The consultation period for the draft proposed Rules of Procedure of the Unified Patents Court (“Rules”) closes on 1 October 2013.  Any life science business with European operations will, sooner or later, find itself before the Unified Patents Court once it becomes operational, either as a claimant or defendant.  The consequences of that litigation will be significant because the decision will affect the whole of Europe, rather than being confined to a single country as under the current litigation model.  The impact of the Rules will therefore be far-reaching, particularly for the life sciences industry, relying as it does on a relatively small number of patents to protect its key products. Now is your last chance to influence the system!

As explained here, in December 2012 the European Parliament voted in favour of the Unitary EU Patent.  The European Commission anticipated that the first Unitary EU Patent would be granted in 2014, although this time line now appears to be delayed.
Continue Reading Time Is Running Out for Commenting on the Unified Patent Court Rules

On 19 June 2013, the European Commission imposed fines totaling EUR 146 million to Lundbeck and several producers of generic medicines, including Alpharma, Merck KGaA/Generics UK, Arrow, and Ranbaxy, for infringement of Article 101 TFEU.  This is the first Commission decision dealing with so-called “reverse payment” patent settlements or “pay for delay” agreements.
Continue Reading Lundbeck: First European Commission Decision on “Pay for Delay”

By Morag Peberdy and Christina Helden

Life sciences companies are already contemplating changing their patent strategies in anticipation of the EU’s Unitary Patent.  However, the timeline for the EU Unitary Patent has been delayed.  When the legislative package was agreed last December, many speculated that the 1 January 2014 date for the implementation of the EU’s Unitary Patent was overly ambitious.  The publication of the UK’s new Intellectual Property Bill (the “Bill”) on 10 May 2013 now gives real substance to this viewpoint.  The provisions of the Bill indicate that the UK will not ratify the Agreement on a Unified Patent Court (the “Agreement”), one of the key legislative instruments required for the Unitary Patent’s implementation, until April or May 2015.  Since the UK must ratify the Agreement before it can be implemented anywhere in Europe, it appears that the timetable has been derailed. 

The Unitary Patent will create a single patent with unitary effect, litigated in a Unified European Patent Court.  Regulation (EU) No 1257/2012 and Council regulation (EU) No 1260/2012 provide for the single patent with unitary effect.  The former also establishes the 1 January timeline for its implementation.  The Agreement creates the court system which will govern the new system.  However, the Unitary Patent cannot come into effect until 4 months after 13 EU member states have ratified the Agreement, which must include the UK, France and Germany. 


Continue Reading EU Unitary Patent is Likely to be Significantly Delayed

This post originally appeared on our sister blog, InsideTechMedia.  

After more than 40 years of discussions, the European Parliament today voted in favour of the “EU patent package,” hot on the heels of the European Council’s approval yesterday.  The EU patent package will create a Unitary EU Patent i.e. a uniform patent which will have equal effect and will be granted, transferred and enforced in a unitary way in most of Europe.  Unitary EU Patents will be granted through the existing European Patent Office, but a new court system will be set up to enforce these patents.

The Unitary EU Patent will, in time, replace the current system of European Patents which – after grant – operate as independent national patents in up to 38 countries.
Continue Reading A Unitary Patent for Europe is Finally Approved

Originally published as Covington E-Alert on December 10, 2012

On 6 December 2012, the EU Court of Justice dismissed AstraZeneca’s appeal of the General Court’s judgment in AstraZeneca v Commission. The Court of Justice affirmed the reasoning and holdings of the General Court and rejected all of AstraZeneca’s arguments, including its challenge to the General

Article originally published in Covington E-Alert, 10 December 2012

On 6 December 2012, the EU Court of Justice dismissed AstraZeneca’s appeal of the General Court’s judgment in AstraZeneca v Commission. The Court of Justice affirmed the reasoning and holdings of the General Court and rejected all of AstraZeneca’s arguments, including its challenge to the General

Article originally published in the Briefing paper for the BioIndustry Association on October 9, 2012

Background:
This note provides an introduction to trade marks and designs, from a European perspective. It aims to explain the relevance of trade marks and designs to bioscience companies. It has been prepared by Morag Peberdy of Covington & Burling

Originally published as Covington E-Alert on May 17, 2012

On 15 May 2012, the Advocate General of the EU Court of Justice issued his opinion on the appeal of the General Court’s judgment in AstraZeneca v. Commission.1 The Advocate General largely agreed with the reasoning and holdings of the General Court, and recommended that the

Article originally published in the Life Sciences Handbook, 2012

1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?

Legislation
The main legislative acts regulating medicinal products are the: