Montserrat Lopez-Bellosta - Excepcion de uso experimental ...€¦ · – “Excepción de uso...

La excepciLa excepcióón de "uso experimental" (Cln de "uso experimental" (Clááusula Bolar) usula Bolar) como la limitacicomo la limitacióón a los derechos del titular de una n a los derechos del titular de una patente que ha sido objeto de mayores patente que ha sido objeto de mayores controversias, modificaciones e interpretacionescontroversias, modificaciones e interpretacionesUna revisión con “fines aclaratorios”

Montserrat López-Bellosta

La Excepción de Uso Experimental y la Cláusula Bolar 1. Situación jurídica en España antes la

introducción de la cláusula bolar2. Implementación de la cláusula bolar en España3. Supuestos efectos retroactivos de la cláusula

bolar en España4. Aclaración de la situación por la Sentencia nº

424/2010 del Tribunal Supremo, Sala de lo Civil, de 30 de junio de 2010

5. Revisión en derecho comparado de la aplicación de la cláusula bolar

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1. Situación jurídica en España antes la introducción de la cláusula bolar

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¿Qué es una patente?

Título que reconoce el derecho de explotar en exclusiva una invención, impidiendo a otros su fabricación, venta o utilización sin consentimiento del titular

Como contrapartida la patente se pone a disposición del público, para que pase a formar parte del conocimiento general

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Duración de la patente(20 años desde la solicitud)

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1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Sal del Principio Activo A

Vida Efectiva de las Patentes

Principio Activo A

Tiempo transcurrido desde la investigación y la comercialización

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Efectos de la patente: El derecho a impedir a cualquier tercero que no cuente con su consentimiento

a) La fabricación, el ofrecimiento, la introducción en el comercio o la utilización de un producto objeto de la patente o la importación o posesión del mismo para alguno de los fines mencionados.

b) La utilización de un procedimiento objeto de la patente o el ofrecimiento de dicha utilización, cuando el tercero sabe o las circunstancias hacen evidente que la utilización del procedimiento está prohibida sin el consentimiento del titular de la patente.

c) El ofrecimiento, la introducción en el comercio o la utilización del producto directamente obtenido por el procedimiento objeto de la patente o la importación o posesión de dicho producto para alguno de los fines mencionados”(Artículo 50 LP)

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Efectos de la patente: El derecho a impedir “la contribución a la infracción”

La patente confiere igualmente a su titular el derecho a impedir que sin su consentimiento cualquier tercero entregue u ofrezca entregar medios para la puesta en práctica de la invención patentada relativos a un elemento esencial de la misma a personas no habilitadas para explotarla, cuando el tercero sabe o las circunstancias hacen evidente que tales medios son aptos para la puesta en práctica de la invención y están destinados a ella.

(Artículo 51.1 LP)

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AGREEMENT ON TRADE-RELATED ASPECTS OFINTELLECTUAL PROPERTY RIGHTS (The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994).

Article 30Exceptions to Rights Conferred

Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

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Excepciones al derecho de exclusiva

Ámbito privado y fines no comerciales

Uso previo

“El titular de una patente no tiene derecho a impedir que quienesde buena fe y con anterioridad a la fecha de prioridad de la patente hubiesen venido explotando en el país lo que resulte constituir el objeto de la misma, o hubiesen hecho preparativos serios y efectivos para explotar dicho objeto, prosigan o inicien su explotación en la misma forma en la que la venían realizando hasta entonces o para la que habían hecho los preparativos y en la medida adecuada para atender a las necesidades razonables de su empresa”

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P

Excepciones al derecho de exclusiva

Actos con fines experimentales

– “Excepción de uso experimental", recogida en el apartado b) del artículo 52.1 de la Ley de Patentes (vigente hasta el 27 de julio de 2006):

"[l]os derechos conferidos por la patente no se extienden: […] b) A los actos realizados con fines experimentales que se refieran al objeto de la invención patentada”

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The U.S. Court of Appeals for the Federal Circuit held that use of a patented drug solely for the purpose of obtaining U.S. Food and Drug Administration (“FDA”) approval for commercial sale of a generic drug equivalent upon the patent’s expiration constituted patent infringement.

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Antecedentes de la Cláusula Bolar: Roche Products Inc. v. Bolar Pharmaceutical Co. (1984)

New York Office31 West 52nd StreetNew York, NY 10019+1 212 878 3245

Washington, DC Office2001 K Street NWWashington, DC 20006+1 202 912 5045

[email protected]

Partner

William E. Wallace

29 noviembre 2010

“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

In response, the U.S. Congress passed the Drug Price Competition and Patent Term Restoration Act, which enacted 35 U.S.C. § 271(e)(1), the “Bolar exemption.”

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Obligación de entregar muestras en las dependencias de la AEMPS

"Se acompañará a la solicitud una declaración en la que se manifieste tener, en cantidad suficiente, muestras de las materias primas, productos intermedios, producto final y material de envasado primario y dosificadores para la realización de un control completo y para la validación de los métodos de control propuestos."Artículo 7. 4 del Real Decreto 767/1993, de 21 de mayo, sobre la Evaluación, autorización, registro y condiciones de dispensación de las especialidades farmacéuticas de uso humano, fabricadas industrialmente


Punto 1- Introducción y principios generales (Anexo II- Real Decreto 767/1993)

"Los datos y documentos que acompañan a las solicitudes de autorización sanitaria, de conformidad con el artículo 7 de este Real Decreto, se presentarán en cuatro partes, respetando los requisitos que se exponen en el presente anexo y teniendo en cuenta las directrices publicadas por la Comisión de las Comunidades Europeas en el volumen II («Nota explicativa para los solicitantes de autorizaciones de comercialización de medicamentos de uso humano en los Estados miembros de la Comunidad Europea»), de las normas sobre medicamentos de uso humano de la Comunidad Europea."


"Notice to Applicants”

“las muestras de los principios (no) activos y el medicamento terminado deben entregarse en el mismo momento en que normalmente deba presentarse el expediente ante las autoridades competentes en Bélgica, Italia, Luxemburgo, España, Suecia y Portugal (…) En otros casos, las muestras deben entregarse a solicitud de las autoridades competentes.”


