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

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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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

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

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

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

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

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

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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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

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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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

© BERKEN IP Todos los derechos reservados. © BERKEN IP All rights reserved. Example: AR Patent No 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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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 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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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 (granted 2008) 1. Chimeric gene comprising 17

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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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

© BERKEN IP Todos los derechos reservados. © BERKEN IP 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

© BERKEN IP Todos los derechos reservados. Thank you © BERKEN IP All rights reserved. Alicia Alvarez Berkenwald – BERKEN IP 21