Biotechnology

Treating Depression With Ketamine? How the Investment Was Made

March 15, 2019
Administrative Law, Biotechnology, Food and Drug Law, Health Law

Hunter Moss, MJLST Staffer

Depression is a serious mental disorder that afflicts millions of Americans each year. One in three of these individuals struggles to find a treatment method that alleviates their condition, and are aptly said to suffer from treatment-resistant depression. In the most severe cases, treating depression can be a life or death decision—depression is the leading cause of over 41,000 suicides every year. For those dealing with depression, every day is a struggle to persevere and try to regain a sense of normalcy.

A new therapy for treatment-resistant depression was approved by the Food and Drug Administration (FDA) earlier this week, one that could help those that have been unable to find relief elsewhere. The unexpected source of the therapy is esketamine. If the name of this drug sounds familiar, it is because the name is based on, and molecularly similar to, the street drug named ketamine. While originally synthesized in the 1960’s as an anesthetic and first used widely in the Vietnam War, ketamine is now known as a party drug, providing the user with mild hallucinations and a sense of euphoria. Due to its dangerous side-effects and potential for abuse, ketamine was placed on the Schedule III of the United States Controlled Substance Act in August of 1999.

In the early 1990’s, researchers at Yale University first recognized the potential for ketamine to treat the symptoms of depression. Since then, scientists sought to confirm the viability of ketamine as a treatment option for individuals who did not experience relief from other treatment methods. A 2012 study out of Baylor College of Medicine proved just that: 85% of patients with severe depression reported the treatment to be effective. Unlike selective serotonin reuptake inhibitors (SSRIs), which are most commonly prescribed to treat depression and can take weeks to build in a patient’s system before becoming effective, ketamine can provide nearly immediate relief with its full effect being felt in as little as two days.

With the science firmly in place, the next hurdle advocates of ketamine faced was of perception—in the eyes of the FDA and the public alike. Radical clinics began to emerge across the country to provide patients suffering from treatment-resistant depression with a safe, heavily-monitored environment to undergo care. Because ketamine had yet to be recognized as a potential aid for depression by the FDA, clinic physicians would often have to prescribe the drug under the guise of using it as an anesthetic. The “don’t ask, don’t tell” approach to a new treatment for a severe mental disorder created some inevitable quandaries for both doctors and patients, who would be unable to receive insurance coverage for a non-FDA approved treatment program.

While the medical community was well aware of the healing potential of ketamine, pharmaceutical companies were reluctant to make the investment. The average price-tag of a clinical trial for the FDA is $19m. There is certainly a market for the drug with countless Americans suffering from depression. The issue holding pharmaceutical companies back is related to patent law. In order to receive a patent, the proposed invention must be novel—and considering that ketamine has been around for nearly sixty years, that would be an impossible claim to make. Without patent protection, the multi-million dollar investment is bad economics for big pharma, even if the trials could provide relief for millions of Americans.

So why did Janssen Pharmaceuticals, the developer of a treatment method for depression based on ketamine, make the investment and receive FDA approval for its new drug Sprovato? The answer is because Sprovato is esketamine, a sufficiently different molecule from ketamine to be patentable. Certain molecules can be left-handed and have right-handed doppelgangers. While it is beyond the scope of this blog piece (and the ability of its author) to explain the difference between the two, esketamine is the left-handed version of ketamine’s right hand. The deviation between the molecules is a significant enough difference to pass the novelty requirement necessitated by the U.S. Patent and Trademark Office (USPTO). While there is some debate as to whether esketamine is as effective as its counterpart, esketamine passed the FDA’s clinical trials and, for the most part, has been received as a viable alternative to ketamine treatment. This development could help legitimize the countless ketamine clinics that have emerged across the United States over the last few years, yielding a promising new alternative for those struggling with severe depression. At the same time, the story of ketamine raises questions about the roles of several actors in the health care system, specifically pharmaceutical companies, the FDA and the USPTO, in delaying the introduction of life saving medication in order to adhere their respective financial and regulatory requirements.

Supervised Injection Facilities: A Step in the Right Direction to Mitigate the Opioid Crisis or a Violation of Federal Law?

