PRIMER FORO INTERNACIONAL DE PATENTAMIENTO EN BIOTECNOLOGIA by Biblioteca CONICYT

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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 2003

INTELLECTUAL PROPERTY THE GENERAL PRINCIPLES COPYRIGHTS TRADEMARKS INTELLECTUAL PROPERTY KNOW-HOW INDUSTRIAL PROPERTY DESIGN

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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

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

THE CRITERIA TO BE GRANTED A PATENT

1-NO VEL TV (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

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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

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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 ยกu 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 ยกssue 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 ยกnvolving ยกndustry 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

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

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

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

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DanIeIIe BERNEMAN-INSTITUT PASTEUR (France)

ISSUES

16-17 Diciembre 2003

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

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.

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The management of the protection of a patent application by muhtiple entities owning an invention is complex. 1 Foro Internacional de Patentamlento enBlotecnología, SanUa?o,

Danielle BERNEMAN-INST!TUT PASTEUR (France)

CHILE

16-17 Diciembre 2003

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

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

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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

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

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.

'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

Danlelle BERNEMAN-INS71TUT PASTEUR (Franco)

16-17 Diciembre 2003

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

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

Danielle BERNEMAN-INSTITUT PASTEUR (France) L

16-17 DicIembre 2003

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

DanleIIe BERNEMAN-INST1TUT PASTEUR (Franco)

16-17 DIciembre 2003

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

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

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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.

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

PROTECCION DE LA PROPIEDAD INTELECTUAL Tipos de creatividad

Ejemplos

Productos, Procesos

Actividades Productivas

Arte, Ciencia

Dibujos, Pinturas, Esculturas, Música

Protección Legal (contra copia) Patentes Secretos Comerciales Variedades Vegetales Derechos de Autor

Películas, Videos, Grabaciones, Avisos Escritura, Literatura, Ciencia, Diarios, etc. Nombres, Emblemas

Productos y Servicios

Marcas Denominaciones de Origen

Formas, Apariencias

ltenis: Domésticos

Industriales

Diseños

EL ADPIC (TRIPs) SIENTA PRINCIPIOS Y NORMAS BASICAS QUE TODOS LOS PAISES MIEMBROS SE OBLIGAN A CUMPLIR

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"

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

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.

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.

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

TRATADO CHILE-EEUU 17.2) Antes dell de enero de 2007, las Partes deberรกn ratificar o adherir al Tratado de Cooperaciรณn en Materia de Patentes

TRATADO CHILE-EEUU 17.3 a) Antes del 1 de enero del 2009, las Partes deberรกn ratificar o adherir a la Convenciรณn Internacional sobre la Protecciรณn de Nuevas Variedades de Plantas (1991)

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.

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 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.

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.

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.

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. 26

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.

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").

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)

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.

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 ( 2025 años), quienes ganan regalías por la variedad protegida.

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)

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.

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 36

• 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.

SE NECESITA UN CLIMA DE SEGURIDAD JURIDICA MAS PROPICIO PARA IMPULSAR LA INNOVACION Y LOS NUEVOS EMPRENDIMIENTOS

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Europaisches Patentamt

European Paterit Office

Office européen des brevets

The European Patent Offic e....-.

Introduction to the EPO • Organisation • Patents • Biotechnology

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2582

TheHague

2210

Berlin

193

Vienna

Total

5 069

European Patent Organisation

European Patent

Administrative Councii

Office The executive body

The legislative body

The Offices task is to grant European patents.

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

President

Counci Secretariat

Ingo Kober .

(FR) Directorate

Vico-President P Kyrlakldes

(UY) Dwectorate- cer1eraiJ [ General 2

s ion Reserve

ce-Presrdent P Messerli (C H) Directorate- General 3

Fund

(DE)

ntroIling Office

Vire-Pren 1 L Baranes

1 1 1 1

Vce-President 1 1 Vice-President1 c Edrjaii M Decantes (SE) (ES) Dlreclorate- D!rectorateGeneral

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Headquarters Munich PschorrHofe

Branch at The Hague

Headquarters Munich sar bullding

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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...

EPO figures (2002 in review) 27 member states • Al! staff: - examiners:

5400 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 60000 1

1997

1998

1999

2000

2001

[iearches F, 1,

Applications

130000 120000 110000 100000 90000 80000 70000 1098 1999

2000

2001 European applica0ons Oled and Euro-PCi appcalions enterrng he European phase โ ข European apphca500s Oled and Euro-PCi appl,cations (inlernahonal phase(

Breakdown of applications by residence of applicants JP 18 -

Others 5% __---- ---

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Granting of Patents is based on • European Patent Convention (EPC) - Convention: Artic les - Implementing Regulations: Rules

• Trilateral Projects

• Guidelines for Examination

• Interna! Instructions

2000: DNA 2001: Reach through claims 2002: 3D/Cnstalline structure 2003: SNPs/Haplotypen

• Notices of the Patent Practice and Procedures Comrnittee

• Decisions of the Boards of Appeal: Case Law

EPO Granting Procedure 1

Application

Search +

opposition le

Appeal

Refusal of the Revocation of the applicationJ LPatents Appl p cantjPatentee

opposiuon

Maintainance of the Patent 3rd Party

EPO fees Filing phase

EUR

Examination phase

EUR 2 400

Grantphase

EUR

EPO fees total

EUR 5 200

1 700 1100

Cost of an average European patent 1) EPOfees

EUR 5200

Percentage of total

16%

Professional representation before the EPO

EUR

Percentage

of total

ransIation in the contracting states Percentage of total

5 500

20%

EUR 11 500 42%

National renewal fees

EUR 5 425

Rercentage of total

20%

flTotal cost

EUR 27 625 "27 states, 10-year terrn

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

Basic Requirements for 2/2 Patentability Industrial application (Article

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

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

Discoveries Aesthetic creations resentation of information Article 52 (4) EPC

lnventions contrary lo morality or public order Plant or animal varieties Biological processes

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 98/44/EC

it 20

Patentable biotechnological subj 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 ยกato 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

โ ข 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).

c 12

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 â&#x20AC;˘ How complete the indication of function should be: â&#x20AC;˘ 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)

c 13

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 SNPs

A specific receptor 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 specifĂc 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?

