scholarly journals Agricultural Biotechnology and the "Early-Working" Exemptions Under the Patent Act

2015 ◽  
pp. 765
Author(s):  
Martin Phillipson
Keyword(s):  
United States ◽  
Research And Development ◽  
Early Development ◽  
Market Entry ◽  
Agricultural Biotechnology ◽  
The United States ◽  
Regulatory Approval ◽  
Legal Issues ◽  
Product Approval ◽  
Patent Expiry

The author explores the availability to genericmanufacturers of two research exemptions under the Canadian <i>Patent Act</i>.  In order to expedite later market entry, processes of research and development and federal product approval are often initiated prior to patent expiry. The question arises of when these "early-working" endeavours will violate the protection offered hy a patent. The "research exemption " has been interpreted narrowly, and may only be of limited use to potential manufacturers engaging in early development of protected products. However, the "regulatory approval exemption" has been given a wider interpretation, both in Canada and the United States, and it is likely that processes related to regulatory approval will not as readily be considered as patent infringing. Finally, the author also briefly explores commercial and strategic considerations as they relate to these legal issues.

A History of Geothermal Energy Research and Development in the United States. Reservoir Engineering 1976-2006

2010 ◽  
Author(s):  
B. Mack Kennedy ◽  
Karsten Pruess ◽  
Marcelo J. Lippmann ◽  
Ernest L. Majer ◽  
Peter E. Rose ◽  
...  
Keyword(s):  
United States ◽  
Research And Development ◽  
Geothermal Energy ◽  
The United States ◽  
Reservoir Engineering ◽  
Energy Research ◽  
History Of

A HISTORICAL REVIEW OF THE ACCOUNTING TREATMENT OF RESEARCH AND DEVELOPMENT COSTS

1992 ◽  
Vol 19 (1) ◽  
pp. 51-78 ◽  
Author(s):  
Paul E. Nix ◽  
David E. Nix
Keyword(s):  
United States ◽  
Research And Development ◽  
Alternative Treatment ◽  
Historical Review ◽  
The United States ◽  
Current Treatment ◽  
Social Consequences ◽  
Financial Accounting ◽  
Development Costs ◽  
Accounting Rules

This study reviews the literature and the practice of accounting for research and development (R&D) costs from the first reference in 1917 to the current treatment. The conceptual treatment of R&D is compared to current financial accounting rules and explanation of the evolution of the current rules is presented. The economic and social consequences of the current rules which require R&D costs to be expressed are examined. The paper explores possible alternative treatment of R&D costs. As a contrast to U.S. practice, the accounting treatment of R&D costs in other countries is discussed. Given the findings of this paper, a strong case can be made for changing the way that R&D costs are accounted for in the United States.

scholarly journals Implementation of a Market Entry Reward within the United States

2018 ◽  
Vol 46 (S1) ◽  
pp. 50-58 ◽  
Author(s):  
Gregory W. Daniel ◽  
Monika Schneider ◽  
Marianne Hamilton Lopez ◽  
Mark B. McClellan
Keyword(s):  
United States ◽  
Health Policy ◽  
Drug Development ◽  
Market Entry ◽  
The United States ◽  
Antimicrobial Drug ◽  
Multifactorial Approach

As part of a multifactorial approach to address weak incentives for innovative antimicrobial drug development, market entry rewards (MERs) are an emerging solution. Recently, the Duke-Margolis Center for Health Policy released the Priority Antimicrobial Value and Entry (PAVE) Award proposal, which combines a MER with payment reforms, transitioning from volume-based to “value-based” payments for antimicrobials. Here, the PAVE Award and similar MERs are reviewed, focusing on further refinement and avenues for implementation.

Sperm and Egg Donor Anonymity

2016 ◽  
Author(s):  
I. Glenn Cohen
Keyword(s):  
United States ◽  
The United States ◽  
Legal Issues ◽  
Gamete Donation ◽  
Sperm Donor ◽  
Egg Donor ◽  
Gamete Donor ◽  
The World ◽  
Ethical And Legal Issues ◽  
Reproductive Tourism

Gamete donor anonymity has become an increasingly active area of legislative, bioethical, and empirical interest over the last decade or so. This chapter begins by detailing the very different status of gamete donor anonymity, contrasting the United States (where the law does not prohibit it) with the rest of the world (where it has been largely prohibited by law) and examining the effects of these policies. The chapter then examines the major arguments that have been offered in favor of and against mandating nonanonymous gamete donation. In particular, it focuses on the effects of removing anonymity on supply and arguments in favor of ending sperm donor anonymity based on the welfare of donor-conceived children or rights claims by them. The chapter also more briefly considers ethical and legal issues related to donor compensation, accidental incest, information reciprocity between donors and recipients, and reproductive tourism.

Pharmaceutical Innovation in the United States: Factors Affecting Future Performance

1993 ◽  
Vol 9 (2) ◽  
pp. 167-173 ◽  
Author(s):  
Michael R. Pollard
Keyword(s):  
United States ◽  
Pharmaceutical Industry ◽  
Research And Development ◽  
Cost Containment ◽  
The United States ◽  
Private Companies ◽  
Factors Affecting ◽  
The Past ◽  
Future Performance ◽  
Regulatory Strategy

AbstractFueled by high returns on its investments, the pharmaceutical industry in the United States has flourished for the past 50 years. The regulatory strategy of demanding stringent testing then allowing market-based pricing has allowed private companies to fund ambitious research and development activities with the assurance that these investments will be recovered. However, aggressive managed-care cost-containment strategies threaten the companies' ability to recoup research and development expenses and may affect their willingness to invest in future innovative research.

Sign in / Sign up

Export Citation Format

Share Document