Tag: patent

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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.

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Innovation Legislation Patent Law

CPIP Co-Founder Testifies at House Judiciary Committee Hearing on IP

U.S. Capitol buildingCPIP co-founder Adam Mossoff testified on June 13 before the House Judiciary Committee’s subcommittee on the Courts, Intellectual Property and the Internet.  He and other witnesses testified about the impact of the Supreme Courts recent decision in TC Heartland LLC v. Kraft Foods Group Brands LLC on innovators and the possibility of future changes to patent law.

For those not familiar with the decision, it held that patent lawsuits against corporations must be filed either where the corporation is incorporated or where it has infringed the patent and has a “regular and established placed of business.” This is different than the rule for most litigation which generally allows a lawsuit to be filed wherever a court may exercise jurisdiction over the corporation.  Thus, TC Heartland placed constraints on patent owners enforcing their rights that don’t exist for other litigants.

Although the hearing was nominally about TC Heartland and venue for patent suits, Members of Congress and witnesses took the opportunity to address broader issues of innovation policy.  In his opening statement, Professor Mossoff primarily described how patent owners—particularly individual inventors and small businesses—will now be required to file multiple lawsuits all across the country to enforce their rights.  This will drastically increase the costs of protecting their property from infringers, which for many innovators will be cost prohibitive.  Professor Mossoff mentioned one such inventor, Bunch-o-Balloons inventor Josh Malone, who is being seriously harmed by the inability to protect his invention from rampant infringement.  Together with the litany of other recent disastrous changes to our patent system, innovators are now in a precarious position when deciding to rely on patents to protect their inventions.

Much of the hearing was taken up by questions of what the impact of the TC Heartland decision will be.  There was general agreement that the concentration of patent cases in only a few districts will continue.  Under the old regime, many cases were filed in the Eastern District of Texas.  Under the new regime, these cases will now be filed in the Northern District of California or the District of Delaware.  There was also general agreement that this would benefit accused infringers, who will now be litigating in their preferred fora.

Adam MossoffUnfortunately, much of the discussion centered around a perceived problem with patent “trolls.”  This epithet based on myths is often used in the place of reasoned debate for patent policy.  As Professor Mossoff explained, as deployed in research and policy debates, this term would make even famous inventors like Thomas Edison a troll.  Furthermore, it is both wrong and irresponsible to assume that patent owners who license their inventions are practicing an illegitimate business model. Just as it is perfectly legitimate for a landlord to rent her property instead of selling it, it is likewise perfectly legitimate for a patent owner to license her patent rights instead of manufacturing and selling products to customers. And just as it is legitimate for a landlord to sue a squatter for trespass, it is equally legitimate for a patent owner who licenses her property rights to sue for infringement.

Several questions focused on broader patent issues in the context of whether or what Congress should do next for patent law. The Global Intellectual Property Center of the Chamber of Commerce recently reported that the United States had slipped from 1st to 10th in their annual ranking of patent systems.  Reasons for the degradation of our patent system are obvious: death squads killing patents at the PTAB, subject matter eligibility standards that make oil rigs outside the scope of patent laws, and the inability of patent owners to prevent others from infringing their rights through injunctions.

As Professor Mossoff emphasized, Congress’ first priority should be “do no harm.” Rather than make another attempt to pass legislation further restricting patent owners’ rights, it would be better for Congress to simply do nothing.  However, Congress could make the patent system better for innovators.  One step already being discussed that would be a positive improvement is the suggestion to amend section 101 to limit the scope of the judicial exceptions to subject matter eligibility.  At the hearing, Professor Mossoff astutely noted that the first patent ever issued in the United States—being held up at that moment by Chairman Darrell Issa—would likely be invalidated under current patent eligibility standards.

Many questions directed at the witnesses asked for them to propose specific solutions to either perceived venue abuses or broader patent law issues. Professor Mossoff stressed that systemic changes to the patent system will not just affect a few bad actors, but all of the individual inventors, small businesses, universities, licensing companies, and R&D-intensive high-tech and bio-pharma companies who rely on the patent system to protect their innovations.  These types of companies have been the fountainhead of the U.S. innovation economy for more than 200 years.  “Reform” that only addresses the concerns of accused infringers, but not the costs to patent owners, is doomed to do more harm than good.

Professor Mossoff’s written testimony can be found here.  Video of the hearing can be found here.

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Copyright Patents Trademarks

From Star Wars to La La Land: How Intellectual Property Fuels Films

The following post comes from Mandi Hart, a rising third-year law student at Antonin Scalia Law School, George Mason University, who worked as a video producer before going to law school.

cameraBy Mandi Hart

Movies are a first-love in America and around the world, and their production is made possible by the existence of intellectual property (IP) rights. Although most moviegoers may not recognize the vital role that IP plays in film, without it, screens would be dark. This post explains the critical role that copyright, trademark, and patents play in film production and financing.

