Major Medical Institutions Allegedly Failing to Report Clinical Trials

December 16, 2015
Drug Policy, FDA

Jessica Jayasuriya, MJLST Managing Editor

The Food and Drug Administration Amendments Act of 2007 requires that parties responsible for clinical trials submit clinical trial inform to the Director of NIH no later than one year after either the end date or the estimated end date of the trial.

However, several sources are alleging that Stanford University, Memorial Sloan Kettering Cancer Center, the University of Pennsylvania, the University of Pittsburgh, the University of California San Diego, and other major medical research institutions are failing to submit their clinical trial results within the deadline, and sometimes even at all.

The public database created by the legislation was intended to help the public, particularly medical professionals, scientists, and other researchers, to quickly access the latest findings on human testing of drugs, medical devices, and the like.

Institutions’ failure to turn in their results, however, is directly counteracting this legislative purpose. This is particularly concerning because doctors may not be getting critical information including adverse events in drug trials.

Interviews with the offending institutions indicate that the primary reason for these deadline lapses on the institutions’ end is due to being too busy and a lack of funding. Memorial Sloan Kettering, however, specifically stating it submitted some of its reporting in order to finish medical journal articles related to its trials. On top of institution failures to submit, is clear that the NIH is compounding the issue by failing to follow up on clinical trial deadlines.

Experts interviewed by the sources have further expressed concern that pressure from sponsoring drug companies may also be part of the reason why these clinical trials are not coming to light.

Circumventing EPA Regulations Through Computer Programs

December 16, 2015
Data, Environment, Environmental Law, EPA

Ted Harrington, MJLST Staffer

In September of 2015, it was Volkswagen Group (VW). This December, it was the General Electric Company (GE) finalizing a settlement in the United States District Court in Albany. The use of computer programs or other technology to override, or “cheat,” some type of Environmental Protection Agency (EPA) regulation has become seemingly commonplace.

GE uses silicone as part of its manufacturing process, which results in volatile organic compounds and chlorinated hydrocarbons, both hazardous byproducts. The disposal of hazardous materials is closely regulated by the Resource Conservation and Recovery Act (RCRA). Under this act, the EPA has delegated permitting authority to the New York State Department of Environmental Conservation (DEC). This permitting authority allows the DEC to grant permits for the disposal of hazardous wastes in the form of an NYS Part 373 Permit.

The permit allowed GE to store hazardous waste, operate a landfill, and use two incinerators on-site at its Waterford, NY plant. The permit was originally issued in 1989, and was renewed in 1999. The two incinerators included an “automatic waste feed cutoff system” designed to keep the GE facility in compliance with RCRA and the NYS Part 373 Permit. If the incinerator reached a certain limit, the cutoff system would simply stop feeding more waste.

Between September 2006 and February 2007, the cutoff system was overridden by computer technology, or manually by GE employees, on nearly 2,000 occasions. This resulted in hazardous waste being disposed of in amounts grossly above the limits of the issued permits. In early December, GE quickly settled the claim by paying $2.25 million in civil penalties.

Beyond the extra pollution caused by GE, a broader problem is emerging—in an increasingly technological world, what can be done to prevent companies from skirting regulations using savvy computer programs? With more opportunities than ever to get around regulation using technology, is it even feasible to monitor these companies? It is virtually certain that similar instances will continue to surface, and agencies such as the EPA must be on the forefront of developing preventative technology to slow this trend.

Warrant Now Required for One Type of Federal Surveillance, and May Soon Follow for State Law Enforcement

December 16, 2015
Constitutional Law, Criminal Law, Cyber Security, Data

Steven Graziano, MJLST Staffer

As technology has advanced over the recent decades, law enforcement agencies have expanded their enforcement techniques. One example of these tools is cell-site simulators, otherwise known as sting rays. Put simply, sting rays act as a mock cell tower, detect the use of a specific phone number in a given range, and then uses triangulation to locate the phone. However, the recent, heightened awareness and criticism directed towards government and law enforcement surveillance has affected their potential use. Specifically, many federal law enforcement agencies have been barred from their use without a warrant, and there is current federal legislation pending, which would require state and local law enforcement agents to also gain a warrant before using a sting ray.

