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Brazilian PTO and EPO Launch Technical and Strategic Patent Partnership
By Carlos Cavalcanti. Lawyer, Managing Partner at Moeller IP Brazil.
Agreement between Brazil and Europe
Memorandum of Understanding – Enhanced Technical and Strategic Partnership
Brazilian PTO and the European Patent Office (EPO) signed a Memorandum of Understanding on an Enhanced Technical and Strategic Partnership on Tuesday, November 26th, aiming to improve cooperation between Brazil and Europe in the area of patents. The agreement was signed by BrPTO President Claudio Vilar Furtado and EPO President Antonio Campinos at the Institute’s headquarters in Rio de Janeiro.
BrPTO’s president Claudio Vilar Furtado stressed the importance of the agreement to stimulate investment in innovation and industrial property, focusing on the generation of new patents, especially in partnership.
Agreement aims
– In this agreement between BrPTO and EPO, Brazilians and Europeans are united so that patents are a central element of a business environment that drives innovation – said the president of BrPTO.
The agreement between the EPO and the largest patent office in Latin America aims to strengthen the patent system in Brazil and Europe to encourage innovation and economic development, as well as to promote trade and investment between companies. two regions.
– Brazil is an essential partner for the EPO and an important market for European companies – said EPO President Antonio Campinos, who added: – This agreement is a milestone in our cooperation and is proof of the economic importance of close ties between our regions. Cooperation aims to ensure efficient patent examination and the granting of high-quality patents. This will benefit local innovative agents and international patent applicants, who can increasingly expect similar conditions to protect their inventions around the world.
Memorandum of Understanding – Patent Prosecution Highway (PPH)
During the ceremony, both offices also signed a Memorandum of Understanding to renew their Patent Prosecution Highway (PPH) pilot program. The new PPH, effective December 1st, will be open to patent applications in all technology fields.
In relation to the enhanced technical and strategic partnership agreement, BrPTO and EPO will cooperate in strengthening local capacity to search and analyze patent applications by training and discussing best practices, sharing tools and exchanging databases. patent data. In addition, by examining patent applications corresponding to applications already processed by the EPO, BrPTO will leverage the search reports in its own review process to further enhance quality and efficiency, freeing up resources to support local innovation. The agreement’s activities will be based on the two-year work plan agreed between the two institutions.
Brazil is the largest economy in Latin America and its trade with Europe accounts for over one third of the total European Union (EU) trade with the region. The EU is also the largest foreign investor in Brazil, with investments in various sectors of the Brazilian economy.
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New post-approval changes of drug products
On March 22, 2016, the Brazilian Health Authority (ANVISA) approved the amendments of Regulation RDC 48/2009, which refers to the post-approval changes of drug products. The amendments establish a new regulatory framework for post-approval changes through the incorporation of different risk analysis depending on the complexity and the health risk of the modified drugs.
Law 6.360 / 1976 establishes that products subject to health surveillance, such as drug products, cannot be marketed without previous approval by ANVISA, which analyses their safety and efficacy.
However, after approval, it is very common for companies to request amendments to the original features of a drug product at any stage of its life cycle, such as changes in its components and composition, the manufacturing site or the manufacturing process, among others. This post-approval process is also subjected to revision by ANVISA, since the requested modifications can potentially have an adverse effect on the identity, strength, quality, purity, or potency of a drug product, which may affect its safety or effectiveness.
It is expected that the new regulations will impact the number of post-approval requests currently pending in ANVISA, since they establish different types of analysis depending on the health risk that a post-approval change involves. Accordingly, ANVISA will focus on the analysis of post-approval changes that involve moderate or high health risks, whereas the approval of those having a lower health risk will be faster.
Source: http://portal.anvisa.gov.br
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Local Health authority signed a draft of cooperation agreement with El Salvador
The Brazilian National Health Surveillance Authority (Anvisa) signed a cooperation project with the Republic of El Salvador through the local regulatory agency for medicine, the National Directorate of Medicines (DNM – “Dirección Nacional de Medicamentos”) and the National Health Institute (INS – “Instituto Nacional de Salud”).
