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Back in 2001, new articles were inserted into the Brazilian Industrial Property Law (Law n° 9.279 / 96 – IPL), among them Article 229-C, which established that the granting of patents for pharmaceutical products and processes depended upon prior consent from ANVISA [Brazilian Health Surveillance Agency].

From 2001 to 2012, the Brazilian PTO initially analyzed the patentability of patent applications and, after concluding that the subject-matter analyzed was patentable, applications related to pharmaceutical products and processes were sent to ANVISA for a second patentability analysis. ANVISA then decided on whether to consent to the patent application. When there was agreement between ANVISA and the BPTO, the application would return to the BPTO, and its status would change to “allowed”. In the case of disagreement between the institutions, when ANVISA did not provide consent, the application would be returned to the BPTO and, in practice, it was not re-examined nor allowed by the BPTO.

In 2009 and 2011, the Brazilian Federal Attorney General (AGU) issued opinions confirming that the examination of patent applications concerning patentability was not the role of ANVISA, and that ANVISA should proceed exclusively with public health analysis. However, if the subject-matter of the analyzed patent application could be used in at least one therapeutic destination related to the Unified Health System (SUS), said application could be analyzed for patentability by ANVISA.

In 2012, the BPTO changed the procedure for forwarding applications to ANVISA, and applications related to pharmaceutical products and processes were first sent to ANVISA. In cases where ANVISA provided consent, the application would have its merit analyzed by the BPTO and, if ANVISA denied prior consent, it would be removed from the active records by the BPTO.

Considering that there was still double patentability analysis being conducted in some situations, it began to generate much discussion and controversy, as ANVISA and the BPTO often have different technical opinions on the same subject-matter.

In order to pacify these procedures, Joint Ordinance No. 1 was published on April 12, 2017, which establishes the following main points:

• ANVISA’s prior consent is still required, in accordance with Law No. 9,279 (Article 229-C of IPL);
• After the formal examination carried out by the BPTO and the request for examination, the application will be sent to ANVISA;
• ANVISA will analyze applications in the light of public health. Applications comprising a pharmaceutical product or process that present a health risk resulting from a substance whose use has been prohibited in the country will be considered contrary to public health. If ANVISA denies consent, the application will be forwarded to the BPTO for definitive removal from the active records;
• In the case of patent applications containing a pharmaceutical product or process of interest to the Unified Health System (SUS), ANVISA may issue an opinion, with patentability analysis, which will serve only as information for aiding the technical examination to be carried out by the BPTO. The BPTO may use its discretion for accepting ANVISA’s opinion in its analysis but is not required to do so.

In the other cases that do not present a health risk to public health nor being interest to the Unified Health System (SUS), ANVISA will automatically prior consent the cases and they will be returned to the INPI to begin the patentability examination.

An important provision of this new Ordinance is that these same principles will be applied to applications that had the administrative instance closed at ANVISA. That is, patent applications, which were previously denied consent, will now be analyzed by the BPTO, taking into account ANVISA’s opinion on patentability as information for aiding the technical examination.

With the publication of Joint Ordinance No. 1, in principle, there will no longer be in Brazil the “double examination” for patent applications related to pharmaceutical products and processes, as it has occurred from 2001 until present. This ordinance will take effect in 60 days.

This new procedure is expected to contribute significantly to reducing the number of pending patent applications (backlog) related to the pharmaceutical field.

For further information, please feel free to contact us at diblasi@diblasi.com.br.

See bilingual PDF: Newsletter – Portaria ANVISA INPI



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