Public health, innovation and intellectual property 1 |
Public Health and Intellectual Property
management: the challenges on access
to medicines
Dr. Inthira Yamabhai
2 |
Overview
Intellectual property (IP) and implications on access to
medicine
– Trade Related Aspect of Intellectual Property Rights (TRIPS)
– TRIPS+ through trade agreements
Sources of information
3 |
Different forms of IP
Trademark: name under which product is marketed
Patent: compound, crystalline forms, process, method of
use, etc
Protection of undisclosed data: clinical test data
Copyright: package insert
Design protection: packaging
4 |
Patents
There is nothing such as a worldwide patent!
WIPO Patent Cooperation Treaty allows for worldwide
filing, but applicant receives a bundle of national patents;
same principle under European Patent Convention
WTO TRIPS sets certain minimum standards:
– Term: 20 years from filing data
– Mandatory for all fields of technology
– Criteria: novelty, inventive step, industrial applicability
– Flexibilities: e.g. parallel importation and compulsory licensing
One drug = one patent???
"…a key element of life cycle
management strategies is to extent
patent protection for as long as
possible by filing secondary patents to
keep generics off the market"
(Burdon and Sloper 2003)
2024
• Broad compound patent (Markush)
• WO2005003147A2
2028
• Compound patent on prodrug
• WO2008121634A2
2031
• Crystalline forms
• WO2011123645A2
2032
• Combination with ledipasvir
• WO2013040492A
2032
• Composition & dosage
• WO2013082003A1
Sofosbuvir: Expiry without patent term extension(s)
Market
Authorization
US: 2013/14
www.who.int/phi/impl
ementation/ip_trade/ip
_patent_landscapes/e
n/
7 |
Incremental innovation vs life cycle management
Incremental advances for public health can include:
ƒƒ Combinations & new dosage forms with improved efficacy:
co-formulation of antiretroviral drugs
ƒ Formulations with better product characteristics: vaccines
stored in fridge rather than freezer
New routes of delivery: tablets or nasal spray vs injections
Paediatric formulations: dispersible flavored tablet of
artemether-lumefantrine
8 |
Granting patent in India:
Imatinib case
Novartis claims the drug is more easily absorbed into the blood that
is enough of an improvement to warrant patent protection. India
Patent Office disagreed that Novartis had shown significantly
increased efficacy and refused to grant a patent on Glivec (imatinib
mesylate)
Novartis file a case and India’s Supreme Court refused to grant a
patent for Glivec, as it’s known in some countries
India’s trade and industry minister, Anand Sharma, has defended the
decision, and was quoted by Agence France-Presse as saying it was
“absolutely justified under the law” and that India’s patent law
“does not accept evergreening.”
9 |
Estimated impact of evergreening
84% of patent applications during 2000-2010 are evergreening
patents
For 59 patented medicines, Thailand could have saved around 1,177
million THB (35 million USD) from 2000-2010
Source: Sutapak U et al (2011), Evergreening patent applications of
pharmaceuticals and access to medicines
10 |
Differential pricing
Sofosbuvir 12 weeks treatment course:
US: US$84,000 (reductions since Abbvie came to market)
UK: US$57,000
Egypt: US$900 (same price offered to public programme in Lao PDR; Mongolia)
Pakistan: US$1,620 (private sector)
11 |
Where to draw the line?
Opposing trends:
Argentina, India and Philippines follow new approaches in the pharmaceutical area to limit secondary patents Brazil and South Africa consider similar rules (only new chemical compounds are patentable unless new form is more efficacious)
US through trade agreements endeavours to expand patentability, e.g. secondary uses, methods of use and to prevent limitation of secondary patents
Public health, innovation and intellectual property 12 |
Policy options
Price controls: ‘Value-based pricing’; price/volume
agreements; pay for performance; risk-sharing
agreement / patient access schemes; reference pricing
schemes…
Differential pricing/price negotiations
Voluntary licensing agreements
Local production/import
TRIPS flexibilities, including compulsory licenses
Public health, innovation and intellectual property 13 |
Voluntary licenses HIV treatments (adults) INN Licensor Year Scope No countries Licsees
EFV MSD 2007 South Africa 1 (allows export to
SSA)
Several
d4T BMS 2001 SSA, India. country list 50 Several
DDL BMS 2006 SSA; India; country list 50 Several
RAL MSD 2011 LIC; SSA 56 2
SQV Roche 2006 LDC; SSA 65 Several
DRV Tibotec (Janssen/J&J) 2012 Non-assert: LDC; SSA
License: India
65
1+non-
assert.
ZDV; ZDV/3TC ViiV Healthcare 2010 LDC; LIC; SSA 69 Several
TPV Boehringer-Ingelheim 2004/07 LIC; LDC; Africa, India 78 Several
NVP Boehringer-Ingelheim 2004/07 LIC; LDC; Africa; India 78 Several
DTG; DTG/ABC MPP: ViiV Healthcare 2014 Country list 73 (+ no patent
count.)
