FEATURES
	Combination Products Require Careful Patent Strategy David J. Dykeman and Joanna Toke
	Piling On: Federal Issues Add to Biotech's Challenges Michael J. Werner
	The Progress of Science and the Public Good: A Novel Reconceptualization of Patetable Justin P. Huddleson
	Life Sciences Companies Remain Firmly in the Crosshairs of the Plaintiffs' Securities Bar David A. Kotler and Michal L. Kichline
	The Nano-Bio Convergence and New Regulatory Challenges Kimberly B. Herman and Daniel E. Balserak
	Analysing the Impact of Social, Regulatory and Ethical Concerns on Nanobiotechnology Investment and Commercialization: A Critical Mass Gradient Hypothesis Bhuvaneashwar Subramanian
	RECENT DEVELOPMENTS
	Safety and Opportunities Bryan A. Liang
	FDA Sets Precedent by Listing Oxycontin Abuse Risk in Drug Safety Report Cody Padgett
	Food Allergies on the Rise in US Children Scott K. Peterson
	Potential Health Risks of Over-the-Counter Cough Medications in Children Cassandra Wolf
	Increased Regulation of Energy Drinks is Necessary to Protect Consumers Kathleen Sweeney
	The Spread of MRSA in Healthcare Facilities Desiree Nguyen
	Effectiveness of Glucosamine and Chondroitin Sulfate on Knee Osteoarthritis Pain Management and Disease Progression Matthew LeGrand
	Opportunities for Investment in Preventive Medicine Matthew Wheeler
	BIOCOLUMNS
	Bioethics/PhRMA Adopts Revised Marketing Code Howard L. Dorfman, Alan Bennett, Ann E. Lewis and Joy J. Liu
	Finance/Biotech Holds Steady as Broader Markets Tumble G. Steven Burrill
	Biopolicy/Federal Health Care Policy: The Road Ahead Robert H. Bradner

Abstract: Combination products that combine biologics or drugs with medical devices have the potential of advancing patient healthcare by offering safer and more effective treatments. To successfully produce and market combination products, companies must first ensure strong patent protection. Developing a strategic patent portfolio for combination products requires protecting each element of the product as well as the combination. A strategic patent portfolio further requires overcoming additional hurdles, including finding qualified patent counsel, conducting freedom-to-operate searches, resolving issues of joint ownership, and navigating a host of regulatory challenges. To achieve success in the growing combination technology market, savvy companies need to navigate the complex intellectual property and regulatory environment to maximize business opportunities. 6 pages.

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The biotechnology industry will be forced to confront significant challenges from Washington for the next two years. The Obama Administration and Congress are likely to promote policies that will greatly impact the industry; some that could significantly impact its growth and stability. Policy makers will be debating proposals regarding drug pricing and reimbursement, approval for follow-on biologics, FDA rules governing clinical trials, and bioethics issues. This article analyzes these issues and identifies threats and opportunities. Companies should make sure they understand these challenges and take action to address them. 5pp

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: This article examines the current scope of patentable subject matter as it pertains to biotechnology. Specifically, it explores this dynamic area from the perspective of ethics and economics. It finds that although there is a strong utilitarian justification for an economic incentive to market, the current broad view of what is eligible subject matter cannot be justified in utilitarian terms alone. From this perspective, the current doctrine is over-inclusive and may threaten emerging technologies. Simultaneously, however, the current exceptions to patentable subject matter that prohibit patents on laws and products of nature are under-inclusive. These exceptions conceptually and theoretically threaten the public's access to the same emerging technologies. Given this seeming contradiction, a more contextualized approach is needed. This article suggests a new doctrine for determining what should be patentable subject matter, one that correlates to scientific progress and is fair to both the public and industry. 13pp

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: In 2007, 25 different pharmaceutical and biotech companies, along with several of those companies' directors, officers, and key medical and research personnel, were sued for alleged securities fraud. These 25 securities fraud lawsuits represent a significant increase over 2006, when 16 securities fraud lawsuits were brought against the industry. Among these 25 lawsuits, securities fraud plaintiffs sued an increasing number of life sciences companies with the largest market capitalizations-and thus the largest potential exposures. That trend is likely to continue in the coming years, as structural industry factors and practices prompt plaintiffs' lawyers to develop new theories of liability. This article highlights some of the trends observed in the securities fraud lawsuits filed against life sciences companies in 2007, including a discussion of some of the notable allegations made in those suits. It also explores significant recent developments and provides observations as to what the future may hold for life sciences companies in the securities fraud arena. In addition, it provides some best practices for life sciences companies to consider for minimizing the risk of, or impact from, securities fraud class action lawsuits. 5pp

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: Drawing parallels between biotechnology and nanotechnology is no new exercise-tremendously broad in their potential, dizzying in their promise, and each successively dubbed The Next Big Thing, both fields have nonetheless traveled the same bumpy road commercially. Just as many investors in biotech ventures still await tardy payoffs, recent years have seen a bust where a boom in nanotechnology was supposed to be. However, as nanotechnology applications increase in their sophistication and cross into the biotech sector, the fortunes of biotech and nanotech are becoming intertwined rather than merely parallel. 4pp

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: Investment opportunities in technology have conventionally looked at financial returns as an indicator of successful deployment. However, the scenario within the nanobiotechnology sector calls for a perspective that considers ethical, legal and social implications in addition to the financial analyses, that typically have not been the mainstay of investments in the nanobiotechnology sector so far. The aim of the article is to suggest a framework for analysis of the critical mass that includes the social, ethical and regulatory implications with respect to the innovation and commercialization potential of nanobiotechnology. It provides analyses of the current investment scenario in the nanobiotechnology space and on the basis of current social, ethical and regulatory trends, suggests a critical mass gradient hypothesis. The critical mass gradient hypothesis suggests that the commercialization potential of nanobiotechnology is inversely proportional to the impact of the critical mass gradient that surrounds nanobiotechnology. The critical mass operates as a gradient because at any given point in time with respect to a nascent technology such as nanobiotechnology, the critical mass would continue to have an impact owing largely to the changing social, economic, political and regulatory environments that influence the scope and acceptance of nanobiotechnology innovations. 9pp

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: No Abstract 1 Page

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The U.S. Food and Drug Administration has designated "misuse, abuse, and overdose" as adverse drug events and potential safety risks of the analgesic Oxycontin in a recent quarterly report. 2pp

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The number of reported food allergies in U.S. children is on the rise. 2pp

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: Potential health risks of over-the counter cough medicines in children has led to FDA warnings. 2pp

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: Scientists and physicians are calling for strict regulation of the burgeoning energy drink industry.

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: There are an increasing number of healthcare facilities reporting Methicillin-resistant Staphylococcus aureus infection. 2pp

©2009 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Click to buy

Effectiveness of Glucosamine and Chondroitin Sulfate on Knee Osteoarthritis Pain Management and Disease Progression

Matthew LeGrand