Transcript Dr. Ratnesh Shrivastava

IPR ISSUES IN PHARMACEUTICAL MARKETS
The land is only one
its pockets filled with ocean
You sit in the North
I sit in the south
But on the same land
The same soil
The same earth
One day we will share the earth
the soil, and the ocean
and the world will be One
And the world will be Won _ _
Dr Ratnesh Shrivastava
Copyright©
ARTICLE 7 TRIPS: OBJECTIVES
THE PROTECTION AND ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS
SHOULD CONTRIBUTE TO THE PROMOTION OF TECHNOLOGICAL
INNOVATION AND THE TRANSFER AND DISEMINATION OF TECHNOLOGY, TO
THE MUTUAL ADVANTAGE OF PRODUCERS AND USERS OF TECHNOLOGICAL
KNOWLEDGE AND IN A MANNER CONDUCIVE TO SOCIAL AND ECONOMIC
WELFARE, AND TO A BALANCE OF RIGHTS AND OBLIGATIONS
ARTICLE 8: PRINCIPLES
MEMBERS MAY IN FORMULATING OR AMENDING THEIR LAWS AND REGULATIONS,
ADOPT MEASURES NECESSARY TO PROTECT PUBLIC HEALTH AND NUTRITION AND
TO PROMOTE THE PUBLIC INTEREST IN SECTORS OF VITAL IMPORTANCE TO THEIR
SOCIOECONOMIC AND TECHNOLOGICAL DEVELOPMENT, PROVIDED THAT SUCH
MEASURES ARE CONSISTENT WITH THE PROVISIONS OF THIS AGREEMENT
APPROPRIATE MEASURES, PROVIDED THAT THEY ARE CONSISTENT WITH THE
PROVISIONS OF THIS AGREEMENT MAY BE NEEDED TO PREVENT THE ABUSE OF
INTELLECTUAL PROPERTY RIGHTS BY RIGHT HOLDERS OR THE RESORT TO
PRACTICES WHICH UNREASONABLY RESTRAIN TRADE OR ADVERSELY AFFECT THE
INTERNATIONAL TRANSFER OF TECHNOLOGY.
GLOBAL MARKET ($825 billion BY
REGION
NORTH AMERICA
40%
EUROPE
32%
JAPAN
10%
LATIN AMERICA
6%
REST OF WORLD
12%
IN BIG MARKETS GOVERNMENT/INSURANCE
MEDICAL REIMBURSEMENT SCHEMES EXIST
MARKETS STUDIED
SIZE OF MARKETS
“VERY LARGE MARKETS” IN RED
“MODERATE TO SMALL” IN YELLOW
“LARGE TO MODERATE” IN GREEN
IF ONE EXCLUDES US, CA, EP, AND JP THE REST OF THE WORLD COMPRISING
ABOUT 82.5% OF THE WORLD POPULATION CONSTITUTES LESS THAN 20% OF THE
MARKET THE REASON IS LACK OF PURCHASING POWER
MARKETS WITH PER CAPITA
>$ 20,000
“A”
INCOME
MARKETS WITH PER CAPITA
$ 5 -10,000
“B”
INCOME
MARKETS WITH PER CAPITA
< $ 5,000
“C”
INCOME
1. UNITED STATES*
1. CHILE*
1. CHINA*
2. EP*
2. MEXICO*
2. PHILLIPINES
3. JAPAN*
3. MALAYSIA
3. EGYPT*
4. CANADA*
4. RUSSIA
4. ECUADOR*
5. AUSTRALIA*
5. BRAZIL*
5. INDONESIA
6. SINGAPORE*
6. TURKEY*
6. INDIA
*: Countries that provide for data exclusivity
THEREFORE THE ISSUE IS THE CONTRADICTION OF THE PROPOSAL OF
EXPANDING TRADE WITH THOSE IN THE WORLD WHO DO NOT HAVE
SUFFICIENT PURCHASING POWER or THEIR GOVERNMENT HAS INSUFFICIENT
ECONOMIC ABILITY TO SUPPORT MEDICAL REIMBURSEMENT
MARKET
“A”
MARKET
“B”
MARKET