La “Excepción basada en el Examen Reglamentario” en la CE y sus Estados Miembros

Las CE y sus Estados Miembros demandaron a Canadá ante la OMC en 1997 por considerar que la “Excepción basada en el Examen Reglamentario” era contraria al estándard mínimo de protección que exige el ADPICLa Excepción de Canadá comprendía: a) los actos conducentes a la obtención de la autorización de comercialización; b) actos de almacenamiento del producto (“stockpiling”)


En su reclamación las CE y sus Estados Miembros destacaron que

“en la legislación de los Estados Miembros de las CE no había ninguna disposición que autorizase a realizar, sin el consentimiento del titular de la patente, las actividades a las que se refería el apartado 1) del párrafo 2 del art. 55 de la Ley de Patentes canadiense”El reproche que las CE y sus Estados Miembros formularon a Canadá fue que la nueva Excepción suponía un acortamiento del período de vigencia efectiva de la patente, toda vez que:

“[…] a falta de esas disposiciones la comercialización efectiva sólo sería posible como pronto dos años después de la expiración del plazo de vigencia de la patente”


En el marco de la denuncia interpuesta por las Comunidades Europeas contra Canadá ante el Órgano de Solución de Controversias de la Organización Mundial del Comercio

La Comisión Europea y los Estados Miembros de las Comunidades Europeas defendieron, de forma unánime, que la "excepción de uso experimental" queda limitada a "actividades experimentales para contribuir al progreso de los conocimientos científicos", y no ampara "las actividades encaminadas únicamente a obtener la aprobación de la comercialización de un producto genérico" (páginas 69 y 250 de la Resolución del Órgano de Solución de diferencias de la OMC de fecha 17 de marzo de 2000)


La CE y sus Estados Miembros confirmaron que en los Estados Miembros no existia Excepción basada en el examen/aprobación reglamentarios


Sentencia del TJCE de 9 de julio de 1997 (“Generics B.V. c. SmithKline & French Laboratories Ltd.”)

3) Cuando un tercero, infringiendo el Derecho de patentes de un Estado miembro, ha presentado, a la autoridad competente para conceder autorizaciones de comercialización de medicamentos, muestras de un medicamento fabricadas según un procedimiento patentado y ha obtenido de dicho modo la autorización solicitada, el hecho de que un órgano jurisdiccional nacional prohíba al infractor comercializar tal medicamento durante un período determinado antes de expirar la patente, con el fin de impedir que obtenga un beneficio injusto de dicha infracción, constituye una medida de efecto equivalente, en el sentido del artículo 30 del Tratado, que puede estar justificada al amparo del artículo 36 del mismo Tratado CE.


Sentencia del TJCE de 9 de julio de 1997 (“Generics B.V. c. SmithKline & French Laboratories Ltd.”)

4) En el caso de que la entrega de muestras de un medicamento a la autoridad competente, con el fin de obtener una autorización de comercialización, haya implicado la violación de una patente, el Derecho comunitario, y en particular el artículo 36 del Tratado CE, no se opone a que el Juez nacional imponga al autor de esta violación una prohibición de comercializar dicho medicamento durante un período de catorce meses a partir de la expiración de dicha patente


El 17 de marzo de 2000 el Órgano de Solución de Diferencias de la OMC destacó lo siguiente

“No había excepciones para actividades relacionadas con la aprobación reglamentaria en los Estados miembros de las CE. Aunque en varios Estados miembros no existía jurisprudencia sobre esta cuestión, allí donde la había se permitían excepciones basadas en actividades experimentales para contribuir al progreso de los conocimientos científicos, pero no se autorizaban las actividades encaminadas únicamente a obtener la aprobación de la comercialización de un producto genérico idéntico”


Auto 26 de septiembre de 2002- Audiencia Provincial de Barcelona- Sección 15ª

El ius prohibendi del titular de la patente se extiende a la entrega de muestras en el marco del procedimiento de autorización de comercialización de un medicamento


EGA (Asociación Europea de Medicamentos Genéricos)“Hasta que la disposición sea incorporada por los Estados miembros, los fabricantes de genéricos deben o bien esperar hasta que caduque la patente original antes de empezar su trabajo de I+D, o confiar en investigación y desarrollo extranjero en países como Canadá, los Estados Unidos o India”(El Global, “La EGA solicita una rápida inclusión de la Disposición Bolar en la EU”5-11 de abril de 2004, p. 9)


Auto 21 de julio de 2005- Audiencia Provincial de Barcelona- Sección 15ª

"el ofrecimiento de SANDOZ a la AEM, en el marco de dos expedientes de autorización de venta de productos farmacéuticos, de aportar muestras no supone por síuna infracción del titular de la patente afectada por dicho producto"


2. Implementación de la cláusula bolar en España


Excepción basada en el Examen Reglamentario- Cláusula Bolar

Tras la modificación del artículo 52.1.b) de la Ley del Patentes operada por la Disposición Final Segunda de la Ley del Medicamento, que entró en vigor el 28 de julio de 2006, dicho precepto ha quedado redactado como sigue:

"[l]os derechos conferidos por la patente no se extienden: […] b) A los actos realizados con fines experimentales que se refieran alobjeto de la invención patentada, en particular los estudios y ensayos realizados para la autorización de medicamentos genéricos, en España o fuera de España, y los consiguientes requisitos prácticos, incluidos la preparación, obtención y utilización del principio activo para estos fines”


Borrador de 24 de febrero de 2005 de anteproyecto de ley de modificación de la Ley 25/1990, de 20-12, del Medicamento (Disposición Final 3ª):

“Se modifica el Artículo 52.1 de la Ley 11/1986, de 20 de marzo, de Patentes, mediante la adición en el apartado de un párrafo g) con el literal siguiente:

g) A la realización de los estudios y ensayos necesarios para documentar la autorización de comercialización relativa a medicamentos genéricos”


Borrador de 9 de junio de 2005:

“Se modifica el Artículo 52.1 de la Ley 11/1986, de 20 de marzo, de Patentes, mediante la siguiente redacción del párrafo b) del apartado: b) A los actos realizados con fines experimentales que se refieran al objeto de la invención patentada, en particular los estudios y ensayos realizados para la autorización de medicamentos genéricos y los consiguientes requisitos prácticos, incluidos la preparación, obtención, y utilización de la sustancia activa para estos fines”


Exposición de Motivos

“Este régimen de protección se completa, como no podía ser de otra manera, con la incorporación, con fines aclaratorios, mediante la oportuna modificación de la Ley de Patentes, de la denominada “cláusula o estipulación Bolar”, según la cual no se considera violación del derecho de patente la realización con fines experimentales de los estudios y ensayos necesarios para la autorización de medicamentos genéricos.”


Directivas 2004/27/CE y 2004/28/CE del Parlamento Europeo y del Consejo

Que modifican la Directiva 2001/83/CE por la que se establece un Código Comunitario sobre Medicamentos de Uso Humano y la Directiva 2001/82, por la que se establece un Código Comunitario sobre Medicamentos VeterinariosFecha: 31 de marzo de 2004 Transposición: 30 de octubre de 2005


Introducción Cláusula Bolar (artículo 1.8 (6) Directiva 2004/27/CE)

"la realización de los estudios y ensayos necesarios para la aplicación de los apartados 1, 2, 3 y 4 y los consiguientes requisitos prácticos no se considerarán contrarios al derecho sobre patentes ni a los certificados de protección complementaria para medicamentos.“Equivalente medicamentos veterinarios

(artículo 13.6 Directiva 2004/28/CE)


Intereses en presencia

“Una mirada de diversos intereses confluyen en esta industria. Es necesario alcanzar todo tipo de equilibrios, por ejemplo entre los productos genéricos y los sujetos a patentes”. (Informe de la Comisión de Medio Ambiente, Salud Pública y Política del Consumidor del Parlamento Europeo de 9 de octubre de 2002)

