Source: This post on the Implications of amendment to patent laws, has been created based on the article, ‘Changes in law will just make medicines more expensive, not better’, published in Indian Express on 22nd April 2024.
UPSC Syllabus Topic – GS Paper 3 – Science and technology – Intellectual Property Rights in India
Context: The article discusses the importance of a robust and affordable pharmaceutical industry in maintaining a good health system.
The Article highlights the role of generic pharmaceutical companies in providing competition to patented drugs, thereby reducing costs and improving access to essential medicines.
Medicines constitute nearly 50 per cent of the health costs incurred by people.
The high cost of medicines is primarily due to patenting, which can be mitigated by allowing competition from generic pharmaceutical companies.
The Indian Patent Law allows for opposition to patenting of medicines, enabling generic companies to produce the same drug and foster competition, which is key to lowering prices.
How patent laws in India amended?
The change in the Patent Act in the early 1970s, which protected only the process but not the product. It facilitated the growth of the generic industry and made India a leading exporter of affordable drugs.
The TRIPS Agreement of 1995 mandated the re-introduction of product patents, but India introduced amendments like Section 3(d) to prevent evergreening of patents and ensure therapeutic efficacy. In Novartis case, Madras High Court upheld Section 3(d) of the Indian Patent Act.
The Indian Patent Act allows the government to issue compulsory licenses to other companies for producing patented drugs in the public interest or if the drug is not reasonably affordable.
Amendment Introduced: However, recently new amendments have been moved, due to some international agreement negotiations and pressure from big pharma companies. Old rules facilitated the filing of Pre-Grant Oppositions (PGOs) by Civil Societies and other parties, which was to be replied by the patent applicant.
The amended Indian Patent Law make it difficult to file pre-grant oppositions (PGOs) to patents, potentially leading to easier patenting and higher drug prices.
Implications of amendment
It discourages patient groups or civil society organizations from opposing frivolous patents.
It gives the patent controller arbitrary power to dismiss PGOs without hearing the opponent.
The amendments also reduce the frequency of reporting on the “working” of patents, making it harder to seek compulsory licensing for non-worked patents.
What should be done?
Reverting or modifying the recent amendments to patent rules could help maintain the ecosystem of affordable generic drugs in India.
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