Bolar exemption

Spanish translation: exención Bolar

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Bolar exemption
Spanish translation:exención Bolar
Entered by: Xenia Wong

20:54 Apr 29, 2005
English to Spanish translations [PRO]
Medical - Chemistry; Chem Sci/Eng / Chemistry
English term or phrase: Bolar exemption
The company is developing certain biopharmaceuticals, i.e. recombinant proteins as generic compounds, sometimes called "Biosimilars" or "Comparable Biologics". Does your patent law provide for any type of Bolar exemption in the pharmaceutical field?
Walter Vargas
exención Bolar
Explanation:
sug.

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Note added at 2 mins (2005-04-29 20:57:02 GMT)
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http://patentlaw.typepad.com/patent/files/professor_amicus.p...
[PDF/Adobe Acrobat]
... the Traditional Experimental Use Exemption under. Section 271(a). ... response to the Federal Circuit s determination, in Roche. Products v. Bolar Pharm. Co., 733 F.2d 858 (Fed ...
patentlaw.typepad.com/patent/files/professor_amicus.pdf


IPAC Competition / IP Group
[PDF/Adobe Acrobat]
... regulatory review (the. Bolar, exemption). Europe has used the statutory experimental use. exemption. It is the failure ... of the invention\" which is the arm of the exemption that is ...
www.intellectual-property.gov.uk/ipac/pdf/030204comp.pdf


No. 03-1237 I
[PDF/Adobe Acrobat]
... Pre-clinical Drug Research Exemption From ... this exemption was created to overrule its prior. decision, Roc he Pro ducts, Inc. v. Bolar Pharmaceutical Co ...
patentlaw.typepad.com/patent/files/aarp_brief_merck_v.%20Integra.pdf


Para 6 Solution of the Doha Declaration, Article 30 of TRIPS and Non-Prohibition of Exports under the TRIPS ...
... of products without even resorting to any use of exemption under Article 30 of the TRIPS agreement. ... in turn was overruled by Bolar Exemption by introduction of Section 271 ...
www.mindfully.org/WTO/2003/TRIPS-Exports-DayaShaker9feb03a....
Selected response from:

Xenia Wong
Local time: 03:48
Grading comment
Thank you very much
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +2exención Bolar
Xenia Wong
4 +2excepción Bolar
Oso (X)
5exección tipo Bolar
frandela


  

Answers


1 min   confidence: Answerer confidence 5/5 peer agreement (net): +2
bolar exemption
exención Bolar


Explanation:
sug.

--------------------------------------------------
Note added at 2 mins (2005-04-29 20:57:02 GMT)
--------------------------------------------------

http://patentlaw.typepad.com/patent/files/professor_amicus.p...
[PDF/Adobe Acrobat]
... the Traditional Experimental Use Exemption under. Section 271(a). ... response to the Federal Circuit s determination, in Roche. Products v. Bolar Pharm. Co., 733 F.2d 858 (Fed ...
patentlaw.typepad.com/patent/files/professor_amicus.pdf


IPAC Competition / IP Group
[PDF/Adobe Acrobat]
... regulatory review (the. Bolar, exemption). Europe has used the statutory experimental use. exemption. It is the failure ... of the invention\" which is the arm of the exemption that is ...
www.intellectual-property.gov.uk/ipac/pdf/030204comp.pdf


No. 03-1237 I
[PDF/Adobe Acrobat]
... Pre-clinical Drug Research Exemption From ... this exemption was created to overrule its prior. decision, Roc he Pro ducts, Inc. v. Bolar Pharmaceutical Co ...
patentlaw.typepad.com/patent/files/aarp_brief_merck_v.%20Integra.pdf


Para 6 Solution of the Doha Declaration, Article 30 of TRIPS and Non-Prohibition of Exports under the TRIPS ...
... of products without even resorting to any use of exemption under Article 30 of the TRIPS agreement. ... in turn was overruled by Bolar Exemption by introduction of Section 271 ...
www.mindfully.org/WTO/2003/TRIPS-Exports-DayaShaker9feb03a....

