Intellectual property (IP)

© patent ™

© ™

i. theory

Aha! new? useful? not obvious?

“static inefficiency”

“dynamic inefficiency”

ii. practice

Lopinavir Ritonavir+

U.S.A., Botswana, India

...and Process NumberRelevant Claim ,648,497RTV moleculeProductNew Chemical Entity ,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 ,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use ,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse ,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * *

Others $2.5 billion

...and Process NumberRelevant Claim ,648,497RTV moleculeProductNew Chemical Entity ,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 ,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use ,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse ,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * * $$

Bayh Dole Act

U.S.A., Botswana, India

...and Process NumberRelevant Claim ,648,497RTV moleculeProductNew Chemical Entity ,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 ,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use ,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse ,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * * 1995

TRIPs

...and Process NumberRelevant Claim ,648,497RTV moleculeProductNew Chemical Entity ,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 ,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use ,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse ,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * * 1995

...and Process NumberRelevant Claim ,648,497RTV moleculeProductNew Chemical Entity ,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 ,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use ,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse ,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * * 1995

NumberRelevant Claim ,914,332LPV moleculeProductNew Chemical Entity *

Others

$ Pre

U.S.A., Botswana, India

...and Process NumberRelevant Claim ,648,497RTV moleculeProductNew Chemical Entity ,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 ,037,157use of RTV to boost a PIUse 6,703,403use of RTV to inhibit cytochrome P450 monoxygenase Use ,914,332LPV moleculeProductNew Chemical Entity 6,284,767use of LPV with RTIs or PIsUse ,232,333soft-gel formulation of RTVProductFormulation 6,458,818soft-gel formulation of RTV & LPVProductFormulation 6,521,651soft-gel formulation of LPVProductFormulation * *

NumberRelevant Claim

Others Others (Imports)

Doha Declaration

August 30 th Decision

Canadian Access to Medicine Regime

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

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

A huge thanks to Michael Steffan for putting this presentation together