Ordinance No.1 Jointly Issued by the BPTO and ANVISA on the Grant of Pharmaceutical-related Patents: Is It Good News?

Recently, Joint Ordinance No.1 issued by BPTO and ANVISA, came into effect, after years of tension between the agencies. The authorities decided to settle their differences and reach na agreement for the granting of pharmaceuticalrelated
patents in Brazil.

As we know, article 229-C of the Brazilian Industrial Property Law (LPI), No. 9.279/96, determines that ANVISA must grant prior consent to patent applications for pharmaceutical products. The situation has aggravated because ANVISA, instead of dealing with issues strictly related to health surveillance, also started to analyze IP Law requirements in these patent applications. This created tension with the BPTO, which, in retaliation, decided not to proceed with the analysis of applications analyzed by ANVISA. The situation has become increasingly unsustainable, forcing more and more applicants to seek judicial remedy.

The Ordinance seeks to mitigate these issues, and its main novelty is the change in ANVISA’s analysis, for purposes of prior consent, which will be restricted to the analysis related to public health issues – basically, whether the patent application covers a substance that is prohibited in the country. In the absence of such risk, consent shall be granted by the Agency. The patentability examination, on the other hand, will be at the sole discretion of BPTO.

This will solve at least two problems. The first one is that requirements such novelty, inventive step, sufficiency, among others, will no longer be an obstacle to the granting of ANVISA’s prior consent. Accordingly, the patent application needs to undergo a sole examination by the BPTO. The second one is that BPTO will no longer refuse to examine applications analyzed by the Agency. In short, there will be no more disputes between the agencies.

Although ANVISA is no longer in the position of granting or denying prior consent, it still can issue opinions on IP Law criteria for patent applications whose subject matter is of interest to the SUS – Brazilian Unified Health System. Such opinions will no longer be issued for purposes of consent, but will be considered as aids for the BPTO’s examination of such applications. Thus, ANVISA can no longer prevent the grant of a patent based on patentability requirements, but may try to convince the BPTO to deny a patent application.

The criticism is that, even though the submission of additional information is not something new and is already provided for in our legislation, since any interested party may submit aids to the BPTO, either by agreeing or by disagreeing with the patent application, ANVISA cannot be regarded as an interested party in the examination process of patente applications. That is because the outcome of a patent application should not to be in the Agency’s interest, due to the fact that it is a public entity. In the absence of such interest, ANVISA’s intervention in patent applications is not justified. Let alone the special treatment granted to ANVISA by this agreement, whether stipulating that the BPTO awaits for the entry of the Agency’s technical opinion to start its substantive examination, or compelling the Office to issue a reasoned position in the event of disagreement with ANVISA’s opinion. In this sense, the role played by ANVISA can be a complicating factor in the equation concerning the patentability of drugs of interest to SUS.

Another relevant issue is the fact that the Ordinance also covers those patent applications whose prior consent were previously denied by ANVISA, based solely upon LPI criteria. Those applications are currently in a limbo. It is not clear how the Agency and BPTO will handle such cases. The fact is, according to the new rules, they should be granted prior consent, and their prosecution should be resumed by the BPTO.

Another aspect to be closely followed is the creation of the “Inter-institutional Working Group”, including representatives of BPTO and ANVISA, aiming at providing a wide Exchange of technical information and harmonization of lines of thought”. The reason for concern is ANVISA’s excessively restrictive position – legally groundless – towards some inventions, such as selection inventions, polymorphs, second uses, enantiomers, among others, that, depending on this Group’s performance, may contaminate the BPTO.

In short, if we see the glass as “half empty”, there are negative aspects in the Ordinance, with emphasis on the special treatment granted to ANVISA, when its analysis on IP Law requirements of a given patent application is returned to the BPTO, regardless the fact that no particular patent application should be in the agency’s interest, or when it provides for the creation of an Inter-Institutional Group aiming at the harmonization of positions, since ANVISA has this unjustifiably restrictive position towards the patentability of some inventions.

On the other hand, if we see the same glass as “half full”, it appears that a series of problems caused by ANVISA’ intervention in the analysis of patent applications are being addressed. The LPI requirements will no longer be an obstacle for the grant of prior consent. The BPTO will no longer refuse to carry out the examination
of applications received from ANVISA. Also, applications previously denied by ANVISA, on LPI ground only, will be removed from the limbo. This may bring a bit more speed and efficiency to the procedure for granting those patents.

In any case, it will be key to closely monitor both Agencies’ performance, in order to find out which view will prevail.

However, there is only one effective answer to ANVISA’s intervention in the procedure for granting pharmaceutical-related patents: to convince our legislators to repeal article 229-C of the Industrial Property Law.

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