Brazil Approval Of Embryonic Stem Cell Research Could Boost Patenting

By Claudia Jurberg for Intellectual Property Watch
RIO DE JANEIRO – After three days of consideration, the Brazilian Supreme Court last week approved by a narrow 6 to 5 margin research involving embryonic stem cells. The 29 May vote followed a protracted fight that consumed three years.

The case arose after former Brazilian Attorney General Claudio Fonteles contested Article 5 of the 2005 Biosafety Law. The law allows the use in scientific research and therapy of embryonic stem cells obtained from human embryos produced through in vitro fertilisation and frozen for more than three years, with the agreement of the progenitors. According to Fonteles, the article is unconstitutional because it violates the right to life of the embryo.

In 2005, the National Congress approved the Biosafety Law (Law 11.105/05) by 352 votes to 60, but Fonteles questioned the legality of the law.

The Supreme Court decision ends a period of uncertainty and frustration for Brazilian cell biologists by allowing them to use embryonic stem cells. Now they can receive more investment from the government and national funding agencies. Until now, this kind of research was “frozen” together with embryos.

Embryonic stem cell research opens new hopes not only for patients with Alzheimer’s, Parkinson and other degenerative diseases but also in areas of scientific and technological development.

Researcher Claudia Chamas of the Oswaldo Cruz Foundation – considered the most important public health institute in Latin America – along with three colleagues did a study about patent protection in the field of stem cells, and proposed some criteria for the granting of patents in that field of knowledge in Brazil.

Chamas said that worldwide many patents are granted on stem cell research. In 2002, 2,000 applications were filed and about 500 were granted in different countries, according to the United States Patent and Trademark Office.

In Brazil, the amount of activity was small in comparison with developed countries. According to data from the National Institute of Industrial Property (INPI), in 1999 only seven patents were filed in this field. The number of filings had increased to 28 in 2004, but fell in 2005 to four. The total from 1999 to 2005 was 78.

Around the world, patenting of stem cells is a subject with many questions. “This creates uncertainty for companies that want to invest in promising therapeutics with this new technology,” said Chamas. There are many imaginable ways to grant a patent on a stem cell, but it depends on the laws of each country. For instance, some, such as Brazil, do not allow patents on living organisms.

In general, researchers could claim to develop new methods of isolation, detection and concentration, stem cell proliferation, differentiation, patient treatment, or lines of stem cells.

In Brazil, the stem cell cannot be patented, as Articles 10 and 18 from the Industrial Property Law (Law 9.279/06) state that the country does not recognise patents on life. But the country accepts patents on processes for obtaining stem cells and other things such as proliferation, differentiation, and patient treatment, with INPI requiring novelty, inventive step, industrial application and other tests.

According to Luiz Eugênio Mello, president of the Federation of Brazilian of Experimental Biology Societies (in Portuguese, Federação de Sociedades de Biologia Experimental), an institution that brings together dozens of national societies and thousands of scientific researchers, the decision at the Supreme Court was an historic moment for science and society.

Mello told Intellectual Property Watch that the scientific community hopes that now this kind of research will have more visibility and expects it will receive more resources. The Health Ministry and the Science and Technology Ministry have a project to release resources totalling US$12 million to this area. “It is true that this value is little money, but we see as a sign of priority by the government,” said Mello.

President of the Brazilian Society of Biophysics, Marcelo Morales, completed Mello’s argument, saying, “We hope that Brazilian scientists can continue to serve the country through the development of national technology to give access to the whole society and not only for those who can pay abroad for treatment. The permission to study embryonic stem cells gives us the possibility that in the future we can cure incurable diseases.”

The biggest public opinion research institute in Brazil (Ibope) did a survey on society’s opinion about use of embryonic stem cells to treat people with serious diseases. The result showed that 75 percent of Brazilian people were in favour. The survey, conducted in January 2008, included 1,863 Brazilian people between 16 and 70 years old. Among interviewed, 1,230 were Catholic and 386 were Evangelical.

Among those with university degrees who were interviewed, 97 percent agreed with the embryonic stem cell research. This number fell to 94 percent among those with less education (only five years). This research was requested by an NGO Católicas pelo Direito de Decidir (Catholics by Right to Decide).

Stem cells can be considered the basis for every organ, tissue and cell within the human body, and are classified into two distinct types: adult and embryonic stem cells. While the former are derived from developed organs or tissues, such as the bone marrow or the cord blood of newborns’ umbilical cords, the second ones latter are obtained from embryos created by in vitro fertilisation.

Adult stem cells, unlike embryonic, cannot grow outside the living body, and have a more limited application, being able to form only a few different tissues, as muscles, bones etc. They are currently used in the treatment of blood diseases. Embryonic stem cells can develop into any kind of cell (even neuron cells) or tissue, representing great hope for cell-based regenerative therapies, to treat diseases such as Parkinson’s, Alzheimer’s, diabetes and spinal cord damage.

Until now, there has not been a therapy with embryonic stem-cells in humans, because we need more research to control these cells and their proliferation. But now Brazil has freedom to investigate.

Claudia Jurberg may be reached at info@ip-watch.ch.