Bio-Science Law Review - Volume 14 - Issue 1

Mining for Gold - capitalising on data to transform drug development

Helen Cline and Marc Dutlich Pinsent Mason LLP

Patent Protection for antibodies: the
evolving challenges
Liz Cohen and Vanessa Rieu
Bristows LLP

Over the last decade, the development, evolution and growth into a multibillion dollar market of the biotech sector, and, in particular of therapeutic antibodies, has thrown sharply into focus the difficulties encountered by the law to keep up to date with the rapid scientific progress in this sector. Patent protection for antibodies, which is of critical commercial importance for those involved in their development, is not straightforward.  Patent offices and courts across Europe face continuous challenges when assessing the patentability of antibody inventions, due in large part to the fact that their uses and characterisation are constantly evolving. 

The present article gives an overview of the approach to the patentability and validity requirements of antibody inventions taken by the UK IPO and EPO and explores how these patents have been treated by the UK courts, in particular as regards to inventive step, sufficiency of disclosure and industrial applicability, and identifies the challenges ahead for practitioners in this exciting and developing field.

Council agrees General Approach for Trade Secrets Proposals
Jennifer Watts Pinsent Mason LLP

On 26 May 2014 the Council of the European Union agreed a general approach to the Proposal for a Directive of the European Parliament and of the Council on the protection of undisclosed know-how and business information (trade secrets). The Proposal aims to unify the law on trade secrets across the EU, and while the Council is broadly supportive of the Proposal, the general approach aims to establish a minimum level of harmonisation across the EU. The Council made a number of recommendations, including an increase in the limitation period for bringing claims and actions to six years. The Council's feedback on the Proposal is outlined in the article. It is anticipated that the general approach will drive the negotiations between the Council and the European Parliament.

The meaning of 'Actice Ingredient' for SPC Protection is again uncertain
Bayer CropScience AG (Case 11/13)
Paul England
Taylor Wessing LLP London