The spectacular success of the rapid development of vaccines against the SARS-CoV-2 coronavirus, not least by German biotech companies, has once again placed the patenting of innovations in biotechnology firmly in the public spotlight. In principle, such biotech patents are subject to criteria very similar to those for patent applications in other technical fields. In other words, biotech innovations are patentable in much the same way as other inventions. Nevertheless, research-based companies and manufacturers need to be aware of certain particularities.
These particularities are primarily due to the fact that ethical questions play an even greater role in the field of biotech patents than in most other areas of patent law. This is reflected in particular through the implementation of the European Biopatent Directive 98/44/EC into German and European patent law. This specifically excludes from patentability processes for cloning humans, processes for modifying the human germ line, and the use of human embryos for industrial or commercial purposes. Precisely delineating, in individual cases, the areas excluded from patent protection under these and other exclusion criteria from those still eligible for protection can be a difficult question. Our attorneys specialising in the field of biotech are happy to advise you in clarifying such borderline cases.
The importance of innovations at the intersections of biology, immunology, genetic engineering, pharmacy, medical diagnostics, and preparative chemistry has also been demonstrated by the development of SARS-CoV-2 vaccines. In particular, in the development of the novel mRNA vaccines, relatively small, young, innovative companies were successful, bringing their developments to market readiness with the support of established manufacturers. Along the way, like all research-based companies, they depended on investor funding to secure financing. Patents, which protect innovations from exploitation by third parties for a limited period, contribute significantly to amortising the sometimes exceptionally high development costs following successful product approval.
Also in connection with biotech patents for SARS-CoV-2 vaccines, calls were made for a temporary suspension of patent protection. Proponents argue that the vaccine shortage in developing and emerging countries could be alleviated by enabling vaccine production in these countries themselves. Opponents point out that the limiting factor for adequate vaccine quantities in developing and emerging countries lies less in any reluctance to grant or release licences by the holders of biotech patents. Rather, it is not possible to transfer the know-how required for the extremely complex production of mRNA vaccines in particular within a short period of time. Furthermore, some of the raw materials needed to produce mRNA vaccines are subject to export bans in many industrialised countries – a temporary suspension of patent protection would not change this.
The ability to obtain time-limited protection for inventions through patenting is a crucial motivator for continued innovation. Weakening patent protection in such an important field as biotech would therefore presumably make it harder for young, innovative companies in particular to find investors in the future.
Innovators in the field of biotechnology should therefore not be deterred by such discussions from protecting their innovations through biotech patents. In this context, it should also be mentioned that the importance of patents is outstanding, particularly in the biotech field. More than half of the best-selling medicines are, at their core, based on biotech inventions and are/were protected by corresponding biotech patents. Therapeutic antibodies, which have revolutionised the field of cancer medicine in particular, are just one example.
Our attorneys specialising in the field of biotech support start-ups, research institutions, pharmaceutical companies, and medical technology manufacturers alike in developing patent strategies and their concrete implementation in the form of biotech patents. Our advisory services also include filing oppositions against patents granted to other applicants, defending your patents against oppositions, and all questions and proceedings relating to patent infringement.
