by Ude Lu, UMN Law Student, MJLST Staff.
GMOs, genetically modified organisms, have long been a part of our daily diet. For example, most of the soybeans and corn on the supermarket shelves are GMOs. Currently, the issue of whether these GMOs should be labeled so that customers can make informed purchases is in a heated debate in California. California Proposition 37, which would require labeling of GMOs, will soon be voted in November this year. Proponents from both sides have poured millions of dollars into the campaign.
GMOs are plants that have been genetically engineered to be enhanced with characteristics that do not occur naturally, so that the harvest can be increased and the cost can be lowered. One example of a prominent GMO is soybean. Monsanto–a Missouri based chemical and agriculture company–introduced its genetically modified soybean, Roundup Ready, in 1996. Roundup Ready is infused with genes that resist weed-killers. In 2010, 93% of soybeans planted in the United States were Roundup Ready soybeans.
Although GMOs are one of the most promising solutions to address the sustainability of food supply in view of the growing global population, there are concerns in the public regarding their safety, and confusion as to which federal agency has responsibility for regulating them.
Amanda Welters in her article “Striking a balance: revising USDA regulations to promote competition without stifling innovation” published in the Minnesota Journal of Law, Science, and Technology explains the current regulatory scheme of GMOs. Three primary agencies regulate GMOs: the Food & Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA). The FDA regulates GMOs in interstate commerce that are intended to be consumed by animals or humans as foods, the EPA monitors how growing of GMOs impacts the environment, and the USDA assesses the safety of growing GMO plants themselves.
Specifically, the Animal and Plant Health Inspection Service (APHIS) in the USDA is responsible for ensuring crops are free of pests and diseases. APHIS is currently in the process of revising its regulations for GMOs in an attempt to improve transparency, eliminate unnecessary regulations and enhance clarity of regulations. Under the proposed regulations there will be three types of permits for GMOs: interstate movement, importation, and environmental release.
Taking the position that GMOs are generally beneficial and unavoidable, Welters suggests that the USDA should frame a regulatory structure similar to the Hatch-Waxman Act and the Biosimilar Act to promote both innovation and competition. Readers interested in the regulatory issues of GMOs and the balance between the interests of patent innovators and generic follow-ons would find Welters’ article informative and insightful.
The Gulf Coast just can’t seem to catch a break. From the devastation of Hurricane Katrina, to the BP Deepwater Horizon oil spill, the region has had its fair share of environmental and natural disasters in recent years. Events this summer have placed the region in the news again–namely 
Given the importance of results discovered by biorepositories and their implications for an individual’s health care choices, I believe that the individual has the right to receive his results despite their lack of verification. However, this right to receive results should be premised upon the individual’s explicit consent to receive his results, and upon the understanding that by receiving these results, the burden of their verification shifts from the biorepostory to the individual.
The written description requirement for patents often resembles the proverbial neglected middle child–it is left to its own devices and entrusted with its own care. The typical patent practitioner carefully chisels away at the claims with a thesaurus, and then proceeds to encase the exquisite sculpture with a glob of written description. Yes, the detailed description of the drawings and alternative embodiments may follow the core structure of the claims, but let’s face it–the average specification is hardly as painfully beautiful as the average claim.
Once just the province of 
