Legal Approaches to Synthetic Biology

by Nihal Parkar, UMN Law Student, MJLST Note and Comment Editor

Synthetic biology is to biology what androids are to humans. Synthetic biology allows moving beyond the evolutionary constraints of life as we know it. Instead of being restricted to using or repurposing cellular genetic machinery, we can now shape our own genetic tools from the ground up. Instead of merely discovering genes, we can now fabricate genes and synthesize a genome, by restructuring the architecture of life itself.

Research institutions and corporations who have been at the forefront of synthetic biology have taken different approaches to protecting IP. Some institutions have taken up the mantle of promoting open source synthetic biology, having being inspired by the parallel open source software movement. On the other hand, corporations have largely played close to their chest, and have adopted the traditional practices of protecting their innovation through patents, copyrights, and trademarks. A recent MJLST article by Professor Andrew Torrance (Synthesizing Law for Synthetic Biology, Issue 11.2 of the Minnesota Journal of Law, Science & Technology) examines the challenges posed by intellectual property rights to the openness of the brave new world of synthetic biology.


Open-Source Biotechnology: Failed to Take Root or Waiting in the Wings?

by Joe McCartin, UMN Law Student, MJLST Staff

Biotechnology encompasses a wide range of cutting-edge fields, from the genetic modification of agricultural crops and energy producing bacteria, to immunology and medical device manufacturing. Rapid innovation in these areas has led to today’s most challenging ethical issues. One such concern is the fear that profits, rather than providing incentives for innovation, will slow down innovation by restricting the dissemination of new technologies, processes, and insights. In Volume 6, Issue 1 of the Minnesota Journal of Law, Science, & Technology, Robin Feldman outlined the problems an open-source biotechnology movement, one similar to the open-source computer programming world, faces in patent law, and ways that movement could navigate those complexities and potentially enhance the common good.

Feldman discussed the work of molecular biologist, Richard Jefferson, founder of Cambia and BioForge, who sought to democratize the field of plant genetics. The failure of those efforts was detailed by Sam Finegold in “The Hard Path to Open Source Bioinnovation.” Jefferson claimed that the financial incentives available to researchers were no match for an industry that had become dominated by a small handful of industrial chemical companies.

So, is there a future for open-source biotechnology? While it would seem that the pharmaceutical industry would present similar challenges to the open-source biotech movement, Connie Wong posits that open-source may be exactly what the pharmaceutical industry needs in the face of shrinking R&D budgets. She argues that small, lean players can fully utilize their competitive advantage and still protect their work by using open-source arrangements that create a fair-playing field that allows them to operate nimbly. Perhaps the Affordable Care Act may transform the pharmaceutical industry in a way that creates room for open-source innovations?

But perhaps open-source biotechnology’s real promise can be found in the work of Matthew Todd, who sought to bring the power of open-source to a neglected disease, flatworm infections. The World Health Organization documented the amazingly quick success Todd had finding more cost-effective methods of producing praziquantel, the preferred method of treating flatworm. While recognizing that the task far exceeded his abilities by himself, by tapping into not only researchers, but pharmaceutical and chemical companies, he found not one but two new methods of producing the drug! This appears to be the perfect example of the promise of open-source biotechnology. The profit motive focused attention on other diseases, restricting innovation until an open-source community sprung up. While open-source may not be the future of biotechnology innovation, it may end up playing a large role in a transformed pharmaceutical industry.


Myriad Genetics: A Look at Recent Developments in Patent Law and the Human Genome

by Roma Patel, UMN Law and Public Health Student, MJLST Staff

Years ago, the Supreme Court ruled that inventors are not entitled to federal patent protection for discoveries of laws of nature. The Court said, “natural phenomena are the basic tools with which every would-be inventor starts, so locking up the right to use them in a monopoly held by a specific patent owner will frustrate others who might want to look for new ways to interpret [those] phenomena.”

On June 13, a unanimous decision by the Supreme Court ruled that, “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but complementary DNA is patent eligible because it is not naturally occurring.” The ruling, authored by Justice Thomas, was issued in Association for Molecular Pathology v. Myriad Genetics, a landmark case bringing an end to the practice of patenting isolated parts of the human genome as they originally exist.

