The sentence by the Supreme Court of the United States that forbids patenting human genome material represents a big step for science and scientists have welcomed the news with great satisfaction. To date, the North American company Myriad Genetics owned the rights to industrial property and commercial exploitation of the BRCA1 and BRCA2 genes, whose detection was crucial for measuring the risk of developing ovarian or breast cancer. This fact hindered other companies from freely using the mentioned genes for diagnosis tests. There is a new scenario now, among other reasons because competitiveness is on the rise, which will result in more affordable tests making them thus accessible for more people. Mètode has talked to some experts on the genome and cancer research to analyse the situation.
Jaume Bertranpetit «Patenting what is discovered is completely absurd because it already exists, it has not been invented» Full Professor of Biology at Pompeu Fabra University (UPF)
What direction is biomedical research now taking? Nothing is going to change. The sticking point is that they had already accepted patents of naturally occurring human sequences. The whole world agrees that inventions should be patented, but not discoveries, because they already exist. Besides, genetic diagnosis consists on describing what you are seeing. Up until now, if you wanted to sequence the BRCA1 or the BRCA2 gene you had to pay money to Myriad Genetics for the diagnosis. That was downright nonsensical.
This sentence leaves the door open to patenting synthetic DNA (artificial products derivative from the gene). How can it be used and how do you assess this decision? Any invention from any material can be patented. Maybe in the near future we will be able to invent things that nature has not invented. This is interesting for those who work on biotechnology and synthetic biology because they would have the possibility of patenting their work.
The pharmaceutical industry keeps claiming that without the protection of Intellectual Property «it will be more difficult to attract investors for researching cancer because patents guarantee recouping that investment». What is your opinion about that? Unless there is a very specific diagnosis technology, patents should only be valid for inventions. A patent where standard technologies are used to describe something that we are seeing and already exists is unconceivable.
Do you think this sentence sets a precedent regarding other kind of patents, like vaccines or antibiotics? No, definitely no, because they are inventions. The most valuable lesson we can extract from this sentence is remembering Craig Venter attempt to patent the whole human sequence. He made it on behalf of the National Institutes of Health, which is a public organism, not to his own profit. So the question remains: was it right? And I say: «Well, he made it just in case somebody did it before him». As we know now that cannot be the case, because it is illegal, everyone is keeping it cool.
«Patents should only be valid for inventions, not for diagnosis, unless there is a very specific diagnosis technology»
Ana Cuenda «It would be easier to do research without the obstacle patents represent»
Head of Department of Immunology and Oncology at the Spanish National Centre for Biotechnology (Centro Nacional de Biotecnología)
What direction is biomedical research now taking? It means a great advance for scientists because they will have the possibility to research the mentioned genes more freely—some of which are involved in cancer-related diseases— which I expect will result in therapeutic applications for patients.
What changes did the sentence produce in the field of cancer research? In general, removing the obstacles the patents of human genes represent speeds up scientific processes, which will develop further and faster, because this restriction disappears.
The pharmaceutical industry keeps claiming that without the protection of Intellectual Property «it will be more difficult to attract investors for researching cancer because patents guarantee recouping that investment». What is your opinion about that? I think this claim can somehow be true for pharmaceutical companies, but I think it is quite the opposite in the long term. The more knowledge generated about cancer, the more profits they can make, because this way research is not limited to only a few scientists.
Although we know it is not legal anymore, is patenting the human gene ethical? My personal opinion is it is not ethical, it is something that should be accessible for everybody, because everybody gets sick and has the right to be healed. Although it could be understandable that for them it is just business and that they want to obtain a profit.
«Removing the obstacles the patents of human genes represent speeds up scientific processes, which will develop further and faster»
José Pío Beltrán «It is nonsense that someone can own a gene»
Institutional delegate for CSIC in the Valencian Community
What direction is biomedical research now taking? That is a difficult question and we must wait and see what happens, because precisely the ones that supported the traditional American stance regarding gene patents —i.e. that they can be patented—, have claimed that that was the way towards personalised medicine. Only for the rich, though. The sentence by the North American judges is a wise one because, in a world where the rich get richer and the poor get poorer, it balances the scale.
