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Innovation Patent Licensing

Focusing on IP for the Next Generation of Mobile Technology

hand holding a phone with holographs hovering over the screenIn advance of our Sixth Annual Fall Conference on IP for the Next Generation of Technology, the Center for the Protection of Intellectual Property will be highlighting works on the challenges brought by the revolutionary developments in mobile technology of the past fifteen years. These articles address issues related to patent licensing, standard setting in the mobile technology sector, and developing business models at the dawn of the 5G era. Contrary to the tread-worn claims that new technological developments render IP rights obsolete, these articles show how stable and effective property rights in innovative technologies continue to foster the groundbreaking advancements that benefit societies.

Much debate in the mobile technology sector has centered on recent policy changes in the standard setting organizations responsible for the development of global industry standards. In a recent paper focusing on the Institute of Electrical and Electronics Engineers Standards Association (IEEE), mobile industry expert Keith Mallinson explores the practical impact of policy changes made in 2015 by the IEEE that implemented the “patent holdup” theory by restricting the rights of owners of patents on technology that is contributed to standards.

Providing an empirical analysis of the activity of innovators of new standards technology since the 2015 change in the IEEE’s patent policy, Mallinson finds that innovators are not contributing their patents resulting from their massive investments over many years into risky research and development of cutting-edge technologies. This is evidence that the one-sided and unbalanced restrictions on innovators, and not on implementers, that were imposed by the IEEE in 2015 under the “patent holdup” theory have slowed the adoption and implementation of pioneering technologies. Mallinson explains that a more balanced and clear respect for the rights of owners of patented technologies that are contributed to standards must be restored in order to better facilitate technological advancements.

To read the Mallinson article, which first appeared on the 4iP Council website in September 2017, please click here.

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Innovation Patent Licensing

Study Finds IEEE’s 2015 Patent Policy Sowing Uncertainty and Slowing Innovation

dictionary entry for the word "innovate"By Kevin Madigan & Adam Mossoff

As the world prepares for the game-changing transition to 5G wireless systems, the high-tech industry must continue to efficiently develop and implement technologies and networks that work together across different platforms and devices. Few people are aware of how this happens, because it occurs solely between the companies who develop and implement technological products and services in the marketplace, such as Qualcomm, InterDigital, Microsoft, Apple, and others. These companies participate in private standard setting organizations, which develop technological standards agreed upon by these companies, such as three-prong electrical plugs, USB drives, hard disk storage drives, and even communications technologies such as Wi-Fi and 2G, 3G, and 4G.

In sum, the development of standards is a key part of how new technological innovations are efficiently sold and used by consumers and work for everyone. The reason standard setting organizations came into existence is because the alternative is neither efficient nor good for consumers. A standards “war” between companies in the marketplace leads to years of incompatible devices being sold while consumers wait for one company to establish (private) market dominance with its products and services such that everyone else must use that standard, such as what happened between VHS and Betamax in the 1980s or the market fight between Blu-ray Disc and HD DVD in the 1990s, to name just two examples. Standard setting organizations preempt this unnecessary and wasteful commercial war by bringing together the innovators and implementers of new technology to agree beforehand on a standard so that new standardized products and services can get into the hands of consumers faster.

Unfortunately, some standard setting organizations are changing their rules for the companies that invest hundreds of millions of dollars in long-term R&D to create groundbreaking technologies like those used in our smartphones. These new rules create uncertainty for these innovators. As a result, this uncertainty is threatening investments in new high-tech products and the ongoing growth in the U.S. innovation economy.

Detailing this troubling trend is a recently released, in-depth, and rigorous study by Kirti Gupta and Georgios Effraimidis, which tracks the changes in the rules for the creators and owners of the technologies incorporated into technological standards by one of the largest and more influential organizations—the Institute of Electrical and Electronics Engineers-Standards Association (IEEE). In 2015, the IEEE adopted a new policy governing how owners of patents on technologies incorporated into its technological standards can protect and secure their investments via their legal rights to their patents. This shift in policy required patent owners effectively to relinquish their legal right to stop deliberate and unauthorized uses of their property and thus made it harder for them to license reasonable royalties for the use of their technology equally among all industry stakeholders.

As Gupta and Effraimidis show through detailed analyses, the IEEE’s new policy has distorted the longstanding market processes and licensing negotiations that have led to billions of smartphones being sold to consumers at relatively low cost around the world over the past decade. This is a vitally important study, because it brings key data to the policy discussions about technological standards, patents, and the incredible products and services made possible by them and on which everyone relies on today.

