Medical device professionals encounter numerous challenges from successfully developing a medical device company to understanding and navigating the various intellectual property issues that arise as they seek to protect and commercialize their inventions. This is an essential resource for understanding the nuances of protecting and launching a medical device in the United States and abroad. Written by IP and patent attorneys with experience representing the unique business needs of startups, entrepreneurs, and early-stage companies, this guide covers creating and leveraging patent portfolios; freedom to operate; limiting risk of infringement; trademarks in the context of medical devices; strategies for licensing and monetizing patents; and more.
This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.
This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.
Recent innovations in the fields of Information and Communication Technologies (ICT), mechanical and electrical engineering or biochemistry have led to the development of brandnew types of tools with broad potential application in the medical field. These technologies are fundamentally changing the paradigms of the medical profession with new ways to exchange information between patients and doctors, or new technical solutions to specific diseases. This evolution has created unique opportunities for the development of new medical devices to be used for diagnostic, monitoring and therapeutic purposes. The market for medical devices is vast and highly segmented, as it covers a large number of different products, such as sticking plasters, syringes, spectacles or wheelchairs. In order to succeed in this challenging, highly competitive industry, innovation and creativity are crucial. The medical device field is an IPR-intensive industry, with an above-average use of IPR per employee, as compared to other industries that use IPRs. Furthermore, inventors and companies active in this field should note that due to the typically short lifecycle of these types of products (usually 18-24 months before an improved product becomes available), to adopt a carefully planned IP strategy is of paramount importance. Accordingly, a recent report by MedTech Europe highlighted that more than 13,000 patent applications were filed in 2017 with the European Patent Office (EPO) in the field of medical technology - 7.9% of the total number of applications -, still more than any other sector in Europe. Moreover, most of these applications come from EU SMEs, which make up around 95% of the medical technology industry in Europe. The purpose of this Factsheet is to offer the reader some guidelines on how to protect and manage your intellectual property in Latin American countries, especially in Argentina, Brazil, Colombia and Mexico.
Recent innovations in the fields of Information and Communication Technologies (ICT), mechanical and electrical engineering or biochemistry have led to the development of brand-new types of tools with broad potential application in the medical field. These technologies are fundamentally changing the paradigms of the medical profession with new ways to exchange information between patients and doctors, or new technical solutions to specific diseases. This evolution has created unique opportunities for the development of new medical devices to be used for diagnostic, monitoring and therapeutic purposes. The market for medical devices is vast and highly segmented, as it covers a large number of different products, such as sticking plasters, syringes, spectacles or wheelchairs. In order to succeed in this challenging, highly competitive industry, innovation and creativity are crucial. The medical device field is an IPR-intensive industry, with an above-average use of IPR per employee, as compared to other industries that use IPRs. Furthermore, inventors and companies active in this field should note that due to the typically short lifecycle of these types of products (usually 18-24 months before an improved product becomes available), to adopt a carefully planned IP strategy is of paramount importance. Accordingly, a recent report by MedTech Europe highlighted that more than 13,000 patent applications were filed in 2017 with the European Patent Office (EPO) in the field of medical technology - 7.9% of the total number of applications -, still more than any other sector in Europe. Moreover, most of these applications come from EU SMEs, which make up around 95% of the medical technology industry in Europe. The purpose of this Factsheet is to offer the reader some guidelines on how to protect and manage your intellectual property in Latin American countries, especially in Argentina, Brazil, Colombia and Mexico.
Intellectual Property and Health Technologies Balancing Innovation and the Public's Health Joanna T. Brougher, Esq., MPH At first glance, ownership of intellectual property seems straightforward: the control over an invention or idea. But with the recent explosion of new scientific discoveries poised to transform public health and healthcare systems, costly and lengthy patent disputes threaten both to undermine the attempts to develop new medical technologies and to keep potentially life-saving treatments from patients who need them. Intellectual Property and Health Technologies grounds readers in patent law and explores how scientific research and enterprise are evolving in response. Geared specifically to the medical disciplines, it differentiates among forms of legal protection for inventors such as copyrights and patents, explains their limits, and argues for balance between competing forces of exclusivity and availability. Chapters delve into the major legal controversies concerning medical and biotechnologies in terms of pricing, markets, and especially the tension between innovation and access, including: The patent-eligibility of genes The patent-eligibility of medical process patents The rights and roles of universities and inventors The balancing of access, innovation, and profit in drug development The tension between biologics, small-molecule drugs, and their generic counterparts International patent law and access to medicine in the developing world As these issues continue to shape and define the debate, Intellectual Property and Health Technologies enables professionals and graduate students in public health, health policy, healthcare administration, and medicine to understand patent law and how it affects the development of medical technology and the delivery of medicine.
