Historic on ANVISA/BRPTO double tier examination in Brazil

 

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was executed in 1994 as a result of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT). Among several other topics, such Agreement ruled the inclusion of several technological fields as patentable statutory matter in countries that previously did not recognized the same; one remarkable example was the pharmaceutical patents in Brazil.

Brazilian Law 10.196 dated February 14, 2001 modified Law 9.279/96 (Brazilian IP Law) including a provision that establishes that the allowance of pharmaceutical patents requires the prior consent from ANVISA (Brazilian Health Surveillance Agency – equivalent to American FDA) along with the usual examination performed by the Brazilian Patent Office (BRPTO).

Although the BRPTO and most experts claimed that ANVISA’s analysis should be limited and focused on a “health risk” analysis, ANVISA has been always analyzing patentability requirements in addition to the analysis on what is contrary/unsafe to health (the so-called “health risk” analysis).This led to a double tier examination procedure, in which both autarchies analyze the patentability requirements of the same patent application. In view of that, both federal authorities has been in a dispute since then for the role of examining patents.

At the first moment, the applications were analyzed by the BRPTO and if such autarchy understood that the application complied with the patentability requirements, the case was sent to ANVISA for the prior consent analysis, i.e. to a re-examination of the same patentability requirements.

In case of conflicting results, (i.e. the BRPTO considered the case as patentable and ANVISA disagreed), filing Lawsuits against ANVISA’s decisions was the only available option to get the case granted.

In 2012, a new workflow for the examination of the pharmaceutical patents was established by Ordinance 1065 of May 25, 2012 developed by a Working Group formed by several Brazilian Ministries. Such workflow is in force until today and defines that a pharmaceutical application should be sent to ANVISA for prior consent before being examined by the BRPTO and, in case ANVISA denies the prior consent, this application should be returned to the BRPTO in order to be shelved, something that in practice never happened.

Inconsistencies between the patentability analysis of BRPTO and ANVISA

As mentioned above, not always the result of the double tier examination handled by ANVISA and by the BRPTO lead to the same result.

In this sense, it should be pointed out that the criteria for approving patents under ANVISA was never clear to the applicants nor to the BRPTO since ANVISA has never published examination Guidelines.

In fact, according to RDC 21/2013, rule that guided ANVISA’s analysis during these years, not all pharma patent applications should be examined. Prior consent should be denied to:

  • applications disclosing a pharmaceutical product/process which involves a health risk; and
  • applications disclosing a pharmaceutical product/process of interest to the policies of the Brazilian public health care system (so called SUS), and that does not meet with the patentability requirements and other criteria established by Brazilian Law # 9.279/96

As per the rule above, it is clear that ANVISA usually analyzes the patentability criteria based on the called “public health interest”, i.e., “of interest of SUS”.

In this sense, it is important to point out that Brazilian Constitution of 1988 stablishes that it is mandatory for the Brazilian Government to provide free medicine to population, which, according to several experts, explains ANVISA’s analysis.

On January 13, 2016 the BRPTO made a statement in a Lawsuit that Abbvie INC filed against ANVISA (in which Abbvie questions ANVISA’s role to analyze patentability requirements related to KALETRA®) which seems to be the clearest and strongest assertion ever made by the BRPTO against ANVISA. Some of the most relevant BRPTO’s assertions, were:

  • that the BRPTO feels discredited by ANVISA’s patentability analysis;
  • ​that there are no legal basis assigning to ANVISA the responsibility of analyzing the patentability requirements;
  • that ANVISA itself issued a Resolution assigning such responsibility when there is an IP Law stating that such responsibility is of the BRPTO, thus contravening the Principle of Legality;
  • that in case the BRPTO is obliged to publish the definitive shelving of a patent application in consequence of an ANVISA’s decision of denying the prior consent, such procedure would not allow the submission of an appeal (since the BRPTO would not be entitled to review ANVISA’s Technical Report) and, thus, this would contravene Brazilian IP Law

Recent legal decisions

In 2015, the ABBVIE INC. filed a Lawsuit requesting a preliminary injunction to withdraw ANVISA’s decision of denying the prior consent of patent applications PI0609173-3 and BR122012002864-9 which refer to KALETRA® as indicated above.

