22 四月 2020
Synapse - May 2020 – 2 / 6 观点
The search for effective treatment options against COVID-19 and effective vaccines against SARS CoV 2 on the one hand, and the time pressure and public pressure to achieve results on the other hand, put pressure on the pharmaceutical industry to innovative forms of cooperation: the worldwide exchange and disclosure of research results.
Renowned pharmaceutical companies are joining forces in the search for drugs and vaccines. For example, the Oxford University Innovation, responsible for technology transfers at Oxford University, recently announced new guidelines for accelerated non-exclusive licensing to potential partners interested in using their COVID-19 related intellectual property.
Politically, the possibility of a patent pool is being discussed, in which relevant medical solutions, know-how and patent rights can be brought in and then licensed out on a non-exclusive basis in order to be made easily available to as many users as possible.
If patent protection is to be achieved with an exclusive right of use for a limited period and the possibility of completely excluding others from use, research results must be applied for a patent as early as possible to ensure that the patentability requirements of novelty and inventive step are sufficiently met. This is the usual procedure to date, especially in the pharmaceutical industry, and prevents an early exchange of research results as long as they have not been protected by a patent application.
If third parties - whether other pharmaceutical manufacturers, non-profit organisations, hospitals outside clinical trials or government agencies - want to use the invention, they must take licences, although the patent holder can in principle refuse to grant them - unless there is a situation of a compulsory licence or a governmental order to use the invention.
Both the research and the later necessary worldwide supply of a vaccine or drug are now forcing the pharmaceutical industry to rethink: Rapid research results can only be achieved if researchers from all countries work together openly and without reservation, regardless of existing or future property rights.
At the same time, manufacturing capacity and supply chains must be broadened if global availability of a vaccine or drug is to be ensured in a very short time. A single pharmaceutical company, regardless of its size, cannot do this only by itself. Both can only be solved if there is legal certainty already at an early stage with regard to the research results and their exploitation.
Research cooperation is usually contractually regulated as R&D projects or joint ventures. Both are regularly preceded by lengthy rounds of negotiations, which are characterised by discussions on ownership and the scope of potential exploitation of the jointly achieved results.
The allocation of invention contributions in case of joint inventions and their exploitation, especially when international researchers and research institutes are involved and many details from applicable law to dispute settlement have to be considered, is very complex and can only be covered by means of complicated contractual arrangements. The negotiation and agreement often takes years. For practical reasons alone, these means seem therefore rather unsuitable for the fight against SARS CoV 2 due to the urgency of the matter.
If research results have been patented, the production and delivery can be spread to several companies or authorities worldwide, ideally to ensure decentralised national production on site and short delivery routes, thus ensuring that all patients - basically the world population - are supplied with a vaccine or drug. In principle, the grant of non-exclusive (or even free) licenses might be a good way to achieve these aims. However, also such licenses must be negotiated and jointly agreed upon, which, if it is done on an individual basis, is complicated and needs extensive time.
In addition, there is a risk that uncertainty about the existence and enforceability of patent rights on the objects currently being researched may inhibit the investment propensity of potential licensees and manufacturers. Furthermore, there is not just one patent, but assuming a multitude of complementary innovations, be it with regard to:
which are interconnected, so that a multitude of license agreements would have to be concluded by each interested manufacturer. This would require correspondingly complex freedom-to-operate analyses and include complex processes of legal and economic consideration.
A solution recently (again) discussed in this context could be the creation of a patent pool, by which researchers and patent holders make their research results and patents for the prevention (vaccination) and treatment of SARS CoV 2 available to third parties, usually for a royalty, while adhering to certain criteria that apply equally to all.
In the field of standardised technologies (eg as in mobile communications in particular), such patent pools are well-known for so-called standard essential patents (ie patents whose use is absolutely necessary to comply with a certain technical standard), even though their handling and enforcement in practice still raises many legal questions.
In the field of pharmaceutical research, the WHO has already investigated the possibility of patent pools in the wake of the SARS epidemic in 2002 and SARS-CoV (1) in 2003 (Simon/Claassen/Correa/Osterhaus: „Managing severe acute respiratory syndrome (SARS) intellectual property rights: the possible role of patent pooling“, Bulletin of the WHO, September 2005, 83 ff .).
Such a patent pool raises a number of patent, antitrust and administrative issues that Simon et al consider, however, solvable. A patent pool would have the advantage of enabling rights of use in a much more efficient and legally secure manner than it would be the case, for example, with coercive measures such as compulsory licenses or state orders for use, which would have to be ordered individually and nationally restricted in each case.
The study by Simon et al cited SARS as an ideal precedent for the creation of a pharma patent pool, particularly because the situation was relatively manageable, since the research as a whole began at the same time and, to the extent that patent applications already existed (which were only published after 18 months), they were still in a comparatively early stage and the number of institutes and companies conducting research worldwide was still manageable.
In the case of SARS CoV 2, these points should now apply in a similar way. If already known active substances prove to be effective against COVID-19 in clinical trials, it can be expected that they are patentable as a second medical use.
In view of the scale of the pandemic and the urgent global need for rapid treatment of COVID-19, in any case it seems to be in the general public interest that the possibility of a pharmaceutical patent pool is not buried in the files.