The Federal Ministry of Transport and Digital Infrastructure (BMVI) is providing EUR 50 million annually until 2023 to promote computer games in order to strengthen Germany as a location for developers. In the now launched second phase, large-volume projects are being funded ...
Background In its ruling of June 15, 2021 (Case No. VI ZR 576/19), the German Federal Court of Justice (BGH) for the first time took a comprehensive position on the scope of the right to access pursuant to Article 15(1) GDPR. Article 15 GDPR standardizes the right of access of a data subject vis-à-vis a controller ...
On 27 May 2020 the Federal Council adopted the Ordinance on Protecting against Cyber Risks (OPCy, available in French and German), which is set to enter into force on 1 July 2020. This move is the next step in a series of measures taken by the Federal Council to adopt a new organisational structure and implement a national strategy to protect Switzerland against cyber risks (NCS, available in German, French, Italian and English) ...
While many countries have introduced far-reaching obligations to report cyber incidents, Switzerland has not yet followed this lead. However, on 13 December 2019 the Federal Council adopted a report which considers key issues with regard to the introduction of a general reporting obligation for operators of critical infrastructure. The report also discusses possible implementation models. A decision is expected by the end of 2020 ...
On 27 November 2019 the Federal Council adopted a dispatch message to improve the legal framework governing distributed ledger technologies (DLT) in Switzerland. The Federal Council's objective is to increase legal certainty, remove obstacles to DLT-based applications and limit the risk of abuse. Parliament will examine the dispatch message in early 2020. The government's press release is available in English, German, French and Italian ...
Judicial rulings on the patent-eligibility of software and business method patents under section 101 of the U.S. Patent Act have run heavily against patent owners since the U.S. Supreme Court’s June 19, 2014 ruling in Alice Corp. v. CLS Bank International, 573 U.S. ___, 134 S. Ct. 2347 (2014). (See Client Update here ...
The Federal Circuit today overruled a federal district judge and held that Oracle’s API computer source code qualifies for copyright protection, potentially breathing new life into Oracle’s billion-dollar lawsuit against Google. Oracle America, Inc. v. Google Inc., Case No. 13-1021 (Fed. Cir. May 9, 2014) ...
Recently, in Amgen Inc. v. Hospira, Inc.,[1] the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods. In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia ...
In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners. In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays). And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc ...
Biosimilar developers have been aggressive in filing petitions for inter partesreviews of biologics patents before the Patent Trial and Appeal Board, many ofthem preceding the filing of a marketing application. Such early IPRs are attractiveto biosimilar makers, because they provide a chance to challenge innovator patentsyears before the biosimilar maker files a marketing application with the U.S. Foodand Drug Administration ...
FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
On September 9, 2014, the U.S. Food and Drug Administration (FDA) published the inaugural “Purple Book,” a list of approved or “licensed” biological products, including all biosimilar and interchangeable biological products. The Purple Book is more formally known as “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” The Purple Book is meant, at a fundamental level, to be the biological equivalent of the “Orange Book ...
The FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19 pandemic. The FDA acknowledges that companies, and the agency, itself, may be hit with workforce shortages during a pandemic at the same time that adverse event reporting for products deployed for the pandemic may increase ...
The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020. This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead ...
The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...
FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
GENERAL 1. How can the government’s attitude and approach to internet issues best be described? The attitude of the Belgian government can be described as positive and their approach is proactive. In 2003, the Belgian authorities announced the introduction of ‘e-government’. The most important initiatives were the introduction of electronic identity cards (e-ID) for all Belgian citizens over 12, and the federal government’s information web-portal ...
For businesses who care about their brands, Pofma may be not be such a bad idea after all.Beyond Meat Inc. makes cows happy and cardiologists sad. Its Beyond Burger uses no meat and has no cholesterol, and contains less fat, fewer calories and more protein than a typical burger ...
Use of a domain name: is it a form of advertising? Following the decision in Case C-657/11 (Belgian Electronic Sorting Technology BV v Bert Peelaers, Visys NV), the rules of fairness imposed by European Directives 84/450 and 2006/114 on misleading and comparative advertising will extend to cover not just the content of a web site, but the domain name at which it is registered as well. See our commentary here ...
The UK data regulator the Information Commissioner’s Office (ICO) has issued a clear warning to organisations that the biggest cyber risk they face is not from hackers themselves but from complacency towards internal data protection compliance. Such companies may face a double whammy of a cyber-attack and subsequent enforcement action. The ICO has fined Interserve Group (a UK based construction company) £4.4 million for breaching data protection law ...
The word on the street is that everybody wants an ERP system, but no one wants to use it. Or rather, no one will use it the way it has been set up as a standard solution. People in general do not like changes. Therefore, the ERP system must first be adapted so that the organisation can work in the same way as it did before. Only then will the organisation be willing to use it. Present ERP systems are better and more mature compared to the ERP systems only a few years ago ...