A Quick Summary of Standard Setting Organizations and Patented Technologies

A traditional requirement of the IEEE and several other standard setting organizations is that innovators commit to license equally their patented technologies that are incorporated into an agreed-upon standard for all companies implementing this standard in products and services. The law already provides that a patent owner will receive a “reasonable royalty” as damages for any past unauthorized uses of a patented technology, and thus standard setting organizations added the contractual requirement that this reasonable royalty also be non-discriminatory. To create a pleasant-sounding acronym, the phrase used is that licensing rates for patented technologies incorporated into market standards must be fair, reasonable, and non-discriminatory (FRAND). The goal of FRAND is to ensure that all companies creating products and services that are sold to consumers in the marketplace pay the same rates for incorporating the necessary standardized technologies into these products and services, such as the standardized 4G transmission technology used by everyone’s smartphones.

About a decade ago, some professors and lawyers posited a theory based on an abstract, economic model that owners of patents on technologies incorporated into these standards could exploit their ability to seek injunctions for violations of their patents and thus impose unduly higher costs on the companies implementing these standards in things like smartphones, laptop computers, tablets, and other devices and services. It was a simple story about property owners “holding up” people who wished to use their technologies, cashing in on the ubiquitous knowledge that any property owner can post a sign that says “no trespassing.” Based on this “patent holdup” theory, which deduced from an abstract model that patent owners would demand inordinately high royalties from the companies that need to incorporate agreed-upon technological standards into their products and services, these academics argued for “reforms” in the law to stop “patent holdup.”

But the “patent holdup” theory is just that—a theory. More than a decade of rigorous empirical studies have not only failed to confirm the “patent holdup” hypothesis of systemic market failures in the patent-intensive high-tech industry, and instead have found market conditions that directly contradict the core claim of “patent holdup” theory (see here for a letter to Assistant Attorney General Makan Delrahim summarizing this research and listing many of the studies). One study has shown that the average royalty rate for key technologies used in smartphones is only 3.4%, which is contrary to the 67% royalty rate predicted by “patent holdup” theory. Another study, among others, found significant quality-adjusted drops in consumer prices of smartphones and increasing entry of new manufacturers of smartphones, as well as other market conditions in the smartphone industry, that directly contradict the predictions of “patent hold” theory.

Unfortunately, in response to lobbying and the successful pushing of the “broken patent system” narrative in Washington, D.C., antitrust regulators forged ahead at the DOJ to push for policy changes at standard setting organizations on the basis of this unproven “patent holdup” theory. (Thankfully, recent antitrust regulators have returned back to evidence-based, balanced policy-making.) Several years after the first article propounding the “patent holdup” theory was published in 2007, implementers began pushing this theory at the IEEE to effect changes in its internal patent policy, which ultimately responded to this effort by revising its patent policy in 2015.

IEEE Policy Changes for Owners of Patents on Technological Standards

As Gupta and Effraimidis explain, the IEEE’s new patent policy has been highly controversial and generated much discussion among academics and industry practitioners. Separate from what they disclose in their article, there have been allegations that the internal process at the IEEE in changing its patent policy was initially cloaked in secrecy and was not open to all IEEE members as to when meetings were held and as to what the substantive decision-making processes were at these meetings. One commentator referred to it politely as an “opaque decision-making process” by the IEEE. If true, this is very troubling given that this violates the exemption accorded to the IEEE under the antitrust laws for operating as a standards setting organization.

Essentially, the IEEE patent policy was changed in 2015 in two key ways that impacted innovators. First, the new policy prohibits a patent owner seeking an injunction until all efforts at obtaining a license fee have been exhausted, including suing and litigating to a final judicial decision awarding a reasonable royalty. This of course incentives purported licensors to drag out licensing negotiations while they are infringing the patent, imposing large costs on patent owners in having to file lawsuits and pursue their legal remedies in court for many years and who have no choice but to allow the unauthorized use of their property during this time.

Extending these negotiations then allows licensors to take advantage of the second major rule change by the IEEE in its patent policy: the policy shifts licensing rates from the longstanding, market-based licensing of the technology given the value of the consumer device to the component level of the value of the chip itself. Of course, a smartphone without 4G or Wi-Fi is a beautiful 1995 cell phone with a very pretty, colorful screen and nothing more, which is why the free market settled on the value added to the entire smartphone for the basis of the licensing rate for this standardized technology. Moreover, calculating royalty rates based on the very cheap computer chips that contain the valuable technology fails to account for the hundreds of millions of dollars in R&D investments in developing the technology in the first place. Again, this is why the arrangement first reached in the free market between innovators and implementers was a balanced approach in device-level licensing rates that accounted for the costs of R&D and the costs of manufacturing the smartphones that contained the technology derived from this R&D. As a recent empirical study has shown, this is approximately 3.4% per smartphone, which is anything but an example of a massive payment to patent owners on 4G or Wi-Fi, especially for these core technologies that make a cell phone a “smartphone.”

