Patient advocacy groups have expressed concerns over the draft Patents (Amendment) Rules 2023. They said the changes undermine public health safeguards, including features like pre-grant opposition, working of patents, etc.
The draft was released late last month by the Department for Promotion of Industry and Internal Trade for comments from stakeholders.
According to advocacy groups, the above features played a key role in two benchmark patent cases involving Novartis blood cancer drug Glivec and Bayer’s kidney cancer drug Nexavar.
“The (proposed) amendments introduce a dynamic and exorbitant fee for filing pre-grant oppositions granting excessive authority to the (Patent) 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,” the representatives said.
Also read: Cancer treatment: UoH gets patent for novel formulation
Equating pre-grant opposition to “peer reviews” in scientific circles, Biswajit Dhar, Vice President, Council for Social Development, said the feature allowed all stake-holders to review a patent application when filed and oppose frivolous ones at the Patent Office. A fee would put it beyond patient-groups,” he said.
On complaints that pre-grant oppositions delaying the patent process, he said, “Data reveal that 0.3 percent of patent applications since 2005 (when the Act was ammended) were opposed; and in 2021-22, 0.69 percent of applications were opposed.”
The 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,” he added.
Eldred Tellis, Director with Sankalp Rehabilitation Trust, said, “ Groups representing marginalised patients would not be able to match such fees. When organisations should be focused on allocating resources to treat patients, “securing funds for filing patent challenges becomes a daunting task, potentially affecting the timely access to essential medicines for those under our care,” he said.
On the discretionary feature that allowed the Controller to disallow a pre-grant on “maintainability”, Leena Menghaney, Global IP Advisor with Medecins Sans Frontieres Access Campaign, said, “It could further bring in delays. Those aggrieved by the decision could go to Court,” she said.
KM Gopakumar, Legal Advisor and Senior Researcher, Third World Network, added that the discretionary feature could “expose the institution to undue influence”.
Also read: Centre fixes price for drugs going off patent
On the “working of the patent” feature, he said, companies had to show details on the annual sale of their patented drug. The requirement now is for three-yearly information.
“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. Extending the interval for filing working statements ……and removing the requirements to disclose how it is worked …could significantly impede the process of obtaining compulsory licenses and making available essential medicines to the public at an affordable price,“ he explained.