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Intellectual Property and Access to ARVs
in BRICS
A review of pro-health provisions in the
patent laws of BRICS Countries
WTO, TRIPS and Health: Context and History
Prior to TRIPS:
Approx. 50 developing countries
either excluded medicines from patentability
or provided shorter periods of protection (7, 11, 17 years)
or operated conditions which restricted patent holders’ rights
India, for instance did not grant product patents on food or medicine
1969-1992: 613 compulsory licences issued by Canada on medicines
After WTO/TRIPS
TRIPS requires all WTO membersto provide patents for 20 years.
The requirement is across the board – a one size fits all approach – rich or poor, a country must provide for patents.
LDCs now the only ones with flexibility not to implement TRIPS or pharma patents
And whether the invention concerned is a luxury item or a necessity, an exclusive right must be granted.
2001: The TRIPS Agreement and HIV
Doha Declaration (2001)
TRIPS “can and should be
interpreted and implemented in
a manner supportive of WTO
members’ right to protect public
health and, in particular, to
promote access to medicines for
all”
CASE NO: 4183/98
THE PHARMACEUTICAL
MANUFACTURERS' ASSOCIATION OF
SOUTH AFRICA First Applicant
v.
THE PRESIDENT OF THE REPUBLIC OF
SOUTH AFRICA, THE HONOURABLE MR
N.R. MANDELA N.O. First Respondent
2015: 15 million PLHIV on ARVs
2001 – 2016: 15 Years of HIV treatment
Absence of patents leads to “three in one AIDS pill”
Eg. d4T/3TC/NVP (fixed dose combination – FDC)
- Individual compounds were not patented in India
- Simplified treatment in resource poor countries
Competition key to lower prices, better
formulations, sustainable treatment access
While ARVs were under monopoly in the early 2000s, prices remained high; as they are now for 2nd/3rd line
Generic competition lowered prices among generic producers and even of originator products; fixed dose combinations and paediatric versions
Evolution of TRIPS flexibilities in the past 15 years: developing countries have had to repeatedly resort to using these mechanisms to ensure generic access
Whether or not generic competition can take place depends on whether national laws and polices INCORPORATE TRIPS FLEXIBILITIES.
Working of the patent system • Pro-health patent examination and
trainings
• Penalties for fraud on the system
• Limit and control divisionals
• Regulate Voluntary Licenses
• Working of the Patent
TRIPS flexibilities in Enforcement of patents
• No Border measures for patents
• Court proceedings to take public interest into account
• Limits on Injunctions and other orders
• Limits on Damages, “judicial” CLs
• Ensure Civil, not criminal remedies
TRIPS flexibilities before the grant of a patent
• Patentable Subject Matter
• Patent exclusions
• Patentability Criteria (including prohibition of evergreening)
• High Disclosure Standards
• Pre-grant Patent Oppositions
TRIPS flexibilities after the grant of a patent
• Research, Bolar and other exceptions
• Parallel Imports
• Personal Use/small quantity exceptions
• Post-grant Oppositions and Revocation
• Compulsory Licenses
• Use of Competition Law
TRIPS Flexibilities before the grant of a
patent: Prevention better than cure ?
Patentable Subject Matter
Patent exclusions
Patentability Criteria (including prohibition of
evergreening)
High Disclosure Standards
Pre-grant Patent Oppositions
Patents only on products and processes; not
new uses 1990s – height of the HIV epidemic
– huge pressure on US government to come up with treatment
US government, Duke University and Wellcome started exploring “new” treatment
In fact zidovudine was originally a cancer medicine and the research showed its effectiveness for HIV
When the drug was introduced, the company announced it’s price: $7000 – 10,000
New USE; NOT a new product
Diagnostic, Medical, Surgical methods
Doctor in the US patented a method of making a self-healing incision
Charged $4 to other surgeons
Sued another doctor for using the method
Court finally stopped him from enforcing his patent.
