Whereas many biotechnological companies pursue patents that allow them to valorise their knowledge, the US Supreme Court recently ruled that DNA sequences in nature (or parts thereof) are not patentable as such. This requires the biotech community to rethink the relationship between open source and patentable knowledge – just like in the case of computer software.
Lux Research, a Boston based company, last month completed a report ‘BioPunks and BioPatents: The Open-source Battle Comes to Synbio IP’ that dug into the relationship between patentable and open-source biotechnology, and the influence of the Supreme Court decision. The ruling affects primarily the field of synthetic biology, a science branch that is rapidly gaining importance in the field of biotechnology. Simply put, synthetic biology is the design and construction of biological devices and systems for useful purposes. It aims to discover how life works, and then alter parts of this mechanism in order to produce valuable products or services.
Patents as high-cost hindrances to innovation
The US biotechnological company Myriad discovered two genes that program the incidence of breast cancer. It tried to patent this knowledge as such, i.e. it claimed the exclusive use of this knowledge. In its AMP vs. Myriad decision, the US Supreme Court ruled that nature as such is not patentable. According to Lux Research, this judgment strikes down an age-old biological patenting system; consequently biotechnology companies need to incorporate open-source into their innovation plans in order to succeed in the emerging landscape. It notes that many classes of biotech patents are increasingly seen as a legally dubious, high-cost hindrance to innovation.
Lux is of the opinion that business and consumers may actually benefit from the enlarged area for open-source biological knowledge. It sees a parallel in the open-source computer codes: standard protocols like GSM and HTML, and modular software. These have transformed information technology and accelerated product innovation. Contrast to that, it says, the software patent battles that are hobbling innovators like Google, Apple and Samsung in a multibillion-dollar morass. Open-source, properly applied, has major advantages. Open-source genetic codes, such as modular DNA sequences, could speed up the development of better drugs, bio-based materials and useful organisms, according to Lux.
Partnering
‘Despite its evident rise, the open-source biology movement should not be seen as an alternative to conventional R&D or an enemy of IP,’ says Mark Bünger, Lux Research Director and the lead author of the report. ‘In fact, corporations should pursue upstream innovations with conventional suppliers, licensors and M&A targets, while using a mix of corporate and academic partners, and the open-source community for earlier-stage research.’
In order to map the future relationship between patenting and open-source knowledge, Lux Research analysts studied more than 10,000 patents in 14 key areas of synthetic biology. They found that patenting is still common practice when engineering organisms to produce useful chemicals and fuels. As ‘the next frontier’ they identify novel structural materials, for instance protein-based materials resembling spider silk. Here, conventional and open-source science is dominant, but patenting is also beginning. And, so they conclude, conventional partnering on the basis of good patents is still a firm basis for new business development.