Copyright is the Lifeblood of Movies

Copyright secures to creators certain exclusive rights in their original works of authorship, including rights of reproduction, distribution, public display, performance, and the creation of derivative works. These exclusive rights make it possible for creators and copyright owners to deploy their creative works as property rights in a free market.

Copyright’s exclusive right to distribute creative works is particularly important in the film industry. Distribution deals are essential to the filmmaking process, as many filmmakers finance the production of their movies by selling the exclusive right to distribute their film in a given territory. Distributors purchase these rights via a pre-sale, committing to pay a certain amount to the producer when the completed film is delivered in accordance with technical specifications. The pre-sale agreement serves as collateral for bank loans that provide actual cash for a film’s production. Once a film is completed and delivered, the payment from the distributor is then used to pay back the loan.

Without copyright, producers would have no distribution rights to sell in the first place, and without distribution deals, many producers wouldn’t be able to secure the funding necessary to make their movies.

Copyright also makes it possible for authors to option pre-existing works for adaptation into movies. An author or publisher can sell a film producer the right to create a derivative work from a novel, short story, play, or comic book. And films themselves might inspire derivative works—think of the breadth and popularity of Star Wars movies and shows today, 40 years after the original movie was released. Copyright not only protects the original creative works that often serve as the foundation for films, it also makes possible the many licensing deals that turn individual films into trilogies, series, or full-blown universes.

Copyright also fuels the music and sounds we hear in movies. From original scores and sound effects to the innumerable songs licensed for use in movies, copyright ensures that the people involved in the creation of movie sounds—whether artists, composers, or engineers—are incentivized and rewarded for their contributions.

By giving artists and creators a property right in the fruits of their artistic labor, copyright provides the foundation for the creation of movies as we know them today.

Trademark Helps Movies Get Made and Protects Their Brands 

Just as copyright protects several aspects of any given film, trademark helps establish and protect a movie’s brand while providing supplemental sources of financing. As studios move away from traditional film financing mechanisms due to economic recession, consolidation within the industry, and risk-aversion in credit markets, a growing number of producers are looking for new funding sources. Product placement has become an increasingly common source of financing, providing mutual benefit to producers and marketers.

Featuring recognizable brands in a film enables a producer to leverage the reputation and public perception of certain products to craft characters and settings. Indeed, a character may become identified with a particular brand or product—think James Bond driving an Aston Martin, ET eating Reeses Pieces, or Carrie Bradshaw wearing Manolo Blahnik. A product may even become a character itself, as with the Wilson volleyball in Castaway.

The inclusion of known brands lends authenticity to the world of the film and the characters inhabiting it. When Mia asks Sebastian to get the keys to her Prius from a valet in La La Land, and Sebastian sees nothing but Prius key fobs on the valet stand, more is communicated to the audience than just the type of car Mia drives. Viewers get a sense of the world in which Mia lives, her friends and associates, and her subculture and values.

And of course, Prius benefits from the connection with an acclaimed film that won multiple Academy awards. While product placement represents a creative choice, it is also a shrewd business move for producers in need of funds and marketers looking for more subtle promotional opportunities than the traditional hard-sell advertisement.

Additionally, trademark serves to protect merchandise and ancillary products created in connection with a film. Marketing trademark-protected clothing, toys, home appliances, bedding, wallpaper, and other film-related merchandise is another critical source of revenue for producers, particularly those hoping to build a film franchise. Just as copyright is central to film financing and content, trademarks make an increasingly vital contribution to production funding and the creation of on-screen worlds.

But Without Patented Technology, Films Wouldn’t Exist

In addition to copyright and trademark, patents also play an essential role in film. A patented invention—the kinetoscope—allowed individual, consecutive images imprinted onto film to be projected in order and at speeds capable of creating the illusion of movement. Thomas Edison, holder of the kinetoscope’s patent, began documenting the world around him and created the first microdocumentaries for exhibition to paying customers. Across the Atlantic, the Lumiere brothers also embraced the possibilities that early film technology offered, creating short fiction films, the most enduring of which, Trip to the Moon, is still watched to this day.

The original film technologies, to both capture and display moving images, gave birth to a new form of leisure and entertainment. In less than three decades an entire industry had been established to exploit the commercial value of film and to satisfy the growing public appetite for movies.

Sound recording and playback technology revolutionized the industry and were followed just a few years later by technicolor, the debut of which—in The Wizard of Oz—changed filmmaking forever. Patented technologies created, then upended, the film industry, and to this day provide the foundation upon which advancements in filmmaking and viewer experience are based.

