Jesús Cuba Valladares and Kelly Sánchez Albitres, OMC Abogados & Consultores, investigate intellectual property laws surrounding second use patents, looking specifically at the case of Pfizer and the patent “Pyrazolopyrimidine, for the treatment of impotence”.
In May 1994, Pfizer requested, for medical use, the patent named “Pyrazolopyrimidine, for the
treatment of impotence”, better known as Viagra, whose chemical compound the “sildenafil citrate” was already used for the treatment of cardiovascular diseases. The application had been rejected on up to 3 previous occasions by the Office of Inventions and New Technologies of the National Institute for the Defense of Competition and Protection of Intellectual Property (hereinafter INDECOPI) of Peru, by contravening what is stated in Article 16 of Decision 344, and Article 43 of the Legislative Decree No.823, in force at that time, which indicated that the products and processes that are already patented “shall not be the object of a new patent, by the simple fact of a different use from that originally contemplated by the initial patent.
However, in June 1997, the Supreme Decree N° 010-97/ITINCI is enacted, 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). This allowed the Office of Inventions and New Technologies of INDECOPI, through Resolution 050-1999/ISO-INDECOPI of 29 January 1999, to grant the patent for Viagra in favor of Pfizer.
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 complaint 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.
On 12th October 2000, the General Secretariat of the Andean Community interposes ACTION OF NONCOMPLIANCE (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”. The Community law expressly prohibits the patenting of second uses or different uses.
Article 24° of the Treaty creating the Court of Justice of the Andean Community: “If the opinion is of noncompliance, and the Member Country required persists in the conduct subject of the complaint, the General Secretariat shall request the pronouncement of the Court. If the General
Secretariat does not file the action within sixty days following the opinion, the claimant country may appeal directly to the Court”.
PHARMACEUTICALS
After several pressures by enforcement mechanisms of Andeanstandards, 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.
What are the second use patents?
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”
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.
Second use Patents and the Pharmaceutical
Industry
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”
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.
In relation to pharmaceutical patents, the Agreement on TradeRelated Aspects of Intellectual Property Rights (TRIPS), identifies three types of general obligations
• Patenting: Whether products (a drug, for example) or procedure (for instance, the method of production of chemical compounds for a drug), although the concession remains subject to the
exceptions set out in Articles 8, 3019, 3120 TRIPS and 4021;
• Non-discrimination: Commitment imposed to Member States to grant patents regardless of the technological field of the inventions. In other words, if the pharmaceutical inventions satisfy the
requirements for patentability (novelty, inventive step and industrial applicability), they will be protected as the rest of patentable inventions that cover other scientific and technical fields.
Furthermore, discrimination cannot be justified either for the place of origin of the invention or for the fact that the products that composed it are imported or produced in a determinate territory.
• Disclosure: Obligation that addresses the need to ensure that the details of the invention must be contained in the patent application, so they can be disclosed to the public. This duty to disclose the specifications of the product or procedure to patent can even lead to the disclosure of the steps to reproduce the invention. We must also indicate that the TRIPS in Article 27 °, do not encourage or forbid the second use patents, so Member States of the WTO that accept or reject them, are not acting against TRIPS.
«It is practically impossuble to separate the production of a drug for a use for which its patent has alreadyexpired.»
a) Patents, for second use, are prohibited in the Andean Community
and in our country because they represent a condemnation for
technology transfer and access to health. Notably, with such
patents, the aim is to extend an industrial duty on a product or
pharmaceutical procedure that is already part of the state of the
art and which is more like a discovery than an invention itself.
The primacy of Community Law in Viagra case.
The Court of Justice of the Andean Community, through the process 89-AI-2000, annulled the patent that was granted to Pfizer by Resolution No. 000050-1999 / INO-INDECOPI which was achieved through the application of the Art. 4 ° from the Supreme Decree No. 010-97 / ITINC, which textually stated:
«To clarify that in accordance with article 43 of decree 823, a different use comprised in the prior state of the technique will be the subject of a new patent if it meets the requirements stablished in article 22º of Legislative Decree No. 823”.
While it is true that the Member States are empowered to issue legal tools for proper implementation of Decision 344, such tools cannot introduce changes that affect its structure. In the present case the Court found that this article distorted the principles of the Andean Community scheme in contravening the provisions of Article 16 ° of Decision 344, which expressly forbade second use patents. Furthermore, INDECOPI was ignoring the commitments made by Peru with the Andean Community to be underwriter part of a Treaty by failing to take into account the normative range applying a standard lower-level instead of Decision 844 which is just below of our Constitution but not under other laws, so no national standard may contradict its provisions.
a) Patents, for second use, are prohibited in the Andean Community
and in our country because they represent a condemnation for
technology transfer and access to health. Notably, with such
patents, the aim is to extend an industrial duty on a product or
pharmaceutical procedure that is already part of the state of the
art and which is more like a discovery than an invention itself.
Conclusions
a) Patents, for second use, are prohibited in the Andean Community and in our country because they represent a condemnation for technology transfer and access to health. Notably, with such patents, the aim is to extend an industrial duty on a product or pharmaceutical procedure that is already part of the state of the art and which is more like a discovery than an invention itself.
«Member States of the WTO that accept or reject them, are not acting against TRIPS».
b) Currently in Decision 486, valid norm at this date, it has conserved the same position about second use patents, as stated in Article 21:
“Products or processes already patented, included in the prior art, in accordance with Article 16 of this Decision, shall not be the object of a new patent, by the simple fact of a different use from that originally contemplated by the initial patent”.
Likewise, in the Legislative Decree 1075, although there is no express prohibition of second use patents, in contrast with the previous legislative decree 826 which was very specific in article 43,
it states in paragraph a) Article 25:
“It is not considered inventions as follows: Discoveries, scientific theories and mathematical methods. ”
This proves that although the global trend, particularly in developed countries, is to grant second use patent, especially in the pharmaceutical field, the Andean community has stand firm in the defense of its owns interests, without yielding to the pressure of multinational companies and industrialized countries.
Résumés
Jesús Cuba Valladares, Intellectual Property specialist, OMC Abogados & Consultores
Mr. Jesús Cuba is a Lawyer specialized in issues related to the fields of the Patrimonial Civil Law, International Trade Law and also the Intellectual Property. As for his professional career, it is worth mentioning that he was worked in the Directorate of Distinctive Signs of Indecopi, as well as in Sunat and some private sector companies. At OMC Abogados & Consultores he is in charge of carrying out the adequacy of the products and / or services listed in the trademark applications, as well as preparing reports about the status of patents filed in Indecopi.
Kelly Sánchez Albitres, Intellectual Property specialist, OMC Abogados & Consultores
Kelly Sánchez is a graduate lawyer, specialist in Intellectual Property Law. She works in the IP department of the Peruvian Law firm OMC Abogados & Consultores. Currently, her function is to prepare the Trademark and Patent applications that will be submitted before the National Institute for the Defense of Competition and Intellectual Property – INDECOPI, writing Legal Reports, retrievals, procedures before the embassies and the judiciary