Recent developments in US law: Remedies and damages for improper patent listings in the FDA's Orange Book

10.5912/jcb29 ◽  
1969 ◽  
Vol 9 (3) ◽  
Author(s):  
Daniel G Brown
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
Pharmaceutical Product ◽  
Pharmaceutical Companies ◽  
White House ◽  
Drug Products ◽  
The Us ◽  
Recent Developments ◽  
The Usa ◽  
Orange Book

The Drug Price Competition and Patent Term Restoration Act (Publ. No. 98-417, 98 Stat. 1585 (1984)), commonly known as the Hatch–Waxman Act (the Act) provides the statutory framework by which most generic drugs are approved for marketing in the USA. Most provisions in the Act concern the standards and procedures the US Food and Drug Administration (FDA) must follow to approve generic drugs. A relatively small number of the provisions, however, create a framework for resolving patent disputes between the brand and generic pharmaceutical companies. These provisions have been the subject of much recent activity, in the US Courts, in Congress, in the FDA itself and in the White House. Much of the activity revolves around a publication by FDA entitled Approved Drug Products with Therapeutic Equivalence Evaluations, known colloquially as the Orange Book.Under present FDA practice, the mere listing of a patent in the Orange Book corresponding to a brand pharmaceutical product invokes a number of statutory provisions that confer valuable exclusivity rights on the brand company, and also possibly on one or more generic companies. This situation creates a strong incentive for patentees and brand pharmaceutical companies to list patents in the Orange Book. A number of recent court cases have addressed the remedies and damages available when the listing is found to be improper. Thus far, the most successful means to challenge or prevent improper listings has been through private and governmental enforcement of the antitrust laws.

3D Printing in Pharmaceuticals: Regulatory Perspective

2019 ◽  
Vol 24 (42) ◽  
pp. 5081-5083 ◽  
Author(s):  
Mohd. A. Mirza ◽  
Zeenat Iqbal
Keyword(s):  
New Technologies ◽  
Pharmaceutical Product ◽  
Regulatory Agencies ◽  
Major Research ◽  
Data Bases ◽  
Drug Products ◽  
Regulatory Perspective ◽  
Regulatory Guidelines ◽  
Recent Developments ◽  
Technical Issues

Background: The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, design and delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employed in fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into the pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of“personalized medicine”. Methods: Data bases and search engines of regulatory agencies like USFDA and EMA have been searched thoroughly for relevant guidelines and approved products. Other portals like PubMed and Google Scholar were also ferreted for any relevant repository of publications are referred to wherever required. Results: So far only one pharmaceutical product has been approved in this category by USFDA and stringent regulatory agencies are working over the drafting of guidelines and technical issues. Major research of this category belongs to the academic domain. Conclusion: It is also implicit to such new technologies that there would be numerous challenges and doubts before these are accepted as safe and efficacious. The situation demands concerted and cautious efforts to bring in foolproof regulatory guidelines which would ultimately lead to the success of this revolutionary technology.

The Foreign Policy of the USA Towards the PRC During Gerald Ford Presidency: 1974-1977

2019 ◽  
pp. 46-56
Author(s):  
Anatoliy V. Goncharenko ◽  
Lybov G. Polyakova
Keyword(s):  
United States ◽  
Foreign Policy ◽  
The United States ◽  
People’S Republic Of China ◽  
People's Republic Of China ◽  
White House ◽  
Republic Of China ◽  
The Pacific ◽  
The Us ◽  
The Usa

The article researches the US foreign policy towards the PRC during Gerald Ford presidency in 1974-1977. It describes the reasons, course and consequences of the intensification of the US foreign policy strategy in the Chinese direction during the investigated period. There was explored the practical realization of the “Pacific Doctrine”by Washington. The role of various groups in the American establishment in the question of the formation of the Chinese White House policy has been analyzed. The specific foreign policy actions of the administration of the US president Gerald Fordon the PRC in 1974-1977 are analyzed. The chief results of the foreign policy of the administration of the President of the United States Gerald Ford (1974-1977) concerning the PRC, which resulted from the real political steps taken by the leaders of both countries, was the establishment of systematic and reliable channels of bilateral ties, expansion of economic, scientific and cultural contacts, the beginning of a systematic exchange of views on the most important issues of international relations. In the second half of the 70’s of the twentieth century this dialogue ensured the continuity of China’s policy in Washington, which was based on the concept of a “balance of power”, while China played a complementary role in the foreign policy strategy of the White House. These factors formed the “Pacific Doctrine” of G. Ford, which gave Beijing the status of an American partner in maintaining a balance of power in the Asia-Pacific region and consolidated a positive assessment of the place and role of the People’s Republic of China in Asian politics in the United States of America. The return of American political thought to the ideas of the combination policy occurred in the formation of US-Soviet strategic parity and awareness of the ruling circles in the United States, due to the defeat in Vietnam, the limited resources of force influence on the international situation. Started in the United States the study of China’s behavior in the international arena and its power parameters made it possible then to draw a preliminary conclusion that the People’s Republic of China can fill the place of the missing link in the “triangle” of the global scheme – a place of counterweight to the USSR; this required the removal of a US-Chinese confrontation. However, the socio-political and ideological contradictions that were pushed to the foreground on the initial stage of the Chinese policy of the administration of G. Ford and the process of normalization of bilateral relations, again made themselves felt at a later stage. Their injection was promoted by the logic of the development of bilateral US-China relations, as well as by a number of internal objective and subjective reasons, as in the People’s Republic of China (a sharp increase in the struggle for power connected with the illness and death of Zhou Enlai and Mao Zedong), and in the United States (Gerald Ford made certain curtseys towards the American right-wing conservative forces and began to intensify approaches to Beijing and Moscow, and also the presidential campaign of 1976). Keywords: the USA, PRC, China, foreign policy, American-Chinese relations, “Pacific Doctrine”, Gerald Ford, Henry Kissinger , Mao Zedong, Deng Xiaoping.

