Tag: patent

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Patent Law Pharma

CPIP Scholars Examine the Flaws in the Term “Evergreening”

scientist looking through a microscopeIn their new paper, Evergreening of Pharmaceutical Exclusivity: Sorting Fact from Misunderstanding and Fiction, Professors Kristina Acri née Lybecker and Mark Schultz, along with CPIP John F. Witherspoon Legal Fellow David Lund, analyze how the term “evergreening” is used in the context of pharmaceuticals.

After sorting through the vagaries and rhetorical excesses that restrict meaningful discussion, they identify seven categories that capture typical uses of the term:

  • The assertion that the duration of existing patents can generally be “renewed” or “extended,” for very long or indefinite periods;
  • Obtaining additional patents related to a particular pharmaceutical or treatment;
  • The use of laws that allow patent owners to restore some portion of their term lost due to governmental delays;
  • The use of laws that give companies a limited term of exclusive time to market a drug;
  • Regulatory barriers that frustrate potential generic competitors’ ability to enter a market;
  • Business practices that largely rely on marketing to advantage innovators; and
  • Settling lawsuits with generic manufacturers that seek to invalidate a patent.

In addition to identifying practices claimed to be “evergreening,” this paper also discusses the impact and value of these practices. For most situations, the practices reflect specific policies that are having their desired effect, such as the increase in studies of drug safety and efficacy in children brought about by pediatric exclusivity. In some cases, the practices are simply legal impossibilities. Only in a few specific situations related to regulatory requirements do the authors observe strategic opportunities that could plausibly be considered problematic.

Because of the number of practices and the diversity of value those practices bring to pharmaceutical commercialization, the term obscures far more than it illuminates. Discussions about patents, exclusivities, and public health would benefit greatly from discussing the practices and policies specifically, rather than attempting to use a nebulous term such as “evergreening.”

The paper, which started as part of Professor Acri’s work through CPIP’s Thomas Edison Innovation Fellowship, can be found here. The abstract is copied below.

***

Evergreening of Pharmaceutical Exclusivity: Sorting Fact from Misunderstanding and Fiction

Abstract

When people use the term “evergreening” to describe pharmaceutical industry practices, they typically display an unwarranted confidence that they know exactly what they mean both descriptively and normatively. However, a consistent and coherent definition of “evergreening” does not appear to exist.

This article surveys legal, academic, trade, and popular sources that use the term “evergreening” to develop a taxonomy of the policies and actions to which the term is applied. We find that the term is used to cover roughly seven categories of circumstances. Our review finds that the use of the term, taken as a whole, is more typified by the diversity of practices to which it applies rather than any consistent meaning. There are some commonalties, but they exist mostly at a general level.

We then analyze these seven categories to determine if the rhetoric matches the reality. Evergreening is most frequently used as a pejorative term, with a common implication that the “evergreener” is engaged in some sort of strategic behavior at least, or perhaps an immoral if not illegal practice. However, the categorical application of a pejorative term such as “evergreening” to any of the general policies and types of actions we examine is unwarranted and inappropriate. Proponents often apply the term to ordinary use of legal rights as they were designed and the concept makes no meaningful distinction between beneficial and problematic actions.

Unfortunately, “Evergreening” is a key concept in health policy that obscures far more than it illuminates. Once the term is stripped of misunderstandings and loose rhetoric, little of value remains. This is not to say that all policies and actions that extend or preserve exclusive rights are prudent or defensible in individual cases. Rather, the discussion regarding patents and public health would gain much clarity and rationality from addressing the disparate things labeled as “evergreening” on their individual merits.

To read the paper, please click here.

Categories
Legislation Patent Law

The STRONGER Patents Act: The House Receives Its Own Legislation to Protect Our Innovation Economy

U.S. Capitol buildingToday, Representatives Steve Stivers (R-OH) and Bill Foster (D-IL) introduced the Support Technology & Research for Our Nation’s Growth and Economic Resilience (STRONGER) Patents Act of 2018. This important piece of legislation will protect our innovation economy by restoring stable and effective property rights for inventors. This legislation mirrors a bill already introduced in the Senate, which I have previously discussed.

The STRONGER Patents Act accomplishes three key goals to protect innovators. First, the Act will make substantial improvements to post-issuance proceedings in the USPTO to protect patent owners from administrative proceedings run amok. Second, it will confirm the status of patents as property rights, including restoring the ability of patent owners to obtain injunctions as a matter of course. Third, it will eliminate fee diversion from the USPTO, assuring that innovators are obtaining the quality services they are paying for.

First and foremost, the STRONGER Patents Act aims to restore balance to post-issuance review of patents administered by the USPTO’s Patent Trial and Appeal Board (PTAB). The creation of the PTAB was a massive regulatory overreach to correct a perceived problem that could have been better addressed by providing more resources towards initial examination. While the USPTO has long been responsible for issuing patents after a detailed examination, it has recently taken on the role of killing patents the same USPTO previously issued. What the USPTO gives with the one hand, it takes with the other.