“C”
Imatinib Pre 1995
6/6
0
0
Nilotinib Post 1995
6/6
3/6
3/6
Antidiabetic
(Novo Nordisk)
Repaglinide Pre 1995
6/6
0/6
0/6
Liraglutide post 1995
5/6
3/6
2/6
Anti HIV
(BMS)
Entecavir Pre 1995
6/6
2/6
1/6
Atazanavir Post 1995
5/6
3/6
2/6
Antiinfective
Clarithromycin Pre 1995
3/6
0
0
Cethromycin Post 1995
4/6
2/6
1/6
DRUG
CATEGOR
Y&
COMPANY
PRODUCTS
Anticancer
(Novartis)
CONCLUSION : INVESTMENT OF RESOURCES IN PATENTING IN LOWER
INCOME MARKETS IS ONLY INCREASED A LITTLE BIT BECAUSE THE
RETURNS ARE SMALL AND IN MOST OF THE COUNTRIES SELECTED
FOR THIS STUDY DATA EXCLUSIVITY IS AVAILABLE
DATA EXCLUSIVITY- TRIPS ARTICLE 39.3 :
MEMBERS, WHEN REQUIRING, AS A CONDITION OF APPROVING
THE MARKETING OF PHARMACEUTICAL OR OF AGRICULTURAL
CHEMICAL PRODUCTS WHICH “UTILIZE NEW CHEMICAL
ENTITIES”, THE SUBMISSION OF UNDISCLOSED TEST OR
OTHER DATA, THE ORIGINATION OF WHICH INVOLVES A
CONSIDERABLE EFFORT, SHALL “PROTECT SUCH DATA
AGAINST UNFAIR COMMERCIAL USE”. IN ADDITION,
MEMBERS SHALL PROTECT SUCH DATA AGAINST DISCLOSURE,
EXCEPT WHERE NECESSARY TO PROTECT THE PUBLIC, OR UNLESS
STEPS ARE TAKEN TO ENSURE THAT THE DATA ARE PROTECTED
AGAINST UNFAIR COMMERCIAL USE.
DATA EXCLUSIVITY
THREE VERY
LARGE MARKETS
THIRTEEN LARGE TO MODERATE
MARKETS
ELEVEN MODERATE TO
SMALL MARKETS
COUNTRY
PERIOD
COUNTRY
PERIOD
COUNTRY
PERIOD
US
5 YRS
CHINA
6 YEARS
INDIA
NEGOTIATION (EU-IN)
EUROPE*
6/ 10 YRS
CANADA
8 YEARS
PHILIPPINES
NO
JAPAN
6 YEARS
MEXICO
5 YEARS
EGYPT
5 YEARS
BRAZIL
10 YEARS
ISRAEL
5 YEARS
S. KOREA
6 YEARS
S. AFRICA
NO
POLAND
10 YRS OR 6 YRS*
CHILE
5 YEARS
TURKEY
6 YRS
ECUADOR
5 YEARS
TAIWAN
5 YEARS
PERU
5 YEARS
AUSTRALIA
5 YEARS
KENYA
NO
RUSSIA
NEGOTIATION IN FTA
SINGAPORE
5 YEARS
INDONESIA
NO
VIETNAM
5 YEARS
ARGENTINA
NO
MALAYSIA
NEGOTIATION (MY-US)
COLOMBIA**
3, 4 OR 5 YEARS
*10 yrs for products filed through EMEA, 6 yrs for products filed through Mutual Recognition Procedure after May 1, 2004
**3, 4 or 5 yrs based on filing during 1st, 2nd or 3rd year respectively of the decree (Data Protection Decree No. 2085, Sep 19, 2002) in force.
1. IF THERE IS INNOVATION IT IS AWARDED THROUGH PATENT GRANT. IF THERE
IS NO INNOVATION THEN WHAT IS INVOLVED IS ROUTINE EXPERIMENTATION
WHICH MAY HOWEVER REQUIRE LARGE INVESTMENT
FOR POTENTIAL GAIN AT A BUSINES RISK
2. TRIPS FLEXIBILITY ALLOWS A MEMBER STATE TO DECIDE WHETHER TO
AWARD FOR INVESTMENT WITH DATA EXCLUSIVITY. STATES WITH LOW PER
CAPITA INCOME NEED TO WEIGH HEAVILY THE RESPONSIBILTY OF PROVIDING
DRUGS AT AN AFFORDABLE PRICE BUT HAVE NO OBLIGATION TO SAFEGUARD
BUSINESS RISKS.
