As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...
Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether ...
Earn-outs are a commonly used payment mechanism in overseas and cross-border M&A transactions. Through earn-outs, transacting parties can set flexible metrics to adjust the buyer’s payment obligation and thereby allocate the risks and benefits between the buyer and seller ...
The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use ...
More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...
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 ...
The third wave of COVID-19 is now spreading all over Thailand. The rise in confirmed numbers of cases and deaths has been reported by the Centre for the COVID-19 Situation Administration (“CCSA”). In response to the outbreak, the Ministry of Public Health announced a vaccination plan which ultimately aims to reduce the spread of COVID-19 infections by having around 50 million people (roughly 70% of the population) in Thailand vaccinated by the end of the year ...
We would like to inform you that the Russian President has signed amendments to Article 1360 the Civil Code of the Russian Federation ('Russian Civil Code'), in terms of providing compulsory licenses to use an invention, utility model or industrial design ('patent rights') on 30 April, 2021. The amendments came into force on 11 May, 2021 ...
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 ...
Decree-Law 36/2021, which amends Decree-Law 176/2006 of 30 August ("Medicines Statute"), was published on 19 May. The new Decree-Law introduces a ban on the advertising of discounts on the price of medicines subject to medical prescription that are reimbursed by the National Health Service ("NHS") or that contain narcotic or psychotropic substances ...
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 ...
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 ...
More recently, many more people are using fertility treatment to conceive; particularly same sex couples, single women and surrogates (Human Fertilisation and Embryology Authority data). This echoes a societal shift in so far as relationships, the formation of families and lifestyles are concerned. As such, there needs to be more emphasis on the development and evolution of the law and sector generally ...
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 ...
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 ...
China began legislating the protection of human genetic resources in 1998, at which time the Ministry of Science and Technology (MOST) and the Ministry of Health jointly formulated the Interim Measures for Administration of Human Genetic Resources; however, there had been no corresponding implementing rules to implement it in practice ...
On March 3, 2022, President Biden signed the long-titled Ending Forced Arbitration of Sexual Assault and Sexual Harassment Act of 2021. Seen as a result of the #MeToo movement, this fairly simple amendment to Title 9 of the United States Code prohibits private employers from mandating that employees submit to arbitration of sexual assault and sexual harassment claims ...
Companies may purchase third party technology from time to time. When acquiring patents from outside the company, or from related entities, there are important factors to be considered. Here are certain issues for buyers when preparing a patent acquisition agreement. The buyer should first determine that all the record owners of the purchased Intellectual Property are party to the patent acquisition agreement. A particular patent may be assigned to a subsidiary of the seller ...
Amy Leech, employment law associate and Shoosmiths’ mental health and wellbeing champion, considers the benefits of having an employee led mental health champion network within your business. As an employer, you will have lots of opportunities to look after your employees’ mental health. However, many organisations are still just paying lip service to it ...
On March 30, 2022 the Division of Examinations of the United States Securities & Exchange Commission published the 2022 Examination Priorities. As in other years, the 2022 Examination Priorities document provides certain data regarding the scope of the examination program and the growth of the investment adviser community ...
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 10 March, 2022, the Federal High Court sitting in Abuja in Suits No: FHC/ABJ/CS/791/2020: Fan Milk International A/S v. Mandarin Oriental Services BV and The Registrar of Trademarks and FHC/ABJ/CS/792/2020: Fan Milk International A/S v. Mandarin Oriental Services BV and The Registrar of Trademarks, delivered two landmark judgements and established certain principles on the determination of trademark infringement ...
Impact on the activity of the pharmaceutical industry At the end of 2021, two laws were published to regulate the general framework for the prevention of corruption in the activity of companies: (i) Decree-Law 109-E/2021 of 9 December, which establishes the general rules for the prevention of corruption (“RGPC”) and (ii) Law 93/2021 of 20 December, which creates rules to protect whistleblowers (“RJPDI”) ...