Data analyzing PTAB outcomes demonstrates just how dire the situation has become. Coordinated and repetitive challenges to patent validity have made it impossible for patent owners to ever feel confident in the value and enforceability of their property rights. In some cases, more than 20 petitions have been filed on a single patent. Although recent headway has been made to address this issue in the administrative context, it only listed factors to be used when evaluating serial petitions. A more complete statutory solution that prohibits serial petitions except in limited circumstances is necessary to fully protect innovators and provide certainty that these protections will continue.

The kill rate of patents by the PTAB is remarkable. In only 16% of final written decisions at the PTAB does the patent survive unscathed. The actual impact on patent owners is far worse. Disclaimer and settlement are alternate ways a patent owner can lose at the PTAB prior to a final written decision. Thus, the fact that only 4% of petitions result in a final written decision of patentability is more reflective of the burden patent owners faced when dragged into PTAB proceedings.

For these reasons, the PTAB has been known as a “death squad.” This sentiment has been expressed not only by those who are disturbed by the PTAB’s behavior, but also those—such as a former chief judge of the PTAB—who are perpetuating it. The list of specific patents that have been invalidated at the PTAB is mind-boggling, such as an advanced detector for detecting leaks in gas lines.

There are even examples where the PTAB has invalidated a patent that had previously been upheld by the Federal Circuit Court of Appeals. One recent examination further found that there have been at least 58 patents that were upheld in federal district courts that were invalidated in the PTAB on the same statutory grounds. The different results are not mere happenstance but are the result of strategic behavior by petitioners to strategically abuse the procedures of PTAB proceedings.

It has been well known that the procedures have been stacked against patent owners from day one. We and others have noted how broadly construing claims, multiple filings against the same patent by the same challengers, and the inability to amend claims, among other abuses, severely disadvantage patent owners in PTAB proceedings.

With the STRONGER Patents Act, these proceedings will move closer to a fair fight to truly examine patent validity. There are many aspects to this legislation that will improve the PTAB, such as:

  • Harmonizing the claim construction standard with litigation, focusing on the “ordinary and customary meaning” instead of the broadest interpretation a bureaucrat can conceive. This will promote consistent results when patents are challenged, regardless of the forum, by assuring that a patent does not mean different things to different people. Sections 102(a) and 103(a).
  • Confirming the presumption of validity of an issued patent will apply to the PTAB just as it does in litigation. This will allow patent owners to make investments with reasonable security in the validity of the patent. Sections 102(b) and 103(b).
  • Adding a standing requirement, by permitting only those who are “charged with infringement” of the patent to challenge that patent. This will prevent the abusive and extortionate practice of challenging a patent to extract a settlement or short a company’s stock. Sections 102(c) and 103(c).
  • Limiting abusive repetitive and serial challenges to a patent. This will prevent one of the most common abuses, by preventing multiple bites at the apple. Sections 102(d), (f) and 103(d), (f).
  • Authorizing interlocutory review of institution decisions when “mere institution presents a risk of immediate, irreparable injury” to the patent owner as well as in other important circumstances. This change will allow early correction of important mistakes as well as provide for appellate review of issues that currently may evade correction. Sections 102(e) and 103(e).
  • Prohibiting manipulation of the identification of the real-party-in-interest rules to evade estoppel or other procedural rules and providing for discovery to determine the real-party-in-interest. Because many procedural protections depend on identifying the real party-in-interest, this change will assure that determining who that real party is can occur in a fair manner. Sections 102(g) and 103(g).
  • Giving priority to federal court determinations on the validity of a patent. Although discrepancies will be minimized by other changes in this Act, this section assures that the federal court determination will prevail. Sections 102(h) and 103(h).
  • Improving the procedure for amending a challenged patent, including a new expedited examination pathway. This section goes further than Aqua Products, prescribing detailed procedures for adjudicating the patentability of proposed substitute claims and placing the burden of proof on the challenger. Sections 102(i) and 103(i).
  • Prohibiting the same administrative patent judges from both determining whether a challenge is likely to succeed and whether the patent is invalid. This section will confirm the original design of the PTAB by assuring that the decision to institute and final decision are separate. Section 104.
  • Aligning timing requirements for ex parte reexamination with inter partes review by prohibiting requests for reexamination more than one year after being sued for infringement. This section will prevent abuses from the multiple post-grant procedures available in the USPTO. Section 105.

Second, the STRONGER Patents Act will make other necessary corrections to allow patents to promote innovation. For example, as Section 101 of the Act confirms, patents are property rights and deserve the same remedies applicable to other kinds of property. In eBay v. MercExchange, the Supreme Court ignored this fundamental premise by holding that patent owners do not have the presumptive right to keep others from using their property. Section 106 of the STRONGER Patents Act will undo the disastrous eBay decision and confirm the importance of patents as property.

Third, the STRONGER Patents Act will once and for all eliminate USPTO fee diversion. Many people do not realize that the USPTO is funded entirely through user fees and that no taxpayer money goes to the office. Despite promises that the America Invents Act of 2011 would end fee diversion, the federal government continues to redirect USPTO funds to other government programs. This misguided tax on innovation is long overdue to be shut down.

