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PONENCIAS

Danielle Berneman Chef du Service des Brevets et Inventions, Institut Pasteur. Conocimientos básicos en leyes de patentamiento (Europa y USA) y la importancia económica de proteger las inversiones en el área biotecnológica.

Félix Rozanski Director Asociación de Derechos Intelectuales ASDIN. Por qué y cómo proteger las inversiones en Biotecnología: posibilidades y límites en América Latina.

Christoph Barnas European Patent Office Biotechnology Division. Patent in the fleld of Biotechnology in the EPO

Rebecca Goodman Office of intellectual Property, UCLA. Technology Transfer at University of California, Los Angeles

Rodrigo Cooper Oficina Alessandri Propiedad Intelectual. Visión práctica del proceso de patentamiento en Chile.

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Danlelle Bememan4nstltut Pasteur (France) 16-17 Diciembre 20031

INTELLECTUAL PROPERTY

THE GENERAL PRINCIPLES

COPYRIGHTS

TRADEMARKS INTELLECTUAL PROPERTY

KNOW-HOW

INDUSTRIAL PROPERTY

DESIGN

PATE NTS

ieIIe BERNEMAN-INS TITUT PASTEUR (France) 16-17 Diciembre 2003

PATENTS ARE THE KEYSTONE OF INDUSTRIAL PROPERTY

BECA USE

THEY GIVE TO THEIR OWNERS A MONOPOLY TO EXPLOIT AN INVENTION AND TO EXCLUDE COMPETITORS FROM TuS MONOPOLY.

-, TUEY ARE A STRATEGIC TOOL FOR NEGOCIATION OF

-a license agreement or a cross-Jicense agreement

-a research and development agreement

-fund-rising by a licensed start-up

1 Foro Internacional de Pate ntarnlento en Biotecnología, Santiago, CHILE 1

Danlelie BERNEMAN-INSTITUT PASTEUR (France) 1647 DIciembre 2003

BIo'rEcH INVENTIONS

Their patentability is based on the same criteria as those applied to inventions made in other dornajos.

They are found ¡n al¡ the patent laws whatever the country mv

¡ Foro Internacional de Patentamiento en Biotecnología, Santlao CHILE

Daniel?. BERNEMAN-INSTIT(JT PASTEUR (France) 16-17 Diciembre 2003 3 - - THE CRITERIA TO BE GRANTED A PATENT

1-NO VEL TV (a)

A scientific result should no¡, have been disclosed

either orally (scientific meetings) or ¡o a written way

(poster, publication, thesis) before the patent application is filed.

1 Foro Internacional de Patentarniento en Biotecnología, Santiago, CHILE

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DanieIie BERNEMAN-INSTITUT PASTEUR (France) 1647 Diciembre 2003

THE CRITERIA TO BE GRANTED A PATENT

1-NOVEL TI' (h)

The use of data banks (free of access or upon subscription) specialized in patents is recommended to check if a relev ant prior art exists.

1 Foro Internacional de Paten!amiento en Biotecnología, Santiago, CHILE

Danlelle BERNEMAN-INSTITUT PASTEUR (France) 16-17 Diciembre 2003 -

THE CRITERIA TO BE GRANTED A PATENT

2-IN VEN TI VE S TEP (NON OB VIO USNESS)(a)

An inventive contribution is more than what was known in the technical domain

and more than to carry out the experiments under the instructions of an inventor.

1 Foro internacional de Patentamiento en Biotecnología, Santiago, CHILE E - -

DanIeIIe BERNEMAN-INSTITUT PASTEUR (France) 16-17 Diciembre 2003

THE CR1TERIA TO BE GRANTED A PATENT

2-IN VEN TIVE S TEP (NON OB VIO USNE SS) (b)

This criteria is often a key point of disagreement between the examiners ¡u the Patent Offices and the inventors:

The exaininers analvsis can be that the invention is infact

a logical result of ihe data already known by the man skill in the art.

This criteria is a very disputed ¡ssue during the examination of the patent application.

DanIeIIe BERNEMAN-INSTTUT PASTEUR (France) 16-17 Diciembre 2003

THE CRITERIA TO BE GRANTED A PATENT

3-UTILITY (OR INDUSTRIAL ,1PPLICATIONS)

The invention has to lead to an improvement of a technique or to a new product ( for example useful for vaccination,

diagnostie or therapeutical applications)

The invention is the solution to a technical problem ¡nvolving ¡ndustry

If the invention does not correspond to this definition, there is no utility.

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DanIeIIe BERNEMAN-1NST1TUT PASTEUR (France) 16-17 Diciembre 2003

THE CRITERIA TO BE GRANTED A PATENT

CONCL USION

The absence of at Ieast one of these 3 entena prevents to protect an invention by a patent application.

Danielie BERNEMAN-INST1TUT PASTEUR (France) 16-17 Diciembre 2003

PATENTS NEWS FROM EUROPE AND USA IN BIOTECHNOLOGY

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DanleIle BERNEMAN-INSTITUT PASTEUR (France) 1647 DicIembre 2003

The Biotechnological Directive (1998) is not yet approved by severa¡ countries such as France,

Germany, Italy, Belgium, etc.

- ¡ Foro Internacional de Patentarnlento en Biotecnología, Santiago, CHILE

fnieiie BERNEMAN-INST1TUT PASTEUR (France) 16-17 Diciembre 2003

Recombinant plants are patentable but not the plant variety

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FnIe BERNEMAN-INST1TUT PASTEUR (Franco) 16-17 Diciembre 2003

The mandate is essential to securize the future licensee against claims from one of the co-owners.

The mandate gives a complete authority when negociations with a company occur.

[nIelIe BERNEMAN-INSTITUT PASTEUR (Franco) 16-17 Diciembre 2003

ISSUES RAISED BY FILING A PATENT APPLICATION

2-0 WNERSFIJP AND CO-O WNERSHJP (c)

Moreover, the designation of any person who did not participate ¡u the invention

as an inventor can lead to the unvalidity of the US patent.

The identification of the true inventors is not an easy task but it has to be done properly.

¡ Foro Internacional de Patentarnlento en Biotecnología. Santiago, CHILE

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nIeIIe BE1NEMAN-INST1TUT PASTEUR (France) 16-17 Diciembre 2003 1

Genes and proteins are considered as chemical products

DanieIIe BERNEMAN-INST1TUT PASTEUR (France) 16-17 Diciembre 2003

RNA or DNA sequences can not be patented

if no function is disclosed

and

if no test of the function is sufficiently proving the activity.

¡ Foro Internacional de Patentamlento en Biotecnología, Santiago, CHILE jj

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Danlelle BERNEMAN-INSTITUT PASTEUR (Franco) 16-17 Diciembre 2003

A putative function of a protein based on homology is not enough (Europe)

¡ Foro Internacional de Patentamiento en Biotecnología, SanUao, CHILE

Danielle BERNEMAN-1NSTITUT PASTEUR (France) 16-17 Diciembre 2003

INVENTIONS LINKED TO GENOMICS

DanIeIIe BERNEMAN-INST1TUT PASTEUR (France) 16-17 DIciembre 2003 j

A 3D structure of a protein is not patentable under the US law but the complex between the crytallized

protein and its ligand can be patented.

Danh4lo BERNEMAN-INSTITUT PASTEUR (France) 16-17 DIciembre 2003

The compounds as ligands identified by in sulco techniques are not patentable (Europe and USA)

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Danlolle BERNEMAN-INSTITUT PASTEUR (France) 1647 Diciembre 2003

Data bases are no patentable but can be protected by copyright as well as softwares.

