Team:UNSW Australia/Human Practices/Law

Law and Regulation

Overview

The legal frameworks surrounding synthetic biology are critically important because they determine what type of research can be undertaken, by selecting for research that is both legally allowable and has potential commercial implications. However, scientists often fail to most effectively lobby for frameworks that support what their research actually needs, instead acquiescing to government policy that bows to vested commercial interests.

As a result, UNSW iGEM 2018 has created a scientist’s guide to writing a policy proposal for government change and written an example submission. We have also documented our discussions with various stakeholders in the process, such as normal scientists and the government departments who receive the submissions. UNSW iGEM 2018 also collaborated with other student organisations, including the UNSW Law Society.

UNSW iGEM 2018 discovered, as part of our foray into commercialisation, that patent law for pieces of genetic information is hard to comprehend from the scientific perspective. This is particularly important for scientists, as without patents, it can make commercialisation of their discoveries hard, and thus dis-incentivise funding of their research. It is further complicated by the international nature of research meeting individual countries’ patent law regimes.

Relevance

The legal sphere may seem divorced from the practice of science in the laboratory, but in reality, they are closely intertwined, with three key points of intersection.

Commercialisation

The law can grant protection over ‘inventions’ made by scientists. The protection the law grants can then allow the invention to be commercialised, and incentivises companies to invest in research to get a competitive advantage in the market – without fear of unmitigated copying. The law aims to encourage and assist innovation, instead of stifling it, by allowing market forces (and the scientists) to capitalise on invention.

It also means that the research with the most funding is typically the research which is the most potentially lucrative – research which can present solutions to problems (like cancer) that affect wealthier societies who can pay more for medicine. This is as opposed to research for diseases almost exclusively present in poorer nations (like dengue).

Our team faced this issue – foundational technologies like the Assemblase system did not fit many of the grant opportunities that were available, being for things much closer to practical use. It did also mean we chose really practical enzymes for our model.

Accessibility & Availability

The law’s protection comes with a stipulation that the protected invention is revealed to the public. As a result, the public has access to that idea once the protected timeframe is over.

It also means that researchers can, in the future, build off that idea to have higher quality research, as well as the disclosure meaning that scientists may choose to stop research in a particular area, and refocus on another.

However, that means that the law can render certain ideas inaccessible for a number of years. The challenge here is that science is built off of the research of others; and a period of years can truly stifle development and innovation.

Our team faced issues surrounding the availability of the protein Spy Tag/Catcher system, because of its legal protection. However, these issues were avoided thanks to the research locations (and protection) being in two different jurisdictions.

Grants & Ethics Approval

The legal ‘tick of approval’ is being introduced into grant applications within Australia, currently being part of grant applications in Europe.

The grants the team received were not dependent on ethics approval of the research; however, we question whether they should be.

The availability of grant money to fund the research also determines what projects can be undertaken – a project ineligible for grant money is far less likely to go ahead.

There is also a correlation between the likely patentability of an invention, or area of science, and the amount of research funding which goes into the area. The Australian Bureau of Industry Economics 1994 Report stated that legal protection seems to ‘increase the incentive for investment in research and development, in a reasonably cost effective way’, and there has not been any significant change from this position in Australia. More evidence of this correlation comes from the US, where 80% of the money spent on basic pharmaceutical research (usually not patentable) comes from public sources.

Analysis

The Assemblase system has posed a number of legal challenges for the team, with these challenges arising from the very beginning of the project.

Early on, the team had questions about the possibility of patenting the new, invented system. Early advice was sought from one of the team mentors (Daniel Winter), and the advice essentially stated that genetic sequences were not patentable or protectable, and therefore there was no possibility of patenting the invention. However, there was a serious lack of clarity within the advice as to the actual reasons why that was so. Further research was then done into the relevant legal decisions establishing sequence protection law, particularly the High Court of Australia decision in Myriad Genetics v D’Arcy. Such research later showed that in actuality, it was the sequences of the proteins which was not protectable – rather than the actual structure and design of the scaffold. There is an equivalent US decision as well; Association for Molecular Pathology v Myriad Genetics, although the scope of protection differs between the two decisions. Dr Alexandra George was also consulted regarding some of the particular aspects of the law in order for the team to then evaluate if our invention would fall under the protected category.

Issues about patents arose yet again when the team decided to use Spy Tag/Catcher and Snoop Tag/Catcher as part of the scaffold. Patent research revealed that Spy Tag/Catcher held a US patent, but we could not find one for Australia. There is a bilateral US – Australia agreement that governs intellectual property in addition to the worldwide TRIPPS treaty, however the agreement does not make US patents enforceable in Australia. The US-Australia agreement tends more towards ensuring that the systems have similar outcomes and protections once patents are granted, and similar terms for granting patents. As a result, we were confident that we were allowed to use the Spy Tag/Catcher system, and did end up using it in the project, as opposed to the Sdy Tag/Catcher system which wasn’t patented but was much more cross-reactive with the other Tag/Catchers. However, given the extensive research that had to be conducted to arrive at this position, the team began to think about how we might be able to push for systemic change.

