| Volume 10, Number 4 (2007)
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| ABSTRACTS |
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| Volume Index |
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Feature
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Preventive Medicine: Liability Protection is Essential for Companies that Employ Healthcare Professionals
Tracey Daniels-Pullen
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Abstract:
Life science organizations leave themselves exposed to tremendous medical malpractice liability if they do not have the proper insurance for the patient care activities of healthcare professionals employed or under contract. General liability policies that provide protection for injuries caused by a drug or medical device do not cover the professional services of licensed healthcare providers. This article highlights key issues related to healthcare professional liability, more commonly known as medical malpractice, which, for many drug and device companies, is an exposure that is hidden in plain sight.
4 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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What Color is Your Swan? Why Biotech Companies Need to Expect (and Plan for) the Unexpected
Mark T. Campbell, Tracee J. Fultz and Gautam Jaggi
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Abstract:
For biotech companies, planning for product-related surprises is a particularly relevant and timely challenge due to increased regulatory and legislative focus, the industry's maturation, and the unique nature of their products. While such events can have very significant consequences for companies' financial performance, the industry is now operating in an environment where product surprises can be anticipated to some extent, and it is important that biotech companies plan for such developments. Planning should include risk assessment and risk mitigation to reduce the potential costs of adverse events and increase the potential benefit of positive surprises. While many development-phase biotech companies may not be very focused on tax issues, advance planning is important, since product-related surprises can have significant tax impacts.
4 pages
©2007
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Leveraging a Life Sciences Patent Portfolio in the Changing Patent Landscape
David J. Dykeman and Joanna S. Toke
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Abstract:
The winds of change are sweeping over the patent landscape, and patent portfolio strategy must be refocused to maximize protection, flexibility and revenue for life sciences companies. The patent changes are coming fast and furious, with the Supreme Court issuing far-reaching opinions, Congress considering patent reform legislation, and the U.S. Patent and Trademark Office proposing major patent rule changes that will impact how patent applications are prosecuted and the strategies behind patent filings. Patent protection can be maximized by building a patent portfolio to weather change, finding freedom to operate to patent white space, and adopting a licensing strategy that includes cross-licensing with competitors to leverage the patent portfolio. Savvy patent filers must adapt to the changing patent landscape to determine the proper
strategy to ensure maximum coverage for their intellectual property assets.
5 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Genetic Engineering In Trees: The International Legal Landscape
Lori P. Knowles and Alethea Adair
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Abstract:
Over the next decade and a half the world's need for wood is expected to increase by 50 percent - a demand that we are not currently poised to meet. Genetic engineering of trees may help meet that need, and may reduce pressure on old growth and tropical forests. In addition, GE trees with modified lignin and those used for phytoremediation have positive industrial and environmental impacts. Like other GE crops, GE trees have been engineered for traits such as herbicide resistance and pathogen resistance although many trials focus on identification of reporter and marker genes. Unlike GE crops, genetic engineering in trees is a truly global endeavor with field trials taking place on a small but global scale. Significant research activity is taking place in the United States, Canada, Europe and China. Most international biotechnology regulations were created with GE crops in mind and do not directly address issues specific to trees, such as life cycles spanning decades or centuries. Acceptable risk associated with the deregulation of commercial GE trees or tree products differs between regions. Legal issues that surfaced with respect to GE crops, including the impact of inadvertent gene flow, will be even more complicated with respect to GE trees. This article examines the state of the technology, international regulation and possible legal challenges accompanying the introduction of GE trees.
7 pages
©2007
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Life Sciences in Ireland
Samara McCarthy
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Abstract:
Much has been written about the Irish success story; the Celtic Tiger, the Irish Miracle; the names and metaphors evolve as the country's prosperity increases. Ireland certainly continues to be a vanguard of industrial development, receiving top global recognition from organizations including The Heritage Foundation, the Economist Intelligence Unit Harvard Business Online, and AT Kearney.
3 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Safety Issues and Biologic Drugs
Bryan A. Liang
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Abstract:
No Abstract
2 pages
©2007
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Beer Cooler Biologics!
Thomas T. Kubic
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Abstract:
Every day, law enforcement officers throughout the United States are engaged in court authorized searches of persons, vehicles, homes and businesses. On occasion, during these searches, officers are surprised at what they uncover. For in some of the most unlikely places, their searches have disclosed the most advanced medicines - biologics, pharmaceuticals products critical to the health of seriously ill citizens. These discoveries are all the more important because they also represent fake, tainted, or diverted drugs that may be ineffective and harmful to patients who buy them. Law enforcement and policymakers must be attentive to this issue to ensure patient safety.
5 pages
©2007
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Behind the Curve: A Critique of NGO Activity with Regards to the Safety Concerns of Biologics
James N. Class
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Abstract:
Non-governmental organizations, or NGOs, play a role in engaging the safety of biological medicines. NGOs should reconsider their roles as safety watchdogs in order to promote positive change with respect to biological medicines.
4 pages
©2007
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Counterfeit Biologics: A Personal Narrative
Rick Roberts
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Abstract:
Counterfeit drugs are not something that happen to someone else. Real people are affected by fake drugs they buy in pharmacies. It is an experience that teaches us the importance of safety of the drug supply. I know, because I was a victim. This is my story.
