Tag: innovation

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Innovate4Health Innovation

CPIP and ITIF Release Innovate4Health Report on Role of IP in Solving Global Health Challenges

Innovate4HealthThis past Tuesday, CPIP and the Information Technology & Innovation Foundation (ITIF) released our joint report: Innovate4Health: How Innovators Are Solving Global Health Challenges. The report details 25 important healthcare innovations that are being created by and for people in the developing world, where some of the most urgent challenges remain. Each of these innovations is supported by a strong intellectual property system, and many would not be viable without the security provided by these rights.

The video from our release event this past Tuesday can be found here and is embedded below. The full Innovate4Health report can be found here, and the Executive Summary is copied below. The individual stories can also be found here on the project’s Medium website.

Innovate4Health: How Innovators Are Solving Global Health Challenges

Executive Summary

Many of the world’s biggest challenges are health challenges. The good news is that, more than ever, people are meeting these challenges with innovative solutions.

While we still face great difficulties, people all over the world live better than ever before thanks to innovation. New medicines prevent or alleviate disease. New devices diagnose problems, repair bodies, and overcome physical challenges. Still other inventions keep vaccines and medicines fresh and effective or ensure their authenticity. New business models help innovation to happen and ensure that it reaches those who need it.

Many of these innovations are secured by intellectual property rights, which support the ability of innovators to invent and bring solutions to market. Property rights, particularly intellectual property rights, foster the freedom of many hands and many minds to work on challenging problems. They put decisions in the hands of those closest to problems—innovators with knowledge of potential solutions and caregivers and consumers who understand their own needs best.

With just a bit of reflection, it becomes clear that innovation and the property rights that secure it are key to meeting global health problems. Sometimes, however, the blinding light of necessity makes it hard to see this fact. When people are in need, it is all too easy to grow impatient with the rights of innovators. When that happens, innovators get treated as an obstacle.

We think that better public policy would result from better understanding of how innovation can meet global health challenges. Our organizations, the Center for the Protection of Intellectual Property (CPIP) at George Mason University’s Antonin Scalia Law School and the Information Technology and Innovation Foundation (ITIF), both non-profit, non-partisan research organizations, have teamed up to tell the exciting story of how innovation is making the world healthier.

Our Innovate4Health initiative culminates with this report, profiling 25 original case studies showcasing how innovators, many in developing countries, are tackling life-sciences/healthcare innovation in their nations and across the broader developing world. The 25 case studies are organized into the six following themes:

  • Adapting healthcare interventions for environments where resources and infrastructure are challenging;
  • Providing affordable and robust tests for diagnosing diseases;
  • Improving HIV diagnosis and care;
  • Affordable interventions to meet basic needs in challenging environments;
  • Getting healthcare to the people in places where it’s hard for people to come to the healthcare;
  • Fostering health innovation in emerging economies.

Collectively the case studies tell a compelling and inspiring story of how entrepreneurs are creating IP-enabled life-sciences innovations that are helping to tackle some of the world’s toughest health issues.

To read the report, please click here.

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Antitrust Patent Licensing

Department of Justice Recognizes Importance of Reliable Patent Rights in Innovation Economy

dictionary entry for the word "innovate"It is undeniable that the patent system has been under stress for the past decade, as courts, regulators, and even the Patent Office itself (as the newly confirmed Director Andrei Iancu has acknowledged) have sowed legal uncertainty, weakened patent rights, and even outright eliminated patent rights. This is why a series of recent speeches by Assistant Attorney General Makan Delrahim—head of the Antitrust Division at the Department of Justice—have signaled an important and welcome policy change from the past decade. It’s just one step, but it’s an important first step to restoring reliability and predictability to property rights in patents, which, as Director Iancu has also been saying in recent speeches, drives innovation and economic growth by promoting investments by inventors, venture capitalists, and companies in the new inventions that make modern life a veritable miracle today.

Delrahim’s speeches are important because one significant point of stress for the patent system and the innovation economy over the past decade has occurred at the intersection of antitrust law and the licensing of patents in standard setting organizations (SSOs). Many people are unaware of this particular issue, and it’s understandable why it flies under the radar screen. The technical standards set by SSOs are the things that make everything work, such as electrical plugs, toasters, and pencils, among millions of other products and services, but they are not obvious to everyday consumers who use these products. Also, antitrust law is a complex domain of lawyers, policy-makers and economists. Still, the patented innovation that comprises technical standards, such as 4G, WiFi, USB, memory storage chips, and other key features of our smart phones and computers, have been essential drivers of innovation in the telecommunications revolution of the past several decades.

In a series of recent speeches, Delrahim has signaled an important and welcome change from his predecessors in how antitrust law will be applied to patented technology that is contributed to the standards that drive innovation in the high-tech industry. Delrahim’s predecessors at the DOJ gave many speeches criticizing (and instigating investigations of) alleged “anti-competitive behavior” by patent owners on technical standards. The DOJ’s approach was one-sided, unbalanced, and lacked evidence confirming the allegations of anti-competitive behavior. Instead, Delrahim is emphasizing the key importance of promoting and properly securing to innovators the technology they create through their long-term, risky, and multi-billion-dollar R&D investments (as succinctly described in two paragraphs here about Qualcomm’s R&D in 5G by an official at the Department of Treasury).

Delrahim has announced that he will return to an evidence-based, balanced antitrust policy at the DOJ. He will not take action against innovators unless there is real-world evidence of consumer harm or proven harm to the development of innovation. The absence of such evidence is well known among scholars and policy-makers. In February 2018, for instance, a group of scholars, former government officials, and judges wrote that “no empirical study has demonstrated that a patent-owner’s request for injunctive relief after a finding of a defendant’s infringement of its property rights has ever resulted either in consumer harm or in slowing down the pace of technological innovation.” It’s significant that Delrahim has announced that the DOJ will constrain its enforcement actions with basic procedural and substantive safeguards long provided to citizens in courts, such as requiring actual evidence to prove assertions of harm. This guards against unfettered and arbitrary regulatory overreach against innocent owners of private property rights. This self-restraint is even more important when overreach negatively impacts innovation, which portends badly for economic growth and the flourishing lives we have all come to expect with our high-tech products and services.

