THE CONTEXT: The issue of patent evergreening has gained prominence in recent years, with the Indian Patent Office set to hear objections against patent claims filed by US-based pharmaceutical giant Gilead Sciences on the HIV prevention drug Lenacapavir.
Patent evergreening is a practice where pharmaceutical companies extend their patent protection on drugs by making minor modifications to existing formulations. This practice has significant implications for public health and access to affordable medicines, particularly in developing countries like India.
INDIAN PATENT REGIME:
- Section 3(d) of Patents Act: This section prohibits the patenting of new forms of known substances unless they demonstrate enhanced efficacy. It states that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not patentable.
- Section 3(e) and 3(i): These sections restrict patenting mixtures of known compounds unless a synergistic effect is proven and prevent patents on treatment methods.
- Patents (Amendment) Rules, 2024: The Indian government has introduced new rules to streamline the patent application process and reduce pendency. These changes aim to balance innovation protection with public health concerns.
India, along with Brazil, Thailand, and South Africa, is one of the few countries with explicit laws against evergreening. In contrast, the United States allows companies to obtain new patents for drugs by altering formulas or changing dosages.
LANDMARK CASES ON PATENT EVERGREENING IN INDIA:
- Novartis AG v. Union of India (2013): The Supreme Court rejected Novartis’ patent application for the cancer drug Glivec, setting a strong precedent against evergreening.
- Roche v. Cipla (2012): The Delhi High Court ruled in favor of Cipla in a patent infringement case over Roche’s anti-cancer drug Tarceva.
- Johnson & Johnson’s TB drug Bedaquiline: In 2023, the Indian Patent Office rejected J&J’s secondary patent application for bedaquiline, used to treat drug-resistant tuberculosis.
INDIA’S POSITION IN GLOBAL CONTEXT:
- India as a generic drug manufacturer: India is known as the “pharmacy of the world” due to its significant role in producing affordable generic medicines. However, patent evergreening threatens this position.
- Biosimilar market potential and challenges: The Indian biosimilars market was valued at $349 million in 2022 and is estimated to grow at a CAGR of 25.2% from 2022 to 2030. However, India currently holds only a 3% share of the global biosimilar market.
PATENT FILINGS:
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- In 2023, India saw 83,000 patent applications filed, a 24.6% increase from the previous year.
- For the fiscal year 2023-2024, a record high of 90,300 patent applications were received.
- Over 100,000 patents were granted between March 15, 2023, and March 14, 2024.
- This translates to approximately 250 patents granted every working day.
Resident vs. Non-Resident Filings:
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- In fiscal year 2023, resident filings accounted for over 50% of total filings, surpassing non-resident filings for the first time.
State-wise Filing:
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- Tamil Nadu led with 9.3% of total patent filings in FY2023.
Sector-wise Filing:
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- Healthcare-related patents, particularly in medical imaging, diagnostics, and testing, saw the maximum applications.
- Automation/Software Development and Retail/E-commerce followed this.
- In Artificial Intelligence, most patents were filed in areas of image processing, Natural Language Processing, and predictive modeling.
Women Inventors:
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- The share of patents filed by women increased to 11.6% in FY2023 from 10.2% in the previous year.
Educational Institutions:
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- Filings from educational institutions increased from 7,400 in FY2022 to 19,200 in FY2023, a 159% jump.
- The Indian Institute of Technology, Madras (IIT Madras) saw patents granted increase from 156 to 300 during 2022-2023.
Corporate Leadership:
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- Qualcomm led in patent filings with about 2,320 patents, followed by Samsung, Huawei, and Ericsson.
Processing Time:
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- The average patent pendency has been reduced to 18 months.
THE ISSUES:
- Gilead Sciences case: Gilead is seeking patents in India for the choline and sodium salt forms of Lenacapavir, an injectable HIV drug. If approved, these patents would extend Gilead’s monopoly until 2038. Sankalp Rehabilitation Trust argues that these claims violate India’s patent laws against evergreening.
- Impact on public health and medicine affordability: Patent evergreening can significantly delay the entry of affordable generic medicines into the market. For instance, Gilead’s price for Lenacapavir in high-income countries is $42,250 annually, while Indian generic manufacturers could potentially produce it for as little as $100 per person per year.