scholarly journals Regulatory Prototype for Biological Products in the United States

2021 ◽  
pp. 60-72
Author(s):  
G. M. Pavithra ◽  
N. Venugopal
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
The United States ◽  
Biological Application ◽  
Biological Products ◽  
License Application ◽  
The Us ◽  
High Degree ◽  
Degree Of Similarity ◽  
Improve Access

Biological products are used for the treatment of many disease, so the biological application submitted for the approval of products are also increasing. The progress of a biosimilarproduct is more difficult and expensive than a small molecule generic product. Biosimilars are not true generic drugs, but demonstrate a high degree of similarity to the reference biological product. In order to improve access to costly biological treatments, a biosimilar pathway in the US was established under the Biologics Price Competition and Innovation Act of 2009. The study highlighted the “Regulatory prospective for the registration of Biological products in US” and a brief description about the development, Manufacturing and approval process of biosimilar products. This article is also focused on the regulatory framework, Biological License Application, Purple book, and Pharmacovigilance of biological products.

scholarly journals The PESCO Program in its current performance and outlook: A «break on the journey»?

2020 ◽  
pp. 95-113
Author(s):  
Yuriy Nikulichev ◽  
Keyword(s):  
Political Geography ◽  
Eastern European ◽  
White House ◽  
The Future ◽  
Recent Developments ◽  
The Usa ◽  
Further Development ◽  
The Eu

Analyzing the recent developments of the European «permanent structural cooperation», the paper focuses on the second and third batches of PESCO projects. The author argues that the future of the Program is basically unclear, considering ambiguity of its relation to NATO. The European innovations in military technologies may develop along two lines – distancing from NATO’s capabilities or adapting to them. The Program itself is contradictory and controversial. Originally, it was positioned as an antithesis of NATO and the USA, but presently this thrust of the initiative is not at all evident. Analyzed are complexities of relations between US and the EU with respect to the Program. It’s argued that the confrontations in this area, that were growing more and more acute with the advent of D. Trump to the White House, in many ways stem from the reluctance of the EU to allow entrance of «third states», including US, to the European defence markets. Described are individual PESCO projects as well as mechanisms for financing them. With regard to political geography, the superiority in the projects implementation belongs to the Old Europe, while the Eastern European states are much less active and tend to collaborate with the neighboring states. Emphasized are differences in French and German strategic cultures, which determine the level of their participation in PESCO. It’s concluded that the further development of the Program will likely face serious difficulties and is, in fact, extremely difficult to predict.

The US Semiconductor Industry: A Locational Analysis

1987 ◽  
Vol 19 (7) ◽  
pp. 875-912 ◽  
Author(s):  
A J Scott ◽  
D P Angel
Keyword(s):  
Semiconductor Industry ◽  
Location Theory ◽  
Silicon Valley ◽  
Linear Discriminant ◽  
Locational Analysis ◽  
The Us ◽  
Recent Developments ◽  
The Usa ◽  
Production Complex ◽  
Organizational Features

This paper is a theoretical and empirical analysis of the locational dynamics of the US semiconductor industry. The analysis proceeds in six major stages. First, we review some recent developments in industrial location theory. Second, we describe the main technological and organizational features of the semiconductor industry. Third, we provide an empirical overview of the growth and development of the industry in the USA. Fourth, we examine the internal geography of the Silicon-Valley production complex. Fifth, we carry out a linear discriminant analysis of the geography of the industry in an attempt to distinguish Silicon-Valley establishments from non-Silicon-Valley establishments. Sixth, we look at the organizational/locational relationships between wafer fabrication and device assembly.

scholarly journals Power Struggle between China and the United States: Lessons of History

2020 ◽  
Vol 13 (1) ◽  
pp. 82-99
Author(s):  
L. Estachy
Keyword(s):  
United States ◽  
The United States ◽  
Industrial Complex ◽  
Wall Street ◽  
Us Military ◽  
The Us ◽  
Us Government ◽  
Recent Developments ◽  
The Usa ◽  
Financial Power

