Expert group assigned to exam­ine pat­ent law in biotechnology

The team of experts will be cru­cial in advising the Com­mis­sion on a num­ber of ques­tions con­cern­ing the Dir­ect­ive (98÷44) of the EU’s Coun­cil of Min­is­ters and the European Par­lia­ment on the leg­al pro­tec­tion of bio­tech­no­lo­gic­al inven­tions, the so-called ​‘Biotech Pat­ent Dir­ect­ive’ (see doc­u­ments on the right side). One par­tic­u­lar area that has raised many ques­tions is on how the Dir­ect­ive affects access to the human gen­ome data and pos­sible restric­tions on the research and applic­a­tions for which this data could be used. The role of the experts will be to assist and advise the European Com­mis­sion in its report­ing require­ments and on the leg­al pro­tec­tion of bio­tech­no­lo­gic­al inven­tions (referred to as ​‘Dir­ect­ive 98/44/EC’). Pat­ents are neces­sary in bio­tech­no­logy as they provide an incent­ive to innov­a­tion. Without the safe­guards provided by pat­ents, industry and oth­er invent­ors would be unwill­ing to invest their time and money in research and devel­op­ment. How­ever, bio­tech­no­logy car­ries a con­sid­er­able amount of high risk invest­ment, par­tic­u­larly in the field of genet­ic engin­eer­ing. So adequate pat­ent pro­tec­tion needs to be in place to encour­age the invest­ment required to cre­ate jobs and main­tain the European Uni­on’s com­pet­it­ive­ness in this import­ant area of research. This is why Dir­ect­ive 98/44 on the leg­al pro­tec­tion of bio­tech­no­lo­gic­al inven­tions was pro­posed and, after lengthy and thor­ough dis­cus­sions with­in the European Par­lia­ment and among Mem­ber States, it was adop­ted. But still, the pat­ent laws sur­round­ing bio­tech­no­logy remain a com­plex issue, par­tic­u­larly the eth­ic­al aspects of inven­tions. For example, dis­cov­er­ies, which do not extend human abil­ity, but only human know­ledge, are by their very nature not pat­entable. Sequen­cing of a gen­ome belongs to the area of dis­cov­ery, which means it can­not be the sub­ject of pat­ent pro­tec­tion. How­ever, 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. This makes such a gene ​‘new’ in the pat­ent sense and there­fore pat­entable, if it was not pre­vi­ously access­ible to the pub­lic and was pre­vi­ously not avail­able. The pos­i­tion that was agreed by both the European Par­lia­ment and the Coun­cil of Min­is­ters after much dis­cus­sion was that pat­ents for inven­tions com­prised of, or based on, gene sequences should be allowed. The Dir­ect­ive there­fore provides that inven­tions based on, or com­prised of, gene sequences or par­tial gene sequences can be pat­en­ted provided that they sat­is­fy the nor­mal cri­ter­ia for any inven­tion as well as mak­ing clear that pat­ents should not be gran­ted where the applic­a­tion does not include spe­cif­ic ref­er­ence to the indus­tri­al applic­a­tion of the gene sequence. How­ever, advances in tech­no­logy have made under­stand­ing the isol­a­tion and man­u­fac­ture of genes easi­er to under­stand, and are taken into account when a pat­ent is examined, in par­tic­u­lar wheth­er the inven­tion in the pat­ent applic­a­tion pos­sesses an invent­ive step. If it is decided by either the pat­ent offices or the nation­al courts that there is no invent­ive step then the pat­ent will either be refused or revoked. It is expec­ted that the addi­tion of a new team of experts will ensure a great­er under­stand­ing of pat­entable bio­tech­no­logy and help to unravel the com­plex­it­ies that sur­round this area. Source: European Commission