Each of the steps in the STRONGER Patents Act will help bring balance back to our patent system. In addition to the major changes described above, there are also smaller changes that will be important to ensuring a vibrant and efficient patent system. CPIP co-founder Adam Mossoff testified to Congress about the harms being done to innovation through weakened patent protection. It is great news to now see Congress taking steps in the right direction.

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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.

Categories
Copyright Patents

CPIP Fall Conference Papers Highlight How Intellectual Property Rights Promote Global Prosperity

2016 Fall Conference flyerBy Alex Summerton

The George Mason Law Review has just published the papers from our Fourth Annual Fall Conference, Intellectual Property & Global Prosperity, which was held at Antonin Scalia Law School, George Mason University, in Arlington, Virginia, on October 6-7, 2016. The conference highlighted the importance of IP rights in the global marketplace and discussed how countries that leverage the availability of such protections enjoy creative, technological, and economic benefits far surpassing those that place less value on IP.

The newly-published papers are outlined below:

Kristina M. L. Acri, née Lybecker, Economic Growth and Prosperity Stem from Effective Intellectual Property Rights, 24 Geo. Mason L. Rev. 865 (2017)

Professor Kristina Acri of Colorado College discusses the importance of IP in incentivizing innovation by enabling firms to recuperate development expenditures. She explains how the static loss resulting from the patent system is far offset by the dynamic gains resulting from both increased innovation and public disclosure of knowledge. Acri identifies how countries employing strong IP regimes realize greater benefits in pharmaceutical innovations in the form of more available treatments and earlier implementation than countries with weaker protections. Furthermore, she highlights how robust IP systems encourage both revolutionary and incremental technology developments, promote domestic technology industries, and foster new employment opportunities for domestic labor forces.Key to this analysis are the fundamental economic forces that drive patented innovation. Acri discusses the importance of patents to innovator companies that must bear substantial fixed costs in the form of research and development, while generic competitors need only compete on negligible marginal costs with the innovators. She further explores how countries employing strong patent protections attract innovation businesses, as well as develop investment industries and educated workforces to support such innovation. Finally, Acri analyzes the positive correlation between a country’s rank as an innovative hot spot and the relative strength of its IP protections.

Walter G. Park, Averting a “Tripsxit” From the Global Intellectual Property System, 24 Geo. Mason L. Rev. 883 (2017)

Professor Walter Park of American University examines the benefits that developing countries can realize by implementing stronger IP right systems in the context of the globalized marketplace. He considers the effect the TRIPS Agreement has had on the relationship between developed and developing countries as a function of the grant rates for technologies originating from various countries and the balance of technology imports and exports. Park seeks to explain why certain countries have developed into technological powerhouses in the last few decades, while others have remained behind and lagged in technological production.Park looks at various factors that could have influenced, and in turn have been influenced by, these divergent development paths, such as trade practices, legal and sociological structure, and the flexibility that TRIPS gives member states to set their own schedules. He concludes that countries seeking to move themselves into modern economies can benefit greatly by examining and adjusting their IP regimes to encourage both domestic and foreign innovations and investment in the local territory.

Stan Liebowitz, The Case for Copyright, 24 Geo. Mason L. Rev. 907 (2017)

Professor Stan Liebowitz of the University of Texas explores several rationales for copyright, commenting on both economic and moralistic perspectives and discussing how, as a common misconception, many people fail to recognize that the property rights imparted by copyright truly enable economic returns. He focuses heavily on the economic case for copyright, seeking to dispel the myth that copyright is an economic monopoly. Liebowitz notes that popular works enjoy unusually high monopoly-like rents because they are uncommon and disproportionately successful as compared to unpopular works, not because they benefit from any economic monopoly imparted by copyright.Liebowitz discusses the concept of market-determined values of works in contrast to alternative systems such as centralized markets and patronage systems, and he concludes that these alternative systems lack the ability to incentivize the production of either high quality or high quantities of works. Finally, he explores the moral justifications for the remuneration of authors of successful works and discusses several alternative, although morally absurd, repugnant, or questionable, systems for securing payments for authors. Liebowitz posits that copyright enables markets to efficiently set the price of works and facilitates the determination of what society does and does not want produced.

Brett Danaher & Michael D. Smith, Digital Piracy, Film Quality, and Social Welfare, 24 Geo. Mason L. Rev. 923 (2017)

Professors Brett Danaher of Chapman University and Michael Smith of Carnegie Mellon University assess the impact of piracy of copyrighted works on the production, in terms of both quantity and quality, of artistic works, particularly films. They discuss the trade-offs of copyright enforcement versus piracy for consumers and producers, and they outline the expected welfare transfers that occur for both users who would and would not otherwise purchase the consumed media in the absence of piracy. Danaher and Smith also delve into the hidden impact that piracy and the non-enforcement of copyright laws have on markets that traditionally have relied on copyright.Danaher and Smith analyze the origination of high-quality works and examine how the rise of online piracy has caused a depression in the production of award-winning films in countries where copyright is laxly enforced. They further identify the collateral negative effects of the lack of copyright enforcement, including the frustration of attempts to secure funding for riskier projects. Danaher and Smith explain how this potentially robs the world of artistically meritorious, but financially unsafe, projects, thereby decreasing overall social welfare.

