© BERKEN IP 2010. Todos los derechos reservados. Pharmaceutical and Biotechnology Patents in...

© BERKEN IP 2010. Todos los derechos reservados.

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

1

© BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved.

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


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


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


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


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


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


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


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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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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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

12


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


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


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


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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© BERKEN IP 2010. Todos los derechos reservados.

Thank you

© BERKEN IP 2011. All rights reserved.

Alicia Alvarez Berkenwald – BERKEN [email protected]

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