Just as the development of VistaVision in the 1950s gave directors more onscreen real estate and enabled sweeping scenic compositions, the implementation of Dolby Surround Sound in the 1980s allowed composers and sound editors to weave rich sonic tapestries. Composers were able to create complex filmic symphonies, and sound editors could immerse the audience more deeply into the world of the film by literally enveloping them in the movie’s aural field.

The switch from analog to digital, and the integration of computer technology into filmmaking, allowed for special effects unlike anything seen before. Computer-generated images put an end to an era of hand-drawn animation and manual splicing, as entire worlds could be created and manipulated digitally. Today, the development of 3D and virtual reality technology are set to revolutionize the film industry, changing the way images are captured and exhibited. Add to the distribution mechanisms numerous exhibition platforms (laptop, tablet, cell phone, etc.), and it is obvious the central role that patented technology plays in film creation and consumption.

Conclusion

In any given film, copyright, trademark, and patent play crucial roles in crafting the story, securing financing, and translating script to screen. Copyright secures property rights in (and incentivizes the creation of) original films as well as adaptations of prior works, while trademark contributes to the development of setting and characters. As an industry founded on patented technology, filmmaking relies on the innovation made possible by a patent system that encourages and incentivizes inventors. Those who developed sound recording and transmission technology, technicolor, panoramic projection, and many other innovations at the heart of moviemaking could not—and would not—have done so without the assurance that they would own the fruits of their innovative labor.

Next time you settle into a plush reclining chair, as the lights dim and the trailers begin, think about all the intellectual property embedded in the story you watch play out on-screen, because without it, that story wouldn’t exist.

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Innovate4Health Innovation

Innovate4Health: Protecting Patients with VanishPoint Retractable Syringes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

*Images courtesy of Retractable Technologies

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

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Uncategorized

Lobbyists Continue to Invoke Discredited Junk Science to Push Patent Legislation

dictionary entry for the word "innovate"It seems no matter how many times the mole gets whacked, it keeps popping back up. The latest incarnation of this problem is a recent op-ed by Katie Johnson of the National Association of Realtors, which relies on a long since discredited study about the state of patent litigation in the United States.  She goes on to make matters worse by using the highly misleading “patent troll” moniker and positively referring to an out of control bureaucracy that is destroying patents at an alarming rate.

Although Ms. Johnson cites only the $1.75 million estimate to defend a patent suit from the flawed study, the entire study was flawed from top to bottom. To achieve its desired result of blaming “trolls” for high litigation costs, the study defined “trolls” to include individual inventors, universities, startups, and even manufacturers who also license their patents. The study also ignores the benefits of the patent system for small business patent owners and inventors who must rely on litigation to stop piracy of their new innovation.

It is important to set things right. Patent litigation is the mechanism by which property owners protect their rights.  This has been true for all types of inventors throughout American history, including such famous American innovators as Thomas Edison, Charles Goodyear, and Elias Howe – all of whom are included in the “patent troll” definition. For software patents specifically, these patents are highly valuable for innovation.  As CPIP founder Adam Mossoff has discussed at length previously, patent protection for software inventions promotes innovation. It is important that every time someone uses junk science and rhetorical epithets to attack the patent system, we continue to call this out for what it is.

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Conferences Innovation

Event Recap: Great Inventors and the Patent System

hand under a lightbulb drawn on a blackboardOn February 16, 2017, CPIP hosted a panel discussion, America as a Place of Innovation: Great Inventors and the Patent System, at the Smithsonian National Museum of American History in Washington, D.C. The event was co-hosted by the Lemelson Center for the Study of Invention and Innovation at the Smithsonian Institution and the U.S. Patent and Trademark Office (USPTO). The video of the event is available here, and the event program is available here.

The panel featured three professors who have written extensively on the role of innovation and patenting in American history. Professor Ernest Freeberg, University of Tennessee, discussed Thomas Edison’s invention of electric light and its effects on American life and culture. Professor Christopher Beauchamp, Brooklyn Law School, discussed Alexander Graham Bell and his fight to secure patent rights in the telephone. Professor Adam Mossoff, Antonin Scalia Law School, George Mason University, discussed the centrality of patents to early American innovations by Charles Goodyear, Samuel Morse, and Joseph Singer. Arthur Daemmrich, Director of the Lemelson Center, moderated the discussion. Alan Marco, Chief Economist at the USPTO, delivered the closing remarks.

The theme of the panel was twofold. First, the late-nineteenth to early-twentieth era was marked by extraordinary innovation and progress. Second, patent rights both spurred and supported American innovation at every critical juncture: from invention and discovery to commercialization, and then to the delivery of life-changing products and services to the American people.

The panel highlighted a broad and rapidly-paced array of contributions that innovators made throughout the late-nineteenth and early-twentieth centuries, enriching and transforming American lives in the process. Several panelists emphasized the enthusiasm that Americans evinced for the inventions of their day. Electric lights, telephones, labor-saving devices, and gadgets were all welcomed by the scientific press and the populace as exciting hallmarks of progress. As Professor Freeberg emphasized, everyone agreed at the turn-of-the-century that American innovation was a deeply democratic act.

