The Government expects that such initiatives will help bringing in transformation of the Indian Pharmaceutical Industry from brilliant and highly successful ‘imitators’ to world class ‘innovators’ of path breaking medicines. Discovery of such medicines in India is also expected to help the Government significantly, to improve access to affordable innovative modern medicines to the common man of the country. All these are no doubt, very laudable initiatives by the DoP, with a very capable, effective and a ‘can do’ leader at its helm.
The DoP plans to bring in significant changes in the clinical trial facilities available within the country. Currently even very basic clinical trials on ‘dogs’ cannot be undertaken because of protests from the activists related to ‘prevention of cruelty on animals’. Such reform measures, I am sure, will be sincerely welcomed by many.
It is interesting to note that the DoP is also planning to extend Regulatory Data Protection (RDP) to innovators. It has been reported that the invaluable data generated by the innovators towards development of the New Molecular Entity (NME) will, in near future, be protected from ‘piracy’ during 20 year patent life of the product. However, the DoP cautions that attempt to ‘evergreen patent’ through data protection, beyond the patent life of a product will not be permitted.
The argument of the innovators on this issue is that Product Patent and Clinical Data are two different types of intellectual properties and should not be considered as one and the same. While patent protection is extended for discovery of the molecule, data protection is for the immense and expensive clinical data that the innovators share with the Government for regulatory approval of the patented molecule, within the country. The argument that such valuable data generated by the innovators is an intellectual property (IP), lies in the premise that if the innovator would not have been required to part with the data with the regulatory authorities, such data would have been regarded as a ‘trade secret’, which is an IP. Therefore, the innovators argue that for sharing this IP with the Government, specific period of data protection to be extended to them, which should be unrelated to the life of the patent.
Thus far, we see that DoP has taken some very important and admirable initiatives to encourage R&D within the country. However, while looking at another important area of its responsibility i.e. protection of IPR within the Pharmaceutical sector, nothing has been announced by the department, as yet.
Encouraging R&D without effective protection of IPR, points towards an incomplete agenda to effectively address pharmaceutical product innovation related issues by the department. I sincerely hope that the DoP will soon announce its policy initiatives towards IPR protection to further encourage the innovators, both within and outside the country.
The DoP has taken some significant steps to address various important issues of the pharmaceutical industry under its terms of reference, within a very short period. I look forward to knowing from the DoP the detail initiatives in each of its nine functions and responsibilities, as announced in the notification of the cabinet secretariat on July 2, 2008.
By Tapan Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.