Patent Injustice, Challenges and Recommendations

Explore the critical issues and ethical dilemmas surrounding patent laws in 'Patent Injustice.' Dive into cases of innovation suppression, monopolies, and the impact of patent regulations on accessibility, progress, and fairness within global markets.

Table of Contents

The Indian biopharmaceutical industry is rapidly expanding, currently valued at $60 billion. This growth is driven by increased innovation, with India rising to 39th place in the Global Innovation Index, up from 81st in 2015.

Definition

Biopharmaceuticals: These are medicines made from living cells, such as yeast and bacteria, as against conventional drugs that are made from chemicals.

Useful in the treatment of chronic diseases like cancer, diabetes, cardiovascular disease, and serious inflammatory autoimmune diseases.
These include biologics and biosimilars.
- Biologic (or biologic drug): It is a medicine made in a living system, such as yeast, bacteria, or animal cells.
- Biosimilars (or follow-on biologics): These refer to a biologic that is very similar to the one that has been cleared by the authorities for prescription by doctors.
  - They are also known as follow-on biologics and share the same efficacy and safety profiles.

Facts

India is a leader in the biosimilar market, being the first country to approve a biosimilar for Hepatitis B.
India has 98 approved biosimilars, with around 50 available in the market, making it the largest market for biosimilars globally.
The Indian biosimilars market, valued at $349 million in 2022, is projected to grow at 25.2% per year to reach $2,108 million by 2030.
Patent expirations for biologic products (worth around $170 billion) by 2030 present an opportunity for India to launch more biosimilars.

National Biopharma Mission (NBM)

Under the Make in India Initiative, the government launched the National Biopharma Mission (NBM), co-funded by the World Bank with a budget of $250 million.
Aims to accelerate biopharmaceutical development through industry-academia collaboration.
Supports nearly 150 organisations and 300 MSMEs, establishing 21 shared infrastructure facilities pivotal for research and biomanufacturing.
Despite these efforts, India holds only a 3% share of the global biosimilar market.

Challenges: Patent Evergreening

Patent Evergreening is a tactic where companies extend a drug’s market monopoly by making minor modifications when the original patent expires.
- This delays biosimilar entry and keeps prices high.
- Example: Roche extended trastuzumab (Herceptin) exclusivity by introducing a modified version as the original patent expired. This practice costs the US healthcare system around $700 million annually.

India’s Legal Framework and Patent Evergreening Prevention

Section 3(d) of India’s Patents Act (1970) prevents evergreening by denying patents for minor improvements without substantial advancements.
- Example: Novartis’s application for Glivec was rejected, setting a strong precedent against evergreening.
Other relevant provisions include:
- Section 3(e), which limits patenting mixtures of known compounds.
- Section 3(i), which prevents patents on treatment methods.
Despite these safeguards, around 72% of pharmaceutical patents granted are for minor modifications, suggesting a need for stronger patent scrutiny.

Global Context: EU and US Patent Practices

In the US, 74% of new patents are linked to existing drugs, with 80% of top-selling drugs granted extended patents.
The European Union has adopted clear biosimilar guidelines, resulting in high adoption rates and cost savings in countries like Germany, the UK, and Nordic nations.

Recommendations

India needs to further strengthen patent opposition mechanisms to prevent evergreening and ensure public health is prioritised.
This approach will improve access to affordable biosimilars and uphold the patent system’s true purpose: encouraging meaningful innovation rather than prolonging monopolies.