US law prevents enforcement of such patents
Article 27.3, TRIPS allows countries to specifically exclude such patents
Traditional Medicines Attempts in the US to patent turmeric
for wound healing properties
Country Options
Not Novel
Specific exemption:
Discoveries
Traditional Knowledge: “an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components” - Section 3 (p) of The Indian Patent Act,
Other approaches include the Traditional Knowledge Digital Library
Patenting of Genes: Breast Cancer Gene 1990s scientists discover mutations in BRCA-1 gene. Mutations of this gene indicate a high risk of breast
and ovarian cancer Discovery allows doctors and hospitals to screen
women for this gene. In 1994 and 1995 Myriad (a US based company)
patented both BRCA-1 and BRCA-2 To screen women for this gene, you need to use the
genes in testing machines. The test costs $3400 [3 times the cost of pre-patent
testing] Patents now invalidated in the US and Australia
Specific exemptions: Discoveries; Brazil: 27.3. : No patents for living beings or “biological materials found in nature”, even if isolated, including the “genome or germplasm” of any living being.
Patentable subject matter and patent exclusions
Products and
processes
only
Diagnostic
and surgical
methods
Plants and
Animals
Genes Traditional
Knowledge
BRAZIL Yes Yes Yes Yes Possibly under
discoveries?
RUSSIA Unclear No Unclear Possibly under
discoveries?
Possibly under
discoveries?
CHINA Unclear Yes Yes Possibly under
discoveries?
Unclear
INDIA Yes Yes Yes Yes Yes
SOUTH
AFRICA
Yes Yes Yes Possibly under
discoveries?
Unclear
Strict patentability criteria and pharmaceutical
patents
BRAZIL ANVISA patent examination
RUSSIA High disclosure standards; unclear if there is impact on pharmaceutical patent
examination
CHINA Strict inventive step standard; patent application rejections on HIV and HCV
INDIA Restriction on evergreening
SOUTH AFRICA No substantive examination of patents
Brazil: ANVISA process
Involvement of Health Ministry
Brazil: Since 1999 grant of patents on pharmaceutical products and processes dependent on the consent of the Brazilian Sanitary Surveillance Agency (ANVISA).
ANVISA scrutinizes patent applications first for compliance with the requirements of patentability and then sends those approved for further scrutiny to the patent office.
For the purpose of making judgments about patentability criteria such as the requirement of an inventive step ANVISA has established a technical group of experts.
BRAZIL: ANVISA review of pharma patent
applications 2001 to 2009:
ANVISA analyzed 1,346 patent
applications; 988 approved
11% rejection rate
Of the 988 who received
approval, 40% only after
changes to the patent
application including the scope
of claims and improved
disclosure.
KEY HEALTH SAFEGUARD IN INDIA’S LAW:
Section 3(d)
The basic patents on Nevirapine (NVP) were
applied for by Boehringer Ingelheim in
November 1990, and were due to expire in
November 2010.
BI also applied for a patent on the hemihydrate
form of NVP, used in the suspension in 1998,
which is due to expire 2018.
Additionally, BI applied for a patent on the
extended release formulation of nevirapine in
2008, which is due to expire in 2028.
1998 application rejected in India; 2008
application should also be rejected
Patent Thickets: The Ritonavir Patent
Landscape
• Original patent filing: 1995
• 805 patent families
• Generic entry for lopinavir/ritonavir likely to be delayed 13-14 years after original patent expiry
1,035 new drugs approved by
FDA (1989-2000)No therapeutic
benefit over
existing
76%
Therapeutic
benefit
23%
Neglected
Diseases
1%
“Changing Patterns fo Pharmaceutical Innovation, National Institute for Health Care”Management Research and Educational Foundation, May 2002, www.nihcm.org
Patents on most drugs introduced
are for new forms, new uses,
or combinations of existing
drugs (crisis in “innovation”).
This is known as ‘evergreening’
– the practice of pharma
companies to extend their
patent terms by making small
changes in existing medicines.
Preventing “Evergreening” or Prevention is better than a cure
South Africa: Impact of lack of substantive
examination
Importance of Patent Oppositions • Importance of patent oppositions and revocations: critical support for
patent offices
• Huge burdens on patent offices: India complied with TRIPS in 2005 and had a mailbox: nearly 10,000 pharma patent applications when opened
• In the US, Generic applicants have prevailed in challenging patents in 73 percent of the cases in which a court has resolved the patent dispute (US Generic FTC Study).