¡ Foro Internacional de Patentamiento en Biotecnología, Santiago, CHILE

Danlelle BERNEMAN-INS TITUT PASTEUR (France) 16-17 Diciembre 2003

The accurate annotation is the only way to protect new molecules (genes or proteins) if it is complemented by

credible tested functions.

1 Foro Internacional de Patentamiento en Biotecnología, Santlaqo, CHILE jj -

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]DanIeIIe BERNEMAN-INSTITUT PASTEUR (France) 16-17 Diciembre 2003 j

ISSUES RA1SED BY FILING A PATENT APPLICATION

¡-JN VEN TORSH1P

An inventor or several co-inventors are the persons who made a contribution for the obtention of the claimed invention.

The Iist of the inventors will be established in a disclosure of invention form

1 Foro Internacional de Patentarnlento en Biotecnologia, Santiago, CHILE

Danielle BERNEMAN-INSTITUT PASTEUR (France) 16-17 DicIembre 2003

The disclosure of invention form contains (a):

¡-The Iist of inventors and the employers.

2-The precise dates of future divulgations in order

to organize them without jeopardizing

the possibility to patent the invention.

1 Foro Internacional de PatentamIento en Biotecnología. Santiago, CHILE

[tianielle BERNEMAN-INSTITUT PASTEUR (Franco) 16-17 Diciembre 2003 j

ISSUES RAISED BY FILING A PATENT APPLICATION

2-O WNERSHIP AND C0-O WNERSHIP (a)

The invention is owned by the employers of the inventors in almost afl the countries but sorne exceptions stihl exist as in the USA where onhy the signature of an assignment by the inventors can transfer their rights to their employer.

The management of the protection of a patent application

EII by muhtiple entities owning an invention is complex.

1 Foro Internacional de Patentamlento enBlotecnología, SanUa?o, CHILE

Danielle BERNEMAN-INST!TUT PASTEUR (France) 16-17 Diciembre 2003 1

ISSUES RAISEL) BY FILING A PATENT APPLICATION

2-OWNERSHJP AND CO-O WNERSHJP (b)

The sharing of the expenses and of the revenues between the parties will be negociated as soon as possible and preferably before fihing the application.

The signature of a co-ownership agreement is also absolutely necessary in order to mandate one of them to be responsible for the protection and the licensing of the invention.

1 Foro Internacional de Patentamlento en Biotecnología, Santiago, CHILE

Danielle BERNEMAN-INSTITUT PASTEUR (Franco) 16-17 DicIembre 2003 1

The disciosure of invention form contains (b):

3-A summary of the invention

4-The encompassed applications of the invention

5-A list of potential concurrents

¡ Foro Internacional de Patentamlento en Biotecnología,Sant!aqo 1 CHILE ,mm

Danlelle BERNEMAN-INST1TfJT PASTEUR (France) 1647 Diciembre 2003

The disclosure form should be automatically registered at the administrative leve] and will be used later to discuss the potential co-ownership

questions.

1Foro Internacional de Patentamiento en Biotecnología, Santiago, CHILE

Danlelle BERNEMAN-INSTITUT PASTEUR (France) 16-17 Diciembre 2003

ISSUES RAISED BY FILING A PATENT APPLICATION

3-THE BIOLOGJCAL MATERIAL (a)

The complete description of an invention in biotechnology comprises

the identification

and

the deposit of the biological material.

[ 1 Foro Internacional de Patentamlento en Biotecnología, Santlago, CHILE TI

[J Danielle BERNEMAN4NSTITIJT PASTEUR (France) 16-17 Diciembre 2003

ISSUES RAISED BY FILING A PATENT APPLICATION

3-THE B1OLOGICAL MATERIAL (b)

Severa] recent cases law in Europe at the European Patent Offic - and also at the US Patents and Trademarks Office confirm the -necessity to deposit ttie ccli strains, the recombinant bacteria,

the isolated viruses etc... in duly international authorized collections.

¡Foro Internacional de Patentemlento en Biotecnología, Santiago, CHILE

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DanIelle BERNEMAN-INSTITUT PASTEUR (France) 16-17 Diciembre 2003

ISSUES RAISED BY FILING A PATENT APPLICATION

3.-THE BIOLOGICAL MATERIAL (b)

Severa¡ recent cases Iaw in Europe at the European Patent Office and also at the US Patents and Trademarks Office confirm the necessity to deposit the celi strains, the recombinant bacteria, the isolated viruses etc... in duly authorized collections.

• The value of the constructed or purified biological material which is a key point in a biotech invention is very high because it is often unique. Example: Hybridoma or an attenuated virus strain are very difficult to select for their particular properties.

¡ Foro Internacional de Patentamiento en Blotecnologla, Santiago, CHILE 1 -

Danielie BERNEMAN-INST1TUT PASTEUR (France) 16-17 Diciembre 2003

ISSUES RAISED BY FILING A PATENT APPLICATION

3-TIJE BIOLOGICAL MATERIAL (c)

The absence of a deposit in a collection which helps for the description of the invention can raise ¡ssues such as insufficiency of disclosure and could provoke the rejection of the patent application.

LI'rhe con sequences of such a decision

would be really damaging for a start-up company.

1 Foro internacional de Patentamlento en Biotecnología. Santiago, CHILE 1 -

Danielle BERNEMAN-INSTITUT PASTEUR (France) 16-17 Diciembre 2003

ISSUFS RAISED BY FILING A PATENT APPLICATION

4-THE LABORA TORY NOTEBOOKS (a)

They prove the materiaiity of the results obtained and the ownership Therefore, the laboratory notebooks must be signed by an appropriate witness ( different from the inventors' group) and by the inventors themselvesin order to prevent future disputes.

They must also be scanned after the signatures on a regiilariy basis.

1 Foro Internacional de Patentarnlento en Biotecnología, Santiago, CHILE -

DanIeIIe BERNEMANINS TITUT PASTEUR (Franco) 16-17 Diciembre 2003

ISSUES RAISED BY FILING A PATENT APPLICATION

4-THE LABOR4TORYNOTEBOOKS (b)

They are proofs of the conception, and the reduction to practice the invention, in an « interference» procedure in the USA or ¡u a « conflict » in Canada (principies of « first to invent »).

1 Foro Internacional de Patentamlento en Blotecnologla, Santiago, CHILE -

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Danlelle BERNEMAN-INS71TUT PASTEUR (Franco) 16-17 Diciembre 2003 1

ISSUES RAISED BY FILING A PATENT APPLICATION

4-THE LABORATORYNOTEBOOKS (c)

Regarding the Sixth Framework program of the EEC (2003-2006), the identificatiori of the pre-existing knowledge of each participant will be the only solution to protect the ownership of the scientific background.

This knowledge is, in a large part, in the laboratory notebooks and ¡u the description of the biological material existing prior to the beginning of the sponsored research program.

1 Foro Internacional de Patentamlento en Biotecnología, Santiago, CHILE

DanleIle BERNEMAN-INSTITUT PASTEUR (France) 16-17 Diciembre 2003 -

ISSUES RAISED BY FILING A PATENT APPLICATJON

5-HOW TO RETRIBUTE THE INVENTORS?

In France:

-The French patent Iaw recognizes the principie of a supplementary financial compensation paid by the employer to the inventor.

- In public institutions, inventors can receive up lo 50% of the income (after deduction of the patent protection expenses).

-In private institutions or companies, the additional revenues are considered as a salary and depend on a case by case basis.

1 Foro Internacional de Patentarniento en Biotecnología, Santiago, CHILE

Danlelle BERNEMAN-INS77TUT PASTEUR (France) 16-17 DicIembre 2003 1

ISSUES RAISED BY FILUG A PATENT APPLICATION

CONCL (JSION

-The identification of the true inventors and their consideration, moraily and tinancially,

-The protection of biological material in specific collections,

-The management of laboratory notebooks,

are sorne of the irnportant points which can strengthen directly or indirectly

the global situation in patenting and licensing an invention.

