exhaustion of iprs: introductory concepts
TRANSCRIPT
Introductory concepts
Doctrine of exhaustion Typical types of exhaustion
Factors to balance Singapore’s balance of access and protection for
patented pharmaceutical products
Lam Pak Nian, 2013/2014
What is exhaustion?
• An intellectual property right is the negative right to exclude
– A patent, inter alia, allows the owner to exclude others from making or selling an invention
• Right to exclude is limited by ‘exhaustion’
– IPR owner’s control over the physical product ends once the product is first sold
– Purchaser is free to use or resell that product without further restraint from patent law
Lam Pak Nian, 2013/2014
Parallel imports
• Exhaustion of rights provides the legal basis for parallel imports
– Parallel imports are goods produced and sold legally but subsequently exported into another jurisdiction
• Take advantage of pricing differences, etc
• Parallel imports take advantage of the purchaser’s right to resell
– Genuine goods, unauthorised resale
Lam Pak Nian, 2013/2014
Typical types of exhaustion International Regional National
IPRs in good exhausted once sold in any country
IPRs in good exhausted once sold within the region
IPRs in good exhausted once sold within the country
Parallel imports allowed once sold in any country
Parallel imports only allowed from countries within the region
Parallel imports not allowed from any other country
Least protection Most access
Most protection Least access
Lam Pak Nian, 2013/2014
International exhaustion
Pill image: D Dinneen
IPRs in good exhausted once it is sold in any country
Exhausted when sold in any country
Position in country: International exhaustion
Lam Pak Nian, 2013/2014
Regional exhaustion
Pill image: D Dinneen
IPRs in good exhausted only when it is sold within the region
Position in country/region: Regional exhaustion
Exhausted when sold in region
Not exhausted when sold
outside region
Lam Pak Nian, 2013/2014
National exhaustion
Pill image: D Dinneen
IPRs in good exhausted only when product is sold within the country
Position in country: National exhaustion
Exhausted when sold in country
Not exhausted when sold anywhere
outside country
Lam Pak Nian, 2013/2014
Typical types of exhaustion International Regional National
IPRs in good exhausted once sold in any country
IPRs in good exhausted once sold within the region
IPRs in good exhausted once sold within the country
Parallel imports allowed once sold in any country
Parallel imports only allowed from countries within the region
Parallel imports not allowed from any other country
Least protection Most access
Most protection Least access
Lam Pak Nian, 2013/2014
Balance?
More access (allow parallel imports)
More protection (block parallel imports)
Consumers and governments want to be able to get pharmaceutical products
Pharmaceutical companies want to be able to
segregate the world and price discriminate
Public health considerations
Incentive and reward
Features of chosen exhaustion regime have an important impact on the parallel trade of pharmaceuticals
Lam Pak Nian, 2013/2014
S 66(2)(g): General parallel import defence (i.e. international exhaustion)
Singapore’s hybrid approach
Pill image: D Dinneen
Before first sale in SG: National exhaustion
S 66(3) 1st mover
adv
S 66(2)(i) Specific
patient use
S 66(2)(h) Marketing approval
After first sale in SG: International exhaustion
S 66(3) 1st mover adv taken
S 66(2)(g) General international exhaustion
for all patented products
Specific to pharmaceutical pdts
Singapore’s balance of access and
protection for patented
pharmaceutical products
Exhausted
Exhausted
Exhausted
Not exhausted
Lam Pak Nian, 2013/2014