Why then did IEEE change its patent policy? Consistent with the concerns about the “opaque decision-making process” at the IEEE, economist Greg Sidak has identified how the new rules were drafted by an ad hoc committee at the IEEE dominated almost entirely by implementers who license the patented technologies from the innovators who develop and contribute these technologies to the standard-setting process. In effect, the licensees strategically dominated the process and used their clout to push through a policy change that devalued the patented technologies, because they were seeking to lower their own manufacturing costs in implementing this technology in the consumer products and services they manufacture and sell in the marketplace. As evidence, Sidak shows that comments submitted in opposition to the new rules were rejected at nearly double the rate of those in support, reflecting a process that betrayed the IEEE’s core principles of openness, consensus, and the right to appeal. Instead of alleviating any alleged problems caused by patent owners, the IEEE’s rule changes actually facilitated collusion among implementers and resulted in “buyer-side price-fixing” of the patented technologies.

Negative Impact on Contributions of New Technology to Standards at the IEEE

The heart of the Gupta and Effraimidis article is not the theoretical and empirical background to the “patent holdup” dispute, but a detailed empirical study of the impact the new IEEE patent policy has had on the standard development process. Focusing on IP-intensive standards related to the development of Wi-Fi and Ethernet networks, the study first looks into the number of Letters of Assurances (LoAs) submitted to the IEEE in the years before and after the patent policy change took effect.

(LoAs are documents submitted by inventing companies who contribute new technological innovation in the standard-setting process. These technology contributors have patents on these innovations, and in these LoAs, they identify what patents may be essential to the standard that is being developed and they identify the terms under which they’re willing to license this technology if it ends up being incorporated into the standard that is ultimately set by the standard setting organization. An LoA is labeled “positive” if the contributor agrees to license its technology under the patent policy set by the standard setting organization or “negative” if the contributor declines to commit to these terms.)

The Gupta and Effraimidis study found that the number of positive LoA submissions has dropped a whopping 91% since IEEE changed its patent policy in 2015 and the number of negative LoAs rose to an all-time high in 2016. Gupta and Effraimidis explain:

The results suggest that many [patent] owners are reluctant to license their patent portfolio on the new FRAND terms. More importantly, the uncertainty on implementers’ side has increased, as new standards . . . have been approved despite the presence of negative and/or missing LoAs . . . .

Their article also tracks changes in the duration of the comments period that takes place before a new standard is approved—this is the period of time during which IEEE members discuss, debate, and resolve any concerns about a standardized technology before it is ultimately adopted as an official standard by the IEEE. Before the IEEE’s new patent policy went into effect in 2015, the average duration of the first two rounds of comments was 233 days. After the new patent policy took effect, Gupta & Effraimidis found a 42.5% increase in the comment period duration, resulting in an average resolution time of 332 days. This increase by almost half in the standard-setting process, especially in an industry marked by rapid development of new smartphones, laptops, and other high-tech consumer products and services, is concerning, to say the least. These delays are wasting private as well as public resources and impeding the commercial development of important IP-intensive technologies.

Finally, the Gupta and Effraimidis study analyzes the change in the number documents submitted at the IEEE that trigger the development of a new standard technology, which is a proxy for the development of new standards by the IEEE. Here, Gupta and Effraimidis’ findings contradict another recent study that alleged a high number of submissions in 2016 reflected a positive impact of the IEEE’s new patent policy. Gupta and Effraimidis reveal that hundreds of the submissions counted in the prior study either came from standards for which no patented inventions were contributed or were for standards of little or no value. Focusing properly on submissions for technologies that have significant value and produce an overwhelming majority of IEEE standards, they find submissions of new standards documents have in fact declined by 16% since 2015.

In sum, the changes in the internal standard-setting process at the IEEE since it adopted its new patent policy in 2015 represent a concerning shift following a strategic and collusive effort by implementers to devalue the patented technology created by innovators and contributed to standard setting organizations like the IEEE. The evidence is slowly building, showing that the IEEE’s new patent policy has devalued the innovative activity of technological innovators based on a purely theoretical and unproven claim that there is a systemic problem with so-called “patent holdup” in the smartphone and other high-tech industries. Unfortunately, in leaping into action on the basis of unproven theories, the IEEE has contributed to pervasive uncertainty and weakened incentives in the development and commercial implementation of innovative technologies, as is increasingly being documented and discussed by legal scholars and economists.