Kevin Madigan & Adam Mossoff, Turning Gold Into Lead: How Patent Eligibility Doctrine is Undermining U.S. Leadership in Innovation, 24 Geo. Mason L. Rev. 939 (2017)

CPIP Legal Fellow Kevin Madigan and Professor Adam Mossoff of George Mason University focus on recent developments at the Supreme Court that have made patenting high-technology inventions, particularly in the computer and biotechnology disciplines, more difficult and the consequential danger this poses to the United States’ position as a global innovation leader. They begin by reviewing the late-20th century jurisprudence that placed the U.S. in a position to be a technological force in the new millennium, especially with respect to the patentability of biotech and computer technology. Madigan and Mossoff then review more recent Supreme Court precedents that have led to a recession from a pro-patentability position while providing very little guidance on what could be patentable.Madigan and Mossoff go on to assess how this change in jurisprudence has resulted in a retreat from America’s position as a patent powerhouse. They point to cases where applications were rejected as unpatentable subject matter in the U.S. while the corresponding technologies were found to be patentable in Europe and China. Madigan and Mossoff also discuss the general trend of rejecting applications and invalidating patents with scant actual justification for why those applications and patents were patent ineligible. They conclude that data available from the last few years shows that the U.S. may be receding as a technological center since its patent laws have become unreliable for inventors and investors seeking protection.

Jiarui Liu, The Predatory Effects of Copyright Piracy, 24 Geo. Mason L. Rev. 961 (2017)

Professor Jiarui Liu of the University of San Francisco analyzes strategic behavior in copyright enforcement, particularly in countries that have not yet developed robust copyright industries and that have lessened incentive to invest in effective copyright policy. He discusses the phenomenon in China, where large copyright entities sometimes prefer pirating of their works to enforcement when they cannot expect any return for their work. As Liu explains, expecting the ability to develop a market and later determine how to recover payments for pirated copies, this lax enforcement of copyright policy results in a suppression of domestic industries that would compete with large entities.Liu outlines the reality of copyright enforcement in China, a lackluster effort on the part of the Chinese government that has led to rampant piracy of a wide range of copyrighted works. He explains how the piracy of software products, such as Microsoft Office, has stunted the development of new and competing technologies, a result implicitly approved by the market-dominant copyright owners. Liu compares this behavior of strategic non-enforcement to predatory pricing practices traditionally viewed as part of antitrust law, since it places the product into consumer hands at an initial loss in order to establish market dominance that will later enable the firm to exert monopoly power once its product has become the dominant force. Finally, Liu discusses possible mechanisms of corrective actions, both private and public, to combat non-enforcement as strategic behavior.

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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
Innovate4Health

Innovate4Health: Nutriset Uses Patents and Trademarks to Fight Severe Malnutrition Across the Globe

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

Innovate4HealthBy Nick Churchill

Malnutrition is one of the greatest global health challenges, particularly with regard to children and pregnant women in developing countries. Undernutrition contributes to nearly half of all deaths among children under the age of 5 and has lifelong consequences for physical and cognitive wellbeing.

Nutriset has confronted the global malnutrition problem head-on by developing a range of innovative nutritional products and using its intellectual property to help developing countries reach nutritional autonomy.

Malnutrition is a blanket term that includes both undernutrition and micronutrient deficiency. An estimated 11 percent of the world’s population, or 815 million people, are undernourished. Undernourished people are particularly vulnerable to disease and death, and both undernutrition and deficiencies in micronutrients can prevent proper growth and development. Undernutrition causes children to underperform in school and makes adults less able to work, perpetuating a cycle of poverty. It can also be deadly. Children suffering from severe acute malnutrition, characterized by very low weight and visible muscle wasting, require urgent treatment to survive.

Severely undernourished patients have traditionally been treated with powdered foods which are dissolved in water before consumption. These powdered products carry risks of dosage errors and bacterial contamination, and they are likely to cause diarrhea in undernourished patients. They also tend to have short shelf lives, particularly in tropical climates.

Nutriset was founded in 1986 by Michel Lescanne with the mission of “focusing on research in the field of humanitarian nutrition, developing innovative solutions and acting as an interface between the worlds of humanitarian aid, nutritionists and food industry technologies.” Since then, Nutriset has developed several therapeutic milks, pastes, and tablets. In 1996, Nutriset partnered with Dr. Andre Briend to create Plumpy’Nut®, the first ready-to-use therapeutic food (or, RUTF) for the treatment of severe acute malnutrition.

This new product was field tested in Malawi by Dr. Mark Manary, who discovered that RUTFs were much more effective than traditional treatments. Dr. Manary was able to clear his hospital’s malnutrition ward and use RUTFs to treat his patients at their homes, while increasing the recovery rate from 25% to 95%. Given the product’s success, Dr. Manary recognized the long-term impact RUTFs could have if they were manufactured in the countries that needed them. Together, the doctors simplified the recipe so it could be produced locally.

