Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post.

On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation (“MA”) application process (the “MA Documents”).  The MA Documents at issue included EMA Assessment Reports on similarity and superiority between Pari’s product (Vantobra) and Novartis’ product (TOBI Podhaler), which has an EU MA as an orphan medicine.  Novartis made the request to the EMA for access to the MA Documents under the Transparency Regulation 1049/2001.  The main case is currently pending before the General Court (Case T-235/15).

The thrust of Pari’s argument before the General Court was that the MA Documents contain Pari’s regulatory strategy for obtaining MA approval, disclosure of which might cause Pari serious and irreparable financial damage.  The President of the General Court acknowledged that the case raised complex issues in the area of confidentiality and stated that the main proceedings (rather than an interim hearing) is the appropriate forum to address such issues..  As such the President considered that the MA Documents fell under a presumption of confidentiality  and ordered the EMA not to disclose the MA Documents.
Continue Reading General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case

The European Medicines Agency (EMA) has recently published for public consultation its draft guideline on clinical development of fixed combination medicinal products (Draft Guideline), which is intended to replace CHMP/EWP/240/95 Rev. 1 (Existing Guideline).  The Draft Guideline applies to fixed combination medicinal products containing two or more active substances within a single pharmaceutical form.  The active substances may be known active substances or substances that have yet to be authorised in the EU.
Continue Reading New Draft EMA-Guideline On Clinical Development Of Fixed Combination Medicines

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?

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

Since Apple launched the first iPhone in 2007, the popularity of smart phones and tablets has sky-rocketed.  These devices, with their sleek design, touch screens and easy access to a myriad of entertainment options, have fast become the preferred method of communication for executives.

In recent years, a growing number of companies have allowed employees to forgo the less glamorous and often outdated technology assigned by their IT department and instead access corporate emails and data on their personal devices – a practice known as “bring your own device” to work, or “BYOD”.

Continue Reading “Bring Your Own Device to Work” – Can Life Sciences Employers Safely Embrace the Trend?

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

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

Article originally published in Concurrences, N° 3-2009 (September 2009)

PROCEED WITH CAUTION ACROSS THE IP/COMPETITION INTERSECTION

DG Competition’s release of its long-awaited Final Report on its Pharmaceutical Sector Inquiry on 8 July 2009 was somewhat of a damp squib compared to the fireworks surrounding the publication of its Interim Report some eight months earlier. The