On 24 March 2021, the EU Member States agreed to begin negotiations with the European Parliament concerning a legislative proposal on health technology assessment. Health technology includes medicinal products, medical devices or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare ...
A key feature of Undertakings for the Collective Investment in Transferable Securities (“UCITS” fund) is the Key Investor Information Document (“KIID”), which provides the retail investor with simplified information from the prospectus. UCITS also qualify as Packaged Retail Investment and Insurance Products (“PRIIPS”) ...
Dear Readers, ALRUD Regulatory practice has prepared a new version of our regulatory Guides. This Guide is devoted to an overview of key changes and trends that took place in 2022. The review was published with the participation of ALRUD experts - Maxim Alekseev, Senior Partner and Head of ALRUD Regulatory practice,Dina Kravchenko, Senior Associate, andBoris Pribylov, Senior Associate. Follow the link below to learn more ...
HARMONIZATION OF CLINICAL RESEARCH CONTRACTS IN QUEBEC OLGA FARMAN and MARIE-ÈVE CLAVET [email protected] [email protected] Over the past few decades, a high-quality system of research and innovation has been built in the Province of Quebec. The contractual research conducted by university-affiliated health-care institutions in Quebec has become a fundamental scientific, economic and social activity ...
The COVID-19 virus (commonly known as the “coronavirus”) is affecting companies’ commercial activities around the world, with particular impact on supply chains and employment and insurance law. There is also a question around the measures the competent authorities may impose to prevent or contain the spread of the coronavirus. A ...
The outbreak of the coronavirus and the measures taken by the Chinese government to contain it have brought production in China as the world's workbench to a complete standstill. Companies that operate in China or purchase such goods are currently facing delivery shortfalls. A similar situation could soon threaten Italy, where the first factory closures have already taken place ...
As noted in Part I and Part II of this series, benefits compliance concerns typically take a backseat to the many good reasons for healthcare organizations to provide or receive the services of leased employees. However, with sufficient awareness, these compliance issues, which often have surprisingly outsized risks, can generally be managed without disrupting the aims of the employee leasing arrangement ...
The London Court of International Arbitration recently published its caseload statistics for 2021, which can be found here. The LCIA is one of the world’s leading international institutions for commercial dispute resolution and administers arbitrations and other alternative dispute resolution proceedings, regardless of location and under any system of law ...
Brick and mortar retailers are rapidly diversifying checkout and payment methods to combat the erosion of sales to online channels and provide an improved shopping experience for consumers. From self-checkout kiosks, to store-specific mobile applications for payment, scan-as-you-go devices, and even ‘just walk out’ models, retailers are reinventing consumer’s notions of the traditional checkout line by going cashierless ...
On May 17, 2024, Law No. 21,664, which amends the Chilean Sanitary Code to define the concept of meat and prohibit the use of this designation for products that are not of animal origin, was published in the Official Gazette. This law introduces a new Paragraph III to Title II of Book Four of the Sanitary Code, called “Of Meat” ...
On September 28th, Law 21,614 of the Ministry of Labor and Social Security was published in the Official Gazette (hereinafter the “Law”), which establishes amendments to Law No.21,063, which Creates an Insurance for the Accompaniment of Children Suffering from Diseases as Indicated and Modifies the Labor Code for these purposes (hereinafter “SANNA Law”) ...
On April 20, 2021, Law No. 21,320 (the “ Law ”), which amends Law No. 19,496 on Chilean Consumer Protection Act (“ CPA ”) regarding extrajudicial collection proceedings and other consumers' rights was published in the official gazette. The Law, which shall be effective immediately, introduced several amendments to the CPA, regarding new principles that will inform the extrajudicial collection proceedings, new duties and legal limitations to suppliers ...
Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021) For the second time in two weeks, our Case of the Week focuses on the written description requirement, in particular where the patent claims a range. In fact, all three precedential decisions issued this week concern issues relating to patents that claim numerical ranges. Below, we discuss two of those cases in our “Also This Week” section ...
Mosaic Brands, Inc. v. Ridge Wallet LLC, Appeal Nos. 2022-1001, -1002 (Fed. Cir. Dec. 20, 2022) In our Case of the Week, the Federal Circuit discussed the corroboration requirement concerning the amount of evidence needed to successfully invalidate a patent as anticipated. Mosaic claimed that Ridge infringed Mosaic’s patent and trade dress for a money-clip wallet. Ridge countered that Mosaic infringed Ridge’s own patent for a money-clip wallet ...
AstraZeneca AB v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1729 (Fed. Cir. Dec. 8, 2021) Our Case of the Week again focuses on numerical values in claims. Last week we addressed a case involving whether there was written description support for a number in a claim, and we addressed a similar issue the week before. This week, our case focuses on the meaning and scope of a number in a claim ...
University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to light-based disinfecting methods to be obvious over the prior art. This case provides a helpful example of how negative claim limitations can affect an obviousness determination ...
Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. Jan. 3, 2022) In this week’s Case of the Week, the Federal Circuit affirmed a district court’s bench trial finding that claims of a pharmaceutical patent were supported by adequate written description under 35 U.S.C. § 112(a) ...
Key Points The Supreme Court's upcoming decision regarding the Affordable Care Act could render its tax provisions retroactively unconstitutional. Depending on the outcome, there is a potential opportunity for refunds on open tax years for taxpayers who paid the net investment income tax and additional Medicare tax. For most taxpayers, the deadline for a protective claim of refund on a 2016 tax return, filed without extensions, is July 15, 2020 ...
“Why don’t I own this?” The words of oil prospector Daniel Plainview to his property advisor, querying the land rights for his oil pipeline to the California coast in the Oscar winning film ‘There Will Be Blood, and a blunt, single sentence reminder of the need for early due diligence on large scale developments ...
On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would establish a new category of over-the-counter (OTC) hearing aids. The rule came in response to President Joe Biden’s July 9 executive order, which among other things, calls for wide availability of low-cost hearing aids in order to promote economic competition ...
The High Court has held that a tenant's short-term storage of documents using just 0.2% of a warehouse's floor space enabled the owner to successfully claim a period of rates relief once the property became vacant again. Under current legislation empty retail property enjoys 100% rates relief for a three month continuous period. Industrial and warehouse property enjoys the same relief for a six month continuous period ...
