to see the actual impact of the guidelines on the prosecution of the applications relating to TK and the use of biological material. As of now, the IPO has published a list of about 520 patent applications relating to ayurvedic and herbal-based medicines. This list will be automatically updated in due course.

Archana Shanker is a senior partner and head of patents and designs at Anand and Anand. She can be contacted at: archana@anandandanand.com

Vidisha Garg is a partner at Anand and Anand’s patents department. She can be contacted at: vidisha@anandandanand.com