1 Foro internacional de Patentamlento en Biotecnología, Santiago, CHILE

LDanielle BERNEMAN-INSTITUT PASTEUR (France) 16-17 DicIembre 2003 1

TUE MANAGEMENT OF PATENT PORTFOLIOS

Filing a patent application is the result

of a long procedure

-from the conception of an invention,

-its reduction to practice

-and finaily its protection.

1 Foro Internacional de Patentamiento en Biotecnología, Santiago, CHILE al

DanleIIe BERNEMAN-INST1TUT PASTEUR (Franco) 16-17 DIciembre 2003 1

T HE MANAGEMENT OF PATENT PØRTFOLIOS

The costs and the duration of the various procedures (between 2 to 8-10 years, rejections by the examiners, appeals, oppositions in Europe, interferences in USA etc... ) lead the owner of an invention to regularly examine

the adequacy between the maintenance of the portfolio or

the abandonment

¡Foro Internacional de Patentamiento en Biotecnología, Santiago, CHILE 1

Danielle BERNEMAN-INSTITUT PASTEUR (France) 16-17 Diciembre 2003

THE MANAGEMET OF PATENT PORTFOLIOS

The maintenance of the portfolio or the abandonment

The decision will be based on sorne entena such as

' the invention is a pioneer invention,

the invention is obsolete,

the invention is licensed but no product is developed,

the cost of the patent portfolio is too high

the territory covered is too broad compared with the knowledge of the market

¡ Foro Internacional de Patentamlento en Biotecnología, Santiago, CHILE -

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DanIeIle BERNEMAN-INST1TUT PASTEUR (France) 16-17 DicIembre 2003

THE MANAGEMENT OF PATENT PORTFOLIO

Conclusion:

Do lot hesitate to reexamine the patent portfolio regularly

in order to minimize expenses and to increase revenues

when entering into negociation or litigation against the

infringers.

1 Foro Internacional de Patentamlentoen Biotecnología, Santiago, CHILE

Daníelle BERNEMAN-INS71 TUT PASTEUR (France) 16-17 Diciembre 2003

ReIerneeL:

- Manual of PaLeal esansinnig procedore 8th Edtion 7001 resised Feb. 2(0)5 (liS Depatirneel of eornme,cc (200))

Le dinit français des signes distinct,fs. rau! Mathely. F.ditions Lihratnc du Jaumal des Nolanes ci des A'c.iS ( 1984)

- Wisting the laboratoty Nolebooks Ilosvaid M Kanore, Eduions ASM Washington 985)

S Vii-anos'. J al Structural amI Functtonal Genornies 2003, Vol 4, p 191-209

Wb,Ites

Afilsl svwsv autni ces Ç- academic assoc,atlonu ros lEe technology ti ansíe, te companies

ASTP wssiv aSlp net 1

LES wsvsv gide ernst International assi,elation for academicand industrial memEces o Ltcenting Lsecutii e SaernI>

Ir;slitut Pastcui wwiv pasteur fr

Europeas Palent office ivivw european-palenl-ofíice nrg

US Pateni office svssss uspto gov

Ema!) cuChad danber5fpastear fi

Intrnatçnal Deoosit authorItlen

ivss'v mace oig uk

us'wsv alce oig

W5VW ompi inI

Endosares

- Lius of sorne international cniluie collection deposil authonlies

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PRIMER FORO INTERNACIONAL DE PATENTAMIENTO EN

BIOTECNOLOGIA

16 -17 DICIEMBRE, 2003

SANTIAGO, CHILE DR. FÉLIX ROZANSKI

AMERICA LATINA

• En el año 2002 la industria biotecnológica estaba

representada por 432 empresas, en su mayoría del sector

agrícola, pequeñas y dedicadas a las aplicaciones comerciales de la microbiología y la biología celular

• Los polos de desarrollo más importantes están en

BioMinas (Brasil), Polo Biotecnológico del Oeste ( Cuba) y en el agro: INTA, (Argentina).

• La biotecnología tiene un potencial enorme a condición

de que se superen barreras a su desarrollo.

2

AMERICA LATINA

a Se comercializan innovaciones

propias en proteínas recombinantes

• anticuerpos monoclonales

• vacunas

• kits de diagnóstico

• fermentos lácteos

• enzimas

• levaduras

TRANSITAMOS UN PERIODO DE PLENA

EVOLUCION

3

4

PROTECCION DE LA PROPIEDAD INTELECTUAL

Tipos de Ejemplos Protección Legal creatividad (contra copia)

Productos, Actividades Productivas Patentes Procesos Secretos

Comerciales

Variedades Vegetales

Arte, Ciencia Dibujos, Pinturas, Esculturas, Música Derechos de Autor

Películas, Videos, Grabaciones, Avisos

Escritura, Literatura, Ciencia, Diarios, etc.

Nombres, Productos y Servicios Marcas Emblemas Denominaciones

de Origen

Formas, ltenis: Domésticos Industriales Diseños Apariencias

5

EL ADPIC (TRIPs) SIENTA PRINCIPIOS Y NORMAS BASICAS

QUE TODOS LOS PAISES MIEMBROS

SE OBLIGAN A CUMPLIR

6

3

TRATADO OMC/ADPIC (TRIPS)

ART. 27,31): "LOS MIEMBROS PODRAN EXCLUIR ASIMISMO DE LA PATENTABILIDAD: LAS PLANTAS Y ANIMALES, EXCEPTO LOS MICROORGANISMOS, Y LOS PROCEDIMIENTOS ESENCIALMENTE BIOLOGICOS PARA LA PRODUCCION DE PLANTAS Y ANIMALES, QUE NO SEAN PROCEDIMIENTOS NO BIOLOGICOS NI MICROBIOLOGICOS, SIN EMBARGO, LOS MIEMBROS OTORGARAN PROTECCION A TODAS LAS OBTENCIONES VEGETALES MEDIANTE PATENTES, MEDIANTE UN SISTEMA EFICAZ SUI GENERIS O MEDIANTE UNA COMBINACION DE AQUELLAS Y ESTE.

LEY DE PATENTES 24.481, SUS MODIFICATORIAS Y

SU DECRETO REGLAMENTARIO 260196

• ART. 6: NO SE CONSIDERARAN INVENCIONES "TODA CLASE DE MATERIA VIVA Y SUSTANCIAS PREEXISTENTES EN LA NATURALEZA"

• EL ARTICULO 6 DEL REGLAMENTO: "NO SE CONSIDERAN MATERIA PATENTABLE A LAS PLANTAS, LOS ANIMALES Y LOS PROCEDIMIENTOS ESENCIALMENTE BIOLOGICOS"

ri

LEY DE PATENTES 24.481, SUS MODIFICATORIAS Y SU DECRETO REGLAMENTARIO 260196

ART. 7: NO SON PATENTABLES:

b) LA TOTALIDAD DEL MATERIAL BIOLOGICO Y GENETICO, EXISTENTE EN LA NATURALEZA O SU REPLICA, EN LOS PROCESOS BIOLOGICOS IMPLICITOS EN LA REPRODUCCION ANIMAL, VEGETAL Y HUMANA, INCLUIDOS LOS PROCESOS GENETICOS RELATIVOS AL MATERIAL CAPAZ DE CONDUCIR SU PROPIA DUPLICACION EN CONDICIONES NORMALES Y LIBRES TAL COMO OCURRE EN LA NATURALEZA.

