Exhaustion of IPRs: introductory concepts

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Exhaustion of IPRs: introductory concepts

  1. 1. 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
  2. 2. 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
  3. 3. 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
  4. 4. 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
  5. 5. 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
  6. 6. 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
  7. 7. 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
  8. 8. 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
  9. 9. 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
  10. 10. 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

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