TRIPS Flexibilities

1
TRIPS Flexibilities

• P. Roffe
• ICTSD
• Bellagio, October 2007

2
The relative importance of flexibilities

• The minimum standards of TRIPS
• The Doha Declaration of 2001
• The WHO and IGWIG process
• Two main issues
• 1. Which flexibilities
• 2. Their implementation

3
Which flexibilities?

• Patent and related fields
• A lot has been said and written
• A possible typology
• Pre and post grant
• UNCTAD current work

4
Pre grant
Use of transition periods in case of LDCs -2013 waiver -2016 waiver
Administrative observations and opposition procedures (could adopt post grant oppositions)
Patentable subject matter -Role of patent examiners -Exclusions from patentability (27.2 and 27.3.a TRIPS) -Definition of invention (treatment of new uses, new chemical entities)
Patentability criteria (novelty, inventive step, industrial application). Narrow or wide interpretations
Options outside the patent system in cases of incremental innovations utility models, compensatory liability regimes
Patent claim construction delimiting the boundaries of the invention
Disclosure of patented inventions in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art
5
Post grant
Exceptions to patent rights (scientific research, experimental use bolar or regulatory exception medical treatment or medical practitioner)
Parallel imports
Compulsory licensing -Doha regime
Control of patent abuses and anticompetitive licensing practices
Protection of clinical test data -Misappropriation -Data exclusivity (FTAs) -Cost sharing
6
Implementation

• General principle freedom to determine the
  appropriate method of implementation within own
  legal system and practice
• Pre-conditions
• Political will
• Right policies and institutions in place
• Human resources for their implementation
• Administrative
• Judicial

7
Implementation

• International cooperation
• Role of bilateral donors
• Roles of WIPO, WTO, WHO
• The WIPO Development Agenda