A woman and child sitting on a bend next to a box. The woman is giving the child something to drink.Plumpy’Nut® has a long, 2-year shelf-life, is formulated to avoid diarrhea-type side effects, and can be eaten right out of the packet, eliminating the risks of dosage errors and contamination associated with mixing a powder with water. Plumpy’Nut®’s long shelf-life, effectiveness, and ease-of-use have led to a rise in community-based treatment of acute malnutrition and have made it possible to treat children in areas that were not reached by traditional methods.

Nutriset has used its patent rights to further increase access to its technologies in developing countries through its PlumpyField® network. Nutriset partners with local entrepreneurs in franchise-like relationships to create sustainable production systems in developing countries. In addition to benefiting from Nutriset’s reputation and manufacturing experience, network partners are given access to Nutriset’s patents and trademarks. The franchise-like system based on granting rights to use its intellectual property allows Nutriset to ensure that all products being locally produced by network members embody the innovations that actually help those suffering from malnutrition. And by supporting the local manufacture of its innovative products, Nutriset enables its partners to provide jobs to local people, source raw materials from local farmers, and customize the products to address the specific nutritional needs of their communities, while decreasing dependency on foreign organizations.

The PlumpyField® network consists of 9 members based in Central America, Africa, Asia, Europe, and the U.S. While the majority of the products are still manufactured in France and the U.S., members in developing countries continue to increase their production capacity, bringing the network’s total capacity to 117,400 metric tons. In 2016, the network’s products were used to treat nearly 8 million children. Thanks to Nutriset’s focus on incentivizing local capacity, that number will surely rise. According to the United Nation’s Food and Agriculture Organization, increasing local production is one of the best ways of ensuring long-term food security. Nutriset’s success in this endeavor would not be possible without its intellectual property rights.

The story of Plumpy’Nut® and PlumpyField® illustrates the power of intellectual property rights to improve and save lives. Not only do IP rights encourage the development of innovative products, they can be used to implement sustainable solutions to some of the world’s most pressing health challenges.

#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: New Oxygen Machine Technology Confronts Blackouts in Emerging Nations

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

Innovate4HealthBy Andrew B. Levey

Oxygen therapy, where supplemental oxygen is used as a medical treatment, is vital to children with pneumonia. Rolling blackouts in Uganda and other developing nations, which can last for hours at a time, are stopping oxygen concentrators—machines that concentrate oxygen from the ambient air—from providing this vital therapy. Problems are worse in more remote places that lack an electricity infrastructure in the first place. As a result, children already vulnerable to pneumonia are denied effective treatment. Currently, pneumonia accounts for at least 18% of all deaths of children under 5 years old.

The World Health Organization has stated that methods for providing oxygen are needed in low resource settings to combat poor energy infrastructure and theft of needed supplies. Through their FREO2 Foundation, Professors Roger Rassool and Jim Black of the University of Melbourne are tackling this problem with the FREO2 – Siphon.

FREO2 has improved upon existing oxygen concentrator technology by locally storing oxygen at low pressure, available when needed to supplement a disconnection of energy to the machine. While developing a new approach to the technology, the team managed to keep costs low and produce a product suitable for remote relocations vulnerable to blackouts. Lack of reliable electricity has been addressed in other ways, but those methods are only sufficient for larger, more established medical facilities. More remote and desolate clinics needed a different solution.

Professors Rassool and Black developed a concentrator which utilizes running stream water to create a low-pressure vacuum, which can be used to separate oxygen from the air in the environment. The team determined that the central issue is not specifically energy related, but a matter of creating a difference in air pressure to create air flow. The final product is cost efficient, easy to use, and simple to operate. Taking a step back and re-imagining the basic concepts of an oxygen concentrator allowed the team to arrive at the conclusion that electricity was not needed. A working prototype is already operating in Gippsland, Australia, with planned expansion to other countries. Professor Rassool is conducting operational and field work studies in Uganda to begin implementation of the device where it is needed most.

FREO2’s patent application describes the foundational innovation. Concentrating oxygen from the atmosphere involves passing air over a “molecular sieve,” which removes nitrogen and leaves primarily oxygen behind. The energy to move the air across the sieve in older technology was electricity creating high pressure to push air into the sieve. Figure 2 from the patent application shows how a siphon operating between two levels of water can accomplish the same goal by pulling the air instead of pushing. The water flowing through the siphon will draw in air, shown in typical patent fashion with a number (13) and a line. Drawing in air creates a vacuum that can be used to pull air into the sieve and concentrate the oxygen.

Figure 2 from the patent application

The Bill & Melinda Gates Foundation and numerous others have recognized the value of the innovation, awarding the inventors funding to continue research, development, and deployment of their invention. FREO2 is posed to continue its research and manufacturing into the near future. Ultimately, the inventors hope to bring their start up to Australia whereby they would establish a network within the community and potentially form manufacturing capabilities for future deployments. As the inventors note, they have a long road ahead but the rewards to be reaped are great.

