Got GMOs?

by Ude Lu, UMN Law Student, MJLST Staff.

Ude-Lue.jpgGMOs, 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.


Hurricane Highlights Need for Better Regulatory Tools

by Kenzie Johnson, UMN Law Student, MJLST Managing Editor

Kenzie-Johnson-Thumbnail-White-Back.jpgThe 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 Hurricane Isaac, and perhaps less publicized, drought that has threatened fresh water supply in southern Louisiana. On the seventh anniversary of Hurricane Katrina, Hurricane Isaac made landfall causing severe flooding in rural areas along the Louisiana coast. In addition, this summer’s drought has also caused water levels to drop significantly in the Mississippi River, causing saltwater to work its way up stream threatening some areas’ fresh water supply.

These two events have, yet again, brought attention to environmental and natural resource issues in the Gulf Coast, but as Daniel Farber points out, environmental degradation in the Gulf-Coast region is not a new phenomenon. In an article published in MJLST, “The BP Blowout and the Social and Environmental Erosion of the Louisiana Coast,” Farber explains that the Gulf Coast has long suffered from disappearing wetlands that are important in reducing storm surges, a large aquatic dead zone that threatens marine life, coastal erosion, and numerous threats to biodiversity. He also discusses the effects climate change will have on the region. Farber argues that improved regulatory tools are needed to restore the region’s ecosystems and prepare for challenges the region is likely to face in the future. Farber also calls for increased restoration funding including the direction of Clean Water Act civil penalties towards Gulf Coast restoration.

In June, 2012, Congress passed the RESTORE Act which directs 80 percent of Clean Water Act penalties into a Gulf Coast Restoration Trust Fund. The Act also creates a Gulf Coast Ecosystem Restoration Council charged with comprehensive planning for restoration of the region and overseeing the use of Trust Fund money. On September 10, 2012, President Obama signed an Executive Order terminating the Gulf Coast Ecosystem Restoration Task Force and moving forward the establishment of the Gulf Coast Ecosystem Restoration Council. The order also names the Environmental Protection Agency and Department of Agriculture as trustees to the Natural Resources Damage Assessment Trustee Council that is charged with assessing natural resource damages from the Deepwater Horizon oil spill, restoring natural resources, and seeking compensation for lost resources.

As can be seen by the recent events, the Gulf Coast region will continue to face natural disasters as well as environmental and natural resource challenges, and the region needs a regulatory system structured to address such events. Recent actions by Congress and President Obama show promise towards long-term restoration, but as Farber points out, the complexities of these issues will take continued action and improvements in regulatory tools to fully restore the region.


An Individual Right to Return of Research Results

by Keli Holzapfel, MJLST Student Editor-in-Chief

Keli-Holzapfel-Thumb-White-Back-II.pngGiven 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.

Biorepositories are collections of biospecimens that are tested and analyzed for scientific purposes. The testing performed on these biospecimens has become the basis for development of various molecular tests, which is becoming critical for the shift toward personalized medicine. Therefore, as technology advances, the quality and management of biorepositories is becoming more important. This is especially critical for the return of accurate patient data resulting from biospecimen analysis. However, managing and conducting a biorepository in the way necessary for return of results can be very complex and expensive. There must be many measures in place to prevent mistakes in identification and to ensure the quality of the biospecimen being tested. Currently, there are many existing biorepositories that do not meet the needed Clinical Laboratory Improvement Amendments (CLIA) standards for return of results. For an in-depth discussion of the current state of biorepositiories and issues surrounding return of results, see the article “Perspective on Biorepository Return of Results and Incidental Findings” written by Steve Jewell. For an example on what biorespositories need to do to improve their management and specimen oversight, see the College of American Pathologists, Accrediation Information.

As alluded to above, some of the important questions that arise from the return of results to an individual are inherently linked to the reliability of the result. For example, what should be the necessary standard for a result to be returned to the individual? Is the current threshold for returning results too high? As mentioned, many biorepositories do not meet the necessary guidelines for CLIA certification, which is required for returning of results. This means that potentially critical information is not shared with the individual involved. Is this ethical? Should biorepositories that discover critical information be required to return results to an individual even though the results are not CLIA certified? But if the results are wrong, is the emotional distress that may ensue from the return of results as unethical as withholding the results?

Due to the current state of biorepositories, and the huge implications that return of results may have, I think the best solution is to allow for consent-based return to an individual, with the understanding that any returned result needs to be independently CLIA certified. Therefore, only individuals who consent to receive results would get them, the individuals would receive the results with the understanding they could be incorrect, and then further testing would be done to validate the results to the necessary high standards. For additional in-depth discussion of issues surrounding CLIA and non-CLIA certified return of results, see “Ethical and Practical Guidelines for Reporting Genetic Research Results To Study Participants: Updated Guidelines from an NHLBI Working Group.”

For other insights and recommendations regarding return of research results, see MLST’s Winter 2012 symposium issue, “Debating Return of Incidental Findings and Research Results in Genomic Biobank Research–Law, Ethics, and Oversight


The Written Description Requirement Strikes Back

by Nihal Parkar, UMN Law Student, MJLST Staff

Nihal-Parkar-Thumbnail-White-Back.jpgThe 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.