The company argued that ANVISA does not have the right of analyzing patentability requirements and the prior consent must be restricted solely to aspects related to public health, for instance, if the subject matter of the application refers to a substance prohibited in Brazil. As indicated above, the BRPTO applied for his entry as an interested third party and file an amicus curiae brief defending that BRPTO is the only autarchy authorized to evaluate patentability criteria.

Federal judge Márcia Nunes rejected the arguments of the Plaintiff and denied the preliminary injunction. The Plaintiff file an interlocutory appeal requesting an advance relief, which was granted by the Superior Court Judge. However, this decision was shortly thereafter reverted and the final decision of the subsequent appeal is pending.

Still on this matter, in later 2016, ABBVIE BIOTECHNOLOGY LTD. filed a similar Lawsuit requesting a preliminary injunction to annul the ANVISA’s decision of denying the prior consent of applications BR1120130116994, PI0920027-4 and PI0716762-8 that covers HUMIRA®.

The company filed identical arguments in this case, and Federal Judge Caroline Somensom granted the injunction and compelled ANVISA to grant the prior consent of said applications and send the files back to the BRPTO for examination.

Although in some cases the decision is unfavorable to the Plaintiff, the jurisprudence is far favorable for decisions annulling the denial of prior consent of ANVISA. The judges who are favorable to ANVISA’s interference in the double tier examination of patentability requirements seem to be a minority.

The opinion of the Union's Attorney General (AGU)  

In March 27, 2015, an opinion of the Federal Attorney General's Office (0006/2015- AGU/PGF/PFE/INPI/COOPI-LBC-1.0) was approved by the chief prosecutor. Said opinion established the BRPTO’s procedure over applications that were submitted to ANVISA’s prior consent analysis. In this sense, the scenarios are the following:

i) If ANVISA denies the prior consent based on patentability criteria, the BRPTO should consider the ANVISA’s opinion as  third parties’ observation and BRPTO’s examiners may or may not take into consideration the content thereof;

ii) If ANVISA denies the prior consent based solely in public health criteria, the BRPTO should definitively shelve the application

It is important to highlight that the above mentioned Federal Attorney General's Office opinion was clear in indicating that these procedures are valid for applications of both flows, i.e., applications that are examined by the BRPTO before the ANVISA stage (previous workflow) and applications that will be examined by the BRPTO after the ANVISA stage (new workflow).

In view of said document, the BRPTO issued (on April 20, 2016) the memorandum MEMO/INPI/DIRPA/Nº 055/2016 that ratifies the understanding of the Federal Attorney General's Office opinion, however it would be applied only to applications classified as being in the previous flow.

Despite the above, so far the BRPTO did not change its practice, and the applications for which ANVISA evaluated patentability requirements (denying or not the prior consent) are in a limbo state, i.e., the BRPTO is keeping then in standby.

Recent developments

Faced with the impasse that emerged from differences in the understanding of the attributions of each of the government agency, the BRPTO and ANVISA finally reached an agreement whose terms were defined by Joint Ordinance 01/2017 (April 12, 2017). Said ordinance defined the responsibilities of each entity in the examination of pharmaceutical patent applications.

As announced, the new workflow would determine that ANVISA will be responsible for the analysis of aspects related to public health and, then, the BRPTO would evaluate patentability criteria. The denial of ANVISA’s prior approval should be issued only when pharmaceutical product comprises, or the pharmaceutical process results in, a substance whose use has been prohibited in Brazil. In this case, the application will return to BRPTO to be definitively shelved.

Patent applications containing a pharmaceutical product or process considered to be of interest of SUS may have the patentability criteria analyzed by ANVISA, however, the opinion issued by said agency will be considered as third party observations for the BRPTO examination.

In view of the above, this impasse between ANVISA and BRPTO seems to have ended by definitively defining the role of each autarchy. The Brazilian patent community is closely following the developments of this Joint Ordinance 01/2017.

 

 

Breno Souza

Consultant. ​Clarke, Modet & Cº Brazil

 

Luisa Rezende Castro

Global Account Manager. ​Clarke, Modet & Cº Brazil

 

Silvia Costa

Consultant. ​Clarke, Modet & Cº Brazil