The defendants, Myriad Genetics, discovered and then patented the location, sequence and mutations of BRCA1 and BRCA2. Both genes are highly associated with a risk of breast and ovarian cancers. If Myriad’s patent claims were found valid, Myriad would have gained the exclusive right to isolate an individual’s BRCA genes–a necessary step in conducting diagnostic testing for the cancers.

The Plaintiffs, represented by the American Civil Liberties Union and the Public Patent Foundation, consist of a coalition of patients and researchers from University of Pennsylvania, New York University, Columbia, Yale and Emory. Plaintiffs claimed that Myriad’s patent monopoly was invalid under 35 U.S.C. § 101 and that patents on isolated natural genetic sequences would restrict medical research, limiting progress. From a patient’s perspective, such exclusive patent rights would make getting a second opinion regarding genetic predisposition almost impossible. Additionally, exclusivity would keep the cost of testing BRCA 1 and 2 higher through the absence of competitive pricing.

While patient’s rights advocates and research and educational institutions applaud the decision, many are critical. Attorney and chemistry professor Bernhard Saxe stated that the Court, “trivializes chemistry and elevates biological “information” over chemical structure in patent law, and that usurps the role of Congress and creates a new class of patent-ineligible subject matter by judicial fiat.” In Issue 2 of MJSLT’s 12th volume, Peter Edwards noted that, “It is unwise to blithely remove patent eligibility from fields in which incentives for innovation have a dramatically positive effect on the population as a whole. Patent law was established to incentivize inventions that are useful to the public, while still allowing fair access to innovations. Because the public benefit resulting from incentivizing gene patents far outweighs the potential for public loss, it is in the country’s best interest to structure and interpret patent law to find genes and methods employing them patent eligible.”

Other case outcomes, Mayo v. Prometheus and In re Bilski have determined most diagnostic claims are not patentable. Now that the Court has determined natural isolated genetic sequences are also not patentable, Myriad’s business model, an enterprise predicated on exclusive administration of the BRCAnalysis test to diagnose breast and ovarian cancers, will be difficult to sustain. Biotechnology businesses driven by research and development and investors may face less of an incentive to innovate, which could mean fewer diagnostic tests available on the market. However, multilateral ownership of such natural phenomena could possibly drive more tests to market at lower prices and provide for more accuracy due to alternate testing options. Time will tell us the precise effect this ruling will have on patients, but for now the road beyond the Myriad decision remains unclear.


Is Obesity a Disease?

by Katelyn DeRuyter, UMN Law Student, MJLST Note and Comment Editor

The fact that many Americans are obese is hardly news. Obesity in America has been a source of news reports, social commentaries and literature for well over a decade. In her book review of “The Omnivore’s Dilemma: A Natural History of Four Meals” by Michael Pollan, published in Issue 8.1 of the Minnesota Journal of Law, Science & Technology, Morgan Holcomb discusses how obesity rates in America were part of Pollan’s motivation to write “The Omnivore’s Dilemma.” More recently, American obesity has been described as an epidemic, and the health risks associated with obesity are gradually becoming common knowledge. Obesity is even compared, by some, to smoking and alcoholism. A recent LawSci blog post, “Is Food the New Tobacco: Science, Advertising, and the War against Obesity?” looks at Roseann Termini’s article, “Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions,” and draws parallels between the role of advertising in the rise of cigarette addiction and the current obesity epidemic.

A question that is overlooked in this dialogue is whether obesity is, in fact, a disease. Whether obesity is considered a disease has real consequences including altering social stigmas, increasing funds allocated for research and expanding treatment accessibility. The debate over whether obesity should be considered a disease is not new. However, new life has been breathed into the debate following the American Medical Association’s (AMA) official recognition of obesity as a disease. The New York Times quoted Dr. Harris, a member of the AMA’s board, as stating that “[r]ecognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately one in three Americans.” A recent Forbes article, “Declaring Obesity a Disease: the Good, the Bad, the Ugly,” provides a closer look at how the AMA reached its decision.

In reaching the conclusion that obesity is a disease, the AMA overruled its own council’s recommendation. The AMA’s Council on Science and Public Health (Counsel on Science) had been tasked with studying this issue over the past year. The Council on Science’s recommendation against categorizing obesity as a disease rested, in part, on the concern that body mass index (BMI) is a simplistic and inaccurate tool; BMI is the tool generally used to define obesity. The Council on Science was also concerned that recognizing obesity as a disease might increase reliance on drugs and procedures and decrease the emphasis on lifestyle changes.

