¿El registro sanitario de un producto farmacéutico se configura como una inminente infracción a una patente?Article 52 of Decision 486(1) regulates the exclusion rights of a patent holder. Accordingly, when the patent claims a product, the holder may prevent a third party, without their consent, from manufacturing the product; offering it for sale, selling it, or using it; or importing it for any of these purposes. In the case of a patent claiming a process, the holder may prevent a third party from using the process or performing the aforementioned acts with a product directly obtained through the process.

On the other hand, Article 238 of Decision 486 states that the patent holder may initiate an action for infringement of their Industrial Property rights even in cases where acts indicating an imminent infringement are involved.

In this regard, on May 10, 2021, Bayer Healthcare LLC from Germany filed a complaint for infringement of its Industrial Property rights against Seven Pharma S.A.C. from Peru(2). Bayer, as the holder of patents for the process and product of Sorafenib, stated that the Peruvian company, upon obtaining the sanitary registration for the commercialization of the product SORAFENID, which contains the active compound sorafenib, intended to import, offer for sale, and market sorafenib.

The first administrative instance resolved that the sanitary registration does not per se constitute an infringement of a patent because there is no legal provision that obliges the holder of the sanitary registration to carry out commercialization acts after obtaining the registration(3). Furthermore, the obtaining of a sanitary registration could imply making a generic product available on the market as soon as the patent expires.The Specialized Intellectual Property

Chamber upheld the decision of the first administrative instance(4). Additionally, it stated that the process of registering a trademark that evokes the active ingredient, purchase orders from different public entities that prove the company’s eligibility to contract, and the supplier of the defendant, a company that has been producing sorafenib in India based on compulsory licensing of inventions developed by the complainant, do not collectively imply an imminent infringement.

1 The Decision 486 (Common Regime on Industrial Property) of the Andean Community contains mandatory rules on the protection of industrial property for the member countries of the Andean Community: Peru, Colombia, Ecuador, and Bolivia.
2 Complaint processed in File No. 684-2021/DIN of INDECOPI.
3 Resolution N° 58-2022/CIN-INDECOPI.
4 Resolution N° 0017-2023/TPI-INDECOPI.