Newsletter 02 - May 2019


STF postpones pipeline trial

STF (Brazilian Supreme Federal Court) trial of the Direct Action of Unconstitutionality (ADI) 4234 on the pipeline patents was postponed. Patent pipelines are a mechanism that allows the revalidation in national territory of a patent granted or applied for in another country, provided that certain requirements are met. The ADI was proposed by the Attorney General’s Office (PGR) and questions the constitutionality of articles 230 and 231, integrated in the Brazilian Industrial Property Law (IPL 9.279/96).

According to ABPI’s vice president Gabriel Leonardos, the term patent pipeline does not exist legally. “This is just a nickname for a patent type that mainly protected drug inventions, an area where it is common for companies investing in research to have innovative pharmaceutical products at various stages of development, not yet launched”, he explains.

Leonardos explains that since the 1960s the Brazilian legislation has contained bans on patents in the pharmaceutical, chemical and food areas. That way the Agreement establishing the World Trade Organization (WTO), which came into force in Brazil on January 1st, 1995, obliged the country to grant patents in all technological areas. “The IPL brought these changes, but the delay of one year between its promulgation and its entry into force gave rise to a political negotiation so that, under certain conditions, patents granted abroad for inventions in areas where Patenting was previously prohibited, i.e. in the pharmaceutical, chemical and food areas, could be revalidated in Brazil”, enlightens ABPI’s vice president.

Thus, from May 15, 1996 until May 15, 1997, explains Leonardos, patents already published abroad (and that therefore, in principle, could no longer be protected in Brazil) could exceptionally be revalidated in Brazil for the remaining term of protection, limited to 20 years, provided the product had not yet been launched, that is, provided it was still in the “pipeline” of the company. “The main objective of this IPL rule was to create an industrial policy that would stimulate international pharmaceutical companies to bring their most innovative drugs to Brazil as quickly as possible, giving them, in our country, the guarantee of legal protection through patents”, he says.

The IPL was careful to make two requirements so that a pipeline patent could be revalidated here: (i) the product could not have been placed in any market; and (ii) that no “serious and effective arrangements” for the purpose of exploring the object of the application or the patent had been made by third parties in Brazil. “That is, the novelty in the market as well as eventual acquired rights of third parties were respected”, he adds.

For Leonardos the legal challenge arises as a matter of form, that is, because they are described in patents already published abroad, these inventions were no longer legally new in the definition of the IPL. “Thus, some say that because the requirement of patent novelty is provided under the IPL, it could also create exceptions to it; others seek to extract from the Constitution a tacit or implicit consecration of this requirement, since there is no express reference to it in the constitutional text”, he explains. “This is the controversy that the STF should decide. It is not known, however, whether the issue of substance will be assessed by the STF, because as the last patent pipeline expired in 2017 (20 years after its protocol abroad), it is possible that the Court simply decides that the suit became moot”, he concludes.