Should ANVISA be permitted to reject pharmaceutical patent applications in Brazil?

Abstract

Pharmaceutical manufacturers who seek new markets for expansion are particularly attracted to Brazil given its potential for growth and the expectation that it will be the fifth largest drug market by 2015. Given the significance of Brazil in the marketplace, strong patent protection for pharmaceutical products and processes is critical. In April 2013, a new workflow came into effect in Brazil which allows the National Sanitary Vigilance Agency (ANVISA), a government agency whose function is to protect public health, to examine and reject any patent application that claims a pharmaceutical product or process before any examination of the application by the Brazilian Patent Office. If a patent application is rejected by ANVISA, the application is returned to the Brazilian Patent Office and filed away, without any further examination, for an unknown period of time. Therefore, the examination of pharmaceutical product and process applications under this new workflow is problematic for local and global pharmaceutical manufacturers for multiple reasons.

Keywords::

• ANVISA
• Brazil
• pharmaceutical patents
• prior consent
• SUS
• two-tier examination

During the past several years, as the mature markets in the United States and Europe have experienced periods of economic and political uncertainty, pharmaceutical manufacturers have searched for new markets for expansion. Manufacturers have been particularly attracted to Brazil, one of the up-and-coming ‘BRIC' countries (along with Russia, India and China), because of its substantial potential for growth due to its rapidly growing middle-class (known as Class ‘C'), low-national debt, growing population, improved business regulations and the government's expansion of healthcare [1,2]. In 2012, Brazil's retail pharmaceutical market was valued at $26 billion [3]. It is expected that by 2015, Brazil will have the fifth largest drug market in the world [4]. For these reasons, strong patent protection for pharmaceuticals in Brazil, for both small molecules and biologics, is important for local and global pharmaceutical manufacturers.

Brazil has a long and rich patent history. In 1809, Brazil became the fourth country to enact a patent law. In 1882, Brazil became one of the founding members of the Paris Convention, in 1978, it became a member of the Patent Cooperation Treaty (PCT), and in 1995 it became a founding member of the World Trade Organization (WTO). Patent applications are filed and examined by the Brazilian Patent Office which is known as the National Institute of Industrial Property (INPI) and applications may be filed either directly in INPI or as a national phase application pursuant to the PCT.

After the publication of Brazilian Law 10.196 of February 14, 2001, which amended the provisions of the Article 229 of the Brazilian Industrial Property Law #9.279/96 (adding Article 229-C), the examination of patent applications claiming pharmaceutical products or processes has been subject to a two-tier examination process [5]. Pursuant to this amendment, any patent application related to a pharmaceutical product or process became subject to the ‘prior consent' of the 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.' At the time, the justification for the amendment was that review by ANVISA was necessary because INPI's patent examiners lacked the expertise necessary to examine pharmaceutical patent applications because under the previous patent law, pharmaceuticals had been ineligible for patent protection.

Under the workflow, INPI conducted a first examination to determine whether or not an application complied with the patentability requirements under Brazilian Industrial Property Law #9.279/96 (namely, novelty, inventive step, enablement, clarity of the claims, etc.). If the application was found to comply with all the patentability requirements, the application was forwarded to ANVISA for a second examination of compliance with these same patentability requirements. The inclusion of ANVISA in the patent examination process enabled the government to have broad control over the prosecution of pharmaceutical patents in Brazil, thereby allowing it to closely supervise the granting of patents to certain pharmaceutical products that could inhibit the entry of generics into the Brazilian market [6].

As part of its examination, ANVISA determines whether an application contradicts public health and issues a grant or denial of ‘prior consent.' ANVISA denies prior consent for any patent application 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 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. If a pharmaceutical product comprises or a pharmaceutical process results in a substance, the use of which is prohibited in Brazil, then the application is 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 if 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] belong 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

• Dengue Fever

• Hanseniasis

• Schistosomiasis

• Leishmaniasis

• Tuberculosis

• Section 3: Nontransmissible chronic diseases

• Alzheimer

• Antiasthmatic

• Antiparkinsonian

• Antipsychotics/anticonvulsants

• Antirheumatic/antiinflammatory

• 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

In view of the inherent conflict between ANVISA and INPI regarding the review of the patentability requirements of pharmaceutical patent applications, an administrative proceeding (which was driven by INPI), 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 (210/2009) on October 16, 2009, which was subsequently approved by the AG. The opinion held that ANVISA's statutory duty to review pharmaceutical patents 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 opinion, ANVISA, with support from the Ministry of Health and others critical of Brazil's patent system, filed a request for reconsideration with the AGU. On July 1, 2011, the AGU issued Opinion No. 337/PGF/EA/2010, which was subsequently approved by the Attorney General, reaffirming the conclusions stated in Opinion No. 210/2009. Specifically, this 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.