LA PATENTE DE INVENCION CONFIERE LOS SIGUIENTES

DERECHOS EXCLUSIVOS: FABRICACION

uso

OFERTA PARA LA VENTA

VENTA

IMPORTACION

9

lo

5

DISPOSICION 63312001 DE LA ADMINISTRACION NACIONAL DE PATENTES

Art. 2 0 - Criterio aplicable a Microorganismos.

• Todo microorganismo que cumpla con los requerimientos de novedad, entrañe una actividad inventiva y sea susceptible de aplicación industrial es patentable. Por ejemplo, microorganismos modificados (bacterias, levaduras y células) son patentables.

• Son patentables porque no son plantas o animales, no son parte M material biológico y genético tal como existe en la naturaleza.

• No son patentables los microorganismos que sean capaces de conducir a su propia duplicación en condiciones normales y libres, tal como ocurre en la naturaleza.

DISPOSICION 63312001 DE LA ADMINISTRACION NACIONAL DE PATENTES

Art. 3° - Criterio aplicable a Compuestos.

• Los compuestos que incluyan microorganismos, cualesquiera

sean las características de los microorganismos, son patentables siempre que tales compuestos cumplan con los requisitos de novedad, entrañen una actividad inventiva y sean susceptibles de aplicación Industrial.

11

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6

DISPOSICION 63312001 DE LA

ADMINISTRACION NACIONAL DE PATENTES

Art. 4° - Criterio aplicable a los Procedimientos Microbiológicos.

• Los procedimientos microbiológicos son patentables en tanto y en cuanto cumplan con los requisitos de novedad, entrañen una actividad inventiva y sean susceptibles de aplicación Industrial.

• Tales procedimientos son patentables aún cuando el microorganismo utilizado, el producto o ambos ya fueran conocidos, siempre que tales procedimientos cumplan con los requisitos mencionados en el párrafo anterior.

• El término "proceso microbiológico" abarca no solamente procedimientos industriales que utilicen microorganismos sino también procedimientos para producir nuevos microorganismos (por ejemplo, por ingeniería genética).

13

DISPOSICION 63312001 DE LA

ADMINISTRACION NACIONAL DE PATENTES

Art. 5° - Criterio aplicable a productos de procedimientos

microbiológicos.

• El producto de procedimientos microbiológicos, Incluyendo un microorganismo, es patentable si cumple con los requisitos de novedad, actividad inventiva y aplicación industrial.

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LA PATENTE EUROPEA

• El Convenio sobre la Patente Europea creó un procedimiento centralizado de concesión lo que representa una gran ventaja por lo que no se necesita obtener una por una las patentes nacionales correspondientes.

• El éxito del sistema: Se reciben 165.000 solicitudes europeas por año, el doble que hace cinco años

• La Directiva 98144 entró en vigor en 1998 y regula la protección jurídica de las invenciones biotecnológicas

LA PATENTE EUROPEA

• Entre sus novedades permite patentear vegetales o animales siempre que la invención no se limite a una variedad vegetal o raza animal (art 4.2)

• La materia biológica aislada de su entorno natural o producida por medio de un procedimiento técnico puede patentarse (art 3.2)

• Un elemento aislado del cuerpo humano u obtenido de otro modo mediante un procedimiento técnico es patentable (art. 5.2) En cambio no es patentable el cuerpo humano, el descubrimiento de sus elementos, o de la secuencia integral o parcial de un gen por tratarse de meros descubrimientos Pero sí pueden patentarse la secuencia o la secuencia parcial de un gen aislado del cuerpo humano que reúna los tres requisitos de patentabilidad.

16

15

8

TRATADO CHILE-EEUU

17.2) Antes dell de enero de 2007,

las Partes deberán ratificar o adherir al Tratado de Cooperación en Materia de Patentes

TRATADO CHILE-EEUU

17.3 a) Antes del 1 de enero del 2009, las Partes deberán ratificar o adherir a la

Convención Internacional sobre la Protección de Nuevas Variedades de

Plantas (1991)

11

18

9

TRATADO CHILE-EEUU PATENTES

17.9.1) Cada Parte otorgará patentes para cualquier

invención, sean de productos o de procedimientos, en

todos los campos de la tecnología, siempre que sean

nuevas, entrañen una actividad inventiva y sean

susceptibles de aplicación industrial. Para los efectos de

este artículo, una Parte podrá considerar las expresiones

"actividad inventiva" y "susceptibles de aplicación

industrial" como sinónimos de las expresiones "no

evidentes" y "útiles" respectivamente.

19

TRATADO CHILE-EEUU

PATENTES

17.9.2) Cada Parte realizará esfuerzos razonables,

mediante un proceso transparente y participativo, para elaborar y proponer legislación dentro de cuatro años desde la entrada en vigor de este Tratado, que permita disponer de protección mediante patentes para plantas a condición de que sean nuevas, entrañen una actividad inventiva y sean susceptibles de aplicación industrial.

C

20

10

TRATADO CHILE-EEUU PATENTES

17.9.4) Si una Parte autoriza la utilización de una materia protegida por

una patente vigente por parte de un tercero, para apoyar la solicitud de

autorización de comercialización o permiso sanitario de un producto

farmacéutico, la Parte deberá establecer que ningún producto

fabricado en virtud de dicha autorización podrá ser fabricado, usado

o vendido en el territorio de la Parte, excepto para cumplir con los

requisitos de obtención de la autorización de comercialización o

permiso sanitario y, si la exportación es permitida, el producto sólo

será exportado fuera del territorio de la Parte para el propósito de

cumplir con los requerimientos para emitir la autorización de

comercialización o permiso sanitario en la Parte exportada.

21

TRATADO CHILE-EEUU

PATENTES

17.9.5) Una Parte podrá revocar o anular una

patente solamente cuando existan razones que

pudieran haber justificado el rechazo al

otorgamiento de la patente.

22

TRATADO CHILE-EEUU PATENTES

17.9.6) Cada Parte, a solicitud del titular de la patente, ajustará el plazo de una patente para compensar las demoras injustificadas que se produzcan en el otorgamiento de la patente. Para los efectos de este párrafo, una demora injustificada se entenderá que incluye una demora en la emisión de la patente superior a cinco años contados a partir de la fecha de presentación de la solicitud en la Parte, o de tres años desde que el requerimiento de examen para la solicitud haya sido hecho, cualquiera de ellos que sea posterior, a condición de que los períodos atribuibles a las acciones del solicitante de la patente no sean incluidos en la determinación de tales demoras.

TRATADO CHILE-EEUU PATENTES

17.9.7) Ninguna Parte usará la divulgación pública

como motivo para no otorgar la patente por falta de novedad o de actividad inventiva, si la divulgación pública (a) fue hecha o autorizada por, o deriva de, el solicitante de la patente; y (b) se produce dentro de los doce meses anteriores a la fecha de presentación de la solicitud en la Parte.

23

12

24

TRATADO CHILE-EEUU PATENTES

17.10.1) Si una Parte exige la presentación de información no divulgada relativa a la seguridad y eficacia de un producto farmacéutico o químico agrícola, que utilice una nueva entidad química que no haya sido previamente aprobada, para otorgar la autorización de comercialización o permiso sanitario de dicho producto, la Parte no permitirá que terceros, que no cuenten con el consentimiento de la persona que proporcionó la información, comercialicen un producto basado en esa nueva entidad química, fundados en la aprobación otorgada a la parte que presentó la información. Cada Parte mantendrá dicha prohibición, por un período de a lo menos cinco años contado a partir de la fecha de aprobación del producto farmacéutico y de diez años contado desde la fecha de aprobación del producto químico agrícola. Cada Parte protegerá dicha información contra toda divulgación, excepto cuando sea necesario para proteger al público.

