The terms " plant varieties", " animal varieties", " biological processes for the production of plants or animals", and " microbiological processes" mentioned in Article 53 b are not defined in more detail in the EPC. In the last years the Boards of Appeal of the European Patent Office (EPO) have issued a number of fundamental decisions for the interpretation of these terms, decisions which naturally have an influence on whether biotechnological inventions are patentable at all.

Only an invention can be the subject of a patent. Discoveries, which do not extend human ability, but only human knowledge, are not patentable. It is often held that all biological inventions, which deal with human, vegetable, or animal genes, involve materials which already occur in nature and can therefore under no circumstances be invented, but only discovered.

Thus the mere sequencing of a genome belongs to the area of discovery and for that reason alone cannot take advantage of patent protection. It is different if a DNA sequence is released from its natural surroundings by means of a technical procedure and is made available for the first time to a commercial application. Here there is a step taken from knowing to being able. Such a gene is new in the patent sense, if it was not previously accessible to the public as such, and thus technically was not available. The same applies to micro-organisms and natural materials, which are extracted from their complex natural surroundings by technical procedures. It is however essential, when patenting the material which has been isolated, that its special function or useful characteristics can be defined.

Directive 98/44/EC also takes this line. Among other things it says: "... the granting of a patent for inventions which concern such sequences or partial sequences should be subject to the same criteria of patentability as in all other areas of technology: novelty, inventive step, and industrial application; whereas the industrial application of a sequence or partial sequence must be disclosed in the patent application.

Whereas a DNA sequence without the indication of a function does not contain any technical information and is therefore not a patentable invention.

The question as to how explicitly the functions must be described especially for sequences that code only for parts of genes (like ESTs) is not yet clarified. In December 1999 the US Patent and Trademark Office issued " Revised Utility Examination Guidelines" that seem to raise utility standards for the protection of DNA sequences. Further clarification is also needed for the breadth of claim when patenting DNA sequences with regard to codon variations and variation of cDNA or amino-acid substitutions.

European patents are not granted for inventions which violate "ordre public" or the rules of propriety.

Article 53(a) of the EPC states:

European patents shall not be granted in respect of:

(a) inventions the publication or exploitation of which would be contrary to "ordre public'' or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;

The discussion of patent law aspects of this exception to patentability took place particularly with regard to gene technology.

According to the practice of the European Patent Office only very exceptional cases, which the public regards as particularly abhorrent, fall under the exception. When discussing the question of whether the requirements of the exception are satisfied, particularly the possible harmful impact and dangers of the invention, must be evaluated and weighed against the benefits of the invention. A case, which dealt with patenting a mouse for experimental purposes, was referred back by the technical board of appeal of the EPO, with the reasoning that the suffering of the animals associated with the use of the invention, and the possible danger to the environment, must be weighed against the benefit of the invention for mankind.

It must however be noted that a patent does not give a positive right to a particular use of the invention, but grants a right to exclude others from the use of the invention for a limited period. Ultimately the legislators have to decide whether and under which conditions particular technical knowledge may be used. Certainly a patent does not represent the right means for preventing misuse of an invention, the handling of dangerous materials, or putting the public at risk. Thus, only the conventional exploitation of the invention compliant with the law can fairly be drawn on to judge this point.

Moreover the rejection of a patent application does not necessarily mean that use of the invention is prevented. Rather a refusal of the grant of a patent places the invention into the public domain and makes it freely available to everyone.

Directive 98/44/EC also addresses this question. Article 6(1) states:

Inventions shall be considered unpatentable where their commercial exploitation would be contrary to "ordre public" or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.

This paragraph specifies a number of cases, in which it is to be assumed that such a breach is present and for that reason alone the invention cannot be patented. The following cases are mentioned:

• 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 them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
  
  

Summarizing it must be noted that patent protection is available for DNA sequences, genes, gene segments, vectors, and micro-organisms. The legal decisions are however not yet fully clarified at the margins, so that uncertainties still exist at present.

