La descarga está en progreso. Por favor, espere

La descarga está en progreso. Por favor, espere

© BERKEN IP 2010. Todos los derechos reservados. Pharmaceutical and Biotechnology Patents in Argentina Alicia Alvarez Berkenwald – BERKEN IP Friday May.

Publicada porRoberta Campuzano Modificado hace 9 años

Presentaciones similares

Presentación del tema: "© BERKEN IP 2010. Todos los derechos reservados. Pharmaceutical and Biotechnology Patents in Argentina Alicia Alvarez Berkenwald – BERKEN IP Friday May."— Transcripción de la presentación:

1 © BERKEN IP 2010. Todos los derechos reservados. Pharmaceutical and Biotechnology Patents in Argentina Alicia Alvarez Berkenwald – BERKEN IP Friday May 13th, 2011. AIPLA Spring Meeting, Palace Hotel, San Francisco © BERKEN IP 2011. All rights reserved. BIOTECHNOLOGY PATENT STRATEGIES IN CHALLENGING MARKETS 1

2 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Argentina – Population marketimetrics.com POPULATION MEN WOMEN AS PERCENTAGES OF TOTAL POPULATION: 36.3 Mio Source: INDEC POPULATION > 65 YEARS OLD ITALIA25% ALEMANIA24% JAPON24% ESPAÑA22% FRANCIA21% CHINA10% ARGENTINA10% INDIA8% BRASIL5% MEXICO5% VENEZUELA4% GUATEMALA 4% 2

3 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Argentina – Life Expectancy marketimetrics.com LIFE EXPECTANCY IN YEARS FROM BIRTH Source: INDEC 3

4 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Argentina – Wealth Distribution marketimetrics.com WEALTH DISTRIBUTION % INCOME OF THE 20% MOST WEALTHY POPULATION Source: INDEC 4

5 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Argentina – Literacy marketimetrics.com LITERACY % OF TOTAL POPULATION Source: INDEC 5

6 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Argentina – Newspaper Readers marketimetrics.com NEWSPAPER READERS % OF HOMES Source: INDEC 6

7 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Argentina - Pharmaceutical Market Information marketimetrics.com CONSUMPTION PER CAPITA Source: CID LATINA 12/2010 7

8 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Pharmaceutical Market Information marketimetrics.com USD NATIO NAL 58% INTER NATIONAL 42% Source: CID LATINA 12/2010 8

9 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. 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 9

10 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. 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 10

11 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. General Patent Issues a.Only one independent claim allowed b.Litigation still infrequent 11

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

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

14 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Patentable Subject Matter Modified substances Synthetic substances different from natural ones DNA, plasmids, proteins, sequences, etc., which are not identical to a natural element 14

15 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. 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 HPPD 15

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

17 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. 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 17

18 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Pharmaceutical Patent Issues - No patent for second and further medical uses - No “Swiss claims” allowed 18

19 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. Pharmaceutical Regulatory Issues - Registration by similarity - No confidential information submitted - No bioequivalence required for most products - No linkage between Patents and Marketing authorization 19

20 © BERKEN IP 2010. Todos los derechos reservados. © BERKEN IP 2011. All rights reserved. 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! 20

21 © BERKEN IP 2010. Todos los derechos reservados. Thank you © BERKEN IP 2011. All rights reserved. Alicia Alvarez Berkenwald – BERKEN IP aalvarez@berkenip.com 21

Descargar ppt "© BERKEN IP 2010. Todos los derechos reservados. Pharmaceutical and Biotechnology Patents in Argentina Alicia Alvarez Berkenwald – BERKEN IP Friday May."

Presentaciones similares

Talking about weather Discussing the weather is a very human thing to do, and every language has its own way of doing it. If you think about it, the weather.

Talking about weather Discussing the weather is a very human thing to do, and every language has its own way of doing it. If you think about it, the weather.
Telling Time (Cómo decir la hora). When we ask what time it is in Spanish, we say “¿Qué hora es?” Some people also say “¿Qué horas son?”

Telling Time (Cómo decir la hora). When we ask what time it is in Spanish, we say “¿Qué hora es?” Some people also say “¿Qué horas son?”
VOCABULARIO #2.4 ¡Aprenda! Forming Questions Señora Sequin.