February 19, 2019
Biotechnology, Ethics, Food and Drug Law, Health Law

Jessica Swanson, MJLST Staffer

Plans for the nation’s first supervised injection facility hit a snag earlier this month when Philadelphia’s top prosecutor filed a federal complaint to keep it from opening its doors. Supervised injection facilities (SIFs) are legally sanctioned facilities that allow people to consume pre-obtained drugs under the supervision of trained staff and are designed to reduce the number of lives that would otherwise be lost to overdoses and provide a bridge to treatment. SIF staff members do not directly assist in consumption or handle any drugs brought in by clients, but are employed to provide sterile injection supplies, free testing, free distribution of the opioid overdose reversal medication, monitoring services for overdoses, and answers to questions about safe injection practices. SIF staff also offer general medical advice and referrals to drug treatment and other social support programs. There are approximately 120 SIFs currently operating in twelve countries around the world, but none in the U.S. However, a handful of U.S. cities, including New York, Seattle, Denver, San Francisco, and Delaware, have inched toward making SIFs a reality as each struggles to combat the increasing amount of drug-related deaths due to the opioid crisis. Philadelphia is by far the closest to becoming home to the nation’s first SIF, incorporated as “Safehouse.” However, on February 5th, the U.S. Attorney for the Eastern District of Pennsylvania, William McSwain, filed a lawsuit aimed at blocking Safehouse from opening its doors.

The civil lawsuit, which is jointly being pursued by Pennsylvania Attorney General Josh Shapiro and the Department of Justice in Washington asks a judge to declare such a facility illegal under federal law. Instead of waiting for Safehouse to open and then conducting arrests and a prosecution, McSwain is asking U.S. District Court Judge, Gerald McHugh, to rule on the legality of SIF plans in general. According to the complaint, a supervised injection site would violate a section of the 1986 Controlled Substances Act (CSA). The relevant section, also known as the “crack house statute,” was enacted during the height of the crack epidemic and was primarily used to shut down crack houses. The CSA makes it a felony punishable by up to 20 years in prison to knowingly open or maintain any place, regardless of compensation, for the purpose of using controlled substances. McSwain argues that Safehouse seeks to disregard the law and override Congress’ regulatory scheme by establishing, managing, and controlling sites in Philadelphia that will allow individuals to engage in the illicit use of controlled substances. Ronda Goldfein, vice president and attorney for Safehouse, argues CSA was not intended to apply to a medical facility focused on saving lives and moving people who are addicted to opioids into treatment. She argues the provision of the CSA in question is widely known to prosecute situations that involve crimes such as drug sales out of a car dealership or music festivals that allowed illegal drugs to flow freely. Safehouse, on the other hand, is a facility with good-faith efforts to improve public health.

Although other states like Pennsylvania are well-intentioned in opening SIFs, it is likely that the Controlled Substances Act is broad enough to encompass SIFs and thus bar them from operating. If Philadelphia or others want to open this type of site, they might want to steer their efforts towards changing the law. Overall, other cities that have expressed their intention of opening a SIF will be watching this case closely as it serves as an important test to determine the legality of SIFs.

Act Fast! Get Access to Your Genetic Past, Present, and Future for One Low, Low Price

October 23, 2017
Biotechnology, Ethics, Health Law

Hannah Mosby, MJLST Staffer

It’s Saturday morning, and you’re flipping through channels on your TV when you hear the familiar vocal inflections of an infomercial. For three monthly installments of $19.99, you can get access to your complete genetic ancestry, and any genetic predispositions that might impact your health—both now and in the future. From the comfort of your couch, you can order a kit, provide a DNA sample, and poof. . . a month or two later, you know everything you could ever want to know about your own genetic makeup. Sounds a little far-fetched, right?

Wrong. It’s 2017, and genetic testing kits are not only readily accessible to the public—they’re relatively inexpensive. Curious about whether you’re really German and Irish? Wondering if you—like your mother and her grandmother—might develop Alzheimer’s disease? Companies like 23andMe have you covered. The company advertises kits that cover both ancestry and certain health risks, and has recorded the sale of over 2 million testing kits. Maybe you’ve heard your friend, your coworker, or your sister talking about these genetic tests—or maybe they’ve already ordered their own kit.

