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.

Patent Office Issues Notice to Streamline Disposal of Cases Relating to Biological Resources

A recent circular by the Patent Office on issues relating to biological resources and patenting may come as a reprieve for patent applicants using biological materials from India in their inventions.

Section 6(1) of The Biological Diversity Act, 2002 prohibits any person from applying for any intellectual property right in or outside India based on any research conducted on biological material obtained from India without obtaining permission from the National Biodiversity Authority (NBA) before making said application. The proviso to section 6 permits a person to apply for permission from the NBA after filing an application for a patent but before grant.

In view of said provision of The Biological Diversity Act, Controllers at the Patent Office have been raising multiple, many-a-times unwarranted, objections relating to obtaining permission from the NBA w.r.t biological material from India. Delays on the part of the NBA in granting permission stall the grant of a patent. Permissions from the NBA and pending patent grants in view of the same have therefore, long been debated between the Patent Office and the stakeholders representing the patent applicants.

The Controller General of Patents, Designs & Trade Marks, Mr. O.P Gupta has actively taken up this issue and through an official notification, has provided instructions/guidelines to streamline the process relating to patent applications that deal with biological material from India. A synopsis of the notice is as follows:

  1. Controllers and Examiners have been directed to refrain from raising objections on obtaining approval from the NBA with respect to inventions which reside in:
  • value added products and not the biological material
  • bio-wastes which are generated after the economic use of the biological material is exhausted.
  • biological material prepared synthetically
  1. The notice has clarified that approval from the NBA is not needed when the Applicant makes an unequivocal declaration that the biological material used in the invention is neither obtained nor sourced from India.
  1. The notice requires Examiners to mark applications involving the use of biological material as ‘NBA approval application’ in the examination module before sending the examination report to the Controller. If the Controller is not satisfied with the requirement regarding NBA permission he can unmark the application from said category by giving reasons thereto.
  1. Where all objections have been complied except submission of NBA approval, the Controller shall mark the application in the examination module as ‘NBA approval pending, but in order for grant’ and the system administrator will tag such cases so that the applications can be treated as disposed of by the Controller.

 

Access Benefit Sharing

Justice U.C. Dhyani of Uttarakhand High court passed a ruling deciding several writ petitions filed by various paper mill companies against notices issued against them by the Uttarakhand State Biodiversity Board (SBB).

The impugned notices were sent by SBB as it considered that the petitioners failed to provide prior intimation to SBB for obtaining biological resources for certain purposes as per sections 7 and 24 of the Biological Diversity Act, 2002.

Section 7 mandates prior intimation for obtaining biological resources for commercial utilization, bio-survey and bio-utilization for commercial utilization. Section 24 gives the SBB the power to restrict or prohibit any of the above activities should they be found to be detrimental. The Petitioners approached the writ court demanding several reliefs challenging SBB’s demand for information on access for material from other states being unconstitutional. The other pleas taken included:

    1. non- applicability of the Guidelines on Access to Biological Resources and Associated Knowledge and Benefit Sharing Regulations, 2014 to transactions between Indian entities;
    2. interpretation of the term “commercial utilization” as per s.2(f)- Petitioners argued that they belonged to an industry, which would not fall under ‘commercial utilization’ as defined in Section 2(f).;
    3. interpretation of the term “‘biological resource’ – Petitioners argued that waste paper is not a ‘biological resource’ as defined u/s.2(c);
    4. no restrictions/actions can be taken by the Board u/s. 24(1) in the absence of rules being framed u/s 63 and s.2(k) of the Act;
    5. reliance of the Board, in the impugned notices, on the act and guidelines issued by the Central government being unconstitutional.

Findings in the order:-

Preliminary objection on the maintainability of the writ petition u/s. 52A of the Act were raised by the SBB arguing that Section 52A allowed for an appeal to the NGT from an SBB or NBA order, which is where the grievance should have been filed.

Section 52 deals with an appeal to National green tribunal (NGT). Section 52A states that any person aggrieved by any determination of benefit sharing or order of the National Biodiversity Authority or a State Biodiversity Board under this Act, on or after the commencement of the National Green Tribunal Act, 2010, may file an appeal to the National Green Tribunal established under section 3 of the National Green Tribunal Act, 2010, in accordance with the provisions of that Act.

Petitioners counter argued that since no order was passed by the SBB u/s. 24(2) of the Act the matter was not cognizable by the NGT and the writ was maintainable. The Court by agreeing with the Petitioners arguments upheld the maintainability of the writ petitions.

The Court refraining from giving any opinion on the issue of whether ‘waste paper’ would be considered as biological resource or not, has ordered that the Petitioner is under liability and is bound to give desired information of access, which is an admitted position, within the territorial boundary of Uttarakhand to the SBB.

Further, the Court dealt with the issue of liability of petitioners of giving information to the SBB in the absence of any rules and prescribed form. The Court ruled that the Petitioners are bound by section 7 of the Act to give prior intimation of any access of biological recourse even in the absence of any prescribed form. Furthermore dealing with the modality of said information, where the SBB has not made any rules and have not provided forms, the Court held that it should be left to the discretion of the Petitioners to supply desired information in whatever form they like but with due regard to the provisions of the act.

The writ petitions were dismissed with the following directions:

  1. the Petitioners to provide information to Uttarakhand SBB in respect of biological resource obtained from Uttarakhand within four weeks;
  2. that Uttarakhand SBB not to compel the Petitioners to submit information from outside the territorial boundaries of the state; and
  3. no penal action to be prosecuted provided the Petitioners comply with this order.