TRATADO CHILE-EEUU PATENTES

17.10.2) Respecto de los productos farmacéuticos amparados por una patente, cada Parte deberá:

• otorgar una extensión del plazo de la patente para compensar al titular de la misma por la reducción injustificada del plazo de la patente, resultante del proceso de autorización de comercialización;

• pondrá a disposición del titular de la patente la identidad de cualquier tercero que solicite la autorización de comercialización efectiva durante el plazo de la patente; y

• negar la autorización de comercialización a cualquier tercero antes del vencimiento del plazo de la patente, salvo que medie el consentimiento o la aquiescencia del titular de la patente.

25

26

13

TRATADO CHILE-UNION EUROPEA

ARTICULO 168

Objetivo

• Las Partes concederán y asegurarán una protección adecuada y efectiva de los derechos de propiedad Intelectual, acordes con las más altas normas Internacionales, incluidos los medios efectivos para hacer cumplir tales derechos previstos en los tratados internacionales.

27

TRATADO CHILE-UNION EUROPEA

ARTICULO 170

a) seguir asegurando una ejecución adecuada y efectiva de las obligaciones derivadas de los convenios siguientes:

• Acuerdo sobre los aspectos de los derechos de propiedad intelectual relacionados con el comercio, Anexo IC del Acuerdo por el que se establece la Organización Mundial del Comercio, (Acuerdo sobre los "ADPIC').

• Convenio internacional para la protección de las obtenciones vegetales 1978 ("Convenio UPOV 1978") o Convenio internacional para la protección de las obtenciones vegetales 1991 ("Convenio UPOV 1991").

28

14

TRATADO CHILE-UNION EUROPEA

ARTICULO 170

b) convenir en y asegurar, para el 1 enero 2007, una ejecución adecuada y efectiva de las obligaciones derivadas de los convenios multilaterales siguientes:

• Tratado de cooperación en materia de Patentes (Washington 1970, enmendado en 1979 y modificado en 1984)

29

TRATADO CHILE-UNION EUROPEA

ARTICULO 171

Revisión

• Al tiempo que las Partes manifiestan su compromiso de cumplir con las obligaciones derivadas de los convenios multilaterales antes citados, el Consejo de Asociación podrá decidir incluir en el artículo 170 otros convenios multilaterales en la materia.

30

n

15

PROTECCION DE NUEVAS VARIEDADES VEGETALES (UPOV)

• La versión de 1978 establece una protección menor, e implícitamente protege legalmente el "privilegio del agricultor"

• La versión más reciente de 1991 establece una protección mayor a los obtentores ( 20-

25 años), quienes ganan regalías por la variedad protegida.

31

LEY 20.247 DE SEMILLAS Y CREACIONES FITOGENETICAS, DECRETOS Y RESOLUCIONES

• CONFORME EL ACTA DE 1978 DE LA UNION PARA LA PROTECCION DE LAS OBTENCIONES VEGETALES.

• CORRESPONDE AL REGISTRO NACIONAL DE LA PROPIEDAD DE LOS CULTIVARES PROTEGER EL DERECHO DE PROPIEDAD DE LOS CREADORES Y DESCUBRIDORES DE NUEVOS CULTIVARES (ART. 19 DE LA LEY)

32

16

CREACIONES FITOGENETICAS

• EL DERECHO DEL OBTENTOR ES PARA QUIEN HAYA CREADO O DESCUBIERTO UNA VARIEDAD DISTINTA A TODAS LAS CONOCIDAS Y LA HAYA DESARROLLADO O PUESTO A PUNTO COMO TAL.

EL MATERIAL DEBE ESTAR ESTABILIZADO (MANTENDRA SUS CARACTERISTICAS EN SUCESIVAS GENERACIONES DE REPRODUCCION Y SER HOMOGENEO ES DECIR UNA NUEVA VARIEDAD VEGETAL TERMINADA O FINALIZADA

PROTECCION DE DATOS DE REGISTRO SANITARIO

DERECHO DEL TITULAR LOS DATOS SON PROPIEDAD DEL PRIMER REGISTRANTE Y NO PUEDEN SER UTILIZADOS EXPLICITA O IMPLICITAMENTE, DIRECTA O INDIRECTAMENTE, SIN SU AUTORIZACION

EL SEGUNDO REGISTRANTE DEBE CUMPLIR CON IGUALES REQUERIMIENTOS Y PRESENTAR SUS PROPIOS DATOS.

NO SE PUEDEN OTORGAR REGISTROS A QUIENES NO SON EL TITULAR O SU AUTORIZADO(S), DURANTE EL PERIODO DE PROTECCION, SALVO QUE REPITA TODAS LAS PRUEBAS COMO Si FUERA EL ORIGINADOR.

33

17

LEY 24.766 SOBRE SECRETOS COMERCIALES Y PROTECCION DE DATOS PARA EL REGISTRO DE

PRODUCTOS FARMACEUTICOS Y AGRO-QUIMICOS

• EN LA MEDIDA QUE LA INFORMACION REUNA LOS REQUISITOS QUE MARCA LA LEY Y SEA EL RESULTADO DE UN ESFUERZO TECNICO Y ECONOMICO SIGNIFICATIVO SERA PROTEGIDA CONTRA TODO USO COMERCIAL DESHONESTO Y NO PODRA SER DIVULGADA.

• SIN EMBARGO LOS ARTICU LOS 5, 6 Y 7 DE LA LEY PERMITEN REGISTROS SANITARIOS POR SIMILARIDAD QUE SE CONTRADICEN CON LA DEBIDA PROTECCION DE DATOS.

COOPERACION SECTORES

GOBIERNO, CIENCIA Y EMPRESA

Sin cooperación el éxito es improbable

35

36

18

• La industria biotecnológica ha sido muy exitosa en desarrollos pero no en resultados económicos frente a las inversiones realizadas. Como consecuencia existe restricciones a la inversión en las etapas tempranas de la investigación.

• Se intenta canalizar el entusiasmo científico en aplicaciones prácticas que permitan obtener protección de patentes y convenios de licencias.

• Ejemplo es el Instituto SaIk de USA, con más de 350 patentes, 250 Convenios de Licencia y 17 compañías en incuvación.

• En el Instituto Saik se estimula pensar sobre las aplicaciones comerciales de los proyectos, e intercambios con los abogados especializados en patentes y expertos en transferencia de tecnología para establecer nuevas asociones

37

PROBLEMAS PRINCIPALES

• PERSISTEN INTERPRETACIONES RESTRICTIVAS DE LAS NORMAS.

• DEMORAS EN LA CONCESION DE LAS PATENTES.

• INCERTIDUMBRE SOBRE LAS DECISIONES JUDICIALES.

• DIFICULTADES PARA HACER OBSERVAR LOS DERECHOS.

38

c

19

SE NECESITA UN CLIMA DE SEGURIDAD JURIDICA MAS

PROPICIO PARA IMPULSAR LA INNOVACION Y LOS NUEVOS

EMPRENDIMIENTOS

39

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The European Patent Offic e....-.

Europaisches Patentamt

0)European Office européen Paterit Office des brevets

Introduction to the EPO

• Organisation

• Patents

• Biotechnology

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EPO staff 2001

Munich 2582

TheHague 2210

Berlin 193

Vienna 84

Total 5 069

2

L European Patent Organisation

European PatentAdministrative Councii

Office

The executive body

The Offices task is to grant European patents.

The legislative body

Important functions: • to adopt the budget

• to approve the Presidents actions in implementing the budget

• to amend the lmplementing

Regulations and Rules relating to Fees

The Administrative Council consists

of delegates from the member

states.

