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Context: Patient advocacy groups have expressed serious concerns regarding the draft Patents (Amendment) Rules 2023, stating that these proposed changes could undermine crucial public health safeguards, including provisions such as pre-grant opposition and the working of patents. The draft rules were released for stakeholder comments by the Department for Promotion of Industry and Internal Trade last month.

Key concerns raised by these advocacy groups

Dynamic and Exorbitant Fees for Pre-Grant Opposition

• The proposed amendments introduce fees for filing pre-grant oppositions, which is a departure from the current practice of not charging any fees for such filings.
• Advocacy groups argue that this could deter patient groups and other stakeholders from providing critical information to the patent office, potentially limiting the examination of patent applications.

Loss of Access to Peer Reviews

• Pre-grant opposition is equated to "peer reviews" in scientific circles, allowing stakeholders to review patent applications and oppose frivolous ones. Introducing fees for this process could make it inaccessible to patient groups and other organizations, limiting their ability to participate in the examination of patents.

Delaying the Patent Process

• Advocacy groups counter the argument that pre-grant oppositions cause delays by pointing out that a very small percentage of patent applications have faced opposition since the relevant Act was amended in 2005. They argue that these oppositions play a crucial role in ensuring the quality and validity of patents.

Significant Challenge to the Indian Patent System

• The proposed amendments are seen as the most significant challenge to the Indian Patent System since 2005. Advocacy groups believe that these changes could have a disastrous impact on access to medicines and are concerned that they are being introduced through less conspicuous means, such as rule changes.

Financial Burden on Marginalized Patients

• The introduction of fees for pre-grant oppositions could place a financial burden on marginalized patients and patient advocacy groups. Instead of focusing on allocating resources to treat patients, these groups might have to divert funds toward filing patent challenges.

Discretionary Authority of the Controller

• The discretionary authority given to the Controller to determine the "maintainability" of pre-grant oppositions is a concern, as it could lead to delays in the patent process. Those dissatisfied with the Controller's decision may resort to legal actions, further extending the process.

Changes in "Working of the Patent" Requirements

• The requirement for companies to provide details on the annual sale of their patented drugs has been changed from yearly to three-yearly information. Advocacy groups argue that this change could hinder the process of obtaining compulsory licenses and making essential medicines available at an affordable price.

Overall, these concerns emphasize the potential consequences of the proposed amendments on public health, access to medicines, and the ability of patient advocacy groups to participate in the patent examination process. The balance between protecting intellectual property rights and ensuring access to essential medicines remains a crucial consideration in the ongoing discussions surrounding these proposed changes. Public consultations and further dialogue are essential to address these concerns and strike an appropriate balance in India's patent system.

Must Read Articles:

PATENT: https://www.iasgyan.in/daily-current-affairs/patent

INTELLECTUAL PROPERTY RIGHTS: https://www.iasgyan.in/ias-gazette-magazine/perspective-intellectual-property-rights

PRACTICE QUESTION Q. What is the significance of the proposed amendments in the draft Patents (Amendment) Rules 2023, and what potential impact could they have on the patent system? What are the main challenges and concerns raised by stakeholders? What might be the way forward to strike a balance between protecting intellectual property rights and ensuring the affordability and availability of essential medicines in India?

https://www.thehindubusinessline.com/news/national/proposed-changes-to-patents-act-will-undermine-public-health-say-patient-advocacy-groups/article67307874.ece

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