Amendments In Patents Ordinance
Amendments in Patents Ordinance
The Patents (Amendment) Ordinances and Acts in India have evolved primarily to align Indian patent law with international obligations, particularly TRIPS, and to clarify patentability, enforcement, and procedural rules.
The main amendments occurred in:
1999 Patents (Amendment) Ordinance – TRIPS compliance.
2002 & 2005 Amendments – Product patents in pharmaceuticals.
2005 Patents (Amendment) Act – Introduced product patents for drugs, medicines, chemicals.
2012 & 2021 Amendments – Procedural efficiency, pre-grant opposition, compulsory licensing.
Key Areas of Amendments
Patentable Subject Matter
Before 2005, India allowed only process patents for pharmaceuticals.
Post-2005 amendment, product patents were allowed in compliance with TRIPS, meaning even drugs, chemicals, and food products could be patented.
Definition of Inventive Step & Section 3(d)
Section 3(d) was introduced to prevent evergreening of patents.
Amendment clarified that mere new forms of known substances are not patentable unless they enhance efficacy.
Compulsory Licensing (Section 84)
Amendment introduced conditions under which patents can be licensed compulsorily to protect public interest and access to medicines.
Pre- and Post-Grant Opposition
Amendments allowed third parties to oppose patent grants before or after issuance, improving transparency.
Patent Term & Transitional Provisions
Adjusted timelines for existing patents and clarified protection of previously granted process patents.
Case Laws on Amendments in Patents Ordinance
Case 1: Novartis AG v. Union of India (2013)
Relevance: Section 3(d) and 2005 Amendments (product patents for pharmaceuticals).
Facts: Novartis claimed a patent for beta-crystalline Imatinib, a cancer drug. Indian Patent Office rejected it under Section 3(d).
Principle: Mere new forms of known drugs without significant therapeutic efficacy cannot be patented.
Outcome: Supreme Court upheld rejection.
Lesson: The 2005 amendment strengthened public health safeguards, preventing evergreening of patents.
Case 2: Bayer Corporation v. Union of India (2009)
Relevance: Compulsory licensing and amendments to patentability criteria.
Facts: Bayer sought to enforce a patent on Sorafenib. Indian authorities considered granting compulsory license to generic companies due to public interest.
Principle: Amendments allow government to override patent rights in exceptional circumstances to protect public health.
Outcome: Licensing negotiations ensued; later patent was challenged on pricing and accessibility grounds.
Lesson: Amendments made Indian patent law flexible to balance rights of patentees and public health.
Case 3: Roche v. Cipla (India)
Relevance: Pre-grant and post-grant opposition amendments.
Facts: Roche held a patent for a lung cancer drug; Cipla applied for pre-grant opposition citing prior art.
Principle: Amendments allowed third parties to oppose patent applications before grant.
Outcome: Indian Patent Office revoked certain claims after opposition.
Lesson: Amendments improved transparency and accessibility in patent enforcement.
Case 4: GlaxoSmithKline (GSK) v. Natco Pharma
Relevance: Compulsory licensing post-2005 amendments.
Facts: GSK patented a cancer drug. Natco applied for a compulsory license citing affordability and public demand.
Principle: Section 84 of amended Patents Act allows compulsory license if reasonable access is not provided.
Outcome: Natco granted license at substantially lower price than GSK.
Lesson: Amendments empower generic manufacturers to increase access to life-saving drugs.
Case 5: Bayer v. Natco Pharma (Sunitinib Malate Case)
Relevance: 2005 & 2012 amendments related to post-grant opposition and compulsory licensing.
Facts: Bayer’s patent challenged by Natco under Section 84.
Principle: Patent amendments allow challenging patents that do not meet affordability or public need standards.
Outcome: Natco was able to manufacture under compulsory licensing.
Lesson: Amendments protect public interest, while respecting patent rights.
Case 6: Novartis v. Union of India (Evergreening Debate)
Relevance: Highlights Section 3(d) and the 2005 amendment preventing evergreening of patents.
Principle: Clarified the difference between patentable innovation and minor modification.
Outcome: Sets precedent for future amendments enforcement.
Lesson: Encourages true innovation while preventing monopolistic extensions of existing patents.
Key Features Introduced by Patents Ordinance Amendments
| Feature | Amendment Effect / Legal Principle |
|---|---|
| Product Patents | 2005 amendment allows drugs, chemicals, food products. |
| Section 3(d) | Prevents evergreening; requires enhanced efficacy. |
| Compulsory Licensing | Section 84 allows government intervention for public health. |
| Pre- and Post-Grant Opposition | Transparency and opposition rights for third parties. |
| Patent Term & Transitional Provisions | Clarifies treatment of existing process patents. |
| Public Health Safeguard | Amendments balance innovation and access to medicines. |
Conclusion
The Patents (Amendment) Ordinances significantly reshaped Indian patent law, especially in pharmaceuticals.
Judicial interventions have reinforced the intent of the amendments:
Encourage true innovation
Prevent evergreening
Protect public health and accessibility
Case laws like Novartis, Natco, Bayer, and Cipla demonstrate practical enforcement of amendments.
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