scholarly journals Property Values

2011 ◽  
Vol 133 (03) ◽  
pp. 32-34
Author(s):  
Leslie I. Bookoff ◽  
Dinesh N. Melwani
Keyword(s):  
Intellectual Property ◽  
Medical Device ◽  
Medical Devices ◽  
Patent Protection ◽  
Property Values ◽  
Third Party ◽  
Property A ◽  
Startup Company ◽  
Target Company ◽  
Medical Device Company

This article focuses on the importance of intellectual property (IP) in startup companies to attract investment. Various examples of startup companies dealing with medical devices were also discussed. Much of a medical device startup’s assets, however, lie in ideas or concepts it hopes to develop into a commercial product. Patent protection often is considered a critical component of corporate transactions involving medical technologies because it can protect the significant upfront investments required for R'D and regulatory activities. Investors evaluating the IP of a target medical device company are attracted to a demonstrated awareness of IP and to a clean house as it relates to administrative issues potentially affecting the company’s intellectual property. A target company also may make investment more attractive by minimizing or eliminating contractual restrictions on the transfer of its IP. A startup company seeking its portion of investment dollars must pay attention to its IP: it must ensure that its technology is freely marketable without infringing third-party rights and that its IP portfolio is free of encumbrances and has the necessary protection.

scholarly journals Intellectual Property as a Legal Mechanism Accompanying the Fight against the Pandemic in the context of the Spread of Coronavirus Infection (COVID-19)

Lex Russica ◽  
2020 ◽  
pp. 134-147
Author(s):  
B. A. Shakhnazarov
Keyword(s):  
Intellectual Property ◽  
Medical Devices ◽  
Viral Infections ◽  
Legal Regulation ◽  
Third Party ◽  
World Health ◽  
Intellectual Activity ◽  
Patent Rights ◽  
Coronavirus Infection ◽  
Health Organization

The paper examines the legal problems of protection and use of intellectual property in the context of fighting the pandemic. It is noted that the recommendations proposed by the World Health Organization to identify, diagnose and isolate, as well as to provide assistance to patients with suspected coronavirus infection in a pandemic can be effectively implemented only with proper legal regulation of the protection of intellectual property rights to the relevant results of intellectual activity, stimulating relevant developments while maintaining a balance between private and public interests. The paper examines the modernization of Russian legislation in the sphere of relations under consideration. Of vital importance are developments related to medicines and medical devices in preventing and overcoming the consequences of the spread of infectious diseases; flexibility of the legislator and the need to implement special-simplified, accelerated-legal regimes for the introduction of medicines and medical devices into trade. The author summarizes regulations at the interface of the legislation on circulation of medicines and intellectual property law in Russia and abroad (USA, Germany), as well as at the supranational level (EAEC). In modern conditions, the possible rapid spread of viral infections and pandemic threats it is essential to establish the legal basis for the balance between the public interest and the interests of patent holders in national legislations, based on a harmonizing international treaty provisions. The authors considers the restriction of patent rights in the extreme urgency with the obligatory non-exclusive and temporary nature of the use of objects of patent rights by a third party based on such restrictions and the mandatory payment of a just compensation to patent holders together with accelerated and simplified mechanisms for registration and introduction into the turnover of the relevant medicines, including vaccines, be a justified and necessary tool to combat the pandemic and the best means of overcoming its consequences.

Toward a Framework of the Process of Open Innovation — Case of Acclarent in the Medical Device Industry

2014 ◽  
Vol 11 (05) ◽  
pp. 1450032 ◽  
Author(s):  
Hua-Hsin Wan ◽  
Xiaohong Iris Quan
Keyword(s):  
Medical Device ◽  
Open Innovation ◽  
Innovation Process ◽  
Third Party ◽  
Medical Device Industry ◽  
Start Up ◽  
Five Elements ◽  
Medical Device Company ◽  
Device Industry

Using a case study of Acclarent, a medical device company, this paper attempts to propose a framework to further illustrate the process of open innovation in the medical device industry. We examined five elements in the mechanism of the open innovation process. Our paper shows how the success of Acclarent — a medical device start-up — depends on effective management of the flow of knowledge to satisfy unmet needs, while integrating in-depth knowledge of FDA regulations and third-party payers' reimbursement policies into the product innovation process.

Protecting User Interfaces

2017 ◽  
Author(s):  
Noam Shemtov
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
User Interfaces ◽  
Patent Protection ◽  
The United States ◽  
Graphical User Interfaces ◽  
Unfair Competition ◽  
European Patent ◽  
Intellectual Property Rights Protection

This chapter examines the scope of protection to which graphical user interfaces may be eligible under various intellectual property rights: namely, trade marks, unfair-competition laws, design rights, copyright, and patents. It first considers the extent of copyright protection over a software product’s ‘look-and-feel’ elements, with particular emphasis on graphical user interfaces protection under US and EU laws. It then discusses trade-mark, trade-dress, and unfair-competition protection for graphical user interfaces, along with intellectual property rights protection for design patents and registered designs. Finally, it describes the patent protection for graphical user interfaces in the United States and at the European Patent Office.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

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