“Es importante mantener ese equilibrio, basado en un período de protección de datos de diez años, a favor de los medicamentos innovadores, y una cláusula del tipo Bolar, a favor de los medicamentos genéricos”. (Propuesta de la Comisión de 3 de abril de 2003)


Equilibrio: Cláusula Bolar/ Periodo de protección de datos

“Los genéricos constituyen una parte importante del mercado de los medicamentos, por lo que, a la luz de la experiencia adquirida, conviene facilitar su acceso al mercado comunitario. Además, se debe armonizar el período de protección de los datos relativos a los ensayos preclínicos y clínicos.”(Considerando 14- Directiva 2004/27/CE)


Periodo de protección de datos: 8 años

1. No obstante lo dispuesto en la letra i) del apartado 3 del artículo 8, y sin perjuicio del derecho relativo a la protección de la propiedad industrial y comercial, el solicitante no tendráobligación de facilitar los resultados de los ensayos preclínicos y clínicos si puede demostrar que el medicamento es genérico de un medicamento de referencia que está o ha sido autorizado con arreglo al artículo 6 desde hace ocho años como mínimo en un Estado miembro o en la Comunidad.


8 + 2

Los medicamentos genéricos autorizados con arreglo a la presente disposición no se comercializarán hasta transcurridos diez años desde la fecha de la autorización inicial del medicamento de referencia.


8 + 2 + 1El período de diez años a que se hace referencia en el párrafo segundo se ampliaráhasta un máximo de once años si, durante los primeros ocho años del período de diez años, el titular de la autorización de comercialización obtiene una autorización para una o varias nuevas indicaciones terapéuticas y, durante la evaluación científica previa a su autorización, se establece que dichas indicaciones aportarán un beneficio clínico significativo en comparación con las terapias existentes.


3. Supuestos efectos retroactivos de la cláusula bolar en España


Sentencia 17 de marzo de 2008- Audiencia Provincial de Barcelona- Sección 15ª

"Esta tesis al tiempo de formularse la reconvención, podía tener amparo judicial, en la medida en que en nuestro Auto de 13 de diciembre de 2004, reconocíamos "la facultad que corresponde al titular de la patente de un procedimiento de fabricación de un medicamento de oponerse a que un tercero utilice, para obtener una autorización de comercialización muestras de un procedimiento [sic] fabricados según dicho procedimiento, forma parte del objeto específico del derecho de patente, puesto que dichas muestras han sido utilizadas sin el consentimiento directo o indirecto del titular de la patente.”



Y de lo que en autos posteriores matizamos, para advertir que la infracción radicaría en la presentación de muestras, pues "aunque sólo fuera por su introducción dentro del territorio español al que alcanza la protección de la referida patente, se habría vulnerado el derecho de sus titulares, al no recabar su autorización previa", pero no en el mero ofrecimiento a la AEM de las muestras del fármaco sobre el que versa la autorización.



En cualquier caso, en estas resoluciones concluíamos que la utilización de una muestra de un producto afectado por la patente para aportarla con la solicitud de autorización de una especialidad farmacéutica, sí constituye una utilización más allá del uso privado y del uso con fines experimentarles, aunque propiamente no sea un acto de comercio, y por ello se vería afectada por el "ius prohibendi" que confiere la patente a su titular.


Sentencia 9 de mayo de 2008- Audiencia Provincial de Barcelona- Sección 15ª

"la tesis de la actora, aunque en un tiempo pudo haber sido estimada, en la actualidad ello no es posible, porque la disposición adicional 2ª de la Ley 29/2006, de 26 de julio , ha introducido la denominada "cláusula Bolar", pero no como una nueva excepción del art. 52.1 LP, lo que hubiera permitido no aplicarla retroactivamente, sino como una especificación de la excepción de "los actos realizados con fines experimentales que se refieran al objeto de la invención patentada" [art. 52.1.b) LP ].


Sentencia 9 de mayo de 2008- Audiencia Provincial de Barcelona- Sección 15ª

Con ello el legislador ha pretendido aclarar que dentro de la anterior excepción de actos realizados con fines experimentales, debían incluirse todos aquellos realizados para la autorización de medicamentos genéricos. De este modo, la realización de actos con fines experimentales, entre los que se encuentran los estudios y ensayos para la autorización de medicamentos genéricos y los consiguientes requisitos prácticos, incluidos la preparación, obtención y utilización del principio activo objeto de P1 y/o P2 para estos fines, no constituye ninguna infracción legal que permita encajar esta conducta en el art. 15 LCD.


Sentencia 16 de septiembre de 2008-Audiencia Provincial de Madrid- Sección 28

La sección 28ª de la Audiencia Provincial de Madrid considera como hechos probados que ALTER llevó a cabo actos de "utilización" del producto directamente obtenido por el procedimiento patentado por ALMIRALLy que, con ese fin, ALTER procedió a su "importación y posesión", pero llega a la conclusión de que tales actos de "utilización", y de "importación y posesión", "no vulneran el derecho de patente al encontrarse amparados por la excepción de uso experimental que contemplaba, ya en su redacción anterior a la introducción expresa de la denominada "Cláusula Bolar", por parte de la Disposición Final Segunda de la Ley 29/2006 de 26 de julio, el Art. 52-1 b de la Ley de Patentes.”



Se sirve de las definiciones de las palabras "experimentar" e "investigar" contenidas en el Diccionario de la Real Academia Española, a partir de las cuales elabora una serie de razonamientos subjetivos, para llegar a la conclusión de que la "Excepción de uso experimental" no incluye únicamente aquellos actos experimentales realizados con el objeto de la patente con el fin de contribuir al progreso técnico y científico, sino también aquellos que aspiran simplemente a la comprobación empírica de un determinado fenómeno.



Los actos de importación, uso y posesión del objeto de la patente dirigidos a la obtención de una autorización de comercialización de medicamentos genéricos y realizados antes de la fecha de caducidad de dicha patente, se encuentran comprendidos en la "Excepción de uso experimental" recogida en el artículo 52.1 b) de la Ley de Patentes en su redacción anterior a la modificación introducida por la Ley 29/2006.


4. Aclaración de la situación por la Sentencia nº 424/2010 del Tribunal Supremo, Sala de lo Civil, de 30 de junio de 2010


Sentencia nº 424/2010 del Tribunal Supremo, Sala de lo Civil, de 30 de junio de 2010

Después de 4 años de incertidumbre, ha venido a confirmar que antes de la entrada en vigor de la Ley 29/2006 la entrega de muestras a las autoridades sanitarias no estaba amparada por la "excepción de uso experimental"



Las Leyes de Patentes de la generalidad de los países de la CE (UE) recogieron la excepción de uso experimental, como la había redactado el CPC de 1.975 (texto que no llegó a tener vigencia), en el sentido de que el derecho de patente no alcanza el uso experimental del producto o procedimiento patentado, y con este contenido se plasmó en el art. 52.1,b) de nuestra LP .Como ya hemos señalado, una modalidad de cláusula BOLAR se incorpora al ordenamiento comunitario (de la UE) por la Directiva de 31 de marzo de 2.004 (transpuesta a nuestro Derecho en el año 2006).