For example, Delrahim has rightly recognized that “patent holdup” theory is just that—a theory about systemic market failure that remains unproven by extensive empirical studies. Even more concerning, “patent holdup” theory—the theory that patent owners will exploit their ability to seek injunctions to protect their property rights and thus “holdup” commercial implementers by demanding exorbitantly high royalties for the use of their technology—is directly contradicted by the economic evidence of the smart phone industry itself. The smart phone industry is one of the most patent-intensive industries in the U.S. innovation economy; thus, “patent holdup” theory hypothesizes that there will be higher prices, slower technological development, and less and less new development of products and services. Instead, as everyone knows, smart phones—such as the Apple iPhone and the Samsung Galaxy, among many others—are defined by rapidly dropping quality-controlled prices, explosive growth in products and services, and incredibly fast technological innovation. The 5G revolution is right around the corner, which will finally make real the promise of the Internet of Things.

In sum, Delrahim has repeatedly stated that antitrust officials must respect the equal rights of all stakeholders in the innovation industries—the inventors creating fundamental technological innovation, the rights of the companies who implement this innovation, and the consumers who purchase these products and services. This requires restraining investigations and enforcement actions to evidence, and not acting solely on the basis of unproven theories, colorful anecdotes, or rhetorical narratives developed inside D.C. by lobbyists and activists (such as “patent trolls”). This is good governance, which is what fosters ongoing investments in the R&D that makes possible the inventions that drives new technological innovation in smart phones and in the innovation economy more generally.

We will delve more deeply into the substantive issues and implications of Delrahim’s recent speeches in follow-on essays. Since his speeches have been delivered over the course of the past six months, we have aggregated them here in one source. Read them and come back for further analyses of these important speeches (and more speeches that will likely come, which we will keep adding to the list below):

  • November 10, 2017. In a speech at the University of Southern California, Gould School of Law, Assistant Attorney General Delrahim discussed why patent holdout is a bigger problem than patent hold-up. “[T]he hold-up and hold-out problems are not symmetric. What do I mean by that? It is important to recognize that innovators make an investment before they know whether that investment will ever pay off. If the implementers hold out, the innovator has no recourse, even if the innovation is successful.” He further noted that antitrust law has a role to play in preventing the concerted anticompetitive actions that occur during holdout.
  • February 1, 2018. In a speech at the U.S. Embassy in Beijing, Delrahim noted that the proper antitrust focus should be on protecting the innovative process, not “short-term pricing” considerations. With this focus, using antitrust remedies should be approached with “caution.”
  • February 21, 2018. In a speech at the College of Europe, in Brussels Belgium, Delrahim observed that antitrust enforcers have aggressively tried to police patent license terms deemed excessive, and “have strayed too far in the direction of accommodating the concerns of technology licensees who participate in standard setting bodies, very likely at the risk of undermining incentives for the creation of new and innovative technologies.” The real problem and solution he noted is that the “dueling interests of innovators and implementers always are in tension, but the tension is best resolved through free market competition and bargaining.”
  • March 16, 2018. In a speech at the University of Pennsylvania Law School, Delrahim expanded on his detailed remarks from his talk at USC by adding some historical context from the founding fathers. He also made the core point that “patent hold-up is not an antitrust problem,” noting that FRAND commitments from patent owners are part of the normal competitive process and are therefore appropriately policed by contract and common law remedies. He further describes the necessary impacts of having a right to exclude in the patent right, including that the “unilateral and unconditional refusal to license a patent should be considered per se”
  • April 10, 2018. In a keynote address at the LeadershIP Conference on IP, Antitrust, and Innovation Policy in Washington, D.C., Delrahim emphasized the harm that can occur when “advocacy positions lead to unsupportable or even detrimental legal theories when taken out of context.” He specifically noted that some advocacy about patent hold-up could undermine standard setting as “putative licensees have been emboldened to stretch antitrust theories beyond their rightful application, and that courts have indulged these theories at the risk of undermining patent holders’ incentives to participate in standard setting at all.”
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Innovate4Health Innovation

Innovate4Health: SaTo Pan Delivers a Sustainable Solution to the Sanitation Crisis in Developing Nations

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Michael O’Keefe

Poor sanitation poses an ongoing threat to the health and well-being of people in the developing world. Severe health problems, death, and disease can be directly linked to unsafe hygiene practices that continue to plague many countries. A UN Fact Sheet notes that 2.3 billion people lack access to improved sanitation. Open-air defecation in particular is a widespread concern, as it leads to the spread of communicable diseases. According to the WHO: “Poor sanitation is linked to transmission of diseases such as cholera, diarrhoea, dysentery, hepatitis A, typhoid and polio.”

One way in which these diseases spread is through the lack of proper toilet or latrine facilities. The WHO claims that 2.4 billion people do not have access to such facilities, with 946 million instead practicing open-air defecation.

SaTo panIn 2012, with support from the Bill and Melinda Gates Foundation’s Water, Sanitation and Hygiene Strategy, and International Development Enterprises (iDE), American Standard Brands developed a potential solution to the hygiene problems stemming from the lack of proper toilet facilities. The SaTo pan – deriving its name from “Safe Toilet” – is an attempt to limit the transmission of disease by ensuring that the toilets being used are closed off from the open air, thus preventing insects or other vectors from communicating those diseases. The basic design is a plastic mold that fits into a concrete base over a pit, which means it can be used even when basic plumbing or sewer infrastructure is absent.

Smell-free, eliminates flies, easy cleanAccess to proper sanitation and clean water is vital for the health and safety of growing populations in both urban and rural areas. When human feces are not disposed of effectively, it can cause a number of health problems. Chronic illnesses spread by feces, such as enteropathy, encephalitis, and diarrhea, can weaken adults as well as children and prevent them from retaining nutrients, potentially causing health problems for their offspring as well. Even when human waste is disposed of in a pit, rather than left out in the open, disease vectors such as flies can potentially still access it, turning latrines into persistent sources of disease for whole communities.

