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Patient groups and public health experts raise concern over draft amendment on Patents Act

Our Bureau, New Delhi
Friday, September 15, 2023, 08:00 Hrs  [IST]

Patient advocacy groups and public health experts in the country have raised concern over the provisions in the proposed Patents (Amendments) Rules, 2023 which could impose a dynamic fee for filing pre-grant oppositions, provide discretionary powers related to acceptance of pre-grant oppositions to the patent official, and limit the options to gather data related to annual sales numbers of patented drugs.

The Draft Patents (Amendment) Rules, 2023, which were made public on August 23, 2023, may aim to streamline the operations of the patent office and expedite patent processing timelines. While these objectives are commendable, experts argue that certain amendments could dilute critical protections, potentially affecting people's right to file pre-grant opposition, the accessibility of compulsory licenses, and transparency in the patent system.

Dr. Biswajit Dhar, vice president, Council for Social Development, said that pre-grant oppositions are peer review systems where the stakeholders including the patient groups can raise issues such as attempt to ever greening patents and now, with the amendment, the controller has the discretionary powers to decide who can qualify to file a pre-grant opposition. The Big Pharma may be able to put pressure on the Patent Office for their interests, he opined.

"The present amendments present the most significant challenge to the Indian Patent System since 2005 and could have a disastrous impact on access to medicines, and they appear to be entering through a less conspicuous back door via the Rules,” said Dhar. He added that the allegations of the pharma industry that pre-grant oppositions are reason for delay in patent approvals is baseless.

During 2021-22, out of the total 70,000 patent applications filed, only 481 were challenged through pre-grant opposition and since 2005, there were only around 0.3 per cent pre-grant oppositions were filed in India as against the total number of patent applications filed. The process is delayed more owing to the lack of manpower in the Patent Office rather than due to pre-grant oppositions, he said. He added that the proposed amendment is going to be only a first step to many such changes in the Act.

To prevent the abuse of patent rights, certain measures require patent holders to disclose how their patents are being worked by filing an annual working statement to the patent office. The draft amendments propose to extend the interval for submitting working statements from annually to once every three financial years. The new amendments also propose to remove the requirement to seek information on whether the patented product is manufactured in India or imported and the prices of the patented products. This information in the past have been used to register patented medicines not available in India, said the experts.
K M Gopakumar, legal advisor and senior researcher, Third World Network, said, "The timely disclosure of the extent to which a patent has been worked in India is crucial to ensure that the patented product adequately meets the reasonable requirements of the public. In the case of medicines, this means to whether a patented medicine is available to the people in India at a reasonably affordable price substantiated by data. Extending the interval for filing working statements to three years from existing one year and removing the requirements to disclose how it is worked—whether manufactured in India or imported and the approximate prices of the patented products could significantly impede the process of obtaining compulsory licenses and making available essential medicines to the public at an affordable price".

The amendments introduce a dynamic and exorbitant fee for filing pre-grant oppositions granting excessive authority to the Controller to determine the “maintainability of the representation.” This makes a departure from the current practice of not charging any fees for pre-grant opposition filings and allowing “any person” to provide critical information to the patent office, aiding the Controller in examining patent applications. 

Eldred Tellis, director, Sankalp Rehabilitation Trust, said, "This proposed introduction of fees running into thousands of rupees for pre-grant oppositions could impose a significant financial burden on organizations such as ours, representing patients’ interest. At a time when our primary focus is allocating resources to treat our patients, securing funds for filing patent challenges becomes a daunting task, potentially affecting the timely access to essential medicines for those under our care".

"Also, granting the Controller discretionary authority to determine who may file pre-grant oppositions is beyond the scope of the Patents Act and contradicts prior judicial rulings, which clearly allowed organizations like ours, as well as anyone, to file pre-grant oppositions. This proposed amendment could potentially curtail our ability to file pre-grant oppositions to prevent the grant of unmerited patents on medicines to ensure timely availability of quality assured, affordable generic medicines," he said.

In the existing law under Section 8 of the Patents Act, patent applicants must periodically disclose foreign patent applications and related developments on their legal status, ensuring transparency. The proposed amendment to the Rules could replace this ongoing periodic requirement with a one-time obligation, potentially hindering timely updates and critical information sharing, which could result in the grant of frivolous and unmerited patents, said Leena Menghaney, Global IP Advisor, Medecins Sans Frontieres Access Campaign.

She added that during the discussions prior to the release of draft amendment, while the pharma companies were given ample opportunity in a meeting to share their views, patient groups were not invited and the patient advocacy groups were allowed very mites time to express their views.

The patients’ groups, civil society organizations, and public health experts called on the government to carefully consider these concerns and revise the proposed draft amendment rules to ensure that the safeguards enshrined in India’s patent system are protected to ensure public health and access to affordable medicines.


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