Untangling the pharma patent puzzle

27-09-2017

Renata Campello Afonso

Untangling the pharma patent puzzle

luchschen / iStockphoto.com

It is too soon to say what impact the new rules for examining pharmaceutical patents in Brazil will have, but there are some early clues, says Renata Campello Afonso of Luiz Leonardos & Advogados.

When it comes to patent protection in Brazil, it is fair to say that the pharmaceutical industry has faced more challenges than any other sector. During the past four decades, it has been necessary to overcome several obstacles, including the prohibition of patents in the pharmaceutical area and the conflict between the Brazilian Patent and Trademark Office (INPI) and the Brazilian Health Regulatory Agency (ANVISA), the entity corresponding to the US Food and Drug Administration.

For more than 20 years, pharmaceutical substances could not be patented in Brazil. Due to governmental policies for developing the domestic industry, our former Industrial Property Code No. 5,772 of 1971 specifically excluded from patent protection chemical-pharmaceutical substances of any kind as well as the processes for obtaining or modifying them (article 9[c]).  

At that time, the technological and economic scenario for the pharmaceutical industry in Brazil was not promising. On the one hand, the local industry was completely technologically dependent on multinational companies and, on the other hand, the non-patentability of pharmaceutical substances and their related manufacturing processes discouraged any investments by these foreign companies in the country, resulting in poor technological and economic development in this technical field.  

This scenario began to change with the implementation of the TRIPS Agreement into our domestic legal system by means of Decree No. 1355 of 1994, bringing good prospects to the pharma industry. The TRIPS Agreement sets out the international minimum standards of protection to be provided for all forms of IP and explicitly excludes discrimination of any field of technology.

As established in article 27 of the TRIPS Agreement, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Article 27 also states that patents shall be available and patent rights enjoyable without discrimination against the place of invention, the field of technology and whether products are imported or locally produced.

INPI v ANVISA

In order to fulfil the required levels of TRIPS, Brazilian IP Law No. 9,279 was enacted in 1996, and came into force in May 1997, confirming the patentability for pharmaceutical substances and their related processes. The conflict between the INPI and ANVISA began a few years after the current Brazilian IP Law No. 9,279 came into force, due to Provisional Measure 2,006—later ratified by Law No. 10,196 of February 14, 2001—which introduced article 229(c) in Law No. 9,279.

Article 229(c) introduced by Law No. 10,196 established that the granting of patents for pharmaceutical products and processes will depend on previous consent of ANVISA. This provision not only created an additional patentability requirement for patents directed to pharmaceutical products and/or processes but it was also considered a discrimination against the field of technology, directly infringing
the provisions of the TRIPS Agreement,
since it is a requirement applicable only for patent applications in a particular technological field.  

In 2008, ANVISA issued Resolution RDC No. 45, which established the administrative procedure in respect to its prior consent, including the analysis of the patentability requirements. ANVISA began issuing office actions requiring amendments to the applications as well as decisions denying prior consent based on lack of novelty, inventive activity and sufficient disclosure, analysis of which should be the INPI’s exclusive competence.

There were numerous cases where, after being granted by the INPI, the application had its prior consent denied by ANVISA based on patentability requirements that had been already analysed by the INPI. In such cases, even if the application had already been granted, it could not be allowed without ANVISA’s prior consent and, therefore, there were several applications in which no final decisions were issued either allowing or rejecting them. 

As a direct consequence of the conflict between these two federal governmental agencies, the backlog of patent applications pending examination in the pharma area has considerably increased since Law No. 10,196 came into force. In this respect, several court actions were filed to determine that the examination of the patentability requirements should be the INPI’s exclusive competence and ANVISA should limit its analysis solely to matters of public health. 

New resolution

The discussion regarding the conflict of competences between the INPI and ANVISA led to the issuance of two legal opinions by the Attorney General’s Office (210/PGF/AE/2009 and 337/PGF/AE/2010), in 2009 and 2010, respectively, declaring that ANVISA should limit its analysis to health control and public health matters and should not analyse patentability requirements.