Federal law enforcement agencies, specifically Immigration, Secret Service, and Homeland Security agents must obtain search warrants before using sting rays, as announced by the Department of Homeland Security. Homeland Security’s shift in policy comes after the Department of Justice made a similar statement. The DOJ has affirmed that although they had previously used cell-cite simulators without a warrant, going forward they will require law enforcement agencies gain a search warrant supported by probable cause. DOJ agencies directed by this policy include the FBI and the Drug Enforcement Administration. This shift in federal policy was largely in response to pressures put upon Washington by civil liberties groups, as well as the shift in American public’s attitude towards surveillance generally.

Although these policies only affect federal law enforcement agencies, there have also been steps taken to expand the warrant requirement for sting rays to state and local governments. Federal lawmakers have introduced the Cell-Site Simulator Act of 2015, also known as the Stingray Privacy Act, to hold state and local law enforcement to the same Fourth Amendment standards as the federal government. The law has been proposed in the House of Representatives by Rep. Jason Chaffetz (R-Utah) and was designated to a congressional committee on November 2, 2015, which will consider it before sending it to the entire House or Senate. In addition to requiring a warrant, the act also requires prosecutors and investigators to disclose to judges that the technology they intend to use in execution of the warrant is specifically a sting ray. The proposed law was partially a response to a critique of the federal warrant requirement, name that it did not compel state or local law enforcement to also obtain a search warrant.

The use of advanced surveillance programs by federal, state, and local law enforcement, has been a controversial subject recently. Although law enforcement has a duty to fully enforce that law, and this includes using the entirety of its resources to detect possible crimes, it must still adhere to the constitutional protections laid out in the Fourth Amendment when doing so. Technology chances and advances rapidly, and sometimes it takes the law some time to adapt. However, the shift in policy at all levels of government, shows that the law may be beginning to catch up to law enforcement’s use of technology.

Disruptive Manufacturing Is Disrupting the Law: Minnesota Journal of Law, Science & Technology Presents a Symposium on the Rapid Emergence of 3-D Printing and Its Legal Implications

December 2, 2015
3-D Printing, Medical Devices, Public Health

Nia Chung, MJLST Symposium Editor

Imagine your six-week old newborn suddenly stops breathing. You rush him to the hospital, where he is diagnosed with tracheobronchomalacia, which means that his windpipe has collapsed. Your doctor tells you that she can provide the conventional treatment of conducting a tracheostomy and putting your newborn on a ventilator which might lead to further breathing problems and possible heart stoppage. She goes on to tell you that she can 3-D print a device that will instantly help your newborn breathe, and she does. This is a true story. Kaiba Gionfriddo, who was treated at C.S. Mott Children’s Hospital through a groundbreaking cross-disciplinary effort between the University of Michigan’s Medical and Engineering schools, doctors, faculty, and researchers in 2011, was the first patient ever to experience a surgery of its kind. Kaiba’s story was just the beginning of medical and surgical breakthroughs using 3-D printing.

But what exactly is 3-D printing? 3-D printing, also called additive manufacturing, is the process of making solid three-dimensional objects from a CAD (Computer Aided Design) digital file. Based on this digital file, 3-D modeling software “slices” the three dimensional model “into hundreds or thousands of horizontal layers. The sliced file is then uploaded to a 3-D printer, which creates the 3-D object. There are several technologies 3-D printer manufacturers can utilize to generate 3-D objects—some use melting or softening material in a technology called “selective laser sintering” or “fused deposition modeling” and others cure a photo-reactive resin with a UV laser. A small, low-quality object can be printed in less than 10 minutes, while larger, high-quality objects may take up to several hours to print. By and large, 3-D printers are cost-effective, efficient, and can provide insurmountable benefits to the healthcare industry.

Baby Kaiba and his biodegradable splint showed the world how 3-D printing can be used in healthcare. Researchers have taken it further by bioprinting trachea, grown using a patient’s own stem cell cultures. This would essentially be the “first artificial bioprinted organ,” and doctors are hoping for Food and Drug Administration (FDA) approval. What the FDA has approved recently, however, is the first ever 3-D printed drug product. In August 2015, the FDA approved Aprecia Pharmaceutical’s Spritam (levetiracetam). A drug product used orally to treat “partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.” Other examples of how 3-D printing is transforming healthcare include 3-D printed blood vessels, heart valves, low-cost prosthetics designed specifically to a patient’s anatomy, and electronic sensors that monitor heart strain, oxygenation, and temperature that can be perfectly attached to a patient’s heart.