• PCT has led to massive increase in patent applications coming into developing country patent offices
• Primary trainings of patent examiners comes from developed country patent offices that do no have or use TRIPS flexibilities or may have different, lower patentability criteria
Patent Oppositions in BRICS
Pre-grant Oppositions Post-grant Oppositions/invalidation
BRAZIL Only input for examination Yes
RUSSIA No Yes
CHINA Third party observation Yes
INDIA Yes Yes
SOUTH
AFRICA
No Yes
MEDICINE WHO HAS APPLIED FOR THE PATENT AND WHERE
WHO HAS OPPOSED THE PATENT APPLICATION (DOES NOT INCLUDE GENERIC COMPANIES)
WHAT IS THE STATUS OF THE PATENT APPLICATION
Imatinib mesylateCancer
NovartisChennai
Cancer Patients Aid Association Patent Application Rejected
Zidovudine/ lamivudineFirst-line ARV
GSKKolkata
Manipur Network of People living with HIV/AIDS, Indian Network for People living with HIV/AIDS
Patent Application Withdrawn
Nevaripine Hemihydrate (syrup)First-line ARV
Boehringer Ingelheim Delhi
Positive Womens Network and Indian Network for People living with HIV/AIDS Patent Application Rejected
Tenofovir Fumarate or TDF (two applications)Preferred first -line ARV
Gilead Sciences Delhi
Delhi Network of Positive People and Indian Network for People living with HIV/AIDS; Brazilian Interdisciplinary AIDS Association (ABIA) and Sahara (Centre for Residential Care and Rehabilitation)
Patent Application Rejected
AmprenavirSecond-line ARV
GSKDelhi
Uttar Pradesh Network of Positive People and Indian Network for People living with HIV/AIDS
Pending
AtazanavirSecond-line ARV
Novartis Chennai
Karnataka Network for People Living with HIV and AIDS and Indian Network for People living with HIV/AIDS
ABANDONED; PATENT APPLICATION ON BISULPHATE REJECTED
ValgancyclovirOI medicine
F Hoffmann-La RocheChennai
Tamil Nadu Network of Positive People and Indian Network for People living with HIV/AIDS
PATENT OVERTURNED
AbacavirSecond-line arv
GSKKolkata
Indian Network for People living with HIV/AIDS PATENT APPLICATION WITHDRAWN
MEDICINE WHO HAS APPLIED FOR THE PATENT AND WHERE
WHO HAS OPPOSED THE PATENT APPLICATION (DOES NOT INCLUDE GENERIC COMPANIES)
WHAT IS THE STATUS OF THE PATENT APPLICATION
LopinavirSecond-line arv
Abbott LaboratoriesMumbai
Delhi Network of Positive People, Network of Maharashtra by People living with HIV and AIDS and Indian Network for People living with HIV/AIDS
PATENT APPLICATION REJECTED
Lopinavir/Ritonavir (Soft Gel)Second-line ARV
Abbott LaboratoriesMumbai
Delhi Network of Positive People, and Indian Network for People living with HIV/AIDS
Patent Application Deemed Abandoned
Lopinavir/Ritonavir (Tablet)Second line ARV
Abbott Laboratories I-MAK PATENT APPLICATION REJECTED
Tenofovir or tdFirst-line ARV
Gilead Sciences Delhi
Delhi Network of Positive People, and Indian Network for People living with HIV/AIDS
PATENT APPLICATION REJECTED
RitonavirSecond-line ARV
Abbott LaboratoriesMumbai
Delhi Network of Positive People, and Indian Network for People living with HIV/AIDS
PATENT APPLICATION REJECTED
Efavirenz (post-grant opposition)First-line ARV
Bristol Myers Squibb Mumbai
Delhi Network of Positive People Pending
Valgancyclovir (post-grant opposition)OI medicine
F Hoffmann-La RocheChennai
Delhi Network of Positive People PATENT OVERTURNED
Pegylated Interferon alpha 2b Hepatitis C
F Hoffmann-La RocheChennai
Sankalp Rehabilitation Trust PATENT OVERTURNED
TRIPS Flexibilities after the grant of a
patent
• Research, Bolar and other exceptions
• Parallel Imports
• Personal Use/small quantity exceptions
• Post-grant Oppositions and Revocation
• Compulsory Licenses
• Use of Competition Law
AIDS treatment: second and third line
HEP C TREATMENT COSTS
Sofosbuvir: $1000 a pill;
$84000 for a 12 week
course of treatment
Pegylated Interferon:
between $2500 - $30,000
(not including doctor’s fees,
medicines for side effects,
loss of employment etc.)
