Oppositions made simple

How to start:Leena Menghaney, MSF

Access Campaign

2000

1987: first ARV AZT1996: TRIPLE HAART THERAPY

2000: Glaxo Blocks Access To Lamivudine/Zidovudine in Ghana

In letters to a drug distributor in Ghana and an Indian generic-drug maker, Glaxo said sales of generic versions of its drug, Combivir, in Ghana would be illegal because they would be violating company patents. As a result, the Indian company, Cipla Ltd. of Bombay, has stopped selling its low-cost version in Ghana, a small country in West Africa.

New Use patent on zidovudine

Source: Lawyers Collective HIV/AIDS Unit

2002 2002 – THAILAND – THE FIRST CHALLENGE

How we started in India

Globalisation of Patent Rules

• 1995 WTO Trade related aspects of intellectual property rights agreement (TRIPS)

• “minimum” standards of protection of intellectual property rights

• 20 year patents on pharmaceutical products

• No differentiation between lifesaving medicines and trivial goods

• 2005 Indian amended its patents act to be compliant with TRIPS and starts to grant product patents (transition period ends).

In 2001 Novartis introduced Glivec (Imatanib Mesylate) in India

The Glivec story

1 month 1 year

Glivec US$ 2,500 US$ 30,000

Generic equivalent US$ 200 US$ 2,500

Comparative prices

INDIA SIGNED AN AGREEMENT WITH

WTO TO MOVE FROM

PROCESS PATENT

2005: PROCESS & PRODUCT

PATENTS FOR MEDICINES

In 1995…

The Glivec story

1998Novartis applied for patent in India on for a crystalline form or polymorphic form of its anticancer drug imatinib mesylate (Glivec)

Jan 2003

Based on this application Novartis applied for 5 yr EMR in India (no examination required or opposition allowed)

Nov 2003

Novartis granted EMR 6/9 pharmaceutical companies told by court to stop marketing affordable generic versions of imatinib

The Glivec story

2004: Result of Glivec’s EMR

CPAA could no longer supply the drug at subsidized rates.Meets with Lawyers Collective for Legal Aid

CIVIL SOCIETY OPPOSITION AGAINST INDIA CHANGING ITS PATENT LAW TOOK PLACE…

ACROSS INDIA…

AND THE WORLD…PROTESTS AGAINST INDIA BECOMING TRIPS COMPLIANT WERE HELD IN…

SOUTH AFRICA

GERMANY

FRANCE

GENEVA

BURKINA FASO

MOROCCO

UNITED STATES OF AMERICA

KENYA

Innovation in decline?patent protection has increased over the last 20

years, but the mean innovation rate has fallen

Only 153 out of 1,035 new-drugs approved by th

e FDA

during a 12 year p

eriod fro

m 1989-2000

were for h

ighly innovative drugs – medicines that contained

new active ingredients and also provide

significant clinical im

provement. (NIHCM Foundatio

n, 2002)

68% of 3,096 new products approved in France

between 1981 and 2004 brought ‘nothing new’

over previously available preparations.

(Prescrire International, 2005)

Only 68 (5.9%) out of 1,147 newly patented drugs appraised by the Canadian Patented Medicine Prices Review Board between

1990 and 2003, met the regulatory criterion of being a breakthrough drug – the first drug to treat effectively a particular

illness or which provides a substantial improvement over existing drug products. (Morgan et al, BMJ 2005)

Prevention is better than cure3 steps

Law/guidelines setting the

patentability criteria Local

examination – law provides for examination of

every application

Pre - Grant Oppositions

Examination system weeds out patent applications that should not be granted

Efforts to stop evergreening:India:

Section 3(d) stipulates that the following shall not be treated as an invention within the meaning of the Act:

“ the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy

Any other personGeneric CompaniesPatient Groups

Pre Grant OppositionPre Grant Opposition

Post Grant OppositionPost Grant Opposition

Challenging Decisions of Patent OfficeChallenging Decisions of Patent Office

Challenging decisions of Appellate BoardChallenging decisions of Appellate Board

Patent OfficePatent Office

Patent OfficePatent Office

Appellate BoardAppellate Board

CourtCourt

Patent InvalidationPatent Invalidation

Appellate BoardAppellate Board

High CourtHigh CourtPatent RevocationPatent Revocation

India Allows Pre-grant and Post-grant Opposition

Oppositions and Appeals Oppositions and Appeals

Novartis patent application on life saving cancer drug – CPAA files opposition in 2005

Glivec’s base compound, Imatinib mesylate, was patented in 1993 and was not eligible for an Indian Patent because India joined the WTO only in 1995.