Although additive manufacturing is cost effective, waste-reducing, and efficient, it presents legal challenges in areas ranging from intellectual property to product liability. A white paper published by Reed Smith outlines the impact 3-D printing will have on areas including regulatory issues, patent and copyright law, tort liability, and insurance. For example, what is a “product”? Is it the CAD digital file, the 3-D printed product, or both? Who is the manufacturer? Is it CAD or is it the 3-D printer? If I am in need of a replacement hip, and agree to have a 3-D printed hip implanted into my body, if that product is defective, who is liable—the hospital that performed the hip replacement surgery, the 3-D printer manufacturer, or the 3-D imaging software? From an intellectual property law standpoint, 3-D printing can provide easier access to counterfeit products, and can blur the line on what constitutes patent infringement. If a hospital 3-D prints repairs a medical device by 3-D printing a nonpatented replacement component, this would likely be lawful. On the other hand, “replicating replicating a patented device by using a 3D printer to create all of its components may well constitute patent infringement.” Because 3-D printing brings, along with its benefits, many unanswered questions in the law, the Minnesota Journal of Law, Science & Technology (MJLST) will be hosting a symposium on these very issues. It will feature experts on intellectual property, regulatory, and tort liability issues surrounding 3-D printing in an all day event. The symposium will consist of several panels and a keynote speech by Candice Ciresi, General Counsel of Stratasys, a leading 3-D printer manufacturer, along with breakfast and lunch. MJLST Volume 17.2, its symposium issue, will publish articles on issues covered at the live symposium.

Today, medical devices, body parts, pharmaceutical drugs, guns, and food can be 3-D printed in a matter of hours to be utilized by private citizens. Please join us at the symposium to hear from some of the nation’s experts on how we must regulate this technology moving forward and what we can expect from 3-D printing in the near future.

Minnesota Journal of Law, Science & Technology presents “A Symposium on Disruptive Manufacturing: The Rapid Emergence of 3-D Printing and Arising Legal Concerns.” The symposium will be held on March 4, 2016 at Walter F. Mondale Hall, The University of Minnesota Law School, 229 19th Ave. South, Room 25, Minneapolis, MN 55455, from 8:00 A.M. to 3:00 P.M. To attend the symposium or for more information, please e-mail chung439@umn.edu or visit the symposium’s website at https://sites.google.com/a/umn.edu/mjlst-symposium-2016-3-d-printing/home. Please visit and RSVP on our Facebook page: https://www.facebook.com/events/1651569518452959/

Disruptive Manufacturing Is Disrupting the Law: Minnesota Journal of Law, Science & Technology Presents a Symposium on the Rapid Emergence of 3-D Printing and Its Legal Implications

December 2, 2015
3-D Printing, Medical Devices, Public Health

Nia Chung, MJLST Symposium Editor

Imagine your six-week old newborn suddenly stops breathing. You rush him to the hospital, where he is diagnosed with tracheobronchomalacia, which means that his windpipe has collapsed. Your doctor tells you that she can provide the conventional treatment of conducting a tracheostomy and putting your newborn on a ventilator which might lead to further breathing problems and possible heart stoppage. She goes on to tell you that she can 3-D print a device that will instantly help your newborn breathe, and she does. This is a true story. Kaiba Gionfriddo, who was treated at C.S. Mott Children’s Hospital through a groundbreaking cross-disciplinary effort between the University of Michigan’s Medical and Engineering schools, doctors, faculty, and researchers in 2011, was the first patient ever to experience a surgery of its kind. Kaiba’s story was just the beginning of medical and surgical breakthroughs using 3-D printing.

But what exactly is 3-D printing? 3-D printing, also called additive manufacturing, is the process of making solid three-dimensional objects from a CAD (Computer Aided Design) digital file. Based on this digital file, 3-D modeling software “slices” the three dimensional model “into hundreds or thousands of horizontal layers. The sliced file is then uploaded to a 3-D printer, which creates the 3-D object. There are several technologies 3-D printer manufacturers can utilize to generate 3-D objects—some use melting or softening material in a technology called “selective laser sintering” or “fused deposition modeling” and others cure a photo-reactive resin with a UV laser. A small, low-quality object can be printed in less than 10 minutes, while larger, high-quality objects may take up to several hours to print. By and large, 3-D printers are cost-effective, efficient, and can provide insurmountable benefits to the healthcare industry.