CANCER TREATMENT COSTS
Imatinib mesylate: Chronic Myloid
Luekemia; $2500 per person per
month
Sorefanib: Liver and kidney cancer;
$4500 per person per month
Trastuzumab (Herceptin): Breast
cancer medicine: Estimates suggest
a year’s treatment costs over
$30,000
Parallel Imports
Under TRIPS, countries can
determine their own rules of
“exhaustion” and whether to allow
parallel imports (Art. 6 and 28)
Companies often charge different
prices for the same medicine in
different countries
Countries can specify that patent
rights on a medicine, once it is sold
anywhere in the world by the
patentee, its licensee or under a
compulsory license, are
“exhausted”
Importance of parallel imports: example of
HCV treatment Sofosbuvir: Directly Acting Antiviral (DAA); in combination with other DAAs there is a high rate of
cure for HCV
Gilead sells sofosbuvir:
In the US: USD 84000 for 12 week course
In Malaysia: USD 17000 for 12 week course (private market)
In Brazil: USD 6900 for 12 week course (govt)
In Thailand: USD 4200 for 12 week course (private market)
In Egypt: USD 900 for 12 week course (govt)
Gilead licensees selling between USD 300-900 for 12 week course
Gilead has excluded key middle income countries with high Hep-C burdens from its voluntary
licenses including Brazil, China and Russia
Through international exhaustion and parallel imports, excluded countries can access the lower
priced sofosbuvir put on the market by Gilead licensees
National
Exhaustion
Regional
Exhaustion
International
Exhaustion
Parallel Imports in BRICS
BRAZIL International Exhaustion
RUSSIA National/Regional Exhaustion
CHINA International Exhaustion (2008
amendment)
INDIA International Exhaustion
SOUTH AFRICA International Exhaustion
Compulsory Licenses (CLs)
Article 31 of the TRIPS Agreement specifically provides for the grant of CLs
Countries have the right to grant CLs but the provisions must be in their law;
countries can decide the grounds for granting a CL
Procedural Requirements: Must negotiate with patent holder
EXCEPT IN NATIONAL EMERGENCY, EXTREME URGENCY AND PUBLIC
NON-COMMERCIAL USE
EXCEPT TO DEAL WITH ANTI-COMPETITIVE BEHAVIOUR
Several CL Conditions: Adequate remuneration,, non-exclusive, CL must be
primarily for domestic market…
Government, Competition Authority, Courts have granted CLs
Doha Declaration specifically confirmed right of all WTO members: : The right to grant compulsory licences and the freedom to determine the grounds on which compulsory licenses can be granted.
