In this paper, we examine and bring up-to-date the story of the US/EU conflict over the regulation of agricultural biotechnology. The paper is organized in six sections. In the first section, we outline briefly the respective regulatory systems put in place during the 1980s and 1990s by the US...

In 2005 the FDA approved BiDil, the first drug ever to include a race-specific indication on its label - to treat heart failure in a “black” patient. In the aftermath of this controversial approval and subsequent marketing of the drug, many have wondered whether BiDil was an anomaly or a...

This comment was filed with the Department of Justice Antitrust Division on December 31, 2009, as "Comments Regarding Agriculture and Antitrust Enforcement Issues in Our 21st Century Economy" in response to the DOJ/USDA request for public comments for the agencies' joint workshops on antitrust...

Most biotech reach-through royalties involve only a license to "use." The focus of this article is on a rarer breed: sales of patented products, the use of which is also subject to a license which is enforceable through an infringement suit. Under the doctrine of patent exhaustion, such a...

The objective of Clinical and Translational Science (CTS) is to reduce the time-to-practice of biomedical scientific discoveries, and the time-to-research of clinical and community health care issues. The guiding mission of the Biomedical Informatics Infrastructure (BII) is to provide the...

Synthetic biology is a new technology that represents a shift from exploitation of genetic resources to lab production of synthetic biological entitles. As a consequence of this transition, synthetic biology will potentially eradicate the interest in genetic resources located in developing...

The scope of this paper is to propose an integrated strategy to support the decision process of a semiconductor company interested in entering a new market and launching a new product in the biotech industry. The complexity of the environment and the high number of factors involved, leads to the...

Although China is one of the world's largest producers and consumers of genetically modified (GM) crops and derived food products, little is known about the level of Chinese consumer awareness, understanding and acceptance of GM food. Initially, China pursued relatively aggressive policies for...

Aim of this paper is to discuss the issue of corporate structure and business models for managing new modular and complementary biotechnology innovations. Corporate structure and business models of Large Diversificated Firms (LDFs) and Dedicated Biotechnology Firms (DBFs). In fact, are at the...

Taking into account the relevance of Biotechnology in the World industry and economic growth, this essay is focused on the analysis of the use of biotech patent information for determining technological trends and generating innovation indicators, because patents are an important technological...