Facts
Background
Decision
Comment
In May 1994, Pfizer filed, for medical use, a patent named "Pyrazolopyrimidine, for the treatment of impotence", better known as "Viagra", whose chemical compound sildenafil citrate was already used for the treatment of cardiovascular diseases. The application had been rejected on up to three previous occasions by the Office of Inventions and New Technologies of the National Institute for the Defence of Competition and Protection of Intellectual Property (Indecopi) on the grounds that it contravened article 16 of Decision 344 and article 43 of Legislative Decree No. 823, in force at that time. These provisions indicate that products and processes which 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".
In June 1997, a decree was enacted to "clarify and interpret several articles of the Decision 344", including article 16.(1) Article 4 of the decree 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" (ie, the traditional requirements of novelty, inventiveness and industrial applicability). On 29 January 1999, the Indecopi Office of Inventions and New Technologies granted the patent for Viagra in favour of Pfizer.(2)
Meanwhile, some Peruvian laboratories had been manufacturing a copy of Viagra, thinking that Pfizer's patent application would be rejected. Pfizer threatened to sue them on the basis of its newly granted patent. This led to the Association of Pharmaceutical Industries of National Origin and Capital filing a complaint to the General Secretariat of the Andean Community on the grounds that the patent violated article 16 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 relate with the already known.
Therefore, patents for second use cover new uses of products or procedures. It often happens that other uses may be attributed to a patented product or procedure that do not alter the patent or make a new one.
Second use patents and pharmaceutical industry
The exclusivity of a product can be extended further if the patenting of the second use for an already known drug is allowed. 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, the patent for which is still in force. The exclusivity of the product will be maintained by the entity that invented the molecule.
This is a sensitive issue in patent law, and the debate on the patentability of second uses continues due to the importance of the right to access health for all people. In relation to pharmaceutical patents, the Agreement on Trade Related Aspects of Intellectual Property Rights (the TRIPS agreement) identifies three general obligations:
- patenting – of both products (eg, a drug) and procedures (eg, a method of production of chemical compounds for a drug), although the concession of such patents remains subject to the exceptions set out in articles 8, 3019, 3120 and 4021 of the TRIPS agreement;
- non-discrimination – a commitment is imposed on member states to grant patents regardless of the technological field of the inventions. In other words, if pharmaceutical inventions satisfy the requirements for patentability (ie, novelty, inventive step and industrial applicability), they will be protected in the same way as 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 of which it comprises are imported or produced in a determinate territory; and
- disclosure – this obligation addresses the need to ensure that the details of the invention are 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.
Article 27 of the TRIPS agreement neither encourages nor prohibits second use patents, so member states of the World Trade Organization that accept or reject them are not contravening the TRIPS agreement.
On 12 October 2000, the General Secretariat of the Andean Community interposed an action of non-compliance(3) before the Court of Justice of the Andean Community against the Republic of Peru for granting a second use patent for Viagra. Andean Community law expressly prohibits the patenting of second uses or different uses.(4)
On 27 August 2002, after pressure from the enforcement mechanisms of Andean standards, the Peruvian government declared the second use patent for Viagra null and void on the ground that it did not comply with the requirements of Decision 344.(5)
While it is true that 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 the article introduced by the decree distorted the principles of the Andean Community scheme in contravening article 16 of Decision 344, which expressly forbade second use patents. Furthermore, Indecopi had ignored the commitments made by Peru to the Andean Community by applying a lower level standard instead of Decision 844. Decision 844 has a status that is just below that of the Peruvian Constitution, but above all other Peruvian laws, so no national standard may contradict its provisions.
Second use patents are prohibited in the Andean Community and in Peru because they could negatively affect 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.
Decision 486, the current law in place, has conserved the 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 Legislative Decree 1075, although there is no express prohibition of second use patents – in contrast with the previous legislative decree, No. 826, which was very specific in its article 43 – article 25(a) states that "discoveries, scientific theories and mathematical methods" are not considered as inventions.
This proves that although the global trend, particularly in developed countries, is to grant second use patents, especially in the pharmaceutical field, the Andean Community has stood firm in the defence of its own interests, without yielding to the pressure of multinational companies and industrialised countries.
For further information on this topic please contact Kelly Sánchez at OMC Abogados & Consultores by telephone (+51 1 628 1238) or email ([email protected]). The OMC Abogados & Consultores website can be accessed at omcabogados.com.pe.
Endnotes
(1) Supreme Decree No. 010- 97/ITINCI.
(2) Resolution 050-1999/ISO-INDECOPI.
(4) Article 24 of the Treaty creating the Court of Justice of the Andean Community states as follows:
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.