Patent Disputes In Pharmaceutical Sector.
1. Introduction
The pharmaceutical sector is one of the most litigation-heavy sectors in patent law due to:
High R&D costs
Public health concerns
Access to affordable medicines
Global trade obligations (TRIPS compliance)
Patent disputes in this sector often revolve around:
Patentability of new forms of known drugs
Evergreening
Compulsory licensing
Infringement and injunctions
Validity challenges
Data exclusivity and regulatory approvals
The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement sets the international backdrop, while the Indian Patents Act, 1970 (amended 2005) governs domestic disputes.
2. Key Grounds of Pharmaceutical Patent Disputes
Section 3(d) – Patentability of New Forms
Prevents “evergreening” by granting patents only if enhanced efficacy is shown.
Infringement
Alleged copying of patented drug formulations, dosage, or process.
Compulsory Licensing (Section 84)
Government may allow production of patented drugs if the drug is unaffordable or not worked in India.
Opposition Mechanisms
Pre-grant opposition (Sec 25(1))
Post-grant opposition (Sec 25(2))
3. Landmark Case Laws in Pharmaceutical Patent Disputes
Case 1: Novartis AG v. Union of India (Gleevec/Imatinib)
Facts:
Novartis applied for a patent on beta crystalline form of Imatinib mesylate (Gleevec) in 1998. The patent was initially rejected under Section 3(d).
Issue:
Whether the new form of a known substance (Imatinib) qualifies as an invention under Indian law.
Held:
Supreme Court rejected the patent in 2013.
Reasoning:
The new form did not show enhanced efficacy over the known substance.
Section 3(d) prevents evergreening, ensuring affordable medicines.
Legal Principle:
India strictly applies Section 3(d) to prevent minor modifications from extending monopoly rights.
Balances patent protection with public health interests.
Case 2: Roche v. Cipla
Facts:
Roche held a patent for Tarceva (Erlotinib), a cancer drug. Cipla challenged it and launched a generic version.
Issue:
Whether Cipla’s version infringed Roche’s patent.
Held:
High Court held that Roche’s patent was enforceable.
Cipla’s formulation had to respect patent claims, but was allowed for export to countries where the patent was not enforceable.
Legal Principle:
Pharmaceutical patents are territorial.
Enforcement depends on exact claim scope and country-specific rights.
Case 3: Bayer Corporation v. Natco Pharma Ltd.
Facts:
Bayer patented Sorafenib Tosylate (Nexavar) for liver and kidney cancer. Natco applied for compulsory license citing affordability issues.
Issue:
Whether Natco could be granted a compulsory license.
Held:
Controller General granted the compulsory license in 2012.
The drug was not affordable and not worked to an adequate extent in India.
Legal Principle:
Section 84 enables access to essential medicines through compulsory licensing.
Affordability and availability are crucial factors.
Case 4: Bristol-Myers Squibb v. Natco Pharma
Facts:
BMS’s patent for Dasatinib (cancer drug) was challenged on validity grounds by Natco.
Issue:
Whether patent claims lacked novelty and inventive step.
Held:
Opposition Board analyzed prior art and held some claims invalid.
Only valid claims survived.
Legal Principle:
Pre- and post-grant opposition can trim unwarranted claims.
Encourages generic competition while respecting innovation.
Case 5: Pfizer v. Cipla (Sildenafil/Viagra)
Facts:
Pfizer sued Cipla for producing generic Sildenafil tablets (Viagra) post-patent expiry in India.
Issue:
Determination of patent term expiry
Whether Cipla’s product infringed any secondary patents
Held:
Court recognized patent expiration and allowed generics.
Reinforced patent term limits and limits of enforcement.
Legal Principle:
Patent rights are time-bound
Public domain drugs can be freely produced post-expiry
Case 6: Gilead Sciences v. Natco Pharma
Facts:
Gilead patented Sofosbuvir (Hepatitis C drug). Natco sought compulsory licensing.
Issue:
Whether the patented drug is affordable and sufficiently worked in India.
Held:
Controller General refused initial compulsory license but negotiations led to voluntary licensing for generic production.
Legal Principle:
Encourages voluntary licensing agreements as a balance between innovation and access.
Regulatory and commercial strategies are intertwined in pharmaceutical patent disputes.
4. Common Themes From Pharmaceutical Patent Disputes
Section 3(d) is key to Indian law
Prevents minor chemical modifications from gaining exclusive monopoly.
Compulsory licensing is a public health tool.
Generic manufacturers often challenge patents to ensure affordable medicines.
Patent disputes combine law, science, and economics
Novelty, inventive step, efficacy, and public interest are assessed.
Global and local jurisdiction differences influence enforcement.
5. Conclusion
Pharmaceutical patent disputes in India:
Are frequent and highly litigated
Focus on balancing innovation incentives and public health needs
Require careful scientific and legal analysis
Often involve evergreening, compulsory licensing, and post-grant oppositions
Indian courts and patent offices consistently emphasize affordable healthcare, while simultaneously protecting genuine innovation.
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