Patent diagrams for SaTo panInvented by Jim McHale, Daigo Ishiyama and Greg Gatarz, the SaTo pan operates much like a trap door, using a counterweight to stay closed except for allowing the passage of waste. The plastic design is cheap and acts as an effective seal over the toilet. In addition to the sanitary benefits, the SaTo pan also acts as a basic safety measure. Because of the nature of some open-pit latrines, young children face the risk of falling inside. When installing SaTo pans in Uganda, one organization reported this as a notable benefit to the communities due to the particular design of latrines in the areas they worked in.

The research team at American Standard settled on the SaTo pan concept after observing the open-pit style latrines commonly used in Bangladesh. Before the pans were installed, such latrines remained open to the air at all times, which meant that not only was the smell free to travel, but flies and other insects could enter and exit the pit, carrying a host of diseases with them. As demonstrated in this video, the pan can be “flushed” after use with a pot of water, but otherwise blocks any unwanted traffic such as insects.

Diagram of SaTo pan (Self-sealing trap door; seal shuts out flies, other insects, and odors)Crucially, the design of the pan allows for potential variations according to local customs and demands, such as using the facilities by squatting or sitting or adapting to the shape of the pit for the latrine. The core concept around which the pan is based is the counterweighted “flapper” itself. The counterweight is specifically set so that the flap remains closed until the additional force of water – not just the waste itself – is poured into the pan. The pour-flush mechanic also creates a liquid seal, with a minimal amount of water remaining on top of the flap after use to help ensure prevention of transmission of insects or gases. This approach, utilizing a basic mechanism while leaving room for responsive adjustments in design, allows the SaTo pan to be adapted globally while maintaining a simple but effective means of providing basic health benefits.

In 2015, American Standard received the Patents for Humanity award from the USPTO for its design of the (then-pending patent application) SaTo pan toilet. The counterweighted trapdoor is significantly more effective than standard squat-hole covers and avoids the risk of blockage that comes with more complex, alternative designs. Utilizing the patented design also allows American Standard to fully gauge the needs of the market, providing the basis for ongoing production and development.

Although American Standard is more generally known as a plumbing manufacturer, the SaTo pan has become a key part of their business structure. American Standard was purchased by the LIXIL Corporation in 2013, and brought within the LIXIL Water Technology (LWT) business unit in 2015. In 2016, LIXIL announced that it was establishing a special unit within LWT devoted to supporting continued development of the SaTo. Currently, three new alternative models of the SaTo pan are in development to meet the varying need of different regions. Although the initial design functions well in areas such as Bangladesh, bringing it to Sub-Saharan Africa presents new challenges, primarily that there is significantly less access to water. As the counterweight system relies on water for its operation, this poses a hurdle to its effectiveness in such regions.

American Standard has been able to use the SaTo pan design as the basis for a broad-ranging business strategy. From 2013-2014, American Standard implemented a donation program, Flush for Good, with each sale of one of its Champion toilets funding the donation of a SaTo pan. 500,000 have been donated to Bangladesh alone. Other donation programs include sending SaTo pans to Nepal after the recent earthquakes and partnerships with NGOs such as UNICEF and Save the Children. By the middle of 2016, SaTo pans had been installed in 14 countries, including Uganda, Haiti, Malawi, Nigeria and the Philippines.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health Innovation

Innovate4Health: Daktari Diagnostics Takes on Africa’s Healthcare Challenges One Diagnostic Device at a Time

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Alex Summerton & Nick Churchill

Africa’s predominantly rural characteristic and limited medical infrastructure are among the region’s greatest challenges to implementing effective healthcare programs and policies for its residents. The high costs for patients associated with diagnosis and treatment in terms of money, time, and travel, along with cultural barriers, often result in individuals failing to seek treatment or only making initial consultations before abandoning the matter. Coupled with poor infrastructure, inadequate facilities, substandard equipment, and insufficient personnel, it is not difficult to see why Africa is still recognized as the setting for the world’s most difficult health crises by the World Health Organization (WHO).

hands taking a blood testOne solution to these problems is to effectively move clinics to the patients through point-of-care technologies. Daktari Diagnostics, located in Cambridge, Massachusetts, is an innovator in this field focusing on microfluidic techniques. These techniques allow the company to develop products that do not require large scale manipulation of high volumes of blood or other biological products. Thus, diagnostic technologies can be made smaller and used anywhere they are needed. Its slogan “Anywhere. Care.” underscores its commitment to developing a cheap, and lightweight, portable diagnostic device to detect HIV, Hepatitis C Virus (HCV), and sickle cell disease.

Efforts eradicating disease are two-part, regardless of where it occurs: diagnosis and treatment. No matter how much time, effort, money, and technology are spent on improving the treatment phase, failures to accurately and affordably diagnose can undermine even the greatest plans. For a rural populace, diagnosis can be frustrated by a number of factors. Many rural clinics do not have the facilities and equipment to conduct diagnostic tests. Reaching a medical clinic with laboratory services may require hours of travel by foot, and many patients fail to return for their results.

Africa is particularly susceptible to these problems. There exists a need for low cost, portable, and durable systems that can be used to facilitate immediate and accurate diagnosis of diseases that commonly affect the population. Lightweight point-of-care diagnostic platforms aim to meet WHO’s “ASSURED” criteria, a set of aspirational guidelines for creating diagnostics tools to meet the socioeconomic challenges of developing regions such as Africa.

However, developing point-of-care technology is costly, and attracting investors requires a reasonable expectation of return on their investments. The developing world is not often considered a lucrative market for the development of medical products. Developing technology that can meet the need of an effective point-of-care testing system and securing funding for the endeavor is a significant challenge.

Daktari Diagnostics machineDaktari (Swahili for “Doctor”) Diagnostics is working on the development of a point-of-care testing platform that meets the ASSURED standards. Daktari’s portable point-of-care platform, Daktari Virology, uses microfluidic techniques to test for both HIV and HCV. Microfluidic devices offer a number of advantages that directly address Africa’s challenges, including small sample sizes, low production costs, fast sampling and processing, and low power consumption. Using a single drop of blood, a microfluidic testing chip prepares the raw sample and performs the tests in one compact system.