What they’re probably not talking about, however, is the host of bioethical implications this sort of at-home genetic testing has. To some, ancestry may be cocktail party conversation, but to others, heritage is an enormous component of their personal identity. Purchasing a genetic testing kit may mean suddenly finding out that your ancestry isn’t what you thought it was, and consumers may or may not understand the emotional and psychological implications of these kinds of results. Genetic health risks present an even bigger ethical challenge—it’s all too easy to mistake the word “predisposition” for a diagnosis. Unless consumers are thoroughly educated about the implications of specific gene variants, companies like 23andMe aren’t providing useful health data—they’re providing enormously impactful information that the average consumer may not be equipped to understand or cope with.

It’s also easy to forget about the data privacy concerns. According to 23andMe’s commercial website, “23andMe gives you control over your genetic information. We want you to decide how your information is used and with whom it is shared.” That sounds nice—but is that “meaningful choice” masked in legal-ese? Existing federal regulation bars discriminatory use of genetic information by insurance companies and employers, but how does that affect other entities, if it does at all? Third-party access to this highly personal information is under-regulated, and it can’t be adequately safeguarded by “consent” without thoroughly explaining to consumers the potential implications of third-party disclosure.

It’s easy to get wrapped up in new and exciting biotechnology—especially when it’s publicly accessible. And we should be excited. . . accessibility and transparency in a field as intimidating as genetics can be is worth celebrating. Further, genetic testing brings with it a host of preventative health and personal benefits. However, it also raises some ethical and regulatory concerns, and it’s important to make sure our enthusiasm—as consumers, but also as entrepreneurs—for genetic technology doesn’t outpace the regulatory systems available to govern it.

Happy Mother’s Day to All the Moms!: Law, Science, Technology and Beagles

May 7, 2017
Biotechnology, Ethics, Food and Drug Law

Angela Fralish, MJLST Guest Blogger

Beagles are well-known as a quintessential family dog because they love humans and listen to their owners (most of the time). What is less known, is that those same traits are the primary reasons they are used in 95% of canine medical experimentation. Although, beagles are not biologically comparable to humans, they are compliant people-pleasers, making them ideal subjects for scientific experiments.

This reality is a hard pill to swallow for animal lovers and scientists alike. To scientists, research beagles are a necessary evil decreasing the pain and suffering of humans. To advocates, beagles are victims of unspeakable cruelty.

One law bridges the divide between these opposing views to help the beagles. The Beagle Freedom Bill, created by the Beagle Freedom Project (BFP), forges a compromise between animal rights lawyers, scientists and medical technologists. The Bill asks that ”tax-payer funded laboratories offer up the “experimentally-spent” dogs and cats for public adoption through rescue organizations.” In other words, once the beagle is no longer used for research, the dog is given a home instead of euthanasia. Minnesota was the first state to sign the Bill into law in 2014, and since then, 5 more states have joined. Currently, 5 additional states are considering adopting this law as well.

In addition to legislative measures, the BFP has found other ways to help research beagles. They have created new technology such as the Cruelty-Cutter app which helps shoppers easily scan products for humane animal testing, and sued the USDA demanding restoration of scrubbed animal records. The Beagle Freedom Project is a leader in animal science law and a great example of how lawyers, scientists and technologists can work together for the greater good of both humans and animals.

Scientists are working to replace this “necessary evil” as well. According to Dr. Teresa Arora’s article Substitute of Animals in Drug Research: An Approach Towards Fulfillment of 4Rs, research methods are being developed that are “superior to using animals to learn about human disease or predict the safety of new drugs [and include] stem cells, microdosing, DNA chips, microfluidics chips, human tissue, new imaging technologies, and post-marketing drug surveillance.” There is even a Center for Alternatives to Animal Testing at John Hopkins University and the NC3R in the UK.

For an employee of medical research looking to carve out meaning in their every day workweek, helping research animals through new collaborative measures is one way to answer the call. As a lawyer, scientists or technologist, you can help develop policy, arbitrate between groups, hold violators accountable, assist in medical technology development, vote for the Beagle Freedom Bill or adopt a research beagle. According to Congressman Earl Blumenauer, “members of Congress are realizing that protecting animals is not just the right thing to do, it’s also developing to become potent politically.” Congress will need help understanding the relationship between animal models and science in order to make improvements. That help will come from people who work in these fields on a daily basis.

The Beagle Freedom Bill highlights the plight of animals languishing in labs and promotes cruelty-free lifestyle choices everyone can make. Now that BFP has opened the door, it is time for all of us to show a little gratitude to the beagles for their sacrifice in advancing medical science such as chemotherapy and insulin. We can do this in our own unique ways, and although we can’t change the world for all beagles, for some beagles, we can change the world.

