/ Ruling recognizes “new chemical entities” status for bioequivalentsAugust 31, 2023
Alessandri leads the legal success of a pharmaceutical laboratory before the Council for Transparency, establishing a milestone in the protection of trade secrets and reinforcing the categorization of bioequivalent medicines as “new chemical entities.”
Alessandri provided crucial counsel to a pharmaceutical laboratory in its successful legal battle against the Council for Transparency. The judgment by the Santiago Court of Appeals establishes a significant precedent in safeguarding commercial secrets within the realm of bioequivalent drugs. Moreover, it constitutes a reaffirmation of the confidentiality of the information that pharmaceutical laboratories provide to the Instituto de Salud Pública (ISP). This case holds added significance as it acknowledges these medications as “new chemical entities”, granting them the protection enshrined in both the Transparency Law and the Industrial Property Law.
In due course, the Council for Transparency (CPLT) ordered the Instituto de Salud Pública (ISP) to deliver the studies submitted to said entity by the laboratory, a decision that was challenged through an illegality claim. Upholding the appeal submitted by Alessandri, the Santiago Court established that CPLT’s resolution does not conform to the law, as it violates the laboratory’s economic and commercial rights, to the detriment of trade secrets that are its property in accordance with applicable legislation.