India needs stronger patent ecosystem

The Economic Advisory Council (EAC) to the Prime Minister of India had recommended in June this year that the period within which patent applications are open to challenge by the public be restricted to a mere six months from the date the patent claims are published. The Council also suggested hiring more patent examiners to fast-track the process of granting patents. These suggestions were apparently made by the Council in a presentation to its stakeholders including the Department of Promotion of Industry and Internal Trade and the country's policy think-tank NITI Aayog.

Presently, as per the Patent Act, a patent opposition can be filed by the opposing companies any time before the grant of the patent by the Indian Patent Office (IPO). If implemented, this move will severely cut short the timeframe in which a patent opposition can be filed by the opposing companies or associations. Obviously, the EAC has made this recommendation to the government to address the perennial issues of delays in patent examination.

As per the data released by the IPO, while around 50,000 patent applications are examined annually, nearly 400 pre-grant oppositions (across all categories) are filed each year. That means a mere less than 1 per cent of all patent applications actually face pre-grant opposition proceedings. So, the delay in disposing of patent applications cannot be attributed to the small number of pre-grant patent oppositions. In any case, fixing a term for filing pre-grant oppositions will not address the issue of delay in adjudication, as patent examination will continue with or without any opposition.

Naturally, there is stiff resistance to this government move by the associations working in the health sector. There are other methods to address the perennial issues of delays in patent examination. The Médecins Sans Frontières (MSF), a medical humanitarian organization, has already called on the IPO to mandate applicants to disclose International Nonproprietary Name (INN) in patent applications to identify the multiple patents on the same drug and vaccine. That will ease the burden of the IPO and increase transparency. Disclosure of INN by the applicant to the IPO would serve as an essential tool to further improve transparency and accessibility of patent information, and also assist in effective management of patent applications across different patent offices. Of course, the six-month timeline is insufficient for filing patent oppositions. The information in patent applications does not permit the public to identify the claimed medical product rapidly. The process is time-consuming as multiple patent claims could be pending on the same medicine, vaccine or technology. With titles that are deliberately vague and meaningless, patent applicants seem to conceal the known INN, which are attributed by the WHO as unique names that identify particular pharmaceutical substances.

To further justify the timeline on pre-grant oppositions, the EAC compares the number of granted patents in India to that of the United States (US) and China. Such a comparison is unjustified considering the large quantity of patent applications filed and granted does not correspond to quality of granted patents in the US and China. In fact, in recent years, the Chinese government has been addressing the issues of quality of patents, including those related to the excessive number of patents.

Experts globally acknowledge that at the time of introducing the WTO-mandated product patent system in 2005, Indian lawmakers made a conscious decision not to replicate the US IP system designed for profiteering by their pharmaceutical corporations. Instead, parliamentarians looked at balancing patent monopolies with the health needs of Indians and people in low-and middle-income countries (LMICs) who need access to affordable generic medicines. Instead of racing to grant more patents at the cost of quality and at the risk of stifling genuine innovation, patent office should contribute to access to more affordable medicines by rejecting evergreening patent applications for known medicines. The current mechanism of pre-grant opposition under India's patents law is an important tool to use in this context.

The MSF has clearly made some valid points. The attempt to dilute the timeline on pre-grant opposition diverts from addressing the real problem facing the patent system in India. The efficiency of the IPO can be effectively addressed by improving the functioning of the patent office. Far from being the problem, pre-grant oppositions are part of the solution as they can help address the problem of low-quality patents by providing relevant and focused information to the IPO for aiding the examination process.