MPP
EVG; QUAD
TDF+FTC+EVG
MPP: Gilead Sciences 2011 Country list 100 Several
EVG; QUAD
TDF+FTC+EVG
Gilead Sciences 2011 Country list 100 + 9 semi-
exclusive licenses for
MICs
4
ATV MPP: BMS 2013 Country list 110 (+ 34 no patent
count.)
MPP
RPV/TDF/3TC or
FTC; RPV
Tibotec (Janssen/J&J) 2011 Country list 112 5
TDF Gilead Sciences 2006/11 Country list 112 Several
TDF; TAF; FTC MPP: Gilead Sciences 2011/14 Country list 112 Several
Public health, innovation and intellectual property 14 |
Recent compulsory licenses & government use
Country Medicine Indication Measure Period Royalties Remarks
Ecuador Abacavir+la
mivudine
HIV/AIDS Gov use 2012 5% of US
price
adjusted by
diff. in GDP
Local prod.
Indonesia Seven
products
HIV/AIDS;
hepatitis
Gov use 2012 0.5% Local prod.
India Sorafenib Cancer CL 2012 6% Local prod.
Ecuador Ritonavir HIV/AIDS Gov use 2010 0.42% of US
price
Import; local
prod.
Thailand erlotinib;
letrozole;
docetaxel;
clopidogrel;
lopinavir/rito
navir
Cancer;
heart
disease;
HIV/AIDS
Gov use 2006-2008 3-5% Import
Brazil Efavirenz HIV/AIDS Gov use 2007 1.5% Import &
local prod.
Thailand Efavirenz HIV/AIDS Gov use 2006 0.5% Import
15 |
Impact of CLs: Examples
Brazil: – price reduction (from US$1.59 to US$0.43)
– first import from India, followed by local production after two years (argument:
lack of sufficient disclosure)
Ecuador: – price reduction (from US$1000 to US$800 initially; 50% reduction anticipated)
– import from India (2010 CL); local production (2012 CL)
Thailand: – price reduction (3.4 to 6.4 fold for efavirenz and ritonavir)
– GPO could initially not ensure local production of high quality products –
import from India
India: – price reduction from Rs.280000 to 8880, plus free supply to 600 patients
annually
Source: Kamp R, Doha Declaration on TRIPS & Public Health:
Creating Legal Avenues for Access to Medicines, Trade and Public Health Workshop,
2016
16 |
New mega-RTAs
Trans-Pacific Partnership (TPP)
Transatlantic Trade and Investment Partnership (TTIP)
(EU-US)
Regional Comprehensive Economic Partnership (RCEP)
(East Asia, 16 countries)
Free Trade Area of the Asia-Pacific (FTAAP) (APEC, 21
countries)
18 |
IP protection requirements: TRIP-Plus
Expand scope of patentability – new forms of existing entities – new uses – new formulations and combinations, etc.
Data exclusivity (exclude use of registration data) 5+ years
New indication, formulation, method of administration 3+ years
Biological products8+ years
Extend patent term for regulatory delays
Patent linkage: Link drug registration and patent status
Criminal enforcement mechanisms for patent infringement
19 |
TRIP-Plus impedes the use of TRIP
flexibilities
IP Chapter Article 18.76:
Special Requirements related
to Border Measures
– German customs authorities
wrongfully seized a drug
shipment of “Amoxicillin” on the
suspicion that it infringed the
brand name “Amoxil” 4 weeks
delay
– Dutch customs authorities seized
a shipment of abacavir sulfate
while it was en route from India to
Nigeria.
Sources: WTO, European Union and a Member State – Seizure Of Generic Drugs in Transit, May 19, 2010. Zarocostas, J., Brazil and India file complaint against EU over seizure of generic drugs, BMJ 2010;340:c2672
• Investment Chapter Annex 9
(3B): expropriation
– Philip Morris filed a case
against Australian government
due to warnings on cigarette
packaging and removing
branding from cigarette
packaging its trademark and
investment rights
Source: https://au.news.yahoo.com/thewest/a/29064155/tobacco-giant-sues-australia/
Public health, innovation and intellectual property 20 |
Sources of Information
WHO-WIPO-WTO Study on “Promoting Access to Medical
Technologies and Innovation (2013): www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf
All you need to know about IP and health:
http://www.who.int/phi/publications/category/en/
Everything that is not happening in the WTO: www.bilaterals.org
WTO RTA database: http://rtais.wto.org
20
21 |
World Trade Report 2011: The WTO and Preferential Trade
Agreements:
http://www.wto.org/english/res_e/publications_e/wtr11_e.
htm
Texts of RTAs:
www.ustr.gov
www.efta.int
http://ec.europa.eu/enterprise/policies/international/facili
tating-trade/free-trade/index_en.htm
Sources of Information
22 |
Thank you
Dr Peter Beyer
Senior Advisor
World Health Organization
Tel. +41-22-791 25 07
Dr Inthira Yamabhai
Technical officer
Top Related