Problems with Brazilian pharma patents
Plagued with an average 10-year backlog, red tape and a lack of examining guidelines, these applicants want a world-class patent system.
The 1999 amendment to the Brazilian patent law created prior approval, an additional patentability requirement for applications claiming pharmaceutical products or processes. This patentability requirement is not examined by the Brazilian patent office (INPI) but by ANVISA, the Brazilian food and drug administration.
The system has never worked properly. 2013 brought changes in the procedures between INPI and ANVISA that worsen the situation.
A few months later the ANVISA regulation RDC #21 of 2013, the impact of the new workflow in pharmaceutical patent prosecution is notable.
"From now on ANVISA (guided by the Ministry of Health) will be the big player in Brazil for pharmaceutical patent applications. The INPI is getting a supporting position."
Effective since April 16, 2013, regulation RDC #21 amends regulation RDC #48 of 2008, regarding ANVISA’s procedures for prior approval for the grant of pharmaceutical applications claiming pharmaceutical products or processes under Article 229-C of the Brazilian Patent Statute #9.279 of 1996, as amended in 1999.
Under RDC #21 of 2013—immediately applicable to all pending patent applications—ANVISA may deny prior approval based on Article 229-C for patent applications considered of interest to the Brazilian public policies concerned with access to medicines and pharmaceutical assistance of the Public Healthcare System (SUS).
RDC #21 of 2013 establishes that a patent application is considered against public health when: the pharmaceutical product or process covered by the patent application presents a risk to health; or when the product covered by the patent application claiming a pharmaceutical product or process is of interest to the public policies of access to medicines and pharmaceutical assistance of SUS and “does not meet patentability requirements and further criteria established by Patent Statute #9.279 of 1996”.
On May 13, 2013, ANVISA issued internal memorandum #003 of 2013 detailing the scope of the examination of risk to health of pharmaceutical products or process under regulation RDC #21 of 2013. Memo #003 establishes that the evaluation of risk to health must be performed through the analysis of the “F” List, in Annex I of Ordinance #344/1998, of the Ministry of Health. This lists substances that have been prohibited in the country.
Memo #003 states that a patent application for a pharmaceutical product or process will be deemed as of interest to the public policies of access to medicines and pharmaceutical assistance of the SUS when it comprises, or results in, a substance established in the Ministry of Health’s Ordinance #1.284 of 2010.
ANVISA’s memorandum #003 of 2013 also establishes that any therapeutic indication listed in Annexes I and II of Ordinance #1.284 of 2010 would also be of interest: anti-HIV treatments, neglected diseases, chronic non-communicable diseases and biologic drugs (eg, monoclonal antibodies).
Even when a drug has the therapeutic indication (the analysis should always take the therapeutic indication into consideration, not the drug or active ingredient) mentioned in Annexes I and II of Ordinance #1.284, this shall not spark the interest of the Brazilian government. The drug needs to have an impact on the public system, which works to grant access to the basic healthcare. As an example, the government has already secured access to several generic drugs for depression, heart problems, blood pressure and multiple sclerosis.
Further, on June 18, 2013, ANVISA denied prior approval for the first patent applications under the new regulations: BRPI0005616-2; BRPI0110371-7; BRPI9912899-3 and BRPI9917843-5.
The denials were grounded on Article 4, paragraph 1, II of RDC #45 of 2008, amended by RDC #21 of 2013. The main issue in those denials is that in addition to plausible deniability issues based not just on patentability requirements and non-patentable subject matter, ANVISA used arguments based on Articles 24 and 25 of the Brazilian IP Statute, regarding statutory requirements for enablement, written description and the relation between specification and claims.
ANVISA’s practice is violating the WTO TRIPS Agreement, the Paris Convention and Brazilian patent law. The fact is that from now on ANVISA (guided by the Ministry of Health) will be the big player in Brazil for pharmaceutical patent applications. The INPI is getting a supporting position.
It is still not clear what the INPI will do with patent applications in case of denial of prior approval, once the lack of prior approval is not a statutory basis for denial or dismissal of patent applications. Since October 2012, ANVISA has not returned any patent application to the INPI, even when it had rejected the prior approval.