3 pages
©2007
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The October 2005 Fake Flu Vaccine Incident
Kevin D. Lammons
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Abstract:
In October of 2005, Houston Texas was the site of a fake flu vaccine scam. Approximately 1400 persons were injected with a substance that was purported to be flu vaccine when in fact it was not. The investigation into this incident revealed that the victims had been injected with purified water and none of the victims suffered permanent harm. The owner of the company that gave the injections and a woman who posed as a nurse were charged and convicted of health care fraud. The owner of the company was also charged and convicted of misbranding or mislabeling of a drug. This article details the investigation and some of the lessons learned from the incident.
4 pages
©2007
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Safety Issues in Regulating Follow-On Biologic Drugs
Bryan A. Liang
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Abstract:
Biologic drugs are expensive, and hence policymakers are considering accelerating copies, or "follow on" biologic products to market using abbreviated pathways. However, important concerns relating to biologic products may have implications for follow on product regulation. The information gaps regarding biologic science, clinical issues associated with product excipients and active ingredient, and supply chain issues and weaknesses call for a regulatory system different from abbreviated approvals for chemical drugs. This article concludes that a policymaker focus upon patient safety rather than any potential reduction in price is appropriate for follow on biological products.
6 pages
©2007
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In Memorium: Erizen Sei Bowles
Bryan A. Liang and Joya K. Raha
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Abstract:
No abstract
1 page
©2007
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HPV Vaccine Mandate Approved in New Mexico
Allison Costain Schneider
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Abstract:
New Mexico is the first state to approve mandatory human papillomavirus (HPV) vaccinations for school-aged girls. The law requires all girls entering the sixth grade to receive the HPV vaccine prior to entering school, but includes an option for parents to waive the requirement.
2 pages
©2007
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First Vaccine for Avian Flu Approved
Genevieve A. Suzuki
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Abstract:
French company Sanofi-Pasteur has manufactured the first vaccine against avian flu for the United States but better vaccines and adequate preparedness for a pandemic are still necessary.
2 pages
©2007
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French Legislation Distinguishes Biosimilar Medicines from Generics
Erizen Sei Bowles
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Abstract:
In February 2007, the French Parliament adopted legislation that establishes a legal definition of "biosimilar" medicines, prevents biosimilar medicinal products from being classed as generics, and bans the automatic substitution of one biological medicine for another.
2 pages
©2007
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FDA Issues New Safety Information on Erythropoiesis Agents
Joya K. Raha
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Abstract:
The U.S. Food and Drug Administration issued a public health advisory detailing revised product labeling for erythropoiesis-stimulating agents. The drugs affected by the new safety information are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit).
2 pages
©2007
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BioCase Study: Impeding Innovation: the Impact of MedImmune v. Genentech
Dennis Fernandez & Brian Bensch
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Abstract:
In recent months, the Supreme Court made the equivalent option a reality for parties engaged in patent-licensing contracts. Licensing contracts between patent-holders and manufacturing firms are a key institution in the high technology industry, making it possible for inventors to profit from their patents without needing the means to take a product to market. However, by allowing a licensee in good standing to challenge the validity of its licensor's patent without first breaching their contract, the Supreme Court's decision in MedImmune v. Genentech threatens the stability of all current and future licensing agreements. It dramatically increases the uncertainty of licensing contracts, which increases the potential for litigation, reduces the value of valid patents, and hinders the overall efficiency of the U.S. patent system. This article will first summarize the facts of MedImmune v. Genentech, analyze and highlight flaws in the Supreme Court's reasoning, and then address the implications of this decision for future and current licensing agreements. Most importantly, in the context of patent theory, the article will conclude by showing why weakening the patent-licensing structure will likely impede overall levels of innovation.
6 pages
©2007
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BioRuminations/ A Government Contract and Grant Lawyer Ruminates on Intellectual Property Issues in U.S. Government Research Contracts & Grants
William Weisberg
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Abstract:
This article started out as a traditional "Current Developments In…" piece. But I recently had occasion to give a speech to an industry group on these issues, and they wanted war stories, and issue spotting, not references to obscure regulations. Anyone can look those up. What they found most useful was learning how to think about these issues. So, here goes…
3 pages
©2007
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BioEthics/ Stem Cells: The Philosopher's Stone or Pandora's Box?
J. Joseph Marr
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Abstract:
As the scientific, medical and financial communities begin their accelerating slide into the area of stem cell applications, perhaps it may be worth considering where we have been and what history might tell us about this new venture that promises so much. We have, after decades of scientific investigation in the area of genomics, proteomics and cellular biology, opened a door into what may truly be called a "brave new world". The siren song of rebuilding organs, restoring functions that have been lost, and regenerating tissue that has been damaged or destroyed may lead us to the Philosopher's Stone or Pandora's Box-but which? The answer is that it will be both, but in what proportion and how the proportion will shift with time is completely unclear. This article highlights the continuum of scientific discovery and bioethical issues that are in the forefront of society today.
2 pages
©2007
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Patents/ Top-12 Most Common Mistakes Related to Intellectual Property Rights During Venture Capital Due Diligence
Dennis Fernandez and Sam Sokhansanj
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Abstract:
Patent procurement is a complex process that requires the utmost amount of careful preparation, diligence, and drafting, thereby reducing the likelihood of mistakes. This article sets out the top 12 most common Intellectual Property mistakes made in patent prosecution, litigation, and portfolio development, and how to avoid these mistakes.
3 pages
©2007
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