Fernand Braudel, the economic historian, gave a key for reading the power struggles occurring today between the United States and China. «Just as a country at the center of a world-economy can hardly be expected to give up its privileges at international level, how can one hope that the dominant groups who combine capital and state power, and who are assured of international support, will agree to play the game and hand over to someone else?» In other words, the ruling circles in the United States, the hegemonic power of today, want to keep their leadership, China, the rising and challenging power, would like to replace the USA as the hegemonic country: the trade war starting in 2018 should be analysed in this context . The paper will deal with the recent developments of this hegemonic struggle: within the American establishment, the Pentagon and the US Department of Commerce have regained control over «Wall Street» which has resulted in an updated version of the US military-industrial complex, with China replacing the USSR in a new "cold war". Complex strategies are developped on both sides, involving manufacturing, technology, trade, financial, diplomatic and military issues. Referring to this geo-economic key for reading, a number of actions taken by the US government since 2018 aims in particular at checking China’s mounting economic and financial power. For the United States, it is about challenging the development of China’s influence in the world, in particular along the new maritime Silk Roads.

scholarly journals Wpływ reformy zdrowotnej w Stanach Zjednoczonych ObamaCare na biznes farmaceutyczny

Ekonomia ◽  
2016 ◽  
Vol 22 (4) ◽  
pp. 35-45
Author(s):  
Łukasz Jasiński ◽  
Marta Makowska
Keyword(s):  
Prescription Drugs ◽  
Health Reform ◽  
Healthcare Reform ◽  
Generic Drugs ◽  
The United States ◽  
Pharmaceutical Companies ◽  
Negative Effects ◽  
The Us ◽  
Insurance Business ◽  
The Impact

Impact of the Healthcare Reform in the United States ObamaCare on the Pharmaceutical Business ObamaCare changes have different influence on diverse healthcare business. Pharmaceutical industry seems to gain on this reform unlike the insurance business. In this article we briefly present the main positive and negative effects of health reform in the US. Then, we point to the impact of ObamaCare on profits, costs and activities of pharmaceutical companies. We discuss changes such as: increase in sales of prescription drugs; new rules of registration of generic drugs; novel tax on sales of original drugs; incentives for pharma to put more attention to specific fields in R&D; bigger transparency in relations between physicians and pharma industry.

Liability of Hosting Provider with Regard to Open Libraries

2011 ◽  
pp. 430-446
Author(s):  
Thanos K. Tsingos
Keyword(s):  
Service Providers ◽  
Copyright Infringement ◽  
Legal Order ◽  
User Generated Content ◽  
Free Access ◽  
Internet Service ◽  
The Us ◽  
Recent Developments ◽  
The Usa ◽  
The Eu

Internet allows free access of information to anyone, without any particular quantitative, temporal or geographical restriction. At the same time, the use of Web 2.0 technologies allows users to offer their personal contributions in order to enrich projects, such as the renowned “open libraries’” project. However, the emergence of “open libraries’, which is much related to the concept of the so called “User Generated content”, may give rise to several types of copyright infringement by reason of impairing one or more of the original author’s exclusive rights. In addition, Internet Service Providers may facilitate users’ infringing activities by offering either a mere access to the net or by providing them with hosting services for various actions to take place that may be properly characterized as copyright infringements by the applicable copyright law. In the abovementioned context, this chapter examines the issue of whether an Internet Hosting provider could be held liable for copyright infringement in terms of any content originated by the user, especially in relation to an open library, by offering a deeper understanding on the rules governing ISP’s liability in the USA and the EU. The author attempts to describe the main recent developments taken place in this area of law and conclude on the most important differences between the US and the EU legal order.

Du sildenafil citrate au Viagra® ou l’art délicat de nommer les médicaments

Terminology ◽  
2014 ◽  
Vol 20 (1) ◽  
pp. 74-91 ◽  
Author(s):  
Pascaline Faure
Keyword(s):  
Pharmaceutical Industry ◽  
Generic Drugs ◽  
Marketing Strategies ◽  
Pharmaceutical Companies ◽  
National Formulary ◽  
International Dimension ◽  
Economic Issues ◽  
The Us ◽  
The World ◽  
Us Fda

In times past, drugs often derived from plants and were quite naturally named after them. Nowadays, considering the significant economic issues at stake (Dutchen 2009), pharmaceutical companies increasingly entrust brand agencies with the naming of their products (Kenagy 2001). In this article, we offer to analyze the names of some brand and generic drugs, exploiting the French VIDAL dictionary, the British National Formulary and the US FDA corpora, with the aim to bring to light the evolution of lexical trends over the last century. Whilst doing so, we wish to demonstrate that, in the field of pharmacology, the process of naming is nowadays not so much underlain by a legitimate need for clarity and scientificity but rather by marketing strategies some of which prove to be misleading for patients. Considering the now international dimension of the pharmaceutical industry, drug names are often the same around the world. Yet, there are exceptions, which we point out and explain. Furthermore, we deemed interesting to underline the extent to which medicines are part of our everyday life by pointing out nicknames that patients tend to give to their treatments — usually sedatives, neuroleptics and the like — and metaphors they may resort to in English and in French. We conclude with the acknowledgement that medicines are henceforth like any other goods, whose financial stakes are such that, besides developing forceful new names, the pharmaceutical industry goes so far as inventing new diseases (disease mongering) to increase its market share (Even and Debré 2012).

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