In any case it is advisable to disclose a DNA sequence in sufficient detail in a patent specification, taking the special provisions of the European Patent Office ( Official Journal EPO, No. 11/1998) into account because sequences must be submitted on a specific data medium with the application.

As for the protection of plants and animals, they can be the subject of patent protection as such, but not plant varieties or animal breeds. The not undisputed biotechnology directive was adopted in this spirit. It must be mentioned in this context that the Netherlands and Italy have instituted proceedings against the directive in the European Court of Justice.

It must also be pointed out that in the case of the protection of new micro-organisms, which cannot be isolated and/or reproduced on the basis of the patent specification without reasonable expenditure, sample organisms must also be lodged with the submission of the application.

By way of illustration here are some patent claims from various patent specifications:

EP 0695351 B1:This patent granted by the EPOin December 1999 in the field of biotechnology has caused turmoil in the beginning of 2000. Due to a translation error the patent seemed to include also humans in the term "method of preparing a transgenic animal...". The English wording of the claim should have included the qualification "non-human". After opposition against this patent was filed the patentee suggested to narrow the wording of the claim to non human application. The proceedings are not yet closed.

US 5817479: The first patent for an expressed sequence tag (EST) was granted in November 1998 by the US Patent and Trademark Office. The gene fragments described in the patent consisted of partial cDNAs coding for novel human kinases. The granting was heavily criticised by legal and biotechnology communities fearing that the broad patent rights will lead to a licensing cascade for adjacent sequences or even the full-length gene.

1. EP 771874 B1 : These are the claims of a patent granted by the EPO, concerning genetically altered mammals, which produce human albumen. Environmentalists have indicated that they will oppose the grant of this patent. The patent claims of the respective European patent application are published in EP 771874 A2
   
   
2. EP 169672 B1: The subject of the claims of this patent is the universally known Harvard cancer mouse. The patent claims of the respective European patent application are published in EP 169672 A1
   
   
3. EP 44723 A2 : These patent claims in this published patent application concern hybrid plants.
   
   
4. EP 93619 B2: The claims of this patent cover the extraction of DNA isolate. The patent claims of the respective European patent application are published in EP 93619 A1
   
   

The following links are recommended in connection with this article:

1. Further literature:
   
   
   • www.cipa.org.uk
     
     
2. UPOV Homepage
   
   
3. The UPOV convention
   
   
4. Some agencies for the protection of new plant varieties:
   
   
   • France
     
     
   • Germany
     
     
   • USA
     
     
   • Community Plans Variety Office (CPVO)
     
     
5. Dictionary
   
   
   • www.biocrawler.com
     
     
   • www.ams.usda.gov
     
     
6. Studies on biotechnology patent practices
   
   
   • Biotechnology and United States Patent Practice
     
     
   • Joint report comparing the positions of the European Patent Office, the Japanese Patent Office and the US Patent and Trademark Office on patentability of DNA fragments (June 1999)
     
     
   • Biotechnology Comparative Study on Biotechnology Patent Practices of the European Patent Office, the Japanese Patent Office and the US Patent and Trademark Office
     
     
7. Recent decisions of the EPO:
   
   T_0315/03 - 3.3.8 [ 2004.07.06 ]
   
   T_0579/01 - 3.3.4 [ 2004.06.30 ]
   
   T_0272/95 - 3.3.4 [ 2002.10.23 ]
   
   T_0870/04 - 3.3.8 [ 2005.05.11 ]
   
   G_0001/98 - EBA [ 1999.12.20 ]
   
   T_1054/96 - 3.3.4 [ 1997.10.13 ]
   
   T_0179/01 - 3.3.8 [ 2005.04.06 ]
   
   T_0606/03 - 3.3.08 [ 2005.01.12 ]
   
   G_0001/03 * - EBA [ 2004.04.08 ]