Bio-Science Law Review - Volume 13 - Issue 3
PATENTS AND ACCESS TO MEDICINE IN THE DEVELOPING WORLD: A CALL FOR BROADER ENGAGEMENT
Co-Head, Healthcare Group and Intellectual Property Partner, Linklaters
CHANGES TO TECHNOLOGY LICENSING IN EUROPE: NEW COMPETITION LAW ANALYSIS WILL AFFECT EXISTING LICENCES AND NEW NEGOTIATIONS
LAURA BALFOUR, ELLEN LAMBRIX AND SUSIE MIDDLEMISS
Slaughter and May, London
Parties to technology agreements in Europe have since 2004 been operating under a framework for technology licensing set out in the technology transfer block exemption (Commission Regulation (EC) No 772/2004 (the “TTBER”)). This expires on 30 April 2014. Various amendments to the existing legislation and guidelines have been proposed by the European Commission.
Although amendments are still under consideration, the drafts have been the subject of consultation and a final draft is likely to emerge later this year, prior to adoption at the end of April next year. This article reviews the current state of play and highlights the issues that are likely to be encountered in this complex area of law.
BETTER MEDICINES FOR CHILDREN? WHAT HAVE BEEN THE BENEFITS AND LESSONS LEARNED AFTER FIVE YEARS OF THE PAEDIATRIC REGULATION?
Associate, Bristows LLP,
Maintaining the pace of innovation in the life sciences sector is a complex and challenging process for all pharmaceutical companies engaged in research and development. Prior to 2006, there was a lack of suitably authorised medicinal products for paediatric use. To combat this problem, the Paediatric Regulation was implemented in order to facilitate the development and accessibility of age-appropriate paediatric medicines. The European Commission has recently published a progress report which provides an in-depth appraisal of the successes and failures of the Paediatric Regulation. The recommendations outlined in this report will shape the development of this important piece of legislation, which is of crucial significance for innovator companies operating in the life sciences sector and to the paediatric population as the ultimate beneficiary of an effective regulatory platform that supports innovation.
PLANT VARIETY PROTECTION REGIMES AND SEED REGULATIONS IN SUB-SAHARAN AFRICA: CURRENT TRENDS AND IMPLICATIONS
MARCELIN TONYE MAHOP, BRAM DE JONGE AND PETER MUNYI
Sub-Saharan African countries must advance their agricultural sector in order to overcome food insecurity, unemployment and poverty. To that effect, they are increasingly embarking on the adoption of workable regulatory frameworks at the national level
and within the framework of regional groupings. This article is concerned with plant variety protection laws and seed regulations in a selected number of sub-Saharan African countries. It provides a pioneering overview of two countries: Burkina Faso and Tanzania. It discusses regional initiatives of the Organisation Africaine de la Propriété Intellectuelle (OAPI), the African Regional Intellectual Property Organisation (ARIPO), the Common Market for Eastern and Southern Africa (COMESA) and the Southern Africa Development Community (SADC). This article explores how national and regional regulatory frameworks address such issues as farmers’ rights and exemptions to plant breeders’ rights and discusses current trends and the implications for agricultural and economic development and for food security.
ALZHEIMER’S PATENT INVALID FOR INSUFFICIENCY – PATENTS MUST BE MORE THAN MERELY ‘RESEARCH PROJECTS’
ELI LILLY AND CO V JANSSEN ALZHEIMER IMMUNOTHERAPY
Senior Associate, SJ Berwin LLP
The High Court has decided that Janssen’s patent relating to use of a class of antibodies for the treatment of Alzheimer’s Disease is invalid on the grounds of insufficiency because the disclosure of the patent did not make it plausible that it would work across the whole scope of the claims.
MEDICAL LAW – A VERY SHORT INTRODUCTION