Does patent protection for personalized medicine still exist in the USA?

2016 ◽  
Vol 5 (2) ◽  
pp. 87-90
Author(s):  
Joan Ellis
Keyword(s):  
Personalized Medicine ◽  
Patent Protection ◽  
The Usa

6. Reflections on ageing and future directions

2016 ◽  
pp. 102-116
Author(s):  
Nancy A. Pachana
Keyword(s):  
Clinical Practice ◽  
Personalized Medicine ◽  
Cognitive Training ◽  
Death And Dying ◽  
Group Living ◽  
Aged Care ◽  
Future Directions ◽  
Green House ◽  
New Directions ◽  
The Usa

‘Reflections on ageing and future directions’ considers some of the new directions in geriatric research and clinical practice; exciting developments in healthcare and technology, including personalized medicine; and new, promising models of aged care, such as the Green House nursing homes in the USA and Small Group Living homes in the Netherlands. It also looks at what we are learning from the growing number of supercentenarian studies. The very end of life, with attendant fears about death and dying, as well as potential positive gains to be made through cognitive training and other ‘brain games’, are also considered.

scholarly journals Pros and cons of patenting stem cells

2020 ◽  
Vol 59 (89) ◽  
pp. 321-334
Author(s):  
Gordana Damjanović
Keyword(s):  
Stem Cells ◽  
Patent Protection ◽  
Embryonic Stem ◽  
Moral Dilemmas ◽  
Patent Law ◽  
Embryonic Cells ◽  
The Usa ◽  
Pros And Cons ◽  
The One ◽  
Further Development

The evolution and transformation of research in the field of biotechnology are clearly reflected in patent rules. In view of further development of biotechnology and the pressure from multinational biotechnical companies, gene patenting was first granted in some legal systems in order to initiate the regulation of patent protection of stem cells. Further research should provide a better understanding of the differentiation and development of stem cells, including their potential effects in curing previously incurable diseases. It should also engender new ways of exploring fundamental issues in biology, such as the mechanism of cell growth. Therefore, researchers and primarily biotech companies advocate in favor of ensuring the monopoly on the results of their research. Such a monopoly is secured by patent law. Although remarkable progress has been made in the research of stem cells, many aspects of their use, especially of embryonic cells, have not been fully clarified and made comprehensible. Successful applications of products that use a stem cell derivative (on the one hand) and moral dilemmas primarily relating to embryonic stem cells (on the other hand) have resulted in a debate that has affected many legal areas, such as patent law. Such morally challenging products have caused great concern in the USA and the EU. However, these two entities have tried to solve the problem in different ways. Different views on law, ethics and embryos have also affected different views regarding patent protection of stem cells.

scholarly journals International Cooperation as a Prerequisite for Improvement of Access to Orphan Biologic Medicines

2021 ◽  
Vol 14 (2) ◽  
Author(s):  
Zbigniew Więckowski
Keyword(s):  
International Cooperation ◽  
Rare Diseases ◽  
Patent Protection ◽  
Positive Impact ◽  
Mutual Recognition ◽  
Orphan Drugs ◽  
Economic Incentives ◽  
Regulatory Agencies ◽  
The Usa ◽  
The Eu

Rare diseases constitute a global problem. Worldwide, 350 million people suffer from such diseases. The number of diagnosed cases are on the rise. Only a small percentage of those suffering have the opportunity to be treated with modern therapies. Medicines used to treat rare diseases are called orphan drugs. Biologic medicines developed for orphan drug indications, besides patent protection, have a period of regulatory and market exclusivity. After this period of time has elapsed, access to orphan drugs could be improved by the introduction of biosimilar medicines. The biggest challenge is to develop effective legal, tax and economic incentives to stimulate the development of biosimilar medicines for orphan indications. The regulatory agencies - EMA in the EU and the FDA in the USA - play a key role in increasing access to orphan biologics. Undoubtedly, the international cooperation, especially the mutual recognition of registration procedures between countries, and the creation of a common vocabulary and the unification of incentives for the pharmaceutical industry would have the positive impact on access to modern therapies.

scholarly journals The quest for generic biotechnology pharmaceuticals in the USA

2005 ◽  
Vol 11 (3) ◽  
Author(s):  
Thomas J Kowalski ◽  
Pamela Fekete ◽  
Nne-Marie C Yvon
Keyword(s):  
Growth Hormone ◽  
Pharmaceutical Industry ◽  
Human Growth Hormone ◽  
First Generation ◽  
Patent Protection ◽  
Human Growth ◽  
Regulatory Framework ◽  
The Usa ◽  
Biotechnology Products

As patent protection expires on the first generation of biotechnology products, such as human growth hormone and erythropoietin, there is an impetus for the development and marketing of generic equivalents. Currently there is no statutory or regulatory framework governing generic biotechnology products. This paper explores the potential solutions that have been suggested by members of the pharmaceutical industry and government, both in the USA and internationally.

scholarly journals Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine

2015 ◽  
Vol 18 (5) ◽  
pp. 249-259 ◽  
Author(s):  
Lada Leyens ◽  
Étienne Richer ◽  
Øyvind Melien ◽  
Wolfgang Ballensiefen ◽  
Angela Brand
Keyword(s):  
Personalized Medicine ◽  
Access To Medicines ◽  
Patient Access ◽  
The Usa ◽  
The Eu
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