Central to the growth of innovative progress was the consolidated strength and support of the American patent system. Professor Beauchamp emphasized the multiple roles that patents play in a strong innovative economy. First, they secure rights that motivate inventors to create and commercialize their work. Second, they are an asset around which companies are organized and in which investors are eager to invest. Third, they are a business tool that enables transactions, contracts, licensing, and the exchange of rights to occur. And fourth, they are a means for disseminating and furthering public knowledge.

Patents were the bedrock of American innovation, but they were frequently also controversial. Professor Mossoff observed that today’s “patent wars” are nothing new, but instead are part of a lineage of disputes over ownership of new inventions, technologies, and commercial products. Historically, however, there is a much more important constant than litigiousness: the unique approach that America took toward patents.

As Professor Mossoff underscored, the commitment to patents is an integral and enduring part of American exceptionalism. Patents were created and protected as property rights of the innovators who created them. This has many important dimensions. Patents were from the start protected through the rule of law. They were granted to inventors not just as an abstract concept, but as a concrete grant of secure and effective rights. And they were a way for people to structure their lives.

Professor Mossoff observed that patents as property ensured that patent owners could use and deploy their inventions however they wanted. Ownership and control over patents were features of the system from its inception. This institutionalization of the patent system was central to the democratization of American innovation. It allowed Americans to invent, commercialize, and in a larger sense to innovate: to take technology and turn it into a commercial, viable product that consumers could actually use and benefit from in the marketplace.

The conversation among the panelists was centered on innovation and its longstanding role in generating disruptive innovation that changes lives as dramatically then as it does now. But an equally powerful theme was that innovation needs patents to make progress commercially viable and to bring products and services to people. It was, and has always been, the exceptional nature of the American patent system that has indeed enabled America to be the place of innovation.

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Innovate4Health

Innovate4Health: mPedigree Battles Counterfeit Drugs Through Innovative Verification System

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

Innovate4HealthCounterfeit medicines sold under a product name without proper authorization are a serious threat to global public health. Classified by the World Health Organization (WHO) as substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products, counterfeit drugs are regularly designed to appear identical to genuine products. However, they fail to effectively treat the disease or condition for which they were intended, and in some instances, they can cause adverse reactions or death.

A recent BBC investigation revealed a multi-billion-dollar global trade in counterfeit drugs resulting in 120,000 deaths a year in Africa alone. And though counterfeit drugs affect economies, health care systems, and patients worldwide, developing nations are most at risk, with an estimated counterfeit rate of 10%-30% of medicines sold. The prevalence of unauthorized drugs in countries with less advanced health care systems has created a dangerous pharmaceutical market with few resources to help consumers distinguish between a drug that could potentially save their life and something that might kill them.

hands holding a phone and a box of "Black Secret Mineral Creme to Powder Foundation SPF 15"In 2007, Ghanaian tech entrepreneur Bright Simons set out to address this troubling threat to public welfare by creating a way to quickly confirm the legitimacy of a pharmaceutical. Realizing that low literacy and technical capacity were limiting the efficacy of existing consumer-targeted controls such as holograms and bar codes, Simons wanted to create a user-friendly system that would help consumers instantly check the authenticity of a drug using their mobile device. Simons envisioned a verification mechanism that would not only enable consumers to protect themselves against dangerous counterfeits, but also help pharmaceutical manufacturers defend their brands and shield shopkeepers from the liability of selling fake drugs.

Simons partnered with drug companies and other stakeholders to upload pedigree information from individual packs of medicine into a central registry using standard mass serialization methods similar to those employed in the radio-frequency identification (RFID) barcode system familiar in the United States and other developed countries. Calling his company mPedigree, Simons built a mobile verification service that enables consumers to text a product code that is then checked against the registry of authentic medicines, instantly verifying that the medicine they’ve acquired is legitimate and safe.

Since forming mPedigree in 2009, Simons has brought his system to Nigeria, Kenya, and India, with pilot programs in Uganda, Tanzania, South Africa, and Bangladesh. In 2015, mPedigree codes appeared on over 500 million drug packets from clients such as AstraZeneca, Roche, and Sanofi, and its verification network has been essential in combating a serious counterfeit antimalarial drug scheme that was putting thousands of Africans at risk.

Though mPedigree is best known for its work with pharmaceutical certification, Simons has expanded its verification system to address counterfeits in other industries through his development of the cutting-edge supply chain transformation technologies, EarlySensor and Goldkeys.

mPedigree’s EarlySensor technology offers a proactive solution to companies plagued by unauthorized imitations by identifying patterns in counterfeiting activity and alerting partner government agencies of suspicious trends. The project “scans large pools of authentication, traceability, supply chain & logistical referencing, and user-generated data to mine insights and plot evolving patterns” to empower both manufacturers and consumers to predict counterfeiting activity before it occurs. EarlySensor technology is currently used by three major pharmaceutical and cosmetic companies in Nigeria, and empirical analysis has shown a 65% reduction in the circulation of counterfeit versions of their brands.

