Recent Brazilian Jurisprudence Concerning the Scope of ANVISA’s Prior Consent

Article 229 of the Brazilian Industrial Property Law #9.279/96 was amended with the publication of Brazilian Law 10.196 on February 14, 2001, to add Section 229-C which provides that “The grant of patents for pharmaceutical products and processes shall depend upon the prior consent from the National Sanitary Vigilance Agency.” Thus, as a result of the addition of this provision, any patent application related to a pharmaceutical product or process became subject to the “prior consent” of the National Sanitary Vigilance Agency (ANVISA), whose mandate is to protect the public by preventing “the production and commercialization of products and services that are potentially harmful to human health.” Therefore, in effect, Section 229-C provides for a two-tier examination process for pharmaceutical products and processes in Brazil.

In view of the inherent conflict between ANVISA and the Brazilian Patent Office {the National Institute of Industrial Property (INPI)} regarding the review of the patentability requirements (namely, novelty, inventive step, enablement of the claims, clarity, etc.) of patent applications directed to pharmaceutical products and processes, an administrative proceeding was conducted before the Attorney General’s Office (AGU) on July 22, 2008. The result of the proceeding was the issuance of Opinion No. 210/PGF/AE/2009 on October 16, 2009 (Federal Opinion), which was subsequently approved by the Attorney General. The Federal Opinion held that ANVISA’s statutory duty to review pharmaceutical patent applications for prior consent should be limited to the examination of issues closely related to its institutional purposes, namely, issues related to public health. Unhappy with the Federal Opinion, ANVISA filed a request for reconsideration with the AGU. On July 1, 2011, the AGU issued Opinion No. 337/PGF/EA/2010 (Second Opinion), which was subsequently approved by the Attorney General, reaffirming the conclusions stated in the Federal Opinion. Specifically, the Second Opinion ratified that ANVISA was required to limit its examination of patent applications only to issues of public health for purposes of granting or denying prior consent.

On August 19, 2013, a civil pro-ANVISA action was brought by a Federal Public Prosecutor in Brazil seeking to:

(1) declare null and void the Federal Opinion;

(2) declare and recognize the legal authority of ANVISA to analyze the patentability requirements for pharmaceutical product and process patent applications; and

(3) declare the full applicability of the provisions of Article 229-C concerning ANVISA’s granting of prior consent.

A preliminary injunction request was also sought to immediately declare null and void the Federal Opinion until a decision on the merits was issued. The trial judge denied this request and an appeal was made to the Federal Circuit. The Circuit court decided not to rule on this appeal until a final decision on the merits was issued by the lower court.

A decision by the trial judge was issued on September 12, 2013, summarily dismissing the claims of the Federal Public Prosecutor. Essentially, the judge held that it did not make sense to assign to ANVISA, the institutional purpose of which is to protect the health of the population, the additional role of reviewing the patentability requirements of pharmaceutical product and process applications for which INPI was charged with the same responsibility. The judge concluded that a fair interpretation of the law was to avoid this sort of “double” patentability analysis.

It is expected that ANVISA will appeal the trial judge’s decision to the Federal Court of Appeals. Please watch the BRIC Wall for future updates on any such appeal.

This post was written by Lisa Mueller and Gustavo de Freitas Morais of Danneman Siemsen.

Examination of Pharmaceutical Patent Applications by ANVISA in Brazil

The publication in April 2013 of Brazil Resolution RDC 21/2013 resulted in the implementation of a new workflow in the Brazilian Patent and Trademark Office (INPI). Specifically, patent applications claiming pharmaceutical products or processes pending as of December 15, 1999, or filed after this date, are forwarded, after a request for examination is filed, from INPI directly to the National Agency of Sanitary Surveillance (ANVISA) for examination based on public health issues. Such examination is conducted by Examiners in ANVISA’s Intellectual Property Division. As a result of its examination, ANVISA determines whether or not an application contradicts public health and issues a grant or denial of “prior consent” to the application. Patent applications for which “prior consent” is granted are returned to INPI for further processing and/or examination, whichever is appropriate.

ANVISA will deny “prior consent” for any patent applications considered to be contrary to public health. A patent application is considered to be contrary to public health when the pharmaceutical product or process disclosed in the patent application (1) presents a health risk (namely, the application claims a substance the use of which use has been prohibited in Brazil); or (2) is directed to a pharmaceutical product or process that is of interest to the policies of medicines or pharmaceutical care in the Brazilian Universal Healthcare System (SUS) and does not comply with the patentability requirements under Brazilian Law #9.279/96 (such as novelty, inventive step, enablement, clarity of the claims, etc.). If a pharmaceutical product comprises or a pharmaceutical process results in a substance the use of which is prohibited in Brazil, then the application will be deemed to present a health risk.

