The Bolar Exception: Legislative Models and Drafting Options
The basic principle of patent law is that once the term of a patent has expired, the protected subject matter becomes a part of the public domain. Hence, it can be freely used, including for commercial purposes, without the interference by the former patent owner. This allows competitors to enter the market immediately after such expiry, eventually leading to lower prices for consumers and welfare gains. (more…)
Implementing Pro-Competitive Criteria for the Examination of Pharmaceutical Patents
This document discusses criteria for implementing the patentability requirements in relation to patent applications covering products and processes, as well as the use of pharmaceutical products. The adoption of rigorous criteria with this purpose is important for four main reasons. (more…)
The grant of patents and the exorbitant cost of “lifesaving” drugs
By Germán Velásquez
The important relationship between the examination of patents carried out by national patent offices and the right of citizens to access to medicines hasn’t always been well understood. Too often these are viewed as unrelated functions or responsibilities of the state. And the reason is clear: patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators. This is the case when patent policy is implemented in isolation from, rather than guided by, public health policy. (more…)
Guidelines on Patentability and Access to Medicines
The important relationship between the examination of patents carried out by national patent offices and the right of citizens to access to medicines hasn’t always been well-understood. Too often these are viewed as to unrelated functions or responsibilities of the State . And the reason is clear: Patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators. (more…)
The WIPO Negotiations on IP, Genetic Resources and Traditional Knowledge: Can It Deliver?
There has been much expectation on what the Intellectual Property Organization (WIPO) can deliver on intellectual property aspects of the protection of genetic resources (GRs), traditional knowledge (TK) and related traditional cultural expressions (TCEs). Results from fourteen years of extensive study, analysis and discussion have been distilled into three negotiating texts. But in July 2014, negotiations suffered a reversal. (more…)
Lack of Progress at the Twenty-Second Session of the WIPO SCP for a Balanced and Development-Oriented Work Programme on Patent Law Related Issues
The twenty-second session of the WIPO Standing Committee on the Law of Patents (SCP) was held in Geneva from 27 to 31 July 2015. About seven years since the Standing Committee on the Law of Patents (SCP) of the World Intellectual Property Organization (WIPO) had reconvened in June 2008 with a focus on developing a balanced work programme on issues relating to the law of patents that would also address development and public policy issues that arise in the context of the patent system, the SCP has been unable to agree on a work programme on any issue related to patents and development. (more…)
Intellectual Property in the Trans-Pacific Partnership: Increasing the Barriers for the Access to Affordable Medicines
Most free trade agreements signed by the United States, the European Union and the members of the European Free Trade Association (EFTA) in the last 15 years contain chapters on intellectual property rights with provisions applicable to pharmaceuticals. Such provisions considerably expand the rights recognized to pharmaceutical companies under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) established in the context of the World Trade Organization. (more…)
Guidelines on Patentability and Access to Medicines
Until recently, the link between the examination of patents carried out by national patent offices and the right of citizens to access to medicines was not at all clear. They were two functions or responsibilities of the State that apparently had nothing to do with each other. Examining the growing literature on intellectual property and access to medicines, it seems that the analysis of one actor has been left out: the patent offices. (more…)
Speaking notes by Martin Khor, Executive Director of the South Centre, for the Social Forum of the United Nations Human Rights Council, 18 February 2015
The following is a statement presented by Martin Khor, Executive Director of the South Centre, during the 2015 Social Forum of the United Nations Human Rights Council which took place from 18 to 20 February 2015 in Palais des Nations, Geneva, Switzerland. (more…)
Patent Examination and Legal Fictions: How Rights are Created on Feet of Clay
Patents are often presented as an absolute property, comparable to property over land. This simplification overlooks that patent rights are conferred without a solid determination of the factual conditions required for such rights to arise out. The examination process of patent applications faces substantial limitations, even in the case of large patent offices, to determine whether a claimed invention actually meets the patentability standards, however defined. (more…)
Transition Period for Providing Patent Protection for Pharmaceutical Products by LDCs: The Need for Extension
How can Least Developed Countries (LDCs) make effective use of the transition period for the purposes stated in Article 66.1 of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), and in particular to promote access to affordable medicines and promote local manufacturing of generic medicines? Should LDCs seek a further extension of the transition period for pharmaceutical products beyond 1 January 2016?
The African Regional Intellectual Property Organization (ARIPO) Protocol on Patents: Implications for Access to Medicines
This paper was commissioned to better understand the workings of the African Regional Intellectual Property Organization (commonly known as “ARIPO”) with regard to its Protocol on Patents and Industrial Designs and to examine the effect of implementation of the Protocol (Section on Patents) on the promotion of access to affordable medicines. (more…)
