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

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.

2018 ◽  
Vol 57 (1) ◽  
pp. 18-37
Author(s):  
Brad Sherman

Intellectual property law has been interacting with software for over sixty years. Despite this, the law in this area remains confused and uncertain: this is particularly evident in patent law. Focusing on U.S. patent law from the 1960s through to the mid-1970s, this article argues that a key reason for this confusion relates to the particular way that the subject matter was construed. While the early discussions about subject matter eligibility were framed in terms of the question “is software patentable?”, what was really at stake in these debates was the preliminary ontological question: what is software? Building on work that highlights the competing ways that software was construed by different parts of the information technology industry at the time, the article looks at the particular way that the law responded to these competing interpretations and how in so doing it laid the foundation for the confusion that characterizes the area. When engaging with new types of subject matter, patent law has consistently relied on the relevant techno-scientific communities not only to provide the law with a relatively clear understanding of the nature of the subject matter being considered; they have also provided the means to allow the law to describe, demarcate, and identify that new subject matter. The inherently divided nature of the nascent information technology industry meant that this was not possible. As a result, the law was forced to develop its own way of dealing with the would-be subject matter.


2017 ◽  
Vol 10 (1) ◽  
pp. 63-89 ◽  
Author(s):  
Jozef Valuch ◽  
Tomáš Gábriš ◽  
Ondrej Hamuľák

Abstract The aim of this paper is to evaluate and differentiate between the phenomena of cyberwarfare and information warfare, as manifestations of what we perceive as postmodern warfare. We describe and analyse the current examples of the use the postmodern warfare and the reactions of states and international bodies to these phenomena. The subject matter of this paper is the relationship between new types of postmodern conflicts and the law of armed conflicts (law of war). Based on ICJ case law, it is clear that under current legal rules of international law of war, cyber attacks as well as information attacks (often performed in the cyberspace as well) can only be perceived as “war” if executed in addition to classical kinetic warfare, which is often not the case. In most cases perceived “only” as a non-linear warfare (postmodern conflict), this practice nevertheless must be condemned as conduct contrary to the principles of international law and (possibly) a crime under national laws, unless this type of conduct will be recognized by the international community as a “war” proper, in its new, postmodern sense.


Author(s):  
AINHOA GUTIÉRREZ BARRENENGOA

El procedimiento monitorio se concibe en la Ley 1/2000, de Enjuiciamiento Civil como un procedimiento de tutela privilegiada de determinados créditos. Sin embargo, estos postulados se contradicen con los problemas que, en la práctica forense, se han suscitado, en muchos casos, por la determinación de la competencia del órgano que debe conocer del procedimiento. En el presente estudio, se analizan las principales cuestiones que se han suscitado en relación con la determinación de la competencia objetiva y territorial en el procedimiento monitorio, con un repaso crítico de las distintas soluciones doctrinales aportadas, y una revisión de la última doctrina jurisprudencial en la materia. Prozedura monitorioa Prozedura Zibilaren 1/2000 Legeak taxutu zuen, zenbait kredituren tutoretza pribilejiatua izateko prozedura moduan. Hala eta guztiz ere, postulatu horiek ez datoz bat praktika forentsean sortu diren arazoekin; izan ere, maiz, prozedura ezagutu behar duen organoaren eskumena nork duen jakitea ez da gauza argia. Lan honetan, prozedura monitorioaren inguruan eskumen objektiboa eta lurraldekoa zehaztu beharraz sortu diren eztabaida nagusiak aztertzen dira, horri buruz agertu izan diren konponbide doktrinalen azterketa kritikoa eginez, eta gaiari buruzko azken jurisprudentzia-doktrina ere lantzen da. The payment procedure is envisaged by Act 1/2000 on the Civil Procedural Code as a procedure for a privileged guarantee of some debts. However, theses propositions conflict with the problems which arose in practice when deciding the subject-matter and territorial jurisdiction in payments procedures. By this study, main questions regarding the subject-matter and territorial jurisdiction within the payment procedure are analyzed with a critical review of the given different doctrinal solutions and a revision of the last case law doctrine on the topic.


Author(s):  
Justine Pila ◽  
Paul L.C. Torremans

Once a European patent has been granted the nature and scope of the protection it confers must be determined. In considering such protection this chapter focuses on four issues of central importance to that end. The first is the effects of a patent, namely, the territories in and term for which it is valid. The second is the object of protection, namely, the subject matter that the public is excluded from using during the term of its protection. The third is the nature of protection, namely, the uses of the subject matter from which the public is excluded. And the fourth is the limitations to protection, namely, the uses of an invention that the law permits notwithstanding its protection by patent grant.


Author(s):  
Hartley Trevor C

This chapter discusses the ‘subject-matter scope’ of Brussels 2012, Lugano 2007, and the Hague Convention. ‘Subject-matter scope’ refers to the scope covered by a measure as regards its subject matter, that is to say the branches and areas of the law to which it applies. For the three legal instruments under consideration, the relevant provisions are contained in Article 1 of Brussels 2012 and Lugano, and Articles 1 and 2 of Hague. A review of case law shows that the distinction between a civil matter and public matter is far from straightforward. There is a significant grey area in which the Court of Justice of the European Union could legitimately go either way.


