On Friday, March 27, 2020, the CARES ACT was signed into law. The Cares Act includes provisions for changing deadlines for patents, trademarks, and copyrights. For patents and trademarks, the Act permits the Under Secretary of Commerce for Intellectual Property and the Director of the United States Patent and Trademark Office to change the deadlines imposed by Title 35 of the United States Code, the Trademark Act, Section 18 of the Leahy-Smith America Invents Act ...
In the wake of COVID-19, cities, counties and states across the nation are issuing shelter-in-place and stay-at-home orders to curb nonessential movement of residents. States and local authorities are invoking powers to evacuate residents through statutes that have historically been used for natural disaster evacuations. While the ability to order and enforce such evacuations is not in dispute, the orders in this context raise many questions ...
Unclassified defense technical data that is properly secured with end-to-end encryption is no longer considered an export when it is transmitted outside the U.S., as of March 25, 2020. Access to the unencrypted data by an unauthorized foreign person, however, remains an ITAR-controlled export. This change resulted from an Interim Final Rule coming into effect from the U.S ...
Faced with the COVID-19 pandemic, the Portuguese National Authority for Medicines and Healthcare Products (“INFARMED”) and the Directorate-General for Health (“DGS”) have issued guidelines for pharmacies. These guidelines address, in particular, the way pharmacies operate and manage medicines ...
Scammers and cyber crooks did not take long to adapt their usual fraud to this uncertain period caused by the Covid-19, refinishing notably their sadly notorious “CEO Fraud” to the present circumstances ...
The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic ...
Q&A procedures before the Public Health Institute (ISP) May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S ...
Dinsmore Intellectual Property Partner Adrian Cyhan and Christopher Smith of Brooks Kushman wrote the following article, "Dawn of a New Era: Licensing Standards in the Coming Age of 5G" for The Licensing Journal. 5G: What’s the Big Deal? The advent of 5G cellular wireless technology represents a major advance in speed and bandwidth of wireless communications ...
With the onset of COVID-19, certain areas of academic and government-fueled research are exploding. However, universities and governments at all levels are also scaling down nonessential research tasks and limiting the enrollment of essential new human subjects or new animal experiments.[1] Similarly, private companies may be suspending or cancelling their research projects in an attempt to conserve financial resources and accommodate researchers working from home ...
Zoom, the social platform which has become nearly ubiquitous in the past few weeks, has unintentionally introduced the world to a new term: “Zoom Bombing." Millions of people are struggling to maintain some semblance of normalcy as they continue to engage in personal and business interactions while simultaneously practicing social distancing during the COVID-19 pandemic ...
In the wake of the COVID-19 outbreak, the business community is faced with unprecedented threats to their cyber-infrastructure and data. Sensitive data, in particular, will be vulnerable to security breaches as a result of reduced human power under emergency legislation. Moreover, criminal hackers will be looking to capitalize on such vulnerabilities at a time like this ...
Through External Circular No. 001 of March 23, 2020, the Superintendence of Industry and Commerce (SIC) made clear that mobile phone operators and private entities in general have legal grounds to provide to the National Planning Department (DNP), as well as to public entities that so require it, personal data that is necessary to address, prevent, treat and/or control the spread of COVID-19 and mitigate its effects ...
In some areas, intellectual property will experience a period of slowdown in activity, at least in the near future. We look at this in more detail below. However, this does not mean mandatory registration of industrial property will come to a halt because, with many bodies, including the Portuguese INPI (National Institute of Industrial Property), registration is done online ...
As if businesses did not have enough to worry about during this COVID-19 pandemic, it’s times like these when cybersecurity risk is at its peak. Distracted employees may be psychologically vulnerable to attack, and shifting quickly and unexpectedly to a remote workforce can create technology and control risks. It’s a perfect storm for cyber risk ...
Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation ...
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 ...
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 ...
An article establishing a procedure for the procurement of medical supplies was recently introduced. This new provision (Resolution No 53960) amended Resolution No 38941-2006-JD of February of 2006, which is the general procurement regulation for the Social Security Administration (CSS for its initials in Spanish) ...
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 U.S ...
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 ...
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 ...
