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Intellectual
property(IP)
©patent ™
patent © ™
i. theory
Aha!new?
useful?
not
obvious?
“static inefficiency”
“dynamic inefficiency
”
ii. practice
LopinavirRitonavir ++
U.S.A., Botswana, India
U.S.A., Botswana, India
...andProcess
Number Relevant Claim1991
5,648,497 RTV molecule Product New Chemical Entity
1993
5,674,882 use of RTV with a PI for HIV Use 5,635,523 use of RTV with an RTI for
inhibiting HIVUse
5,541,206 use of RTV for inhibiting HIV Use 5,846,987 combination of RTV and an RTI
ProductCombination
5,886,036 combination of RTV and a PI Product Combination1996
5 ,037,157
use of RTV to boost a PI Use
6,703,403 use of RTV to inhibit cytochrome P450 monoxygenase
Use
1996
5,914,332 LPV molecule Product New Chemical Entity
6,284,767 use of LPV with RTIs or PIs Use 1997
6,232,333 soft-gel formulation of RTV Product Formulation 6,458,818 soft-gel formulation of RTV &
LPVProduct Formulation
6,521,651 soft-gel formulation of LPV Product Formulation
*
*
Others
$2.5 billion
...andProcess
Number Relevant Claim1991
5,648,497 RTV molecule Product New Chemical Entity
1993
5,674,882 use of RTV with a PI for HIV Use 5,635,523 use of RTV with an RTI for
inhibiting HIVUse
5,541,206 use of RTV for inhibiting HIV Use 5,846,987 combination of RTV and an RTI
ProductCombination
5,886,036 combination of RTV and a PI Product Combination1996
5 ,037,157
use of RTV to boost a PI Use
6,703,403 use of RTV to inhibit cytochrome P450 monoxygenase
Use
1996
5,914,332 LPV molecule Product New Chemical Entity
6,284,767 use of LPV with RTIs or PIs Use 1997
6,232,333 soft-gel formulation of RTV Product Formulation 6,458,818 soft-gel formulation of RTV &
LPVProduct Formulation
6,521,651 soft-gel formulation of LPV Product Formulation
*
*
$$
Bayh Dole Act
U.S.A., Botswana, India
U.S.A., Botswana, India
...andProcess
Number Relevant Claim1991
5,648,497 RTV molecule Product New Chemical Entity
1993
5,674,882 use of RTV with a PI for HIV Use 5,635,523 use of RTV with an RTI for
inhibiting HIVUse
5,541,206 use of RTV for inhibiting HIV Use 5,846,987 combination of RTV and an RTI
ProductCombination
5,886,036 combination of RTV and a PI Product Combination1996
5 ,037,157
use of RTV to boost a PI Use
6,703,403 use of RTV to inhibit cytochrome P450 monoxygenase
Use
1996
5,914,332 LPV molecule Product New Chemical Entity
6,284,767 use of LPV with RTIs or PIs Use 1997
6,232,333 soft-gel formulation of RTV Product Formulation 6,458,818 soft-gel formulation of RTV &
LPVProduct Formulation
6,521,651 soft-gel formulation of LPV Product Formulation
*
*
1995
TRIPs
...andProcess
Number Relevant Claim1991
5,648,497 RTV molecule Product New Chemical Entity
1993
5,674,882 use of RTV with a PI for HIV Use 5,635,523 use of RTV with an RTI for
inhibiting HIVUse
5,541,206 use of RTV for inhibiting HIV Use 5,846,987 combination of RTV and an RTI
ProductCombination
5,886,036 combination of RTV and a PI Product Combination1996
5 ,037,157
use of RTV to boost a PI Use
6,703,403 use of RTV to inhibit cytochrome P450 monoxygenase
Use
1996
5,914,332 LPV molecule Product New Chemical Entity
6,284,767 use of LPV with RTIs or PIs Use 1997
6,232,333 soft-gel formulation of RTV Product Formulation 6,458,818 soft-gel formulation of RTV &
LPVProduct Formulation
6,521,651 soft-gel formulation of LPV Product Formulation
*
*
1995
...andProcess
Number Relevant Claim1991
5,648,497 RTV molecule Product New Chemical Entity
1993
5,674,882 use of RTV with a PI for HIV Use 5,635,523 use of RTV with an RTI for
inhibiting HIVUse
5,541,206 use of RTV for inhibiting HIV Use 5,846,987 combination of RTV and an RTI
ProductCombination
5,886,036 combination of RTV and a PI Product Combination1996
5 ,037,157
use of RTV to boost a PI Use
6,703,403 use of RTV to inhibit cytochrome P450 monoxygenase
Use
1996
5,914,332 LPV molecule Product New Chemical Entity
6,284,767 use of LPV with RTIs or PIs Use 1997
6,232,333 soft-gel formulation of RTV Product Formulation 6,458,818 soft-gel formulation of RTV &
LPVProduct Formulation
6,521,651 soft-gel formulation of LPV Product Formulation
*
*
1995
Number Relevant Claim1996
5,914,332LPV molecule Product New Chemical Entity
*
Others
Others
$Pre - 2005
U.S.A., Botswana, India
U.S.A., Botswana, India
...andProcess
Number Relevant Claim1991
5,648,497 RTV molecule Product New Chemical Entity
1993
5,674,882 use of RTV with a PI for HIV Use 5,635,523 use of RTV with an RTI for
inhibiting HIVUse
5,541,206 use of RTV for inhibiting HIV Use 5,846,987 combination of RTV and an RTI
ProductCombination
5,886,036 combination of RTV and a PI Product Combination1996
5 ,037,157
use of RTV to boost a PI Use
6,703,403 use of RTV to inhibit cytochrome P450 monoxygenase
Use
1996
5,914,332 LPV molecule Product New Chemical Entity
6,284,767 use of LPV with RTIs or PIs Use 1997
6,232,333 soft-gel formulation of RTV Product Formulation 6,458,818 soft-gel formulation of RTV &
LPVProduct Formulation
6,521,651 soft-gel formulation of LPV Product Formulation
*
*
Number Relevant Claim
Others
Others (Imports)
Doha Declaration
August 30th 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, waitfor 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 isnot a solution, it's unacceptable”
Dr. Felipe Garcia de la Vega, MSF
A huge thanksto Michael Steffan for putting this presentation together