The cooperation project will strengthen the technical capacity of the regulatory authorities of El Salvador through the transfer of technological and regulatory expertise in pharmacovigilance, also known as drug safety. Price regulation, rational use of medicines, technology assessment and a laboratory tax analysis also will be a focus.
International cooperation promoted by Anvisa is one of the targets set in the strategic planning of the Agency, which aims to strengthen the regulatory capacity of countries in the region.
Source: www.anvisa.gov.br
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ANVISA improves timeframes for medical device market applications
According to an analysis of data from the Brazilian Health Surveillance Agency (ANVISA) performed the Medical Device Consulting EMERGO, Brazilian regulators for the medical device market have reduced timeframes in 2015 for responding to and processing submissions from registrants of some medical device market applications.
Throughout most of 2015, ANVISA was able to provide initial responses to 99 percent of market applicants within 90 days of submission. ANVISA’s success rate (90 days) applied mainly to new applications. In cases where the regulator requests additional information from Brazilian market applicants, the 90-day target response time once applicants provide additional information was met at lower percentages throughout 2015.
In terms of number of days it actually took ANVISA to respond to additional information provisions, the agency did perform better for most of 2015 than in previous years, but did not meet its 90-day target in any given month last year.
ANVISA also published data showing total numbers of medical device applications submitted to the agency over the course of 2015. The biggest category of submissions, “materials” that include implants, syringes and catheters saw a marked decline in volume.
Source:
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Drug registration hits new high
According to the recent statistics released by the Brazilian Health Surveillance Agency (ANVISA), 742 medicines were registered in Brazil in 2015, a 105 percent overall increase over 2014.
Among these, there has been a 116 percent increase in the authorization of generics over 2014 and a 286 percent increase in similar drugs.
Additionally, ANVISA has reported that in 2015 a license for the marketing of drugs for the treatment of hepatitis C was granted, and the first two biosimilar drugs as well as the first vaccine against dengue were registered.
Source: http://portal.anvisa.gov.br
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List of pesticides available online
The Brazilian Health Surveillance Agency (ANVISA) announced that since December 21, 2015, pesticide registrations analyzed by its Toxicology General Department (GGTOX) will no longer being published in pdf or similar format, but instead are available through ANVISA´s Registration System (Datavisa) at: http://www.anvisa.gov.br/listadepeticoes/index.asp.
In Brazil, pesticide registration is evaluated by three Agencies: the Ministry of Agriculture (MAPA), responsible for the registration issuing; the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA, Ministry of the Environment); and ANVISA (Ministry of Health). Each agency is responsible for aspects related to agriculture, environment and health, respectively. ANVISA carries out toxicological analysis for new pesticide registration and for the re-evaluation of molecules that have already been registered.
ANVISA has reported that the applications will be analyzed in chronological order. However, applications declared to have priority treatment by the registration office (MAPA) due to phytosanitary emergency, or other technical justification, will also receive priority treatment by ANVISA. According to Decree 4,074/2012, the registration for the following products will be prioritized:
- Low toxicity products, provided a duly justified request for priority process filed by the applicant has been approved by the relevant agency.
- Equivalent technical products or products formulated on the basis of equivalent technical products.
- Plant protection products approved for use in organic agriculture.
Source: http://portal.anvisa.gov.br
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ANVISA has reduced the average authorization time by 165 days
According to the latest survey conducted by the Brazilian Health Surveillance Agency (ANVISA), the average time for any petition related to permits is 45 days. In September 2012 it was 210 days, so this is a reduction of 165 days.
The time reduction is the result of a series of actions taken by ANVISA over the past two years, including the use of computerized systems for the granting of Operating Permits (AFEs) of pharmacies and the simplification of rules for companies in a single standard published last year in the resolution RDC 16/2014.
In addition, a change in the Law 9.782 / 1999 also contributed to a large reduction of deadlines. The average terms for granting AFEs and Special Authorizations (EA) for companies, pharmacies and drugstores fell by more than five months in the last two years.
