Brazil: Brazilian Patent Statute Under Attack: An Overview Of Potential Changes (Part V) – ANVISA's "Prior Approval" On Pharmaceutical Patents

Last Updated: 26 October 2015
Article by Carlos Aboim

There are currently 30+ bills pending before the Brazilian Congress that were drafted for the purpose of amending the Brazilian Patent Statute (Law # 9,279/96)1. The House of Representatives conducted a study that resulted in the proposal of bill 5402 in 2013 ("PL 5402/2013"). The bill, also known as the 'Patent Reform Bill', triggered much debate within the IP community due its provisions on the reform of patent law. One of the controversial provisions in the patent reform bill, would have the effect of strengthening ANVISA's powers to deny pharmaceutical patents in the prior approval examination.

I. Background and current status of ANVISA's prior approval

The requirement of prior approval by ANVISA for pharmaceutical patent applications was created by the Provisional Measure # 2.006, enacted by the Executive Branch of the Government in 2009.This provisional measure, which was later ratified and consolidated by Law # 10.196 of 2001, included the following paragraph "c" to Art. 229 of Law # 9,279/96:

Art. 229-c: The grant of patents on pharmaceutical products or processes shall depend on the prior approval of the National Sanitary Surveillance Agency (ANVISA)."

Since the enactment of Art. 229-c, there has been a conflict between the BPTO and ANVISA with regard to the application of this provision, which was also challenged by a great number of applicants before Federal Courts in respect of the scope of ANVISA's "prior approval". The Brazilian Patent Office maintains that it has exclusive competence to examine patentability requirements, and the great majority of judicial decisions have limited ANVISA's analysis to matters of public health2. However, there has been no decision from the Superior Court of Justice3 or the Supreme Court4 on the issue to date. Despite the overwhelming number of judicial decisions, ANVISA insists on examining patentability requirements arguing that such analysis is important to prevent a negative impact on public health.

II. The proposed new legislation on ANVISA's prior approval

The justification in bill 5402/2013 for the amendment of Art. 229-c is very specific. The aim of the bill is to provide ANVISA with the capacity to deny prior approval for pharmaceutical applications based on the very same analysis of patentability requirements performed by the Brazilian PTO. The bill states that "certain inquiries have been raised about ANVISA`s role in the prior approval exercise"5. It goes on to state that "the strengthening of ANVISA's participation in the process of granting patents will bring social, economic, and technological benefits for Brazil".

The explanation in the bill is that "the participation of ANVISA in the analysis of pharmaceutical patents, besides preventing the grant of numerous invalid patents, already corrected dozens of imprecisions in applications that, in the view of the BPTO, were ready to be granted". Critics say that the bis in idem on the assessment of patentability requirements by two government bodies is designed to establish a control in the prosecution of patents that could harm the interests of the "national industry", which has close ties with the Sanitary Surveillance Agency6.

Therefore, the "patent reform bill" proposes changes to the legal capacity of ANVISA and also in Art. 229-c in the Patent Law:

Law no. 9782/99:

Article 7. [The Sanitary Agency shall implement and enforce the provisions set forth under sections II through VII of Art. 2 of this Law, and the Agency shall:]

XXVIII – participate in the process of examination of patent applications for pharmaceutical products and processes, including the analysis of the patentability requirements and the other criterion set forth under the specific legislation." (Emphasis added)

Patent Act:

"Art. 229-c. The granting of patents for pharmaceutical products and processes shall depend on the prior consent from the National Sanitary Agency – ANVISA, that shall examine the object subject to the patent application in light of public health.

§ 1 – A patent application shall be considered as contrary to public health, according to further regulation, where:

I – the product or pharmaceutical process in the patent application presents a health risk, or

II – the patent application for pharmaceutical product or pharmaceutical process is of interest to an access to medicines policy or to a pharmaceutical care program under the National Health System – SUS, provided that it does not meet the patentability requirements and the other criteria established by this law." (Emphasis added)

§ 2 – Following the prior consent examination and after the decision is published, ANVISA shall return the application to the Patent Office, that shall examine the approved application, and definitively archive the application that has not been approved."