The FREO2 device will save lives. As the inventors emphasize, the innovative technology allows remote clinics to keep oxygen concentrators performing by simply utilizing available water sources, which will support their primary mission—saving lives. And the benefits of IP protection will help assure that they fulfill their mission.

#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 Patents

Innovate4Health: Nanobiosym’s Gene-RADAR Brings Real-Time Results for Zika Testing

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

Innovate4HealthBy Gabrielle Eriquez

Because there is currently no preventative vaccine for Zika, a mosquito-borne virus known to cause severe birth defects in pregnant women, the ability to obtain a fast and accurate diagnosis is critical. However, especially in the developing world where Zika’s presence is greatest, there are significant issues with current diagnostic tests: they are in extremely high demand, especially during the summer months, and, accordingly, are very costly.

Enter Nanobiosym’s Gene-RADAR: a tablet-sized device which can detect Zika RNA from human serum. Though it is currently only authorized for Zika testing pursuant to an FDA Emergency Use Authorization, this device has the potential to facilitate the availability of faster, cheaper Zika testing worldwide.

Due to the scale of the disease, getting tested for Zika is not as simple as a quick trip to a local clinic. Testing criteria prioritize pregnant women who have possibly been exposed to the virus. These criteria result in many others who are not pregnant, but still may have been exposed, being turned away from getting tested.

mosquitoThe problem is even greater in developing countries in Latin America. Poor areas lacking adequate sanitation and air conditioning are favorable breeding grounds for mosquitoes. The only advice that many of these countries give to women to combat Zika is to avoid pregnancy; however, these countries have the world’s highest proportion of unintended pregnancies.

The difficulties in preventing and combating Zika that impoverished people in Brazil face have been well documented. For those living in more affluent areas, Zika testing is available even for patients who are not pregnant. But at free public clinics in poorer neighborhoods (where it is easier to contract Zika), lines are out of the door. Symptomatic patients spend hours waiting, only to receive saline for dehydration and to still have to return if their symptoms persist.

The lack of available testing for many patients in developing countries is influenced by cost. Tests are typically hundreds of dollars. For those who can’t even afford window screens or insect repellant, affording a Zika test at this price is next to impossible.

Timing is the other likely factor contributing to this issue. Dr. Anita Goel, CEO and founder of Nanobiosym, noted that even in Florida, testing was back-logged due to medical centers having to ship patients’ samples to outside labs. Results could take up to five weeks to come back.

Outside the U.S., 4 billion people don’t even have access to this basic, albeit inefficient, centralized testing mechanism. “[In developing countries], clinical testing is offered by the occasional network of unregistered laboratories operating without regulatory oversight. Services might be of too poor quality to be of any worth in medical decision-making.” Timing is obviously crucial for pregnant women, but it is also important for any other potentially-infected person, since Zika can be transmitted sexually whether or not symptoms are present.

Gene-RADAR has the potential to remedy these issues by decentralizing and mobilizing testing, thus lowering cost and wait time. Gene-RADAR employs nanobiophysics to diagnose in real time diseases that contain DNA or RNA.

This foundational technology is not limited to Zika. The mobile device was an award nominee for Saving Lives at Birth’s 2015 Grand Challenge for Development for utilizing the platform to detect early HIV in infants in Rwanda. It was also presented in the same year as a diagnostic solution for other global pandemics such as Ebola.

Centralized lab platforms can run from several hundred thousand to one million dollars. Though Gene-RADAR’s cost is still being optimized, the goal is to make it affordable even to the poorest areas of the globe. In terms of wait time, Gene-RADAR should be able to return results in about an hour, eliminating the back-log problem that comes with centralized testing mechanisms.

Gene-RADAR is patented, and does not require running water, constant electricity, or highly-trained personnel to operate. The patented improvements over previous technologies both result in a smaller machine and improvements in the accuracy of testing.

The device’s footprint is much smaller than that of large, centralized testing machines. Gene-RADAR is tablet-sized and only 3.5 pounds, versus 50-plus-pound platforms that are certainly not mobile and likely do rely on constant electricity.

Gene-RADAR diagnosis is also more accurate than that of the other Zika tests currently available. Current testing methods that look for Zika-specific antibodies have a high proportion of false positives. Other tests, like Gene-RADAR, look for DNA or RNA. But these other tests also result in false positives by confusing a sequence with that of another Zika-like virus, such as Dengue. The advances in Gene-RADAR improve accuracy to solve these problems by detecting a virus’s precise RNA sequence.

From a public health perspective, testing as many people as possible in at-risk areas will help contain the virus. If people know quickly whether they’re infected, there is less of a chance of infecting others. Through multiple global initiatives, Nanobiosym’s next step is to increase production and distribution where the need is greatest.

According to Dr. Goel, patent protection via the Nanobiosym incubator has allowed this revolutionary technology to expand beyond the research labs. “Our incubator focuses on bringing together a holistic approach using physics, medicine, nanotechnology, and information technology to create new science or technology, then incubate it all into different products and spin-off companies that can transform how we solve some of the world’s greatest challenges.”