From a legal perspective, this classification raises interesting questions regarding future interpretation of Congressional intent when “disease” is used without a specific definition. While only time will be able to tell the actual effects of this classification, this is certainly a “must watch” area for health law attorneys.


Countdown Sochi ’14: Will the USOC Avoid Repeat of Ravelry Stitch?

by Comi Sharif, UMN Law Student, MJLST Staff
Next month, the United States Olympic Committee (USOC) will launch its “Road to Sochi Tour” to count down the final 100 days leading up to the 2014 Winter Olympics. As the games draw near, we are likely to see a rapid increase in the amount of Olympic advertisements and related promotions. From cereal box covers to credit card commercials narrated by Morgan Freeman, materials will flood the market for the weeks leading up to the competition, to the point where one cannot help but get caught up in “Olympic Fever“. The Olympics bring the joy of cheering on our fellow countrymen (and countrywomen) regardless of whether we have ever heard of them or their sport, let alone watched on television before the Games. Though American athletes put in countless hours of commitment in preparation to represent our country, all of it would be for naught without the efforts of the USOC.

Formed in 1894, the USOC is driven by its mission to support U.S. Olympic and Paralympic competitive excellence while exhibiting the values of the Olympic Movement. The key element of this responsibility is generating and allocating revenue. Though the USOC is federally sanctioned under the Ted Stevens Olympic and Amateur Sports Act (ASA), the non-profit corporation does not receive federal financial support. For this reason, the USOC relies heavily on sponsorships to fund its programs.

Due to the importance of sponsorships, the USOC has a major incentive to maintain its positive brand along with the reputation of the Olympics as a whole. For this reason, the ASA also grants the USOC exclusive rights to use a number of words and marks in a commercial or athletic context, including the name “United States Olympic Committee,” the International Olympic Committee symbol (consisting of 5 interlocking rings), and the words “Olympic,” and “Olympiad.” Congress has even granted enhanced protections and enforcement powers to the USOC in some circumstances. As part of these rights, the USOC can authorize the use of the protected words and marks by sponsors as well as bring legal action against violators under the Lanham Act. The rationale is that the more control over Olympic intellectual property the USOC holds, the further it can maintain and promote its good name. This, in turn, makes the exclusive right to use Olympic words and marks more valuable to sponsors, which generates more capital that can be used for the U.S. Olympic program.

The scope of the exclusive rights under the ASA has often been a source of controversy, however. Though many alleged infringers discontinue their use upon the receipt of a USOC-issued cease and desist letter, a number of disputes have been brought to court to challenge the scope of the USOC’s protection and enforcement rights under the ASA.

Author Marcella David discusses one case in particular in Trademark Unraveled: The U.S. Olympic Committee Versus Knitters of the World (Minnesota Journal of Law, Science & Technology, Vol. 14.2), involving alleged infringement by Ravelry.com in its use of the word “Ravelympics.” Rather than sending a conventional cease and desist letter, the USOC informed Ravelry.com that their use was not only infringing on the USOC’s trademarks, but that their use tends to “denigrate the true nature of the Olympic Games.” Instead of convincing Ravelry.com to switch the name of its event, the letter sparked outrage throughout the online community. Ironically, in an attempt to protect its reputation, the USOC managed to do the exact opposite shortly before the Olympics were set to begin. In her article, David assesses the USOC’s claims of infringement against Ravelry.com while noting areas in need of improvement in the current legal framework of trademark infringement enforcement.

As intellectual property infringement becomes increasingly difficult to prevent and enforce against in the age of the Internet, owners need to be creative and proactive to limit unauthorized use. In regards to the USOC, this means not going too far in enforcing rights, however. So until there is more clarity as to the extent of the USOC’s protection under the ASA, we may be in store for a repeat of the Ravelry fiasco in the coming months. Let the countdown begin!


The Art of War on Drugs

by Ke M. Huang, UMN Law Student, MJLST Staff

Ke M. Huang.jpgA recent New York Times article addressed the research of a psychology professor at Columbia University that aimed to discredit misperceptions about drug addicts. The article cited Professor Carl Hart saying: “Eighty to 90 percent of people who use crack and methamphetamine don’t get addicted,” Hart continued, “And the small number of who do become addicted are nothing like the popular caricatures. His research showed that, for example, recruited addicts who were given a choice between a dose of crack and $5.00 sometimes chose the money. Findings such as this led Professor Hart to conclude that addicts can make rational economic decisions.

