Life Science Patents

Patenting in life sciences

"No patents on life“ is currently a typical headline referring to an issue that moves hearts more than hardly any other subject, and which borders between natural science, ethics and jurisprudence: the patenting of biological inventions. Fundamentally, the entire field of biotechnology and medicine patentability still remains open.

German Patent Law and the European Patent Convention both contain a general clause excluding patentability of such inventions, which breach public order and are contra bonos mores. If, for example, all citizens or some demographic groups reject certain technologies based on ethical or political considerations, it is the task of the legislator to establish the respective legal norms outside of the realm of patent law. For a patent does not imply any right of use, but allows the patent holder to exclude third parties from the use of the invention.

The EU Directive governs protection

What is patentable in the area of biotechnology and medicine is defined in detail on a European level at EU-Richtlinie 98/44/EG (EU Directive 98/44/EG) “Legal Protection of Biotechnical Inventions” from June 6, 1998. All key points of the Directive were adopted by the European Patent Convention (EPÜ) on September 1, 1999.

The Law Implementing the Biopatent Directive, (see Das Gesetz zur Umsetzung der Biopatentrichtlinie) was, however, first announced in the Federal Law Gazette on January 28, 2005 and entered into force on February 28, 2005. Here, limits were established as to the absolute protection of compositions of natural human gene sequences: for human gene sequences, composition protection is only valid for human gene sequences for the application which is concretely described in the patent.

Biotechnical inventions must, just as all other inventions, fulfill the three criteria of patentability: novelty, inventive step and industrial application. This is also valid for “biological material,” which contains genetic information and is replicable in a biological system:

What is patentable:

• Naturally occurring biological material, which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature, e.g. DNA, RNA, vectors, proteins and antibodies
• Plants or animals, if the application of the invention is not technically confined to a single plant or animal variety, e.g. viruses, microorganisms, transgenic plants, transgenic animals
• A microbiological or other technical process or a product obtained by means of such a process, as long as it is not dealing with a particular plant or animal variety
• An element isolated from the human body or otherwise produced by means of a technical process, including sequences or partial sequences of genes, even where the structure of that element is identical to that of a natural element
• Sequences or partial sequences of genes, as long as this function is specifically described in the patent application

What is not patentable:

• Plant and animal varieties. Essentially biological processes for the production of plants or animals. (a process is essentially biological if it consists entirely of natural phenomena such as crossing or selection)
• Processes for cloning human beings
• Processes for modifying the germ line genetic identity of human beings
• Uses of human embryos for industrial or commercial purposes
• Processes for modifying the genetic identity of animals, which are likely to cause the animals suffering without any substantial benefit to man or animal, as well as animals resulting from such processes
• The human body, at the various stages of its formation and development and the simple discovery of one of its elements, including the sequence or partial sequence of a gene
• Sequences with no known function

The practice of patenting of countries outside the EU, particularly in the U.S. can differ significantly from that of the criteria provided here.

Find detailed information on patentability of biotechnological inventions at Downloads. You will also find the PROvendis manual with practical patenting guidelines “Medizin + Patente” at this link.