Patent protection for prenatal genetic diagnostic methods in the United States

2015 ◽  
Vol 10 (11) ◽  
pp. 805-807
Author(s):  
Eddy D. Ventose
Author(s):  
Fred. W. Brearey

The remarks made in this paper are due to the action of the United States Patent Laws, as interpreted by one of the examiners, whose duty it was to adjudicate upon the practicability of an invention submitted to him, and whose decision was adverse to the granting of a patent. Protection was solicited for an improvement upon a previously patented mechanical aërial machine, the success of which had been proved by the inventor through the action of a model. The patent was refused on account of the alleged impracticability of the invention owing to the absence of gas as a supporting, or partly supporting, medium. Total misapprehension of the principles of flight is displayed whenever the balloon is recommended to take off part of the weight of any mechanical arrangement. However successfully the pure mechanical action may have proved itself in the conveyance of weights in the air whilst in the model form, the principle seems to be distrusted by some when proposed for extreme weight. But it fortunately happens that the resistance of the air to a body in motion, upon which we depend for success, bears a greatly increasing ratio to the extent of surface which that body assumes.


2017 ◽  
Vol 107 (7) ◽  
pp. 804-815 ◽  
Author(s):  
Timothy D. Murray ◽  
Brenda K. Schroeder ◽  
William L. Schneider ◽  
Douglas G. Luster ◽  
Aaron Sechler ◽  
...  

Rathayibacter toxicus, a Select Agent in the United States, is one of six recognized species in the genus Rathayibacter and the best known due to its association with annual ryegrass toxicity, which occurs only in parts of Australia. The Rathayibacter species are unusual among phytopathogenic bacteria in that they are transmitted by anguinid seed gall nematodes and produce extracellular polysaccharides in infected plants resulting in bacteriosis diseases with common names such as yellow slime and bacterial head blight. R. toxicus is distinguished from the other species by producing corynetoxins in infected plants; toxin production is associated with infection by a bacteriophage. These toxins cause grazing animals feeding on infected plants to develop convulsions and abnormal gate, which is referred to as “staggers,” and often results in death of affected animals. R. toxicus is the only recognized Rathayibacter species to produce toxin, although reports of livestock deaths in the United States suggest a closely related toxigenic species may be present. A closely related but undescribed species, Rathayibacter sp. EV, originally isolated from Ehrharta villosa var. villosa in South Africa, is suspected of producing toxin. Many of the diseases caused by Rathayibacter species occur in arid areas and the extracellular polysaccharide they produce is believed to aid in their survival between crops. For example, R. “agropyri” was isolated from infected plant material after being stored for 50 years in a herbarium. Similarly, the anguinid vectors associated with these bacteria form seed galls in infected plants and are capable of surviving for very long periods of time under dry conditions. The addition of R. toxicus to the list of Select Agents has raised concern over its potential introduction and a realization that current diagnostic methods are inadequate to distinguish among Rathayibacter species. In addition, little is known about the Rathayibacter species and their seed gall nematode vectors present in the United States.


1993 ◽  
Vol 23 (1) ◽  
pp. 147-160 ◽  
Author(s):  
Joel Lexchin

In response to high drug prices, the Canadian government amended the country's patent act in 1969 to allow for compulsory licensing to import pharmaceuticals. As a result of the legislation, by 1983 drug costs in Canada were over $200 million lower than they would otherwise have been. The multinational drug industry was strongly opposed to compulsory licensing, despite any evidence that its economic position had been harmed. Restoration of patent protection for drugs was one of the key U.S. demands during free-trade negotiations between Canada and the United States in 1985–1987. The result was Bill C-22, which gave new drugs protection from compulsory licensing for seven to ten years. This article analyzes the impact of Bill C-22 on the generic industry, the creation of jobs in research and development, drug prices, and research and development expenditures. It concludes with an examination of future demands from the pharmaceutical industry.


1997 ◽  
Vol 10 (1) ◽  
pp. 160-184 ◽  
Author(s):  
C M Black

Infections caused by Chlamydia trachomatis are probably the most common sexually transmitted diseases in the United States. Commonly unrecognized and often inadequately treated, chlamydial infections can ascend the reproductive tract and cause pelvic inflammatory disease, which often results in the devastating consequences of infertility, ectopic pregnancy, or chronic pelvic pain. C. trachomatis infections are also known to increase the risk for human immunodeficiency virus infection. The obligate intracellular life cycle of C. trachomatis has traditionally required laboratory diagnostic tests that are technically demanding, labor-intensive, expensive, and difficult to access. In spite of these historical challenges, however, laboratory diagnosis of C. trachomatis has been a rapidly advancing area in which there is presently a wide array of commercial diagnostic technologies, costs, manufacturers. This review describes and compares the diagnostic methods for C. trachomatis infection that are currently approved for use in the United States, including the newest DNA amplification technologies which are yet to be licensed for commercial use. Issues to consider in selecting a test for purposes of screening versus diagnosis based on prevalence, performance, legal, social, and cost issues are also discussed.


2019 ◽  
Vol 25 (1) ◽  
Author(s):  
Javier Saladich Nebot

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.


Author(s):  
Sean Bottomley

Abstract This paper surveys the American and British patent systems in the period prior to the latter’s reform in 1852 and coinciding with the period of the first industrial revolution. It has been suggested that the British system’s archaic application procedure, extortionately high fees and hostile courts were indicative of an oligarchic socio-political system that purposively sought to restrict access to patent protection, as was apparently typical across Europe. Conversely, the American system was an open and democratic one, intended to provide patent protection to as many sections of society as possible. This paper argues for a less stylized comparison. British courts were not so hostile to patents (and patentees) as has been commonly supposed. Neither was it so difficult to obtain patent protection: for all its faults, the evidence that the British patent system was designed to restrict access to its provisions is nugatory. Consequently, explanations for America’s technological catch-up and eventual supplantation of Britain and Europe as global technological leader cannot invoke ‘superior’ patent institutions as a contributory factor.


Author(s):  
A. G. Barabashev ◽  
D. V. Ponomareva

The article deals with a unique legal phenomenon that requires regulation in the context of protecting the rights of inventors to the results of scientific activity — patent trolling. Due to the imperfection of the patent system and patent legislation, the subjective rights of “bona fide inventors” in the field of scientific and innovation activities are constantly violated by “patent trolls”. On the example of the law enforcement practice of the United States of America, legal methods of countering this phenomenon are illustrated, the conditions conducive to its occurrence are analyzed. A conclusion is presented on the need to take into account the experience of the United States when amending the legislation of the Russian Federation on patent protection. It is noted that in the era of the fourth industrial revolution, the issue of combating “unscrupulous” copyright holders becomes one of the most acute. The criteria for assessing the “bad faith” of a patent infringement claim, developed by an American legislator, can become the basis for the development of similar legal norms on Russian soil and throughout the post-Soviet space.


Sign in / Sign up

Export Citation Format

Share Document