The main objective of these measures taken by ANVISA is to optimize its workforce on the most relevant activities.
Source: www.anvisa.gov.br
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List of “clone” drug applications now available
The Brazilian Health Surveillance Agency (ANVISA) recently published a list of applications relating to the simplified procedure for the approval, post-approval and renewal of generic,similar, specific, dynamized (i.e. homeopathic) and phytotherapeutic(herbal) drugs, as well as biological products linked to the technical and clinical reports of a “mother” application (related to a “mother” or reference drug). This simplified procedure is referred to as a “clone” procedure.
On May 30, 2014, ANVISA published Resolution 31/2014 that revised the simplified “clone” procedures.According to the resolution, the clone drug must be of the same dose, form and presentation as the reference drug and it can only differ from it in the brand name, packaging layout and wording of the package insert and labeling.
According to Resolution 31/2014, ANVISA will approve a clone application with a mother application that contains all the technical and clinical information needed to request the approval of a reference drug, and also has been approved, provided it complies with the aforementioned requirements.
ANVISA reports that this list of applications will be updated monthly with the data obtained from ANVISA´s Registration System (Datavisa).
Clone applications awaiting analysis are divided into two lists: the first one includes applications where the “mother” application has no pending renewal, registration or amendments, and the second list comprises applications where the “mother” application is still pending analysis by ANVISA.
This simplified procedure is currently speeding up marketing authorizations for “clone” drugs in Brazil from months or years to a few days.
Source: http://portal.anvisa.gov.br
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Change for the registration of cosmetics
On June 2, 2015, the Brazilian Health Surveillance Agency (ANVISA) published Decision 202/2015 changing the way of registration for cosmetics, personal care products and perfumes.Since June 15, 2015, the registration of these products must be done exclusively through the Agency Registration System (Datavisa), instead of the previous Electronic Automatic System (SGAS).
For cosmetics, personal care products and perfumes exempt from registration according to ANVISA Resolution 07/2015 of February 11, 2015, the registration should continue to be done at SGAS.
The owners of registers and post-registration applications for cosmetics, personal care products and perfumes filed through SGAS with test results that have not been yet published in the Official Gazette, should re-file the originally filed information.
ANVISA´s decision to return to the use of the previous registration system Datavisa was due to the identification of important inconsistencies in the SGAS and an effort to reduce the time of the registration process.
Source: http://portal.anvisa.gov.br
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New regulations for clinical trials in Brazil
Aimed at speeding up the start of clinical trials for the development of new drugs and health products, Regulations RDC 09/2015 and 10/2015 were published on March 3, 2015, in the Official Gazette.
The new regulations, which revoke the previous RDC 39/08, take on a regulatory model in line with the main international health agencies regarding the submission of technical documentation and good clinical practice. They are also aimed at providing higher quality and administrative efficiency in the assessment of clinical tests by the Brazilian Health Authority (ANVISA).
One of the new features introduced by the regulations is the establishment of a fixed deadline for ANVISA to perform the evaluation of the drug clinical development dossiers (DCDD), which contain the projects of clinical trials to be performed in Brazil. This text containing the phase III clinical trials with synthetic drugs and carried out in other countries will now have to be reviewed by ANVISA in a maximum of 90 days.
This new rule also establishes that in those cases where ANVISA does not respond within 90 days, the study can be started, provided it has been approved by the authorities that assess the ethical aspects of the research. Requests for authorization currently awaiting technical evaluation and already in ANVISA prior to the validity of this regulation, also fall under this 90-day rule.
Phase I and II clinical trials with biological drugs or carried out only in Brazil, will have to be reviewed by ANVISA within 180 days. However,in this case the study cannot be started until it has been evaluated by the agency.
The new regulations seek to harmonize clinical trials in Brazil with other international standards and agencies. They are also aimed at encouraging the integration of Brazil in research that is carried out simultaneously in other countries.
These new regulations are the result of a public consultation carried out in 2014 among the Brazilian clinical research sector and, that received 641 contributions.
Source: http://portal.anvisa.gov.br
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