The Draft Patent (Amendment) Rules, 2023 is quite the mixed bag. The rules, if passed, are surely a strong attempt towards fighting the long-standing issue of pendency in the Indian Patent Office, but concurrently it can also led to dilution of material safeguards within the Patent Act, which are in place to ensure that applicants/ patentees stick to their end of the patent bargain.
The Indian patent prosecution stage holds a very important spot in the overall patent regime of the country. Processing patent applications hasn’t always been seamless/ swift and this has been vehemently called out by the Courts (for instance see Natco v. Union of India where the Delhi High Court observed the delay in patent prosecution owing to both the applicants as well as the opponents.) And while there are multiple issues ranging from shortage of manpower to uncertain timelines, one reason that is frequently cited is the often hefty compliances within the Patent Act that an applicant is required to meet. However, these compliances (like providing a working statement, informing about foreign applications, pre-grant oppositions) play a very important role in ensuring that only high-quality patents are granted by the patent office, considering the impact that they can have in various parts of society – from developing local technological capacity, to increasing access to medicines, and more.
Considering the enormous impact these proposed changes can have on the overall patent regime, it is surprising to see that there were no public calls for stakeholder consultations prior to the draft rules’ publication. Or if there were, we have not been able to find any such notification. We’ve seen at least one mention of “long winding discussions of the stakeholders with the Government of India”, so it seems that some stakeholders did get to participate. Unfortunately, with no public records being noticeably available, it is anyone’s guess as to who was invited to participate, and what was discussed in those discussions.
Regardless, there is at least now a call for comments on the draft. On the blog, Md. Sabeeh published a post on the proposed changes to the timelines here, and later Swaraj and Praharsh published an in-depth assessment of these proposed amendments here. Outside of the blog, BananaIP published their comments to the DPIIT, on the draft rules. And another law firm, Kan & Krishme published their take on the proposed amendments here. Apart from these comments from the law firms, there were other editorial pieces published by Bindu Shajan Perappadan in the Hindu and Charu Singh, in BQ Prime. Last week, we also received a press release combining comments from Medecins Sans Frontieres Access Campaign, Third World Network, Sankalp Rehabilitation Trust and Council for Social Development on the impact that these amendments may have in accessing affordable medicines and other treatments by patients in India. So on that note, here are the comments from these organizations.
[Please note: We’d be happy to link to/share other submissions to the Ministry if anyone would like to share their comments with us.]
Comments from MSF, TWN, Sankalp Rehabilitation Trust and Council for Social Development on the Potential Impact of the Draft Patent (Amendment) Rules in Accessing Affordable Medicines
The release of Draft Patents (Amendment) Rules, 2023 last month by the Department for Promotion of Industry and Internal Trade for stakeholder comments has caused significant concerns among patient groups working to ensure access to affordable medicines, diagnostics, and vaccines for patients in India and other developing countries.
Civil society organizations, academics, and intellectual property and public health experts dedicated to addressing pharmaceutical monopolies are among those voicing apprehensions about the potential impact of these proposed rules on essential safeguards within India’s patent system. The proposal is a result of constant push from multinational pharmaceutical industry lobbies over the last year to remove essential safeguards from India’s patent laws.
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.
Pre-grant opposition is one of the important public health safeguards against patent evergreening and unmerited monopolies, ensuring that quality-assured and affordable generics remain accessible. However, the proposed draft amendments bring significant changes. 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]: “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.”
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.
[K M Gopakumar, Legal Advisor and Senior Researcher, Third World Network]: “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.“
[Dr Biswajit Dhar, Vice President, Council for Social Development]: “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.”
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.
Patients’ groups, civil society organizations, and public health experts are calling 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.