Compulsory License provisions in BRICS
Emergency Extreme
Urgency
Public Non-
Commercial
Use
On application of
competitor, non-
working
For export Other grounds
BRAZIL Yes Yes Yes Yes Unclear Abuse of patent,
public interest,
dependent patents
RUSSIA Yes Yes Unclear Yes Unclear National Security,
Dependent Patents
CHINA Yes Yes Yes Yes Yes Public Interest,
Public Health,
Dependent patents
INDIA Yes Yes Yes Yes Yes Affordability,
Insufficient supply
SOUTH
AFRICA
No specific
mention
No specific
mention
Yes Yes No
Brazil’s Compulsory Licence (2007)
• Efavirenz (HIV treatment)
• Presidential Decree nº 6.108 (2007)
• ”compulsory license, on the ground of
public interest, of Efavirenz’s patents,
for public non-commercial use”
• Duration: 5 years, allowing extension
for equal period
• Royalty:1.5% cost of finished product
• Patent owner obligated to transfer
knowledge and information necessary
to reproduce the patented medicin
• Renewal of CL by the Decree nº. 7723
(04/may/2012)
-
5.000.000,00
10.000.000,00
15.000.000,00
20.000.000,00
25.000.000,00
30.000.000,00
35.000.000,00
40.000.000,00
45.000.000,00
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
-
20.000
40.000
60.000
80.000
100.000
120.000
EFV 600mg
EFV 200mg
TOTAL OF PATIENTS
YearE
fa
vir
en
z's
Co
st (
US
$)
Pa
tie
nts o
n T
re
atm
en
t
India’s first Compulsory Licence (2012)
• Sorefanib Tosylate (liver and kidney
cancer)
• Patent issued to Bayer in 2008
• Availability
• Bayer only sold 539 boxes in 2011
• Need was 27000 boxes
• Bayer supplied medicines to a little
above 2% of patients
• Affordability
• Bayer’s price: $5000per person per
month
• Natco’s price: $160 per person per
month
Case Study: Thai CLs (2007-08)
Before 1992, Thailand did not have product patent protection on medicines
Thailand was able to produce generic first line ARVs
By 1999, Thailand amended its patent law to becomes TRIPS compliant i.e. granting patents on medicines
Although Thai GPO was producing first line medicines, second line ARVs were patented and expensive
In 2006-2007, the Thai Ministry of Health announced public non-commercial use (for use in the public sector) of three medicines:
Clopidogrel (heart disease)
Efavirenz (HIV)
Lopinavir/Ritonavir (HIV)
In 2008, the Thai Ministry of Health announced public non-commercial use of three more medicines:
Letrozole (cancer)
Docetaxil (cancer)
Erlotinib (cancer)
Thailand CLs
For efavirenz, between 2007 and 2010,
the number of people on the drug increased from less than 5000 to
over 25000.
The savings of the Thai government on this drug between 2008 and
2011 has been over 65 million dollars.
On lopinavir/ritonaivr, between 2007 and 2010
From a few hundred to over 7000 people living with HIV.
ovThe cost savings for the Thai government on lopinavir/ritonavir
between 2008 and 2011 has been er 77 million dollars.
Compulsory Licences
Country Year Product
United States 2002 Tumour Necrosis Factor (Competition Authority)
Zimbabwe 2002 Any HIV medicine
Mozambique 2004 Lamivudine, stavudine, nevirapine
Zambia 2004 Lamivudine, stavudine, nevirapine
Malaysia 2004 Didanosine, Zidovudine, lamivudine/zidovudine
Indonesia 2004 Lamivudine, Nevirapine
United States 2005 Treatment delivery Drug Eluting Stents
(Competition Authority)
Cameroon 2005 Lamivudine/zidovudine, Nevirapine, Lamivudine
Eritrea 2005 HIV/AIDS medicines
Compulsory Licences
Country Year Product
Italy 2005 Imipencem/cilastatine (antibiotic); Competition
Authority
Ghana 2005 HIV/AIDS medicines
Italy 2006 Sumatripan succinate (migraine) (Competition
Authority)
Indonesia 2007 Efavirenz
Thailand 2007 Lopinavir/ritonavir, clopidogrel, efavirenz
Italy 2007 Finasteride (prostrate); Competition Authority
Brazil 2007 Efavirnez
Compulsory Licences
Country Year Product
Thailand 2008 Docetaxil, letrozole, Erlotinib
Ecuador 2010 Lopinavir/ritonavir
India 2012 Sorefanib tosylate (cancer)
Indonesia 2012 Efavirenz, Abacavir, Didanosine,
Lopinavir/ritonavir
Indonesia 2012 Tenofovir, Tenofovir/emtricitabine,
Tenofovir/emtricitabine/efavirnez (Hep B)
Ecuador 2012 Abacavir/lamivudine
PATENT LAW REFORM IN BRICS
COUNTRIES
2012 Global Commission on HIV and Law
Recommendation
“The UN Secretary-General must convene a neutral, high-level body to review and
assess proposals and recommend a new intellectual property regime for pharmaceutical
products. Such a regime should be consistent with international human rights law and
public health requirements, while safeguarding the justifiable rights of inventors. Such a
body should include representation from the High Commissioner on Human Rights,
WHO, WTO, UNDP, UNAIDS and WIPO, as well as the Special Rapporteur on the Right to
Health, key technical agencies and experts, and private sector and civil society
representatives, including people living with HIV. This re-evaluation, based on human
rights, should take into account and build on efforts underway at WHO, such as its
Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual
Property and the work of its Consultative Expert Working Group. Pending this review,
the WTO Members must suspend TRIPS as it relates to essential pharmaceutical
products for low- and middle-income countries.”