TRIPS ARTICLES 1: MEMBERS SHALL GIVE EFFECT TO THE PROVISIONS OF THIS
AGREEMENT. MEMBERS MAY, BUT SHALL NOT BE OBLIGED TO, IMPLEMENT IN
THEIR LAW MORE EXTENSIVE PROTECTION THAN IS REQUIRED BY THIS
AGREEMENT, PROVIDED THAT SUCH PROTECTION DOES NOT CONTRAVENE THE
PROVISIONS OF THIS AGREEMENT.
TRIPS ARTICLE 8.1: MEMBERS MAY, IN FORMULATING OR AMENDING THEIR LAWS
AND REGULATIONS, ADOPT MEASURES NECESSARY TO PROTECT PUBLIC HEALTH
AND NUTRITION, AND TO PROMOTE THE PUBLIC INTEREST IN SECTORS OF VITAL
IMPORTANCE TO THEIR SOCIO-ECONOMIC AND TECHNOLOGICAL DEVELOPMENT,
PROVIDED THAT SUCH MEASURES ARE CONSISTENT WITH THE PROVISIONS OF
THIS AGREEMENT
4. DATA EXCLUSIVITY IS IRREVOCABLE BUT PATENTS CAN BE
REVOKED .
EXAMPLES OF SOME DRUGS FOR WHICH PATENTS HAVE BEEN
REVOKED OR ARE CHALLENGED
• TENOFOVIR DISOPROXIL FUMARATE, VALGANCYCLOVIR,
TEKTURNA (ALISKIREN), REYATAZ (ATAZANAVIR),
VIBATIV (TELAVANCIN), ABACAVIR (WITHDRAWN),
• COMBINATIONS: VALTURNA (ALISKIREN-VALSARTAN),;
YAZ (DROSPIRENONE-ETHINYL ESTRADIOL), YASMIN
(ETHINYLESTRADIOL-DROSPIRENONE. FORMOTEROL
FUMARATE AND MOMETASONE FUROATE INHALATION
AEROSOL COMBINATION,
5. ARE FTAs COMPLIANT WITH THE PRINCIPLE OF TRIPS
ENSHRINED IN ARTICLE 8.
OTHER TRIPS PLUS PROVISIONS
Patent extensions allowed only in few countries
Some Countries with
High per capita income
Some Countries with
Moderate per capita
income
Some Countries with
Low per capita
income
United States, Europe
Japan, Australia
Singapore,
Israel, Chile, Taiwan
Russia, Korea,
Belarus,
Kazakhstan, Panama
Mexico (Term equal
to that in origin
country)
Morocco,
Some Countries with high per capita income and large market not having
patent extension include: Canada, Latin America, China, Indonesia
PATENT LINKAGE
• UNITED STATES: PARA IV CHALLENGES, COSTLY
•
•
•
LITIGATION, 30 MONTH STAY OF GENERIC APPROVAL,
180 DAY EXCLUSIVITY AND ITS FORFEITURE
CANADA: PATENT CHALLENGES, LITIGATION, 24 MONTH
STAY, NEW CASE CAN AGAIN BE FILED ON MARKETING.
NO EXCLUSIVITY
AUSTRALIA: APPLICANT MUST DECLARE THAT PATENTS
ARE NOT INFRINGED AND HEATH AUTHORITIES MAY
NOT PROVIDE APPROVAL. APPLICANT MUST NOTIFY
PATENTEE
CHINA: SFDA MUST BE SATISFIED THAT PATENTS ARE
NOT INFRINGED BEFORE ISSUING APPROVAL
PATENT LINKAGE
 SINGAPORE: APPLICANT TO CERTIFY AS TO PATENTS,



LICENSING AUTHORITY MAY REQUIRE THE APPLICANT
TO NOTIFY THE PATENTEE AND THE PATENTEE MAY
APPROACH THE COURT OR THE PATENT OFFICE TO
BLOCK APPROVAL
JORDAN AND UAE: APPROVAL NOT PERMITTED DURING
PATENT TERM
MEXICO: HEALTH AUTHORITY WILL CHECK WITH THE
PATENT OFFICE THAT PATENT IS NOT INFRINGED.
PATENT OFFICE MUST RESPOND IN 10 DAYS
INDIA: BAYER VS UNION OF INDIA, High Court of Delhi
at New Delhi, LPA 443/2009 (Sorafenib case) : The
court affirmed that the attempt at bringing in patent
linkage on the basis of existing provisions of the patents
act and the DCA can not be countenanced