Moving Forward

The Gupta and Effraimidis study analyzes for the first time empirical data in fully detailing the effects of the IEEE’s new patent policy on the standard setting process. Their study shows that innovators are unwilling to continue to contribute the technologies they develop to the standard setting process under onerous terms requiring them effectively to give up their legal rights to their patents, and that these policies are having a perverse effect in creating inefficient licensing negotiations and delayed standards development. Their findings may sound intuitive to patent lawyers and innovators, but it is imperative to bring data into the public policy debates after ten years of concerted efforts to implement unproven theories, such as “patent holdup” theory, in both law and in the policies of private organizations like IEEE.

Gupta and Effraimidis conclude that a proper patent policy for a standard setting organization like the IEEE “should enhance incentives of technology contributors to innovate, while ensuring unlimited access to the new technology standards.” In considering its key role as a long-time professional association for the high-tech industry reaching back to Nikola Tesla and Thomas Edison, as well as its key role as standard setting organization in the innovation economy, the IEEE hopefully will reconsider its patent policy in light of actual economic and legal evidence. It should return back to the balanced patent policy that successfully promoted the computer and mobile revolutions of the past four decades. The future of new and innovative consumer products is at stake, such as the 5G technology that was first being developed many years ago and will start to be introduced into consumer products in the coming year.

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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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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: Augmented Reality Technology Helps Bring Surgical Expertise to Conflict Zones and the Developing World

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

Innovate4HealthBy Gleb Savich

The majority of people in the world do not have access to safe and affordable surgical care. More than 2 billion people cannot receive surgical care simply because there are no surgical facilities where they live. Up to 3 billion more people do not have access to surgical care that is safe, timely, and affordable. The availability of surgical care is extremely uneven around the world. While 95% of the population of South Asia and several regions of Africa lack access to surgical care, less than 5% of the population of the high income areas of North America and Western Europe lack such access.

doctors in surgeryThe problem of access to surgical care may be particularly acute in conflict zones, where the need is often the greatest. Getting much-needed surgical expertise in war-ravaged countries is already a nearly impossible task. To make matters worse, in such countries as Syria, Yemen, and Sudan, targeting healthcare workers and facilities for destruction has become a warfare strategy.

Talal Ali Ahmad is a Boston-based Lebanese entrepreneur who built his career in mobile phone development. While on a mission to El Salvador as a volunteer for the Global Smile Foundation, he observed firsthand the obstacles faced by doctors providing healthcare in remote regions. Leveraging his background in mobile phone technology, Ahmad began developing tools that allow surgeons to remotely assist their colleagues with surgical procedures.

To further develop and implement the technology, Ahmad teamed up with Nadine Hachach-Haram, a London-based Lebanese surgeon. Together, they founded Proximie, bringing together a team of clinicians, engineers, and designers. In 2016, Ahmad obtained a patent on his invention and secured the backing of a Lebanese venture capital firm, Cedar Mundi Holdings.

Diagram. Top center box: Electronic Health Records 180. Bottom center box: Server 120. A two-way arrow connects the boxes. Left box: Local Site 110. A doctor (labeled 14) stands by a bed (labeled 160). Right box: Remote Site 130. A doctor (labeled 150) stands by a computer (labeled 170). Two-way arrows connect the bottom center box with both the left and right boxes.The augmented reality technology that Ahmad and his team developed, also called Proximie, is simple. It uses any pair of computers, tablets, or smartphones with cameras. One unit is located at the site of surgery, and the other is at a remote location. A surgeon at the remote location can observe the surgical field as 2D or 3D images or a real-time video feed. Using a touchscreen, the remote surgeon can make markings that are overlaid on the images of the surgical field and transmitted to the surgical site. For example, the remote surgeon can mark where to make an incision. The remote surgeon and the local team can communicate with each other by audio or text.

A more sophisticated version of Proximie utilizes a dataglove that senses the position and movements of the wearer’s hand. The hand movements of the remote surgeon wearing such a glove are overlaid on the images of the surgical field and transmitted to the site of surgery, guiding the local team on how to perform a procedure.

Proximie utilizes existing technology and can be implemented on any suitable device or platform. Its simple interface allows doctors to use the platform with just a few days of training. This simplicity and accessibility is critical. Dr. Hachach-Haram explains: “What attracts us to this is that the challenges facing public healthcare are hugely complex, yet the solutions offered by technology are beautifully simple. This idea of bringing forms of surgery to places where they haven’t been available before with nothing more than an internet connection and mobile devices seems very powerful to us.”

