Future Of Biotechnology And IP: Research Exemptions, Ceilings, Trade Secrets

Patenting of biotechnologies is a growing trend and is increasingly raising questions about legal and ethical implications and a lack of harmonisation, according to speakers at a recent World Intellectual Property Organization (WIPO) symposium.

The 25 November event, entitled Symposium on Future Challenges on International Law: The Way Forward in Patenting Biotechnology, was organised by WIPO in cooperation with the University of Bern and the World Trade Institute (WTI).

Biotechnology has human rights implications, trade implications, and development dimensions, according to WTI, which presented the work of the National Centres of Competence in Research (NCCR) project on biotechnology, referred to as IP-9, as it is the ninth individual project.

The centres are the research instrument of the Swiss National Science Foundation. The NCCR on Trade Regulation is located at WTI and works in collaboration with several universities. IP-9 aims at addressing the regulation of biotechnology in the fields of agriculture and healthcare within the World Trade Organisation, according to the IP-9 website.

Research exemption from patenting is important in the field of biotechnology, said Thomas Cottier, managing director of the WTI, because of the risk of patent “thickening,” in which several patents stack up on inventions, for instance, through mergers and acquisitions. Although this risk is debated, a lot of biotech start-up companies having IP rights are bought up in mergers and acquisitions by larger companies, he said.

There are different angles to the debate on research exemptions, according to Cottier, whether people work with a patent, or on a patent, or whether they use the so-called Bolar exception in the United States, which allows the use of pharmaceutical trial data under patent to produce generic drugs as soon as the patent expires.

There is no uniformity of the law in this field, he said. Germany, Belgium, Switzerland and Italy, for example, have adopted research exemptions, but even countries that “don’t have it on the books” are practicing it in case law.

However, there is uncertainty about research exemptions being compliant with the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). He asked whether a research exemption is a fair use exemption, and whether it can be justified under Article 30 of TRIPS, which states: “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.”

“We have that justification for the Bolar exemption,” he said.

Research exemptions are a good example of ceilings, he said. The TRIPS agreement, as a minimal agreement, only defines the minimum protection, while research exemption defines the maximum protection. “This is a paradigm shift,” he said.

“This is an area where we should go for harmonisation,” he said, as there is a large bulk of materials for research exemptions in the world and a lot of countries want to go in that direction. Cottier called for the issue to be introduced and discussed in multilateral negotiations.

“The TRIPS agreement essentially treats all countries alike,” Cottier said. However, they are different from an economic and social development point of view and should be treated differently, he argued.

A progressive liberalisation or graduation in the field of IP would be helpful, he said. The idea would be to use threshold legislation. “There would be one set of rules on the book but whether or not a country is obliged to introduce protection would depend on economic factors which reflect an appropriate level of competitiveness in the sector, and in the economy as a whole.”

In the TRIPS dispute settlement, disputes are brought between countries and companies that are competing. “Nobody cares” if a least-developed country implemented the TRIPS agreement, but “when you enter into a zone where you start competing, people take an interest for you to comply; this is what happened to China, for example,” Cottier said.

Graduation is already applied by some countries when they implement the TRIPS waiver of Article 31, allowing the issuing of compulsory licences. A number of countries introduced thresholds to define the level of compensation these countries have to pay for receiving drugs under compulsory licences, he said. One of the factors they used is their level in the Human Development Index for the United Nations Development Programme.

Man-Made or Nature-Made Inventions

For Nuno Pires de Carvalho, deputy director, patent division, in the Global Challenges Division at WIPO, there are different inventions; ones made by nature and ones made by man. Inventions made by nature are non-patentable in most WIPO member states, he said.

Europe has modified patent systems to address the question of patenting biotechnology, in order to prevent the appropriation of nature-made inventions

The myth is to believe that “if you don’t want inventions to be made, you take away the patents,” he said. Patents are important when the research is made in the private sector, but it is commercial opportunity that encourages inventions and although in some cases, patents are the only way to extract profit from commercial opportunities, in other sectors there are trade secrets.

In order for the patent community to adapt to the characteristics of biotechnology, a review of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, could be an idea, he said. Some countries have used it for cells and cell lines, and the treaty could be made more encompassing and transformed into an international treaty on biotechnology, he said.

In biotechnology, companies have alternative to patents, such as trade secrets, said Jayashree Watal, a counsellor at the WTO Intellectual Property Division. Commercial opportunities have a larger influence than patents when it comes to commercialisation, she said.

“You cannot blame the TRIPS agreement” for not allowing an ethical exception in the area of biotechnology, she said. WTO members, as an option, could exclude an invention from patentability, but there is one condition, that it should be necessary to prevent commercial exploitation of the innovation, according to Article 27.2, she said.

There has been some misreading of this article, she said, which was meant to prevent the exception to circumvent patent protection from the right holder. Some have read this to the contrary, even in the climate change context.

Human and Animal Genetic Resources; Different Debates

In human genetic resources, the ethical debate concentrates mainly on stem cell research, said Michelangelo Temmerman, senior research fellow at WTI. Diverging patent regimes may have trade distorting effects which are bound to increase in the future, he said.

If harmonisation of international patent rules appears recommendable, all countries might not be willing or ready for it, according to Temmerman. TRIPS creates legal uncertainty and should reflect internationally accepted core ethical agreements.

In the area of animal genetic resources, there is an increasing role of IP rights, according to Susette Biber-Klemm, also a senior research fellow at WTI. The IP-9 project, of which Biber-Klemm is alternate leader calls for a new IP regime but analogies to plant genetic resources should be looked at with caution because animal-related regulations are built against a very different background,.

The IP-9 project also calls for exclusion of all animals from patentability “who are likely to suffer in a manner that is disproportionate to the progress in research that can be achieved,” Temmerman told Intellectual Property Watch later. As this is the usual limitation to research and development, the team says that the rule should not be different in patent law, he said.

Kaitlin Mara contributed to this story