1978 ◽  
Vol 9 (3) ◽  
pp. 348-374
Author(s):  
Christopher D. Gilbert

The abolition of all appeals from the High Court to the Privy Council, coupled with the High Court's recent statement that it no longer regards itself as bound by Privy Council decisions, highlights the fact that appeals still lie, in many matters of State jurisdiction, from State Supreme Courts direct to the Privy Council. In this article, Mr Gilbert is primarily concerned to examine the extent to which section 106 of the Commonwealth Constitution may provide protection for these “direct” appeals. To this end, Mr Gilbert examines what case-law exists on section 106, and attempts to place the section in perspective in relation to the rest of the Constitution. The difficult (and largely unexplored) relationship between section 106 and section 51 is considered, to discover the possible reaches of Commonwealth legislative power with respect to the subject-matter protected by section 106. The position of “direct” appeals within the States’ constitutional structures is looked at, in order to determine the possible ambit of whatever protection is offered by section 106, and finally, Mr Gilbert analyses the recent comments by Mr Justice Murphy that the abolition of Privy Council appeals from the High Court has meant the consequential demise of “direct” appeals from State courts.


Author(s):  
Florian Faust

This chapter discusses the relationship between comparative law and economic analysis of law. After providing an overview of the characteristics of the economic analysis of law, it explains how one of the two disciplines can operate as an ancillary discipline to the other; this has been termed ‘Comparative Law and Economics’. The next section describes how comparative law and economic analysis of law can be brought together by making one discipline the subject matter of the other. It suggests that the role of economic analysis of law may be greater in case law systems than in codified systems and that this role may vary according to the subject of legislation. The section concludes with considerations on the role comparative law plays and should play in different contexts. Finally, it is argued that comparative law and economics should not be considered a discipline on its own.


1927 ◽  
Vol 21 (2) ◽  
pp. 257-267
Author(s):  
Irvin Stewart

The reëstablishment of treaty relations with Germany seems to have afforded occasion for a new type of treaty incorporating new principles,restating old ones and generally rearranging the subject-matter considered.Provisions relating to consular privileges and immunities show the influence of this new consideration. The Treaty of Friendship, Commerce and Consular Rights with Germany has been followed by similar treaties with Estonia and Hungary. Ratification of a like treaty with Salvador has been advised and consented to by the United States Senate, but the exchange of ratifications has not yet been announced. A consular convention with Cuba follows the corresponding provisions in the treaties of friendship, commerce and consular rights so far as consular privileges and immunities are concerned. As press reports have indicated that similar treaties may be negotiated with other states, it is possible that there may be an extensive redefinition of consular privileges and immunities along the lines of the provisions of the recently published treaties. In the light of this possibility the contents of this part of the treaties are of great importance and an examination of them of present interest. As the Treaty of Friendship, Commerce and Consular Rights with Germany was the first of the series,the following discussion is based upon the provisions of that treaty, with attention being given to the more important departures in the later treaties.


2005 ◽  
Vol 8 (16) ◽  
pp. 199-218 ◽  
Author(s):  
Louis-Edmond Hamelin

The great advances that geomorphology has made in recent years make necessary a critical re-examination of the relationships between this science and the field of geography. Is geomorphology truly geographical ? And if not, how can it become so ? Geomorphology has its roots in geology and was, of course, not designed to meet the specific needs of geographers. Under the leadership of W. M. Davis, geographers eventually adopted the study of geomorphology but did Utile to adapt it to particular purposes of their discipline. Most geographers can never aspire to true excellence in geomorphology because of their generally inadequate training in the physical sciences. We have found that most geographers tend to fall into one of four groups : 1. Those who consider themselves to be geomorphologists (about one-fourth of all geographers) ; 2. Those who just try to be informed in geomorphology ; 3. Those who ignore the existence of geomorphology ; 4. The « complete » geographer who practices a « functional » geomorphology. It also appears that the majority of geographers do not consider land-man relations to be their principal field of interest. The definition that we as geographers give to geography tends to sanction the kind of geography that we are capable of doing. For example, the classical géographie globale, which is characterized by an explanatory description of a complex of physical and human eclectic elements, does not normally require either a « complete » or a genetic geomorphology ; also, complex techniques of geomorphological investigation are not essential. Of greater importance is a geomorphology'-which is functional to geography and which will help us to understand better man's distribution and activities on the surface of the earth. This partial or « functional » geomorphology has achieved its greatest development in France (as an integral part of géographie globale) and is practised by a large number of geographers. Géographie totale, an expression which refers more to the subject matter of this geography than to its methodology, is an ensemble of specialized yet inter-related disciplines (one of which is geomorphology). This pluralistic geography daims many more adherents than does géographie globale. Géographie totale allows us to study all aspects of what is now called geomorphology (but which may eventually be termed « cosmomorphology  »). This new geomorphology is based on geophysical laws and is strictly quantitative. It is an integral part of the physical sciences but this does not mean that it is automatically divorced from man. Scientists of both the United States and the U. S. S. R. are actively engaged in this new geomorphology. We believe that it would be mutually advantageous for both the « functional » and the « complete » geomorphologists to group themselves into a new international association. To achieve this end we urge that the structures of the international Geographical Union be modified or that an « International Association of Geomorphology » be founded.


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