Central Idea

On August 23, the Department for Promotion of Industry and Internal Trade in India unveiled draft patent amendment rules.
These changes, if enacted, may have significant implications for pharmaceutical companies and patients, particularly in the global South.

Draft Patent Amendment Rules: Key takeaways

Financial Burden: A notable modification is the introduction of variable fees for filing pre-grant oppositions, potentially placing a substantial financial burden on civil society organizations and patient groups.
Maintainability Decision: Of particular concern is the provision granting the controller the authority to determine the maintainability of representation by individuals or civil society organizations seeking to file pre-grant oppositions.

Key Public Health Safeguard: Pre-grant opposition serves as a crucial public health safeguard against practices like patent evergreening and the granting of unwarranted monopolies. It ensures continued accessibility to quality-assured and affordable generic medicines.
Lobbying for Weakened Safeguards: The draft amendment rules have raised concerns that they may undermine these safeguards and potentially extend patent protection on frivolous grounds. Big pharmaceutical companies have long lobbied to remove critical safeguards from India’s patent laws.

Lack of Rational Basis: Critics argue that the rules’ provision for controller-determined maintainability lacks a rational basis and may create more problems. Without clear guidelines, decisions on the eligibility of pre-grant opposition filers could become arbitrary.
Favouring Corporations: Some believe that the government is aligning with pharmaceutical companies’ interests, as these corporations often seek to limit pre-grant opposition.
Unique Provision at Risk: Pre-grant opposition, an exceptional provision within the Indian Patent Act, has been crucial in protecting public health interests. Weakening this provision could have dire consequences for patients and the generic drug industry.

Past Precedents: Pre-grant opposition filed by patient groups and civil society organizations has led to the rejection of patent extensions pursued by pharmaceutical companies based on weak claims of “novel invention.”
Notable Instances: Examples include opposition to patents for drugs like Tenofovir disoproxil fumarate (TDF), Nevirapine, Glivec (imatinib mesylate), Zidovudine/Lamivudine (HIV medicines), and Lopinavir/Ritonavir (HIV medicines).

Global Implications: The proposed changes could disproportionately impact patients in India and the global South, who heavily rely on India’s production of affordable generic drugs and vaccines.
Threat to Access: Weakening pre-grant opposition may impede access to essential medicines, putting patients at risk and affecting the generic drug industry.
Concerns Raised: Experts emphasize that any erosion of this provision within the Indian Patent Act would be a significant change, jeopardizing patients’ ability to access affordable medications and enabling pharmaceutical corporations to exert greater control over the market.

The draft patent amendment rules have sparked concerns that they may undermine essential safeguards, potentially benefiting pharmaceutical giants while posing a threat to patients’ access to affordable medicines.
The pivotal role of pre-grant opposition in safeguarding public health interests is at risk, raising questions about the impact on patients in India and beyond.