The recent draft patent amendment rules proposed by India’s Department for Promotion of Industry and Internal Trade (DPIIT) have provoked concerns over potential ramifications on affordable drugs and vaccines. These rules appear to impede pre-grant opposition, a critical guard against unwarranted patent extensions, thus posing threats to public health.
Draft Patent Amendment Rules: A Closer Look
The draft patent amendment rules are suggested changes to the current patent regulations in India, detailing procedures and fees associated with filing, examining, approving, and opposing patents. Key features encompass the introduction of tiered fees for filing pre-grant oppositions, ranging from Rs. 1,500 to over Rs. 40,000 determined by the category and quantity of applicants. The rules also delegate authority to the controller of patents to assess the admissibility of representation by individuals or civil society organizations wishing to file pre-grant oppositions.
Concerns Surrounding Proposed Changes
Safety measures like pre-grant opposition, which serve as bulwarks against practices such as patent evergreening and granting of unreasonable monopolies, may be compromised by these prospective amendments. The escalating official fee for filing post-grant oppositions, equivalent to the aggregate patent filing cost borne by the applicant, and the introduction of fluctuating fees for filing pre-grant oppositions could impose substantial financial constraints on civil society organizations and patient groups.
The Impact on Public Health Safeguards
A potential threat to access to essential drugs and vaccines could put patients at risk and disturb the generic drug industry. This scenario could predominantly affect patients in India and the global South, who heavily rely on India’s provision of cost-effective generic drugs and vaccines.
Patent Opposition: Rules and Procedures
The Indian Patent Act, 1970 permits the public to file objections against patents at two stages: pre-grant and post-grant opposition. Pre-grant opposition allows any person to file a written opposition following the patent application’s publication but preceding its grant, backed by comprehensive specifications. Post-grant opposition comes into play once a patent is approved. A written counter can be filed after publication, and must be submitted to the Controller within 12 months of the patent’s appearance in the Indian Patent Journal.
Successful Pre-Grant Oppositions: A Glimpse into History
There have been instances where pre-grant oppositions led by patient groups and civil society organizations resulted in the refusal of patent extensions desired by large pharmaceutical companies based on tenuous claims of “novel invention.” Three significant cases included Sahara’s TDF patent, Boehringer Ingelheim’s pediatric Nevirapine patent, and Novartis’ cancer drug Glivec.
Consequences for Access to Affordable Drugs
The proposed rules could potentially limit access to affordable generic drugs by making it more difficult to challenge patents. Increased fees and the introduction of hierarchical fees for filing pre-grant oppositions might place a significant financial burden on civil society organizations and patient groups.
The Discretion of the Controller
Presently, under the Patents Act, 1970, any person can file a pre-grant opposition, thereby providing a democratic route to oppose patents. However, the draft rules suggest giving the controller the power to determine the admissibility of those filing pre-grant oppositions, creating unease due to potential biases and difficulties for those opposing patents.
Patent Evergreening: A Threat to Affordable Medicines
Evergreening of patents, a tactic used to extend the term of a patent by securing new patents before the original one expires, is a challenge to continued access to quality-assured, affordable generic medicines. Indian patent law does not permit evergreening, thereby keeping essential medicines within the reach of the public. However, weakening pre-grant opposition might result in unwarranted patent extensions.
Pharmaceutical Lobbying and Global Impact
Concerns have emerged that the amendments favor pharmaceutical companies and could potentially undermine India’s unique provision of pre-grant opposition. The impact could extend globally, particularly affecting the global South, as these regions rely heavily on India’s production of affordable generic drugs and vaccines.