Pues bien, resolviendo ya el problema del alcance interpretativo del precepto del art. 52.1,b), antes de la reforma por la Ley 29/2006 , y teniendo en cuenta el antecedente histórico (art. 27 del CPC de 15 de diciembre de 1.975), el pensamiento general en el Derecho Comunitario anterior a la Directiva 2004/27/CE, además de la "ratio" de ésta de establecer una normativa de equilibrio entre los intereses en conflicto, y que la norma examinada es limitativa o restrictiva de un derecho subjetivo (el de patente) y por lo tanto debe ser interpretada restringidamente, hay que entender que su contenido exige dos requisitos: que los actos han de realizarse con fines de experimentación o de ensayo, con referencia exclusiva a los de carácter técnico o científico, y han de referirse al objeto de la invención patentada.



Lo que resultaba una interpretación clara ha venido a enturbiarse con ocasión de la reforma introducida en el precepto por la Ley 29/2009, de 26 de julio, concretamente por la expresión "en particular" utilizada en el nuevo texto y la referencia a "fines aclaratorios" a que se alude en la Exposición de Motivos, porque de tratarse de una norma aclaratoria habría que entender que su contenido ya estaba comprendido en el precepto, y entonces tendría efecto retroactivo



Sin embargo, los reparos expuestos no son razones suficientes para mantener una interpretación diferente de la antes expresada, y esto no sólo ya por la carencia de valor normativo de la Exposición de Motivos y la ambigüedad al respecto que aquí se examina del término "en particular", sino sobre todo porque las dos excepciones responden a "ratio" diferentes y, además…



… lo que hace la Ley de 2.006 es incorporar, como dice la propia E. de M., la denominada "cláusula o estipulación Bolar", la cual no existía al tiempo de redactarse el precepto -art. 27 del CPC de 1.975 - del que se tomó el originario de la LP de 1.986, de ahí la propia incoherencia interna de la E de M, que se acentúa si se tiene en cuenta, por un lado, que tal incorporación responde fundamentalmente a la necesidad de transponer (lo que ya debía haber tenido lugar hacía meses) la Directiva 2004/27/CE,…



… la cual solo tiene eficacia en las relaciones entre particulares desde su transposición por la exigencia a los órganos jurisdiccionales de observar una "interpretación conforme" en la aplicación de la norma interna, la cual no tiene efecto retroactivo ( S. 24 de noviembre de 2.006 ( RJ 2006, 8136) ), y, por otro lado, que resultaría paradójico, y por lo tanto absurdo, que España hubiera mantenido en la perspectiva internacional (reclamación contra la Ley Canadiense) una postura jurídica contraria a la de su propio derecho interno.


5. Revisión en derecho comparado de la aplicación de la cláusula bolar


New York São Paulo Washington DCAmsterdam Barcelona Brussels Bucharest Düsseldorf FrankfurtKyivLondon Luxembourg Madrid MilanMoscow Munich Paris PragueRome WarsawAbu DhabiDubaiRiyadh*BangkokBeijing Hong KongShanghai SingaporeTokyo

*Clifford Chance also has a co-operation agreement with Al-Jadaan & Partners Law Firm in Riyadh and a 'best friends' relationship with AZB & Partners in India and with Lakatos, Köves & Partners in Hungary


1. Wording and details of the rule, law or case law governing and implementing the Bolar provision


“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

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1- Drug Price Competition and Patent Term Restoration Act, 35 U.S.C. § 271(e)(1)

New York Office31 West 52nd StreetNew York, NY 10019+1 212 878 3245

Washington, DC Office2001 K Street NWWashington, DC 20006+1 202 912 5045

[email protected]

Partner

William E. Wallace

THE UNITED STATES

29 noviembre 2010

Conducting the necessary studies, tests and trials with a view to the application of article 10, paragraphs 1, 2, 3 and 4 of Directive 2001/83/EG on the Community code relating to medicinal products for human use or article 13, paragraphs 1, 2, 3, 4 and 5 of Directive 2001/82/EG on the Community code relating to veterinary medicinal products and the consequential practical requirements shall not be regarded as a breach of patents on medicinal products for human use as well as veterinary medicinal products.

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Alvin Khodabaks

T +31 20711 9374

E [email protected]

F +31 20 710 0374

Clifford ChanceDroogbak 1A1013 GE, AmsterdamThe Netherlands

THE NETHERLANDS 1- Article 53 paragraph 4 of the Dutch Patents Act 1995 states as follows

29 noviembre 2010

“Conducting the necessary studies, testsand trials with a view to meeting the conditions and modalities referred to in the intends 1 to 7 of this paragraph and all the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates”.

1- Article 6bis, 1, of the Belgian Medicines Act of 25 March 1964 ('BMA') on the requirements for applying for a marketing authorisation for generic drugs includes a quasi literal copy of article 10(6) of Directive 2004/27

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Thomas Vinje

T +32 2 533 5911Fax: +32 2 533 5959

E: [email protected]

Clifford ChanceAvenue Louise 65Box 21050 BrusselsBelgium

BELGIUM

29 noviembre 2010

No se considera infracción:where a patented medication or patented medical device is made, used or imported in order to provide information necessary for administrative examination, or which is manufactured or imported specifically for a party for said purpose.

E ling.ho@ cliffordchance.com

T +852 2826 3479

Head of Asia Intellectual Property GroupCo-Head of China Litigation and Dispute Resolution

Ling Ho

1- China's version of a Bolar provision was introduced in Article 69(5) of the most recent (third) Amendment to the Patent Law of the People's Republic of China, effective on October 1, 2009

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CHINA

29 noviembre 2010

« Les droits conférés par le brevet ne s’étendent pas:d) Aux études et essais requis en vue de l’obtention d’une autorisation de mise sur le marchépour un médicament, ainsi qu’aux actes nécessaires à leur réalisation et à l’obtention de l’autorisation ».

1- Article L 613.5 d) of the French Intellectual Property Code (CPI) disposes that:

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Jean-Frédéric Gaultier

T +33 1 44 05 52 31

E [email protected]

F +33 1 44 05 52 00

Clifford Chance Europe LLP9, place Vendôme CS 5001875038 Paris Cedex 01France

FRANCE

29 noviembre 2010

"The effect of a Patent shall not extent to

2. Acts done for experimental purposes relating to the subject matter of the patented invention;2b. Studies and trials and the consequential practical requirements which are necessary for obtaining the pharmaceutical market authorization for the marketing in the European Union or for the marketing in the Member States of the European Union or in third countries."