For HIV testing, the technology uses a novel microfluidic technique to capture a key cellular indicator for the management of antiretroviral therapy in a patient’s blood. The device then uses nonoptical detection to count them. The effect is rapid testing that can give an accurate assessment of a patient’s HIV viral load in approximately half an hour.

To secure rights in its microfluidics technology, Daktari has been diligently working to assemble a patent portfolio around its innovations. Its website lists over 20 patents already granted internationally and even more applications pending. Leveraging these rights has helped Daktari overcome the challenges associated with conducting expensive R&D for the developing world by securing several rounds of funding. Daktari is using this capital to develop its microfluidics assaying technology for other diseases. In January, Daktari met a funding milestone in a partnership with Merck by completing the design of a prototype HCV point-of-care system suitable for commercial production. Recently, Daktari licensed its technology for integration into a connectivity platform that enables healthcare providers to assist global health officials by monitoring and reporting disease data in real time.

Point-of-care testing is a realistic approach to overcoming challenges in improving diagnostic and monitoring technologies in developing countries, where space, money, time, and training are often limited. Utilizing its intellectual property rights, Daktari continues to develop the technologies that can address some of the world’s most pressing health needs and connect its innovations with the communities that need them.

CPIP has previously discussed the benefits of point-of-care testing in its profile of Fydor Biotechnologies’ Urine Malaria Test, a device enabled by patented technology licensed from John Hopkins University, and ITIF has highlighted a public-private partnership that created the Visitect CD4 point-of-care HIV test.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovation Patents

New White Paper Explores the Importance of Property Rights to National Wealth and Security

a hand reaching for a shining, hanging keyA new white paper, Property Rights: The Key to National Wealth and National Security, was published today by Dr. James Edwards, the Executive Director of Conservatives for Property Rights. In the white paper, Dr. Edwards explores how stable and effective property rights in both tangible and intangible property are critical to human flourishing and progress, and he notes that a renewed commitment to strengthening property rights will help to restore U.S. industrial competitiveness as a top national economic priority.

The white paper was launched at a briefing today on Capitol Hill that featured a speech by Congressman Thomas Massie, who noted the prescience of the Founders in formulating the Constitution’s IP Clause. Dr. Edwards discussed the new white paper and then joined a panel discussion that included Kimberly Chotkowski, CEO of Licensing Executives Society, Preston Noell, President of Tradition Family Property, and Robert Taylor, Founder and Owner of RPT Legal Strategies.

The prologue from the white paper is copied below:

PROLOGUE

Intellectual property is the basis of national economic development, wealth, power, and security. As our Founding Fathers recognized, the ideas represented in a patent form the basis for the advancement of science, technology, and industry. These advances are brought to fruition in the manufacturing process, which in turn provides useful products, including defense articles, as well as jobs, incomes, economic growth, and social stability. Manufacturing based on patents also creates opportunities for further research into and development of even better ideas and products — a continuous feedback loop that encourages more technological and thus societal advances. The loss of manufacturing in particular reduces opportunities for technological progress and economic growth.

Patents have developed historically, and the American system, embodied in the Constitution, is based on centuries of legal and philosophical developments. Perhaps the most central idea to emerge is the grounding of patents in property rights: The owner of the patent, whether the inventor or someone to whom he has sold or licensed the patent, has an exclusive right in the technology or processes or ideas contained in the patent. That right is in essence the ability for a limited time to employ the judicial system to stop others from using the patented matter and to enforce monetary damages for violation of the patent.

The ability to commercialize patents in a manufacturing enterprise requires investors who are willing to put up significant sums of money in the expectation of getting a decent return on their money. If the discovery contained in a patent is not recognized as a property right and protected for a sufficient period to allow the inventor and the investors to recoup their initial expenditures plus a reasonable profit, there will be fewer inventors and no investors, and much less progress.

The technological, economic, and social success of the United States has been built largely on the foundation of patents as property rights. Patent law and case law have evolved over the last two and a quarter centuries, but the concept of a patent as an exclusive right of an inventor for a limited period has remained at the center. However, in recent years, legislation and judicial decisions have moved away from the concept of an issued patent as securing a property right.

This paper analyzes the necessary foundation of private property rights for achieving citizens’ thriving, economic prosperity through both individual flourishing and industrial competitiveness, and national security that preserves independence. It considers property rights’ cornerstone role in attaining industrial competitiveness through the lens of President Reagan’s commission on U.S. industrial competitiveness. This approach provides the benefit of hindsight and several decades of perspective, giving a clearer view of what went right and what went wrong. This framework also gives a longer view for assessing our present challenges.

After an introduction comparing the Reagan era to the present time, the first section examines industrial competitiveness: What is this concept and what are its purposes? The second section delves into invention and patents, developing a case study from a pillar of a property rights-based, competitive in­dustrial backbone. The third section pulls back the lens from the case study to apply the lessons from the previous section to other aspects of property rights, forms of property, and industrial competitiveness more broadly. The final section makes concrete recommendations for reestablishing private property rights in pursuit of reinvigorated U.S. industrial competitiveness for the 21st century.

To read the white paper, please click here.

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Innovate4Health Innovation

Innovate4Health: Indian Startup Develops Nanomaterial Filter to Help Solve Global Drinking Water Crisis

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Gleb Savich

Access to clean water remains a critical issue on a global scale. According to the latest statistics by the World Health Organization (WHO), 844 million people lack a basic drinking water service and at least 2 billion people use contaminated water that can transmit cholera, dysentery, typhoid, polio, and other diseases. Contaminated drinking water causes more than 500,000 deaths each year. And in low- and middle-income countries, more than one-third of the health care facilities lack even soap and water for handwashing.

many hands catching water under a faucetThis drinking water crisis disproportionately affects the poor in the developing world. However, problems with access to safe drinking water may arise in any part of the world due to man-made or natural disasters—including in the United States. One recent example is the public health crisis that erupted in Flint, Michigan, where drinking water became contaminated with lead when the city switched to a different water source.