SDG 3b: Imperative for reviews and
incorporation of all TRIPS flexibilities
“[s]upport the research and development of vaccines and
medicines for the communicable and non-communicable
diseases that primarily affect developing countries, provide
access to affordable essential medicines and vaccines, in
accordance with the Doha Declaration on the TRIPS
Agreement and Public Health, which affirms the right of
developing countries to use to the full the provisions in the
Agreement on Trade-Related Aspects of Intellectual Property
Rights regarding flexibilities to protect public health, and, in
particular, provide access to medicines for all.”
BRICS and TRIPS Flexibilities
7. Emphasized the importance and need of technology transfer as a means to
empower developing countries. They underlined the importance of ensuring access
to affordable, quality, efficacious and safe medical products, including generic
medicines, biological products, and diagnostics, through the use of TRIPS
flexibilities, for the realization of the right to health. They also renewed commitment
to strengthening international cooperation in health, and South-South cooperation in
particular, with a view to supporting efforts in developing countries to promote health
for all.
12. Reiterated their commitment to use TRIPS flexibilities to promote access to
medicines, foster innovation and share these experiences with other developing
countries.
- Joint Communiqué of the BRICS Member States on Health
on the Sidelines of the 68th WHA, 2015
Public interest based patent law reform
South Africa Draft IP Policy 2013
“A country like India resorted to pre- and post-grant opposition to facilitate a possibility of opposing weaker patents as described above…This procedure has been a success to challenge “weaker” patents or patents that do not meet the requirements of “newness”, “novelty, ”obviousness” and “usefulness for trade/agriculture.”
Recommendation: The Patents Act should be amended to have both pre- and post-grant opposition to effectively foster the spirit of granting stronger patents.”
Brazil Review of Patent Law (October 2013): examines Indian example in detail and will recommend amendment of patent law to exclude:
(i) patents for new forms of known substances that do not result in the improvement of the known efficacy of the substance, for they are mere discoveries and lack inventive step, and (ii) patents that claim any new property or new use of a known substance, for they are mere discoveries, lack novelty and industrial application…
TRIPS, BRICS and the future of access to medicines
UN bodies and several resolutions at the UN General Assembly call
on countries to ensure use of TRIPS flexibilities and guard against
measures that go beyond TRIPS (UNGASS Declaration of
Commitment, MDG Outcome document, NCD Resolution, SDGs)
All BRICS countries have critical safeguards in their laws and
opportunities in hand to ensure access to ARVs as well as to review
their laws to ensure full incorporation of all TRIPS flexibilities.