With Goldkeys, mPedigree has developed a set of web tools to provide brand owners with “complete, real-time, control of key events in their supply chain.” The technology enables companies to manage distribution networks and retail point integration, as well as track end-consumer activity through web applications and cloud computing. Goldkeys also allows consumers to “call in” their product by voice call or text on a mobile device to ensure authenticity and receive consumer support.

mPedigree - Bringing Quality to LifeThrough the combination of EarlySensor and Goldkeys, mPedigree’s innovative technology is facilitating the protection of both brand owners and consumers and ensuring that data collection and authentication mechanisms are leading to the safer distribution of medicines, cosmetics, seeds, and other essential products.

As a company dedicated to helping others protect their product reputation and brand, mPedigree understands the importance of effective IP rights and has utilized patent, copyright, and trademark protection in the development and commercialization of its own brands and services. In the early days of the company, as it formed partnerships with tech and pharmaceutical industry giants, mPedigree was careful to retain the rights to its creations, with Simons stating in a recent interview that, “[w]e had one interest to protect: our intellectual property.”

hands holding a phone and a seed packetBy providing a dynamic link between consumers and manufacturers, mPedigree is making communications at the point of purchase routine and creating value for consumers, manufacturers, regulatory agencies, and sellers. A project ten years in the making, mPedigree is built on the recognition that protecting intellectual property—both mPedigree’s and its clients—can save lives.

Bright Simons’ vision and dedication to fighting the counterfeit drug epidemic in Africa and beyond through pharmaceutical verification is a testament to the vital role innovation and technology play in confronting global challenges, and as its motto states, mPedigree is indeed “bringing quality to life.”

*Images courtesy of mPedigree Global Image Archives

#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

Innovate4Health: Eye Exams On-the-Go with PEEK

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

Innovate4HealthHundreds of millions of people worldwide have vision problems that could be fixed or relieved if only they were diagnosed early enough. Unfortunately, current eye screening equipment is expensive, bulky, and requires specialists to operate it. As a result, the vast majority of patients in the developing world have limited or no access to eye screening services and often suffer unnecessarily from eye problems.

Innovative new applications for smartphones promise to take eye exams out of the doctor’s office and bring them to the people who need them most. Several promising solutions have emerged. Not only are they mobile, but they are also affordable and non-specialists can operate them.

These solutions could benefit vast numbers of people. According to data from the World Health Organization, 285 million people worldwide are visually impaired. Of this group, 39 million are blind and 246 million have low vision. About 90% of visually-impaired people live in low-income countries, where there is an acute shortage of practicing ophthalmologists. Yet, 80% of all visual disorders could be treated or even prevented if diagnosed at the outset.

When it comes to eye disorders, early diagnostics is the key. In fact, four out of five cases of visual impairment can be prevented or cured if timely detected. But in developing countries, there is a huge disparity between population size and the number of eye care providers. In Kenya, for example, there are only 86 ophthalmologists to cover a population of over 40 million people. Many of those who need eye care live in rural, distant areas and are often unable to get to clinics or hospitals to seek help until after it is too late. As a result, millions of people in low-income countries are losing their vision.

PEEK kit laid outOne promising example of these new mobile diagnostic applications for eye care is the Portable Eye Examination Kit, or PEEK. PEEK is essentially an eye clinic that fits in a pocket. It combines both a traditional ophthalmoscope and a retinal camera in a smartphone, enabling affordable, fast, and easy eye examinations in the remotest of communities. PEEK consists of an app and a clip-on camera adapter that slides over a smartphone. Designed to be operated by community workers with minimum to no training, PEEK brings a low-cost and simple-to-use eye screening technology to the most underserved places of the world.

PEEK was born from Dr. Andrew Bastawrous’ frustrating experience trying to bring eye care to rural Kenyans. Bastawrous, a British eye surgeon, experienced a logistical nightmare attempting to transport the bulky, costly, and fragile eye equipment to remote areas of Kenya in 2007. Back then, Bastawrous was a PhD student at the London School of Hygiene and Tropical Medicine, working on a study of eye diseases that involved setting up 100 clinics in rural Kenya. One of the biggest problems facing Bastawrous was that the villages he visited often had no electricity or road access, making it very difficult to transport and use medical equipment.

