NEW RULES OF THE EUROPEAN PATENT OFFICE
FOR BIOTECHNOLOGICAL INVENTIONS
Dr. Franz Zimmer
Partner of Grünecker, Kinkeldey, Stockmair & Schwanhäusser
I.
Introduction
The Biotech Directive 98/44/EC1 of the EU entered into force on July 30, 1998.
The EU member states are required to implement the Directive into their national
law by July 30, 2000.
The European Patent Organization - not being a EU member state - is not subject
to this formal requirement of implementing the Directive. It is, however, highly
desirable to have a common standard throughout Europe regarding the patenting
of biotechnological inventions. The European Patent Organization recently
decided to implement the rules of the Directive into the Implementing Regulations
to the European Patent Convention.
The following Rules are derived from Chapter I of the Directive, which regulates
the patentability of biotechnological inventions. Although the principles set forth in
said rules of the Directive themselves are based on the relevant provisions of the
EPC and established case law and practise, the Implementing Regulations of the
EPC were amended in order to ensure that the patentability provisions of the EPC
also continue to be interpreted in line with the Directive.
Under Article 164(1) EPC the Implementing Regulations are an integral part of the
Convention and, hence, are equally binding to the Boards of Appeal of the EPO
(Article 23(3) EPC) and to national courts. For the practical application of the
convention, only the interpretation laid down in the Implementing Regulations is
binding to the Boards. Other interpretations of individual provisions are possible
1OJ ECL 213/13 and OJ EPO 1999, 101
2
only where it is specifically demonstrated that the provisions of the Implementing
Regulations are inconsistent with the Convention itself.
Therefore, the addition of the Rules for Biotechnological Inventions to the
Implementing Regulations emphasizes that the general provisions of the
Convention apply unrestr