The perils of patent amendments
News Except:
The Union government recently released the Draft Patents (Amendment) Rules, 2023. The 2023 draft amendment proposes several significant changes, including introducing fees for pre-grant opposition filings and centralising authority with the patent controller.
Impact:
- The Indian Patents Act 1970, by allowing process patents and introducing shorter terms for patent protection, fueled the growth and innovation of the pharmaceutical industry while ensuring a balance between innovators' rights and public health concerns.
- The proposed amendments to the Patent Rules 2003 raise concerns about how they may impact the standard of patents granted by the Patent Office and the transparency of the patent system in India.
Reason for Impact:
- India is the leading generic drug producer in the world. India fulfils more than 60 per cent of the global demand for vaccines. India plays a critical role in the realm of vaccines by meeting 40-70% of the World Health Organization’s demand for DPT and BCG vaccines and 90% of the global market for measles vaccines.
- However, India has long struggled to access good quality and affordable medicines. Soaring costs of healthcare, including medicines, push 3% of Indians into poverty every year.
- The Economic Survey 2023 projects the share of out-of-pocket expenditure (OOPE) in healthcare at 48.2%, significantly higher than the global average of 18 per cent.
Harmful Amendments and its effects:
- Proposed amendments include introducing fees for pre-grant opposition filings and centralising authority with the patent controller. These changes deviate from not charging fees for pre-grant opposition filings and allowing anyone to provide crucial information to the patent office under Section 25(1) of the Indian Patents Act, 1970.
- Restricting who can file pre-grant oppositions, especially patient groups, could impede efforts to prevent the issuance of undeserved patents for medicines. This is concerning, as it might affect the timely availability of cost-effective generic medications.
- The working statement submission interval may be extended from annually to once every three financial years, and the need to disclose whether patented products are made in India or imported, along with their pricing details, could be eliminated. These proposals could have a detrimental effect on India's healthcare system, limiting the ability of patient groups to initiate pre-grant oppositions, which are crucial for preventing undeserved patents on medicines.
- Discretionary powers may be granted to the patent controller to determine who can file pre-grant oppositions, contrary to previous judicial decisions that allowed both organisations and individuals to do so. These changes could weaken the safeguards in India's patent system, which is ironic considering that earlier in the year, the Indian Patent Office rejected a US pharmaceutical giant's application to extend a monopoly on a key tuberculosis drug.
- Extending the time frame for working statement submissions and eliminating the need for manufacturing details and pricing information may obstruct the procedure for obtaining compulsory licenses, potentially hindering access to essential medicines at affordable rates.
Need to stand firm:
- India should actively address challenges related to patents and intellectual property rights and strongly oppose any efforts to restrict the waiver of patents for drugs and vaccines. India is already compliant with the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and has aligned its Patent Act accordingly.
- Access to affordable medicines is vital for vulnerable communities globally, and India, often considered the pharmacy of the world, plays a crucial role in ensuring this accessibility. With India's growing population, the government must explore ways to keep high-quality medications affordable and accessible to impoverished and marginalised populations within and abroad.
- The Indian Patent Office is currently overwhelmed with patent applications, straining its capacity to process them effectively. Proposed amendments aim to simplify the patent application and granting process. While these amendments may ease the burden on the patent office, there are concerns that they disproportionately favour global pharmaceutical giants; hence, a balance should be maintained.
Conclusion:
The existing patent regulations are essential for ensuring access to a wide range of newer medicines. The anticipated impact of these amendments is negative, potentially reducing the availability and accessibility of medicines and promoting monopolies and profiteering by major pharmaceutical companies. Therefore, the government must reconsider the proposed amendments to protect the accessibility of affordable medicines and eliminate provisions that benefit the global pharmaceutical industry.
Mains PYQ
Q. Bringing out the circumstances in 2005 which forced amendment to the section 3(d) in Indian Patent Law, 1970, discuss how it has been utilized by the Supreme Court in its judgement in rejecting Novartis’ patent application for ‘Glivec’. Discuss briefly the pros and cons of the decision. (UPSC 2013)
Q. Scientific research in Indian universities is declining, because a career in science is not as attractive as are business professions, engineering or administration, and the universities are becoming consumer-oriented. Critically comment. (UPSC 2014)