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Dr. Claudia Milbradt

T +49 211 43 55 59 62

E [email protected]

F +49 211 43 55 56 00

Clifford Chance PartnerschaftsgesellschaftKönigsallee 5940215 DüsseldorfGermany

GERMANY 1- The Bolar provision was implemented into German law through a new paragraph 2b to section 11 of the German Patent Act

29 noviembre 2010

1- Section 10 of Legislative Decree 219/2006 implemented almost literally Section 10 of Directive 2001/83/EC regulating an abridged application for the authorisation of generic medicinal products.

Moreover, a specific exception on the clinical trials was set forth by Legislative Decree no. 30/2005 (the Intellectual Property Code, hereinafter the "IPC"), Section 68, let. A, as recently amended by Legislative Decree no. 131/210 (the so called Decreto Correttivo). Following this, the new provision is to be read as follows: "Independently from the subject matter of the invention, the exclusive patent rights do not cover: [...] b) the studies and the trials aimed at obtaining (also in foreign countries) the marketing authorisation for pharmaceuticals and the subsequent practical accomplishments such as the making and the utilization of the raw materials containing active ingredients that are necessary thereto."

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T: +39 02 806341

Monica Riva

E: monica.riva@ cliffordchance.com

F: +39 02 80634220

Senior Associate

ITALY

29 noviembre 2010

Under Art. 69 sec. 1 point 4 of the above Law, the patent is not infringed if an invention is used to the extent necessary to carry out actions required by law to obtain a registration or permit which is a necessary condition for certain products to be admitted to trading due to their designated use. This applies particularly to medicinal products.

1- The Bolar provision was introduced into the Act - Industrial Property Law of 30 June 2000 regulating the patent issues in Poland. The Law came into force on 22 August 2001.

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Magdalena Cybulska

T +48 22 627 1177Fax: +48 22 627 1466

E: [email protected]

F

Clifford ChanceNorway Houseul. Lwowska 1900-660 WarsawPoland

POLAND

29 noviembre 2010

1- The United Kingdom implementing legislation came into force on the 30 October 2005 and amends Sections 60(5) and 60(7) of the Patents Act 1977.

(i) it consists of -(i) an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC, or (ii) any other act which is required for the purpose of the application of those paragraphs.

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T: +44 20 7006-4503

Vanessa Marsland

E: vanessa.marsland@ cliffordchance.com

F: +44 20 7006-5555

Partner

U.K.

29 noviembre 2010

2- Would the Bolar exemption in your jurisdiction cover clinical trials with generic and/or non-generic drugs with the objective of gaining marketing approval?


2- Only generic products: Belgium, the Netherlands and the United Kingdom

Before the implementation of the Bolar exception in Belgian law, the Brussels Court of appeal had already admitted that the mere fact of filing an administrative request for obtaining a marketing authorization for a generic drug, without such request entailing the submission and hence introduction of any sample on Belgian territory, could not be considered as an infringement of the original patented drug.


2- China: generic and innovative products

The law does not make a distinction between the various kinds of drug and regulatory application. As long as the clinical trial was conducted in order to provide information "for administrative examination (and approval)," it should be covered by the Bolar provision.


2- France: generic and innovative products

No case law nor doctrine. The law is broad and not limited to generics. Case law prior to the Bolar exemption was already exempting acts undertaken with a view to obtain a MA, under the experimental use exemption. Thus, these would also most likely be exempted under either Bolar or the experimental use exemption.


2- Germany: generic and innovative products

The wording of sect. 11 para. 2b PatG – the implementation of the Bolar exemption – does not differentiate between different kinds of drugs, i.e. generic and non-generic, innovative products or biosimilars. It generally refers to "studies and trials (…) necessary for obtaining marketing approval" without specifying the object of those studies and trials. Hence, the broad wording of sect. 11 para. 2b PatG does at first glance cover all varieties of drugs.


2- Italy: Literally the provision is apparently broad...

However, the prevailing interpretation (which is also consistent with the narrow structure of the exceptional use in the past) is in the sense that such exemption shall be limited to those studies and trials required to a company pursuing an application for a marketing authorisation and does not apply to "preparatory acts" carried out for the purpose of launching an "innovative" product, i.e. a product which does not have an underlying patent that is about to expire.


2- Poland: all products

In Poland the Bolar provision is particularly important in pharmaceutical industry. According to the opinion of legal academics, medicinal products were mentioned in the provision under discussion only as an example so other products may also fall into this scope.


2- The United States

The U.S. Supreme Court has held that the exemption covers the use of patented inventions to develop and submit information for marketing approval from a federal regulator. Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) (holding that Section 271(e)(1) exempts from infringement the use of patented inventions reasonably related to the development and submission of information needed to obtain marketing approval of medical devices under the Federal Food, Drug, and Cosmetic Act).


2- España: Sólo medicamentos genéricos o también innovadores?

"[l]os derechos conferidos por la patente no se extienden: […] b) A los actos realizados con fines experimentales que se refieran al objeto de la invención patentada, en particular los estudios y ensayos realizados para la autorización de medicamentos genéricos, en España o fuera de España, y los consiguientes requisitos prácticos, incluidos la preparación, obtención y utilización del principio activo para estos fines”


3- Would the Bolar provision in your jurisdiction cover the test to establish the bioequivalence of the generic drug with the innovative product or product of reference?


YES, IT IS THE EXEMPTION’S PRIMARY PURPOSE

Section 271(e)(1) was intended to apply to “[t]esting so that generic manufactures can establish the bioequivalency of a generic substitute.” H.R. Rep. No. 857 (1984). Integra Lifesciences I., Ltd. v. Merck KGaA, 496 F.3d 1334, 1350 (Fed. Cir. 2007) (“The exemption’s primary purpose is to permit generic manufacturers to perform research on drugs in the pipeline for [U.S. Food and Drug Administration] approval.”).


4- Would the Bolar provision in your jurisdiction cover the test to demonstrate to third –party companies-clients or potential clients or others-that the product works?


4- NO (The Netherlands, Belgium, China, France, Germany and U.K.)

There is no Belgian case law on the subject, certain Belgian doctrine has confirmed that such acts will most probably be interpreted as having a purely commercial objective, and will therefore not be covered by the exemption. No, because the test was not conducted in order to provide information "for administrative examination (and approval)."


4- NO (Germany)

Demonstrating the functionality and the qualities of a product to third-party companies, especially future clients, does not serve the purpose of obtaining marketing approval. It rather serves publicity and marketing purposes, which are not covered by the German implementation of the Bolar provision.


4- Italy

Even though such conduct may fall within the unlawful advertising of the product, it may be argued that it is a "preparatory act" allowed by Section 68, let. A), IPC.


4- Poland

Yes, it may be interpreted that the Bolar provision covers the test to demonstrate to third –party companies- clients or potential clients- that the product works.


4- The United States: May…

Demonstration of a product to potential clients may fall under the Section 271(e)(1) exemption if some of the demonstration activity is “reasonably related to identifying potential clinical investigators and, therefore, to generating data for submission to the FDA.”Intermedics, Inc. v. Ventritex, Inc., 775 F.Supp. 1269, 1287 (N.D. Cal. 1991) (demonstration of patented defibrillator at various medical trade shows was in part related to identifying potential clinical investigators and therefore reasonably related to generating data for submission to the FDA and within exemption).