Xenia Wong
Local time: 03:48
Native speaker of: Native in SpanishSpanish, Native in EnglishEnglish
PRO pts in category: 4
Grading comment
Thank you very much

Peer comments on this answer (and responses from the answerer)
agree  Gabriela Rodriguez
32 mins
  -> gaby, tnanks lots......xen

agree  *TRANSCRIPT
12 hrs
  -> TRANSCRIPT, many thanks......xen
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9 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
excepción Bolar


Explanation:
Hola Walter,
Otra posibilidad.
Buena suerte y saludos del Oso ¶:^)

"...Estados Unidos admite el uso "experimental" de un procedimiento o producto patentado para obtener el permiso de entrada al mercado, desde que en 1984 el Congreso agregó ***la llamada excepción "Bolar"**** a la legislación nacional sobre patentes. El objetivo era no cumplir con el fallo de un tribunal de justicia que le dio la razón a Roche Products cuando le negaba a Bolar Pharmaceuticals el derecho de fabricar y presentar un producto para conseguir su aprobación de entrada al mercado antes del vencimiento de la patente. El derecho de Estados Unidos no parece prever la producción previa y el almacenamiento, como la legislación canadiense. Sin embargo, ***la excepción Bolar*** indica que los fabricantes deben aumentar proporcionalmente y completar el proceso de fabricación, desde la etapa de desarrollo del producto, hasta tener al menos tres veces el volumen de producción que se requiere a escala comercial.
Pero no hay indicaciones de qué hacer con ese triple volumen comercial de producción. ¿Se destruye o queda en manos de su productor? Y si es así, ¿es almacenamiento? ..."


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Note added at 2005-04-29 21:08:02 (GMT)
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\"...En los Estados Unidos se admite expresamente (35 USC 271.e.1) la fabricación, uso o venta de medicamentos y productos veterinarios biológicos antes del vencimiento de la patente, cuando tal uso está \"razonablemente relacionado\" con el desarrollo y presentación de información para la aprobación de tales productos.
Esta ***excepción se conoce como \"excepción Bolar\"***, en virtud del nombre de la parte que litigó en un caso con Roche Products Inc. en la que se tomó una posición desfavorable a la excepción de experimentación, luego revertida por la Drug Price Competition and Patent Term Restoration Act (1984).
La mencionada norma permite que los competidores puedan introducir al mercado productos sustitutivos del patentado ni bien se produce el vencimiento de la patente, con el objetivo de favorecer el acceso del público a productos más baratos. ...\"

http://www.vi-fema-abf.org.ar/alifar.html


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Note added at 2005-04-29 21:12:22 (GMT)
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\"...The \"Bolar exemption\" is a policy that allows generic manufacturers to prepare production and regulatory procedures before patents expire, so that products can be ready for sale as soon as the patent ends, rather than having to go through the lengthy preparatory process only after the patent period is over. Even though Bolar is a common feature of patent law in many countries (such as Canada and the USA), it does not exist in the EU.

In the EU, the development and testing work required to make an application can only take place after the patent expiry, resulting in delays by around 2 years. More commonly, the development work and first wave of manufacturing is carried out outside the EU, where Bolar-type provisions exist, and the generics are imported shortly after patent expiry. Bolar exemptions are in agreement with WTO rules on trade-related aspects of intellectual property rights (TRIPS), and are included in the Commission\'s proposal for reform. ...\"

http://www.euractiv.com/Article?tcmuri=tcm:31-103658-16&type...

Fun-Fact:

\"Bolar Pharmaceutical Company (Bolar) is a generic drug company that duplicates drugs no longer under patent and sells the compounds to wholesale distributors. ...\"

http://www.law.berkeley.edu/institutes/bclt/courses/fall99/r...




    Reference: http://www.tercermundoeconomico.org.uy/TME-133/tendencias01....
Oso (X)
Native speaker of: Native in SpanishSpanish
PRO pts in category: 88

Peer comments on this answer (and responses from the answerer)
agree  bigedsenior
8 mins
  -> Muchas gracias, bigedsenior ¶:^)

agree  Gabriela Rodriguez
23 mins
  -> ¡Un millón de gracias por tu apoyo, Gaby! ¶:^)
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 5/5
bolar exemption
exección tipo Bolar


Explanation:
Fuera de USA y Canada se conoce como Bolar-type exemption. En la directiva Europea prevista para octubre de 2005 se prevé un exección tipo Bolar.

Directive 2004/27/EC was passed on 31 March 2004 and amends directive 2001/83/EC relating to medicinal products for human use. The provisions introduced so far amend reporting obligations on licence holders, changes to packaging obligations and changes to the reliance on clinical study data in specific circumstances. Unfortunately, the long awaited Bolar-type exemption to patent infringement for generic medicines which is contained in the Directive has not yet been implemented into UK national law. The last date for implementation of the Directive into national legislation is 30 October 2005.





    Reference: http://www.olswang.com/news.asp?page=newssing&sid=112&aid=83...
frandela
Local time: 10:48
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 15
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