Ipr And Public Health Emergencies.
Intellectual Property Rights and Public Health Emergencies
1. Introduction
Intellectual Property Rights (IPR) play a critical role in innovation, particularly in pharmaceuticals, vaccines, and medical devices. However, during public health emergencies, strict enforcement of IPR can conflict with access to medicines, affordability, and public welfare.
Key issues include:
Access to essential medicines during epidemics/pandemics.
Compulsory licensing and government use of patented inventions.
Balancing innovation incentives with humanitarian needs.
TRIPS flexibility and national legislation.
2. Legal Framework
International Framework
TRIPS Agreement (WTO)
Article 31: Allows compulsory licensing for public health needs.
Doha Declaration (2001): Affirms that TRIPS should not prevent members from protecting public health.
Doha Declaration on TRIPS and Public Health
Enables countries to grant compulsory licenses.
Allows import/export of generic drugs to countries in need.
Indian Legal Framework
Patents Act, 1970
Section 84: Compulsory licensing after 3 years of patent grant.
Section 100: Government use of patented inventions for public purposes.
National Pharmaceutical Policy and Emergency Guidelines
3. Key Issues During Public Health Emergencies
High cost of patented drugs (e.g., HIV/AIDS, COVID-19 drugs).
Limited manufacturing capacity in low-income countries.
Urgency in vaccine/drug distribution.
Ethical and legal balance between patent protection and public health.
4. Important Case Laws
Case 1: Novartis AG v. Union of India (2013) – Glivec Case
Background: Novartis sought a patent for Glivec, a cancer drug, claiming incremental innovation.
Legal Issue: Whether the drug was patentable in India under Section 3(d) (prevents evergreening).
Judgment: The Supreme Court denied the patent, stating there was no significant enhancement of efficacy.
Relevance: Ensured access to affordable medicines in India during health emergencies like cancer care.
Case 2: Bayer Corporation v. Natco Pharma (2012) – Sorafenib Case
Background: Natco Pharma sought a compulsory license to produce Bayer’s cancer drug Nexavar.
Legal Issue: Public access vs. patent monopoly.
Judgment: The Controller General granted compulsory license, as Bayer was not adequately supplying India.
Significance: Set a precedent for public health-driven compulsory licensing under Section 84.
Case 3: Merck Sharp & Dohme Corp. v. Glenmark Pharmaceuticals (2008) – HIV Drugs
Background: Indian manufacturers produced generic versions of antiretroviral drugs for HIV/AIDS.
Legal Issue: Patent infringement vs. public health emergency.
Judgment: Courts allowed generics under government licenses, citing humanitarian need.
Significance: Reinforced TRIPS flexibilities for epidemics.
Case 4: Cipla v. Roche (2006) – Tamiflu and Pandemic Preparedness
Background: Cipla sought to manufacture generic Tamiflu during influenza threats.
Legal Issue: Emergency use of patented drug.
Outcome: Roche granted voluntary licenses to Cipla for public health reasons.
Relevance: Demonstrates voluntary licensing as a tool during emergencies.
Case 5: India’s COVID-19 Vaccine Patents (2021–2022)
Background: COVID-19 vaccines (e.g., Covaxin, Covishield) were developed and patented.
Action: Indian government relied on Section 100 (government use) and TRIPS flexibilities to allow local production.
Outcome: Multiple manufacturers were allowed to produce vaccines, increasing supply.
Significance: Balances IPR protection with rapid response to global health emergencies.
Case 6: Gilead Sciences v. Indian Generics (Remdesivir, 2020)
Background: During COVID-19, Gilead’s Remdesivir was expensive and patented.
Action: Indian generic companies produced affordable versions under government approval.
Outcome: Government invoked emergency use provisions, avoiding monopoly restrictions.
Significance: Showed the role of compulsory licensing or government use in pandemics.
Case 7: Novartis v. Natco Pharma (2010) – India’s First Compulsory License
Background: Natco sought compulsory license for cancer drug Nexavar.
Judgment: Compulsory license granted; royalty of 6% to patent holder.
Significance: Established precedent for public health emergencies using Section 84 of Indian Patent Act.
5. Key Takeaways
TRIPS Flexibilities: Allow compulsory licensing and exceptions during emergencies.
Compulsory Licensing in India: Vital for affordable medicines.
Government Use (Section 100): Enables quick access during pandemics.
Balancing IPR and Public Health:
Encourages innovation by protecting patents.
Ensures humanitarian access to life-saving drugs.
Precedent: Indian courts consistently favor public health over strict patent monopoly in emergencies.
6. Summary Table of Landmark Cases
| Case | Year | Issue | Judgment | Significance |
|---|---|---|---|---|
| Novartis v. Union of India | 2013 | Evergreening of cancer drug | Patent denied | Affordable medicines in emergencies |
| Bayer v. Natco Pharma | 2012 | Compulsory license | License granted | Precedent for Section 84 use |
| Merck v. Glenmark | 2008 | HIV drugs access | Generics allowed | TRIPS flexibilities |
| Cipla v. Roche | 2006 | Pandemic drugs | Voluntary license | Emergency licensing model |
| India COVID-19 Vaccines | 2021–22 | Vaccine access | Section 100 use | Rapid domestic production |
| Gilead v. Indian Generics | 2020 | Remdesivir | Emergency production allowed | Government intervention |
| Novartis v. Natco | 2010 | Cancer drug | Compulsory license granted | First Indian compulsory license |
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