However, ignoring the opinion of the AGO, in April 2013, ANVISA changed the two-tier examination process with the publication of the Resolution RDC 21/2013 which resulted in the implementation of a new workflow in INPI. Specifically, 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 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 an application contradicts public health and issues a grant or denial of prior consent. Patent applications for which prior consent is granted are returned to INPI for further processing and/or examination, whichever is appropriate.

On May 13, 2013, ANVISA published an internal Orientation Guide detailing how pharmaceutical product and process applications are to be 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 examiner. Interestingly, the Orientation Guide clarifies that ANVISA intends to review the patentability of any pharmaceutical application deemed to be strategic to the interests of SUS. In fact, for 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.

In order to handle the implementation of this new workflow, ANVISA hired a number of new examiners. While ANVISA has not officially disclosed the exact number of examiners hired, the number is believed to be 14. Interestingly, some of those hired were former examiners at INPI. Some of these former examiners are experts in the chemical and pharmaceutical area and others are specialists in sanitary vigilance. Currently, ANVISA is in the process of hiring additional examiners; and once hired, these examiners will have to be trained in the patent examination process which could take up to two years.

An applicant receiving a written opinion from ANVISA (either an unfavorable opinion denying prior consent or an Office Action) has 90 days from receipt to submit a reply (according to the 5th Article of Resolution RDC # 21/2013). 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.

An applicant can file an administrative appeal to the Collegiate Board of ANVISA within 60 days of receipt of the opinion denying prior consent. 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 under this new workflow.

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 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 18 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, ANVISA's denial of prior consent has been reversed. 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.

Expert opinion

The examination of pharmaceutical patent applications by ANVISA under the new workflow in Brazil is problematic for several reasons. First, ANVISA simply does not possess the legal competence or expertise to evaluate the patentability requirements of patent applications. Second, this new workflow, like the previous workflow, violates Article 27.1 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement which requires TRIPS members to make patents available for any invention, in all fields of technology, without discrimination. Clearly, the workflow in Brazil discriminates against pharmaceutical patent applications. Therefore, the examination of pharmaceutical patent applications should be left to INPI which is specifically authorized under the Brazilian constitution to review patent applications and has requisite competence and expertise to do so. As held time-after-time by the courts and AGU in Brazil, ANVISA should restrict its review of pharmaceutical patent applications to only health issues and should leave the evaluation of patentability requirements to INPI.

Third, the new workflow allows ANVISA to make the main decisions regarding the patentability of pharmaceutical patent applications, thereby placing INPI in a secondary role, thus hindering INPI's ability to do its own work. Specifically, the early intervention by ANVISA in the examination of pharmaceutical patent applications contributes to the already existing backlog of pending pharmaceutical patent applications by adding another step in the examination process. In fact, after a pharmaceutical patent application is analyzed and accepted by ANVISA, the application is forwarded to INPI for examination which typically takes from six to eight years.

Fourth, with respect to the ‘shelving' of a pharmaceutical patent application without any examination by INPI, several Brazilian patent attorneys believe that an argument can be made that such shelving is illegal and perhaps even unconstitutional [7]. Their argument is that payment of an examination fee to INPI entitles an applicant to have its application examined by INPI. Although an applicant can file an administrative appeal within INPI against a shelving decision, it is likely that such an appeal will ultimately be unsuccessful. In such an instance, an applicant will have no choice but to seek relief through the Brazilian courts, which will most likely hold that ANVISA has exceeded its authority and that Article 229-C is unconstitutional.

Therefore, the only option available for an applicant to deal with ANVISA's intervention in the examination of a patent application is to file a court action in Federal Court to cancel ANVISA's denial of prior consent and compel INPI to complete the examination process and grant the patent if all patentability requirements are met.

The content of this article is intended to provide a general guide to the subject matter. Advice from a specialist should be sought for your specific circumstances.

Declaration of interest

L Mueller is a Patent Attorney and Partner of Michael, Best & Friedrich in Chicago, Illinois. SM Taketsuma Costa is a Patent Attorney with Dannemann Siemsen in Brazil. The authors have no conflict of interest and received no payment in preparation of this article.