Brazil harvests the wealth of its rain forests
With biomedial research on the rise since the reform of Brazil's patent regime, the Amazonian jungles are yielding new treasures. (Photos.com)
By Michael Ryan
This article by Michael Ryan was first published in the IP Legal Times of May 2006. Professor Ryan is the Director of the Creative and Innovative Economy Center at the George Washington University Law School. He is currently writing a book on drug innovation, patents, and health security in developing countries. This article is reproduced with the permission of the author.
When a man in Brazil injured his knee while playing football, a local healer urged him to apply the leaf alcohol of the maria milagrosa plant on his knee to relieve the swelling. It worked. The injured man, who was the founder of the French-Brazilian drug manufacturers, Aché, was impressed with the market potential for such a wonder remedy in a country full of football players. He recruited a University of Sao Paulo scientist to isolate the active compound.
But that was the easy part. Who would pay to develop the best formulation of a new anti-inflammatory drug? Who would pay for the toxicology studies? Who would pay for the laboratory tests, the animal trials, and the human trials? If all these investments were made, how could competitors be prevented from analyzing the chemical composition of the final product and selling it under their own brand names?
The story took place in Brazil in the early 1980s, when Brazilian law did not permit the patenting of pharmaceuticals. That meant the answers to all the above were negative: not Aché and, indeed, no-one, as competitors could not be stopped from freely copying the invention. Government scientists may have seen the myriad possibilities, but a lack of financial investment in the private sector severely constricted the pipeline from laboratory to marketplace.
Going for the green
Brazil has long recognized that the vast jungles traversed by the Amazon River hold tremendous wealth. But traditionally efforts to exploit these resources focused on drilling for oil and natural gas, mining for minerals, cutting of trees, and planting of agricultural crops. Amazonia possesses the world's greatest biodiversity – extraordinary flora and fauna seen nowhere else – however biomedical research was not a priority for Brazil. Companies were reluctant to invest in the long process of research and development. And the public and private sectors did not work together.
That started to change in 1996 when the Brazilian government undertook a major reform of its patent law. The new patent regime permitted patents on pharmaceutical products and processes, provided a 20-year term of exclusive rights, and barred parallel imports of patented products.
The new policy had immediate effect. That same year Aché's founding families decided to hire a team of executives with experience in global pharmaceutical management. The new president articulated a business strategy to market drugs previously unavailable in the Brazilian marketplace in partnership with multinational companies and to push Aché itself into the innovation business.
The new R&D director heard the story of the anti-inflammatory remedy that had never been developed and saw real market potential. Because Aché lacked its own internal R&D capabilities, it sought partnerships with universities and hospitals to establish a program of toxicology research, animal testing, and human trials. Aché paid for this initiative by, among other things, winning a government grant.
Seven years of study, testing, and trials demonstrated the maria milagrosa compound to be both effective and safe. The Brazilian public health authority approved the compound for sale in November 2004. Aché filed for patent protection in Brazil, the United States, and Europe. The anti-inflammatory cream Achéflan went on the market in the summer of 2005.
Achéflan is apparently the first patent-protected biomedical product to be developed by Brazilians from a natural resource. And it was an instant hit with professional football players, weekend athletes and their doctors.
Buoyed by its medical and financial success, Aché has gone on to establish more R&D partnerships with universities. Together Aché and its partners are seeking to develop therapeutic treatments in such areas as anxiety, diabetes, high blood pressure, liver disease, and sleep disorder.
Making a deal
A biotec alliance between BioLab and Biosintetica aims to develop innovative drugs from Brazil’s many snake and insect species. (Photos.com)
Other Brazilian drug makers are also stirring the creative juices. Two companies, BioLab and Biosintetica, have formed an R&D strategic alliance because, in the words of one manager, "innovation is fundamental to survival." Their first-of-its-kind initiative in Brazil was five years in the making. Its goal was to develop new drugs from Brazil’s many snake and insect species.
The partners, whose independent R&D efforts have resulted in some three dozen international patents between them, saw in each other complementary business capabilities. But they realized that they also needed to connect with university researchers. Not surprising, BioLab and Biosintetica managers report that their collaborative agreements with academia were difficult to negotiate. (Aché tells a similar story about its research arrangements with universities and hospitals.) In general, universities in Brazil did not have experience with these kinds of collaborative relationships. Academic researchers did not trust the private sector as partners. They also lacked both know-how and capabilities with respect to intellectual property management. And they brought to the table some unrealistic expectations regarding risks, rewards, and royalties.
But over time, the BioLab and Biosintetica negotiators built up a level of mutual trust. Eventually, they figured out how to protect everyone’s interests to everyone’s satisfaction. To date, the R&D partnership has yielded 11 international patents, although it has not yet brought any innovative new products to market.