As Mahatma Ghandi stated, “The greatness of a nation and its moral progress can be judged by the way its animals are treated.” I hope ours is one of progress.

Is There a Reasonable Pot of Gold at the End of the Rainbow?: Legal Ethics, Brain Stimulation and Neuroprosthetics

March 3, 2017
Biotechnology, Ethics, Neuroscience

Angela Fralish, MJLST Invited Blogger

As expert bioethicist Dr. Walter Glannon remarks, “Interventions in the brain raise general ethical questions about weighing the potential benefit of altering neural circuits against the potential harm from neurophysiological and psychological sequelae.” Laws governing human subject research for these interventions mandate that “risks to subjects are reasonable in relation to anticipated benefits.” Modern brain technologies in neuroprosthetics make the harm/benefit analysis challenging because there are many unanswered questions surrounding neuroprosthetic implementation.

So what is a neuroprosthetic? Neuroprosthetic devices use electrode muscle and nerve stimulation to produce muscle contraction and restore motor function. Basically, since the brain controls the body, a device is put on the brain telling it to make the body work. Through neuroprosthetics devices, a person may restore movement by bypassing nervous system damage which allows greater independence in daily living. To someone whose dependence is caused by non-working body parts such as blindness, Parkinson’s or spinal cord paralysis, this technology holds great potential for a higher quality of life.

However, the use of a neuroprosthetic may involve negative side effects. Some are more behavioral such as gambling and addiction while others are biological like pain from overstimulation. For instance, Steffen K. Rosahl discusses how “relatives and friends sometimes complain of personality changes in the patient, ranging from transient confusion and bradyphrenia to euphoria or depression.” Further, implanting the device is not an exact science and if done incorrectly, a completely different result may occur such as loss of speech or other unknown changes. Research also indicates that an autonomy-capable neuroprosthetic can influence the brain if its actions go unchecked, making it a threat to the user and his or her surroundings. There are serious risks and concerns associated with the use of neurprosthetic technology.

The juncture of law, science and research is especially prevalent in modern neurological research. The cochlear implant is one such example. While the implant has allowed many children all over the world to hear for the first time, it has also led to shock and convulsions. In Sadler v. Advanced Bionics, Inc., the plaintiffs won a $7.25 million verdict in a negligence action when the manufacturer failed to adequately test or obtain approval for a new material in one of their implant designs. The unanswered legal questions in this case evolved around product recalls for implants, overcoming federal preemption, regulatory laws governing research submissions and product liability. Exactly how does a business recall an implant in someone’s brain!?

Clearly, legal-science partnerships are in high demand in advancing neurological research. Scientists need to understand the law and lawyers need to understand science. This principle is critically important when research institutions weigh the risks and benefits to subjects before that device ever hits the market. As Stephen Breyer, associate justice of the U.S. Supreme Court, stated, “In this age of science, we must build legal foundations that are sound in science as well as in law. Scientists have offered their help. We in the legal community should accept that offer.”

Bet on Science: Transplantation Without Human Donation

February 17, 2017
Biotechnology, Healthcare

Rhett Schwichtenberg, MJLST Staffer

There is no question that the American organ donor process is flawed. An individual makes the selfless decision to become an organ donor, but upon death their organs remain in their body. Although the law states that the donor is the only person that can revoke an anatomical gift, hospital practice will almost never harvest an organ without the family’s consent. A recent article published in the Minnesota Journal of Law, Science & Technology has proposed a solution to the 120,000 Americans waiting for organs: paying the donor $5,000 per organ. This solution could have many positive impacts, but many negative ones as well.

First, this solution will have a strong influence on the socio-economically poor, as an individual could make up to $40,000 for their family by donating the eight organs currently eligible for donation (not including hands and face, added in 2014). This amount of money would put low-income families in a horrible position where they might choose to forego medical treatment in order to provide for their family. This reward manages to take the decision away from the socio-economically poor by incentivizing death. Though middle-class individuals might also elect to choose money over treatment, the decision is based more on want than on need.

Second, with advancing technologies, organs harvested from fatalities will become less frequent. Take, for instance, the new technology of self-driving cars. In the near future, self-driving cars will dominate the automotive industry. Given that in 2016, 13.6 percent of organ donors died in a road accident, the number of available organs will only decrease in years to come. In a very recent article, Elon Musk stated that nearly all new cars will be self-driving within ten years.

