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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
Important notification of four new guidelines for the compilation of mandatory codes of practice, which are binding in terms of the Mine Health and Safety Act 29 of 1996 (“the MHSA”).Kindly take note that on Friday, 5 February 2016, notices were published in Government Gazette No ...
In the light of the current geopolitical situation, including severe counter sanctions and restrictions imposed by the Russian Government, we would like to provide you with an update on the current IP regulation in Russia. Partial legalization of parallel imports On 29th March, the Russian government issued a Decree No ...
Introduction On 21 January 2021 a new royal decree was published in the Official Gazette which has temporarily extended occupational doctors' role in combating the COVID-19 pandemic in the workplace ...
As the latest signal in the priority of the Duty to Report in Ohio, the State Medical Board has updated its Duty to Report video.[1] The video is offered by the Board for physicians to fulfill the mandatory continuing medical education (CME) component of the license renewal process in Ohio. Introduced in a new regulation on May 31, 2021,[2] the Board began mandating one hour of CME on the topic of the legal duty to report misconduct ...
Ohio legislators are once again attempting to transform the state’s medical marijuana control program after a similar effort stalled out last year. Proponents of the proposed legislation, Senate Bill 9, seek to expand medical marijuana access to Ohioans and revamp the structure of the current program. The proposal would establish the Division of Marijuana Control (“DMC”) under the Department of Commerce ...
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries ...
As we near the second year of the COVID-19 pandemic, trademark maintenance deadlines in 2021 create new obstacles for registrants. To maintain a federal trademark registration, registrants must periodically file an affidavit of use under Section 8, swearing that the mark is in use in commerce or that the registrant has an acceptable excuse for nonuse. Recent office actions show that the U.S ...
Since 2013, the National Medical Products Administration ("NMPA")Center for Drug Evaluation("CDE")has been releasing a Drug Review Annual Report ("Report")each year, which summarizes its work on drug review of the previous year ...
China's National Medical Products Administration (NMPA) released the 2023 Drug Review Annual Report on its official website on February 4, 2024, closely followed by the 2023 Medical Device Registration Annual Report on February 5. According to the public information, more than 60 innovative drugs have been approved by NMPA from 2022 to 2023, and a total of 61 innovative medical devices have been approved in 2023 ...
The world is in an upheaval now with the pandemic raging for over a year. The discussions and decisions that probably would never have been made a few years ago are being made today in the interest of the greater good and the public at large. When Bill Gates expressed his reservations against lifting IP protection on vaccine patents, it left the world reeling and his comments understandably criticised by experts and laymen alike ...
The impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available ...
Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