Fig 5. Diagram. Medical Instruction Interface in rectangle. Participants (labeled 510) in upper left box: Drs. John Smith, Mary Jones, and Paul Davis. Live video in lower left box, labeled 520; image of baby’s face, labeled 521. Boxes under image labeled 1, 2, 3, +, and an arrow, all labeled together as 522. Center box: Work area, labeled 530. Large image of baby’s face, labeled 531. Selection on nose, marked 532. Ruler for scale, marked 534. Boxes underneath marked 1 through 5, labeled 533 together. Long right box, Snapshots, labeled 540. Three images on top of each other of baby’s face. Top labeled 541, with arrow pointed at baby’s left nostril and labeled 542. Middle labeled 541, with arrow pointed at baby’s right nostril and labeled 542. Bottom labeled 541, with selection of baby’s mouth labeled 542. Boxes underneath marked 1 through 3 and labeled together as 543.Proximie conducted its initial trials in 2015 in collaboration with the Global Smile Foundation. Surgeons in the U.S. guided teams in Peru and El Salvador in repairing cleft palates of local children. The following year, surgeons in Gaza, Syria, and Iraq performed wound surgeries assisted by their colleagues in Lebanon using Proximie.

Dr. Abu-Sitta, a plastic surgeon, used Proximie to lead surgeries in the Gaza strip from his home base in Beirut, hundreds of miles away. In one such surgery, he showed the local surgeons in Gaza how to repair a blast injury. In another, he showed them how to operate on a congenital hand anomaly. Previously, Dr. Abu-Sitta tried helping overseas surgeons by sending them audio recordings, photos, and X-rays. But Proximie is far more interactive. Dr. Abu-Sitta notes: “We wanted to push the idea that with only the minimum hardware, and minimum infrastructure you can still pull it off. With just two tablets, iPad to iPad, we’re able to perform this surgery.”

One of the surgeons that conducted the surgery in Gaza described his experience: “It is like the consultant is with you in the same room, giving you an opinion so that the surgery can be perfect.”

In addition to helping surgeons in remote areas and conflict zones to benefit from the expertise and real-time guidance of experts located elsewhere in the world, Proximie can be a valuable training tool. Proximie has partnered with the Royal Free Hospital and University College London in the U.K. and Yale Medical School in the U.S. to provide support for medical students. “Surgeries are being streamed from the Royal Free Hospital theaters and the students can log on and interact directly with the operating surgeon. Students can also capture and store photos and videos on Proximie’s cloud-based server for future learning,” explains Dr. Hachach-Haram.

Driven by their belief that everyone should benefit from the same high quality of healthcare and training opportunities, no matter where they live, the Proximie team continues to develop their technology to increase access to surgical care and training around the world.

#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: 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: DNAe Enhances HIV Treatment By Monitoring the Effectiveness of Antiretroviral Therapy

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

Innovate4HealthBy Alex Summerton

HIV/AIDS is a complex disease presenting a range of challenges for all stages of a patient’s progression. Effective detection, diagnosis, management, and monitoring are all crucial, and problems anywhere in the treatment chain can make later stages more difficult or undo the careful work of earlier stages. Significant technological improvements in healthcare have increased the effectiveness HIV/AIDS treatment in the developed world. However, many of these advances are inaccessible to developing world countries for reasons of cost, size, complexity, or infrastructure requirements.

Developments in the use of Ion Sensitive Field Effect Transistors (ISFETs) by DNA Electronics (DNAe) has resulted in a new method for monitoring the effectiveness of antiretroviral therapy (ART). Where traditional ART effectiveness monitoring techniques often require bulky, specialized equipment with a large laboratory footprint and long turnaround times, new ISFET based testing is quicker and far more discrete as the entire testing platform has been reduced to a USB stick and requires only half an hour to perform a test.

enlarged image of microscopic cellsART comprises the administering of a combination of antiretroviral drugs inhibiting HIV’s ability to infect and reproduce in healthy cells. HIV, like any pathogen, can develop resistance to the drugs used to treat it. Monitoring is crucial to ensuring ART is effective, and when treatment isn’t it becomes necessary to switch the drugs used. Several indicators can give a window into the efficacy of treatment, either by directly or indirectly monitoring the presence of HIV. The recommended method of monitoring for HIV treatment failure is testing the concentration of viral bodies in the blood stream, or the “viral load.” The World Health Organization recommends testing every 6 to 12 months to balance the cost of testing with the need to ensure the effectiveness of ART.

However, with accuracy comes costs. Testing equipment is roughly the size of a photocopier, requires support infrastructure, and takes up considerable laboratory space, limiting its deployment and making testing costly. Testing also requires preparatory work and trained support staff, further limiting where testing is carried out. For developing countries with HIV/AIDS crises, these attributes often limit monitoring technology to large urban areas. This imposes additional costs on persons living with HIV in rural areas who often must pay for a trip to test the efficacy of their ART and a return trip days later to receive the results.