Natural disasters may disrupt the water supply in areas that normally have access to safe drinking water. As of October 2017, over a month after Hurricane Maria devastated the island of Puerto Rico, many of its residents still did not have access to clean water, precipitating an outbreak of leptospirosis, a rare bacterial disease.

Climate change, population growth, and urbanization pose further challenges to water supply systems. According to the World Health Organization, by 2025, half of the world’s population will be living in water-stressed areas. These varied challenges to one of humanity’s most fundamental problems require flexible and creative solutions. 

Dr. Thalappil Pradeep is a professor in the Department of Chemistry at the Indian Institute of Technology (IIT) Madras. His decades of research focusing on nanomaterials has led to several discoveries that have already begun to help solve the global problem of access to clean drinking water.

The first breakthrough came in 2004 when Dr. Pradeep’s team developed nanoparticles that can break down certain pesticides dissolved in water. Many of these chemicals are not removable by standard water filters and have been shown to pose environmental and health risks. Although the use of some of these pesticides is banned, the compounds persist in the environment decades later. The problem is particularly relevant in India, one of the world’s largest pesticide producers, where pesticide water contamination is a serious problem in certain areas.

enlarged image of a moleculeThe pesticide removal technology developed by Dr. Pradeep and his colleagues works by utilizing the ability of gold and silver nanoparticles to bind pesticides from flowing water through adsorption. Dr. Pradeep and his coinventor obtained both Indian and U.S. patents on their technology and licensed it to Eureka Forbes, an Indian manufacturer of vacuum cleaners and water purifiers.

The technology is estimated to have reached 7.5 million people and is the first nanomaterials-based water filter to be commercialized. To further develop nanomaterials-based water filtration technologies, Dr. Pradeep and his team founded a startup, InnoNano Research, in 2004.

Their next breakthrough came in 2012, when the team developed a novel nanomaterial capable of being adapted for the removal of multiple types of water contaminants. The new filter, dubbed AMRIT for Arsenic and Metal Removal by Indian Technology, can remove microbial contamination as well as arsenic, iron, and other heavy metals from drinking water.

The antimicrobial properties of silver ions were well known, but their large-scale implementation for water filtration had been hampered by technological obstacles, such as lack of suitable substrates in which to embed the ions. The novel nanoparticle material developed by Dr. Pradeep and his team solves these issues.

Silver nanoparticles are embedded in this material to remove microbes, while the incorporation of other compounds allows for the removal of other contaminants. For example, the incorporation of iron achieves the removal of both iron and arsenic. Thus, this technology allows for manufacturing of multistage filtration systems suitable for particular needs.

Discussing this filtration system, Dr. Pradeep explains: “If this will be useful for water, it has to be very cheap, have a low carbon footprint, require no electricity, and should not contaminate water sources in the process.” And his team’s technology meets these challenges. According to : Dr. Pradeep, manufacturing requires no heating or electricity and uses materials with a low carbon footprint.

Removal of arsenic from drinking water is of particular interest in India, where ground waters used for drinking and irrigation are often contaminated with dangerous levels of arsenic. To begin addressing this problem, by the summer of 2016, AMRIT filters were installed in 750 locations in several Indian provinces, providing clean water to nearly half a million people.

In 2016, InnoNano Research succeeded in securing one of the largest investments for an Indian tech startup when it obtained $18 million from Nanoholdings LLC, a U.S. venture capital firm specializing in investing into material science-based energy and water startups. This investment is particularly significant in light of the difficulties that Indian startups often face when it comes to scaling up their technologies.

Dr. Pradeep explains: “We have no efficient mechanisms for partnering, scaling and incubating – those are the lacunae in our system.” While universities provide startups with access to labs and research grants, more funding is needed to achieve the scale necessary for further product development.

Leveraging intellectual property enables startups to raise funds necessary to bring their innovations to those who need them. With the help of Nanoholdings LLC, Dr. Pradeep hopes to expand the company’s operations into Africa, Southeast Asia, and Latin America, and to continue developing the technology to filter out other dangerous contaminants found in drinking water.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health Innovation

Innovate4Health: Miriam Bridges the Gap Between Developing-World Infrastructure and Cancer Detection

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Alex Summerton

Originally a disease diagnosed only in developed countries, cancer is now a leading cause of death in the developing world with over half of all new cases annually. The rise in cancer in the developing world is attributed to improving technological, medical, and socioeconomic conditions. People are living longer due to reducing other causes of mortality such as infectious disease, unsanitary conditions, and maternal and infant mortality. The result is populations living long enough to begin seeing end of life diseases like cancer.

However, the advances leading to the higher prevalence of cancer in the developing world have not been accompanied by the advances to fight it. Treatment costs remain prohibitively high. Detection occurs late during the disease’s progression, generally after symptoms begin to present and chances of survival decrease. Underdeveloped infrastructure makes accessibility to screening and treatment difficult. Doctors’ offices can be remote and crowded, and trained oncologists are few and far between, leaving necessary expertise inaccessible to patients.

The overall effect is a developed-world disease outstripping developing-world technology and infrastructure.

Miroculus aims to combat the challenges of cancer screening, in both the developed and developing world, by providing accurate, low-cost, and accessible technologies that can be easily deployed at the earliest stages when treatment is cheaper and more effective. Founded by Alejandro Tocigl, Foteini Christodoulou, and Jorge Soto, Miroculus is developing a method of screening for cancers via microRNA.

The flagship product of Miroculus is Miriam, a cancer detection platform enabling accurate, early screening of cancer. Debuted at TEDGlobal in 2014, Miriam is a non-invasive tool that can rapidly screen for a wide range of cancers. Its design means it can be deployed during routine health examinations, rather than as part of cancer testing once symptoms have presented. Miriam works by assaying blood for the presence of microRNAs. Miroculus’s team has shown that certain microRNAs in a patient’s blood are correlated with specific types of cancer. So far, Miroculus has proven the concept of enabling Miriam to detect pancreatic, lung, breast, and hepatic cancer.

gloved hand holding screening toolMiriam achieves its goals through a simple yet elegant construction, requiring only a camera, computer, and testing substrate in a standard well plate. Each well contains a reactant keyed to a specific microRNA. A patient’s sample is added to each well and tested for the presence of microRNA. When the particular microRNA in the well is present in the patient’s sample, the reaction produces a luminescent effect. Miriam’s camera monitors these reactions by recording the change in luminosity of the wells during testing, sending these images via Miriam’s computer to Miroculus’s cloud computer. Miroculus then analyzes the pattern to determine which microRNAs are present and whether the patient has cancer.

