Bio-Science Law Review - Volume 15 - Issue 1


Promoting the Off-label Use of Medicines: Where to Draw the Line?
White & Case LLP, Brussels

A trend has emerged among EU Member States to actively promote the off-label use of medicines, meaning outside the limits of their marketing authorisation, on the ground that they are cheaper than the alternative, authorised medicine. The latest development in this direction is a report of the Belgian 'Health Care Knowledge Centre', a federal scientific organisation tasked with advising policy-makers on decisions relating to health care and health insurance. The article suggests that this approach is wrong as a matter of EU law, and questionable as a matter of policy, as it undermines both the EU regulatory system for approving medicines and the national pricing and reimbursement systems. 

The UPC Rules of Procedure are Agreed. What do they Say?
PAUL ENGLAND Taylor Wessing, London

It is nearly ten years since the European Commission decided, after decades of setbacks, that it would again relaunch the project for a pan-European patent system. This has led to the development of a Unitary Patent and Unified Patent Court. The progress of this system has now reached the important stage in which the Rules of Procedure, which will govern actions in the Unified Patent Court day-to-day, have been agreed. This article provides an overview of the key features and powers described in those Rules.

Diagnostic Method Claims in Canada
Y. LYNN ING Smart & Biggar/Fetherstonhaugh, Toronto 

The Canadian Patent Office released a long-awaited Practice Notice on medical diagnostic method claims on June 29, 2015. The Practice Notice introduces a new analytical approach to be followed by patent examiners to assess whether a medical diagnostic method claim defines statutory subject-matter. The approach asks whether the claim includes a physical step of data acquisition as an essential element, which will likely be statutory; or consists solely of essential elements that are disembodied, which will be considered defective.

Isolated Nucleic Acid Sequences no Longer Patentable in Australia: D'Arcy v Myriad Genetics Inc.
KIM O'CONNELL AND JAMES ELLSMORE King & Wood Mallesons, Sydney

The High Court of Australia has held that patent claims for isolated nucleic acid sequences, indicative of a predisposition to breast cancer, are not patentable subject-matter. This overturns the decision of the Full Federal Court and the decision at first instance, which both found that the nucleic acid sequences in question were patentable subject-matter. 

Calculation of SPC Duration: Case C-471/14 Seattle Genetics

The CJEU has given a ruling on a reference from the Higher Regional Court of Vienna, concerning the correct date to act as the trigger for the calculation of SPC duration. For the purposes of marketing authorisations granted via the centralised procedure, the correct date for the Article 13 SPC trigger is now fixed as the date of the notification of the implementing decision to the applicant.