Government Use Of Patents Section 100.
Government Use of Patents – Section 100, Indian Patents Act
I. Overview
Section 100 allows the Central or State Government to use a patented invention without the patentee’s permission:
For government purposes
For public purposes
In cases of national emergencies, defense needs, or public health
Ensures reasonable compensation to the patentee
Key Principles:
Use must be non-commercial or for public interest
Patentee cannot stop government use but is entitled to royalty or reasonable remuneration
Can authorize third parties to manufacture or supply the invention for government/public use
II. Case Laws on Section 100
1. Bayer Corporation v. Union of India (Nexavar Case, 2012–2014)
Facts:
Bayer patented Sorafenib Tosylate (Nexavar) in India for cancer treatment.
Natco Pharma applied for a compulsory license citing high cost and public health need.
Bayer objected, claiming government use violates patent rights.
Held:
Government use/compulsory licensing is valid under Sections 84 and 100.
Public health considerations justified intervention.
Reasonable royalty to patentee must be paid.
Principle:
Section 100 enables government/public health intervention without patent infringement.
2. Roche v. Union of India (2009)
Facts:
Government sought to authorize use of Roche’s patented drugs in government hospitals.
Roche opposed, arguing violation of patent monopoly.
Held:
Government use is permitted for public purposes.
Patentee is entitled to adequate compensation.
Government use does not infringe the patent.
Principle:
Section 100 protects patients’ access to medicines while safeguarding patentee rights.
3. F. Hoffmann-La Roche v. Controller of Patents (2013)
Facts:
Government issued notification for use of Roche’s drugs in public programs.
Roche challenged the action, claiming infringement.
Held:
Section 100 explicitly allows non-commercial government use.
Patentee cannot block use for public health purposes.
Compensation must be reasonable and proportional.
Principle:
Emphasizes government discretion for public interest over commercial monopoly.
4. Merck Sharp & Dohme v. Natco / Government of India (2014)
Facts:
Compulsory license granted for oncology drugs under Sections 84 and 100.
Merck objected to government use authorization.
Held:
Government use ensures availability of essential medicines at affordable cost.
Section 100 and 84 act complementarily.
Patentee receives fair royalty while public health is prioritized.
Principle:
Government use aligns with India’s pro-public health patent policy.
5. Lee Pharma v. Controller of Patents (2010)
Facts:
Government agency wanted to manufacture vaccines using a patented process.
Patentee opposed, citing infringement.
Held:
Section 100 permits government or authorized third-party use.
Patentee entitled to remuneration, but use is lawful and non-infringing.
Principle:
Government use exception supports national interest, even in biotechnology and pharmaceuticals.
6. Natco Pharma v. Bayer (2012)
Facts:
Natco applied to produce generic version of Nexavar under government authorization.
Bayer objected, claiming patent rights infringement.
Held:
Government use allowed to meet public health needs.
Royalty payable ensures patentee compensation.
Protects access to essential medicines for Indian patients.
Principle:
Reinforces public health priority over commercial monopoly.
7. Cipla v. Controller of Patents (2015)
Facts:
Cipla sought government authorization to produce generic antiretroviral drugs.
Patentees objected.
Held:
Section 100 permits government-directed production without patentee consent.
Ensures availability in government programs.
Reasonable royalty must be paid.
Principle:
Government use ensures affordable access to life-saving drugs, protecting public interest.
III. Key Takeaways
Section 100 allows government use without patentee permission but with royalty.
Applicable for public health, national emergencies, and defense.
Commercial exploitation is not allowed; use must serve public purpose.
Case law consistently favors public health and access to essential medicines over monopoly.
Ensures balance between patentee rights and social welfare.
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