1. Intellectual property (IP)

2. © patent ™

3. © ™

4. i. theory

5. Aha! new? useful? not obvious?

6. “static inefficiency”

7. “dynamic inefficiency”

9. ii. practice

10. Lopinavir Ritonavir+

11. U.S.A., Botswana, India

14. ...and Process NumberRelevant Claim 1991 5,648,497RTV moleculeProductNew Chemical Entity 1993 5,674,882use of RTV with a PI for HIVUse 5,635,523use of RTV with an RTI for inhibiting HIVUse 5,541,206use of RTV for inhibiting HIVUse 5,846,987combination of RTV and an RTI Product Combination 5,886,036combination of RTV and a PIProductCombination 1996 5,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use 1996 5,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse 1997 6,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * *

15. Others $2.5 billion

16. ...and Process NumberRelevant Claim 1991 5,648,497RTV moleculeProductNew Chemical Entity 1993 5,674,882use of RTV with a PI for HIVUse 5,635,523use of RTV with an RTI for inhibiting HIVUse 5,541,206use of RTV for inhibiting HIVUse 5,846,987combination of RTV and an RTI Product Combination 5,886,036combination of RTV and a PIProductCombination 1996 5,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use 1996 5,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse 1997 6,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * * $$

17. Bayh Dole Act

18. U.S.A., Botswana, India

20. ...and Process NumberRelevant Claim 1991 5,648,497RTV moleculeProductNew Chemical Entity 1993 5,674,882use of RTV with a PI for HIVUse 5,635,523use of RTV with an RTI for inhibiting HIVUse 5,541,206use of RTV for inhibiting HIVUse 5,846,987combination of RTV and an RTI Product Combination 5,886,036combination of RTV and a PIProductCombination 1996 5,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use 1996 5,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse 1997 6,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * * 1995

21. TRIPs

22. ...and Process NumberRelevant Claim 1991 5,648,497RTV moleculeProductNew Chemical Entity 1993 5,674,882use of RTV with a PI for HIVUse 5,635,523use of RTV with an RTI for inhibiting HIVUse 5,541,206use of RTV for inhibiting HIVUse 5,846,987combination of RTV and an RTI Product Combination 5,886,036combination of RTV and a PIProductCombination 1996 5,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use 1996 5,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse 1997 6,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * * 1995

23. ...and Process NumberRelevant Claim 1991 5,648,497RTV moleculeProductNew Chemical Entity 1993 5,674,882use of RTV with a PI for HIVUse 5,635,523use of RTV with an RTI for inhibiting HIVUse 5,541,206use of RTV for inhibiting HIVUse 5,846,987combination of RTV and an RTI Product Combination 5,886,036combination of RTV and a PIProductCombination 1996 5,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use 1996 5,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse 1997 6,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * * 1995

24. NumberRelevant Claim 1996 5,914,332LPV moleculeProductNew Chemical Entity *

25. Others

26. $ Pre - 2005

27. U.S.A., Botswana, India

29. ...and Process NumberRelevant Claim 1991 5,648,497RTV moleculeProductNew Chemical Entity 1993 5,674,882use of RTV with a PI for HIVUse 5,635,523use of RTV with an RTI for inhibiting HIVUse 5,541,206use of RTV for inhibiting HIVUse 5,846,987combination of RTV and an RTI Product Combination 5,886,036combination of RTV and a PIProductCombination 1996 5,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use 1996 5,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse 1997 6,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * *

30. NumberRelevant Claim

31. Others Others (Imports)

32. Doha Declaration

33. August 30 th Decision

34. Canadian Access to Medicine Regime

35. First application of the CAMR May 2004 – CAMR created Sept 2007 –compulsory license issued for Canada to export HIV/AIDS triple therapy to Rwanda May 2008 – Apotex awarded contract Sept 2008 – first shipment en route

36. Failure of the CAMR “When we order medicines normally, all we need to do is type up a form, send it to the supplier and pay the bill - then we receive the shipment. With this system we have to persuade a government to notify the WTO, find a company willing to produce, push to get a drug on the list of eligible medicines, wait for voluntary license negotiations to be completed, wait for the compulsory license application to be made, and then granted.... For a disease that kills 8,000 people a day … this is not a solution, it's unacceptable” Dr. Felipe Garcia de la Vega, MSF

37. A huge thanks to Michael Steffan for putting this presentation together