This sentence leaves the door open to patenting synthetic DNA (artificial products derivative from the gene). How can it be used and how do you assess this decision? It is not very useful yet, but once genetic material can be copied and pasted, a door will be open to the synthesis of genes that do not exist in nature and to finding practical applications. The difference is that we are not talking about cultural heritage, but about something that emerges in a laboratory.
The pharmaceutical industry keeps claiming that without the protection of Intellectual Property «it will be more difficult to attract investors for researching cancer because patents guarantee recouping that investment» What is your opinion about that? Yes, it is a setback for the companies that try to understand the genetic and molecular basis of diseases. But it is not a dramatic setback and they should be able to recover, because there is a long way ahead to recoup investments. What is clear is that nobody can own a gene, it is nonsense. Although I think that the uses of that genetic material should be regulated. For instance, if someone designed a procedure to prevent or heal a disease from that genetic material, there is an intellectual property to defend, but that does not mean that other companies cannot design other methods using the same genes. That is why we need to establish regulations.
Do you think this sentence sets a precedent regarding other kind of patents, like vaccines or antibiotics? We can’t allow for genetic material to be patented, and that should also apply to animals and plants, not just to human genes.
«We can’t allow for genetic material to be patented, and that should also apply to animals and plants, not just to human genes»
Manuel Pérez Alonso «Almost 30% of human genes were patented before the sentence was issued» Bioentrepeneur and Head of Bioval (Bioregion of the Valencian Community)
What direction is biomedical research now taking? This sentence affects thousands and thousands of already existing patents. From now on, many laboratories, both public and private, will be able to use knowledge and derivative applications without paying attention to the patents that controlled them, because up until now, it was the owner of the company who had to authorise their use. Almost 30% of human genes were patented before the sentence was issued. So, from now on, we expect a great deal of medical applications in the field of genetics.
This sentence leaves the door open to patenting synthetic DNA (artificial products derivative from the gene). How can it be used and how do you assess this decision? It is what we call recombinant DNA molecules, which among other things can be used for the creation of useful tools for the discovery of medicines. We need to guarantee a kind of protection that stimulates research in this branch of biotechnology.
The pharmaceutical industry keeps claiming that without the protection of Intellectual Property «it will be more difficult to attract investors for researching cancer because patents guarantee recouping that investment». What is your opinion about that? In my opinion this principle is not applicable to the diagnosis field, because I think it is possible to attract investors even without patents. The patents that existed previously were completely absurd, and we have already lived this absurdity for a very long time.
«Many laboratories, both public and private, will be able to use knowledge and derivative applications without paying attention to the patents that controlled them»
Alfonso Valencia «Now companies may look for sophistication in gene manipulation to justify an invention» Vice-director of Basic research at the Spanish Nacional Cancer Research Centre (CNIO)
What direction is biomedical research now taking? One of the changes is that it will be easier for the companies to make diagnosis tests, which I consider is a positive thing. In fact, some companies, despite having better technologies, could not carry them out because of the patents. Another unexpected consequence that may come is that companies tend to look for sophistication in gene manipulation to justify an invention, since the sentence emphasises that products deriving from genes can be patented. There will be more business opportunities in the synthetic biology sector.
The pharmaceutical industry keeps claiming that without the protection of Intellectual Property «it will be more difficult to attract investors for researching cancer because patents guarantee recouping that investment». What is your opinion about that? It is difficult to know up to what point these statements are true or if they reflect an unfounded fear that it may negatively affect their interests. The lesson we have learnt from the sequencing of the human genome is that it has caused an important growth of the industry, with the creation of between 350,000 and 400,000 jobs in the United States. It seems that numbers do not support the idea that the lack of patents on genes may harm the industry.
Although we know it is not legal anymore, is patenting the human gene ethical? It is not just unethical, but very little reasonable as well. It would be like patenting a tree or anything you find in nature.
Do you think this sentence sets a precedent regarding other kind of patents, like vaccines or antibiotics? It is clearly extensible to all natural products, those obtained directly from nature, be they genomes or other chemical products like proteins.
«The sequencing of the human genome is that it has caused an important growth of the industry. Numbers do not seem to support the idea that the lack of patents on genes may harm the industry»
