By Tilman Siebert and Dr. Corinna Kammerer on Posted in EME Life Sciences
The German Federal Ministry for Economic Affairs and Energy implemented further amendments to the Foreign Trade and Payments Ordinance (Außenwirtschaftsverordnung – AWV) due to the COVID-19 pandemic to prevent the buyout of German companies active in the life sciences and infection protection sectors by investors from outside the EU (or EFTA). The amendment entered into … Continue Reading
On 2 June, the European Commission (Commission) published a roadmap (Roadmap) that will pave the way for the Commission’s communication on the EU pharmaceutical strategy, which is now due in the last quarter of 2020. The Roadmap should be read together with the Commission’s proposal for a recovery of the EU’s economy (Next Generation EU), … Continue Reading
If they serve health care professionals (HCPs) in EU member states, manufacturers that provide personal protective equipment (PPE) or medical devices used by HCPs caring for known or suspected COVID-19 patients should familiarize themselves with a recent European Commission recommendation. This recommendation is designed to accelerate the time to market for these products, provided that … Continue Reading
Global life sciences companies have been carefully watching the European effort to launch a Unified Patent Court (UPC). As we discussed in a previous post, the UPC would have a profound effect on how life sciences companies set about their patent strategies – from filing through exploitation to enforcement. Efforts to implement the UPC, however, … Continue Reading
As corporations continue to grapple with economic issues surrounding COVID-19, global life sciences companies must start to determine how laws in each of the jurisdictions in which they operate will impact their contractual responsibilities and opportunities for remedies in their business relationships. Life sciences companies with operations in France must recognize that their COVID-19 response … Continue Reading
The Innovative Medicines Initiative (IMI) was created in 2008 as a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).[1] Its overall goal is to increase the competitiveness of R&D in the European pharmaceutical sector by encouraging companies to work with each other and with the public sector. … Continue Reading
By Anette Gaertner and Jonathan Diehl on Posted in EME Life Sciences
Germany is one of the most important patent litigation jurisdictions in Europe, making developments in its patent law very important to life sciences companies operating globally. In recent years, the number of cases regarding claims for the transfer of patents has risen steadily in Germany. If an application is filed by someone who is not … Continue Reading
The United Kingdom (UK) is scheduled to leave the European Union on 29 March 2019. Certain key aspects of the Brexit deal now seem to have been agreed upon, including a 21 month “transitional period” after the UK’s exit, but the full agreement has not yet been finalized and there is currently a risk of … Continue Reading
Did you know the U.K. patents system penalizes a failure to record a patent transaction at the Patent Office by depriving a successful plaintiff of its entitlement to recover its full legal costs in any subsequent infringement litigation on that patent? It’s a little-known trap for the unwary, and the subject of our London partner … Continue Reading
With the Unified Patent Court now stalled for at least the near future, U.S. life sciences companies will continue to face the question of where to bring patent infringement cases in Europe. The German courts offer a variety of potential advantages for such companies. Two-thirds of all patent infringement cases in Europe are brought to … Continue Reading
The UK held the first two hearings under its new opt-out class action procedure. The precise rules governing UK class actions will be developed over time from the general guidelines in the statute. There are significant similarities between the U.S. and UK rules on a number of topics related to collective proceedings, and barristers and … Continue Reading
In France, transparency requirements are regulated by two main sets of laws: “The French Anti-Gift Law” regulates the provision of gifts, discounts and other incentives to health care providers by life sciences companies, while “the French Sunshine Act” imposes disclosure obligations on companies relating to benefits granted to, and agreements concluded with, health care providers. … Continue Reading
As we discussed in a prior post, the introduction of the Unified Patent Court (UPC) will be a significant change to the European patent landscape and will have a profound effect on how life sciences companies set about their patent strategies – from filing through exploitation to enforcement. Consequently, life sciences companies should take note … Continue Reading
The introduction of the Unified Patent Court (UPC) is undoubtedly the most significant change to the European patent landscape since the European Patent Convention of 1973. It will have a profound effect on how life sciences companies set about their patent strategies – from filing through exploitation to enforcement. Leaving aside the inevitable delays to … Continue Reading
European Patent Office oppositions are a very powerful way of litigating newly granted patents. In reality these are pan-European revocation proceedings, with profound strategic significance for life sciences companies – this is the only way through which all national parts of a European patent can be revoked simultaneously in one set of proceedings. Unsurprisingly, EPO … Continue Reading
Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals, pharmaceutical and medical device manufacturers, and government officials, among others. As Reed Smith partner Daniel Kadar points out in “The French Sunshine … Continue Reading
The French government issued a bill on March 17 for the extension of class actions to health-related claims in France. Starting today, March 31, the text will be discussed at the French National Assembly, particularly to address the issue of compensation for personal injury within the framework of the proposed class action.… Continue Reading
Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent decision by the French Supreme Administrative Court (Conseil d’Etat) that expands the scope of the French Sunshine Act. “French Supreme Administrative Court Decision Significantly Broadens the Scope of the French Sunshine Act,” written by Reed Smith attorneys Daniel Kadar and Caroline Gouraud, … Continue Reading
French Minister for Economic Affairs Emmanuel Macron recently introduced a bill proposing the recognition of legal privilege for in-house lawyers in France, which does not currently exist. However, this recognition was rejected by the Special Commission of the French National Assembly before the bill was passed by the lower chamber - a decision consistent with the Grand Chamber of the European Court of Justice's 2010 ruling in Akzo.… Continue Reading
Since January 21, the European Medicines Agency (EMA) has been holding a public consultation on the new European Clinical Trial Regulations (CTRs), which are intended to streamline the application process for clinical trials and increase the availability of information and results. However, the CTRs have met with some concerns regarding commercial and patient confidentiality. As … Continue Reading
In “From Sea to Shining Sea: French and US Sunshine Laws,” (Law360 subscription required), Reed Smith attorneys Elizabeth Carder-Thompson and Daniel Kadar discuss recent legislation from both sides of the Atlantic designed to increase the transparency of relationships between drug and medical device manufacturers on one hand and physicians and teaching hospitals on the other. … Continue Reading
France has recently adopted the class action system. This system is, however, framed and - temporarily - excludes health- or environment-related litigation. An overhaul is already scheduled in 30 months.… Continue Reading
A new draft order to the French Sunshine Act may soon change some procedures in a way that may help with implementation of the rules, and provide a new timeline for pharmaceutical and medical device companies to disclose specified payments to health care providers.… Continue Reading
In April 2013, an independent review of the regulation of cosmetic interventions in the UK was published, highlighting an insufficient amount of regulation in this industry by the UK government, due in part to the rapid growth of cosmetic procedures in the United Kingdom. Cases such as unauthorized (and potentially defective) materials being used in … Continue Reading