In turn, these legal opinions motivated the creation of a working group formed by representatives of the Ministry of Development, Industry and Foreign Trade, Ministry of Health, Attorney General’s Office, ANVISA and the INPI. This working group produced a new Resolution RDC No. 21, enacted in April 2013, which changed the prosecution flow of patent applications for pharmaceutical products and processes.

According to Resolution RDC No. 21, before beginning the substantive examination, the INPI should forward all pharma-related patent applications to ANVISA. After ANVISA’s decision on prior consent, the application would return to the INPI to either (i) proceed with the substantive examination of the application, if prior consent had been granted; or (ii) publish a notice confirming the application has been shelved due to the denial of ANVISA’s prior consent based on public health matters.

An important point to be emphasised, however, is the fact that while Resolution RDC No. 21 confirmed that ANVISA should analyse said pharma-related patent applications based on public health matters, denying its prior consent for those applications considered as being contrary to public health, it also established that a patent application should be considered contrary to public health when (i) the pharmaceutical product or process contained in the application presents risks to health (containing a pharmaceutical product or process related to a substance that has been prohibited in Brazil); or (ii) the patent application is of interest to the public health policies of the Brazilian Public Healthcare System (SUS) and does not meet the patentability requirements and other further conditions established by Law No. 9,279.

In summary, according to Resolution RDC No. 21, ANVISA should not analyse the patentability requirements of all pharma-related applications but only of those containing subject matter of interest to SUS. 

While this resolution purportedly aimed to establish the role of each agency in the analysis of pharma-related patent applications, the ultimate purpose was to avoid the embarrassing situation where the INPI granted an application that later had its prior consent denied based on the very same requirements that had already been examined by it. 

Joint ordinance

In April this year and after almost two decades of conflict of competences, the INPI and ANVISA signed a joint ordinance formalising new rules regarding ANVISA’s examination of patent applications related to pharmaceutical products and/or processes, which came into force on June 12. As a result, on June 27, the INPI published Normative Instruction 01/2017, establishing procedures for pharmaceutical patent applications under article 229(c) of Law No. 9,279. 

"ANVISA can no longer deny its prior consent based on patentability requirements and prior consent should be restricted to the impact on public health."

According to Normative Instruction 01/2017, ANVISA will examine patent applications related to the pharmaceutical area focusing on public health issues and will deny prior consent for the applications only when subject matter is considered against the public health, that is, those containing a pharmaceutical product or process related to a substance that has been prohibited in Brazil (or representing a risk to human health). The application having prior consent denied by ANVISA on such grounds will be forwarded to the INPI for the publication of the denial of prior consent and the notice confirming the application has been shelved.

With regard to applications directed to pharmaceutical products or processes that are of interest to the public health policies of the SUS, ANVISA will be able to issue a technical opinion on the patentability requirements, that is, on the aspects related to novelty and inventive activity. Nevertheless, this technical opinion will be considered by the INPI as a third-party observation, ie, as support to the technical examination of the application, which means that the INPI will carry out an independent examination and is not bound to accept, or even comment on, ANVISA’s opinion.

Briefly, according to these new rules, ANVISA can no longer deny its prior consent based on patentability requirements and prior consent should be restricted to the impact on public health.  

While it is expected that these new rules will solve the impasse related to the scope of ANVISA’s examination that existed for almost 20 years, and help in the reduction of the backlog of examination of patent applications in the pharmaceutical field, it is still too early to say that it will be effective.

Specifically regarding the backlog, there have been some positive outcomes in taking the matter to the courts. Recently, some federal courts of first instance and federal court of appeals for the second circuit have issued decisions determining that the INPI should immediately proceed with the examination and decision of long pending applications, based on article 5, LXXVIII, of the Federal Constitution, which guarantees a reasonable term for decisions to be rendered in administrative proceedings.

Therefore, we believe that in cases of interest, it may be worthwhile to take the matter to court in an attempt to speed up the examination with the possibility of obtaining preliminary injunctions.

Renata Campello Afonso, Luiz Leonardos & Advogados, ANVISA , pharmaceutical, patent, INPI, applications, Brazilian Public Healthcare System

WIPR