Professor Christofer Toumazou of Imperial College London and DNAe have created a method for viral load testing using ISFETs to detect subtle changes in blood caused by the presence of HIV. Using ISFET technology overcomes challenges of cost, time, and complexity. DNAe has also used ISFETs to overcome the size and centralization issues by implementing its innovative testing technology on a USB stick. A USB based ISFET testing platform boasts several advantages over traditional equipment that decrease the cost and burden imposed by testing. Dramatically smaller size means increased portability and reduced power demand, untethering testing from the lab and allowing it to travel to patients. ISFET testing technology also operates far more quickly than current testing methods. Current tests take days to perform. DNAe’s USB test returns an accurate result in 20 minutes, allowing patients to receive results in a single visit. Furthermore, USB implementation reduces the complexity of testing and consequently the need for extensive training to perform tests.

Genealysis, DNAe’s underlying ISFET technology, operates by detecting changes in pH caused by the reaction of HIV genes on a specialized microchip. The change in pH is sufficient to change the electrical state of the chip and turn it on. Thus, Genealysis uses these pH changes to identify the presence or absence of HIV in the blood by measuring pH changes related to HIV RNA and monitoring if the ART is working.

Professor Toumazou formed DNAe to commercialize his innovations in DNA analysis with a mission “to bring dramatic, life-changing improvements to healthcare and beyond with fast, simple and scientifically sound products.” The patented ISFET technology serves as the backbone of DNAe’s business operations, allowing it to secure the necessary funding for further research and development. Genealysis is currently being adapted for a sepsis diagnosis platform with the same improvements in testing time, accuracy, and cost ISFETs have shown for HIV testing. DNAe’s intellectual property rights have allowed it to secure over $70 million in investment from the U.S. Department of Health and Human Services for research and development to expand its diagnostic technology to other innovative, life-saving applications, including rapid detection of biothreat agents, antimicrobial resistant infections, and influenza. DNAe has also used its patents to increase the speed of innovation and adoption of this important technology by granting non-exclusive licenses to certain life science companies.

HIV is a disease for which treatment lasts a lifetime. Technological improvements at all stages of a patient’s progression, detection, diagnosis, treatment, and monitoring help lessen the burden HIV imposes. ISFET technology is a promising avenue to reduce the burden ART monitoring imposes on persons living with HIV in the developing world, and DNAe is poised to adapt its patented innovations for other life-saving applications.

#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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Antitrust Innovation

Letter to Antitrust Chief Applauds DOJ’s New Evidence-Based Approach to IP Enforcement

hand under a lightbulb drawn on a chalkboardA group of judges, former judges and government officials, law professors and economists with expertise in antitrust law and patent law sent a letter to Assistant Attorney General Makan Delrahim earlier today applauding his recent announcements that the Antitrust Division of the Department of Justice (DOJ) would now take a balanced, evidence-based approach in applying antitrust law to patent licensing, especially to patented innovations that have been contributed to technological standards.

Signatories to the letter include Judge Douglas H. Ginsburg of the D.C. Circuit, former Chief Judge Paul Michel of the Federal Circuit, former FTC Commissioner Joshua D. Wright, and former Director of the U.S. Patent & Trademark Office David Kappos, among others.

A few weeks after his confirmation this past September, AAG Delrahim delivered remarks at a conference held at the USC Gould School of Law in Los Angeles, California. The comments signaled a major shift in intellectual property (IP) policy for the Antitrust Division from the policies pursued by the previous Obama Administration. Indeed, AAG Delrahim pointed out that he is the first head of the Antitrust Division to be a registered patent attorney, and his plans for protecting free market competition in the IP licensing realm reflected a robust understanding of what drives our innovation economy.

AAG Delrahim indicated that antitrust enforcers had “strayed too far” in protecting the interests of implementers of patented technology at the expense of innovators who create the technology in the first place. Such “misapplication of the antitrust laws,” he said, “could undermine the process of dynamic innovation itself.” In particular, AAG Delrahim stated that the recent focus on the “so-called ‘hold-up’ problem,” where innovators threaten to withhold licenses to implementers, fails to recognize the “more serious risk” of the “hold-out problem,” where implementers threaten to use the technology without taking licenses from innovators. AAG Delrahim explained that the “one-sided focus on the hold-up issue” posed a “serious threat to the innovative process.”

Last month, a group of industry representatives sent a letter to AAG Delrahim expressing concerns over the Antitrust Division’s new approach to IP licensing. The letter claimed that “patent hold-up is real, well documented, and harming US industry and consumers,” and it argued that the hold-out problem did not raise similar competition law issues. Remarkably, the industry representatives did not offer one citation to back up their broad claims about the supposed harm from “patent hold-up” or lack of harm from patent hold-out. Given the data connecting stable and effective patent rights and economic growth, the burden should be on the advocates for the “patent hold-up” theory to produce at least some evidence to support their position. Thankfully, AAG Delrahim made clear that he will let the evidence be his guide.

