its Paragraph IV letter with regard to the XXX and XXX patents.

Spanish translation: su carta del párrafo IV sobre las patentes xxx y xxx

12:01 Feb 4, 2017
English to Spanish translations [PRO]
Law/Patents - Law: Patents, Trademarks, Copyright
English term or phrase: its Paragraph IV letter with regard to the XXX and XXX patents.
Hola a todos,

Por acá tengo un texto en donde hablan de litigios y hablan de un "ANDA ((Abbreviated New Drug Applications) litigation" en donde dicen que una compañía fue el primer "filer" (supongo que se traduce como "solicitante") de la ANDA en relación a un producto X. Luego comentan que:

its Paragraph IV letter with regard to the XXX and XXX patents asserted non-infringement based on its ANDA for sale of XXXX drug.

No estoy segura de la traducción de este enunciado.

Mi intento: el párrafo IV de su carta con relación a las patentes XXX y XXX afirmaba que no se cometía ninguna infracción según su ANDA para la venta de XXX.


Muchas gracias por sus sugerencias.
MendozaK
France
Local time: 12:47
Spanish translation:su carta del párrafo IV sobre las patentes xxx y xxx
Explanation:
Seguramente se puede redactar mejor que lo que propongo, sobre todo, si se tiene el resto del contexto, pero diría que estás interpretando la sintaxis.

Parece una referencia al «Section 505(j)(2)(A)(vii)(IV))» de la Public Law 98-417. Seguramente esa carta es una certificación o algún tipo de documento referido a la certificación. Lo mejor es que busques la ley y te leas que dice el ordinal cuarto. Por «párrafo» podrías usar otro término más español, pero parece que se usa bastante como abreviación de ese apartado de la ley (por ejemplo, en este dominio: http://www.paragraphfour.com/explained/process.html).


When a company is ready to file its ANDA, the Act requires it to declare how its activities when it begins to market the drug will relate to patents listed in the Orange Book; there are four options or "certifications": it can state that there never were patents listed, or that listed patents have expired, or that it will not market the drug until the all the patents listed in the Orange Book have expired, or that it believes the patents in the Orange Book are not relevant or are invalid. These 4 alternative statements are referred to as the Paragraph I, II, III, and IV certifications (named after Section 505(j)(2)(A)(vii)(IV)). [2] The Act incentivized companies to file paragraph IV certifications by rewarding the first company to file an ANDA with such a certification with 180 days of administrative exclusivity if their ANDA is approved - during that period the FDA cannot approve another generic.[3] Because the Act also made it clear that the act of filing an ANDA with a paragraph IV certification was an act of patent infringement, the law actually promotes litigation between private parties; the innovator is prompted to commence patent enforcement litigation against the generic infringer, and the generic company is incentivized to file a countersuits to have the patents listed in the Orange Book be declared invalid.[3]
https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Pat...

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Note added at 4 horas (2017-02-04 16:38:51 GMT)
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«interpretando mal la sintaxis», quería decir.
Selected response from:

Javier Sancho Durán
Spain
Local time: 12:47
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4su carta del párrafo IV sobre las patentes xxx y xxx
Javier Sancho Durán


  

Answers


4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
its paragraph iv letter with regard to the xxx and xxx patents.
su carta del párrafo IV sobre las patentes xxx y xxx


Explanation:
Seguramente se puede redactar mejor que lo que propongo, sobre todo, si se tiene el resto del contexto, pero diría que estás interpretando la sintaxis.

Parece una referencia al «Section 505(j)(2)(A)(vii)(IV))» de la Public Law 98-417. Seguramente esa carta es una certificación o algún tipo de documento referido a la certificación. Lo mejor es que busques la ley y te leas que dice el ordinal cuarto. Por «párrafo» podrías usar otro término más español, pero parece que se usa bastante como abreviación de ese apartado de la ley (por ejemplo, en este dominio: http://www.paragraphfour.com/explained/process.html).


When a company is ready to file its ANDA, the Act requires it to declare how its activities when it begins to market the drug will relate to patents listed in the Orange Book; there are four options or "certifications": it can state that there never were patents listed, or that listed patents have expired, or that it will not market the drug until the all the patents listed in the Orange Book have expired, or that it believes the patents in the Orange Book are not relevant or are invalid. These 4 alternative statements are referred to as the Paragraph I, II, III, and IV certifications (named after Section 505(j)(2)(A)(vii)(IV)). [2] The Act incentivized companies to file paragraph IV certifications by rewarding the first company to file an ANDA with such a certification with 180 days of administrative exclusivity if their ANDA is approved - during that period the FDA cannot approve another generic.[3] Because the Act also made it clear that the act of filing an ANDA with a paragraph IV certification was an act of patent infringement, the law actually promotes litigation between private parties; the innovator is prompted to commence patent enforcement litigation against the generic infringer, and the generic company is incentivized to file a countersuits to have the patents listed in the Orange Book be declared invalid.[3]
https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Pat...

--------------------------------------------------
Note added at 4 horas (2017-02-04 16:38:51 GMT)
--------------------------------------------------

«interpretando mal la sintaxis», quería decir.


    https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act
Javier Sancho Durán
Spain
Local time: 12:47
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 8
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