Result of CPAA’s opposition

•Patent for Glivec rejected

•Generic versions of Glivec were once again available in the Indian market at affordable prices

Jan 2006

MSF worried

But since January 2005, India is obliged to grant

patents on medicines the source of HIV medicines

may dry

MSF pharmacist: Generic pipeline

Needed for(according to WHO)

TDF 1st and 2nd line

TDF based FDC 1st line

LPV/r tabs 2nd line

Ritonavir 2nd line

EC ddI 2nd line

ATV 2nd line

ABC 1st and 2nd line

All these needed ARVs will be at risk of production if patents are granted

Prognôsis

A granted patent in India for an essential drug (including

Antiretrovirals) will block generic production by Indian

companies and make drugs either unavailable or unaffordable

(or both) across the developing world

Partnerships: PLHIV networks, legal AID groups and MSF need

to work together on opposing HIV medicine patent applications

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

1970-71

1975-76

1980-81

1984-85

1985-86

1986-87

1987-88

1998-89

1989-90

1990-91

1991-92

1992-93

1993-94

1994-95

1995-96

1996-97

1997-98

1998-99

Year

Nu

mb

er o

f A

pp

licat

ion

s

Domestic

Foreign

Patent Applications in India

US received 288K patent applications in 1999

Source: Annual Reports of the IPO

Source: Annual Reports of the IPO

• Major Increase in the number of patent applications filed at the Indian Patent Office (IPO)

• PCT is the favorite filing route

–~60% applications filed with the IPO were national phase filings under PCT

• Majority of filers are foreign residents (Bayer, Gilead)

• Major Increase in the number of patent applications filed at the Indian Patent Office (IPO)

• PCT is the favorite filing route

–~60% applications filed with the IPO were national phase filings under PCT

• Majority of filers are foreign residents (Bayer, Gilead)

Patent Filing Trends in India

0tan28a566028

0tan6a56736

0tan16a568716

0tan25a570125

0tan6a57156

0tan15a572815

0tan25a574225

0tan4a57564

0tan14a576914

No. Patents Filed

Patent Filings at the IPO

Searching Indian Patents – A BIG Challenge- Opposition dependent on information available. But how

does patent office manage publication in India:- no searchable database to identify applications

(reduced to manual searching through thousands of patent applications)

- Publication of only abstract. requirement of publication of patent specification deleted making it difficult to oppose effectively.

- Information only available after visiting four patent offices in Mumbai, Delhi, Kolkata and Chennai (no centralised system)

- Refusal to provide examination report Access to examination report available under USPTO & EPO

- Refusal to provide copies of patent decisions/case law (trademark decisions are available in journals) under sec 153, rule 134 f).

How we did it : • Manual procurement of patent copies from the Indian

Patent Office• Need to submit request and fees at one of the four patent

office branches where the application was filed (involves travel time & cost)

• Regular follow-up required to obtain the copy of the patent application

• May take three to four weeks for one application

Ex. of AZT+3TC patent application

« a pharmaceutical composition and a method of inhibiting human immunodeficiency virus (HIV) is disclosed which comprises administering to an HIV infected patient a homogenous composition of lamivudine, zidovudine and a pharmaceutical glidant in an amount which achieves antiviral efficacy »

Patent WIPO India Status

Lopinavir Crystalline WO 01/74787

IN/PCT/2002/1243/

MUM Rejected

Divisional of (1243) WO 01/74787 894/MUMNP/

2007 Abandoned

Lopinavir Crystalline - process and intermediatesWO/

2002/018349259/MUMNP/

2003 Pending

Divisional of (259)WO/

2002/0183491732/MUMNP/

2009 Pending

Ritonavir Polymorphs WO00/04016

PCT/2001/00018/

MUM Abandoned

Divisional of (00018) WO00/04016676/MUMNP/

2007 Abandoned

Divisional of (00018) WO00/04016677/MUMNP/

2007 Abandoned

Divisional of (00018) WO00/040161638/MUMNP/

2007 Pending

Ritonavir - dosage formulationWO2006/09152

96733/DELNP/

2007 Pending

Lopinavir/Ritonavir - Heat stable tabletWO2005/03955

1339/MUMNP/

2006 Rejected

Divisional of 339WO2005/03955

1726/MUMNP/

2009 Abandoned

Divisional of 339WO2005/03955

12474/DELNP/

2009 Withdrawn

Lopinavir/Ritonavir - Soft Gel formulation WO 00/74677

IN/PCT/2001/01312/

MUM Abandoned

LPV/r Patent Status

Efforts to stop evergreening

Not all patent applications are valid. Many patent applications are for a new

use of an old drug, or simply for derivatives of old drugs or combinations of old

drugs. (TRIPS requires patent protection for ‘inventions’) E.g. AIDS drug patent applications:1. a fixed dose combination of lamivudine/zidovudine

used in the treatment of HIV/AIDS: not a new invention but simply the combination of two existing drugs. Status of application - Withdrawn