BRICS countries have significant API and formulations
manufacturing capacities that impact access to medicines not just
locally but across the globe; must make full use of flexibilities
Word of caution: TRIPS-plus (free trade agreement negotiations)
IMPLICATIONS FOR ACCESS TO
TREATMENT FOR HIV AND HEPATITIS C IN
DEVELOPING AND LEAST DEVELOPED
COUNTRIES
Free Trade Agreements, WTO Accession and
TRIPS-plus provisions:
54
TRIPS-plus demands
More products may be patented Because there are more patent applications (PCT, PLT, regional patent offices,
patent prosecution highways)
Because more types of products are allowed patents (‘patentability’)
Because people can no longer oppose patent applications (‘pre-grant opposition’)
Patents may last for longer (‘patent term extensions’)
Restrictions on parallel importation
Requirement of Data exclusivity
Patent Linkage
Limitations on Compulsory licences
Harmonisation of intellectual property laws
TRIPS-plus IP enforcement - border measures
Investment provisions
55
TRIPS-plus: Many paths; one destination
• Lobbying , Litigation and Pressure
• Malaysia: Adoption of data exclusivity
• India: Bayer’s attempt at patent linkage through the courts, US pressure to adopt
data exclusivity, Novartis attempt to weaken Section 3(d) through courts
• Biased technical assistance
• Through WTO Accession
• China (2001): Data Exclusivity
• Cambodia (2004): Even though LDC agreed to implement TRIPS by 2007; strong
public pressure allowed resistance of DE
• Vanuatu (2011): Even though LDC agreed to implement TRIPS by December
2012; Data Exclusivity
• Russia (2012): Data Exclusivity
• Through FTA Negotiations (usually demanded by developed countries)
Free Trade Agreements in force
Free Trade Agreement• FTA
– Free Trade Agreement
• TIFA
– Trade and Investment Framework Agreement
• EPA
– Economic Partnership Agreement
• PCA
– Partnership and Co-operation Agreement
• RTA
– Regional Trade Agreement
• BIT
– Bilateral Investment Treaty
General Framework of FTAs
• Trade in Goods
• Trade in Services
• Government procurement
• Competition
• Intellectual Property • Substantive
• Enforcement
• Transparency
• Regulatory Coherence/ harmonisation
• Investment
• Dispute Settlement/Committees
• Co-operation
TRIPS-PLUS DEMANDS - PATENTS
61
Patent term extension – delays in patent or
marketing approval grant
– TRIPS: patents only have
to be for 20 years
• TRIPS+ :
• Patent term extension for
patent office delays
• Patent term extension for delay
in marketing approval
62
Impact of Patent Term Extension
EU-ANDEAN TRADE AGREEMENTS
ON ACCESS TO MEDICINES IN
PERU, 2009 (ICTSD/WHO/PAHO
methodology)
To maintain current consumption
levels, implementing Supplementary
Protection Certificates (i.e. patent
term extention) extending the
effective patent period by 4 years
would require a USD 159 million
increase in pharmaceutical
expenditure in 2025.
• A Korean study concluded that
the extension of patent term is
likely to cost the Korean National
Health Insurance Corporation
what amounts to US $529m for
extending drug patents for 3
yrs and US $757m if it has to
agree to a 4 yr extension
(2006)
63
TRIPS-PLUS DEMANDS – DATA
EXCLUSIVITY
64
Data Exclusivity: Creating an entirely new monopoly on
medicines• TRIPS
• Article 39.3: Data Protection
• Requires governments to protect data from unfair commercial use
• However when FDA approves generic version, NOT releasing the confidential information, only relying on it to see if the drug is safe and effective – the work of a regulator is not “commercial use”
• TRIPS+ (‘data exclusivity’):
– FDA would be prevented from
registering generic for a certain
period of time
– So the generic has to repeat the
clinical trials if it wants to be
approved in the DE period or wait
before it can be registered and reach
patients.
– In effect: keeps generics off market
– Would be applicable to off-patent
medicines
TRIPS+ data exclusivity (DE)
Situation : No patent
TRIPS (no DE): when there is no patent, generic versions immediately reach patients
TRIPS+ (with DE): no generic medicine is available until the end of the data exclusivity period, even though there is no patent. There may be no patent because:
No patent applied for, or
The medicine is not new or inventive enough to be granted a patent, or
The patent is not in force as the fees have not been paid, or
The patent has expired, or
The patent has been revoked as it was invalid
Impact of Data Exclusivity
• Colombia 2006 (WHO/PAHO):
– DE would be responsible for increasing average medicine prices by up to 30% or USD 674 million by 2020
– Or a reduction of 30% in consumption if there is no increase in spending
– Would cause national industry to lose up to 47% of its market share
Jordan (2012): 110 new drugs
registered in Jordan between 2000
and 2004 – NO PATENTS
Impact of DE cost Jordan’s retail
market USD 18 million in 2004 or
14% of private sector annual
pharmaceutical expenditure
Price difference between originator &
generics was 55%
Average increase of 17% in the
total price of medicines between
1999 and 2004.
