Arnold & Porter Kaye Scholer LLP

Arnold & Porter is a firm of nearly 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Client-driven and industry focused, our lawyers practice across more than 30 practice areas, including bankruptcy, corporate finance, intellectual property, litigation, real estate and tax, to help clients with complex needs stay ahead of the global market, anticipate opportunities and address issues that impact the very value of their businesses. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders, to offer clients forward-looking, results-oriented solutions that resolve their US, international and cross-border legal needs.

Arnold & Porter Kaye Scholer LLP Blogs

Latest from Arnold & Porter Kaye Scholer LLP

In the coming weeks, Members of European Parliament are due to vote on whether the draft EU Copyright in the Digital Single Market Directive will come into force. The proposed copyright reforms have sparked large scale controversy amongst the tech giant community, condemning the reforms as impractical and burdensome. Whereas many (not all) authors and members of the performing artist industry have welcomed such proposals, favouring fairer protection and remuneration for their works. What is the…
On 28 January 2019, the European Commission (Commission) published its Report to the Council and the European Parliament on Competition Enforcement in the pharmaceutical Sector (2009-2017) (Report). This takes stock of all the pharma cases that the Commission has pursued at EU level and that national competition authorities have investigated over the past 10 years.  It responds to recent concerns raised by the Council and European Parliament that anti-competitive practices of pharmaceutical companies may prevent…
The UK Government published today details of the temporary tariff regime that will apply from 11pm on 29 March 2019 if the UK leaves the European Union (EU) without a deal (see here). This is being published ahead of the vote in Parliament on no deal to ensure that the members of parliament are well informed. The new regime is temporary, and the government intends to closely monitor the effects of these trade tariffs…
On 23 January 2019, the European Data Protection Board (EDPB) adopted an Opinion on the interplay between the Clinical Trials Regulation (CTR), which is likely to become applicable in 2020 (if not later), and the European General Data Protection Regulation (GDPR). The Opinion focusses on an area provoking much discussion since the GDPR came into force; that is, as we discussed in our previous blog, which legal bases under the GDPR are appropriate for…
On 20 February 2019, the English High Court delivered its eagerly awaited judgment in Canary Wharf v EMA [2019] EWHC 334 (Ch), rejecting the EMA’s argument that the United Kingdom’s withdrawal from the European Union would amount to a frustrating event allowing it to terminate its lease of premises in London. What is frustration Under English law, frustration allows a contract to be set aside on the basis of an unforeseen event which renders…
On 14 February 2019, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-423/17 Netherlands v Warner-Lambert Company, finding in line with the opinion of Advocate General Kokott issued on 4 October 2018, that “carving-out” indications or dosage forms covered by the patent right of a third party, leading to a skinny label for the product, is a request to limit the marketing authorisation for the generic medicinal product. In…
The Falsified Medicines Directive 2011/62/EU (FMD) introduced a new requirement for safety features to appear on the packaging of all prescription-only medicinal products: a unique product identifier and an anti-tampering device (ATD). Commission Delegated Regulation (EU) 2016/161 sets out technical detail around the characteristics of the safety features, how authenticity should be verified and by whom. With the deadline to demonstrate compliance with the Delegated Regulation fast approaching (9 February 2019), we draw your attention…
Thousands of European and US companies will have been relieved by the recent announcement that the EU-US Privacy Shield (the framework for regulating transatlantic exchanges of personal data) is secure for another year. However, it may be premature to rejoice: the EU Commission’s review highlighted two key issues: the continued reluctance by the US to institute fundamental safeguards for individuals’ personal data; and the imminent need to appoint an independent ombudsman. Coupled with the impending…
As we approach one year to go before the application of Regulations (EU) 745/2017 (Medical Devices) and 746/2017 (In Vitro Diagnostic Medical Devices) (applicable in May 2020 and May 2022, respectively), the European Commission has updated its website to collate all of its guidance on the legislation. This includes a recently published series of nine non-binding practical reference guides, which is now available in a new section of the website entitled “Spread the word
On 18 January, a new statutory instrument, the Human Medicines (Amendment) Regulations 2019 (the Amending Regulations), which amend the Human Medicines Regulations 2012,  was laid before Parliament.  These regulations will come into force on 9 February 2019. The principal purpose of the amendments is to transpose into UK legislation the remaining provisions of Directive 2011/62/EU (the Falsified Medicines Directive), which require two new safety features to appear on the packaging of certain medicinal products,…