To that end, the letter submitted today by judges, government officials, legal academics, and economists points out the glaring omissions in the letter by the industry representatives: The claims about “patent hold-up” are merely theoretical, and they are “inconsistent with actual market data.” Moreover, today’s letter notes that the implications of the “patent hold-up” theory are testable, and that the empirical studies to date have failed to show that innovators are harming consumers or inhibiting innovation. To bolster its claims, the letter includes an appendix of rigorous empirical studies that directly contradict the “patent hold-up” theory proffered by the industry representatives.

Read the letter below or download it here: Letter to AAG Delrahim

***

February 13, 2018

Assistant Attorney General Makan Delrahim
Department of Justice Antitrust Division
950 Pennsylvania Ave. NW
Washington, DC 20530-0001

Dear Assistant Attorney General Delrahim,

As judges, former judges and government officials, legal academics and economists who are experts in antitrust and intellectual property law, we write to express our support for your recent announcement that the Antitrust Division of the Department of Justice will adopt an evidence-based approach in applying antitrust law equally to both innovators who develop and implementers who use technological standards in the innovation industries.

We disagree with the letter recently submitted to you on January 24, 2018 by other parties who expressed their misgivings with your announcement of your plan to return to this sound antitrust policy. Unfortunately, their January 24 letter perpetuates the long-standing misunderstanding held by some academics, policy activists, and companies, who baldly assert that one-sided “patent holdup” is a real-world problem in the high-tech industries. This claim rests entirely on questionable models that predict that opportunistic behavior in patent licensing transactions will result in higher consumer prices. These predictions are inconsistent with actual market data in any high-tech industry.

It bears emphasizing 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. Given the well understood role that innovation plays in facilitating economic growth and well-being, a heavy burden of proof rests on those who insist on the centrality of “patent holdup” to offer some tangible support for that view, which they have ultimately failed to supply in the decade or more since that theory was first propounded. Given the contrary conclusions in economic studies of the past decade, there is no sound empirical basis for claims of a systematic problem of opportunistic “patent holdup” by owners of patents on technological standards.

Several empirical studies demonstrate that the observed pattern in high-tech industries, especially in the smartphone industry, is one of constant lower quality-adjusted prices, increased entry and competition, and higher performance standards. These robust findings all contradict the testable implications of “patent holdup” theory. The best explanation for this disconnect between the flawed “patent holdup” theory and overwhelming weight of the evidence lies in the institutional features that surround industry licensing practices. These practices include bilateral licensing negotiations, and the reputation effects in long-term standards activities. Both support a feed-back mechanism that creates a system of natural checks and balances in the setting of royalty rates. The simplistic models of “patent holdup” ignore all these moderating effects.

Of even greater concern are the likely negative social welfare consequences of prior antitrust policies implemented based upon nothing more than the purely theoretical concern about opportunistic “patent holdup” behavior by owners of patented innovations incorporated into technological standards. For example, those policies have resulted in demands to set royalty rates for technologies incorporated into standards in the smartphone industry according to particular components in a smartphone. This was a change to the longstanding industry practice of licensing at the end-user device level, which recognized that fundamental technologies incorporated into the cellular standards like 2G, 3G, etc., optimize the entire wireless system and network, and not just the specific chip or component of a chip inside a device.

In support, we attach an Appendix of articles identifying the numerous substantive and methodological flaws in the “patent holdup” models. We also point to rigorous empirical studies that all directly contradict the predictions of the “patent holdup” theory.

For these reasons, we welcome your announcement of a much-needed return to evidence-based policy making by antitrust authorities concerning the licensing and enforcement of patented innovations that have been committed to a technological standard. This sound program ensures balanced protection of all innovators, implementers, and consumers. We are confident that consistent application of this program will lead to a vibrant, dynamic smartphone market that depends on a complex web of standard essential patents which will continue to benefit everyone throughout the world.