The proposed amendments would provide ANVISA with the power to perform the same analysis of patentability requirements that is assigned by law to the Brazilian PTO. Moreover, such proposal would establish the dominance of ANVISA's analysis of patentability requirements, as the Brazilian Patent Office will be barred from analyzing pharmaceutical application without the "prior approval" of the Sanitary Surveillance Agency. The proposed legislation also leaves room for "further regulation" by ANVISA, creating additional uncertainty for patent applicants.

III. Conclusion

The proposed amendments aim to provide ANVISA with the capacity to analyze patentability requirements despite an overwhelming number of judicial decisions stating that its role in the "prior approval" of pharmaceutical patents is limited to the assessment of potential harm to public health. The patent reform bill also establishes that ANVISA's analysis of patentability requirements will trump the Brazilian PTO's, as the latter will be required to "definitively archive the application that has not been approved".

The participation of ANVISA in patent proceedings under any law can always be challenged before Federal Courts. The grant and issuance of a patent is not discretionary and all administrative acts during prosecution are subject to judicial review. The above described proposal to broaden the scope of ANVISA's role in "prior approval" does not modify the patentability requirements set forth in the patent statute7. At the very least, the intended "prior approval" requirement will create an unnecessary step in the analysis of patentability requirements, wasting already limited public resources. In the worst-case scenario, patent applicants will have to challenge politically biased decisions of the Brazilian FDA before Federal Courts.


1 Please check the previous issues of Prevail in order to find out more information about the bills seeking to amend the Patent Statute. A timeline of all bills is available at
2 "...the prior approval set forth on Art. 229-c of the IP Law must be limited to issues of public health, as only the Patent Office can analyze patentability requirements..." (appeal # 00364288320094013400, Federal Court of Appeals for the First Circuit, published on October 3rd, 2014); " order to conclude that a patent is being unduly granted for failing to meet patentability requirements, we cannot disregard the competence and legal attribution set forth on law for the federal agencies... ...we are not allowed to provide such a broad interpretation to law 9.782/99 [law that created ANVISA] to the point of allowing two agencies to decide contrary to one another on requirements of patentability..." (Appeal # 201202010081961, Federal Court of Appeals for the Second Circuit, decided on December 14, 2012).
3 Court sitting in Brasilia with jurisdiction to review decisions rendered by appellate courts as a matter of law to provide an uniform interpretation of Federal Law in Brazil. The leading case will be an appeal (appeal # REsp 1473970) filed by ANVISA against a favorable appellate court decision rendered for Abbott GMBH. Justice Campbell issued a decision sending the case to the chamber of Private Law (intellectual property) and we filed an internal appeal pointing out that the controversy is not about IP, but jurisdiction of federal agencies for assessment of patentability requirements, which is a matter of Public Law. A decision is still pending.
4 Court sitting in Brasilia with jurisdiction to review decisions rendered by appellate courts as a matter of law that may violate constitutional provisions. There is no appeal before the Supreme Court so far.
5 The expression "certain inquiries" is probably a reference to the overwhelming number of judicial decisions stating that the assessment of patentability requirements extrapolates ANVISA's legal attributions, and that its role in the prosecution of patents must be limited to issues of public health.
6 In an article published in 2011, Mr. Marcos Lobo de Freitas Levy mentions an interview given by the former Intellectual Property Coordinator at ANVISA, Mr. Luis Carlos Wanderley Lima, on the "prior approval" requirement (,MI140425,61044-Pela+manutencao+do+ injustificavel): "At the end of the interview, the interviewee states that without the prior approval requirement there will be less competition and higher prices, because when patents are not granted the field for introduction of generics is open. This claim reveals the real reason for the existence of the prior approval requirement. The fact is that some Brazilian health authorities and some national companies never agreed with the granting of patents for pharmaceuticals."
7 There are other proposed provisions in the "patent reform bill" PL 5402/2013 that may, for instance, raise the standard of inventive step, requiring it to be "significant". This will be the subject of another article about the proposed patent reform.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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