September 28 2023 0Comment

Apprehended Drawbacks of Draft Patents (Amendment) Rules 2023

 The year 2023 has been a significant year for patents in India. We have witnessed significant growth in the patent filing. As per a report prepared by NASSCOM, the fiscal year 2022 recorded the highest annual increase during the last decade, by 13.6%. 

There is a rise in domestic filing by 4.44% of the total patent applications filed during FY 2022, which was 41.6% during FY 2021. 

According to an analysis of the patents submitted over the past ten years, 2,66,000 of the 5,84,000 patents submitted in India between FY2010 and FY2022 were in the technology field, with 1,60,000 of those patents covering cutting-edge technologies like AI, IoT, Big Data, Cybersecurity, and Blockchain. Around 2.4% of all telecommunications-related patent applications had something to do with 5G or 6G. 

The President of NASSCOM, Debjani Ghosh, said that India is widely adopting emerging technologies that result in a surge in innovation, evident from the increasing number of patent applications filed. 

India’s place on the innovation map of the world and its leadership in cutting-edge technologies like AI are highlighted by this trend. 

On the other hand, the “Draft Patents (Amendment) Rules, 2023” was announced on August 22, 2023, the Ministry of Commerce and Industry’s Department for Promotion of Industry and Internal Trade. Till September 23, 2023, any suggestions or objections regarding the amendment were accepted. 

Besides the benefits and streamlining of the patent works, certain privileges are compromised, such as

Undermined Pre-grant Opposition:  

The drafted patent amendment regulations made public on August 23 may greatly benefit big pharma. Still, they could be terrible for patients in India and other developing nations who depend on generic medications created in India for access to low-cost medicines and vaccines. 

A few substantial changes were made to the Department for Promotion of Industry and Internal Trade’s draft rules that were made available for stakeholder feedback, and these changes will make it more difficult to oppose patents before they are granted. First, the draft amendment rules included a variable cost for pre-grant opposition filings. The proposed imposition of fees might cost thousands of rupees, placing a heavy financial strain on patient advocacy groups and civil society organisations that file pre-grant opposition. 

The controller now has the authority to assess whether pre-grant opposition requests made by individuals or groups of civil society organisations can be maintained. This is the most significant change. 

Leena Menghaney, India Head and Global IP Advisor of Medecins Sans Frontieres – Access Campaign, said pre-grant opposition is necessary for public health safeguards against patent evergreening and unmerited monopolies. 

It is one way to ensure that generic medicines with guaranteed quality and reasonable prices are still available. 

However, the provision in the draft patent rules that prevents the duration of a patent from being extended on wholly arbitrary grounds is in jeopardy. For many years, Big Pharma has fought to have India’s patent rules changed to eliminate crucial protections. 

Intellectual property experts claim that the new law favours big pharma companies as they don’t want pre-grant opposition. The law introduces updated terms and conditions. The new draft rules do not include any guiding factor for the controller to decide the maintainability. 

‘Proposed amendments in patent rules could hurt patients’ rights and access to drugs 

The proposed Patents (Amendment) Rules, 2023, may reduce essential safeguards for public health against patent evergreening and unlawful monopolies, according to an article in The Hindu. Experts in intellectual property, public health, and civil society organisations have raised worry that the Rules may limit people’s ability to submit pre-grant opposition to patents. 

The group asserted that the proposal was made in reaction to the international pharmaceutical industry’s alleged persistent lobbying to remove necessary safeguards from India’s patent laws over the previous year. Concerns have been raised by organisations working to ensure that patients in India and other developing countries have access to affordable diagnostics, drugs, and immunisations. 



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