However, Bastawrous observed that these remote villages did have cellular phone coverage. From that observation came the idea of a smartphone-based ophthalmic tool. To make this idea a reality, Bastawrous teamed up with software developer Stewart Jordan, biomedical engineer Mario Giardini, and ophthalmologist Iain Livingstone to found PEEK Vision. Since 2011, the PEEK team has relied on its expertise in international eye health, biomedical engineering, and ophthalmic research to develop smartphone-based visual assessment tools.

phone showing PEEK app imageHow does PEEK work? An app and a clip-on adapter use the smartphone’s built-in camera and flash to perform various eye exams within seconds. From basic testing for visual acuity, color and contrast sensitivity, and cataracts to scanning the retina, PEEK examination tools can help identify patients who need cataract surgery and detect early signs of diabetes, malaria, and other diseases. The PEEK clip-on adaptor itself can be made with a 3D printer and works with common smartphone models such as iPhone, Samsung, HTC, and Sony.

PEEK also enables efficient remote screening and treatment. A healthcare worker using PEEK can scan over 1,000 people per week. With minimal training, even non-healthcare workers can operate PEEK. Workers in the field can send information to eye care specialists, as PEEK makes high-quality images for further diagnosis and treatment readily available. PEEK also records patient contact information and GPS data, which it then emails to the treating physician.

The developers of PEEK have used IP rights to coordinate the development and deployment of this technology. They applied for a U.S. patent and have already obtained a U.S. trademark registration. PEEK tools are still in the process of being approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the U.S. Food and Drug Administration.

PEEK is working with NGOs and private donors to deploy the technology. It received funding from the Queen Elizabeth Diamond Jubilee Trust in 2013 towards testing the technology in different communities around the world. In 2014, the company started a crowdfunding campaign on Indiegogo to seek additional funds. Donors had an option either to purchase a PEEK kit for themselves or to donate it to a clinic in need.

PEEK is a great example of how innovation can address global healthcare challenges. It is a low-cost and easy-to-use invention that builds on widely-available, popular technology. It has a tremendous potential to improve millions of lives.

*Images courtesy of Peek Vision Ltd

March 13, 2017, update from PEEK Vision: “Peek is a growing team and is working with many partners to achieve its mission to create tools and knowledge that radically increases access to eye care worldwide. In 2016 Peek Vision Ltd was set up as a company and any profits go to its owner, the Peek Vision Foundation.”

#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 Patent Law

Innovate4Health: Global Good’s “Arktek”: A Life-Saving Super-Thermos Vaccine Cooler

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

Innovate4HealthMore than 1.5 million children die every year from diseases that existing vaccines could prevent. Why aren’t these children vaccinated? One big reason is that vaccines need to be kept cool until they reach patients, but that’s a really hard task in parts of the world where power is unreliable.

A new, patented “super thermos,” the Arktek Passive Vaccine Storage Device, aims to solve this global challenge. The Arktek was developed by Global Good, a collaboration between the Gates Foundation and the innovation lab of Intellectual Ventures.

The Arktek mends gaps in the “cold chain,” the refrigerated vaccine supply chain. Breaks in the cold chain occur because power is unreliable or minimal in many places. Also, many people live in places that cannot be reached by refrigerated transport. These gaps make it impossible to keep the vaccines fresh, and thus render them unusable in less than a week’s time.

In 2008, the Gates Foundation challenged Intellectual Ventures to help fix the cold chain problem. The resulting collaborative effort, spearheaded by Global Good, invented the Arktek Passive Vaccine Storage Device, nicknamed the “super-thermos” and the “keg of life” by Bill Gates.

The Arktek keeps vaccines at a temperature between zero and eight degrees Celsius for 30 to 60 days, depending on outside temperatures and humidity. Testing shows that it retains its cooling capacity even when outdoor temperatures rise to 43 degrees Celsius (110 degrees Fahrenheit). It does not rely on outside sources of electricity or other power. This is a major step forward in vaccine cooling systems, especially in much of the developing world, in which stand-alone cold storage devices struggle to keep vaccines at proper temperatures for a maximum of five days.

The “super-thermos” bears some resemblance to an ordinary coffee thermos. In 2013, the leader of the vaccine cooler development team described it as “a super-insulated, double-walled [bottle] that holds the vaccine and ice in the middle in an inner bottle. A vacuum space separates it from the outer bottle, like a large coffee thermos.” The device combines a double-walled bottle filled with vacuum insulation with multi-layer insulation technology of the type used to protect spacecraft from extreme temperatures. It holds approximately 16 pounds of ice.

Incredibly, a vaccine kept in the Arktek for weeks will be as cold as the moment it was placed inside. No powered refrigeration or additional ice is needed.

Keeping vaccines cold isn’t the only problem that the Arktek solves. Gaps in the cold chain tend to occur in places where travel is rugged and environments are challenging. Also, sophisticated medical facilities are rarely waiting at the end of a gap in the cold chain. Any solution has to be extremely tough and user-friendly.

