BIOLOGICS IN INDIA
“THE NBA ALSO APPEARS TO BE UNEQUIPPED TO HANDLE THE BURDEN THAT IS LIKELY TO ARISE FROM THE INCREASE IN THE NUMBER OF APPLICATIONS.”
Te guidelines have also required the disclosure of source and origin under a separate heading in the specification body—irrespective of whether the biological material was obtained from India or not.
Beyond the statutory provisions
Although the intention of the IPO guidelines is to bridge the gap between the Patents Act and the BDA, in practice it has posed serious challenges in obtaining patent protection. To begin with, the mandatory disclosure of the source and origin of the biological material under a separate heading in the description goes beyond the statutory provisions of the Patents Act.
Te statute requires such disclosure only when the biological material is not sufficiently described in the specification and/or is not available to public. By making this requirement independent of such a clause, and even applying it to cases where the biological material has not been obtained from India, the IPO has tried to establish a link that not only looks beyond the Patents Act, but is likely to impose an undue burden on the applicant.
Te impact of the guidelines can already be
felt in practice, as the requirement is being raised by default in all applications disclosing biological material, regardless of whether such a requirement is applicable.
Another challenge created is obtaining prior approval from the NBA. By itself, it is an extremely cumbersome and time-consuming process, and making it a mandatory prerequisite to the grant of a patent magnifies the challenge, as it is expected to result in inordinate delays in the granting of patents.
Interestingly, in appreciation of the objectives of the CBD, the NBA, while granting the approval,
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is required to impose a benefit-sharing fee and/ or a royalty arising from the commercial use of such patent rights. However, the paradox here is that, unless such patent rights are granted and commercially worked, economic benefits arising from them cannot be predicted.
Terefore, a patent applicant is placed in a ‘Catch 22’ situation, where on the one hand without the prior approval of the NBA a patent application cannot proceed to grant. On the other, without the grant of a patent the benefits arising from its commercial working cannot be declared in order to seek NBA approval.
Adding to the plight of applicants, the NBA also appears to be unequipped to handle the burden that is likely to arise from the increase in the number of applications. Te data published by the NBA reveals the small number of applications that have been approved so far.
Amid the challenges, there is a separate NBA permission required by ‘foreign’ applicants for access to biological material (from India) before they can seek permission to apply for an IP right. Te IPO has failed to design any procedure for such prior permission and has shiſted the entire responsibility concerning this to the NBA.
Te NBA, on the other hand, has chosen to remain silent on the validity of such applications. Tey clearly contradict the very objective of ‘prior approval’ and put a foreign applicant in
a position where it seeks permission for access to biological material aſter, not only has it been accessed, but also used to conceptualise the invention for which patent protection is sought.
Terefore, a foreign patent applicant can find itself in a quandary as, technically, it would be required to go through a formal procedure for seeking permission for access to biological material before gaining NBA permission to apply for IP.
In summary, the linking of patent applications with prior approval from the NBA cuts both ways. While it serves to bridge the gap between the BDA and the Patents Act, it fails to steer itself away from emerging as a stumbling block.
Terefore, there is a need for further deliberation and a multi-faceted approach that not only confines the requirements of a patent application to the patent
statute, but introduces a kind
of ‘NBA approval highway’ that promises the vigorous and speedy grant of approvals.
Ranjna Mehta-Dutt is a partner at Remfry & Sagar. She can be contacted at:
ranjna.dutt@remfry.com
Neha Srivastava is a managing associate at Remfry & Sagar. She can be contacted at:
neha.srivastava@
remfry.com
Ranjna Mehta-Dutt is a partner at Remfry & Sagar. She has practised in the IP field for more than 18 years, with experience in draſting patent specifications and handling patent
applications in
technology fields including chemistry, biotechnology and pharmaceuticals. She also prosecutes design applications and handles patent/design oppositions and litigation.
Neha Srivastava is a managing associate at Remfry & Sagar. A biotechnology specialist, she has more than eight years’ experience in the patent field and has been involved in handling applications covering chemical, pharmaceutical and biotechnological inventions. She is also involved in providing opinions on patentability and general Indian patent law.
Life Sciences Intellectual Property Review Volume 2, Issue 1 37
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