{"id":5472,"date":"2016-07-02T19:49:02","date_gmt":"2016-07-03T00:49:02","guid":{"rendered":"https:\/\/omcabogados.com.pe\/?p=5472"},"modified":"2025-08-12T11:11:28","modified_gmt":"2025-08-12T16:11:28","slug":"las-patentes-de-segundo-uso-el-caso-viagra-en-el-peru","status":"publish","type":"post","link":"https:\/\/omcabogados.com.pe\/en\/the-second-use-patents-the-viagra-case-in-peru\/","title":{"rendered":"Second use patents: The Viagra case in Peru"},"content":{"rendered":"
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1. Background: <\/strong><\/p>

En Mayo de 1994, Pfizer solicit\u00f3 para uso m\u00e9dico la patente denominada \u201cPirazolopirimidinona para el tratamiento de la impotencia\u00bb, m\u00e1s conocida como Viagra, cuyo compuesto qu\u00edmico el \u201ccitrato de sildenafil\u201d ya era usado para el tratamiento de enfermedades cardiovasculares. La solicitud hab\u00eda sido rechazada hasta en 3 ocasiones anteriores por la Oficina de Invenciones y Nuevas Tecnolog\u00edas del Instituto Nacional de Defensa de la Competencia y de la Protecci\u00f3n de la Propiedad Intelectual (en adelante INDECOPI) del Per\u00fa, al contravenir lo se\u00f1alado en el Art\u00edculo 16 de la Decisi\u00f3n 344, y el Art\u00edculo 43 del Decreto Legislativo No.823, vigentes en ese momento, los cuales se\u00f1alan que los productos y procedimientos ya patentados \u201cno ser\u00e1n objeto de nueva patente, por el simple hecho de atribuirse un uso distinto al originalmente comprendido por la patente inicial.\u201d<\/p>

However, in June 1997, enacts the Supreme Decree N\u00b0 010-97\/ITINCI, in order to \"clarify and interpret several articles of the Decision 344\", Including Article 16. This Supreme Decree, particularly in Article 4, stipulated that \"a different use included in the prior state of the art will be subject to a new patent if it meets the requirements laid down in Article 22 of Legislative Decree No.823\" (i.e., the traditional requirements of novelty, inventiveness and industrial applicability), thus allowing the Office of Inventions and New Technologies of INDECOPI, through Resolution 050-1999\/ISO-INDECOPI of 29 January 1999, granted the patent for Viagra in favor of Pfizer.<\/p>

Meanwhile, some Peruvian laboratories had been manufacturing a copy of Viagra, thinking that the patent application of Pfizer would be rejected. Pfizer threatened to sue them on the basis of its newly granted patent, this led to file a complain by the Association of Pharmaceutical Industries of National Origin and Capital (ADIFAN), to the General Secretariat of the Andean Community for the violation of article 16 of Decision 344.<\/p>

On 12th October 2000, the General Secretariat of the Andean Community, interposes ACTION OF NON-COMPLIANCE (process 89-AI-2000) before the Court of Justice of the Andean Community, against the Republic of Peru for granting a second use patent for the \"Pyrazolopyrimidine product for the treatment of impotence\", where Community law expressly prohibits the patenting of second uses or different uses.<\/p>

After several pressures by enforcement mechanisms of Andean standards and as a result of this action for breach of the Treaty, the Peruvian Government through its competent agency, INDECOPI, the invention of second use named \" Pyrazolopyrimidine for the treatment of impotence\", registered in favor of Pfizer Research and Development Company N.V.\/S.A., by merit of the resolution 000955-2002\/ONI-INDECOPI issued on 27\/08\/02, was declared null and void by not complying with the requirements of Decision 344.<\/p>

2. What are the second use patents?<\/strong><\/p>

According to Dr. Fernandez Novoa Valladares, \"one of the sectors where the pharmaceutical companies are increasingly focusing their research activities is in the discovery of new therapeutic utilities for compounds already known. The question that arises is what kind of protection can be given to this class of inventions that relate to a compound of which is already known a particular therapeutic activity and that has discovered a new utility does not related with the already known\"[1]<\/span><\/p>

Therefore Patents for second use are due to new uses of products or procedures. It Occurs on several occasions that a patented product or procedure or who simply has a specific use may be attributed other uses under modifications which do not alter the patent or make a new one.<\/p>

3. Second use Patents and the Pharmaceutical Industry<\/strong><\/p>

The exclusivity of a product can be extended further if the patenting of the second uses for a drug already known is allowed. For reasons of industrial production, it is practically impossible to separate the production of a drug for a use for which its patent has already expired from the production of the same product for a second indication, which its patent is still in force. It happens that the exclusivity of the product will be maintained by who invented the molecule<\/p>

This is a sensitive issue in the Patent Lawas and the debate on the patentability of second uses, continues due to the importance of the right to access to health for all people as well as in the treatment of diseases.<\/p>

In relation to pharmaceutical patents, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), identifies three types of general obligations.<\/p>