Under the patent statute, any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act, or method, and primarily includes industrial or technical processes. The term “machine” used in the statute is self-explanatory ...
Institutional Shareholder Services, Inc. (“ISS”) and Glass, Lewis & Co. (“Glass Lewis”) recently released their 2019 proxy voting policy updates. ISS and Glass Lewis are two of the leading proxy advisory services worldwide, and each evaluates and updates their proxy voting policies annually. The key ISS and Glass Lewis updates for the 2019 proxy season are summarized below. ISS ISS published its 2019 Proxy Voting Guidelines Updates on November 19, 2018 ...
On November 7, 2023, Ohio voters passed Issue 2, a measure that will legalize the purchase and use of recreational marijuana. By passing this initiative, Ohio becomes the 24th state to legalize recreational marijuana. Issue 2 creates Chapter 3780 of the Ohio Revised Code. This new law will become effective on December 7, 2023 ...
President Trump recently signed the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) and the cannabis industry quickly and widely celebrated passage as clearing the way to sell products containing cannabidiol (better known as CBD). But is it really? As one might expect, this lawyer’s answer is that “it depends.”CBD has become known for its purported health benefits in relation to a wide range of conditions ...
We are glad to present you a current digest of the most significant bills, regulatory changes, and measures affecting the pharmaceutical and healthcare industry for the period from June to October 2022. Follow the link to download the digest. ALRUD_Newsletter_Key_changes_in_Life_Sciences_for_the_June-October_2022_period_upd ...
On Oct. 31, 2019, the United States Department of Agriculture (USDA) published its highly anticipated interim final rules, establishing the USDA Domestic Hemp Production Program to be administered by the Agricultural Marketing Service (AMS) ...
On July 14, 2023, the Ministry of Science and Technology of the PRC ("MOST") issued the Notice on Updating the Guidelines on Administrative Approval Items and the Scope and Procedures for Filing and Prior Reporting of Human Genetic Resources, which unveiled six documents, including the administrative guidelines on collection approval, biobanking approval, exportation approval and international collaboration approval of human genetic resources ("HGRs"), as well as the scope and procedures for int
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") ...
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") ...
The Department of Agriculture (USDA) announced in late February that it's delaying enforcement of certain requirements set forth in its Interim Final Rule (IFR) on the Domestic Hemp Production Program (84 FR 58522) under certain circumstances until October 31, 2021, or until publication of the final rule on such hemp production program, whichever occurs first ...
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 ...
Last month the Scottish Government published “Land Reform in a Net Zero Nation”, a consultation paper on a new Land Reform Bill. The paper sets out the proposals for the bill and seeks views on various related issues, including measures aimed at “large-scale holdings”, changes to subsidies, the introduction of a new type of agricultural tenancy, and transparency of land ownership ...
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 ...
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" ...
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 ...
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’) ...
On 1 September 2023, the legal framework for seed farming in Russia will take effect. At present, lawmakers are preparing highly controversial regulations, which essentially aim to limit foreign investments in the Russian seed farming sector. The central idea is to implement a set of rules that require Russian companies involved in the production of agricultural plant seed varieties and hybrids to localize their activities (“Localization Rules”) ...
There has been concern within the agricultural industry for some time the race to achieve carbon net-zero is leading to the loss of productive agricultural land to forestry purchasers. Another perceived threat is from investors, both private and institutional, looking to invest in natural carbon, for example, by way of peatland restoration and rewilding projects ...
Agricultural and rural settings present significant health and safety risks, which must be carefully managed and mitigated by employers and landowners operating in the sector. This was brought into sharp focus after two fatalities led to prosecutions following investigations by The Health and Safety Executive (HSE). Prosecution one In February, a farmer was prosecuted after a tragic fatal incident on farmland in Leeds ...
The Scottish Government, SEPA and industry have identified significant opportunities for the growth of the finfish aquaculture sector in Scotland. This expansion is an express policy objective of the Scottish Government, and was confirmed through the National Marine Plan published in 2015. Nevertheless, whilst there has been some growth in the sector since the plan’s publication, the sector has yet to realise its full potential ...
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 ...
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 ...
On Monday, June 3, Governor Gretchen Whitmer and the Michigan Department of Agriculture and Rural Development (MDARD) announced MDARD’s decision to allow for commercial solar energy development on land currently enrolled in the Farmland and Open Space Preservation Program, commonly known as PA 116. PA 116 was established in 1975 and is designed to preserve farmland and open space in Michigan ...