The successes of BioLab, Biosintetica, and Aché begin to point the way to more public-private pairings.
For many years, the Brazilian government has made significant investment in the country’s public research universities and national laboratories. This investment has been most pronounced in the State of Sao Paulo, which dominates the Brazilian economy. For 50 years, the State of Sao Paulo Research Foundation – commonly known as FAPESP (Fundacao de Amparao a Pequisa do Estado de Sao Paulo) – has funded basic scientific research and graduate education at the University of Sao Paulo, the University of Campinas, and Paulista State University.
The biomedical research base in Brazil also includes two important publicly supported research institutes, the Instituto Bhutantan and the Oswaldo Cruz Foundation. As operations of the Ministry of Health, both institutes seem to have been organized to create biomedical development and production capability for government-owned pharmaceutical facilities, which in Brazil produce some 200 different drugs and vaccines. But the institutes have not traditionally served to encourage much innovation or to push the commercialization of technology through public-private partnerships.
The problem for Brazil was that the public investments in basic science and technology had not yielded many marketable products. And the private sector in general still invested too little in R&D. FAPESP data show that two-thirds of R&D spending comes from the government; only one-third is invested by the private sector. Seventy-five percent of scientists and technologists work in the universities; only 18 percent work in private business.
Most industrial R&D carried out in the Brazilian private sector occurs in the agriculture, aircraft, and energy industries. Until very recently, private-sector biomedical R&D was close to nil. Few companies run their own research laboratories. There are not many private-sector jobs for biomedical graduates and thus modest incentives to pursue higher education in the biomedical sciences.
Clearly, something needed to be done to jump-start the engine of private innovation.
In December 2004, the Brazilian government promulgated another major legal reform, the Technology Innovation Law. The purpose of the legislation is to encourage more public-private cooperation by making it easier for public and private enterprises to share resources, raise capital and clarify intellectual property rights.
Eight provisions are key:
- Public research institutes are permitted to share their laboratory facilities with private-sector enterprises.
- Public research institutes and private-sector enterprises are permitted to enter into capital relationships for the purpose of R&D.
- Public and private partners may specify the ownership of any future intellectual property rights by contract.
- Public research institutes and their employees must protect trade secrets associated with their research.
- Public research institutes may license their technologies to private enterprises.
- Individual public researchers may share in the economic returns associated with the successful commercialization of a new product.
- Public researchers may take leave from their public position in order to work for a private enterprise.
- Government development agencies should provide financial and human resource assistance in support of private-sector R&D.
By substantially reforming its patent law and removing major institutional barriers to technological development, Brazil has made certain that the innovation will not end with Achéflan. The stage has been set for the next fruitful act in Brazil’s quiet biomedical revolution.
|The Brazilian Innovation Law|
The 2004 Brazilian Innovation Law was introduced to provide the legal framework needed to improve the country’s capacity to generate and commercialize technology. The Law deals with incentives to increase the establishment of cooperative links between public scientific and technological institutions (STI) and enterprises. It also regulates the use and negotiation of IP generated from collaborative activities between STIs and firms.
To improve its innovative capacity, Brazil needed to encourage more firms to invest and become involved in technological developments. The Ministry of Science and Technology estimated that 70 percent of R&D in Brazil is financed with public resources. In addition, 80 percent of Brazilian researchers carry out their activities within public institutions, concentrating on the production of scientific papers. The country produces 1.5 percent of the worldwide total of papers in scientific fields – a percentage similar to Korea. However, whereas the number of USPTO patents granted to Brazilian inventors only increased from 33 in 1980 to 113 in 2000, in Korea the increase in the same period was from 30 to 3,472.
Public STIs have long struggled to formalize activities involving collaboration with enterprises. The previous legal framework regulating STIs compelled them, among other things, to undertake a public bidding process for the licensing of technologies. According to the new Innovation Law, STIs are only requested to publish a previous "request for licensees" for the purposes of transferring or licensing their technologies. With this new regulation, STIs are able to accelerate the process of licensing and selecting the best partners.
The Law allows STIs to negotiate the use of their laboratories with SMEs. This possibility will facilitate R&D among small companies. In addition, there is a special requirement for funding agencies to promote specific programs to stimulate innovative projects in micro and small enterprises.
The Innovation Law serves as an incentive to establish partnerships aimed at developing new technologies. Researchers have the possibility to work in other STIs and continue to receive their regular salaries. Researchers are also able to request special leave without pay to become involved with a start-up company in order to further develop their new technologies.
- From "In Search of an Innovative Environment – The new Brazilian Innovation Law" (2005) written by Maria Beatriz Amorim Páscoa, then Director of Institutional Partnerships and Technological Information at INPI Brazil.