New rules for granting pharma patents

In August, the Brazilian vice-commissioner for patents, Julio Cesar Moreira, announced that the Brazilian Patent and Trademark Office (INPI) was implementing new rules in order to reduce the current backlog of patent applications, which averages eight years, to three years, and minimise delays in granting patents.

The most important rule is the creation of a priority line for pharmaceutical patents. However, the creation of a priority line for patents for medications considered vital for the Brazilian government’s Unified Health System (SUS), and mentioned by Moreira in order to reduce the average time for granting, was introduced in 2008.

Resolution #191 of 2008 established the guidelines for priority examination of patent applications before INPI. Article 4 of Resolution #191 of 2008 established a priority line of examination of pharmaceutical patent applications covering drugs purchased by the SUS: “Article 4: Will be examined as a priority, as requested by the Ministry of Health, patent applications related to drugs regularly acquired by SUS.”

Article 4 states that only the Ministry of Health can ask INPI to treat a drug patent application as a priority. Therefore, the applicant cannot ask for this priority examination.

The delay in implementing Article 4 might have occurred because of the Ministry of Health’s lack of political will. INPI has a policy to examine applications in the strict order that they were received by the office. It is known that requesting early examination with the entry of the national phase or filing a patent application claiming priority has never made a difference to the speed of INPI’s examination.

The change to INPI’s policy might have been required by the Ministry of Health. This demonstration of political power made by the ministry could be seen as anti-patent development, if it is used to deny patent applications for political reasons.

“INPI IS OFTEN UNDER PRESSURE FROM ANVISA TO PUBLISH THE DISMISSAL OF THE APPLICATION, WITHOUT FURTHER ADMINISTRATIVE APPEAL AND NO SUBSTANTIVE EXAMINATION, DESPITE THE LACK OF STATUTORY AUTHORITY.”

Another important policy development was published in May 2012, as Inter-Ministerial Ordinance #1065, to solve the dispute between INPI and ANVISA (Brazil’s food and drug administration) over the approval of patents for medications. Ordinance #1065 changes the relationship between the two regarding ANVISA’s prior approval for the grant of drug patents. According to Ordinance #1065, if properly filed and duly published, patent applications claiming pharmaceutical drugs or processes will be sent to ANVISA to proceed with the prior approval analyses after examination is requested by the applicant. Therefore, INPI will not be able to do any previous substantive examination before forwarding the application to ANVISA.

If ANVISA rejects the application, the agency will send the application to INPI. INPI is often then under pressure from ANVISA to publish the dismissal of the application, without further administrative appeal and no substantive examination, despite the lack of statutory authority. If the opposite occurs, and ANVISA grants prior approval, the agency will send back the application to INPI, which will proceed to the examination under the criteria of novelty, non-obviousness, utility, and other legal requirements.

Ordinance #1065 has anti-patent language and should be understood as an attempt by the current political party to revisit commitments made by Brazil recently in the international community.

The report suggests that substantive examination by ANVISA will be limited to Article 18, I of Law #9.279/96, following the decision of Brazilian courts in the Takeda case.

But ANVISA is still issuing decisions denying prior approval based on lack of patentability requirements, such as novelty and inventive step, which creates doubts about the political leeway ANVISA will exercise in the prior approval procedure.

It is still too early to understand the full impact of these changes, but Ordinance #1065 is being viewed as another anti-patent act by the current Brazilian administration that might jeopardise investment in the country.