Bio-Science Law Review - Volume 14 - Issue 2
Going Full Circle: Bolar in Europe and the UPC
Paul England, Matthew Royle and Christophe De Coster
Taylor Wessing LLP
The experimental use exemption, although based on the Community Patent Convention 1975, is provided in national law by national statutes and varies from one European country to another in the precise activities that are excluded. Doubt has centred on the extent to which, if at all, protection is afforded by this exemption to the conduct of clinical trials and other tests necessary to obtain a marketing authorisation. Hence, the 'regulatory review' defence, better known as the 'Bolar exemption', was introduced into European law by Directive 2001/83/EC. The purpose of this provision was to address uncertainty about the scope of application of the experimental use exemption, specifically, to clinical studies and other potentially infringing work conducted for the purpose of obtaining an abridged marketing authorisation for a generic product. However, its varying implementations in the Member States have, much like the experimental use exemption, created Bolar provisions of widely differing scope. This article examines this divergence, with a focus on the key jurisdictions of the United Kingdom and Germany. It also reviews other developments relating to Bolar in these countries, and looks ahead at the likely impact of the Unified Patent Court.
Poisonous Divisionals: Any end in sight?
Dr Sara Michels and Dr Gabor Mester
GRUND Intellectual Property Group, Munich
There is as yet no solution to the problem of so-called 'poisonous' divisional applications to the European Patent Office. This arises when a divisional application is published later than the date of filing of its parent application, yet includes embodiments that are entitled to an earlier priority date than the subject-matter claimed in the parent application. It is hoped that a decision by the Enlarged Board of Appeal on the question of split priority might provide guidance in the future.
Isolated Nuceleic Acid Sequences Patentable in Australia: D'Arcy v Myriad Genetics Inc
Kim O'Connell, James Ellsmore and Tom Naylor
King & wood Mallesons, Sydney
On the Australian front of Myriad Genetics' fight to maintain its BRCA gene patents, a full bench of the Federal Court of Australia has confirmed the patentability of isolated nucleic acid sequences under Australian law. The decision may be contrasted with that of the Supreme Court of the United States which in 2013 held that genes and the information they encode were not patent eligible under US law because the gene had been isolated from the surrounding genetic materials.
GM v Organix Farming: Marsh v Baxter
Alexandra Meade and Michael Blakeney
University of Western Australia
This Comment looks at the recent decision by the Supreme Court of Western Australia concerning a dispute between two neighbouring farmers arising from the loss of organic certification by one farmer attributed to the harvesting practices of his GM-producing neighbour. This was a world's first, as previous disputes had been between organic farmers and the GM seed producer and with the GM certification authorities. In this Australian case the plaintiff failed in negligence and nuisance claims as the damage which he suffered was attributed to the over-strict standards of the organic certifier.
Intellectual Property Law of Plants
Mark D janis, Herbert H Jervis and Richard C Peet