Miriam’s advantageous three piece construction provides low-cost implementation while remaining clinically effective. Driven by Miroculus’s objective to democratize cancer screening technology, a Miriam testing platform can be created using cheap and readily available technologies in the developing world. During Miriam’s first debut, one of the founders showed the technology being deployed via a 3D-printed test chamber and a smartphone. Both 3D printing and smartphones are viewed as platforms for bringing developed-world medical technologies to the developing world. Combining innovative biological science and versatile technology such as 3D printing and smartphones allows Miriam to substitute for complex specialized equipment requiring far more training and resources to implement.

Miroculus is employing a blend of IP protections in the distribution of Miriam. It is combining an open source release of how to construct the Miriam platform, including copyrighted design plans for making the 3D printed device, with patent protection over its microRNA based testing method. Choosing to use this dual IP protection allows Miroculus to ensure a quality product in real world use with sufficient income to both run the company and develop the next generation of technologies.

To test the deployment and efficacy of Miriam, Miroculus has elected to employ open source distribution of Miriam. Instructions for building a fully functional Miriam are currently available on GitHub, including 3D printing instructions and software, firmware, and hardware instructions for a testing computer implemented on Arduino. These documents and code are published under open source licenses. This owner-driven free exercise of rights provides Miroculus with two major advantages. First, Miroculus can enjoy open collaboration and improvement on Miriam’s design and software. Second, making Miriam open source can encourage the adoption of the technology leading to additional economies of scale and providing Miroculus reputational benefits in the marketplace.

Miroculus is also utilizing patent protection for aspects of Miriam that require technical sophistication beyond having access to a 3D printer. It is globally seeking patents for testing wells and the detection system. By patenting the disposable wells, Miroculus can secure a return on its research and investment into Miriam. Because Miroculus views supplying the testing wells as the best income strategy for the technology, with revenue from supplying platforms being only incidental, Miroculus will be able to leverage the low-cost adoption of Miriam afforded by delivering an open source platform.

Miriam is a story of modern technology being used to bridge the gap between the developed and the developing world. Miroculus has a goal of enabling cheap, routine screenings for a wide range of cancers to lower the costs, both economic and human, of the disease. By making its testing device easily available, Miroculus aims to reach its goal of accessibility. And by securing patent protection for its testing wells, Miroculus will be able to ensure a return on its technology. This will allow further development and democratization of the necessary technology for combating the world’s most pressing diseases.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

Categories
Innovation Patent Law

An Ever-Weakening Patent System is Threatening the Future of American Innovation

dictionary entry for the word "innovate"Over the past ten years, the United States patent system has been transformed by new legislation, regulatory actions, and numerous decisions by the Supreme Court addressing nearly every area of patent doctrine. The many disruptive legal changes have affected infringement remedies, licensing activities, and what types of inventions and discoveries are eligible for patent protection, resulting in a profound sense of uncertainty for most stakeholders. This current state of doubt about the American patent system is pushing investors to look outside of the US for less risky ventures. And because investors are shifting their focus overseas, foreign countries are for the first time poised to bypass the US as the forerunners of innovation.

Last month, the United States Patent & Trademark Office (USPTO), along with the University of Texas Law School and Antonin Scalia Law School, George Mason University, hosted the 12th annual Advanced Patent Law Institute in Alexandria, Virginia. The program featured a distinguished panel of patent experts discussing “current issues around patenting, licensing, enforcing, and monetizing patents in the U.S., and look[ing] at what the UK, EU, and China are experiencing and the impact on U.S. patent practice.” Titled The Current Patent Landscape in the US and Abroad and focusing on the economic factors that spur invention, the consensus was that dramatic changes to the US patent system are driving investment in research and development outside the country and threatening the future of American innovation.

US Patent System No Longer Adequately Incentivizes Investment

Serving as co-moderator with the Hon. Paul R. Michel, Robert Sterne—a leading patent attorney and founding partner of Sterne, Kessler, Goldstein & Fox—kicked off the panel with an overview of a patent system that is falling behind China and the European Union as a driver of innovation. Questioning the Supreme Court’s radical distortion of patent law over the last ten years and the institution of post-grant review, Sterne pointed out that the Patent Trial and Appeals Board (PTAB) has produced over 6,000 proceedings, with patent owner success rates hovering between a meager 30 to 40%. Because of these discouraging numbers, and because injunctive relief has become almost impossible to obtain for patent owners, Sterne warned that critical investment in small and medium-sized companies and universities is rapidly declining.

Judge Michel echoed many of the same sentiments, expressing concern with the “health and vitality and effectiveness of the patent system.” Michel stressed that the principle goal of the patent system is to incentivize investment, but that continued assaults on the system are driving investors to foreign jurisdictions and moving the US in the direction of “off-shore invention.” Citing studies by the Kauffman Foundation and US Census Bureau, Michel explained that most new jobs come from small start-up companies dependent on technology, and that without adequate incentives to invest in these job creators, the patent system and economy are in serious danger.

Expanding on the problem of investment incentivizes, Paul Stone—a partner at venture capital firm 5AM Ventures—discussed his backing over 60 life science startups in the last 15 years, all of which specialized in therapeutics aimed at developing life-saving drugs and drug delivery technologies. Stone offered the following three points to consider regarding the current innovative investment landscape: (1) 60% of the new drugs approved in 2016 came from venture capital-funded small biopharmaceutical companies, not pharma industry giants, (2) of these new approvals, the origin of half the molecules are outside the United States, a much higher percentage than ten years ago, and (3) personalized medicine and the influence of information technology on biotech is leading to smaller market sizes, and a weaker patent system is threatening the ability to realize a return on investments in this area.