Organisational structure of the EPO

[ ! sidenfs Office 1 President

1 Counci s Secretariat Ingo Kober . ion Reserve

Fund ntroIling Office (DE)

Vire-Pren 1 Vico-President ce-Presrdent Vce-President 1 1 Vice-President1 L Baranes P Kyrlakldes P Messerli 1 1 c Edrjaii 1 M Decantes

1 (FR) (UY) (C H) 1 (SE) 1 1 (ES) 1 Directorate Dwectorate- 1 Directorate- 1 Dlreclorate- D!rectorate-

cer1eraiJ [ General 2 General 3 General J L General 5 J

3

Headquarters Munich Branch at The Hague PschorrHofe

Headquarters Munich sar bullding

I'i"Berlin sub-office

Vienna sub-office

Current EPO offerings

- European patents

- Process offerings • Search • Examination & Opposition

Information & efficiency offerings • esp©cenet & epoline®....

Setting standards

• Law, Documentation, Classification, Search, Inventive Step...

4

EPO figures (2002 in review)

27 member states

• Al! staff: 5400 - examiners: 3300

• 143600 searches cornpleted

• 47200 patents published

• 31 million e!ectron. searchable patent docs

• Operating result: 1200 (in EUR millions)

Filings and Searches 1997-2001

160000] )

140000

120000

100000

goúooFz

600001

1997 1998 1999

2000 2001

[iearches F, 1,

5

Applications

130000

120000

110000

100000

90000

80000

70000

-

ri1098

19992000

2001 European applica0ons Oled and Euro-PCi appcalions enterrng he European phase

• European apphca500s Oled and Euro-PCi appl,cations (inlernahonal phase(

Breakdown of applications by residence of applicants

Others JP 5%

18 __---- ---

- A DE

ami¡ NL FR

6

Granting of Patents is based on

• European Patent Convention (EPC)

- Convention: Artic les - Implementing

Regulations: Rules

• Guidelines for Examination

• Decisions of the Boards of Appeal: Case Law

• Trilateral Projects 2000: DNA

2001: Reach through claims

2002: 3D/Cnstalline structure

2003: SNPs/Haplotypen

• Interna! Instructions

• Notices of the Patent Practice and Procedures Comrnittee

EPO Granting Procedure 1 Application

Search +

le opposition

Appeal / Appeal opposiuon

Refusal of the Revocation of the Maintainance of the applicationJ LPatents Patent

Appl p cantjPatentee 3rd Party

7

EPO fees

Filing phase EUR 1 700

Examination phase EUR 2 400

Grantphase EUR 1100

EPO fees total EUR 5 200

Cost of an average European patent 1)

EPOfees EUR 5200 Percentage of total 16%

Professional representation before the EPO EUR 5 500 Percentage of total 20%

ransIation in the contracting states EUR 11 500 Percentage of total 42%

National renewal fees EUR 5 425 Rercentage of total 20%

flTotal cost EUR 27 625

"27 states, 10-year terrn

8

What advantages does an European patent have?

Convenient • One apptication One language

Cost-effective • Costs less than 3 separate national patents

Stróng • Thorough search -

42 million documents

Stringent examination Sound legal protection

Basic Requirements for Patentability 1/2

• Novelty (Article 54 EPC) - the c]airned subject-matter must be new

Inventive step (Artice 56 EPC) - the invention must be not obvious (to try) for a skilled

person working in the relevant field of technology

the invention must solve a techriical problem

9

Basic Requirements for Patentability 2/2

Industrial application (Article 57 EPC) the claimed subject-matter can be made or used in any kind of industry, including agriculture

Sufficiency of disclosure (Article 83 EPC) the application must be so clear and complete that a skilled person working in the relevant field of technology shall be able to reproduce the claimed subject matter

T NON PATENTABLE INVENTIONS

r Exclusions

]

Exceptions 1 [Article 52(2)(3)][Anide 53(a)(b)]j

Discoveries lnventions contrary lo Aesthetic creations morality or public order

resentation of information Plant or animal varieties Article 52 (4) EPC Biological processes

10

EPO Biotechnology

Art. 52 (4) EPC

Art. 54 (5) EPC Art. 53 (a)(b) EPC

, Rule 23(b) - (e) EPC Guidelines C IV 2a, 3, 4

EU-Biotech-Directive it 98/44/EC

20

Patentable biotechnological su bj ect matter (general):

• Polypeptides and enzymes

• Isolated DNA and RNA sequences (mcl. ribozymes etc.)

• Plasmids, vectors

• Antibodies and hybridomas

• Microorganisms (e.g. celis, bacteria,viruses and phages)

• Transgenic plants and non-human animais

• As well as methods for the preparation of these products and their use

The EU Biotech Directive 98/44

Member States shall protect biotechnological inventions under national patent law. They shall, ifnecessary, adjust their national patent Iaw to take account of the provisions of this Directive.

Carne ¡ato force on 30.7.1998 Confirmed 1. 10.2001 by EU Court ofJustice

Inserted into the EPC by decision of the Administrative Council on 16.6. 1999 Carne into force on 1.9.1999

Patentable biotechnological subject matter:

Rules 23b - 23e EPC_entered into force on September 01,

General and definitions

Patentable biotechnological inventions

Exceptions to patentability

human body and its e1ements

• The EU-Biotech-Directive 98/44/EC of 6 July 1998 is used as a supplementary means of interpretation of Rules 23b - 23e EPC ( OJ EPO 1999, p. 101).

c12

Discovery vs. Invention

Rule 23c(a) EPC: Biotechnological inventions shall be patentable ifthey concem

biological material which is isolated from its natural environment or technically produced even if it previously occurred in nature.

Rule 23b (3) EPC: ,,Biological Material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

e.g. nucleic acids, genes, celis, viruses

Keyword: function of sequences • How complete the indication of function should be:

• Nucleic acid sequences encoding a protein with a function that has been verified by experimental data e.g. erythropoietin, a celi marker

Sequences with a function deduced on the hasis of sequence homology:

the deduced function should be specific

anci credible

Nucleic acid sequences without a function e.g. ESTs: such sequences do not solve a technical prohlem and are, thcrefore, not inventive (Art. 56 EPC)

c13

Directive 98/44/EC, recital 23:

A mere nucleic acid sequence without indication of a function does not contain technical information and is therefore not a patentable invention.

No: Yes:

ESTs A specific receptor SNPs

Insulin Hypothetical use or function

Polynucleotide for use as a hybridisation probe

(T

14

Transgenic plants

Article 53 (b) EPC: European patents shall not be granted in respect of

plant or animal varieties.

However:

Rule 23c(b) EPC: Biotechnological inventions shall also be patentable if

they concern plants or anirnais ifthe technical feasibility of the

invention is not confined to the particular plant or animal variety.

and:

Decision G1/98 (20.12.1999): A claim wherein specifíc plant varieties

are not individually claimed is not exciuded from patentability under

Art. 53 (b) EPC even though it may embrace plant varieties

LAre claims to plants patentable? 1

Yes If they are directed to a plant in general

T (no specific variety being claimed per se) Rule23c(b)andGl/98

No If a specific plant variety is claimed per se

Article 53(b) Rule 23b(4), 23c(b)(c)

15

Example:

•NO:

• A plani variety such as durum wheat type wh222 deposited at a seed depository

• A maize variety designated mv222, comprising a recombinant DNA coding for protein X

• YES:

• A transgenic plant,comprising

a recombinant DNA coding for protein X

Are animais/animal varieties patentable? 1

YES H NO

It animais in general are claimed If a specific variety is claimed

(No specific variety being claimed) Rule 23c(b)

Rule 23c(b) and T19/90

HOWEVER: • No accepted definition of animal variety • Different terms are used in the three official languages

(Animal variety, Tierart and race animale)

16

Are processes for the production of plants patentable?