Sincerely,

Jonathan Barnett
Professor of Law
USC Gould School of Law

Ronald A. Cass
Dean Emeritus,
Boston University School of Law
Former Vice-Chairman and Commissioner,
United States International Trade Commission

Richard A. Epstein
Laurence A. Tisch Professor of Law,
New York University School of Law
James Parker Hall Distinguished Service Professor of Law Emeritus,
University of Chicago Law School

The Honorable Douglas H. Ginsburg
Senior Circuit Judge,
United States Court of Appeals for the District of Columbia Circuit, and
Professor of Law,
Antonin Scalia Law School
George Mason University

Justin (Gus) Hurwitz
Assistant Professor of Law
University of Nebraska College of Law

David J. Kappos
Former Under Secretary of Commerce and Director
United States Patent & Trademark Office

The Honorable Paul Michel
Chief Judge (Ret.),
United States Court of Appeals for the Federal Circuit

Damon C. Matteo
Course Professor,
Graduate School of Economics and Management
Tsinghua University in Beijing
Chief Executive Officer,
Fulcrum Strategy

Adam Mossoff
Professor of Law
Antonin Scalia Law School
George Mason University

Kristen Osenga
Professor of Law
University of Richmond School of Law

David J. Teece
Thomas W. Tusher Professor in Global Business
Haas School of Business
University of California at Berkeley

Joshua D. Wright
University Professor,
Antonin Scalia Law School
George Mason University
Former Commissioner,
Federal Trade Commission

 

Appendix

 

Richard A. Epstein & Kayvan Noroozi, Why Incentives for Patent Hold Out Threaten to Dismantle FRAND and Why It Matters, Berkeley Tech. L. Rev. (forthcoming), https://ssrn.com/abstract=2913105

Anne Layne-Farrar, Why Patent Holdout is Not Just a Fancy Name for Plain Old Patent Infringement, CPI North American Column (Feb. 2016), https://www.competitionpolicyinternational.com/wp-content/uploads/2016/02/North-America-Column-February-Full.pdf

Anne Layne-Farrar, Patent Holdup and Royalty Stacking Theory and Evidence: Where Do We Stand After 15 Years of History?, OECD Intellectual Property and Standard Setting (Nov. 18, 2014), http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=DAF/COMP/WD%282014%2984&doclanguage=en

Alexander Galetovic & Stephen Haber, The Fallacies of Patent Holdup Theory, 13 J. Comp. L. & Econ., 1 (2017), https://academic.oup.com/jcle/article/13/1/1/3060409

Alexander Galetovic, Stephen Haber, & Lew Zaretzki, An Estimate of the Average Cumulative Royalty Yield in the World Mobile Phone Industry: Theory, Measurement and Results (Feb. 7, 2018), https://hooverip2.org/working-paper/wp18005

Alexander Galetovic, Stephen Haber, & Ross Levine, An Empirical Examination of Patent Hold-Up (Nat’l Bureau of Econ. Research, Working Paper No. 21090, 2015), http://www.nber.org/papers/w21090.pdf

Douglas H. Ginsburg, Koren W. Wong-Ervin, & Joshua Wright, The Troubling Use of Antitrust to Regulate FRAND Licensing, CPI Antitrust Chronicle (Oct. 2015), https://www.competitionpolicyinternational.com/assets/Uploads/GinsburgetalOct-151.pdf

Douglas H. Ginsburg, Taylor M. Ownings, & Joshua D. Wright, Enjoining Injunctions: The Case Against Antitrust Liability for Standard Essential Patent Holders Who Seek Injunctions, The Antitrust Source (Oct. 2014), https://ssrn.com/abstract=2515949

Gerard Llobet & Jorge Padilla, The Optimal Scope of the Royalty Base in Patent Licensing, 59 J. L. & Econ. 45 (2016), https://ssrn.com/abstract=2417216

Keith Mallinson, Theories of Harm with SEP Licensing Do Not Stack Up, IP Fin. Blog (May 24, 2013), http://www.ip.finance/2013/05/theories-of-harm-with-sep-licensing-do.html

Jorge Padilla & Koren W. Wong-Ervin, Portfolio Licensing to Makers of Downstream End-User Devices: Analyzing Refusals to License FRAND-Assured Standard-Essential Patents at the Component Level, 62 The Antitrust Bulletin 494 (2017), https://doi.org/10.1177/0003603X17719762

Jonathan D. Putnam & Tim A. Williams, The Smallest Salable Patent-Practicing Unit (SSPPU): Theory and Evidence (Sept. 2016), https://ssrn.com/abstract=2835617

Gregory Sidak, The Antitrust Division’s Devaluation of Standard-Essential Patents, 104 Geo. L.J. Online 48 (2015), https://georgetownlawjournal.org/articles/161/antitrust-division-s-devaluation-of/pdf

Joanna Tsai & Joshua D. Wright, Standard Setting, Intellectual Property Rights, and the Role of Antitrust in Regulating Incomplete Contracts, 80 Antitrust L.J. 157 (2015), https://ssrn.com/abstract=2467939

Joshua D. Wright, SSOs, FRAND, and Antitrust: Lessons from the Economics of Incomplete Contracts, 21 Geo. Mason L. Rev. 791 (2014), http://www.georgemasonlawreview.org/wp-content/uploads/2014/06/Wright-Website-Version.pdf