Baby Kaiba and his biodegradable splint showed the world how 3-D printing can be used in healthcare. Researchers have taken it further by bioprinting trachea, grown using a patient’s own stem cell cultures. This would essentially be the “first artificial bioprinted organ,” and doctors are hoping for Food and Drug Administration (FDA) approval. What the FDA has approved recently, however, is the first ever 3-D printed drug product. In August 2015, the FDA approved Aprecia Pharmaceutical’s Spritam (levetiracetam). A drug product used orally to treat “partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.” Other examples of how 3-D printing is transforming healthcare include 3-D printed blood vessels, heart valves, low-cost prosthetics designed specifically to a patient’s anatomy, and electronic sensors that monitor heart strain, oxygenation, and temperature that can be perfectly attached to a patient’s heart.

Although additive manufacturing is cost effective, waste-reducing, and efficient, it presents legal challenges in areas ranging from intellectual property to product liability. A white paper published by Reed Smith outlines the impact 3-D printing will have on areas including regulatory issues, patent and copyright law, tort liability, and insurance. For example, what is a “product”? Is it the CAD digital file, the 3-D printed product, or both? Who is the manufacturer? Is it CAD or is it the 3-D printer? If I am in need of a replacement hip, and agree to have a 3-D printed hip implanted into my body, if that product is defective, who is liable—the hospital that performed the hip replacement surgery, the 3-D printer manufacturer, or the 3-D imaging software? From an intellectual property law standpoint, 3-D printing can provide easier access to counterfeit products, and can blur the line on what constitutes patent infringement. If a hospital 3-D prints repairs a medical device by 3-D printing a nonpatented replacement component, this would likely be lawful. On the other hand, “replicating replicating a patented device by using a 3D printer to create all of its components may well constitute patent infringement.” Because 3-D printing brings, along with its benefits, many unanswered questions in the law, the Minnesota Journal of Law, Science & Technology (MJLST) will be hosting a symposium on these very issues. It will feature experts on intellectual property, regulatory, and tort liability issues surrounding 3-D printing in an all day event. The symposium will consist of several panels and a keynote speech by Candice Ciresi, General Counsel of Stratasys, a leading 3-D printer manufacturer, along with breakfast and lunch. MJLST Volume 17.2, its symposium issue, will publish articles on issues covered at the live symposium.

Today, medical devices, body parts, pharmaceutical drugs, guns, and food can be 3-D printed in a matter of hours to be utilized by private citizens. Please join us at the symposium to hear from some of the nation’s experts on how we must regulate this technology moving forward and what we can expect from 3-D printing in the near future.

Minnesota Journal of Law, Science & Technology presents “A Symposium on Disruptive Manufacturing: The Rapid Emergence of 3-D Printing and Arising Legal Concerns.” The symposium will be held on March 4, 2016 at Walter F. Mondale Hall, The University of Minnesota Law School, 229 19th Ave. South, Room 25, Minneapolis, MN 55455, from 8:00 A.M. to 3:00 P.M. To attend the symposium or for more information, please e-mail chung439@umn.edu or visit the symposium’s website at https://sites.google.com/a/umn.edu/mjlst-symposium-2016-3-d-printing/home. Please visit and RSVP on our Facebook page: https://www.facebook.com/events/1651569518452959/

Just Not Mayo

December 2, 2015
Competition, FDA, Food and Agriculture

Nolan Hudalla, MJSLT Staffer

In August 2015, the U.S. Food and Drug Administration (FDA) issued a warning letter to Hampton Creek Foods, the makers of the popular vegan mayonnaise substitute “Just Mayo.” This letter informed the company that its product had a misleading name and label imagery, because, by FDA regulation, mayonnaise must contain one or more eggs. This opinion by the FDA was in response to a high-profile lawsuit brought against Hampton Creek by Unilever (the makers of Hellmann’s Mayonnaise) and a similar class action filed in Florida state court, both alleging violation of the Florida Deceptive and Unfair Trade Practices Act and unjust enrichment. But, in an era of healthier alternatives – a world of Whole Foods, Thanksgiving Tofurky, and even eggless mayo – is the FDA missing the point? Instead of relying on food recipes enshrined in agency regulations from the 1970’s to identify whether an eggless substitute is mayonnaise or not, maybe the FDA needs to modernize its definitions instead.