Patent applications directed to pharmaceutical product or processes are considered to be of interest to the policies of medicines or pharmaceutical care of the SUS when they comprise or result in a substance that (1) is listed in the Ordinances of the Brazilian Ministry of Heath or any updates thereof that define a strategic product of the SUS; and (2) belongs to a therapeutic categories listed in Ordinance 1284/2010 or any updates thereof. The therapeutic categories listed in Ordinance 1284/2010 are provided below:

Section 1: Antiviral / antiretroviral

Section 2: Neglected Diseases

–          Malaria

–          Chagas disease

–          Leishmaniasis

–          Tuberculosis

Section 3:  Non-transmissible chronic diseases

–          Alzheimers

–          Antiasthmatic

–          Antiparkinsonian

–          Antipsychotics / anticonvulsants

–          Antirheumatic / anti-inflammatory

–          Immunosuppressants

–          Osteoporosis

–          Pulmonary arterial hypertension

–          Others

Section 4:  Products obtained through Biologic pathways

–          Monoclonal antibodies

–          Enzymes

–          Hormones

–          Proteins

Section 5:  Vaccines and Hemoderivatives

Section 6: Drugs for Treating Accidents and Incidents related to nuclear accidences

An Applicant receiving a written opinion from ANVISA (either an unfavorable opinion denying prior consent or an Office Action) has ninety days from receipt to submit a reply. If an Applicant chooses not to submit a reply, ANVISA will deny prior consent for the application. All written opinions reporting the conclusion of ANVISA’s analysis regarding prior consent (both granting and denial) are published in the Brazilian Official Gazette.

If prior consent of an application is denied, an Applicant can file an administrative appeal to the Collegiate Board of ANVISA within sixty days of receipt of the opinion. In the event the appeal is unsuccessful, the denial of prior consent will be ratified by ANVISA. After ratification of the denial, the application will be sent back to INPI. At this point, INPI will essentially “shelve” the application for an unknown period of time. Presently, no patent application for which prior consent has been denied has been shelved by INPI.

Several Brazilian patent attorneys have expressed their opinion that they believe the “shelving” of a patent application without any examination by INPI is illegal and perhaps even unconstitutional. Their argument is that by paying an examination fee to INPI, an Applicant has the right to have its application examined by INPI (which is specifically authorized under the Brazilian constitution to review patent applications).

In the event an application is “shelved” by INPI, an Applicant can file an administrative appeal. The prosecution and judgment of administrative appeals within INPI is handled by its President, as represented by a Board of Examiners. If the appeal is rejected, the only remaining option available to an Applicant is to file a lawsuit in a Brazilian Federal Court against ANVISA’s intervention in the substantive examination of the pharmaceutical patent application and INPI’s refusal to examine the application.

Approximately eighteen lawsuits have been filed against ANVISA in connection with its denial of prior consent under the previous workflow (where applications were first examined by INPI and then sent to ANVISA for examination based on public health issues). In a majority of these lawsuits, the court has reversed ANVISA’s denial of prior consent. In these cases, the court has held that ANVISA must restrict its review of an Applicant’s patent application to truly health issues, meaning that if INPI approved a patent application directed to a pharmaceutical product or process then a patent should be granted.

On May 13, 2013, ANVISA published an internal Orientation Guide detailing how pharmaceutical product and process patent applications are screened by its Examiners. According to the Orientation Guide, a patent application falling within any of the therapeutic categories in Ordinance 1284/2010 will be subject to substantive examination on the merits by an ANVISA patent Examiner. Interestingly, the Orientation Guide clarifies that ANVISA intends to review the patentability of any pharmaceutical patent application deemed to be strategic to the interests of SUS. In fact, for patent applications where ANVISA has denied prior consent, such applications have been considered to be strategic to the interests of SUS as falling under the therapeutic categories in Ordinance 1284/2010. Generally, in instances where ANVISA has denied prior consent, such unfavorable decisions have found the claims to lack novelty and/or inventive step.

The Brazilian Official Gazette published on May 24, 2013, reported that ANVISA had granted prior consent in sixty six patent applications. Of these applications, thirty eight were analyzed without any prior formal examination by INPI. Fifty six of these applications were granted prior consent because ANVISA determined that these applications did not present a health risk or were not of interest under SUS’s policies. For the remaining ten applications, ANVISA granted prior consent for the applications even though the applications were deemed to be of interest under SUS’s policies. Additionally, these applications were found to comply with the patentability requirements under Brazilian patent law. It will be interesting in future editions of the Brazilian Official Gazette to see the types of applications for which ANVISA denies prior consent. Please watch the BRIC Wall for future posts on ANVISA’s granting and denial of prior consent for patent applications.

Thanks to the Dannemann Siemsen firm for providing their assistance in reviewing this post and providing their insights to the BRIC Wall regarding ANVISA’s granting of prior consent under the new workflow in Brazil.