Yes If they are directed to a plant in general (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)

Example: • YES:

•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

• A transgenic plant,comprising a recombinant DNA coding for protein X

Are animais/animal varieties patentable?

YES

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)

Are processes for the production of plants patentable? â&#x20AC;˘ Article 53 (b) EPC: European patents shall not be granted for essentially biological processes for the production of plants or animais; â&#x20AC;˘ this provision does not apply to microbiological processes or the products thereof. â&#x20AC;˘ 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)

Example of a claim to a technical process â&#x20AC;˘ 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 â&#x20AC;˘ 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.

Examples of suffering of animais versus benefits to man 'NO • The naked mouseA transgenic mouse used to test hair cosmetic products

•YES • The Harvard OncomouseUsed as a model for studying cancer ,11 Y97 ,41

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.....

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Rule 23e (2)(3) EPC: â&#x20AC;˘ 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. â&#x20AC;˘ The industrial application of a (partial) sequence of a gene must be disclosed in the patent application.

â&#x20AC;˘ 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!

(7 (

Patentability of human embryonic stem celis - EPC Art.53a â&#x20AC;˘ Rule 23d,c exciudes ,,uses of human embryos for industrial or cornmercial purposes" â&#x20AC;˘ 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..."

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").

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.

Summary 1/2 â&#x20AC;˘ 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 â&#x20AC;˘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 â&#x20AC;˘ Processes involving human embryos are not patentable The patentability of human embryonic stem cells is debatable

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

Plant variety breeding

(G1198; Directive 981441EC)

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,

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

Plant Variety Breeding VS. Biotechnology PLANT VARIETY 1 BREEDING

E> I(Of

- defined by Its genotype aH genes - bred to be stable)

Var. A X

Plant

Var. A

Var.B

x Var.0

x Var. Q » Var, D » Var. F x X

Plant

FBIOTECHNOLO

- 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

EPC

Breeders Rights uP0v61-91

Article 53(b) EPC European patents shall not be g ranted in respect of plant or animal varieties (or essentially biological processes for the production of plants or animals)

c 28

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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

Patent AgreementPurpose/lntent • Comply with Bayh-DoIe requirements • Encourage innovation • Create incentive to teli university about invention • Share Iicensing revenue

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

I_ Jc o.r: UCSan Fnnçiscu UCSotCn

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• Lawrence Livermore National Laboratory • Los Atarnos National Laboratory (New Mexico)

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UC S..

•UC • UC .olAnC4cs • UC Ir*.n UC S. DIg

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Structure of Univ. of California Technology Transfer Activities • Locations at each campus and lab • Plus one Central Office of Technology Tía nsfer (aTT)

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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

As of June 30, 2002, the UC system manages 5,472 active inventions CAMPUS INVENTION PORTFOLIOs hP!! 1 IP!!! li..

IjCB LICO

GB 1 63G

Iji UCL

727

uu p

210

UCSC

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UCIA'

1- 'hl

.Iit. ' '',ith nvn 1 il ! JILhí_l .

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UCSD

1.274

JSF

1,152

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

liC PATENT PORTFOLIO

3CCC 2500

2c00

II t II 1

FYO2

UCLA E E

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Issued U.S. Patents - Campus Breakdown CAMPUS US PATENT PORTFoIjo'

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UCB

417

uco

143

UGLA

348

UGP

UGSB

159

ucsc

UGSD

362

UGSF

645

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In FY02, 973 new inventions were disclosed by faculty researchers (141 from UCLA) INVENTION [)ISCLOSURES 8V e

AMPUS

E' I

UCLA

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In FY02, active ¡¡censes - 867 utility patent licenses, plus approx. 500 plant patents licenses TOTAL UTILITV LICENSES BY CAMPUS'

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!JCB

174

UCD UCI

UiL-.

UCLA

UCP

UCSB

UCSO

UOSD

181

UCSF

289

Total licensing revenue for FY02 TOTAL IICENSINGREVENIIES BY CAMPUS

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

LCB

0580

£16401 4257

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

UCLA

•

$10118

OCR

341

LCSC LCCO

$12.6:

OCSF

$3.1344 'El 051

Top 5 earning inventions for Univ. of California lic T0PERNINC INVENTIONS'

Invention (Campus, Vear Disclosed) I1.I:3tItIE .Ir:iul

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Ii.itru '.• p it Iiitr.i ' 'rniiit Aliiji 'i Ti. i LA. h1-1iLqI apl1iL rvliilk ií[ [.i:''iiti

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Subtotal (Top Five

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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 Structure frM,. A..oc.I. W. ChMC.IO lo, E4ro.

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Deceo,ber 2003

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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

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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

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Agreements handied by OIPA • secrecy agreements • collaboration contracts • material transfer agreements • inter-institutional ag reements • bailments • Ietters of intent • option agreements • patent ¡¡censes

UCLA

O,ot Intehectui Prope,1y

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

OIPA'S Webpage E

UCLA

Office of intellectual Property

hflø//wwwreseprchuçIp edu/p ¡ Da!

http://wwwreseprçhuclpedu/jnnpvptjpn/

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