HIV Treatment and Intellectual Property Rights: The

Experience of the Medicines Patent Pool

Esteban BurroneMelbourne – International AIDS Conference

July 2014 1

Innovation in HIV treatment

• 29 new ARV molecules developed for the treatment of HIV since virus discovered

• Several fixed dose combinations developed that contain 3 or 4 ARVs in one single pill

• Innovation on an unprecedented scale

• Need to ensure access

1985     1990       1995       2000       2005       2010       2015       2020       2025     2030

 TRIPS Transition for Developing Countries                                                  

  TRIPS Transition for Least Developed Countries                                       Zidovudine      Didanosine      Stavudine      Saquinavir      Nevirapine      Abacavir      Emtricitabine      Lamivudine      Indinavir                  Efavirenz                                  

Darunavir1985     1990       1995       2000       2005       2010       2015       2020       2025     2030   ` Lopinavir    Atazanavir    Tenofovir Disproxil Fumarate (TDF)    Fosamprenavir    Maraviroc    Etravirine  

Tenfovir Alfenamide Fumarate (TAF)  Rilpivirine    Raltegravir    Elvitegravir  

Ritonavir heat-stable  Dolutegravir    Cobicistat  1985     1990       1995       2000       2005       2010       2015       2020       2025     2030

* Secondary patents on some of these products may extend patent protection beyond the date shown.

Patents on new ARVs

3

Increased Patenting of ARVs in Developing Countries

• Increased patenting of ARVs in developing countries for ARVs developed since 1995

• Analysis based on information for 75 developing countries accounting for 80% of people living with HIV

4

Pre-1995 ARVs Post-1995 ARVs

0

5

10

15

20

25

30

35

40

Median number of develop-ing countries in which basic patents on ARVs were filed

(out of 75)

Source: Medicines Patent Pool Patent Status Database on Selected ARVs (2012)

Pattern particularly visible in key countries of production of generic ARVs

5

Albania

Arm

eniaB

osnia and Herzego...

EAPO

(9 countries)G

uatemala

Honduras

JordanLithuaniaM

oldovaM

ongoliaPanam

aV

ietnamC

olombia

IndiaIndonesiaK

yrgyzstanM

oroccoN

icaraguaPeruTajikistanEgyptG

eorgiaSri LankaU

zbekistanA

lgeriaB

razilC

hileM

alaysiaU

kraineU

ruguayO

API (16 countries)

ThailandA

RIPO

(18 countries)C

hinaM

exicoPakistanR

ussiaA

rgentinaPhilippinesSouth A

fricaTO

TAL possible

0

4

8

12

Pre-1995 ARVs 1995 and later ARVs

Num

ber

of

AR

Vs f

or

whic

h

basic

pate

nts

were

sought

Source: Medicines Patent Pool Database

• Patenting of ARVs in developing countries is more common for medicines developed after 1995 than for those developed before 1995 (date of entry into force of the TRIPS agreement)

Challenges for Fixed Dose Combinations

Generic access

Patent held by A

• Fixed-dose combinations improve treatment adherence for adults and children alike

• But patents on single ARV can impact on the development of whole FDC

• There are also patents on the combinations themselves

Generic access

Long Lag from Originator Market Approval to Generic Availability

FDA/EMA Approval

0 1 2 3 4 5 6 7 8 9 10

Timeline From Originator Approval to Generic Availability:

Generic Approvals

Years

• Time from US FDA approval of new ARV molecules to availability as quality assured generics for developing countries has generally ranged from 5 to 10 years

THE MEDICINES PATENT POOL

8

PATENT HOLDERS

LicencesSub-Licences Medicines

MANUFACTURERS PEOPLE LIVING WITH HIV

ROYALTIES

Medicines Patent Pool

Established in 2010 with the support of

9

Key objectives

Promote robust competition to enable price

reductions for new ARVs

Facilitate the development of fixed-dose combinations

Promote development

of special formulations needed for

children living with HIV

Accelerate availability of new ARVs in developing countries

Prioritising HIV Medicines

Clinical Analysis:

“Which drugs are most

important for HIV

treatment?”

IP Analysis: “Which drugs are patented in developing countries?”

MPP priorities+ =

List of MPP Product PrioritiesCOMPOUNDS CLINICAL

PRIORITYMARKET/IP PRIORITY

Atazanavir High High

Dolutegravir High High

Lopinavir High High

Ritonavir High High

TAF High High

Cobicistat High High

Elvitegravir High High

Abacavir (paediatrics) High Medium

Emtricitabine High Medium (comb patents)

Efavirenz High Medium (comb patents)

TDF High Medium (comb patents)

Darunavir Medium/High Medium

Nevirapine Medium/High Medium

Etravirine Medium High

Raltegravir Medium High

Rilpivirine Medium High

Key Elements of MPP licences

• Negotiated from a public health perspective

• Non-exclusive licensing to qualified generic manufacturers

• Publication of full text of all licences

• More developing countries are able to benefit

• Enable development of fixed-dose combinations and paediatric formulations

• Possibility of technology transfer

• Enable supply to countries using TRIPS flexibilities

• Seek inclusion of provisions to open up markets for key medicines

Raising the bar for licensing in the HIV field

MPP Agreements

Medicines Patent Pool

Bristol-Myers Squibb

Gilead Sciences

National Institutes of Health

Roche Viiv Healthcare AbbVie Gilead

Sciences Merck/MSD

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• Atazanavir • Tenofovir Disoproxil

• Fumarate (TDF)

• Emtricitabine• Cobicistat• Elvitegravir

• Darunavir (only secondary patent)

• Valganciclovir (discounted price)

• Abacavir (paediatric)

• Dolutegravir

Concluded Agreements Under negotiation

• Raltegravir (paediatric)

• Tenofovir Alafenamide Fumarate (TAF)

• Lopinavir (paediatric)

• Ritonavir (paediatric)

Medicines Patent Pool Out-Licensing

• MPP

Sublicensees

Aurobindo

Cipla

Desano

Emcure

Hetero

Laurus

Micro Labs

Mylan

Shasun

Shilpa

MPP has licensed 7 ARVs to 10 generic partners:• Tenofovir Disproxil

Fumarate• Emtricitabine• Elvitegravir• Cobicistat• Abacavir (paediatric)• Atazanavir• Dolutegravir

Currently managing 35 sub-licences

15

Key Challenge: inclusion of certain middle-income countries in licences

2000 2010 20200%

20%

40%

60%

80%

100%

70%

37%

13%

High

Upper middle

Lower middle

Low

Income category

Proportion of people living with HIV by country income category, 2000 - 2020

Source: UNAIDS, IMF 2012

One possible approach to address challenge in some MICs

• Market Segmentation (public/private)

– In many countries, national treatment programs cater for vast majority of people on treatment

– Generics able to supply national treatment programs

– Originators continue to cater for small private market

• Introduce royalties that are differentiated according to countries’ socio-economic circumstances

– Enables countries to benefit from robust generic competition which results in lower prices

– Royalty could take into account different variables: GDP per capita, inequality, disease burden, others

Thank you

eburrone@medicinespatentpool.org

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