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European Biopharmaceutical Review

Absolute or Limited Product Protection for Biotech Inventions under the relevant EC Directive

Current discussion about the scope of protection of product patents in the field of biotechnology was sparked by EC Directive 98/44 on the protection of biotechnological inventions (hereafter referred to as BIO-DIR). It was to be implemented on 30th July 2000 and has since given rise to considerable controversy in the contractual states. The nullity suit in the Netherlands, which received support from Italy and Norway, was rejected by the European Court of Justice (ECJ) on 9th October 2001. To date only Great Britain, Ireland, Denmark, Finland and Greece have followed their duty of implementation. Now there is increasing pressure on the so far hesitant states to ratify a national law of implementation. Due to the ongoing debate on the ethical aspects of gene patenting, the German Parliament has not yet decided on the draft of this law, nor on the product protection for gene sequences.


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By Dr Uta Kцster, Associate with Bardehle Pagenberg Dr Uta Kцster is an Associate with the Munich-based intellectual property law firm Bardehle Pagenberg Dost Altenburg Geissler. The firm provides the combined services of patent attorneys and attorneys-at-law, offering prosecution, litigation and counselling in all matters related to intellectual property, covering all fields of technology.
Dr Kцster is an Attorney-at-Law with a doctorate degree in Biology. She is active in counselling and litigation, with a practice focus on patent law, in particular biotechnology patents.

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Dr Uta Kцster
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