Innovation is Moving Overseas

Damon Matteo of Fulcrum Strategy, an IP asset management firm, began his comments with an ominous warning: “Be afraid, be very afraid.” As a practicing IP attorney, Matteo noted that he has seen clients increasingly interested in securing their IP in Europe and China rather than the US, and that China specifically is embracing the software and business method patents that have been abandoned by the US system. Investment has been moving overseas because that’s where patents still have value. Matteo also pointed out that China has been much more favorable to patent owners in IP litigation, as plaintiffs in infringement suits prevail 60% of the time. And injunctive relief—which has become a completely improbable outcome in US litigation—is granted in upwards of 90% of infringement cases in China when there’s been a finding of infringement.

Peter Detkin, founder of the IP development and licensing company Intellectual Ventures, weighed in on some of the “alternative facts” and hysteria that have resulted in the current state of the US patent system. Despite claims over the last 15 years that extortionary demand letters were being sent by the thousands, patent ligation had gotten out of control, and patents were killing investment in R&D and startups, Detkin pointed to multiple analyses by government agencies such as the FTC and the Government Accountability Office that revealed no such exceptional activity. Unfortunately, policymakers took the bait, and entrepreneurs in Silicon Valley have suffered as a result of over-reactive legislative and judicial efforts.

As in-house Chief Intellectual Property Officer of Vivant, a fast-growing home security technology company, Paul Evans provided more insight into how absolutely vital patents are to investments and private equity–backed tech startups, emphasizing how “patents have historically created an important competitive advantage in the marketplace.” Sharing a recent professional anecdote, Evans recounted a conversation with the managing director of a private equity firm with $10 billion in assets in which they discussed the past successful sale of a company based largely on its strong patent portfolio. The two agreed that the transaction would never have happened today due to the immeasurable decline in the value of patents. Evans noted that about 85% of small businesses in the US are now technology based, and that if our patent system can’t protect the inventions they rely on, investments and jobs will be reallocated to jurisdictions that will.

Shifting the discussion to the effect innovation uncertainty is having on universities, patent law and tech transfer expert Chris Gallagher warned that university research funding is at risk, and that the system of grants can no longer be relied upon. Despite a recent case that found the 11th amendment shielded state-chartered schools from IPR exposure, Gallagher encouraged all stakeholders to reach out to Congress to push back on the persistent troll narrative that continues to affect university research.

Efficient Infringement is Devaluing Patents

The panel then moved into a discussion of the increasingly common practice of “efficient infringement,” where companies choose to infringe patents instead of licensing, understanding that the current system has made enforcing patents too expensive and risky. Damon Matteo likened the practice to robbing a bank, getting caught, and as a punishment, only having to return a fraction of the money. Peter Detkin then expanded on the analogy:

It’s a great analogy — the bank robbery — because you not only get to say whether you get caught, but if you get caught, you’ll then be able to argue to the Federal Reserve that the bank really shouldn’t have existed in the first place. Then if that fails, you get to argue to them again that their certificate never should have issued, because it’s a different ground than the first time you argued. Then you could argue that the money was improperly issued to the bank… you have all these administrative ways.

Commenting on efficient infringement, Paul Evans explained that bringing a suit for patent infringement now makes no sense, as the current ecosystem demands high costs to defend patents subject to inter partes review (IPR). According to Evans, the cost of each IPR is between $200,000 and $300,000. IPRs are instituted 70% of the time, and of those cases, 80% of the challenged claims are invalidated. Evans noted that investors are aware of these realities and are hesitant to back certain patent-reliant companies. As a result of the uncertain innovative economy in the US, Peter Detkin noted that patent application filings are down, as well as enforcement actions. Alternatively, countries in Asia and the European Union that have embraced software and biotech patents have seen an increase in filings, enforcement actions, licensing, and investment.

Judge Michel then identified software and health science technology as suffering the most under the current “huge cloud of uncertainty,” and pointed out that China and Europe have broadened patent eligibility in these two tech fields as the US Supreme Court has narrowed it. Michel questioned how anyone could make a eligibility determination given the vague standard set by the Mayo and Alice decisions, and expressed frustration in the Supreme Court’s denial of cert in Sequenom v. Ariosa—a case that would have given the Court an opportunity to correct or at least clarify the Section 101 eligibility analysis. With the Supreme Court unwilling to clean up its mess, Judge Michel expressed support for statutory amendments to 101 recently proposed by the Intellectual Property Owners Association (IPO).

Confidence Must Be Restored in the US Patent System

Wrapping up the panel, Robert Sterne made clear that the patent troll narrative that contributed to so many drastic changes in the US patent system is outdated and no longer relevant. While uncertainty about Section 101 eligibility is ubiquitous, Sterne asserted that “[w]hat is clear is that things are not getting better for innovators in the United States who are relying on the U.S. patent system and who are creating a large bulk of the innovation in our country.” And in addition to losing an edge to foreign jurisdictions in industrial competiveness and job creations, Sterne warned that missing out on innovations in the technology the US employs to protect itself could have dire consequences for national security.

In conclusion, Sterne asked each panelist—as practitioners working in the innovation economy—what they would suggest to bring a sense of confidence back to the bleak patent law landscape. Judge Michel encouraged writing to bring awareness to the situation, including articles, op-eds, and direct letters to members of Congress. Paul Stone urged all stakeholders to focus on quality—specifically on the quality of patents reviewed and the quality of advice given to clients. Damon Matteo suggested adopting a financial mindset that considers the dynamics of returns on investments, which would help stakeholders see patents for the commercial instruments they are and should be. Peter Detkin stressed the importance of relying on hard, verifiable data, not anecdotes and hysteria. Paul Evans discussed the need to create an ecosystem that can be viewed by the investment community with some sense of understanding and confidence. Finally, Chris Gallagher insisted that, no matter the excuses of not having enough time, or not wanting to offend the wrong people, everyone must get involved to insert integrity back into the innovative ecosystem.

