compulsory licensing Flashcards
TRIPS and CL
The TRIPS Agreement allows member nations to grant compulsory licenses under certain conditions, such as in emergencies or for public non-commercial use. Article 31 outlines conditions like non-exclusivity, compensation, and case-by-case evaluation.
CL under Indian Patent Law
Indian law (Sections 84 to 92) allows any interested party to apply for a compulsory license if the patented invention is not available to the public at a reasonable cost, or if it isn’t being used in India.
terms and conditions for CL
license must ensure reasonable royalties,
public access to the invention at reasonable prices.
The licensee’s rights are non-assignable
focused on supplying the Indian market.
CL for exporting patented pharmaceuticals
allowed under specific circumstances, such as when the importing country has insufficient capacity to address public health issues.
termination of compulsory license
When the conditions that justified the compulsory license no longer exist:
The licensee is not complying with the terms:
benefits of CL
can help ensure access to life-saving drugs, resolve deadlocks in technological development, foster the local pharmaceutical industry, and serve the public interest
drawbacks of CL
interference with patent holders’ exclusive rights, diminished innovation incentives, and safety concerns with counterfeit generics. It may also affect trade relations and foreign direct investment.
public interest and CL —> WHAT DOES THIS MEAN
Compulsory licensing can be granted in the public interest, but definitions of “public interest” vary between countries. For example, German law allows it if the public interest cannot be satisfied by other means.
CL to combat anti-competitive practices
n the U.S., compulsory licenses have been granted to combat anti-competitive practices. For example, in U.S. v Glaxo Group Limited, licenses were required to address antitrust violations.
The TRIPS Agreement permits compulsory licenses when the use of a patented invention is dependent on another invention. Both the primary patent holder and the dependent patent holder can benefit through cross-licensing.
The U.K. and the U.S. have used compulsory licensing for governmental purposes. Under Article 31 of TRIPS, governments can use patents for public purposes with remuneration to the patent holder.
France considered compulsory licensing for the abortion pill RU 486.
Ecuador and Brazil have dealt with cases related to pharmaceutical patents.
In Cameroon, a request was made for compulsory licensing of HIV/AIDS drugs.
