Patents

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”

The UK Patent Box regime aims to incentivise companies to retain and commercialise existing patents and to develop new innovative patented products. The regime allows companies to apply a lower rate of corporation tax to qualifying worldwide profits attributable to qualifying patents and other similar intellectual property (“IP”) rights. It forms part of the UK Government’s growth agenda to encourage companies to locate the high-value jobs associated with the development, manufacture and exploitation of patents in the UK and maintain the UK’s position as a world leader in patented technologies. The regime came into force on 1 April 2013 and will be phased in until April 2017.

The headline rate for qualifying profits will be 10% (phased in by April 2017). However, the effective tax rate is likely to be higher as certain expenses are disallowed and certain profits are excluded from the regime. Therefore, the UK Patent Box regime does not provide tax rates as low as can be achieved elsewhere in Europe (e.g., Luxembourg, Switzerland, Ireland, the Netherlands and Belgium). Companies that do not want to incur the cost and complexity of establishing separate IP holding companies are likely to welcome the new regime as are companies with existing IP structures that are concerned about recent ministerial statements about tackling tax base erosion.
Continue Reading The UK Patent Box Regime: An Overview

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
Continue Reading Judgment of the Court of Justice in AstraZeneca v Commission

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

Continue Reading Judgment of the Court of Justice in AstraZeneca v. Commission

Article originally published in Journal of European Competition Law & Practice Advance Access on July 31, 2012

This survey article discusses the major EU competition law developments in the pharmaceutical sector from 1 July 2011 through 30 June 2012. The developments during this period were largely incremental, but presage what
Continue Reading The Application of EU Competition Law in the Pharmaceutical Sector

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
Continue Reading The Advocate General’s Opinion in Astrazeneca v. Commission

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:

Article originally published in PLC Life Sciences Handbook 2009/2010

Many life science companies rely on their employees’ inventiveness to fuel their research and development (R&D) efforts and generate patents. The most successful inventions can generate billions of euros of sales annually. In some circumstances, the employees who created the patentable
Continue Reading Employee’s Rights to Compensation for Inventions – a European Perspective