In an effort to demonstrate just how committed the government is to keeping Just Mayo from poaching the traditional mayo market, consider the American Egg Board’s (AEB) response to Just Mayo. The AEB, a group appointed by the US Department of Agriculture, may have used public funds to conspire against Just Mayo. According to a Guardian article, “the government-backed egg lobby had organized a concerted effort to tackle Hampton Creek, a company described in leaked emails as a ‘major threat’ and ‘crisis’ for the $5.5bn-a-year egg industry.” This investigation led to the resignation of the AEB’s CEO Joanne Ivy. In addition, the FDA sent Just Mayo its warning letter despite an enormous show of popular support against the agency’s policy. Over 112,000 petitioners scrambled to sign a petition started by Food Network star Andrew Zimmern entitled “Stop Bullying Sustainable Food Companies,” to Unilever Chairman Michael Treschow. This public uprising boiled to the point that Unilever voluntarily dropped its initial lawsuit within two days of filing.

Even if the Florida state court suit amounts to nothing, this issue will not be over easy for the FDA. As demonstrated by the petition, consumer preferences are changing, and not just for mayonnaise. Similar battles are being fought over peanut butter, milk, yogurt, and ice cream. Retail sales of vegan products rose by over 6% last year, and 36% of U.S. consumers use milk or meat alternatives. This raises the question of whether it is really worth all of the government’s money and effort to maintain 1970’s ideas of food. Instead of deviling these modern alternatives, maybe the FDA should buy in too. After all, it’s just mayo.

Liability in Driverless Car Accidents

November 30, 2015
Autonomous Vehicles

Daniel Mensching, MJLST Staffer

Driverless cars made national headlines last week when a police officer in California pulled over a car for driving too slowly only to find that there was no driver to be ticketed. While this car was pulled over only for being too slow and no laws were actually broken, this incident is an example of the legal problems that will arise as driverless cars become a reality.

Driverless cars are currently being developed by several large automobile manufacturers, and Google is also producing a model which they plan on making available to the public in 2020. Advocates of driverless cars emphasize not only the convenience of not needing to drive, but also pointing out that they are much safer than human drivers. Robots will not experience road rage, they will not get drunk, and they will not text. That being said, accidents will inevitably occur and the legal system will need to determine liability and provide recourse to those who are injured.

Some commentators have noted that the problem of determining liability has the potential to kill automated vehicles despite the fact that these vehicles are safer than human drivers.

Some states have already passed statutes in anticipation of the rise of driverless cars, but these laws only make driverless cars legal for research purposes, and there are still many questions to be answered. The most likely legal policy that will emerge will be that manufacturers of driverless cars will be the sole target in lawsuits arising from accidents involving driverless cars. In fact, Volvo has already released a statement where the Swedish automobile manufacturer claimed that it would take full responsibility for any accident involving a driverless Volvo.

The legal system will most likely provide recourse to those injured in accidents by finding manufacturers liable in product liability cases. Plaintiffs can use several legal theories to win these cases, including design defect, manufacturing defect, or failure to warn. The legal system should avoid creating a strict liability standard for driverless car accidents, as this would have the effect of chilling research and development of this technology, which will have the overall effect of saving scores of lives and making society more efficient.

Digital Millennium Copyright Act Exemptions Announced

November 17, 2015
Copyrights, Data, Intellectual Property, Internet, Privacy

Zach Berger, MJLST Staffer

The Digital Millennium Copyright Act (DMCA) first enacted in 1998, prevents owners of digital devices from making use of these devices in any way that the copyright holder does not explicitly permit. Codified in part in 17 U.S.C. § 1201, the DMCA makes it illegal to circumvent digital security measures that prevent unauthorized access to copyrighted works such has movies, video games, and computer programs. This law prevents users from breaking what is known as access controls, even if the purpose would fall under lawful fair use. According to the Electronic Frontier Foundation’s (a nonprofit digital rights organization) staff attorney Kit Walsh, “This ‘access control’ rule is supposed to protect against unlawful copying. But as we’ve seen in the recent Volkswagen scandal . . . it can be used instead to hide wrongdoing hidden in computer code.” Essentially, everything not explicitly permitted is forbidden.

