Kene Gallois

Kene Gallois

Samantha Salim

Samantha Salim

Since 2001, the grant of pharma-related patent applications in Brazil has come to depend on a prior approval analysis by the National Health Surveillance Agency (ANVISA).

Initially, ANVISA and the Brazilian Patent and Trademark Office (INPI) agreed that pharma-related applications should be sent to ANVISA for prior approval only after INPI examination. However, in 2012 this workflow was reversed and applications were sent to ANVISA first.

In theory, ANVISA’s analysis should be limited to public health issues and the patentability examination should be carried out by the INPI. However, ANVISA’s understanding regarding public health at that time included patentability requirements. This elicited much debate and a significant number of lawsuits were filed by applicants which challenged the legitimacy of ANVISA's patentability requirement analysis and requested that their applications be returned to the INPI for examination. This contributed to the growing backlog of unexamined pharma-related applications in Brazil, as many applications underwent two patentability examinations; it was not uncommon to find opposing decisions issued by the agencies in the same case.

Recent developments
To resolve this impasse, the agencies signed Joint Ordinance 1/2017 on April 12 2017, which outlined roles and clarified issues relating to the allowance and denial of prior approvals from ANVISA. According to the ordinance, ANVISA’s task is to assess whether the subject matter of a patent application represents a risk to public health (ie, if it relates to a pharma product comprising or a pharma process resulting in a substance which is prohibited in Brazil, such as narcotics).

The INPI’s role remains the same: to analyse the patentability requirements of the claimed matter. If ANVISA denies prior approval for an application, the case will be sent back to the INPI, which will be responsible for the publication of ANVISA’s decision denying prior approval and final dismissal. For any remaining cases that are not considered contrary to public health, prior approval will be granted and the case will be sent back to the INPI for examination.

Practitioners initially doubted that a consensus would be reached. However, the following case law gives cause for hope.

Brazilian Patent Application PI0409133-7
ANVISA issued a first opinion alleging that the claimed matter was contrary to public health as one of the possible covered combinations would be directed to prohibited substances in Brazil, such as opium and heroin. In response, a new claim set was submitted and the cited prohibited substances were excluded. ANVISA accepted the proposed amendments and the prior approval was published.

The ordinance also predicts that for applications containing pharma-related products or processes that could be of interest to the Brazilian Public Healthcare System, ANVISA may issue technical opinions based on patentability requirements. These opinions cannot be used for denying prior approval, but will be considered third-party observations by the INPI.

Brazilian Patent Application PI0307123-5
In this instance, ANVISA's opinion on patentability was interpreted as a third-party observation.

ANVISA examined the patentability requirements of a patent application and stated that a certain claim was not considered an invention relating to a therapeutic method. The withdrawal of this claim was requested as a condition to grant prior approval. The claim was a dependent product claim that defined the application and use of the product in therapy. To speed up prosecution, the applicant opted to delete the claim and thus the prior approval was issued. When the application was returned to the INPI, the patent office remarked on ANVISA's examination and disagreed with its findings.

According to the INPI, the claim sought no protection for a therapeutic method and instead referred to a product. Therefore, the application and its use were considered additional features of the claimed subject matter. In light of this, the INPI disregarded the claim amendments made during ANVISA’s examination.

Brazilian Patent Application PI1106509-5
In this instance, the INPI proceeded to examine cases previously rejected by ANVISA.

In July 2017 the INPI published its opinion on a pharma-related application that had been refused prior approval by ANVISA. The INPI clarified that ANVISA's opinions on patentability would be interpreted as a third-party observation, and followed the same approach for at least 16 other cases.

On May 31 2017 the INPI published Rule 1/2017, which ratified the ordinance and clarified administrative procedures. According to the rule, INPI examiners will analyse any modifications performed in the application during ANVISA’s examination, regardless of whether prior approval was denied or granted, and may incorporate them during its own examination.

On August 10 2017 ANVISA published Rule 168/2017, which ratified the ordinance and established additional administrative procedures regarding prior approval. ANVISA clarified that its opinions on patentability formulated before the publication of the ordinance should also be considered by the INPI as third-party observations.

Remaining issues
While the uncertainty between the INPI and ANVISA seems clearer, unresolved issues remain. For example, according to Article 229(c) of the Industrial Property Law, a pharma-related application must receive prior approval to be granted – how this issue will be addressed by the two agencies remains unclear. If the agencies make no changes and a pharma-related application is granted without receiving prior approval from ANVISA, this patent could be challenged for not complying with Article 229(c).

Both agencies are expected to cancel the decision relating to the denial of prior approval and publish the grant of prior approval in cases other than those relating to substances that are prohibited in Brazil. They are also expected to follow the provisions established in the ordinance – which also applies to pending applications – and improve examination transparency and efficiency by resolving any remaining issues.

For further information please contact:

Kene Gallois
DANIEL Legal & IP Strategy
www.daniel-ip.com
Email: kene.gallois@daniel-ip.com
Tel: +55 21 2102 4212