In the Volume 11, Issue 1 of the Minnesota Journal of Law, Science & Technology, Eagleman et al. also shed light on drug addiction by offering two additions to drug policy. After presenting an overview of the shortcomings of the U.S. drug policy, and a summary of the modern neuroscientific understanding of chemical dependency, Eagleman et al. suggested that the government should try implementing (1) cocaine vaccines, and (2) neuroimaging feedback to treat drug addiction. The first measure creates on the recipient of the vaccine an immune response to cocaine molecules that can weaken, if not eliminate, the high of the cocaine. The second measure, like biofeedback, allows an individual to view a graphical representation of the activity in a certain area of her brain, and let her practice to control it. Thus Eagleman et al. support a more rehabilitative, rather than retributive, policy to addressing issues of chemical dependency.

As someone who was raised in the country with one of the least criminalized drug policies in Europe–Portugal, I stumbled upon literature that also suggested that a country’s war on drugs does not have to be a hot war. Since 2001, Portugal implemented a drug decriminalization reform. A drug user is not arrested, but referred to a squad often times made up of a lawyer, a social worker, and a medical professional. The squad finds whether the user is addicted. If yes, he may be then referred to a treatment or be penalized, such as being banned from a certain neighborhood or losing a driver’s license. If not, he is unlikely to be sanctioned. About 5% users are brought before the squad the second time in the same year. A 2010 study in the British Journal of Criminology concluded that Portugal’s drug policy reform was quite successful. Teen drug use decreased, law enforcement authorities seized more drugs, and, though adult drug use rates climbed, the rates were lower than the neighboring nations that did not adopt drug policies like those in Portugal.

About 2500 years ago, Sun Tzu wrote “the skillful leader subdues the enemy’s troops without any fighting.” Similarly, the literature discussed indicates that the war on drugs could be a peaceful fight after all.


Country of Origin Labeling for Food and Pharmaceutical Products

by Daniel Schueppert, UMN Law Student, MJLST Staff

The USDA has recently lifted restrictions on the practice of shipping US Chicken to China for processing, for an eventual return to the US. Under the present regulations, chicken originating from US farms can be shipped to China for processing, then shipped back to the US for sale. This chicken need not include Country of Origin Labeling (COOL) to indicate that it has been processed in China. This change comes in the wake of a years of food safety scares relating to China’s food supply. Although the Food Safety Inspection Service (FSIS) has completed audits of the China’s “poultry processing inspection system” and certified some of the Chinese processing plants and procedures, American consumers have retained some reservations about the safety of chicken processed in China. As it stands, this system leaves consumers in the position of not knowing which country their chicken products have been processed because the Chinese operations are considered a comparable food component to what results from US processing.

This recent action by the USDA clearly raises questions concerning the United States’ food safety, and perhaps security. A sophisticated consumer may nevertheless be able avoid chicken products known to be processed in China, but absent COOL disclosures this may be a difficult task and arguably involve some guess work. This is not necessarily the case with generic pharmaceuticals, an area in which there are substantial parallels to the chicken debate. Some of the concerns raised relating to the quality and safety of chicken processed in China also bring to light the COOL requirements for other consumables like pharmaceuticals. Import screening and labeling for pharmaceuticals, and particularly off patent generics, is a convoluted area of regulatory law where Federal agencies to not always agree. Currently many of the various components of just one pharmaceutical drug are manufactured all over the world and come from a variety of sources. Manufacturing in India, China, and Eastern Europe account for a large part of the market.

The FDA’s main measure on determining the quality of components in generic drugs is a fuzzy spectrum concerning the “bioavailability” of certain chemicals but this measure does not necessarily take account of inert components or varying quality or quantities of active ingredients. Much like chicken, a consumer or regulatory agency would be hard pressed to find a problem with these products until a quality control issue develops and American consumers are put at risk. COOL labeling regarding Chicken and Drugs are developing issues without a clear regulatory action in sight. Stay tuned to the Minnesota Journal of Law, Science & Technology for further updates.


