Tag: Pharmaceutical

The approved project that reduces the term of patent of medicines

The Social Affairs Commission (CAS) approved the Senate Bill (PLS) 437/2018 on Wednesday. The bill limits the ownership of drug patents by 20 years. Authorized by Senator José Serra (PSDB-SP), the proposal adapts Brazilian legislation to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which Brazil is a signatory.

TRIPS – signed by Brazil, the United States, the European Union, Japan and other nations in 1994 – provides that property rights over intellectual creation, a patent, expire after 20 years of registration.

PLS 437/2018 received a favorable vote from the Rapporteur, Senator Romário (Podemos Party-RJ). In his evaluation, the project has the potential to improve the licensing of medicines patents in the country. From the sanitary point of view, said Romário, the project corrects flaws or omissions in the legislation in force.

“Through these extended patent validation strategies, the industry delays the arrival of generic drugs on the market and prolongs its economic gains from the original product monopoly. This harms both consumers directly and public pharmaceutical care policies, in which the main purchaser of medicines is the government, and in this context, the measures envisaged in the project under review reinforce Anvisa’s role and its obligation to evaluate patent applications from the perspective of health interest,” said the senator.

The text was followed by the Commission for Science, Technology, Innovation, Communication and Information Technology (CCT) and then by the Commission on Constitution, Justice, and Citizenship (CCJ), which will be a final decision.

 

News from: Agência Senado

Brazil discusses marijuana cultivation release for medical and research purposes

The National Health Regulatory Agency (Anvisa) discussed on Tuesday, June 11, 2019, the legalization of marijuana cultivation and production in the country for medical and scientific purposes. Currently, cannabis planting, the plant’s scientific name, is banned in Brazil. However, but some groups and associations have obtained judicial decisions for the cultivation of marijuana in Brazil.

The board of Anvisa discusses the possibility of bringing to the public consultation two proposals under analysis since 2017. The first that creates rules the cannabis planting in Brazil for research and production of medicines. A second on the criteria for registration, monitoring, and marketing of these products.

Currently, in the country, the agency already authorizes applications for the importation of oils and drugs mainly based on cannabidiol, the most common marijuana substratum in drug production. Currently, only the production of a drug is allowed in the country.

The use of marijuana derivatives is more common in degenerative diseases like Parkinson’s disease and multiple sclerosis up to some levels of autism and cancers.

If both opinions of the technical consultancy of Anvisa are approved, the proposals will be taken to the public consultation. After this stage, the technicians finalize a final project that will have to be voted by the Agency’s board again. There is no estimate yet when the technical standard could take effect.

Prohibition inhibits research and new herbal medicines

According to the president of Knox Medical, Mario Grieco “The lack of regulation and the prohibition of local cultivation of cannabis inhibit the research and the development of innovative medicines based on the herb in Brazil”. In addition to the economic benefits, local production could enable more than two million patients to use the herb in the treatment of various diseases. “We have a repressed market of potential users, but it will expand as studies into new indications for medical cannabis are completed,” he says.

According to the president of ABPI, Luiz Edgard Montaury Pimenta, bureaucratic issues in Brazil have hampered the pace of innovation by companies in the national market. “The recovery of the country’s economy is strongly linked to investments in innovation,” says Pimenta.

Data from a recent economic study on cannabis produced by Green Hub in partnership with New Frontier Data will be analyzed by Mario Grieco during the 39th International

Congress on Intellectual Property of the Brazilian Association of Intellectual Property (ABPI) from August 25 to 27, in Rio de Janeiro. According to him, there are over six thousand studies in progress in the laboratories, which exceed US $ 1 billion per year, on the use of cannabis.

The event, the largest of its kind in Latin America, is expected to receive around 1,000 participants, including experts, magistrates, consultants, lawyers, government officials and heads of international entities – such as the CTA – China’s intellectual property AIPPI – International Association of Intellectual Property -, as well as private research centers.

 

News from: Estadão and DCI

Signed a New Agreement for the Examination of Pharmaceutical Patent Applications in Brazil

Yesterday (04/12/2017), in a formal ceremony held in Palácio do Planalto, in the capital Brasília, it was signed the much anticipated agreement between the Brazilian Patent and Trademark Office (BPTO) and the National Health Surveillance Agency (ANVISA) regarding the examination of pharmaceutical patent applications.

In addition to expediting the processing and examination of patents in the pharmaceutical field, this will put an end to many lawsuits that exists over this issue. This will convert in benefits to Brazil, since this new found stability can attract investors to the field. Also, a final decision over certain patent applications can encourage companies to increase the production of certain products, generating more offers of pharmaceutical products in the Brazilian market.

The agreement signed yesterday was published also yesterday as a Joint Ordinance No. 1, with full effect on both entities proceedings. The main aspects of such agreement is summarized below.

As currently required by Article 229-C, ANVISA will continue to issue prior consent over patent application for pharmaceutical product or process (article 1 of the Joint Ordinance). However, article 4 of the Joint Ordinance prescribes that ANVISA will limit its analysis to the risk of the product or process to the public health. The risk is characterized by prohibited substances in Brazil. 

This procedure will be performed soon after the filing of examination request presented to the BPTO  (article 2 of the Joint Ordinance).

For those cases that may have great effect or consequences on public policies for health (related, for example, on the access of certain medications), ANVISA will be capable to offer subsidies for BPTO Examination. Therefore, ANVISA cannot interfere in the analysis of patentability requirements.

The BPTO, in turn, will evaluate the patentability requirements.  This Joint Ordinance is already in effect and, by force of its article 8, will affect all current patent application still pending, even the ones already examined by ANVISA.

Our office and our attorneys act before the BPTO and the ANVISA. We will be able to enforce the new Join Ordinance on benefit of your clients.

If you are interested in finding more about this Join Ordinance or the measures that can be taken to expedite your client’s patent applications in the pharmaceutical field in Brazil, please contact us at info@tavaresoffice.com.br