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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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) ...
Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them ...
New technology is most often associated with telecommunications, IT or robotics. Food is seen as a group of products in which innovation is little important, because it is believed that consumers are mostly concerned with prices and quality, but not innovations. However, the dynamic growth in market share of functional foods calls for a critical review of myths that have arisen around R&D projects in the food sector ...
On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
On May 7, 2020, the amendment to Decree No. 466 was published in the Official Gazette, which approves the Regulation of Pharmacies, Drugstores and other pharmaceutical establishments, regarding the sale of medicines through electronic means. Particularly, article 8 of said Decree is modified, in order to allow the electronic sale of medicines in pharmacies, incorporating the following sentence: "Pharmacies may dispense medicines through electronic means ...
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
On February 25, 2021, the Ministry of Health and Social Protection issued Resolution 223 of 2021 (the “Resolution”) to update the general biosecurity measures set for the management of Covid-19 in Colombia. The main novelties included in this regulation are mentioned below: 1. Scope The Resolution extended the scope of the general biosecurity measures to all "social and economic activities carried out by individuals" ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
Fast-growing e-commerce has changed lifestyles and invented new ways of consumption, amid which demand has rapidly increased for Internet-based medical services such as online drug sales and online medical diagnosis. Since the regulation and promotion of "Internet-based healthcare services" was included as part of the Outline of the "Healthy China 2030" Plan, China's Internet healthcare industry has been flourishing, channeled by a series of favorable policy decisions ...
Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...
Although the U.S. Department of Justice (DOJ) reported a slight decrease in settlements with life sciences companies in FY2019 (the most recent year for which data is available),[1] this likely will be a temporary trend. Several significant settlements and investigations in 2020 provide key insights into government enforcement priorities as we look toward 2021 ...
CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes" ...
Welcome to the Life Sciences & Healthcare Newsletter, a publication prepared by our multidisciplinary team dedicated to the Healthcare industry, under the coordination of partners Lior Pinsky and Renata Fialho de Oliveira. INSURANCE ANS establishes operating rules for electronic administrative proceedings, effective as of end of March 2021 Andrea Piccolo Brandão In accordance with Decree No. 8,539, of Oct. 08, 2015 ("Dec ...
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...
On September 8, 2023, the China National Center for Biotechnology Development (the "CNCBD"), a public institution under direct charge of the China's Ministry of Science and Technology (the "MOST"), released the"Notice on Issuing Answers for Frequently Asked Questions on Human Genetic Resource Administration"(the "Updated FAQs"), which summarized and responded to questions that are constantly raised among the relevant industry (the "Industry") ...
On September 7, 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the"NMPA") released "Annual Report on Progress of Clinical Trials for New Drug Registration in China (2022)"(the"2022 Annual Report") ...