The innovative technology that is Gene-RADAR is a prime example of innovation working to promote groundbreaking solutions to real-world challenges. For Zika (and other diseases with genetic footprints), this means the potential for cheaper, faster, and more readily-available testing that would undoubtedly benefit global health.

#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 Patents

Innovate4Health: GRIT Leveraged Freedom Chair Brings Mobility to Developing World

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

innovate4healthThe World Health Organization (WHO) estimates that over 65 million people in the developing world need an appropriate wheelchair. Over 75% of people in the developing world live in rural areas, where standard wheelchairs do not work, as they are hard to mobilize over rugged terrain and rough local roads that may not be paved. Further, most wheelchairs are difficult to maintain: they are comprised of many pieces that are easy to break and hard to repair, and they are expensive to replace.

The Leveraged Freedom Chair (LFC) is a wheelchair that solves this international humanitarian problem. It enables people with disabilities in developing countries to gain mobility and independence, and it gives them the ability to navigate their environment in life-changing ways and at a viable cost. The LFC is built out of steel and bicycle parts that are commonly available in rural areas of developing countries. The parts and tools for maintenance and repair are inexpensive and commonly found. This makes it easier to repair the wheelchair at local bicycle shops or wherever spare parts may be found.

The construction of the LFC is engineered to meet the diverse challenges that arise in developing countries. The LFC uses a unique lever drivetrain which makes it both faster than conventional wheelchairs and sturdier when traveling over rough terrain. It does not use gears and derailleurs, which can be expensive and easily broken; it instead uses levers connected to the drivetrain to control velocity and speed. By using readily available bicycle parts in the production of the LFC, costs are kept down and users can maintain and repair the chairs themselves.

The lever construction is one of the high points of inventiveness of the LFC. Instead of pushing on the wheels like a regular wheelchair, LFC riders push on two levers, which are designed to be biomechanically efficient. LFC riders can shift gears by moving their hands up and down the levers. For smoother roads, riders push on a low part of the levers and shift into “high gear,” which enables them to travel 80% faster than a regular wheelchair on tarmac. For rougher terrain, riders push on a high part of the levers and shift into “low gear,” which enables them to ride over obstacles with 50% more torque than a regular wheelchair. The levers can be removed and stored on the wheelchair, which allows the LFC to be used like a regular wheelchair indoors.

The LFC was conceived and developed in 2007–2008 by four graduate students in the mechanical engineering program at MIT who then founded a company in 2012 called Global Research Innovation and Technology, or GRIT, to develop and commercialize their invention. The LFC has been in development since 2008. First-generation prototypes of the LFC were constructed in Kenya and Vietnam with community partners who were also local wheelchair producers. In 2014, GRIT secured Patent No. 8,844,959 for the LFC, a “wheelchair with level drivetrain.”

The company now manufactures the LFC in India with a local partner and sells it in bulk for $250 per chair to non-governmental organizations (NGOs) and other development organizations. The aid agencies and NGOs that purchase the chair generally distribute the LFC to users free of charge. In 2015, the GRIT management team estimated that it had shipped almost 1,200 LFCs to 17 countries, including Guatemala, Haiti, Kenya, Uganda, Tanzania, India, the Philippines, and Vietnam.

The team at GRIT runs the company as a “social enterprise,” pursuing a social mission (like a nonprofit) but also retaining the ability to make money off their patented invention. As a for-profit social enterprise, GRIT can accept money from nonprofit foundations that is congruent with its mission, but it can also raise private equity like a regular startup.

GRIT has earned numerous awards and honors for the LFC, including winning a Patents for Humanity Award from the U.S. Patent and Trademark Office in 2015.

After spending several years developing the LFC, GRIT decided to build upon its patented technology and develop wheelchairs similar to the LFC but more suited to use in first-world countries. The GRIT Freedom Chairs are somewhat sleeker in design, and have certain features that appeal to first world riders, such as a lightweight frame, optional customization, and the ability to be folded and stored in the trunk of a car. The sale of these chairs is intended in part to defray the costs of distributing chairs at or below cost in developing world countries. GRIT Freedom Chairs afford users access to previously-inaccessible terrains, and offer versatility to a broad array of riders, including American veterans. They are directly marketed in the U.S. in order to keep costs down.

People with limited mobility in developing countries face many daunting obstacles, and the lack of appropriate wheelchairs can severely limit their mobility, opportunities, access, and independence. The GRIT Leveraged Freedom Chair is an elegantly simple, inexpensive, and ingenious device that confers freedom to wheelchair users in the developing world. Its underlying technology, secured by vital U.S. patents, is also the basis of the GRIT Freedom Chair, which likewise transforms the lives of users in the developed world. Both the LFC and the Freedom Chair rely on secure property rights that enable their parent company to develop and market life-changing products that users can afford to ride, repair, and maintain. The “all-terrain wheelchair” is truly an invention with worldwide relevance and reach.

