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Pharmaceutical and BiotechnologyPatents in Argentina
Alicia Alvarez Berkenwald – BERKEN IPFriday May 13th, 2011. AIPLA Spring Meeting, Palace Hotel, San Francisco
© BERKEN IP 2011. All rights reserved.
BIOTECHNOLOGY PATENT STRATEGIES IN CHALLENGING MARKETS
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Argentina – Populationmarketimetrics.com
6,0 4,0 2,0 0,0 2,0 4,0 6,0
0-4 años
5-9
10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
75-79
80-84
85-89
90-94
95 y más
MUJERES
VARONES
COMO PORCENTAJES DE LA POBALCION TOTAL : 36,3 MILLONESFuente : INDEC - CENSO POBLACION 2001
P IRAMIDE POBLACIONALARGENTINA
POPULATION
MEN
WOMEN
AS PERCENTAGES OF TOTAL POPULATION: 36.3 Mio Source: INDEC
POPULATION > 65 YEARS OLD
ITALIA 25%ALEMANIA 24%JAPON 24%ESPAÑA 22%FRANCIA 21%CHINA 10%ARGENTINA 10%INDIA 8%BRASIL 5%MEXICO 5%VENEZUELA 4%GUATEMALA 4%
2
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Argentina – Life Expectancymarketimetrics.com
EXPECTATIVA DE VIDA AL NACEREN AÑOS - FTE: UNESCO 2000-2005
67,074,2
68,173,4
WORLD ARGENTINA BRASIL MEXICO
LIFE EXPECTANCYIN YEARS FROM BIRTH
Source: INDEC
3
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Argentina – Wealth Distribution marketimetrics.com
DISTRIBUCION DE LA RIQUEZA% DE INGRESOS DEL 20% DE POBLACION MAS RICA
20%
51% 55%64%
POBLACION MASRICA
ARGENTINA BRASIL MEXICO
WEALTH DISTRIBUTION% INCOME OF THE 20% MOST WEALTHY POPULATION
Source: INDEC 4
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Argentina – Literacymarketimetrics.com
ALFABETIZACIONEN % DE POBLACION - FTE: UNESCO 2000-2004
81,7%
97,0%88,2% 90,5%
WORLD ARGENTINA BRASIL MEXICO
LITERACY% OF TOTAL POPULATION
Source: INDEC
5
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Argentina – Newspaper Readersmarketimetrics.com
62%
78%
33% 27%
38%
22%
67%73%
LATAM ARGENTINA - BA BRASIL - SP MEXICO - DF
READS NEVER READS
NEWSPAPER READERS% OF HOMES
Source: INDEC
6
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Argentina - Pharmaceutical Market Informationmarketimetrics.com
10,9
10,6
9,6
7,6
9,1 10
,1
10,5 11
,4 12,3
14,6 15
,1
14,1
13,1
12,9
-
2,0
4,0
6,0
8,0
10,0
12,0
14,0
16,0
18,0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
UN
ITS
PE
R C
AP
ITA
PE
R Y
EA
R
CONSUMPTION PER CAPITACONSUMPTION PER CAPITACONSUMPTION PER CAPITA
Source: CID LATINA 12/2010
7
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Pharmaceutical Market Informationmarketimetrics.com
3.9
31
3.9
37
3.6
55
1.3
09
1.7
90
2.0
76
2.3
42
2.6
25
3.0
88
5.1
70
5.4
97
3.7
30
3.8
76 4
.65
9
0
1.000
2.000
3.000
4.000
5.000
6.000
7.000
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
US
D (
Mio
)
USDUSDUSD
NATIONAL
58%
INTERNATIONAL
42%
Source: CID LATINA 12/2010 8
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General Patent Issues
a. Argentina is not a PCT member
i. Only Convention priority can be claimed
b. Grace term: one year preceding AR filing or priority filing date
ii. Disclosure must be declared at AR filing date
iii. Publication by a Patent Office excluded from grace term
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General Patent Issues
a. Chronological order for Examination determined by the date of request (and not by the date of filing)
b. No provisional protection
c. No Continuation or Continuation-in-part applications
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General Patent Issues
a. Only one independent claim allowed
b. Litigation still infrequent
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Patentability Criteria in Biotech
Not Considered Inventions
• Discoveries
• Any kind of living matter and substances …
… pre-existing in nature or identical to a natural element
• Even if isolated and purified
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Not Considered Inventions
a. Animals, parts or components that lead to a whole individual
b. Plants, propagation materials, parts or components that lead to a whole individual
c. Microorganisms pre-existing in nature
-- even if isolated and purified
d. Cells that may lead to a plant or animal
- However, any cell component is considered a substance 13
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Patentable Subject Matter
• Modified substances
• Synthetic substances different from natural ones
• DNA, plasmids, proteins, sequences, etc., which are not identical to a natural element
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Example: AR Patent No. 002169 B1 Claims originally filed related to:• Isolated DNA sequence from a gene of non-human origin ... characterized by the
fact that:
– It expresses a HPPD (hydroxy phenyl pyruvate dioxygenase)• Sequence … 1, characterized by the fact that:
– It is of bacterial or vegetable origin• Process for isolating the gene …• Chimeric gene for genetically transforming plants, the gene comprising:
– at least a promoter sequence from a gene normally expressed in plants
– an heterologous codifying sequence
– at least a polyadenylation sequence
characterized in that the coding sequence expresses HPPD15
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Granted Claim Set
1. A chimeric gene comprising:
- at least one promoter regulation sequence from a gene expressing itself naturally in plants
- a heterologous coding sequence under control of the promoter regulation sequence and
- at least one polyadenylation sequence
characterized in that the coding sequence expresses HPPD. (…)
11. Vector comprising a chimeric gene according to claim 1 to 10.
12. Plant cell comprising a chimeric gene according to claim 1 to 11, with the proviso that
said cell is not able to give rise to a plant.
13. A method of selective herbicidal treatment of plants, which comprises applying an HPPD
inhibiting herbicide to a plant containing the chimeric gene of claim 1 (plant not claimed as in
US and EP)16
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Comparison with Equivalent Patents in USA and Europe
a. US 6,268,549 B1 (granted in 2001)
1. Isolated gene which expresses a (HPPD) from Pseudomonas
2. Sequence according to claim 1…
3. Chimeric gene comprising …
b. EP 0828837 (granted 2008)
1. Chimeric gene comprising
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Pharmaceutical Patent Issues
- No patent for second and further medical uses
- No “Swiss claims” allowed
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Pharmaceutical Regulatory Issues
- Registration by similarity
- No confidential information submitted
- No bioequivalence required for most products
- No linkage between Patents and Marketing authorization
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Suggestions and Tips
• Even if imperfect, the AR patent system is the safest and most effective means of protection
• For new products, new formulations, new processes: include Argentina in your country filing list
• Remember to declare non-prejudicial disclosure at filing date
• Consider requesting examination as soon as possible
• And remember that Argentina is not PCT!
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Thank you
© BERKEN IP 2011. All rights reserved.
Alicia Alvarez Berkenwald – BERKEN [email protected]
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