The concerns expressed by this panel are being echoed by stakeholders in almost every section of the innovation economy, and without a concerted effort to bring sense and clarity back to the patent system, the US is in danger of losing its competitive and innovative edge.

Categories
Innovate4Health Innovation

CPIP & ITIF Launch “Innovate4Health” Policy Research Initiative

Innovate4HealthIn celebration of World Intellectual Property Day on April 26, 2017, the Center for the Protection of Intellectual Property (CPIP) today joined with the Information Technology and Innovation Foundation (ITIF) to launch “Innovate4Health,” a joint project to promote the critical role that intellectual property rights play in spurring innovative solutions to pressing global health challenges.

People all over the world live better than ever before thanks to innovation. New medicines prevent or alleviate disease. New devices diagnose problems, repair bodies, and overcome physical challenges. Still other inventions keep vaccines and medicines fresh and effective or ensure their authenticity. New business models help innovation to happen and ensure that it reaches those who need it.

Many of these innovations are secured by intellectual property rights, which support the ability of innovators to invent and bring solutions to market. Property rights, particularly intellectual property rights, foster the freedom of many hands and many minds to work on challenging problems. They put decisions in the hands of those closest to problems — innovators with knowledge of potential solutions and caregivers and consumers who understand their own needs best. They fund individual careers and industries dedicated to fixing health problems, as well as the businesses that get these solutions to individuals.

Our Innovate4Health project is providing case studies that describe how IP-driven innovation is tackling some of the world’s toughest health issues, including:

• A cooler that ensures vaccines are safe in areas without power;
• A portable eye examination kit to move care out of the office and into the field;
• Retractable syringes to prevent needlestick injuries;
• A baby warmer that can adapt to volatile electricity conditions;
• Point-of-care testing for malaria that anyone can use;
• A smartphone app that instantly checks the authenticity of pharmaceutical drugs; and
• A new anti-inflammatory drug derived from Brazil’s diverse ecology.

Learn more about Innovate4Health here.

Categories
Innovate4Health Innovation

Innovate4Health: Protecting Patients with VanishPoint Retractable Syringes

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthNeedlesticks are not just the fear of 4-year-olds receiving their vaccinations; they are also the source of blood-borne infections afflicting millions of healthcare practitioners. When a conventional needle is left exposed after use on a patient, it can accidentally stick another person, such as a healthcare worker. The accidental needlestick can infect that person if the patient had any blood-borne diseases. Recent estimates place the number of needlestick injuries in the United States at more than 300,000 per year, with infection by HIV or Hepatitis as possible consequences.

The spring-retractable syringe, VanishPoint, was created to prevent needlestick injuries and ameliorate other unsafe injection practices.

Worldwide, the problem from needle injuries is even greater. The risks from needlestick injuries can increase with other unsafe injection practices, such as needle reuse and improper medical waste collection. These practices are more likely to occur in developing countries. The consequences of these unsafe injection practices include 21 million hepatitis B infections per year and 41% of new cases of hepatitis C.

The conventional syringe leaves the needle exposed after the injection is complete. Until a healthcare worked places the syringe in a specially-designed plastic garbage container, it remains exposed and capable of harming anyone nearby. Unfortunately, over 1.8 billion conventional syringes are sold each year in the United States. These outdated syringes account for more than half of needlestick injuries.

syringesThomas J. Shaw, founder of Retractable Technologies, created a technological solution to the problem after seeing a television report of a doctor who contracted HIV from an accidental needlestick. He designed a single use spring-loaded syringe that immediately pulls the needle back inside the just-used syringe. Thus, the needle is automatically covered and incapable of harming anyone.

The basics of how the syringe works are simple enough to explain. The needle is engaged for use when the package is opened. A nurse or other practitioner fills the syringe normally. However, when the plunger is fully depressed to inject the patient, a spring pulls the needle back into the body of the syringe. Before the nurse has moved the syringe away from the patient, the needle is already covered and incapable of causing injury.

Despite the simple concept, designing a functional and usable product took ingenuity and persistence. Shaw purchased pigs feet from a local butcher to test his designs in his workshop. In the classic mode of biomedical innovators including Jonas Salk (inventor of the polio vaccine), he first tested his device on himself.

Retractable Technologies, Inc.From these initial tests, Shaw founded Retractable Technologies, and the value of his innovation was immediately recognized. He received awards from the National Institute for Drug Abuse at the National Institutes of Health to further develop his work and eventually commercialize it. Congressional representatives touted the important advances of this small business. The final product, the VanishPoint syringe, embodies his innovation.

The challenges faced by Shaw and Retractable Technologies in entering the medical device market have been extensively chronicled. The way hospitals purchase supplies such as syringes advantages large incumbent sellers and manufacturers over small startups such as Retractable Technologies. The story of Shaw’s disruption of the automatic safety syringe market was even turned into a feature-length movie.

Retractable Technologies confronted this challenge by relying on its patent portfolio. The patents covering the syringe included patents on the retractable needle design as well as tamperproof features that protect against intentional as well as accidental misuse. Large, established manufacturers could have easily copied Retractable Technologies’ designs from the published patents. However, these patents assured that Retractable Technologies could protect its innovation against invasion.

syringesThe value of the retractable syringe design has been important to advancing health care goals worldwide. The World Health Organization has recognized the value of the technology in Australia, China, Indonesia, and Gambia among others. According to the Global Alliance for Vaccines and Immunizations, African countries continued using auto-disable syringes after the completion of international aid programs because of the public health benefits. These benefits include not only the prevention of needlestick injuries, but preventing needle reuse, which had undermined other vaccine initiatives.

PATH, a non-profit organization devoted to health innovation, highlighted the introduction of VanishPoint syringes in Peru as an important step in advancing public health goals. In addition to preventing injuries in the clinic, PATH noted that the syringes increased safety in waste disposal, where some waste handlers had described needlestick injuries as “common.”

Prevention of needlestick injuries and infections has been a decades-long challenge for public health. From humble beginnings and the story of one infected doctor, Thomas Shaw’s invention shows how one innovator can revolutionize health care. Patents have given him protection in the U.S., but his innovation knows no borders.

*Images courtesy of Retractable Technologies

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.