5- Would the Bolar provision in your jurisdiction cover the manufacture, import and storage of samples and batches for validation?



At least one U.S. court has found that the exemption covers the manufacture and storage of samples and batches if such acts are “reasonably related” to obtaining approval from a federal regulator. See NeoRx Corp. v. Immunomedics, Inc., 877 F.Supp. 202, 206 (D. N.J. 1994) (production of “commercial-scale lots” of products for possible submission to FDA is exempted non-infringing activity).



The exemption has also been found to cover the importation of patented products if the imported product is used for the exempt purpose of the development and submission of information under a federal law regulating the manufacture, sale and use of drugs. Amgen, Inc. v. Int’l Trade Comm’n, 565 F.3d 846, 848 (Fed. Cir. 2009).


5- Germany

It is likely that the Bolar exemption in Germany would cover the manufacture, import and storage of samples and batches provided that these measures are necessary for the performance of the clinical and bioequivalent studies and trials being necessary for the application for marketing approval.


5- France / Italy /Spain/ U.K./ Belgium/ The Netherlands

Yes. It would depend on the quantities. If these are too large, a court might consider it exceeds the needs for a mere validation.Presumably yes, as long as it is ascertained that those acts were performed in the context an application for the marketing authorisation pursuant to Section 68, let. A), IPC.


5- Poland

It is possible to use an invention by storing samples required for validation to the extent necessary, whereas in the case of production, import and batches of products, there may be a risk of patent infringement and potential court proceedings in this respect.


6- Would the Bolar exemption in your jurisdiction cover the preparation and utilization of pharmacologically active raw materials necessary for obtaining a marketing authorization?


6- Yes (Germany)Sect. 11 para. 2b PatG covers all "studies and trials and the consequential practical requirements". It has not yet been clarified by any case law what "consequential practical requirements" includeHowever, an explanatory statement to the Draft Law amending the German Drug Act states that the inclusion of this phrase was necessary in order to clarify that, in addition to the necessary steps of development, related steps such as the import of active raw material and the manufacture of samples are allowed


6- Yes: Belgium/ China/France/Italy/ Poland/ The Netherlands

There is no Belgian case law on the subject, but this will most probably be covered by the exception since it is covered by "all consequential practical requirements" to obtain a marketing authorization.


6- The United Kingdom

“The carrying out of chemical and biological synthetic processes suitable for the making, disposal or keeping of the active substance(s) including the manufacture or the import of batches in quantities sufficient to provide material for preparing investigative batches of the medicinal product and to validate the processes to the satisfaction of the competent authorities. “

U.K. Intellectual Property Office’s view (no legal effect)


6- The United Kingdom“The development of the final pharmaceutical composition and manufacturing processes for the medicinal product to be marketed including the making, disposal or keeping or import of product batches in quantities sufficient to conduct the necessary pre-clinical tests, clinical and bioavailability trials and stability studies of the medicinal product and to validate the processes to the satisfaction of the competent authorities. “



7- Would the Bolar provision in your jurisdiction cover filing samples together with the marketing application before the drug agency?


7- Germany

Against the application of the Bolar exemption, it may be argued that the European Parliament discussed during the legislative procedure whether the provision should be amended as to the coverage of the filing of samples by the Bolar exemption; but an explicit clause was not amended at the end. A clarification on German and European level might be desirable.


7- GermanyAs to the necessity of the filing of samples for obtaining marketing approval, one has to refer to the marketing authorization regulation in the German Drug Act. There is no general obligation for filing samples together with the marketing application in Germany. However, the Federal Drug Agency may request a sample. In the latter case, the filing of samples could become necessary in the meaning of sect. 11 para. 2b PatG and the Bolar exemption may cover it.



The exemption has been found to cover the manufacture and storage of samples if such acts are “reasonably related” to obtaining regulatory approval under federal law Production of “commercial-scale lots” of products for possible submission to U.S. Food and Drug Administration falls under exemption

(See NeoRx Corp. v. Immunomedics, Inc., 877 F.Supp. 202, 206 (D. N.J. 1994))


7- U.K. (Belgium, China, France, Italy, Spain, Poland, The Netherlands)

“The manufacture and supply to the competent authorities of samples of active substances, their precursors, intermediates or impurities and of finished product samples.”



8- Would the Bolar provision in your jurisdiction cover the production of commercial batches?



At least one U.S. court has held that the exemption may cover the manufacture and storage of commercial-scale batches if such acts are “reasonably related” to obtaining regulatory approval under federal law. Production of “commercial-scale lots” of products for possible submission to FDA is exempted non-infringing activity.

See NeoRx Corp. v. Immunomedics, Inc., 877 F.Supp. 202, 206 (D. N.J. 1994)


8- The Netherlands (Belgium, China, France, Italy, Poland and Spain)

No. The production of commercial batches would be aimed at marketing, which constitutes an infringement of the patent rights.


8- Germany (UK)There is no literature or case law on this point. However, if "commercial batches" means the production of batches intended for future sales or marketing activities, it would most likely not be covered by the Bolar provision. In general, the manufacture of products which are protected by a patent is prohibited by sect. 9 PatG. As far as the production of commercial goods does not serve the purpose of obtaining marketing approval but rather aims at the selling process, such production is not covered by the Bolar exemption in Germany.


9- Would the Bolar provision in your jurisdiction cover publications and marketing, or the offering of the product intended to be marketed once the patent has expired?



U.S. courts have held that the use of data gained from clinical tests for promotional or fundraising purposes may fall within the exemption. Alleged infringer’s advertising of device on website, in medical and scientific journals, at academic conferences, and at trade shows falls within exemption because reasonably related to obtaining FDA approval.

See, e.g., Nexell Therapeutics, Inc. v. Amcell Corp., 143 F.Supp.2d 407, 420-21 (D. Del. 2001)


9- Belgium

Case-law considered that "preparation of the marketing of generic products is not prohibited by article 27 BPA and that the production of computing and advertisement supports must be considered as a mere preparation of such marketing. However, their edition and distribution fall within the scope of the prohibition of marketing under article 27 BPA" (Civil court of first instance of Brussels, 8 April 2008).


9- The Netherlands (China, France, Italy, Poland, Spain and U.K.)

The Bolar provision does not cover publications and marketing. Such acts would be regarded as an infringement of the patent rights.


9- GermanyPublications and marketing would be considered as an offer in the meaning of sect. 9 PatG and not as a mere preparatory measure (RG GRUR 43, 247, 248). Such acts are therefore prohibited by sect. 9 PatG as long as the patent is not expired. It is reasonable to assume – without any case law or legal literature available on this aspect –that this kind of action is not exempted by the Bolar provision because it is aimed at selling and marketing a product, not at obtaining the necessary marketing approval.


10-Would the Bolar provision in your jurisdiction cover taking pre-orders to be delivered once the patent has expired?


