Patent protection for the BRCA1 gene and genetic diagnostic methods in the USA

2011 ◽  
Vol 7 (1) ◽  
pp. 7-11
Author(s):  
E. D. Ventose
Keyword(s):  
Patent Protection ◽  
Brca1 Gene ◽  
Diagnostic Methods ◽  
The Usa

scholarly journals Feline caliciviruses (FCVs) isolated from cats with virulent systemic disease possess in vitro phenotypes distinct from those of other FCV isolates

2007 ◽  
Vol 88 (2) ◽  
pp. 506-517 ◽  
Author(s):  
Robert J. Ossiboff ◽  
Alexander Sheh ◽  
Justine Shotton ◽  
Patricia A. Pesavento ◽  
John S. L. Parker
Keyword(s):  
Tissue Culture ◽  
Morphological Changes ◽  
Phylogenetic Analyses ◽  
Systemic Disease ◽  
Growth Conditions ◽  
Diagnostic Methods ◽  
Culture Cells ◽  
The Usa ◽  
Multiple Cycle

During the past decade, several outbreaks of severe systemic disease associated with Feline calicivirus (FCV) have occurred in the USA and the UK. This new disease has caused high mortality in the affected animals and has been termed virulent systemic (VS)-FCV disease. Currently, there are no genetic or in vitro diagnostic methods to distinguish viruses isolated from cases of VS-FCV disease from other isolates. Here, five in vitro properties, as well as the capsid and proteinase–polymerase (pro–pol) sequences, of a set of FCV isolates that included seven isolates from five distinct VS-FCV outbreaks (‘VS isolates’) were investigated. Although all of the FCV isolates investigated had similar kinetics of growth under single-cycle conditions, VS isolates infected tissue-culture cells more efficiently under multiple-cycle growth conditions. Moreover, it was found that cells infected with VS isolates showed cytopathic effects earlier than cells infected with non-VS isolates, although no difference in relative ATP levels were noted at times when morphological changes were first seen. Both VS- and other (non-VS) isolates of FCV demonstrated similar temperature stabilities. Phylogenetic analyses and alignments of the capsid and pro–pol regions of the genome did not reveal any conserved changes that correlated with virulence, and the VS isolates did not segregate into a unique clade. These results suggest that VS isolates have arisen independently several times since first being described and can spread more efficiently in tissue culture than other isolates when infected at low multiplicity.

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.

Patents and Diagnostic Methods in the U.S.: The Subject Matter Eligibility Trap

2019 ◽  
Vol 25 (1) ◽  
Author(s):  
Javier Saladich Nebot
Keyword(s):  
Subject Matter ◽  
Patent Protection ◽  
Case Law ◽  
The United States ◽  
Diagnostic Methods ◽  
General Application ◽  
Health Technologies ◽  
Potential Benefits ◽  
The Subject ◽  
Social Importance

Diagnostic methods have been gaining medical recognition and social importance as innovations that can be useful to provide individuals with a diagnosis, prognosis or prediction with regard to a condition that they currently have or that they are in risk of developing. Despite the great amount of resources deployed to produce these health technologies and their potential benefits for healthcare systems and patients or prospective patients alike, their exclusive protection in the United States has faced resistance from patent examiners and courts on the basis that diagnostics constitute a dubious innovation. Inconsistent arguments used for the refusal of patent protection have led to a labyrinth where innovators in the diagnostics sector cannot reasonably expect their application or their protection after the patent is in place to stand.  This paper aims to convey the doctrine of subject matter eligibility as applied to diagnostic methods and the relevant guidelines and case law. In doing so, it aims to depict the pitfalls resulting from the general application of a non-patentability rule to diagnostics, and to suggest opportunities still available for innovators to overcome uncertainty by filing compliant applications while maximizing the likeliness of enjoying protection once the patent is awarded.

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