#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 Patents

Innovate4Health: Treating Neonatal Jaundice in the Developing World with D-Rev’s Brilliance

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

Innovate4HealthBy Nick Churchill

Severe neonatal jaundice kills over 100,000 newborn babies annually and causes severe brain damage to thousands more. In most cases, the condition can be treated by simply shining a blue light on a baby’s skin. However, each year more than 6 million infants worldwide do not receive adequate treatment. The problem is particularly severe in low-income countries, where many hospitals cannot afford the equipment to treat jaundice.

To address this global health problem, the innovators at D-Rev, a non-profit firm based in San Francisco, designed a high-performance, affordable device called Brilliance to treat severe neonatal jaundice. Brilliance has been praised by users as “effective and user-friendly,” and it was honored as the top innovation in the Health category of the 2016 Tech Awards. Since the introduction of the first Brilliance model in 2012, D-Rev estimates that the device has treated over 250,000 babies and has averted approximately 3,400 infant deaths and disabilities.

Neonatal jaundice occurs when a newborn has elevated levels of bilirubin in the blood. Approximately 18% of babies have severely high levels of bilirubin, which, left untreated, can lead to brain damage, cerebral palsy, hearing loss, and even death. Severe jaundice can be treated with a process called phototherapy, which involves placing the baby under special blue lights. When the light is absorbed by the infant’s skin, it helps break down bilirubin. Treated properly, severe jaundice usually does not cause lasting damage.

Phototherapy has long been recognized as a simple and effective treatment for severe neonatal jaundice; but at around $3,000, traditional phototherapy devices are prohibitively expensive for many hospitals in developing countries. Hospitals that can obtain a traditional unit are often unable to afford the maintenance and repair costs necessary to keep it running. The unreliable electrical systems in many developing countries can cause voltage spikes that damage device components. Commonly used fluorescent lamps require frequent replacement. As a result, phototherapy is unavailable to babies in many developing communities.

D-Rev is a product development company founded in 2007 to provide world-class, affordable healthcare technologies to people living on very low incomes. After learning that severe jaundice continues to cause brain damage in many parts of the world, D-Rev staff members visited hospitals in India and Nigeria to assess the availability of effective phototherapy and found that most of these hospitals did not have phototherapy devices that met standards for care. With the problem identified, D-Rev’s design team got to work.

D-Rev’s advanced devices, for which they are seeking a patent, uses LEDs that last 60x longer than fluorescent lamps, saving hospitals over $240 per year on replacement bulbs. Brilliance is designed to withstand a range of power fluctuations without affecting performance and operates without cooling fans or filters, so there are fewer parts to maintain. The device is height-adjustable and can be integrated with the wide variety of other critical neonatal medical equipment found in hospitals serving low-income communities.

Importantly, D-Rev’s devices are inexpensive to manufacture, which allows D-Rev to sell them for hundreds, instead of thousands, of dollars. The newest model incorporates the technology in their patent application, which ensures light intensity levels remain consistent across the treatment area at any angle of tilt. D-Rev also developed an integrated light meter to help healthcare providers ensure that infants receive appropriate doses of light, something many low income hospitals were previously unable to do. Thus, the innovations developed by D-Rev are improving the technology and reducing cost, making much needed treatments more accessible in the developing world.

After successfully designing an affordable and effective phototherapy device, D-Rev’s next challenge was to find a way to deliver Brilliance to the hospitals that needed it most. D-Rev’s CEO, Krista Donaldson, recognized that the firm would need help to establish a sales and distribution network, noting, “We knew we needed to license in this case.” To achieve its goals, D-Rev needed to find a partner willing to manufacture its products and distribute them to hospitals and clinics in the poorest communities in the world.

D-Rev licensed its technology to Phoenix Medical Systems, a neonatal equipment firm based in India, who agreed to manufacture and distribute Brilliance while capping its price. The licensing agreement was structured so that D-Rev would take a smaller royalty on sales to public and district hospitals, which tend to serve lower-income patients. In this way, D-Rev used its intellectual property rights to align the incentives of Phoenix’s sales team with D-Rev’s goal of reaching those patients who are most in need of affordable phototherapy.

Donaldson has explained why D-Rev’s protection of its intellectual property “is a prerequisite to having the broadest possible impact.” First, intellectual property rights allow D-Rev to ensure that the quality of its products remains consistent. As Donaldson notes, a medical device “cannot fail the user, particularly a user in a vulnerable population.” Second, inconsistency erodes consumer trust, which limits the impact of a product. Third, D-Rev recognizes that designing an effective product does not necessarily solve the targeted problem. By retaining control of its intellectual property, D-Rev can ensure consistent manufacturing of its products, sustainable delivery to users who need it, and continued maintenance and support. Finally, D-Rev protects its intellectual property because the market is “the most economically sustainable and scalable way” of reaching their intended customers.

D-Rev has demonstrated that the value of intellectual property goes beyond incentivizing life-saving innovation like Brilliance. Intellectual property rights empower innovators to increase their impact by partnering with market leaders like Phoenix. As Donaldson concluded: “To succeed, serious partners (for-profit or non-profit) must also make an investment, and none are willing to do that with the threat of knock-offs.”

#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.