Although self-driving cars might be farther down the road than Musk declared, scientists have made a major breakthrough in the biological field. Researchers have successfully used an enzyme to integrate human stem cells into developing pig embryos. This technology makes it possible to edit a pig’s DNA sequence coding for a certain organ, and insert code that would “theoretically grow a human organ for patient transplantation.” Artificially creating human organs would single-handedly eliminate the need for organ donation.

In addition to biological advancements, the tech industry has been a major player in organ creation. The use of 3D printing in the medical industry was instantly commercialized for its ability to create prosthetics and fake organs to practice surgical procedures. Today, Wake Forest Institute for Regenerative Medicine has developed a 3D printer capable of “print[ing] tissues and organs by utilizing cells as the main filament or component of the 3D printer.” Using an individual’s own cells to 3D print new organs for them would also eliminate the need for organ donation.

With such large advancements in science and technology, I do not believe there is a need to incentivize organ donation. This would result in a disparity between rich and poor and create situations where an individual has to choose between life or death for all the wrong reasons. Until science reaches the point where human organs can be created, individuals who wish to donate their organs upon death need to take steps to ensure their wish is fulfilled. Such steps include preparing an advance directive or a living will, signing a donor card, obtaining a health care power of attorney, and informing family members of their decision. Paying someone for their organs is simply not the solution.

Exploring the Final Frontier—The Relevance of Brain Imaging in Litigation

February 15, 2017
Biotechnology, Litigation, Neuroscience

Mary Riverso, MJLST Staffer

Human curiosity and technological advancements have led to the exploration of the ends of the earth, the deep seas, even outer space. We have learned so much about the animals we live amongst, the nooks and crannies of planet Earth, and our role in the universe. But as we continue to explore farther and farther outward, we often overlook how little we actually know about ourselves.

The human brain remains predominantly mysterious and unknown. Neuroscientists continue to attempt to map the brain, to assign different functions and behaviors to the different regions of the brain supposedly responsible for them. However, a thorough understanding remains nearly impossible given the intricate circuitry of brain functioning. While certain areas of the brain are sometimes responsible for discrete tasks, complex functions are not exclusively localized. It is more accurate to think of the brain as composed of neuron circuits – the different regions constantly connecting with one another via neuron circuits to work together to process information and complete tasks. Technological advancements now allow for many groundbreaking and non-invasive means of observing the functioning brain. For example, devices administering scans for functional magnetic resonance imaging, or fMRI, monitor blood flow to detect areas of activity. Whereas an electroencephalogram, or EEG, is a test that measures and records the electrical activity of your brain. Finally, magnetoencephalography, or MEG, captures the magnetic fields generated by neural activity. As the capacity and means to monitor brain functioning expand, the potential for successful brain mapping increases. As a result, using brain images resulting from these scans as evidence in litigation becomes more tempting.

The potential for brain imaging to be used as expert evidence in litigation is already being explored. Criminal defendants, such as Herbert Weinstein, want to use the results from brain scans and tests to show that they are not responsible for their criminal actions due to a physical mental disease or defect. Other defense teams see the potential of brain imaging to aid in assessments of truth-telling. Physicians who administer the tests must be willing to testify as expert witnesses to the results and their medical conclusions. Often times, the physicians probe brain function and analyze energy utilization of the brain and then administer tests of human behavior and mental representations to provide a basis for their medical conclusions. However, a major hurdle for potential neuroscientific evidence is its relevance under Federal Rule of Evidence 401 (“FRE 401”). FRE 401 demands that before such evidence be admitted, it must have a tendency to make a fact of consequence more of less probable. But because the brain remains so misunderstand, it is difficult, or arguably impossible, to draw any exact conclusions that a physical disease or defect in fact caused a behavioral or mental defect. As a result, courts have come out on either side of the threshold issue in FRE 401 – some have found that the neuroscientific evidence is appropriate for consideration by a jury who can decide what inferences to draw from it, while others find that this kind of evidence is too prejudicial while being only minimally probative and exclude the evidence under FRE 403, and still others allow the evidence but only for limited purposes, such as the sentencing phase of proceedings instead of the guilt phase. As technology continues to advance and neuroscientists continue to learn more about brain functioning, this kind of evidence may become commonplace in litigation. But for now, the admissibility decision seems to be fact-and-circumstance dependent, based on the case, the expert, the evidence, and the judge.