The Arktek meets these challenges by providing near-indestructible structural integrity and high-usability in the field. To make the device sturdy, user-friendly, and easy to maintain and use, the development team at Global Good sacrificed a bit of longevity in favor of efficiency. The sixth and current prototype is therefore created for maximum efficiency, and can hold routine vaccinations for approximately 200 children or a village with a population of 6,000.

Other features help both local users and remote health officials to monitor the integrity of the vaccines. Sensors measure key information at 15 minute intervals, including the Arktek’s interior temperature, its exterior temperature, and how long it has been opened. It alerts users when temperatures begin to rise too much, and even has an LED light that comes on when a user opens the lid.

The data collected by the Arktek’s sensors is extremely accessible to all concerned. On-site users can download data logs using a simple USB stick. Meanwhile, an antenna sends data via SMS to a local telephone number every day at midnight. It provides remote personnel a summary of the day’s temperatures, location, and statistics recording when the device has been opened and for how long a period. Finally, a GPS sensor allows health officials to track the location of the devices at any given time.

During pilot testing, Global Good found the sensors to be particularly useful. For instance, if a health official was not using the device properly, Global Good was notified, and could contact the official directly and assist with training them appropriately. Armbruster observed that this kind of monitoring could eventually be relegated to local ministries of health to enable them to ensure that “they have a reliable cold chain all the way to the end point.”

Armbruster sees the Arktek as best-suited to modest villages of 5,000 to 15,000 people, in which it will be cost-effective to have a device that can be refreshed once a month by health officials. He says it may be somewhat less-suited to larger villages of 25,000 to 50,000 people, in which a large solar-powered or ice-lined refrigerator is feasible. And it may not be necessary in locales that have a reliable and consistent source of power. The cost per unit for this device currently ranges from $1,200 to $2,400, which makes it relatively affordable to health officials in the developing world.

Currently, the Arktek is in the early adoption stage of development. The WHO has “prequalified” the Arkteks under its Performance, Quality and Safety (PQS) program, which is an important seal of approval for government procurement. Global Good has collaborated with the Clinton Health Access Initiative, PATH, UNICEF, and other United Nations organizations to conduct field trials of the Arktek in Ghana, Senegal, Ethiopia, and Nigeria.

While the Arktek is still being refined for further roll-outs, it has already seen some action where it could do the most good. For example, it has stored vaccines for tuberculosis, polio, influenza, whooping cough, tetanus, hepatitis B and diphtheria. In 2014, Global Good donated 30 Arkteks to help the WHO deliver vaccines during the Ebola outbreak; and in the following year, it donated Arkteks to Nepal to assist with vaccinations after the 2015 earthquake.

Global Good is relying on property rights and commercial distribution to develop and deploy the Arktek. Aspects of the technology have been patented. Meanwhile, Global Good is currently partnering with AUCMA, a leading refrigeration manufacturer, to help commercialize Arktek and produce it at scale at an affordable price.

In 2016, Global Good received a “Patents for Humanity” award for the Arktek from the U.S. Patent and Trademark Office.

The Arktek is a vivid illustration of how patented innovation can tackle global challenges. It’s a clever, pragmatic and practical invention with a global reach and import. It reminds us that secure property rights can generate, develop and disseminate life-saving solutions to seeming intractable problems.

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

Categories
Innovation

How IP Helps Individuals

the word "inspiration" typed on a typewriterThis is the second in a series of posts summarizing CPIP’s 2016 Fall Conference, “Intellectual Property and Global Prosperity.” The Conference was held at Antonin Scalia Law School, George Mason University on October 6-7, 2016. Videos of the conference panels and keynote address, as well as other materials, are available on the conference website.

The second panel of CPIP’s 2016 Fall Conference discussed the positive impact of intellectual property (IP) on people’s lives. Day or night, wherever we are, IP is around us—from movies, music, books, smartphones, and computer tablets to essentials like transportation, clothing, food, and medicines—each involving some aspect of IP. Yet we rarely think of how these products are brought to us, or more importantly, the ways in which they have changed our personal and professional lives.

The panelists, Prof. Kristina Lybecker (Colorado College), Ken Stanwood (WiLAN), Howard Rachinski (Christian Copyright Licensing International), Stephen Bock (Church Music Publishers Association), and Prof. Mark Schultz (Southern Illinois University School of Law, Center for the Protection of Intellectual Property) revealed how intellectual property benefits individuals by creating jobs, promoting cultural diversity, and bringing innovative products, services, and medicines to marketplaces worldwide.

Prof. Kristina Lybecker discussed how intellectual property helps individuals by promoting innovation, job creation, and international trade. She presented an international competitiveness index showing that the most innovative economies have the strongest IP regimes. The opposite is also true, and economies with weaker IP protection are less innovative and competitive on a global scale. Comparing data from the top-30 countries that comprise nearly 80% of the global economy, including the U.S., U.K., France, Japan, Australia, and Singapore, Lybecker showed that the correlation between innovation and IP protection is indeed very strong.

