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F&E Patent

Product-by-process claims in biotechnologiy

The Enlarged Board of Appeal provided a decision considering the scope of product by process claims in the area of biotechnology

Product-by-Process Claims concerning “biopatents”

In their decision G 1/08, G2/07 the Enlarged Board of Appeal of the EPO specifies the term “essentially biological processes” answering key questions raised during oppositions challenging the tomato (T 1242/06) and broccoli patents (T 83/05). Considering earlier decisions of the Technical Boards of Appeal interpreting the exception to patentability according to Art. 53 (b) EPC (T 320/87, T 356/93), the Enlarged Board of Appeal follows the concept of considering non-microbiological processes comprising steps of crossing whole genomes of plants and subsequent selections steps as being essentially biological processes and therefore non-patentable. One technical step that itself adds or changes a feature of the genome not being the result of genetic mixing by crossing may however justify patentability of the process. A step merely supporting crossing or selection on the other hand cannot justify patentability according to Art. 53(b) EPC.

The Enlarged Board of Appeal, however, does not clarify if product-by-process claims concerning animal/plants as products of essentially biological processes are/should be admissible. In Germany this faces major public and also governmental concerns. In a recent statement the BMELV notes that a tension exists in the exception to patentability of essentially biological processes of Art. 53(b) EPC and the admission of product-by-process claims comprising as a main feature a process that is a non-patentable essentially biological process. In the view of the current scope of protection of product-by-process claims in Europe this might result in monopolies on the product “plant” that would exceed a reasonable price awarded for the inventive activity.

To summarize, there still seems to be a need for clarification of the admissibility of product-by-process claims in the area of biotechnology and in addition a major interest of the public exists. Prior to their decision G 2/07, G 1/08 the Grand Panel of Appeal of the EPA received amicus curiae letters of more than 180 individuals/parties in this case.

The final decisions of the Technical Boards of Appeal in the broccoli (T 83/05) and tomato (T 1242/06) cases is still pending and it is questionable whether the concerns will hold true that obtaining a monopoly by a plant patent is possible before all instances of the EPA.

Dr. Simone Pajonk