10- The United States/ Belgium

We have not identified any U.S. precedent expressly addressing whether the exemption covers taking pre-orders to be delivered once the patent has expired. To our knowledge, there is no specific Belgian case law or doctrine on the subject.


10- The Netherlands / China / Spain

The Bolar provision does not cover taking pre-orders. Such acts would be regarded as an infringement of the patent rights.


10- France No case law. In my opinion, a pre-order implies that the generic company has undertaken some prior commercial activity with the potential client, and has thus offered the infringing product for sale. Offer for sale is an infringement. Main issue we face in France is that usually pre-orders are not made in France, but in some patent-free place. If we could get copies of these pre-orders, indicating that said pre-orders are intended for France, we may claim infringement


10- Germany (UK)

Any kind of offering a product which is subject matter of a patent is prohibited. Pre-orders to be delivered once the patent has expired may, however, in some cases not be prohibited. Accepting such an order –without having offered it first – may be allowed if combined with the assurance that the product will only be produced and delivered once the patent has expired.


11-Would the Bolar provision in your jurisdiction cover stockpiling, i.e. accumulating a large stock of product to be able to launch the very next day after the patent has expired?


11- The United StatesOne U.S. court has held that stockpiling products in preparation for immediate marketing upon FDA approval was not “reasonably related” to obtaining regulatory approval under federal law and therefore did not fall within the exemption. Spending US $24 million “[t]o stockpile and prepare to market Avonex immediately upon the anticipated, imminent FDA approval” did not fall within scope of exemption.

See Biogen, Inc. v. Schering AG, 954 F.Supp. 391, 396 (D. Mass. 1996)


11- The Netherlands (Belgium, China, France, Germany, Italy, Spain and U.K.)

The Bolar provision does not cover stockpiling. Such acts would be regarded as an infringement of the patent rights.To our knowledge, there is no specific Belgian case law or doctrine on the subject.


12-Would the Bolar exemption in your jurisdiction cover acts delimited to the subject-matter of the patented invention which are necessary for obtaining a marketing authorisation for a medicinal product only for humans or also for animals?


12- The United StatesThe statutory language of the exemption specifically excludes medicinal products for animals: “(other than a new animal drug or veterinary biological product)”. Section 271(e)(1) exemption does not apply to “new animal drugs or veterinary biological products”.

See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 674 (1990)


12- The Netherlands (Belgium, China, France, Germany, Italy, Spain, Poland and U.K.)

The Bolar exemption covers acts delimited to the subject-matter of the patented invention which are necessary for obtaining a marketing authorisation for a medicinal product for both humans and animals.


13-Can the studies and trials performed in your jurisdiction under the Bolar exemption be used for registration in your jurisdiction only or in any other country (EU or EEA, for example)?



U.S. courts have held that data obtained from studies and trials performed under the exemption may be submitted to foreign regulators for foreign regulatory approval and still fall under the exemption.


13- The United StatesWhere data is first submitted to U.S. regulator, subsequent submission of same data to foreign regulator is not infringing act.U.S. courts have also held, however, that shipping samples to a foreign regulatory agency may fall outside of the exemption. “Using a patented product to seek access to foreign markets is arguably not a de minimisact of patent infringement.”

See NeoRx Corp. v. Immunomedics, Inc., 877 F.Supp. 202, 208 (D. N.J. 1994)


13- No se indica en la norma si sólo se puede utilizar en el país en cuestión o en el extranjero

Holanda/Francia/ Bélgica/Polonia/ U.K.The Belgian clause does not limit the use of the studies and trials performed in Belgium under the Bolar exemption for registration in Belgium only. It seems that only studies and trials in view of filing applications for a marketing authorisation in the EU fall within the scope of clause 10(6) of Directive 2004/27/EC. There is however no Belgian case law on the matter.


13- China

The answer will depend on the regulation of other jurisdictions. In China, SFDA generally does not accept global data without appropriate number of Chinese patients.


13- Se indica en la norma si se puede utilizar en el país en cuestión o en el extranjero

“En España o fuera de España”In Germany, the Bolar exemption explicitly covers trials and studies in view of marketing applications in the EU, the member states of the EU and even third countriesItaly: “The studies and the trials aimed at obtaining (also in foreign countries) the marketing authorisation…”


14-Are uses of patented inventions in preclinical research, the results of which are not ultimately included in a submission to the drug agency, exempted from infringement under the Bolar provision?


14- The United StatesThe U.S. Supreme Court has held: “At least where a drugmaker has a reasonable basis for believing that a patented compound may work ... and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is ‘reasonably related’ to the ‘development and submission of information under ... Federal law.’” Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 207 (2005).


14- GermanyThere is no case law or legal literature on this matter. Judging by the wording of the German implementation of the Bolar provision, it seems that the provision should only cover acts necessary to obtain marketing approval. Thus, research which is not included in a submission for approval does not seem to be covered at first sight. However, preclinical research may be a necessary first step in order to conduct clinical research based on the results of the preclinical research.


14- Germany (UK)Thereby, the preclinical research could well qualify as necessary for obtaining marketing approval because it is necessary to conduct the clinical research, which in turn surely is covered by the Bolar exemption. In addition, the wording chosen by the EU legislator argues in favor of including preclinical research. Art. 10 para. 6 of the Directive 2004/27/EC refers to all studies necessary to the application of its paragraphs 1 through 4, which in turn mentions clinical and pre-clinical research.


15-Could the Bolar exemption apply to the upstream development and identification of new drugs that will in turn be subject to respective drug agency approval (experiments which are not intended to supply information for submission to the drug agency, but instead identify the best drug candidate to be subject to future clinical testing under the drug agency procedures)?



In Merck, the U.S. Supreme Court held that the Section 271(e)(1) exemption applies to “[a]ll uses of patented inventions that are reasonably related to the development and submission of any information” to a federal drug regulator. Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005).


15- The United States“This necessarily includes preclinical studies of patented compounds that are appropriate for submission to the [U.S. Food and Drug Administration] in the regulatory process.”The Court stated that “[i]n the vast majority of cases, neither the drugmaker nor its scientists have any way of knowing whether an initially promising candidate will prove successful over a battery of experiments. One cannot know at the outset that a particular compound will be the subject of an eventual application to the FDA.”


15- China / France / Poland

No, but might be covered under the "research exemption" It would most probably not benefit from the Bolar exemption. But, if the study/essay is made for experimental purposes and concerns the subject matter of the invention, it would be exempted under the research use exemption.


15- Germany (UK)The measures taken here do not seem to have any link to the aspired marketing approval of one singular drug. It rather focuses on general research in order to develop and identify new drugs, independent from a possible future application for marketing approval. While this may involve "studies and trials", they are most likely not necessary for obtaining marketing approval with regard to one specific drug.


15- Germany

The Bolar exemption would most likely not apply to the case at hand. However, experiments done for the purpose of developing and identifying new drugs may be covered by the experimental use exemption codified in sect. 11 para. 2 PatG if they relate "to the subject matter of the patented invention".


