Thursday, May 26, 2022

The Indian Patent Regime Is Accommodating Unreasonable Demands Of The US, But People Are Not Aware

After four meetings of WG since its establishment, there are ample signs that accommodation of US demands are being done at the cost of India’s socio-economic interest.

The Indian Patent Regime Is Accommodating Unreasonable Demands Of The US, But People Are Not Aware

The fourth meeting of India US annual High-Level Intellectual Property (IP) Working Group (WG) took place as part of the USA India Trade Policy Forum (TPF), the annual forum to discuss bilateral trade issues.
Unlike previous years there is no joint statement issued this year and therefore there is no information about the outcomes of WG.  The three joint statements issued in previous years show that Indian patent regime is accommodating the unreasonable demands of US and undermining the public interest and development orientation of the Indian Patents Act.  This has resulted in the debasing of legislative intent of the patent act since it is happening not through legislative amendment parliament and people are not fully aware of it. 
The WG was established in 2014 during Prime Minister Modi’s first visit to the US. The decision to establish the WG astonished the IP Watchers because it was a departure from India’s response to US demands on IP. Till then, India had no bilateral engagement on IP with the US because US demands on IP compromises the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and pose a challenge to access to medicines and technologies.
Since Indian Patents Act fully complies with the TRIPS Agreement there was little chance for the US to obtain a remedy from WTO. Therefore many IP watchers afraid that a bilateral engagement on IP would slow down if not curtail the deployment of public interest safeguards in the Indian Patents Act.  
 However, some policymakers viewed that WG is an attempt to provide the way out to the US government to ease the domestic pressure from a coalition of industry associations lead by Pharmaceutical Research Manufacturers of America (PhRMA). Therefore the working group is only talking shop and would not lead to any adverse outcome for India's public interest-oriented Patents Act. After four meetings of WG since its establishment, there is ample signs accommodation of US demands at the cost of India’s socio-economic interest.
 In the first meeting of WG India raised concerns on the patenting of traditional knowledge and access to medicines. On access to medicines, both parties "reiterated the goal of ensuring the poorest populations in India and the United States have access to quality healthcare and recognized the important role that trade, intellectual property, and innovation policies play in enhancing access to quality health and affordable medicines for the public at large". However, no concrete measures were proposed or agreed.
 India has not raised any other concrete concerns related to patents. However, India agreed to address the US concerns on patents such as the pendency of patents and patenting of computer-related inventions.  
Further, both parties also agreed to increase the interaction and cooperation at the operational level between Indian Patent Office and the US. Such operational-level cooperation may result in the functional harmonization of the patent law, which would undermine the provisions limiting the scope of patentability in the Indian Patents Act.
There is already an evidence prior to the establishment of WG that Indian Patents Office granted patents on isolated genes, the pharmaceutical substance in public domain and software, which is prohibited under the law. The fear is that enhanced cooperation may lead to a functional harmonization and neutralize the statutory prohibition against the above-mentioned inventions. 
 Patenting of computer-related inventions (CRI) is a case in point. The Patents Act under Section 3 (k) excludes mathematical or business method or a computer programme per se or algorithms from patent protection. The exclusion with regard to computer programmes does not exclude a hardware containing computer program such as embedded software. However, it clearly excludes if the technical advancement of the hardware is solely based on the software.
India developed three versions of the patent examination guidelines on computer-related inventions (CRI) in 2015, 2016 and 2017. The 2015 guideline diluted the statutory prohibition and allowing patents on computer programmes along with business models.  Due to the intervention of civil society groups and experts, a revised Guideline was published in 2016, which restored the pre-2015 position with clear guidance to the examiners.  
As per the joint statement of TPF 2016 "India has set up a Committee to re-examine the guidelines on examination of CRI patent applications, and expressed hope that a final decision would be taken soon in this regard consistent with Indian law".  The new guideline published in 2017 removes the specific examples and guidance given to the patent examiners in the 2016 guideline. As a result, the very purpose of the guideline is defeated and the examiner is to exercise a great degree of discretion. This element of discretion makes patent office vulnerable to undue influence. 
 Since 2014, Patents Office rejected at least two-pre grant opposition including the blockbuster medicine on Hepatitis C and granted patents, which were, rejected elsewhere.  In the case of Sofosbuvir, the Patents Office rejected the patent in in 2015 January and reversed its decision in 2016. The Egyptian Patent Office rejected the patents citing the same reasons on which Indian patents office rejected the patent in 2015. 
 Similarly, the patent office also rejected a compulsory license application The US India Joint Business Council submission to US government reveals that the Indian officials gave an oral assurance that India would not issue any compulsory license. Further, the submission also states that the Government partnered with USIBC to organize training for examiners and invited USIBC to organize more such seminars.
Training of examiners by the industry, which is having the conflict of interest, clearly goes against good governance norms.  Similarly, the government also now allows the out of turn fast-track examination and grant of patent applications in the name speedy decision. This push for fast-track examination would result in the grant of the poor quality patents becoming a rule rather an exception. 
 Till date, the parliament has not been informed about the details of outcomes WG or related engagements with the US. There is an urgent need for the government to ensure transparency and accountability in this regard. The government should not undermine the legislative intent behind Patents Act without informing the parliament. 
(The writer is a legal advisor and senior researcher with the Third World Network)