Intellectual Property

The European Commission published its Fifth Monitoring Report of Patent Settlements today. Patent settlements enable patent-related disputes to be resolved without having to litigate issues such as patent validity or patent infringement.  The Commission takes the view that patent settlements can infringe competition law when they prompt generic suppliers to…
Continue Reading EU Commission Publishes Fifth Report On Patent Settlements In the Pharmaceutical Sector

The Confidential Disclosure Agreement (“CDA”) is widely used in the Life Sciences Sector, and provides protection for a key asset – a party’s confidential information and trade secrets.  This post does not propose to go through the various possible provisions of a CDA or their negotiation, but instead sets out five practical considerations to take into account when preparing and implementing a CDA.

1. Absolute protection?

Each CDA will provide for certain legal remedies in the event that the other party breaches the agreement, however once an important piece of confidential information is made publicly available it can be difficult or impossible for a party to obtain adequate compensation.  It is stating the obvious to note that the best way to keep confidential information confidential is not to disclose it, however this is sometimes forgotten where a CDA is in place.  On a case by case basis, it is important to consider, prior to disclosure, whether a particular piece of information really needs to be disclosed for a given commercial deal.
Continue Reading The CDA – Five Practical Considerations

Hannah Edmonds, a trainee associate in Covington’s London office, contributed to this post.

Currently, legal  regimes governing protection of trade secrets and confidential information across the EU are fairly disparate. A study published by the European Commission in July (http://ec.europa.eu/internal_market/iprenforcement/docs/20130711/final-study_en.pdf)  has identified a ‘widespread appetite for a harmonized approach’ across the region. Harmonisation of the rules could be of significant financial and practical benefit to life sciences companies.

Ensuring that sensitive information (such as customer supply lists, R & D data and process know how and technology) is legally protected from misuse by employees, consultants, competitors and other third parties is a key concern in the life sciences sector. ‘Trade secrets’ often form the bedrock of a company’s assets. 75% of the 537 EU firms who responded to the Commission’s preparatory survey (some of which were SMEs in the life science sector) indicated that trade secrets were of significant strategic importance to their company’s growth, competitiveness and innovative performance.
Continue Reading A Move to Harmonise Trade Secret Laws Across Europe?

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

Taking a licence from a university or other academic institution raises specific considerations in addition to those that would normally apply in a purely commercial setting.  We set out below ten key considerations for any commercial entity taking a licence from a university in the EU.

1. Continuing academic research in the field and publication rights

Commonly a university will wish to continue to carry-out research in the field within the scope of the licence for academic purposes leading to a risk of intellectual property/confidential information leakage.  Where the university is a charity, it will often have an obligation to publish results in the public interest.


Continue Reading Ten Considerations When Taking a Licence From a University

Overview

A one-way jurisdiction clause (also known as “hybrid”, “asymmetrical” or “unilateral non-exclusive” jurisdiction clauses), requires that one of the parties to a contract must always submit a dispute arising from the contract to a particular country’s courts, whilst allowing the other party the flexibility to commence proceedings in the courts of any country it may choose.

One-way jurisdiction clauses are becoming more prevalent in Life Science transactions where, by way of example, licensors want the flexibility to deal with patent related disputes in the courts of the country where the patent is applied for or granted.

Recent court decisions in a number of jurisdictions have questioned the validity of one-way jurisdiction clauses.

To maximise the likelihood of a one-way jurisdiction clause being enforceable, consider taking the following steps:

  • choose as governing law the laws of a jurisdiction that recognises the validity of one-way jurisdiction clauses;
  • include in the one-way jurisdiction clause an explanation of why the unilateral right to bring proceedings in a second jurisdiction is required – many of the recent decisions on the validity of one-way jurisdiction clauses focus on the lack of fairness to one party; if there is an objective reason for making the jurisdiction clause it may give better arguments to defeat this “unfairness” defence;
  • if you know at the outset that disputes are likely to arise in certain jurisdictions, take local law advice on the enforceability of one-way jurisdiction clauses in these jurisdictions before executing the contract;
  • consider presenting a one-way jurisdiction clause as a non-exclusive jurisdiction clause.
    Continue Reading The Perils of One-Way Jurisdiction Clauses

The implementation of a free trade deal concluded with Korea – the EU’s tenth-largest trading partner – is well on the way, notes the European Commission.  In 2009, Korea became the first Asian country to sign a free trade agreement (FTA) with the EU eliminating tariffs and non-tariff barriers in almost all products, including pharmaceuticals.  The FTA has been in force since July 2011.

The EU is a net exporter of pharmaceuticals to Korea.  The European Commission’s trade statistics show that in 2012 the EU’s pharma exports to Korea reached € 1,530 million whereas  imports from Korea totaled € 124 million.  In 2009, prior to conclusion of the FTA, the EU’s pharma exports to Korea totaled € 1,007 million and imports from Korea € 71 million.  A Korean source observes that in the first 15 months after the FTA came into force, the EU’s top medical export to Korea was ‘drugs for retail sale’ while its most imported medical product from Korea was ‘ultrasound diagnostic devices’. (Source: KHIDI Brief Vol. 49 as published on November 19, 2012.)

In addition to tariffs, the EU-Korea FTA addresses a number of non-tariff issues impacting pharmaceuticals, notably intellectual property (IP) protection.  The FTA includes a comprehensive chapter on this subject with important provisions on patent protection, as discussed below.  Some of these provisions in fact reflect existing laws, while others represent new developments.Continue Reading Drug Patent Protection in Korea under the EU-Korea Free Trade Agreement

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

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