Anti-Cyberbullying Efforts Should Focus on Everyday Tragedies

by Alex Vlisides, UMN Law Student, MJLST Staff

Cyberbullying. It seems every few weeks or months, another story surfaces in the media with the same tragic narrative. A teenager was bullied, both at school and over the internet. The quiet young kid was the target of some impossibly cruel torment by their peers. Tragically, the child felt they had nowhere to turn, and took their own life.

Most recently, a 12 year old girl from Lakeland, FL, named Rebecca Ann Sedwick jumped to her death from the roof of a factory after being bullied online for months by a group of 15 girls. The tragedy has spurred the same news narrative as the many before, and the same calls for inadequate action. Prosecute the bullies or their parents. Blame the victim’s parents for not caring enough. Blame the school for not stepping in.

News media’s institutional bias is to cover the shocking story. The problem is that when considering policy changes to help the huge number of kids who are bullied online, these tragic stories may be the exact wrong cases to consider. Cyberbullying is not an issue that tragically surfaces every few months like a hurricane or a forest fire. It goes on every day, in virtually every middle school and high school in the country. Schools need policies crafted not just to prevent the worst, but to make things better each day.

It is incredibly important to remember students like Sedwick. But to address cyberbullying, it may be just as important to remember the more common effects of bullying: the student who stops raising their hand in class or quits a sports team or fears even going on social media sites. These things should be thought of not as potential warning signs of a tragedy, but as small tragedies themselves.

The media will never run headlines on this side of bullying. This means that policy makers and those advocating for change must correct for this bias, changing the narrative and agenda of cyberbullying to include the common tragedies. The issue is complex, emotional and ever-changing. Though it may not make for breaking news, meaningful change will honor students like Rebecca Ann Sedwick, while protecting students who continue to face cyberbullying every day.


The “Loss of Chance” Doctrine after Dickhoff

by Alison Key, UMN Law Student, MJLST Staff

In May 2013, the Minnesota Supreme Court recognized a new cause of action against healthcare providers for medical malpractice. In Dickhoff ex rel. Dickhoff v. Green, A11-0402, 2013 WL 2363550 (Minn. May 31, 2013), Minnesota joined a growing group of states that permit medical malpractice claims for “loss of chance.”

Under traditional principles of tort law, the elements of a tort include existence of a duty, breach of the duty, causation, and injury, all of which a plaintiff must prove to the standard of “more likely than not.” This standard of proof has posed problems for plaintiffs in medical malpractice suits where the patient had less than a 50% chance of survival before the alleged negligence occurred. If the patient is already “more likely than not” going to suffer the injury of death from a condition before the negligence of a physician, it is impossible to argue that any physician conduct, even if negligent, was the but-for cause of the patient’s ultimate death.

Courts across the country have long grappled with this issue, but have struggled to find a solution. From a patients’ rights perspective, states are uncomfortable with the notion that there is virtual immunity from malpractice liability for physicians who begin treating patients after they are already terminally ill. At the same time, courts have been unwilling to hastily depart from traditional principles of tort causation and standards of proof that require a physician to be the but-for cause of the patient’s injury.

States have confronted this issue in a few ways. One is to adhere to traditional principles of tort causation and not recognize a cause of action for a patient who brings a claim of medical malpractice (generally failure to timely diagnose) after an illness was already “more likely than not” the cause of death. This would not necessarily preclude a patient from bringing an action if she had a greater than 50% chance of survival (whose condition will not “more likely than not” cause death) but due to a physician’s negligence, her chance of survival was reduced to below 50%. In such a case, the physician can be said to have caused by his negligence the injury that is “more likely than not” going to cause the patient’s death. This is the approach Minnesota took before Dickhoff.

Another “solution” is the relaxed causation/substantial factor approach. Similar to the way that tort law deals with concurrent causation, some jurisdictions have held that if the physician’s negligence and the patient’s condition are concurrent causes of death, a jury will determine whether the physician was a “substantial factor” in the injury, and award damages accordingly. This acknowledges, but “relaxes,” the causation requirements in malpractice claims with terminally ill patients, permitting recovery for the whole injury.

