Archives: EME Life Sciences

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COVID-19 pandemic: German government further extends foreign investment control rules with regard to transactions in the life sciences sector

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

European Commission Recommendation Could Expedite Access to Medical Devices, Personal Protective Equipment Needed to Care for COVID-19 Patients

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

German Constitutional Court Rules Germany’s Ratification of the Agreement on a Unified Patent Court is Void

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

COVID-19’s Potential Impact on Continuation of Business Relationships in France

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

EU funding call for Coronavirus projects

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

Munich Regional Court Clarifies When Claims for Transfers of Patents Become Time-Barred

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

Little-Known Trap in U.K. Intellectual Property Litigation Could Cost Successful Plaintiffs: What Life Sciences Companies Need to Know

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

Lessons from the Competition Appeal Tribunal Hearings in Merricks v. MasterCard and Gibson v. Pride Mobility Scooters

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

New Regulations Reshape Transparency-Related Obligations in France, Could Impact Life Sciences Companies

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

Unified Patent Court Could be Operational as Early as December 2017

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

European Patent Litigation for Life Sciences Companies: a Silver Lining to the Brexit Cloud?

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 to Make Pan-European Revocation Proceedings Faster, More Efficient as of July 1

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

The Continuing Evolution of the French Sunshine Act

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

Toward Class Actions for Health-Related Claims in France

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

French Sunshine Act’s Scope Expands with Recent French Supreme Administrative Court Decision

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

In-House Lawyers in France Remain without Legal Privilege

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

Public Consultation Examines Potential Confidentiality Issues with New European Clinical Trial Regulations

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

Law360 Article – U.S. and French Sunshine Laws Present Compliance Challenges for Manufacturers

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

UK Government Addresses Lack of Regulation and Legislation in Cosmetics Industry

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
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