Patents serve to safeguard investments in technical innovation. A patent protects the patent holder from unauthorized use of a technical invention by competitors or other third parties. A patent requires a patent application, filed with the respectively designated patent office. Upon request, the office will examine whether an application meets the patent requirements, in particular regarding novelty and inventive step. As an examined technical intellectual property right the patent offers a secure basis for evaluating infringement cases. A patent becomes valid with the date of publication of the grant and expires, at the latest, 20 years after the date on which the application was filed.

Importantly, there are profound differences with regard to the patenting of biological and biotechnological inventions between Europe/Germany and other countries, such as the US or Russia. The drafting and defending of patents as well as the attack on patents that protect biological and biotechnological inventions all require profound knowledge on the legal peculiarities of this specific field as well as on biology as such.

The team members of the biotechnology group of GLAWE DELFS MOLL are biologists and chemists, who can build on a broad basis of experience made in years of biological research. The technological fields covered by the biotechnology group based on its team members' scientific experience covers e.g. cellular and molecular immunology, cell biology, genetics, gene technology, molecular biology, microbiology, biochemistry, neurobiology and protection of plant varieties.

Basically, all inventions related to biological material can be protected by patents. However, some national as well as European peculiarities need to be considered, which are briefly described in the following.

Exclusion from protection for ethical reasons

European as well as German patent law consider the basic principle that inventions, which would violate public order or morality are excluded from patentability. In particular, patents are not granted for methods of cloning human beings; methods for changing the genetic identity of a human being's germ line; the use of human embryos for industrial and commercial purposes; methods for changing the genetic identity of animals that can cause suffering to these animals without having substantial medical benefit for humans or animals, as well as the animals produced by said method.

Surgical, therapeutic and diagnostic methods

In general, German and European patent law both exclude surgical, therapeutic and diagnostic methods performed on the human or animal body from patentability in order to avoid that the medical doctor is prevented from doing his job by patents. However, it has been the European and German legislators' intention that products, such as technical devices and medicaments, are not affected by this exclusion.

Patents on human DNA sequences

In contrast to more traditional fields, such as mechanics, the problem with genetics is that the subject of the invention, e.g. a gene sequence isolated from a human being, is not "invented", but is simply there by nature. In other words, human genes and their functions are not inventions but discoveries and, according to the critics of biotechnological patents, should therefore be bared from patentability as part of the human body.

On the other hand, the utilization of genetic information of human origin for medical and pharmaceutical purposes does require extensive investments in research and development. Accordingly, the redemption of such investments needs to be secured, in order to provide further motivation for more investments and, also, in order to reward the inventor.

The European legislator has considered this in the Directive 98/44/EC on the Protection of Biotechnological Inventions of 1998, in which genetic sequences were declared to be patentable.

Germany has implemented this EC-directive into national law by the German Law on Biotechnological Patents, which came into force on February 28, 2005. The implementation of the EC-directive into German law has turned out to be clearly more restrictive compared to the European Patent Convention (EPC).

Following German patent law, a compound claim on a gene sequence or part of a gene sequence, which is identical to a natural human gene sequence or partial human gene sequence, also needs to comprise the concrete use of said sequence or partial sequence. Thus, only the concrete use of the human gene sequence or partial sequence, as laid down in the patent claim, is protected.

In other words, absolute protection of natural human genes and gene sequences as well as of sequences identical to said sequences, as contemplated in the EC-directive and as adopted in the EPC, is not possible according to German patent law.

Apart from general biological knowledge and technical experience, this is another issue that needs to be looked at, in order to secure a biological invention by a patent.