2. tenofovir disoproxil fumarate (TDF), a key AIDS drug: forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is common practice within the pharmaceutical industry, and should not be considered a new invention. Status of applications - Opposed

II. Any person can oppose the grant of a patent application

Combivir patent opposition – Indian and Thai groups hold protests on the same day, issue joint press release…

…GSK announces withdrawal of Combivir patent application

7 August 2006: PLHIV protest outside GSK offices in Bangkok, Thailand.

7 August 2006: Indian groups demonstrate outside GSK offices in Bangalore, India.

Loon Gangte, President of DNP+ being interviewed on the tenofovir opposition, 10 May 2006

Rejections due to local examination and application of strict patentability criteria

Source: Lawyers Collective HIV/AIDS Unit

Legal safeguards: Prohibition of Evergreening & right to file oppositions

• The basic patents on Nevirapine (NVP) were applied for by Boehringer Ingelheim in November 1990, and are 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.

• India has a specific provision in its patent law that does not grant patents on minor changes to existing medicines.

• It allows any person to file a technical opposition

STAGES OF EXAMINATION

PUBLICATION OF APPLICATION

REQUEST FOR EXAMINATION

REJECT/GRANT OF PATENT

3rd Party Representation

Revocation/Amendment

OPPOSITION

• PROMPTLY AFTER 18 MONTHS

• WITHIN 48 MONTHS FROM F.D.

• ALL OBJECTIONS TO BE COMPLIED WITHIN 12 MONTHS

• WITHIN 12 MONTHS

FILING OF APPLICATIONPROVNL. / COMPLETE

Decision of Controller

EXAMINATION-ISSUE OF FER

Appeal

Appellate Board

Shortlist drugs Shortlist drugs

• Use organisations like MSF, Pharmacists, other treatment providers like CPAA• Use organisations like MSF, Pharmacists, other treatment providers like CPAA

Strategy for India : Identifying Barriers

Study US/EP/PCT patent families of short-listed drugsStudy US/EP/PCT patent families of short-listed drugs

• As almost 80% patent filers are foreigners, there are good chances that the patent would have patent applications in US/EP/PCT

• Since full texts of all granted patents are not available online, and manual procurement of patents takes time, PCT, US, EP documents help in quick assessment

• As almost 80% patent filers are foreigners, there are good chances that the patent would have patent applications in US/EP/PCT

• Since full texts of all granted patents are not available online, and manual procurement of patents takes time, PCT, US, EP documents help in quick assessment

Order full text of patents from relevant branch of the IPOOrder full text of patents from relevant branch of the IPO

• Note the branch of the IPO in the application number, and order the full text from that branch only

• Presence of local vendor helps in regular follow up with the IPO and quicker delivery of patents

• Note the branch of the IPO in the application number, and order the full text from that branch only

• Presence of local vendor helps in regular follow up with the IPO and quicker delivery of patents

Order full text of patent applications/patents from patent officeOrder full text of patent applications/patents from patent office

• You can ask a patent agent to find

• You can directly ask patent office for equivalent patent application

• Protests, Right To Information laws, prominent leaders can help

• You can ask a patent agent to find

• You can directly ask patent office for equivalent patent application

• Protests, Right To Information laws, prominent leaders can help

Patents Not Absolute

• Patent applications can be opposed during examination process (pre-grant oppositions)

• Patents can be challenged after grant (post grant opposition)

• Patents considered valid until challenged (ex: Thai patent on ddI

Message: Why are pre-grant oppositions important?

• Pressure on patent offices to do thorough analysis of patent applications

• TRIPS does not define:– inventions– patentability criteria

• Great majority of patent applications are on new forms / improvements of known compounds

• Rejection means access to generic medicines which are affordable

Check legislation

• Does your country examine application locally and then

• Some countries have no pre-grant opposition procedure but have post grant

• Some countries have pre-grant but no post grant (Thailand)

• Some countries have both (India) • Some countries have neither (South Africa)• Some countries grant opponents right to be heard

(India) but others do not (Brazil)

Growing movement – SA, Thailand, Argentina, Philippines - Examination system weeds out patent applications that should not be granted. Direct benefit with earlier expiry of patents on ARVs.

Compulsory licensingChina - key announcement of proceduresIndia – applications by generic competitorsSouth Africa – reforms needed