67
TRIPS-PLUS DEMANDS – IP
ENFORCEMENT
68
Intellectual property enforcement
TRIPS
TRIPS: Customs officials
should be empowered to act
on imports of goods infringing
trademarks and copyright
TRIPS-plus :
Customs officials shall be
empowered to take action:
Seizures of goods infringing
patents, in-transit, exports
69
IMPACT of TRIPS+ Customs enforcement: EU-
India Dispute• 17 shipments of generic medicines from India
to Africa and Latin America seized by EU
customs authorities in transit
• Grounds for seizures: Infringement of EU
patents and trademarks
• Destinations:
• Peru
• Colombia
• Ecuador
• Mexico
• Portugal
• Spain
• Brazil
• Nigeria
Shipments included:
• Medicines
• Cardiologic medicines (in total, 100,000 pills and 1850 kg)
• Lifestyle medicines (in total, 400 kg)
• AIDS (in total, 30,000 pills and 24 kg)
• Medicines against dementia (94,000 pills)
• Medicines against schizophrenia (500,000 pills)
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INVESTMENT PROTECTION: IMPACT
ON PUBLIC HEALTH
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Intellectual Property as Investment
TRIPS
Treaty between two countries –
if dispute one country sues the
other (WTO – EU v. Canada)
For companies, they sue
governments in local courts (for
instance, Novartis sued the
government of India over the
rejection of its patent
application on anti-cancer drug,
imatinib)
TRIPS+
Investment chapters of FTAs or in
Bilateral Investment Treaties
Companies sue governments for
treaty violation
Secret, international arbitration
Includes intellectual property as
investment
Arbitration panels do not look at
domestic laws or constitutional
obligations on health
Awards against governments in 100s
of millions of dollars
• Eli Lilly v. Canada
• Overturning of patent on strattera
• Case went all the way up to the
Supreme Court
• Canada’s entire legal doctrine for
determining an invention’s “utility”
and, thus, a patent’s validity
• 100 million dollars in compensation
• Challenging the use of TRIPS
flexibilities
Eli Lilly suing Canadian
government under NAFTA
investment rules
Ground: CANADIAN COURTS
overturned two patents
Atomoxetine (ADHD)
Olanzapine (schizophrenia
and bi-polar)
Canadian courts applying strict
patent criteria
Suing for 500 million dollars73
Eli Lilly v. Canada (2013)
Concerns with TRIPS-plus provisions
Impact of FTAs and TRIPS-plus provisions is well documented:
UN Special Rapportuer on Health: TRIPS-plus standards increase medicine prices as they delay
or restrict the introduction of generic competition.
CIPIH: Bilateral trade agreements should not seek to incorporate TRIPS-plus protection in ways that
may reduce access to medicines in developing countries.
Global Strategy on Innovation, Public Health and Intellectual Property: International
negotiations on issues related to intellectual property rights and health should be coherent in their
approaches to the promotion of public health.
UN agencies advice to developing countries is clear:
UNDP, UNAIDS and WHO: “In 2009, funding for HIV was lower than in 2008. This is putting current
treatment programmes under increased strain because of reduced budgets and competing
priorities. In addition, proposed bilateral and regional free trade agreements could limit the ability of
developing countries to use the TRIPS flexibilities. Governments in both developed and developing
countries should ensure that any free trade agreements comply with the Principles of the Doha
Declaration.”
Concerns over impact of trade agreement on
Universal Healthcare Commitments? “Some Member States have expressed
concern that trade agreements
currently under negotiation could
significantly reduce access to
affordable generic medicines. If these
agreements open trade yet close
access to affordable medicines, we
have to ask: Is this really progress at
all, especially with the costs of care
soaring everywhere?”
- Dr. Margaret Chan, 19 May 2014
• 12 December 2012
• UN Resolution urges countries to establish universal health coverage
TRIPS-plus provisions: way forward
• FTAs are negotiated in secret making a public health assessment of the provisions difficult
• Developing countries in FTA negotiations should conduct public health impact assessments
• Developing countries should consider revising existing FTAs and Bilateral Investment Treaties to ensure that access to affordable generic medicines is safeguarded
• Developing countries should reject TRIPS-plus demands
• Pro-active use of TRIPS flexibilities in developing countries is necessary to ensure access to affordable medicines and sustainability of universal healthcare
76
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