A recent paper by Aaron Rabinowitz in Volume 12 of the Minnesota Journal of Law, Science & Technology, Ending the Invalidity Shell Game: Stabilizing the Application of the Written Description Requirement in Patent Litigation, analyzes this paradox in the context of how courts apply the written description requirement to routinely invalidate patents issued by the USPTO–those very issued patents that have gone through the tortious path of examination at the PTO and have been vetted by examiners and reshaped in course of the ping-pong game of office actions and their replies.

A high level of invalidation by the courts seems problematic. After all, shouldn’t patent owners be entitled to rely on the PTO’s evaluation of their patent, and be freely able to assert the patent against alleged infringers in court, without fearing that the court will find the written description to be as addled with holes as the typical chunk of Swiss cheese? Well, the courts can’t quite be blamed, given that the PTO works in mysterious ways. Reviewing the file wrapper often does not explain how each claim fulfilled the written description requirement in combination with the rest of the specification. A law firm helpfully points out, “Make Sure Your Patents Do Not Prove Their Own Invalidity!” To add to the complexity of the situation, the “written description requirement is separate from enablement.”

Patent owners would be wise to worry about the potential pitfalls of the written description getting shredded between Scylla and Charybdis. As Rabinowitz points out, “over 2000-2009, parties that attacked a patent on written description grounds succeeded more than forty percent of the time.”

Fortunately, Rabinowitz does not merely cry wolf, but supplies some solutions to keep the wolf at bay. To strengthen a patent’s validity, patent applicants can choose “to affirmatively identify the written description support for their claims in the application”. And then eagerly wait for “the PTO to either approve or question the applicant’s statement of support.” Of course, with patent examiners already being somewhat overburdened, the PTO may not be enthusiastic about yet another step in prosecution.

Rabinowitz’ article raises an interesting question that is often overlooked, and provides a practical, workable solution that is likely to be of benefit to patent owners, patent challengers, the PTO, and the courts.


Social Media Evidence: Not just an Attorney Niche

mjlst-logo-button.pngOnce just the province of Generation Y and high tech culture, it is not breaking news that social media is now as mainstream as . . . well . . . the internet. What is new is that social media issues are no longer just an interesting specialty niche for tech savvy lawyers, but something that likely touches most attorneys’ practices.Social-Media-Evidence.PNG

A look at the rapid rise of appellate level cases involving social media evidence gives a hint at just how common social media evidence is becoming in civil litigation and criminal prosecution. The chart accompanying this post, while not a definitive study, shows the results of a Westlaw search for the number of appellate cases that likely involved the admission of evidence related to the major social media outlets — increasing 8-fold since 2008 and doubling in the past two years.

In separate research, eDiscovery firm “X1 Discovery” recently reported finding 674 appellate cases in 2010-2011 that mentioned social media evidence. With that many cases involving social media evidence at the appellate level, it is not unreasonable to conclude that social media evidence must be seen frequently by the lower courts.

Whether it is understanding how to authenticate a Tweet during trial, or avoiding a career-ending discovery sanction for spoliation of Facebook evidence, there is a growing need for litigators and other attorneys to understand the implications of social media for clients.

In issue 13.1 of the Minnesota Journal of Law, Science & Technology, Professor Ira P. Robbins of American University’s Washington College of Law outlines the challenges involved in authenticating social media evidence and proposes an authorship-centric approach to the authentication of such evidence. Read “Writings on the Wall: The Need for an Authorship-Centric Approach to the Authentication of Social-Networking Evidence


Bioethic Concerns 34 Years After 1st Test Tube Baby

mjlst-logo-button.pngProfessor Susan Wolf, Founding Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences (which oversees and manages MJLST) discusses the latest bioethical concerns related to in vitro fertilization (IVF) on Minnesota Public Radio‘s The Daily Circuit program (click play button below):

In related content, MJLST Issue 10.1 included an article by Debora Spar, author of The Baby Business: How Money, Science and Politics Drive the Commerce of Conception and attorney Anna M. Harrington entitled “Building a Better Baby Business” that offers a road map to ensuring quality and equity in the reproductive technology industry.

For insights into understanding legal responses to technological change, using in vitro fertilization as an example, see Understanding Legal Responses to Technological Change of In Vitro Fertilization, by Lyria Bennett Moses in MJLST Issue 6.2.


FDA Approvals are a Matter of Life and Death

Sapien-Transcatheter-Heart-Valve.jpg
mjlst-logo-button.pngMJLST faculty editor-in-chief Ralph Hall and Andrew Von Eschenbach, former commissioner of the U.S. Food and Drug Administration (2005-2009), wrote an opinion piece in the June 18 Wall Street Journal on ways to move medical devices more quickly into the hands of health care practitioners. They cite the example of the American-made SAPIEN Transcatheter Heart Valve (pictured right) that was available to patients in Europe four years before those in the United States. Read “FDA Approvals Are a Matter of Life and Death” (WSJ). (NOTE: the WSJ article can be viewed in full by using Google to search “FDA Approvals Are a Matter of Life and Death” and then clicking the first link to WSJ in the results.).

In a related article in MJLST issue 13.1, Professor Hall and Eva Stensvad outlined problems with the 510(k) medical device clearance process and argued that while the Institute of Medicine (IOM) is generally an invaluable policy resource, invaluable policy resource, its Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process is not fairly balanced and unable to fairly and accurately perform its duties. Read: Left to Their Own Devices: IOM’s Medical Device Committee’s Failure to Comply.