- Prevalence of secondary patents: Despite legal safeguards, recent studies reveal that around 72% of granted pharmaceutical patents in India are minor or secondary.
- Barriers to biosimilar development: Patent evergreening poses a significant challenge to developing and launching affordable biosimilars, as seen in the ongoing controversy surrounding pertuzumab, used to treat certain types of breast cancer.
- Technology and Software Industry: Companies often release incremental updates or new versions of software to extend copyright protection and maintain market dominance. Microsoft’s continuous updates to the Windows operating system can lead to forced obsolescence and compatibility issues for users.
- Consumer Electronics: Manufacturers frequently release slightly modified versions of existing products. Apple’s annual iPhone releases have had minor improvements. This can create artificial demand and contribute to electronic waste.
- Agricultural Sector: Companies develop new plant varieties or slightly modified genetically modified organisms (GMOs). An example is Monsanto’s (now Bayer) continuous development of new Roundup-Ready crop varieties. This can lead to increased farmer dependence on specific seed companies.
- Automotive Industry: Car manufacturers make minor design changes or add features to extend design patents—Tesla’s continuous software updates and minor hardware modifications. This can potentially limit third-party repairs or modifications.
THE WAY FORWARD:
- Balancing Innovation and Public Health: Refining Section 3(d) of the Patents Act to provide clearer guidelines on what constitutes a significant enhancement in efficacy, rather than imposing blanket restrictions.The Novartis AG v. Union of India (2013) case highlighted the need for this balance. The Supreme Court’s rejection of Novartis’ patent application for Glivec set a precedent against evergreening while emphasizing the importance of genuine innovation.
- Strengthening R&D Infrastructure and Incentives: Increase gross expenditure on R&D from the current 0.7% of GDP to at least 2% by 2030, in line with developed economies. Expand the National Biopharma Mission (NBM) to cover more sectors and increase its funding from the current $250 million. As per the Global Innovation Index 2023, India ranks 40th, showing improvement but still lagging behind many countries in R&D investment.
- Streamlining Patent Application and Examination Process: Implement AI-powered tools for preliminary patent searches and examinations, reducing human error and processing time. Establish specialized patent benches in High Courts to expedite patent-related disputes. The Indian Patent Office has reduced the average patent examination time from 72 months in 2015 to 12-30 months in 2022, but further improvements are needed.
- Enhancing IP Awareness and Education: Integrate IP education into school and university curricula, following the model of countries like Singapore. Expand programs like KAPILA (Kalam Program for IP Literacy and Awareness) to reach a wider audience, including rural innovators. Collaborate with industry associations to conduct regular IP workshops for SMEs and startups.
- Addressing Evergreening Concerns: Implement a more rigorous examination process for secondary patents, requiring clear evidence of enhanced efficacy. Introduce a system of pre-grant oppositions with safeguards against frivolous objections, balancing the concerns raised in the Patents Rules 2024. Establish a specialized committee to review and provide recommendations on evergreening practices in different sectors.
- Promoting International Collaboration and Harmonization: As recommended by the Ayyangar Committee, align Indian patent laws more closely with international standards while maintaining flexibilities for public health. Expand bilateral Patent Prosecution Highway (PPH) programs beyond the current pilot with Japan. Actively participate in global IP forums to shape international IP norms considering developing countries’ needs.
THE CONCLUSION:
India’s approach to patent evergreening will significantly impact its healthcare landscape and global position as the “pharmacy of the world.” By refining its patent laws, strengthening R&D infrastructure, and fostering international collaboration, India can safeguard public health while promoting genuine innovation in the pharmaceutical sector.
UPSC PAST YEAR QUESTION:
Q. What is the present world scenario of intellectual property rights with respect to life materials? Although India is second in the world to file patents, still only a few have been commercialized. Explain the reasons behind this less commercialization. 2024
MAINS PRACTICE QUESTION:
Q. India’s patent regime aims to balance innovation protection with public health concerns, particularly in the pharmaceutical sector. Critically examine.
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