Patent Injustice: The Challenge of Evergreening in Biopharmaceuticals (GS Paper 2, Science)
Context
- The issue of patent evergreening—where drug manufacturers make minor tweaks to formulations to extend patent protection—poses significant public health challenges.
- This practice can hinder the availability of affordable medicines, especially in the biopharmaceutical sector.
Biopharmaceuticals
Definition and Importance
Biopharmaceuticals are drugs produced from living cells, including yeast and bacteria, as opposed to traditional chemical-based medicines. They have transformed the treatment landscape for chronic diseases such as cancer, diabetes, and autoimmune disorders. The category includes:
- Biologics: Original biopharmaceuticals that receive regulatory approval.
- Biosimilars: Highly similar versions of biologics that have been approved for use, demonstrating comparable efficacy and safety. They are often referred to as follow-on biologics.
Indian Biopharmaceutical Sector
Rapid Growth
- India’s biopharmaceutical industry is one of the fastest-growing globally, currently valued at approximately $60 billion.
- The country has made significant strides in innovation, climbing from 81st to 39th in the Global Innovation Index since 2015.
India's Position in the Global Biosimilars Market
- Market Leader: India is a pioneer in the biosimilars market, being the first country to approve a biosimilar for Hepatitis B. There are currently 98 approved biosimilars in India, with at least 50 commercially available.
- Growth Forecast: The Indian biosimilars market was valued at $349 million in 2022, with expectations to grow at a rate of 25.2% annually, reaching $2.1 billion by 2030. With $170 billion worth of biologics set to lose patent protection by 2030, Indian biosimilars stand to expand significantly.
National Biopharma Mission (NBM) and Government Support
Objectives and Funding
- The National Biopharma Mission aims to foster biopharmaceutical development in India under the Make in India initiative.
- This $250 million initiative is co-funded by the World Bank and supports various organizations and MSMEs (Micro, Small, and Medium Enterprises) through shared infrastructure facilities.
Achievements
- The mission has led to over 200 grants and 18 successful product launches, improving healthcare accessibility in India.
Patent Evergreening: Barrier to Biosimilars Market Growth
Understanding Patent Evergreening
- Patents traditionally provide a 20-year exclusivity period to incentivize R&D investment. However, pharmaceutical companies often engage in "evergreening" by making minor modifications or introducing new formulations to prolong exclusivity.
- A notable example is Roche's extension of trastuzumab exclusivity via a subcutaneous formulation close to the original patent's expiration.
- This strategy imposes substantial costs on healthcare systems—estimated at $700 million annually in the U.S.
India’s Legal Framework Against Evergreening
Relevant Legislation
India has implemented several legal provisions to combat evergreening:
- Section 3(d) of the Patents Act, 1970: Prevents patenting minor modifications unless they offer significant technical advancement. For instance, Novartis' patent for Glivec was rejected on these grounds.
- Sections 3(e) and 3(i):
- Section 3(e): Disallows patenting mixtures of known compounds without proving a synergistic effect.
- Section 3(i): Prevents patents on treatment methods.
Challenges
- Despite these regulations, approximately 72% of pharmaceutical patents granted in India are for secondary modifications, which complicates access to biosimilars.
Global Comparison and Potential Solutions
United States
- In the U.S., around 74% of new patents relate to existing drugs, leading to extended monopolies on many top-selling medications.
European Union
- The EU has established biosimilar guidelines since 2005, facilitating a more accessible approval process and promoting biosimilar adoption.
- Countries like Germany and the UK have reaped significant cost savings and improved access to biosimilars.
Way Forward
- To safeguard public health and foster genuine innovation, India must enhance its patent opposition mechanisms.
- This will ensure that the patent system serves its intended purpose—promoting research and development—rather than extending monopolies through trivial modifications.
- By addressing these issues, India can improve access to affordable biosimilars for patients suffering from serious diseases, including cancer, thereby fostering a healthier populace.
