The futur of biotech patents – part 1


[En français]

What is the futur (if any) of biotech patents? What did the Bilski ruling change? Did it change something at all? I’m not a specialist, but I’ll give it a try. First, this posting will adress the question about the definition of what patenting the living means. In another one, I’ll try to go more into some historical details and their importance for the futur of biotech patents.

The first question to adress is: what are these biotech patents about? In other words, what is patentable when talking about biology and life sciences domain?

Surprisingly or not, there are many answers. Depending on whether you are in the US or in Europe, for example. Thus, the USPTO (United-States Patent and Trademark Office) has a vision about patenting a part of the genome and the EPO (European Patent Office) has its. According to the USPTO, a patent application is judged on four criteria:

  1. The invention must be useful e.g. the inventor must identify some useful purpose for it;
  2. The invention must be  novel i.e. not known or used before the filing;
  3. The invention must be nonobvious as well, i.e. it must not be an improvement easily made by someone trained in the relevant area;
  4. The invention also must be described in sufficient detail to enable one skilled in the field to use it for the stated purpose (also called the enablement criterion).

According to the EPO (European Office of Patents), biotechnology inventions have to meet the same criteria as those in any other technical field:

  1. The invention is new;
  2. The invention is susceptible of industrial application;
  3. It involves an inventive step.

But given the nature of biotechnology, various other rules also apply.

Raw material is not patentable, which means that it is sufficient to isolate and purify a DNA sequence to make it “non natural” and thus, eventually patentable. In other words, given that Do It Yourself biology (DIYbio) is developping more and more, who knows: maybe extracting some DNA from a home-modified bacteria is patentable…

In general, the USPTO follows what is called the first-to-invent rule while in the majority of the other countries in the world the rule first-to-file is followed to give priority to patent. According to the USPTO, 3 years are needed to issue a patent versus 1 year and a half in the case of the EPO. Both offices deliver patents which are valide for 20 years from the date of filing.

What do gene patents mean in practice? The patent holders own the exclusive rights to the genetic sequences which have been patented, to their usage, and chemical composition. Therefore, anyone who makes or uses a patented gene without permission of the patent holder (for  commercial or noncommercial purposes) commits patent infringement and can be sued by the patent holder for it. Several surveys have established that nearly 20% of identified human genes are subjects to patents…

Because of its controversial definition, gene patenting is a tough story. For this and other reasons, the Human Genome Project decided to make all genetic sequence available in the public domain. The patenting and licensing issues are still there though: what about everything which is not a gene strictly speaking, such as a haplotype, SNP, gene expression data,…? A study by the National Human Genome Research Institute (NHGRI) in collaboration with NIH was completed in 2006; here is the description:

The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.

Quite surprisingly – or should I say paradoxally, – patents on diagnostic tests seem to be discouraged but not those on treatments.

In the US, many scientists complete a PhD degree and choose “a career away of the bench” which is, for instance, become a patent examiner/agent or technology transfer specialist. You do not need a law degree to do this work. In Europe, many universities offer courses on patenting inventions.

How did people begin patenting the living? If I’m not abused, it began in the 19th with a scientist in Finland patenting a way to make yeast cultures; Pasteur also patented his yeast-making method. In the 1980s, the ruling of Diamond v. Chakrabarty where the US Supreme Court was devided in 5 vs. 4and it was stated that a an engineered bacterium able to ingest oil was not “a product of nature” and thus, the innovation was technical and subject to patenting.

So, why do patents exist? They provide benefits to those who hold them. People say that patenting a technology/discovery is source for innovation. Researchers are reawarded for their work and it prevents others to duplicate the efforts. One even claim that transparency is forced and every researcher willing to access the innovation is free to do it with respect to the patenting law.

I should say I’m totally shocked when reading and/or hearing this kind of considerations:

  • They provide benefits to those who hold them: for sure. So, when someone is in academia, is it for gathering and producing knowledge or is it for making financial benefits on a quite personal basis? What about all the people such as technicians, trainees and other students who have worked on the subject? I’m suspicious about them being equal patent holders.
  • Patenting a technology/discovery is source for innovation: this one is the best one. So, it is just impossible for me to imagine how a gene being protected by tons of pages of prohibitions to use is a source of innovation. I’m not even talking about the absurdity of pretending to own something which just exists. The patenting system insures monopolies to a small number of companies. But when you imagine that for numerous labs it is even difficult to pay for publishing, how could someone imagine patenting genes is a scientific incentive?
  • Researchers are reawarded for their work and it prevents others to duplicate the efforts: this is fallacious, untruthful even. So, for a scientist to be reawarded, there is only one way: have a patent on a gene? And what about the other jerks who have no patents? They do useless work? Interesting consideration. Furthermore, the idea of the isolated crazy researcher doing close-to-magic stuff in a smoky lab is a cliché and totaly unreal. Nowadays, there are teams working with highly complexe technology and in most of the cases, collaborations are ongoing because the equipement is very expensive and the data is too huge to be handled by one person alone. So, when a team publishes a  paper reporting newly sequenced genome or whatever else, the data has to be included in a public database. It is therefore made public and accessible by whoever needs it, for free. Moreover, in more and more cases, the databases and public repositories are manually curated, which means that there is a real person taking care of the quality of the data which is there. I think I’m not crazy or idiot saying that having data produced by all researchers in the world pucblicly available is enough to reduce the secrecy and avoid duplication of efforts.

My question at the end of this posting is: why should we keep on obeying to a deprecate law system?

Image (CC-by)

A translation in French is also available.

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