• Article 53 (b) EPC: European patents shall not be granted for essentially biological processes for the production of plants or animais;

• this provision does not apply to microbiological processes or the products thereof.

• Rule 23b (5) EPC: A process for the production of plants is essentially biological if it consists entirely of natural phenomena such as crossing or selection

Article 53(b) and Rule 23b (5) Are processes for the production

of plants and animals patentable?

NO

if the process is essentially biological

(if it simply copies nature)

VES

if the process is technical

(it does not simply copy nature)

17

Example of a claim to a technical process

• Claim:" Process for producing a plant , which process comprises transforming celis of said plants with a DNA encoding enzyme ,,X", regenerating plants from the plant cefls transformed with said DNA and, optionally, biologically replicating said last mentioned plants"

o The transformation is clearly a technical step

Transgenic animais

• Rule 23d (d) EPC: European patents shall not be granted for:

processes for modifying the genetic identity of animais which are Iikdy to cause them suffering without any substantial medical benefit to man or animal, and also animais resulting from such processes.

18

Examples of suffering of animais versus benefits to man

'NO

• The naked mouse-

A transgenic mouse used to test hair cosmetic products

•YES

• The Harvard Oncomouse-Used as a model for studying cancer

,11

L

Y97,41

A.

The human body and its elements

Rule 23e(1) EPC

• The human body, at the various stages of As formation and development, and the simple discovery of one of its elements, including a (partial) gene sequence, cannot constitute a patentable invention.

• However.....

r

y 19

Rule 23e (2)(3) EPC:

• An element isolated from the human body or otherwise produced by means of a technical process, ineluding the (partial) sequence of a gene, may constitute an patentable invention, even ifthe structure of that element is identical to that of the natural element.

• The industrial application of a (partial) sequence of a gene must be disclosed in the patent application.

• Patentable may be an element isolated from the human body or produced by technical means including the (partial) sequence of a gene even if its structure is identical to that of a natural element.

However: function!

A

20

Patentability of human embryonic stem celis - EPC Art.53a

• Rule 23d,c exciudes ,,uses of human embryos for industrial or cornmercial purposes"

• Edinburgh decision (EP-B-695351, Jul 2003) : Not patentable as the hES cells have to be obtained from embryo blastocyst

- Not considered relevant: National law(s) and regulations, Opinion EU group of Ethics (2002) Celi unes in culture vs celis

Treatment and Diagnostic Methods Art. 52(4) EPC: Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application (Art. 57). This provision shall not apply to products, in particular substances or cornpositions, for use in any of these methods.

Not patentable:

Method of treatment of the disease Y with the composition X ..."

,,Treatment of a patient having disease Y comprising the administration of composition X..."

"Use of composition X for the treatment of disease Y..."

(7

(

21

Patent protection can be obtained on the basis of

claims formulated as first-medical use claims"

• ,,Compound Y for use as a medicament..."

,,Compound X for use as an antibacterian..."

• ,,Compound X for use in treating disease Y..."

• ,,Compound X for use in treating disease Y

wherein X is administered ..."

and product claims:

• ,,Medicament containing the compound X..."

Medical use of known compositions

Art. 54(5) EPC: The provisions of paragraphs 1 to 4 (Novelty) shall not exciude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 52, paragraph 4, provided that its use for any method

referred to in that paragraph is not comprised in the state of the art.

The inventor of a ,,first medical indication" of a known

substance can obtain a purpose-limited product protection

thereof (must be formulated as first medical use claim").

22

Second/further medical use of known compositions (G5183)

When for a known composition a secoud or further medical indication is found, ifsuch an indication is novel and inventive, patent protection can be obtained on the basis of claims formulated as foliows (,,second medical use claim"):

,,Use of composition X for the manufacture of a medicament for the treatment of Y..."

,,Use of composition X for the manufacture of a medicament for the treatment of Z..." etc...

Unity of invention, Art. 82 EPC

The European patent application shall relate to one invention only or to a group of inventions so Iinked as to form a single general inventive concept.

- Polypeptide X - Polynucleotide Y encoding the polypeptide X

Host ceil comprising polynucleotide Y - Antibody specific for polypeptide X - Method comprising the use of the antibody.

23

Summary 1/2

• Genes and proteins if isolated from their natural environment are considered chemical compounds and therefore, patentable

They shou!d be structurally defined by their primary sequence

r A specific and credible function should be disclosed in •the application that makes them industrially applicable

Their use may be claimed in 1 s or 2nd medical use claims or in diagnostic methods (not practised on the human or animal body)

Summary 2/2

Transgenic nonhurnan animais are patentable

If they are not restricted to a specific variety

Only ifthe potential medical benefit is commensurate to suffering caused by their genetic modification

• Processes involving human embryos are not patentable

The patentability of human embryonic stem cells is debatable

24

Exceptions to patentability

- cloning of human beings

- modifying the human germ une

- industrial or commcrc ial use of human embryos

- the generation of genetically modified animais iftheir production causes suffering without substantial medical beneiit (not the case in 'Onco-mouse")

Sources of information

• European Patent Convention

• Guidelines for Examination in the European Patent Office

• Official Joumal EPO

• www.epo.org

Patentability of Plants and Plant Varieties

- Intellectual property aspects of plant varieties

• TRIPs Agreement (1994)

• Classical plant variety protection systems (Breeder's Rights) UPOV (revised in 1991)

• Convention on Biological Diversity (1992)

• Patent Law - Plant related inventions

Europe - recent developments (G1198; Directive 981441EC)

- Plant variety breeding vs. genetic engineering

UPOV Convention suigeneris system as in Article 27.3 (b) TRIPs

UPOV = Union Internationale pour la Protection des Obtentions

Végétales

>signed 1961, Paris, entered into force 1968, revisions in 1972,

1978 and 1991

>Al¡ Acts of the UPOV Convention have two main functions.

-prescribe mínimum scope of protection to plant breeders

-establish novelty, distinctness, uniformity and stability as well as

the requirement for a suitable denomination as the standard

criteria for the grant of protection,

26

Article 1 4(5)(a)(b) UPOV 91 The Breeder's right extends to four subject matters:

(i) the protected variety its&f; (u) varieties which are fol clearly distinguishable from the protected variety; (iii) varieties which are essentially derived from the protected variety; (iv) varieties whose production requires the repeated use of the protected variety.

Essentially derived varieties may be obtained e.g. by - natural or induced mutagenesis - somaclonal variation - selectiori of variant individual - backcrossing - transformation by genetic engineering

UPOV 91 - Definition of Plant Article 1 (vi) UPOV 91

Variety

Variety is a plant grouping within a single botanical taxon of

the Iowest known rank, which grouping, irrespective of

whether the conditions for the grant of a breeder's right are fully met, can be

• defined by the expression of the characteristics

resulting from a given genotype or combination of genotypes,

• distinguished from any other plant grouping by the

expression of at least one of said cha racteristics and

• considered as a unit with regard to ¡ts suitability for

being propagated unchanged

27

Plant Variety Breeding VS.

Biotechnology PLANT VARIETY 1 - defined by Its genotype

BREEDING E>I(Of

aH genes - bred to be stable)

Var. A X

»Var. A

Var.B x Plant x Var. Q » Var, D » Var. F

Var.0 X x

Plant

FBIOTECHNOLO E - defined by its effectlfunctlon - engineerable in ,,plants"

Gene X » Plant comprislng gene X

Non-varieties + afl varieties comprising gene X

- Gist of the invention is not the variety but the invention of gene X

EPC vs. Breeders rights

Breeders Rights

EPC uP0v61-91

Article 53(b) EPC

European patents shall not be granted in respect of plant or animal varieties (or essentially biological processes for the

production of plants or animals)

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U C L A Oof Intellectual Property..