VOCABULARIO #2.4 ¡Aprenda! Forming Questions Señora Sequin.
Helping Your Child at Home with Math Agenda Welcome and Overview Math Tools Using Math Strategies Homework Grade Level Games Closing: Mathematics Vision.

Helping Your Child at Home with Math Agenda Welcome and Overview Math Tools Using Math Strategies Homework Grade Level Games Closing: Mathematics Vision.
Spanish –er and –ir verbs. Verbs in General English and Spanish both conjugate verbs. They can be organized as 1rst, 2 nd, and 3 rd person. If you need.

Spanish –er and –ir verbs. Verbs in General English and Spanish both conjugate verbs. They can be organized as 1rst, 2 nd, and 3 rd person. If you need.
SOCIEDAD PARA EL DESARROLLO REGIONAL DE CANTABRIA (SODERCAN) Knowledge Management tools Knowledge management tools.

SOCIEDAD PARA EL DESARROLLO REGIONAL DE CANTABRIA (SODERCAN) Knowledge Management tools Knowledge management tools.
LA MES DE LA HERENCIA HISPANA MARIA ALAS LIBERTY HIGH SCHOOL 2011-2012.

LA MES DE LA HERENCIA HISPANA MARIA ALAS LIBERTY HIGH SCHOOL
Lesiones orales y estado inmunológico de pacientes VIH+ expuestos o no al consumo de alcohol. Blanca Lucía Acosta de Velásquez Elisa María Pinzón Gómez.

Lesiones orales y estado inmunológico de pacientes VIH+ expuestos o no al consumo de alcohol. Blanca Lucía Acosta de Velásquez Elisa María Pinzón Gómez.
1 – 999,999,999.

1 – 999,999,999.
Cómo compartimos el planeta / Sharing the Planet/Los Organismos Vivos y  Los Organismos No Vivos: Por: Jeena Clavijo.

Cómo compartimos el planeta / Sharing the Planet/Los Organismos Vivos y  Los Organismos No Vivos: Por: Jeena Clavijo.
El Verbo Ser Yonosotros/nosotras tú x él, ella, usted ellos,ellas,ustedes Write the subject Pronoun Equivalent. 1. Chris y Noah = ___________ 2. Haley.

El Verbo Ser Yonosotros/nosotras tú x él, ella, usted ellos,ellas,ustedes Write the subject Pronoun Equivalent. 1. Chris y Noah = ___________ 2. Haley.
Notes #18 Numbers 31 and higher Standard 1.2

Notes #18 Numbers 31 and higher Standard 1.2
-AR Verbs In Spanish, there are three classes (or conjugations) of verbs: those that end in –AR, those that end in –ER, and those that end in –IR. This.

-AR Verbs In Spanish, there are three classes (or conjugations) of verbs: those that end in –AR, those that end in –ER, and those that end in –IR. This.
Hacer Ahora Miercoles, el 9 de febrero Note: the verbs below are all e  ie stem changing verbs!

Hacer Ahora Miercoles, el 9 de febrero Note: the verbs below are all e  ie stem changing verbs!
Subject pronouns In order to use verbs, you will need to learn about subject pronouns. A subject pronoun replaces the name or title of a person or thing.

Subject pronouns In order to use verbs, you will need to learn about subject pronouns. A subject pronoun replaces the name or title of a person or thing.
Telling Time (Cómo decir la hora). When we ask what time it is in Spanish, we say “¿Qué hora es?” Some people also say “¿Qué horas son?” (México y Centroamérica)

Telling Time (Cómo decir la hora). When we ask what time it is in Spanish, we say “¿Qué hora es?” Some people also say “¿Qué horas son?” (México y Centroamérica)
 ¿Quieres BONUS en el Unit Examen #5?  0-10 pts. › Canciónes, arte, poemas, etc.

 ¿Quieres BONUS en el Unit Examen #5?  0-10 pts. › Canciónes, arte, poemas, etc.
Frases / oraciones phrases/sentences

Frases / oraciones phrases/sentences
Quasimodo: (son las doce)

Quasimodo: (son las doce)
What has to be done today? It can be done in any order. Make a new ALC form Do the ALC Get two popsicle sticks Get 16 feet of yarn. That is 4 arms width.

What has to be done today? It can be done in any order. Make a new ALC form Do the ALC Get two popsicle sticks Get 16 feet of yarn. That is 4 arms width.

Presentaciones similares

Anuncios Google