Genetically Modified Foods and the Consumer Quest for Disclosure

February 14, 2017
Administrative Law, Agriculture, Biotechnology, Food and Drug Law

Nicholas Ratkowski, MJLST Staffer

In 2000, the Minnesota Journal of Law, Science, and Technology (MJLST) proudly published its first issue, spanning a variety of issues between Patent Protection of Computer Programs to an analysis of the First Amendment through the lens of Jesse Ventura. One Note addressed how genetically modified foods (GMOs) should be labeled, if at all. In the seventeen years since MJLST’s inception, much has changed – how has the landscape of GMO labeling progressed?

In 2000, the principal argument was whether or not GMOs should be specially labeled as such; the author references unexpected concomitant protein allergies and environmental effects as prime concerns. As of 2000, scientists had not identified any negative effects from consuming GMOs. The Note notes different approaches between Europe and the United States, with the former relying on strict disclosure requirements, and the latter ignoring the issue (for the most part). At the time of authorship, “[m]ore than 4,500 GM plants ha[d] been tested, and at least 40 ha[d] passed government reviews” and “as much as 70% of processed foods contain[ed] GM components. The Note “propose[d] that the most appropriate method of resolving the labeling issue involves developing a new, international, voluntary labeling standard for products that have not been developed through genetic engineering techniques or do not contain genetically engineered ingredients.”

Now to the fun part – has anything changed? The short answer is not really. In 2013, Connecticut became the first state to “successfully enact a law requiring food containing genetically modified ingredients to be labeled as such, though it comes with the unusual requirement that four other states must pass similar legislation.” As of 2017, more than 70 bills across 30 states have been proposed in an effort to require labeling of GMOs. Only two states (Vermont and Maine) have joined Connecticut’s lead in forcing disclosure of genetically modified foods. Maine’s disclosure law requires disclosure, but is subject to a litany of exceptions. Vermont’s seems a bit more stringent, but is also easily circumvented. See §3043(d) and §3044 (for example, “Any processed food that would be subject to subsection 3043(a) of this title solely because it includes one or more materials that have been produced with genetic engineering, provided that the genetically engineered materials in the aggregate do not account for more than 0.9 percent of the total weight of the processed food”).

It is perhaps surprising then that GMOs remain mostly invisible to the average consumer in the United States, considering “[m]ore than 70 percent of Americans say they don’t want genetically modified organisms in their food” and “92 percent of Americans want genetically modified foods to be labeled,” according to a 2014 Consumer Reports survey. I’m not smart enough to tell you whether or not eating GMOs has any effect on health, much less whether that effect would be positive or negative. I can, however, posit a theory to explain this paradox, albeit not a novel one – the Pro-GMO lobby is simply too powerful for states to butt heads with in the courts on the taxpayers’ dime. With Monsanto leading the charge, the pro-GMO lobby has spent tens of millions of dollars to fight state-level labeling initiatives. In 2013, lobbyists spent $9,300,000 to prevent GMO disclosure requirements. In just the first quarter of 2014, lobbyist spent another $9,000,000. How can states compete?

If the U.S. ever makes the policy decision to implement widespread labeling requirements for GMOs, doing so will require federal legislation; states have been shown to lack the resources necessary to fight the purveyors of incomplete information that are GMO lobbyists. On the other hand, would labeling have any discernable effect on consumers? Maybe not, but I believe consumers should have the choice to pick what they eat, and how their food is sourced.

Broad Inst. Inc. v. Regents of the Bd. of the Univ. of Cal: PTO to Decide CRISPR Gene Editing Ownership

January 26, 2017
Biotechnology, Patents

Jeffrey Simon, MJLST Staffer

The Broad Institute and the University of California will argue claims related to ownership on Patents relating to CRISPR (clustered regular interspaced short palindromic repeats) gene editing technologies. The arguments will be heard on Dec, 6 by the Patent Trial and Appeals Board.

