The 'Harvard Oncomouse' patent claimed a method for producing transgenic non-human mammals with a predisposition to developing cancer. The prospect of the commercialisation of animals fated to develop cancer was the cause of significant protest. More
Advocate-General Antonio Tizzano's opinion in the IMS Health case was published on 2 October 2003. It considers the situations under which an intellectual property right (IPR) may be subject to compulsory licensing under Article 82 of the EC Treaty. More
Regulatory documents that address clinical biotherapeutics such as monoclonal antibodies and recombinant DNAderived proteins are written in broad generalities to accommodate variability in the types of products, patient populations, dosage, and produ More
The University of California at San Francisco claims credit for identification of the DNA of the human growth hormone. Genentech was alleged to have taken and used the University's actual DNA invention without permission. More
There are four procedures for applying for a marketing authorisation for a medicinal product. These are a national procedure, a centralised procedure, the mutual recognition procedure and the decentralised procedure. More
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