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.