Intellectual Property in Brazil

Intellectual Property in Brazil

Much of the work done at Biokyra is related to the protection of intellectual property. Intellectual property refers to patents, copyrights and trademarks that can be bought or sold. The laws regulating them try to balance the interests of creators who wish to gain greater control over their ideas and take advantage of them, and the rest of society, calling for a greater flexibility of control.

A patent, in its classic formulation, is a public concession, granted by the State, which grants the holder the exclusive right to commercially exploit his creation. However, access is available to the public on the knowledge of the key points and the claims that characterize the novelty in the invention. The exclusive rights granted by the patent relate to the right to prevent others from manufacturing, using, selling, offering to sell or importing the said invention.

The Patent Cooperation Treaty, or PCT was signed on June 19, 1970 in Washington, in order to develop the patents and technology transfer systems. The PCT provides basically a means of cooperation between industrialized and developing countries. By October 2009 there were 142 countries signatories to the PCT.

The World Intellectual Property Organization (WIPO) is an intergovernmental organization with headquarters in Geneva, Switzerland. It is a specialized agency of the United Nations Organizations, and is responsible for the PCT. The PCT aims to simplify the necessary procedures in the case of a request for patent protection in several countries, making more effective and economic for both the user and for the government agencies in charge of the patent system administration. Brazil is a signatory to the PCT since 1978.

Biokyra has its own team to write patent applications and to monitor the process of obtaining intellectual property. 

Minimally Invasive Surgeries

The global market for minimally invasive devices and instruments has been growing at a high rate 7.9% between 2011 and 2016, when it is expected to reach US$21.1 billion worldwide.

Minimally invasive surgeries (MIS) have been performed in the United States and in Europe for more than 10 years. Since then, techniques and instruments have improved and nowadays many organs can be operated through minimally invasive surgery. 

MIS is performed without the need for a large incision in the patient. It is performed through natural orifices or by small incisions through which tubes, catheters or laparoscopes are inserted, and by imaging techniques such as video-endoscopy or fluoroscopy, allowing the surgeon to access the sick region. 

This classification also includes prostheses and devices that can be implanted by minimally invasive techniques.

Some of the advantages of MIS are:

• Accelerated and less traumatic recovery for patients;
• Faster procedures for physicians;
• Lower costs for hospitals;
• Lower costs for health insurance companies;
• High value added products for the industries;
• Increased number of people served in the society.

Does Medical Device industry need start-ups to continue the innovation process?

Big companies seek innovation and efficiency to meet the market demands that is always running in a high competitiveness environment, meanwhile the start-ups with good ideas and solutions need to ensure economic survival to bring their products to market.

In a global scenario, and with specific knowledge of the brazilian market, brazilians start-ups gain notoriety not only due to challenges such as risk taking in business, but also by bringing to market the benefits of their innovative ideas. This business model has drawn attention of big companies.

Start-ups do not have the strong, hard and slow structures a big company has. The creative environment and people who can generate new ideas make possible to make mistakes and try again fast and agile.

Typically, start-ups must focus on one idea at a time; however, if that first idea is not as disruptive as first hoped, the end of that idea could also be the end of the company. Those that do survive often form the backbone of larger corporations’next-generation offerings, through acquisition or licensing.

Despite the crucial role that start-ups play in the medical technology industry, the current economic climate cannot be overlooked. Continuing the trend of previous years, in the USA in 2011 we have seen a decline in early stage investment in medical technology start-ups. The investment that has been made has focused on start-ups whose technologies are perceived to have a simpler regulatory pathway to market. The most complex regulatory pathways are often associated with complex technology areas (for example, in vivo imaging and surgical implants) and one could argue that it is these areas that most need disruptive technologies.

For their part, the more progressive medical corporations continue to recognize the importance of these smaller companies (approximately 73% of the United States’ 5300 medical device companies had a head-count of less than 20 in 2007) and many are taking a more collaborative approach to fostering new technologies. Rather than buying an idea outright before significant development has occurred, they are working with start-ups to bring products closer to market through equity or resource investment.

That could be also a great way and opportunity to develop the domestic brazilian medical device industry, that it, working with start-ups to bring products closer to market through equity or resource investment.

To read more about it, please, visit: http://medtechinsider.com/archives/26930

Patent granting in Brazil

A patent is a form of intellectual property granted to an inventor for a limited period of time. The procedure for granting patents varies widely from country to country, but it usually requires novelty and non-obviousness. The exclusive right granted to a patentee in most countries is the right to prevent others from making, using, selling, or distributing the patented invention without permission.

Granting patents is important to promote invention, once that developing new products, for example, takes time and money. If there is little opportunity to benefit from the initial investment, then inventors and companies won’t focus on creating new products.

In Brazil, the law 9.279, of 1996, establishes the rights and duties concerning to patents. According to Isaias Masiero Filho, one of the founders of Biokyra, obtaining right over a patent is extremely important for those who work on the development of new products because it protects the inventor and guarantees the return on the investment made in the initial phases.

The INPI (National Institute of Intellectual Property) is the office responsible for analyzing patent applications. In Brazil the application can be issued by the inventor him/herself, but it is highly recommended to have the orientation of a lawyer because the process involves several deadlines and documents. The average application fee in Brazil is R$200 (US$108).

To know more about patent granting in Brazil, check out the following websites:

http://www.revistagestaoenegocios.com.br/gestao-motivacao/33/artigo225232-1.asp

http://www.inpi.gov.br/index.php/english

Brazilian healthcare industry – economic data

In 2010 the Brazilian healthcare industry generated R$8 bi in business, employing more than 100.000 people. Most healthcare companies are mid-sized or small (71.5%) companies and 7.1% of the products/services are exported. The most important trading countries in 2010 were the United States, Argentina, and Venezuela.

You can find the complete data on: http://www.abimo.org.br/content.php?page=DADOS_ECONOMICOS_PT

The Brazilian healthcare industry will grow more than the Brazilian GDP

In 2011, it’s expected that the Brazilian healthcare industry will grow 19%, achieving R$13.5 bi. This growth is much higher than the Brazilian GDP growth, which is expected to grow less than 4.5%. Throughout the year, 6.000 jobs were created in the healthcare industry. Some of the reasons for such a good performance are the strengthening of the Brazilian economy, the creation of new jobs, and the dollar price. 

To read more about it, please, visit:http://www.hospitalar.com/index.php

Brazil and the Global Harmonization Task Force (GHTF)

According to the FDA, the Global Harmonization Task Force (GHTF) fosters international harmonization in the regulation of medical devices. Regulatory and industry authorities from Europe, Asia-Pacific and North America collaborate to encourage the harmonization of regulatory practices to ensure the safety, effectiveness and quality of medical devices.

The GHTF was founded in 1992 and its main purpose is to standardize medical device regulations around the world by the exchange of information. Some of the benefits of the standardization are the convergence in regulatory practices related to ensuring safety and facilitating international trade.

On November 11, Brazil, Argentina, Colombia and Cuba’s regulatory agencies agreed to work in cooperation, through the inspection of manufacturers of medical devices in each country. The Brazilian regulatory agency (ANVISA) requires a Good Manufacturing Practices (GMP) certification from medical devices manufacturers, and the inspection is conducted by the agency itself. From January of 2013 the GMP certification issued by the Argentinean, Colombian, and Cuban agencies will be accepted in Brazil as well, which means more efficiency in the certification process.