CRISPR technology utilizes prokaryotic DNA segments to confer immunity to foreign genetic elements. CRISPR editing technology has the potential to alter human DNA sequences by removing existing genes or inserting new ones. Moving forward, CRISPR technology has the potential to develop into a form of gene therapy, whereby the human genome can be edited to fortify one’s immune system against infectious diseases or other hereditary issues. CRISPR technology raises ethical concerns, especially relating to the potential use in altering the genes of human embryos.

Although CRISPR technology has been understood for over a decade, the current case revolves around an improvement using cas9 protein that splices DNA at a specific locus. The Broad Institute asserts that patents filed on behalf of the Massachusetts Institute of Technology and Harvard University Researchers (Broad Institute being the eventual assignee of the patents) maintain priority over those owned by University of California. However, the relevant patents have been asserted pre-AIA. Therefore, priority date will be established by date of the invention rather than under the AIA standard of application date. The Patent Trial and Appeals Board (PTAB) initially maintained that the date of invention was properly asserted prior to the patents upon which the challenge was brought. If the decision of the PTAB is upheld, the University of California patents will invalidate the patents held by MIT and Harvard. It’s important to note that both parties are asserting priority date to a previous University of California patent relating to CRISPR technology. The PTAB may determine that both parties failed to prove priority date ahead of the US Patent Application No. 13/842,859, thus invalidating both parties claims.

The Broad Institute is a research institute associated with MIT and Harvard University. It’s unclear how the decision will affect CRISPR technology moving forward. CRISPR technology has attracted lucrative investments from government agencies and private entities alike. Additionally, since the initial patenting of CRISPR, University of California has licensed out the use of CRISPR technology to numerous firms interested in its applications.

A New Year! a New You!: Update Your Look on Regenerative Healing Law

January 2, 2017
Administrative Law, Biotechnology, Ethics, Food and Drug Law, Health Law, Patents

Angela Fralish, MJLST Invited Blogger

Stephen Breyer, Associate Justice for the Supreme Court remarked that in this age of science, we must build legal foundations that are sound in science as well as in law, because a judge is not a scientist and a courtroom is not a scientific laboratory. Further, our decisions should reflect a proper scientific and technical understanding so that the law can respond to the needs of the public.

Human regenerative healing from embryonic stem cell research has sparked many debates on the public’s needs. On one hand, this research has the ability to relieve great suffering and even death, but on the other hand, it is accompanied by the using and destroying of human life. Moral controversy is a dark cloud looming over any courthouse looking to rule on the science of regenerative healing.

Legislative measures have ebbed and flowed with presidencies. Presidents Clinton, Bush and Obama have used executive orders to either expand or reduce federal funding of regenerative healing. President-Elect Trump’s policy is unknown. According to an NPR article issued in November 2016, “his campaign said little about research and development in general, or health research in particular.” This will be an important point in the near future as a Swedish scientist broke taboo in September of this year by altering healthy human embryos. Further, the NIH plans to lift the ban on regeneration in chimeras in early 2017. As it stands, the federal perspective towards future regenerative healing technology remains unclear.

The most recent executive response has been the Cures Act signed on December 13th of last year by President Obama. Sections 3033-3036 support an expedited FDA review of regenerative therapies and demand an update to regulatory law. Practically speaking, this means that clinical trials will be shortened to get the product on the market faster. While some worry this change will compromise ethics, others worry about the United States ability to keep up with a global market. Dr. Brenda Canine quotes, “If concerted long-term investments in research are not made, America will lose an entire generation of young scientists.”

One established principle in regenerative healing is ownership rights under intellectual property law. Challenges have been made on the grounds that researchers are attempting to patent “life,” but courts have allowed ownership rights to certain cell lines. Dr. Nicholas Zachariades wrote in his article titled Stem Cells: Intellectual Property Issues in Regenerative Medicine that “with respect to the stem cells and their use in the field of regenerative medicine, the U.S. Patent and Trademark Office has recognized inventions involving stem cells as patent-eligible subject matter.” He cites to Consumer Watchdog v. Wisconsin Alumni Research Foundation (WARF) where the plaintiff sued WARF for the patent being too broad, but lost because they lacked standing. WARF maintains a valid patent for “in vitro cell culture.”

Keeping up with science will continue to be a challenge. While it is against norms to destroy healthy embryos, there is a pressing need for the U.S. to compete in a global market. Hopefully, researchers, lawyers and politicians will eventually find a way to merge ethical, legal and federal funding policies related to stem cell research and regenerative healing into a solid legal foundation.

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