Likewise, intellectual property contributes significantly to jobs, wages, and trade. Lybecker presented data showing that there are 55 million jobs in the U.S. supported by IP-intensive industries, representing 46% of all private sector employment. These industries contribute $5.8 trillion to U.S. output each year, accounting for nearly one-third of total GDP. Wages in IP-focused industries are 30% higher than in other sectors, and 74% of U.S. exports come from IP-related industries. Lybecker noted that stronger IP regimes attract greater foreign direct investment and R&D spending, which increases the spread of technology and spurs market growth.

Finally, Lybecker discussed the strong correlation between drug availability and IP rights in the pharmaceutical industry. Data shows that countries with the strongest IP protection enjoy the quickest launches for new medicines and the greatest availability of treatments and cures for their populations. The U.S., for example, has the strongest IP protection for both pharmaceutical products and processes, and it is a global leader in pharmaceutical innovation.

Ken Stanwood from WiLAN highlighted the role that intellectual property in the wireless sector plays in improving people’s lives. WiLAN invented a fundamental technology that is used in the Wi-Fi physical layer that was a significant stepping stone toward broadband cellular technologies like smartphones. Since then, wireless IP has created new markets and provided better access to existing markets. For example, wireless communications and GPS technology enable popular services such as Uber and Car2Go.

Stanwood discussed how wireless IP empowers women in developing countries. For instance, Grameen Bank’s “village phone” program provides microloans to women in Bangladesh to purchase cellphones that are then shared with others in their villages. Not only has this program improved the lives of individual women by increasing their role in the family, but it has also created social and economic benefits for the entire community by providing better access to health care, education, and business transactions.

The introduction of the portable eye examination kit in Africa was another of Stanwood’s examples of how wireless IP improves people’s lives. A special portable camera attached to a smartphone enables schools, remote health providers, emergency medical workers, nurses, and general practitioners to perform various eye exams for afar, including pupil assessment, retinal evaluation, cataract examination, and even to diagnose cerebral malaria.

Howard Rachinski and Stephen Bock discussed how IP in the church music industry benefits congregations. With over 350,000 churches in the U.S. and 2.18 billion Christians around the globe, the industry is massive both in publishing and consumption. Before the digital age, publishers distributed hymnals to churches while paying royalties to songwriters and copyright owners. Congregants sang only those songs found in the hymnals, which could often be decades old. The digital age, however, changed this paradigm, and people now want a larger variety of songs. This change in music consumption has brought many challenges.

Rachinski and Bock noted that the entire church music industry reconsidered its practices and searched for new ways to empower worship by facilitating access to legal content. Christian Copyright Licensing International (CCLI) contracted with copyright owners to aggregate their rights and make them available to churches for an affordable annual fee. CCLI currently works with 250,000 churches in 40 countries to provide more than 100,000 licensed songs of worship. Not only has this licensing scheme ensured the very survival of the church music industry, but it has also enabled more Christians to become professional songwriters.

Prof. Mark Schultz discussed how IP helps bring products to consumers. Organizations like the Gates Foundation often talk about how hard it is to bring medicines to people. In some places, vaccines are delivered on the backs of camels and donkeys. The World Health Organization estimates that nearly 2 billion people around the globe have no access to medicine. And yet, Schultz noted, some products are available in every corner of the world. For example, Coca-Cola sells 2 billion servings of its products daily across the globe.

Indeed, Schultz pointed to Coca-Cola as a valuable case study on international network distribution and asset management. The protection of its brand allows Coca-Cola to secure returns on investment, protect its good will, and prevent copying of its products. Coca-Cola reduces costs by working with nearby distributors to produce, bottle, and ship its products locally. Finally, Coca-Cola has a network of local stakeholders (licensees, distributors, and consumers) who are interested in genuine products being delivered to the market. Schultz noted that the system works best when the local IP system is stable.

Lastly, Schultz turned to the evidence establishing the correlation between strong IP rights and economic growth. He referred to one economic index that demonstrated a positive relationship between patent protection and importations into developing countries. Likewise, Schultz discussed the index he created with Prof. Douglas Lippoldt illustrating that the strength of the trade secret system has positive effects on exports. They found that stronger IP regimes lead to the delivery of more pharmaceuticals and the introduction of more technological services.

Together, the five panelists gave concrete examples of the critical role of IP in helping individuals both domestically and internationally. Not only does IP create jobs, new markets, and business opportunities, but it also enables access to healthcare, medicines, education, and technologies. A strong IP system bolsters innovation, invites investment, and brings products to people. With the right IP strategy, companies can continue innovating and making a positive impact on people’s lives.