On June 13, 2013, in a seminal case on the patentability of the genetic code, the U.S. Supreme Court unanimously held that “naturally occurring DNA … is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.” See Association for Molecular Pathology v. Myriad Genetics Inc. (2013) ...
When a patent is issued under the seal of the United States Patent and Trademark Office, it is signed by the Director of the USPTO or an Office official. The patent contains a grant to the patentee, and a printed copy of the specification and drawing is annexed to the patent and forms a part of it ...
Because American courts have interpreted insurance policies in some unexpected ways over the past several decades, many insurance carriers and policyholders have shied away from U.S.-based insurance coverage and have flocked to Bermuda to use what are commonly referred to as “Bermuda Form” policies. The idea is that the use of these foreign policies can mitigate some of the perceived risks posed by the American court system ...
The financial pressures resulting from the “narrow network” phenomenon are well-known to healthcare providers and payers. Many providers have been eliminated from existing networks in order to allow participating providers access to a greater volume of patients. Those remaining providers have seen lower reimbursement rates and other cost containment measures ...
On 6 January 2019, UAE Cabinet Resolution No. 7 of 2019 Concerning the Administrative Fines Imposed by the Insurance Authority was published in the UAE Official Gazette, which lists a total of 204 items that are considered to be violations by the Insurance Authority and their corresponding penalties ...
The Ministry of Health and Social Protection issued Resolutions 677, 679 and 681 adopting the biosecurity protocols for the control and management of COVID-19 risk in the transportation, transportation infrastructure and games of luck and chance sectors. These protocols are complementary to the general biosecurity protocol adopted through Resolution 666 of 2020 and to other measures implemented by corresponding companies ...
Digemid authorized Pfizer the second conditional sanitary registration of the COVID-19 vaccine manufactured in the United States. A total of 4 vaccines authorized by the Peruvian health authority are added to this registry ...
Please be informed that a new Counter-Sanctions Regime of Making Payments in IP-Related Agreements in Russia was established by the Presidential Decree No. 322 dated May 27th, 2022 “On the temporary procedure for fulfilling obligations in respect of certain right holders” (“Decree No. 322”). It came into force on the date of signing. Download the file to see more. https://alrud ...
Two new bills, the Insurance Amendment Bill and the Insurance Amendment (No. 2) Bill have recently been gazetted making significant changes to the regulatory regime for insurance companies. Insurance Amendment Bill Special purpose insurer An amendment is made to allow registration of an insurance company which engages in special purpose business only ...
After being reviewed four times in three years, the Social Insurance Law of the People’s Republic of China (the “Social Insurance Law”) was finally adopted by the Standing Committee of the National People’s Congress of China on 28 October 2010. Its implementation rules (the “Implementation Rules”) were subsequently released by the Ministry of Human Resource and Social Security (“MHRSS”) on 29 June 2011. Both the Social Insurance Law and the Implementation Rules came into force on 1 July 2011 ...
The European Council has just adopted a new dual-use regulation. The new dual-use regulation is a recast of the current dual-use regulation and aims, among other things, to modernize European export controls in a number of areas. The regulation is directly applicable in all EU Member States and is expected to enter into force in 2021. In this Insight, Plesner's export control specialists outline the main changes resulting from the new dual-use regulation ...
New rules will apply to disability benefit claims and appeals under certain plans that are subject to the Employee Retirement Income Security Act of 1974 (ERISA), effective for claims made after April 1, 2018. According to the Department of Labor (DOL), the new rules are intended to provide greater protection to claimants, and are modeled on the enhanced claims and appeals procedures that apply to health benefit claims under the Affordable Care Act (ACA) ...
On April 9, 2021, the IRS released Private Letter Ruling (PLR) 202114002 (January 13, 2021), which provides additional context to taxpayers worried about whether their Fintech or Insurtech shares represent Qualified Small Business Stock (QSBS) under Internal Revenue Code (IRC) section 1202 ...
Recently the “guideline for the supervision and regulation of the nutritional composition of foodstuff and its advertisement (“the guideline”) was published by the Undersecretary of Health.The guideline´s main objective is to, “guide the process of supervision and regulation of foodstuff”, taking into consideration the upcoming implementation of Decree No. 13 (June 27, 2016), which modifies the Health Regulations for Food Products ...
On, May 27th, Governor Greg Abbott signed into law what has become known as the Texas “Hailstorm Bill ...
On August 16, 2007, the Court of Appeal issued a judgment, written by Mr. Justice Paul-André Gendreau, pertaining to the absence of an initial disclosure of risk to the new insurer in the context of the transfer of an insurance portfolio by a broker.(1) An insurer who accepts the transfer of a policy without ascertaining its current exposure to risk, is deemed to have waived his right to this information ...
On 3 March 2015 IVASS published Regulation No.8 (the “Regulation”) on the simplification of procedures and requirements in the relationship between insurance companies, intermediaries and clients, implementing section 22, paragraph 15 bis, of Law Decree of 18 October 2012,No. 179, converted into Law No. 221 dated 17 December 2012 ...
Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic. EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...
Introduction A plant variety right (PVR) is an IP right which rewards breeders of new plant varieties for their efforts in creating those varieties. The current PVR law dates back to 1975 and is based on the 1961 International Convention for the Protection of New Varieties of Plants. The convention has since been amended several times, most recently and radically in 1991 ...
Introduction Mdeon, the legally recognised Belgian ethical platform for healthcare professionals and the pharmaceutical industry, announced several new ethics rules applying from 1 January 2023. The present blog post discusses their practical importance for the broader healthcare community, and particularly (i) several new ethic rules in light of the ascendant trend of virtual and hybrid scientific events, and (ii) new maximum hospitality amounts that can be offered to healthcare professionals ...
The European Commission published a draft proposal for a revised Product Liability Directive (the “PLD Proposal”) on 28 September 2022, which aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global value chains. This blog focuses on the main changes the PLD Proposal brings and its impact on life science companies ...
This article discusses new regulation introducing some novelties which in essence incorporate many comments coming from the industry. Some modifications to the legal framework provided for the previous regulation address the following: D&O Insurance; Side B. Coverage; Defense Costs; Individuals as Policyholders; Nominated Risks; Penalties; Environmental Risks.: and Side C. The Official Gazette published a new regulation enacted by SUSEP governing D&O insurance. Circular No ...
The Insurance (Bancassurance) Regulations, 2017 were recently gazetted, giving effect to bancassurance under the Insurance Act, 2017 (which is yet to commence) and the Financial Institutions Act, 2004.The introduction of Bancassurance in UgandaBancassurance refers to an arrangement where an insurance company uses a bank’s sales channels to sell insurance products ...
Regulation (EU) 2017/745 of 5 April came into force on 26 May to create a single set of rules applicable to all medical devices, other than in vitro diagnostic medical devices. Here are some of the main changes to the rules that now come into force: 1. Broadening of the scope of application of the rules and of the concept of medical device With this Regulation, medical devices without a medical purpose that have characteristics similar to medical devices (e.g ...