However, these restrictions are not iron clad. Every three years, users are allowed to request exemptions to this law for lawful fair uses from the Library of Congress (LOC), but these exemptions are not easy to receive. In order to receive an exemption, activists must not only propose new exemptions, but also plead for ones already granted to be continued. The system is flawed, as users often need to have a way to circumvent their devices to make full use of the products. However, the LOC has recently released its new list of exemptions, and this expanded list represents a small victory for digital rights activists.

The exemptions granted will go into effect in 2016, and cover 22 types of uses affecting movies, e-books, smart phones, tablets, video games and even cars. Some of the highlights of the exemptions are as follows:

  • Movies where circumvention is used in order to make use of short portions of the motion pictures:
    • For educational uses by University and grade school instructors and students.
    • For e-books offering film analysis
    • For uses in noncommercial videos
  • Smart devices
    • Can “jailbreak” these devices to allow them to interoperate with or remove software applications, allows phones to be unlocked from their carrier
    • Such devices include, smart phones, televisions, and tablets or other mobile computing devices
      • In 2012, jailbreaking smartphones was allowed, but not tablets. This distinction has been removed.
    • Video Games
      • Fan operated online servers are now allowed to support video games once the publishers shut down official servers.
        • However, this only applies to games that would be made nearly unplayable without the servers.
      • Museums, libraries, and archives can go a step further by jailbreaking games as needed to get them functioning properly again.
    • Computer programs that operate things primarily designed for use by individual consumers, for purposes of diagnosis, repair, and modification
      • This includes voting machines, automobiles, and implantation medical devices.
    • Computer programs that control automobiles, for purposes of diagnosis, repair, and modification of the vehicle

These new exemptions are a small, but significant victory for consumers under the DMCA. The ability to analyze your automotive software is especially relevant in the wake of the aforementioned Volkswagen emissions scandal. However, the exemptions are subject to some important caveats. For example, only video games that are almost completely unplayable can have user made servers. This means that games where only an online multiplayer feature is lost, such servers are not allowed. A better long-term solution is clearly needed, as this burdensome process is flawed and has led to what the EFF has called “unintended consequences.” Regardless, as long as we still have this draconian law, exemptions will be welcomed. To read the final rule, register’s recommendation, and introduction (which provides a general overview) click here.

“DRONE WARS”: THE BATTLE for MIDWESTERN SKIES

November 17, 2015
Drones, Law Enforecement, Privacy

Travis Waller, MJLST Staffer

Given the new Star Wars: The Force Awakens film upcoming this December, introducing a discussion on recent policies involving drone regulation seemed like a worthwhile addition to this week’s blog.

While the robotic “drones” of our day and age are certainly not cut from the same titanium alloy as George Lucas’ quasi-humanoid “droid” characters in many of his films, North Dakota may well be on it’s way to starting it’s own “robotic army” of sorts.

A friend and colleague from the University of Connecticut School of Law brought to my attention an article by Ben Woods, discussing the 2015 ND House Bill proposing the arming of drones with “non-lethal weaponry” for police functions. With the shocking amount of police deaths reported in this country last year, North Dakota may well be leading the way in finding an innovative alternative to placing human officers in potentially dangerous confrontations. However, this benefit does not come without a cost. As presented in a segment by Ashley Maas of the NY Times, drone regulation is still up in the air (excuse the pun). Only within the last year has the FAA determined that they are able to take action against civilian violators of drone regulations.

Moreover, with recent reports involving the hacking of automated vehicles, as well as Maas’ examples of civilians using drone technology for less than constructive purposes, placing dangerous technology on these machines may well develop into a major public policy concern.

While it is this author’s humble opinion that a fair amount of time exists before we, as a people, need be concerned with an Invasion of Naboo type situation, this may be exactly the type of situation where more time is needed to allow for the security measures around the technology, as well as the legal infrastructure surrounding drone regulation, to catch up to the state legislatures hopes for drone usage. As the matter stands now, allowing drones to be used in a police capacity risks a host of possible problems, including potential 4th amendment violations, and even increasing an already shockingly high risk of civilian causalities related to police activity.