16-Is the use of patented “research tools”in preclinical experiments exempted (i.e. included in the Bolar provision) from patents relating to technology aimed at discovering new drugs or new drug candidates (e.g. screening or diagnosing methods)?


16- The United StatesU.S. law on this point is unclear, but some case law indicates that the use of research tools may fall within the exemption. The U.S. Supreme Court has not decided the issue. See Merck KGAA v. Integra Lifesciences I, Ltd., 545 U.S. 1893, 205 n. 7 (2005) (“We therefore need not- and do not-express a view about whether, or to what extent, 271(e)(1) exempts from infringement the use of ‘research tools’ in the development of information for the regulatory process.”).


16- The United StatesOther courts, however, have indicated that the exemption may protect the use of patented research tools. For example, in a dissenting opinion, Judge Rader argued that the U.S. Court of Appeals for the Federal Circuit impermissibly applied the exemption to research tools in Integra Lifesciences I, Ltd. v. Merck KGaA, 496 F.3d 1334, 1348 (Fed. Cir. 2007) (Rader, J., dissenting). The majority opinion, however, explicitly stated that research tools were not at issue. 29 noviembre 2010 138


Further, one U.S. federal district court has applied the exemption to research tools. See Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., No. 95 Civ. 8833, 2001 WL 1512597, at *3 (S.D.N.Y. 2001) (finding that “patented intermediaries come within the meaning of Section 271(e)(1)”).


16- China/ France/Poland

No, but might be covered under the "research exemption" . Likely to be exempted on the grounds of experimental use.


16- Germany

The question whether the use of patented research tools is exempted from patents relating to technology is discussed in German legal literature, but not finally clarified by a court decision.


16- Germany (France and UK)The use of research tools in order to do research on new medicines would not be covered by the general experimental use exemption. This exemption covers only experiments related to the subject matter of the patented invention itself (finding out more about the subject matter of the invention. It does not cover situations in which the invention (such as a diagnostic kit) is used to test something else.


16- Germany (UK)

However, in the case at hand, the patented research tool is not the subject matter to be researched. It is merely used to do research on other inventions.Regarding the Bolar provision, the wording of the provision does not make reference to research tools at all. The use of patented research tools in experiments aiming at a marketing approval for new medicines could, thus, be covered by the provision.


16- Germany

However, there are good arguments against such an interpretation of the Bolar provision. It would reduce the value of the patented research toolFurthermore, it is argued that such a broad interpretation of the Bolar provision would lead to a systematic contradiction to the general experimental use exemption


17-Does the exemption extend to research for which a new drug application is not ultimately filed?


17- The United StatesThe U.S. Supreme Court has held that the exemption extends to such research: “Congress did not limit § 271(e)(1)’s safe harbour to the development of information for inclusion in a submission to the FDA; nor did it create an exemption applicable only to the research relevant to filing an [abbreviated new drug application] for approval of a generic drug. ... Properly construed § 271(e)(1) leaves adequate space for experimentation and failure on the road to regulatory approval ....” Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 1893, 206-207 (2005).


17- Belgium/China/France/The Netherlands / U.K.

Yes, although this is not explicitly confirmed, article 6bis, 1 BMA is sufficiently broad to cover such acts ("with a view to the application of paragraphs (…)). Most probably yes, on either grounds (Bolar and experimental use).


17- GermanyThere is no express case law or legal literature on this aspect. The wording of sect. 11 para. 2b PatG, however, appears to exclude such research. If an application is not ultimately filed, the research was not necessary for obtaining marketing approval. Judging by the purpose of sect. 11 para. 2b PatG, however, which enables producers of generic drugs to accelerate their market entry after a patent is expired by allowing them to take all necessary measures for obtaining marketing approval while the patent is still in force, it is likely that the above-mentioned research would be allowed, if they are made for testing the bioequivalence or other adequate preclinical or clinical trials for obtaining marketing approval.


17- GermanyIn order to privilege manufacturers of generic drugs, the success of the ultimate application cannot be the criterion for the admissibility of research. Thus, if obtaining marketing approval was the professed aim of the research and then, "last minute", the project was abandoned, the research cannot constitute retroactively an infringement of patent law. It is therefore possible that a German Court would extent the Bolar exemption to this kind of research, if there was the serious intention of using it for obtaining marketing approval.


18-Is basic scientific research into a particular compound, performed with no intention of developing a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, covered by the Bolar exemption? If not, would it be covered by the experimental use exemption in your country?


18- The United StatesThe U.S. Supreme Court has held that such research is not covered by the statutory exemption: “Basic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, is surely not ‘reasonably related to the development and submission of information’ to the FDA” and therefore not included in the exemption. Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 1893, 205-206 (2005).



The common law experimental use exception would apply only if the potential infringer’s use had no commercial or business motive. U.S. common law recognizes an infringement defense for experimental use of a patented invention. The “[e]xperimental use defense is very narrow and limited to actions performed ‘for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.’” Madey v. Duke Univ., 307 F.3d 1351, 1362 (Fed. Cir. 2002) (quoting Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1349 (Fed. Cir. 2000)).


18- The United StatesUse of a patented invention does not qualify for the experimental use exception if “[i]t is undertaken in the ‘guise of scientific inquiry’ but has ‘definite, cognizable, and not insubstantial commercial purposes.’”“In short, regardless of whether a particular institution or entity is engaged in an endeavour for commercial gain, so long as the act is in furtherance of the alleged infringer’s legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental use defense.”


18- The Netherlands / China / Belgium / France/ U.K.

No, not covered by the Bolar exemption. Such would be covered by the research exception under article 53 paragraph 3 of the Dutch Patents Act.Such research would be covered by article 28, 1 of the of the Belgian Patents Act of 28 March 1984 (the Belgian experimental use exception) following which the rights granted under a patent do not include (among others): (i) acts in a private situation that are not carried out for commercial purposes; and (ii) acts carried out on/with the object of a patented invention, for scientific purposes.


18- Germany

The Bolar exemption expressly covers "studies and trials (…) which are necessary for obtaining marketing approval". Basic scientific research without any intention to obtain marketing approval would most likely not be covered by this wording. If a marketing authorization is not even the intended purpose of the research, it can hardly be necessary to it.


18- Germany

The experimental use exemption according to sect. 9 para. 2 PatG, however, covers all "acts done for experimental purposes relating to the subject matter of the patented invention". Should the basic scientific research thus be related to the subject matter of the "particular compound", it would most likely be covered by the experimental use exemption.


ConclusionesLa Cláusula bolar en España entró en vigor en julio de 2006 y no tiene efectos retroactivosAntes de la entrada en vigor de la Ley 29/2006 la entrega de muestras a las autoridades sanitarias no estaba amparada por la “excepción de uso experimental”El Tribunal Supremo ha venido a interpretar magníficamente el pasado (régimen jurídico anterior a julio de 2006)Nos queda mucho por delante: interpretar la aplicación de la cláusula bolar


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