International Life Sciences Update

21 May 2014

In this edition we report on a range of recent developments and decisions, at EU national level, relating to patent law and regulatory matters. We hope you enjoy reading this update and are happy to address any comments or questions you may have, either through your usual contact or through any of the contacts listed in this update.


New UK 'Bolar' Exemption to Patent Infringement
Geoff Hussey, London

On 6 May 2014 a draft Legislative Reform (Patents) Order 2014 (the "Order") was placed before Parliament to amend the UK Patents Act 1977 (the “Patents Act") by exempting certain clinical and field trials for drugs from patent infringement. The Order will amend section 60 of the Patents Act by broadening the so-called 'Bolar' exemption so as to cover the carrying out of necessary trials and health technology assessments... Read more>>

The Bolar exemption – protection of API suppliers
Elizabeth Wright, London

The CJEU has recently been asked by the German courts to consider whether the Bolar exemption extends to a third party manufacturer which supplies a patent-protected substance to a generic drug company for use in trials for the purpose of generating data to be used to support an abridged marketing authorisation application... Read more>>

Italy: the abuse of a dominant position by Pfizer in Xalatan case
Giovanni Galimberti and Eveline Marchesoni, Milan

The decision no. 693/214 of the Consiglio di Stato (Italy's highest administrative Court) filed on February 12, 2014 closed the saga of the Xalatan case in Italy, ruling that Pfizer had abused its dominant position. Read more>> 

Regulatory News

Promoting early access to new medicines – building an “adaptive licensing” framework.
Sarah Faircliffe, Legal Director, London

Referred to by various terms (staggered approval, managed entry, progressive authorisation), “adaptive licensing” is a departure from the traditional approach to authorising new medicinal products. Under the current system, the initial grant of a marketing authorisation (MA) tends to be regarded as a “magic moment”, at which point the medicine is suddenly held to be safe and efficacious... Read more>>

Are my technology transfers ready for the new TTBER and the UPC?
Marc van Wijngaarden and Janneke Kohlen, The Hague

On May 1, 2014, the revised EU block exemption regulation for technology transfer agreements, the so-called TTBER, entered into force, together with the new guidelines for technology transfer agreements (TT-Guidelines) . They bring important changes for future and existing technology license agreements... Read more>>

Developments in the publication of clinical trials data by the European Medicines Agency.
Polina Lanckriet, Lyon

The EMA has announced a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of clinical trial data. The policy seeks to balance the commitment to provide the widest possible access to data with the need to protect personal data and legitimate commercial confidential information. The Agency has been releasing clinical trial reports on request once the decision-making phase of the marketing authorisation process has been completed since November 2010 as part of its access to documents policy... Read more>>

CFDA inspection of foreign drug manufacturing enterprises: 2014 update
Caroline Wong, Hong Kong

Since 2011, the China Food and Drug Administration (the "CFDA", formerly known as the SFDA) has conducted inspections of foreign drug manufacturing sites producing drugs for import into China.
The CFDA announced its plan to conduct inspections of 25 foreign manufacturing sites including those of AstraZeneca, Roche Pharma, 3M Drug Delivery, Dr Reddy's, Abbott Biologicals and Samyang Corporation in 2014... Read more>>