With the law having already gone into effect on August 1st of this year, we will just have to wait and see how these issues play out.

Until next time,

-Travis

*Special Thanks to Monica Laskos, University of Connecticut School of Law ’17, for the idea to pursue this topic.

Supreme Court to Hear Willful Infringement Cases: Will the Justices Clear the Way for Enhanced Damages for Patentees?

November 17, 2015
Competition, Intellectual Property, Patents

Na An, MJLST Staffer

The U.S. Supreme Court granted certiorari to hear two patent cases challenging the current Federal Circuit standard for proving willful infringement on October 19, 2015. The finding of willfulness allows judges to award triple damages, providing more leverage for patentees in licensing and settlement negotiations. The patent litigation world watches with great anticipation as the Court’s Octane Fitness decision rejected a similar rule for awarding attorney’s fees in patent cases last year.

The Federal Circuit established the current willfulness test in its landmark Seagate decision in 2007, which required the patentee to prove that there was an objectively high likelihood that the infringer’s actions constituted infringement and that the likelihood was either known or so obvious that it should have been known to the accused infringer. The Seagate two-prong test overruled decades of precedents that had imposed an affirmative duty on accused infringers to obtain opinion of counsel and posed a substantially heightened burden for a patentee seeking to establish willfulness. Later on, the Federal Circuit recognized the complexity of post-Seagate inquiry and held in Bard Peripheral Vascular that the threshold objective prong of the test is a question of law, reallocating the roles of the judge and jury in determining willfulness of the infringement. Consequently, as opposed to the traditional consideration of willfulness as a question of fact, a district court must now determine whether a reasonable person would have found there to be a high likelihood of infringement (first prong), while the jury determines the patent infringer’s subjective intent (second prong).

Upon a finding of willfulness, the court has discretion to increase the damages up to three times the amount found or assessed, as authorized in 35 U.S.C. § 284. This statutory provision is very similar to § 285, which grants the court power to award reasonable attorney fees in exceptional cases. Before the Supreme Court’s Octane Fitness decision last year, the Federal Circuit restricted its application of § 285 to cases, in which the losing party’s position was “objectively baseless” and brought in “subjective bad faith.” Octane Fitness rejected such a rigid rule and held that judges can decide to award fees when a case “stands out from others.” Seagate’s two-prong test bears a striking resemblance to pre-Octane fee inquiry, sparking much anticipation among practitioners and scholars that the high court would similarly strike down the restrictive willfulness test. The Court found its opportunity in Halo and Stryker.

Halo involves infringement of three US patents, which disclose “surface mount electronic packages containing transformers for mounting on a printed circuit board inside electronic devices.” The Federal Circuit affirmed the district court’s denial of increased damages because the patentee failed to satisfy the objective prong of the Seagate test. Similar issues arose in Stryker. The patents in Stryker were directed to devices that deliver pressurized irrigation for different medical therapies, and the Federal Circuit again denied increased damages due to district court’s failure to undertake an objective assessment of the infringer’s defense. Interestingly, Judge Kathleen O’Malley, concurring in Halo, called for a complete reevaluation of the two-prong test for finding willful infringement, and she reasoned that increased damages and attorney fees should be grouped, given their analogous frameworks and statutory provisions. Therefore, in light of the Octane Fitness decision, the Seagate two-prong test merits reconsideration.

The Federal Circuit voted 8-2 in March not to reconsider the willfulness standard en banc in Halo; nevertheless, the Court granted certiorari without a sharp divide in the lower court. It signals that the Court is unlikely to retain the Seagate standard. But the question remains how much more flexible the new test will be. Will the Court use the same “stands out from others” language in Octane Fitness? Are the justices taking the second prong of the Seagate test away from juries? Or are we going back to the pre-Seagate rule that a mere notice of patent infringement triggers an affirmative duty on the defendant to obtain opinion of counsel? Additionally, the statutory language in § 284 says nothing about willfulness. Will the court give judges even broader discretion to award increased damages in absence of willfulness? If so, is there a danger of more forum shopping? We eagerly await the high court’s decision.

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