PATENT APPLICATIONS INVOLVING BIOLOGICAL RESOURCES FILED IN INDIA

The National Biodiversity Authority grants permissions to patent Applicants using Indian Biological resource in their inventions for obtaining Intellectual Property Rights. There are several patent applications filed in this category and are pending before the Indian Patent Office.

The National Biodiversity Authority has recently clarified that all such patent applications which are pending but were filed before 1st July 2004 i.e. when the Biological Diversity Act and Rules came into force, would be exempted from taking permission from the National Biodiversity Authority.

The Indian patent office can therefore now clear all the back log for those biological resource involving applications which were filed before aforementioned date and have been awaiting grant but have been withheld only for the sake of pending permission from the National Biodiversity Authority. More clarification with respect to the applications filed after 1st July 2004 is still awaited for speedy grants and permissions.

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NATIONAL BIODIVERSITY ACT: ISSUES AND RECOMMENDATIONS

An IP stakeholders meeting was held on 14th December 2016 at Udyog Bhawan, New Delhi.  Upon the request by the government, Anand and Anand made a short note with regard to the NBA related patent issues along with the recommendations. The note is being reproduced below for purpose of dissemination of information and awareness of issues in relation to NBA.

1. DELAY/90 DAYS WINDOW CRITICAL- COLLABORATION OF NBA AND PATENT OFFICE

LEGAL POSITION

Under Section 6 of the Biodiversity Act,2002 the NBA is required to dispose of an application for permission to apply and be granted an IP right within a period of 90 days from the date of receipt.

ISSUE

The NBA is taking close to 6 to 7 years to grant approval/ permission under Section 6 of the Bio Diversity Act, 2002.

RECOMMENDATION

  • Creation of IP cells: IP cells can be created within NBA, after discussion with the Ministry of Environment and Forest for scrutinizing and disposing of applications for permission under Section 6 of the BD Act.
  • Milestones with timelines can be put in place after due consultation with the NBA for the IP Cell to dispose of requests under Section 6 of the BD Act. The following timeline is recommended:

ADHERENCE TO 90 DAYS TIMELINE CRTICAL FOR AT LEAST THE FOLLOWING REASONS:

  • Section 6 prohibits anyone from making an application for patent outside India without NBA approval.
  • All Paris convention application/PCT applications are time sensitive and, therefore, filing of foreign applications/PCT application cannot be withheld indefinitely.
  • The first proviso to Section 6 states the following:

“Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned”

Therefore if an applicant makes an application outside of India, the grant/rejection of his patent by a foreign patent office is not in their control and the applicant cannot be punished for delays with the approval authorities in India.

Proposed time for quick disposal of applications:

0 –DAY: Date of receipt of application

30th DAY: Issuance of formal objections

45th DAY: Terms of Agreement for Seeking IPR

60th DAY: Hearing

90th DAY: Disposal of Application

2. BD/PATENT LINKAGE

LEGAL POSITION

Under the Indian Patents Act, there is no concept of BD/Patent linkage.

ISSUES

Currently, the Indian patent office has not been granting and withholding the grant of patents solely based on the approval not having been obtained from NBA.

RECOMMENDATIONS

  • There is no provision under the Indian Patents Act for withholding the grant for patent subject to NBA approval.
  • Given the limited term of the patent, a patent should be granted if the applicant is able to produce his application for approval made under Section 6. In the event, the NBA approval is declined, the patent holder will not be able to commercialize his patent without penal consequences under the BD Act
  • There is already inbuilt mechanism within the Bio Diversity Act wherein a patent holder by merely seeking and obtaining a patent will not be able to commercialize his research/ invention till such time the patent holder has necessary approvals from the NBA.
  • This is akin to inventions in the field of pharmaceutical. While the applicant might be granted a patent under the Indian Patents Act, it does not give the applicant the right to commercialize the pharmaceutical drug till such time
  • Access; protection of IP rights and commercialization of IP are three different aspects and all cannot be clubbed together for seeking the registration of an invention by the patent office.
  • Therefore, noncompliance of Section 6 is an offence under the BD Act and not under the Indian Patents Act

3.SINGLE WINDOW CLEARANCE 

As of now there are at least three authorities with which an applicant for patent has to deal with:

  1. PATENT OFFICE for seeking registration of patent under the aegis of Ministry of Industry and Commerce;
  2. NBA permission for applying for IP under the aegis of Ministry of Environment And Forest, and
  3. DEPOSITORY INSTITUTES, for e.g NBPGR under the Ministry of Agriculture and Farmers Welfare

RECOMMENDATIONS

A single platform/ window clearance should be created at the macro level wherein of the three ministries streamline procedural issues solely for IP, so that the approval process become hassle free.

4. THE EXAMINATION OF PATENT APPLICATIONS RELATING TO VALUE ADDED PRODUCT/NTC (NORMALLY TRADED AS COMMODITIES)

ISSUE

  • Normally in a first examination report, the Controllers are unable to distinguish as whether the invention uses biological resource/value added product/NTC.
  • Section 6 of the BD Act applies only to biological resource and not to value added product or NTC.
  • Under Section 2(p) of the BD Act, value added products are exempt.
  • Section 40 of the BD Act also clearly states that the Central Government may by notification declare that the provisions of BD Act do not apply to any item including biological resources normally traded as commodity.
  • The Controllers while by way of abundant caution may raise an objection with regard to Section 6 of the BD Act, they need to waive of such an objection and proceed to grant a patent if the applicant gives a declaration or a statement to the effect that the invention does not use biological resources as defined under the BD Act but is for a value added product or NTC as defined under Section 40 of the BD Act.