As a result, consultations were sought with Lan Le (Research Ethics and Compliance Support) and Brad Walsh (CEO of Minomic International Ltd.). These consultations, in addition to speaking with Carl Stubbings (Head of Commercialisation, Minomic International Ltd.) at our team’s symposium, brought to our attention one other important impact legal protection has on science – it plays a major role in determining to which research the money flows. Lan spoke about how legal (and ethics) approval was becoming a prerequisite for any grant funding, while Brad and Carl spoke about how legal protection allows them to capitalise on their investment into research – which is essential for them to have more funds to reinvest in research. Further research into this area revealed that the link between possible legal protection and funding is quite substantial. For our iGEM team, in applying for grants we found that we our research wasn’t eligible for many opportunities, with many more opportunities for research into direct medical applications, where there is clearly a better chance for a profit to be made.

As a result, our team was convinced that the current balance between legal protection for science and not stifling innovation was not quite right. This position however is not new, being one that is constantly argued over. However, in exploring how we could contribute our voice and experience to the conversation, the team has discovered a ‘missing link’ of communication between science and the law, despite the many important effects that law has on the practice of science. One possible way to re-establish this link is through writing to government, which is why UNSW iGEM 2018 has created a policy guide and example policy submission.

The policy submission, and suggestions for improvement, were critically evaluated and analysed in light of comments from Dr Alexandra George and the Pasteur Paris iGEM team. The Pasteur team particularly gave us insight into the differences between the civil law European regime and the Australian process, and Dr Alexandra George also gave insight into how the French system’s benefits are replicated here, but in a slightly different way.

Integration

The team’s research into the legal frameworks and implications on scientific research has affected the direction of our project. Firstly, it affected the decision of whether to patent the Assemblase system, by providing the framework to discuss the likelihood of a successful protection claim. As legal information gathered suggested that a patent was an unlikely outcome, the focus of the system refocused on the modularity of the system, and using ‘ideal’ test enzymes. It also affected the way we consulted with other academics and people in industry, as we were more open with our ideas, and they could give us better feedback (being more directed towards the project).

Secondly, it affected the decision surrounding which covalent protein attachment system was going to be chosen to use with the scaffold. Initial legal research had made us aware of the patent system, and further research was undertaken to establish whether an Australian patent was held for the system we wanted to use, whether that patent would stop our use of the system (educational exceptions to patents) and whether a US patent which did exist would stop our use of the system. Fortunately, using the research we came to a conclusion that the best systems to use (Spy Tag/Catcher and Snoop Tag/Catcher) were not protected in Australia, and that we could use them. The legal information gathered also led us to present an alternative in case of protection; the use of Snoop Tag/Catcher and Sdy Tag/Catcher systems, being that these were not patented in both relevant countries of the United States and Australia.

There were also several indirect effects of legal systems on our project. Namely, the availability of certain methodologies in sufficient detail to allow them to be replicated within the modelling aspect of the project. It seemed that some of the key papers’ writers were trying to patent part of their research, and so did not publish very many details on their method – which proved to be challenging when our team tried to replicate part of their research using our enzymes. Additionally, it appears that the legal system fed into the lack of funding opportunities available; as outlined above, the lack of legal protection is associated with a lack of funding opportunities, particularly from independent companies, as they look for inventions which can give them a commercial edge in the market.

  1. Productivity Commission 2016, Intellectual Property Arrangements, Inquiry Report No. 78, Canberra. D’Arcy v Myriad Genetics (2015) 258 CLR 334 [20].
  2. N V Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655.
  3. Patents Act 1990 (Cth).
  4. Andrew Stewart et al, Intellectual Property in Australia (Lexis Nexis Butterworths, 6th ed, 2018).
  5. Donald W Light and Joel R Lexchin, ‘Pharmaceutical research and development: what do we get for all that money?’ (2012) 343 British Medical Journal 4348; United States Congressional Budget Office, United States Congress, Research and Development in the Pharmaceutical Industry (2006), 7.
  6. CCOM Pty Ltd v Jiejing Pty Ltd (1994) 28 IPR 481.
  7. Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253.
  8. Association for Molecular Pathology v Myriad Genetics Inc (2013) 569 US 12-389.
  9. Powell, D. and Tsourkas, A. (2016). Spycatcher and spytag: universal immune receptors for t cells. WO2017112784A1.
  10. US Free Trade Agreement Implementation Act 2004 (Cth) implementing the Australia-United States Free Trade Agreement.
  11. Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement (1993).
  12. Yajie Liu et al, ‘Tuning SpyTag–SpyCatcher mutant pairs toward orthogonal reactivity encryption’ (2017) 8 Chemical Science 6577-6582.
    13. D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334; CCOM Pty Ltd v Jiejing Pty Ltd (1994) 28 IPR 481; Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253.
  13. Donald W Light and Joel R Lexchin, ‘Pharmaceutical research and development: what do we get for all that money?’ (2012) 343 British Medical Journal 4348; United States Congressional Budget Office, United States Congress, Research and Development in the Pharmaceutical Industry (2006), 7.