intellectual property and access to arvs in brics a review

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


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



RitonavirSecond-line ARV




Efavirenz (post-grant opposition)First-line ARV

Bristol Myers Squibb Mumbai

Delhi Network of Positive People Pending

Valgancyclovir (post-grant opposition)OI medicine


Delhi Network of Positive People PATENT OVERTURNED

Pegylated Interferon alpha 2b Hepatitis C


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


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


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)

70

INVESTMENT PROTECTION: IMPACT

ON PUBLIC HEALTH

71

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

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