A final approach is the doctrine of “loss of chance.” Rather than address the causation problems when a patient is already “more likely than not” going to suffer death, the loss of chance doctrine changes the nature of the compensable injury. Instead of regarding the injury as death, the court acknowledges that any loss of chance of survival is a compensable injury itself for which the physician must be held accountable. Under this doctrine, a patient who sees a physician when her illness is already terminal, let’s say 40% chance of survival, would be permitted to recover if the physician’s negligent failure to timely diagnose her injury reduced her likelihood to 30% before treatment was administered. Under the traditional approach, there would be no way to prove that the physician “more likely than not” caused death, because the illness was always 60% likely to cause death. But under the “loss of chance” doctrine, her 10% loss of opportunity to recover is itself the injury for which the patient can recover. This is the position that the Minnesota Supreme Court took in Dickhoff, permitting patients to recover for a “loss of chance” at life.

While this doctrine has intuitive appeal, it is not without its criticisms. While the Anderson opinion rightly champions patients’ rights, physicians in “loss of chance” jurisdictions raise legitimate concerns. Subjecting physicians to liability under this standard is an imposition that no other professional organization subject to malpractice faces, payment for a loss in the likelihood of success. Such a departure from professional malpractice norms should be seriously considered before imposed. Particularly as physicians are faced with limitless options for testing and treatment, all of which may be reasonable, and for all of which another physician is willing to testify that he would have taken a different course of action. Further, many raise concerns about how loss of chance can be measured, and whether juries will be able to evaluate “likelihood” claims from experts to arrive at reasonable conclusions. There is also the effect of rising healthcare costs that often comes with an increase in liability expenses for healthcare providers.

But the Minnesota Supreme Court assures that these concerns are outweighed by adopting the loss of chance doctrine, which “will advance, not undermine, the fundamental purposes of tort law: deterrence and compensation.” There is an argument that these two justifications will not outweigh the concerns of the medical community. Aside from being offended at the notion that a physician needs a lawsuit as deterrence to responsibly treat a terminally ill patient, the issue with a deterrence justification is that most medical malpractice cases claim negligence in diagnosis. In such cases, the physician is unaware the patient is terminally ill and he has “immunity” to liability. Therefore, physicians argue that the deterrence mechanism is insufficient to warrant such an imposition and uncertainty on health law and the practice of medicine as a whole. Further, the “compensation” rationale does not sit well with many physicians who claim that compensating patients for injury and treatment that was likely to occur anyway will be a windfall for the patient at the expense of the healthcare system (the treatment and outcome for 40% likelihood of success is often the same as the treatment and outcome for 30% likelihood of success). The Dickhoff case was remanded back to the district court for further proceedings after determining that “loss of chance” was a legitimate cause of action. Further cases will show how the patients’ rights issues and the physicians concerns with this system will play out.

For further discussion of the “loss of chance” doctrine, see Tory A. Weigand, Loss of Chance in Medical Malpractice: The Need for Caution, 87 Mass. L. Rev. 3 (2002), reprinted here.


Cyber Security Investigation and Online Tracking

by Ude Lu, UMN Law Student, MJLST Staff.

Ude-Lue.jpgOn April 18th, 2013, Cyber Intelligence Sharing and Protection Act (CISPA) was passed with wide spread controversies. CISPA aims to help national security agencies to investigate cyber threats by allowing private companies, such as Google and Facebook, to search users’ personal data to identify possible threats. Commentators argue that CISPA compromises the Fourth Amendment, because, under CISPA, agencies can get privacy data of suspects identified by the privacy companies without a judicial order. CISPA bridges the gap between crime investigations and the privacy data stored and analyzed by social media companies.

Google and Facebook regularly track their user’s online behaviors, such as websites they visited or products they purchased, to figure out their personal preferences to perform targeted advertisements. These personal behavior analyses raise serious privacy concerns. Omer Tene and Jules Polonetsky in their article published in Volume 13 Issue 1 of the Minnesota Journal of Law Science and Technology, To Track or “Do Not Track: Advancing Transparency and Individual Control in Online Behavioral Advertising discussed these privacy concerns.

Tene and Polonetsky described that while targeted advertisement provides many advantages, one particular criticism is that users are deprived from meaningful control of their data. This led to various administrative proposals in the US and EU. In the US, FTC proposed “Do Not Track”, a signal sent by users’ browser to internet content providers requesting them not to track cookies. In the EU, the e-Privacy Directive required an opt-in consent for cookie tracking. The authors argue that whether cookie tracking should be “opt-in” or “opt-out” depends on how tracking is valued by the society. If the society in general values tracking as a positive measure to provide valuable services, then opt-out should be applied. On the contrary, if tracking is viewed by the society as an invasion to privacy, then opt-in should be applied.