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Technology Transfer at

University of California, Los Angeles

December 2003 NEOS

Technology Transfer in US

• In a broad sense, Technology Transfer can take many forms

o Education o PubIcation

• Collaboration

• Former students with jobs in industry

• Specifically, Technology Transfer refers to University Licensing under Bayh-DoIe Act

LXL4

Bayh-DoIe Act - Historical Perspective

• Post-WWII - 1970's • Expansion of Government R&D

• Especially university research funding

• By late 1970's - Much Untapped Potential • 28,000 patents owned by federal government

• only 5% licensed

• Intellectual Property management lacked uniformity

Bayh-DoIe Act (35 U.S.C. §200-212)

• Federal law enacted in 1980

• A fundamental change to patent ownership

• University owns patent rights to government sponsored inventions

• University reports inventions to government

• Government gets a non-exclusive ¡¡cense

• Royalties must (1) be shared with inventor and; (2) used for research, education

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Technology Transfer at University of California

• Patent Agreement signed by faculty and employees o inventions must be disclosed to university

• university will own patentable inventions

• net revenue will be shared

UCLA

Patent Agreement - revenue sharing

• After expenses (mostly patent costs), revenue will be shared:

• 35% to inventors

• 15% to department/laboratory

• 50% to university

3

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Patent Agreement-Purpose/lntent

• Comply with Bayh-DoIe requirements

• Encourage innovation

• Create incentive to teli university about invention

• Share Iicensing revenue

i

Structure of University of California

• 9 campuses across state

• U.0 also manages 3 national laboratories for the Dept of Energy

• Lawrence Berkeley National Laboratory

• Lawrence Livermore National Laboratory

• Los Atarnos National Laboratory (New Mexico)

1 9 !! JÁ

I_ Jc o.r:

.IJC UCSan Fnnçiscu * 4f4 •'• CMr,d UCSotCn

UC S.. • •UC

UC .olAnC4cs • UC Ir*.n

UC S. DIg

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Structure of Univ. of California - Technology Transfer Activities

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• Locations at each campus and lab

• Plus one Central Office of Technology Tía nsfer (aTT)

1 1 ,'« 913

Central Office of Technology Transfer (OTT)

• based in Oakland, California

• develops university technology transfer policy

• gives final legal approval for campus deals

• provides central accounting services

• operates fuil service licensing operation

• campus dependence on OTT vares

• relationship to individual campuses is evolving - trend to more decentralization

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As of June 30, 2002, the UC system manages 5,472 active inventions

CAMPUS INVENTION PORTFOLIOs hP!! 1 IP!!! li..

IjCB GB 1 LICO

63G

Iji

UCL 727

uu p 210

UCSC 19

UCSD 1.274

JSF 1,152

ir

li^Ii' .Iit. ' '',ith nvn . i - . ni Lii

UCIA' 1- 'hl 1 il ! JILhí_l . UIib'' iii

At the end of FY02, there were 2,502 US and 2,051 foreign patents issued

TOTAL liC PATENT PORTFOLIO

3CCC

2500

2c00

ME

1 II t II FYO2

UCLA E E c E-E Le,

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Issued U.S. Patents - Campus Breakdown

CAMPUS US PATENT PORTFoIjo'

UCB 417

34

UD 143

UGLA 348

'

uco

UGP 71

UGSB 159

ucsc 18

UGSD 362

UGSF 645

II.JC I..A • ri,,,:,:, ;;L;Itl I;.,r::1ir:, r: : Ir

In FY02, 973 new inventions were disclosed by faculty researchers (141 from UCLA)

INVENTION [)ISCLOSURES 8V e AMPUS

E' I

1 L IJLA r

lic.p 4,1 UCLA -

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In FY02, active ¡¡censes - 867 utility patent licenses, plus approx. 500 plant patents licenses

TOTAL UTILITV LICENSES BY CAMPUS'

III 1

!JCB 174

UCD

UCI 45

UiL-.

UCP 13

UCSB 24

UCSO 3

UOSD 181

UCLA UCSF 289

Total licensing revenue for FY02

TOTAL IICENSINGREVENIIES BY CAMPUS

• Total licensing revenue for all campus = approximately $100 Milhion

• Of the $100 Mihlion, approximately $12 Mihlion = reimbursement of patent expenses

UCLA

- :LCB 0580

LD £16401

Ci 4257 -

kXLi $10118

• OCR

o 341

LCSC

LCCO $12.6:

OCSF $3.1344

'El 051

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Top 5 earning inventions for Univ. of California

lic T0PERNINC INVENTIONS'

Invention (Campus, Vear Disclosed)

I1.I:3tItIE .Ir:iul l''7'in'i i'i) 1 ?1 4 (1

Ii.itru'.• p it Iiitr.i ' 'rniiit Aliiji 'i Ti. i LA. 1.1

h1-1iLqI apl1iL rvliilk ií[ 1.)

[.i:''iiti 0ii1 riLhr_I i:F 1-i

IntcF:IitLiI i j iii lh' í.ip iII' 1 2

Subtotal (Top Five Inventions) $ 40,405

UCLA

Other important inventions from Univ. of California

• Cochlear Implants (SF, 1979) $1,476,000 • Nicotine Patch (LA, 1984)

$534,000

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Office of Research Administration (ORA)

• Office of Contract & Grant Administration • Government

• Private Industry

• Extramural funding • Office of Intellectual Property Administration

UCLA

Technology Transfer at UCLA

• Office of Intellectual Property Administration (OIPA)

• httD://www.research.ucla.edu/oipa/ • Part of Research Administration (mcl. Contracts

& Grants) • Has grown in Iast year (from 5 to 17 people) • StiH very small compared with other universities

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OIPA's Organizational frM,.

A..oc.I. W. ChMC.IO lo, R..n,ct 1 E4ro.

Structure

1 L1 JLf!i [ 1[ C141,* WM. R.b.o. Oeo.n L.d. H. & T.ch T,sld., Off,©.. T.a, T,r.4, Offlc. 0.01, T,.n(., O.0,.

.n Bob lld.Oo, K.t,y W~1Mob.lngM.o.ç., NTAAOIy.l

z

bB. $I0'blilflhIii.a*-------------------------------------------

----

-------------------------------------

Deceo,ber 2003 _________

OIPA's unique features

• highly trained professionals (JD ' s, MBA'S, Ph.D's)

• use of business development managers with strong industry ties

• functional sub-units (e.g., patenting, marketing, licensing)

• relationship with business school

• collaboration with local investors and VCs

• creation of pre-seed fund

MÁ

UCLA "success stories" - Start-up

companies

• Cytyc

• Coatue

• Concord/Microtherapeutics

• Prometheus

Services provided by OIPA to faculty

• assistance with intellectual property matters

• facititate industry interactions

• educational outreach

• negotiate and prepare agreements

Jim- Á

12

Agreements handied by OIPA

• secrecy agreements

• collaboration contracts

• material transfer agreements

• inter-institutional ag reements

• bailments

• Ietters of intent

• option agreements

• patent ¡¡censes

U C L A O,ot Intehectui Prope,1y

• 10920 Wilshire Boulevard, Suite 1200 Los Angeles, CA 90024-1406 Tel: 310.794.0558 - Fax: 310.794.0638

13

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OIPA'S WebpageE

U C L A Office of intellectual Property

hflø//wwwreseprchuçIp edu/p ¡ Da!http://wwwreseprçhuclpedu/jnnpvptjpn/

Dlscover UCLA s Res ea rch Inerestsf

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