Patent Rights & Public Health: What are India’s Options?

Syllabus: GS2/Issues Related To Health; GS3/ S&T

Context

• India stands at a critical intersection between the enforcement of Intellectual Property Rights (IPRs) and the fulfillment of its public health obligations.

Public Health and Patent Rights in India

• Public health obligations demand equitable access to affordable medicines and technologies, while patents are designed to promote innovation and encourage investment in research.
• It is essential for ensuring that Intellectual Property (IP) laws serve both innovation and humanity, as India (Bharat) serves as the ‘pharmacy of the Global South’.

Constitutional and Institutional Framework

• Article 21 of the Constitution: It guarantees the right to life, a right that the Supreme Court has consistently interpreted to include the right to health.
• World Trade Organization (WTO): India is a member of the WTO and bound by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.
  • It mandates the protection of intellectual property and allows flexibilities like member states have the right to protect public health and promote access to medicines for all (Doha Declaration on TRIPS and Public Health, 2001).
• The Patents Act, 1970 and its amendment in 2005 provides the legal backbone for India’s patent system.
  • It embeds safeguards to prevent abuse of monopoly rights while it protects genuine inventions.

TRIPS Flexibilities and India’s Strategic Use

• India’s patent regime utilizes TRIPS-compliant flexibilities to promote health equity. These include:
  • Parallel imports: Allowing importation of patented products marketed abroad at lower prices.
  • Compulsory licenses for export (Section 92A): Permitting production of patented drugs for export to countries with insufficient manufacturing capacity.
  • Price control mechanisms: Ensuring affordability through the National Pharmaceutical Pricing Authority (NPPA).
• Such measures have earned India recognition as a model for developing nations, balancing TRIPS obligations with social justice.

Concerns & Issues Surrounding Public Health and Patent Rights in India

• Evergreening Challenge: Evergreening in the pharmaceutical and agricultural sectors undermines equitable access to essential goods.
  • Pharmaceutical companies from the Global North often attempt to ‘evergreen’ patents by making minor modifications such as new salts, formulations, or dosage forms without significant therapeutic advancement.
    • It restricts competition, delays generic entry, and inflates drug prices.
• Conflict Between Innovation and Access:
  • For innovators, patents represent recognition of intellectual effort and a means to recover R&D investments.
  • For society, excessive monopoly protection risks making essential medicines unaffordable, particularly for low-income populations.
• High Cost of Patented Drugs: Patented medicines in India often cost ten to thirty times more than generic alternatives.
  • Patent monopolies directly affect affordability and access, especially for chronic and life-threatening diseases like cancer and hepatitis.
  • As a result, millions of Indians are pushed into catastrophic health expenditure every year due to high drug costs.
• Limited Use of TRIPS Flexibilities: Though TRIPS allows nations to adopt flexibilities like compulsory licensing, government use provisions, and parallel imports, India’s use of these tools has been sporadic and cautious.
  • Since 2012, only one compulsory license has been granted largely due to political pressure and fear of trade retaliation from developed countries.
• Pressure from Global Trade Partners: India faces significant diplomatic and trade pressure from developed nations, especially the United States and the European Union to strengthen IP enforcement and dilute domestic safeguards and compulsory licensing.
  • Inclusion of India on the US Trade Representative’s ‘Priority Watch List’ reflects ongoing scrutiny of its patent practices.
  • Such external pressures threaten India’s sovereign right to design IP policies suited to its public health and socio-economic realities.
• Weaknesses in Healthcare Infrastructure: It includes inadequate distribution of essential drugs in rural areas, dependence on private healthcare, where drug prices are unregulated, and limited public procurement of patented or life-saving medicines.
• R&D and Indigenous Innovation Gaps: Domestic innovation remains underfunded, as India spends less than 1% of its GDP on R&D, compared to over 2.5% in developed countries.
• Abuse of Dominant Position: Some patentees engage in anti-competitive behavior, such as imposing excessive licensing fees; restricting supply chains; and engaging in ‘patent clustering’ to deter generic entry.
  • Such practices may violate the Competition Act, 2002, but enforcement remains limited.

Balancing Public Health and Patent Rights in India

• Safeguards Against Evergreening: The Section 3(d) of the Patents Act prohibits patents on new forms of known substances unless they result in enhanced therapeutic efficacy.
  • It prevents pharmaceutical companies from ‘evergreening’ patents prolonging monopolies through trivial modifications to existing drugs.
• Compulsory Licensing: The government or any interested party can seek a compulsory license (under Sections 84 and 92A of the Patents Act) to produce a patented drug without the patentee’s consent if:
  • The drug is not available at a reasonable price,
  • The patentee has failed to meet domestic demand, or
  • It is required for public health or export to countries lacking manufacturing capacity.
• Protecting Public Health: India’s Patents Act gives the central and state governments several powers to safeguard public health:
  • Section 47(4): Allows the government to use or import patented inventions for public institutions without patentee consent.
  • Section 66: Permits revocation of a patent if it is ‘mischievous to the state’ or ‘prejudicial to the public’.
  • Section 102: Authorizes the government to acquire a patent in the public interest, compensating the patentee fairly.
• Balancing Through Competition Law: The Competition Act, 2002 acts as a complementary mechanism to the Patents Act.
  • It prohibits abuse of dominant position and anti-competitive practices by patent holders.
  • India promotes both innovation and affordability by integrating competition principles with patent law.

Policy Recommendations for a Sustainable Balance

• Formulate a National Patent Policy integrating public health objectives.
• Encourage indigenous innovation through state-funded R&D and academic partnerships.
• Enhance the use of TRIPS flexibilities, including compulsory licensing in public interest.
• Strengthen collaboration between the Patent Office, Drug Controller, and Competition Commission.
• Improve drug distribution systems, ensuring rural access to essential patented and generic medicines.
  • These measures can ensure that intellectual property rights coexist with India’s constitutional commitment to health and welfare.

Source: IE