Month: March 2017

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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 These outdated syringes account for more than half of needlestick injuries.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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Copyright Legislation

Register of Copyrights Selection and Accountability Act is First Step Towards a Modern Copyright Office

U.S. Capitol buildingThe House Judiciary Committee today overwhelmingly approved the bipartisan Register of Copyrights Selection and Accountability Act by a vote of 27-1. Introduced last Thursday by Chairman Bob Goodlatte and Ranking Member John Conyers, Jr.—with the support of Senate Judiciary Committee Chairman Chuck Grassley, Ranking Member Dianne Feinstein, and Senator Patrick Leahy—the Act is the first legislative effort to follow a four-year review of U.S. Copyright law and aims to kick-start an overdue modernization of the United States Copyright Office (USCO).

Focusing on the selection process of the Register of Copyrights, the concise bill requires the Register to be nominated by the President of the United States and subject to confirmation by the U.S. Senate, rather than appointed and dismissed at the pleasure of the Librarian of Congress. Today’s markup saw the inclusion of an amendment that would create a panel—made up of the Speaker of the House, President Pro Tem of the Senate, House and Senate Majority and Minority Leaders, and the Librarian of Congress—tasked with submitting a list of three qualified nominees to the President, who would then nominate an individual subject to confirmation by the Senate. The bill reflects the need for greater stakeholder and Congressional input in the selection of a leader Congress looks to for expert advice and analysis on the copyright system, and it represents the first step in an unquestionably necessary Copyright Office modernization effort.

In 2013, the House Judiciary Committee began a comprehensive bipartisan review of the copyright system that included 20 hearings, testimony from over 100 witnesses, and a listening tour that invited input from copyright stakeholders across the country. According to the Committee, the goal of the review was “to determine whether the copyright laws are still working in the digital age to reward creativity and innovation.” In December 2016, the first policy proposal to come out of the review focused on Copyright Office modernization and stressed the need for information technology (IT) upgrades, the creation of advisory committees and a small claims system, and overall decision making autonomy.

The Copyright Office is currently part of the Library of Congress, a legislative government agency and the main research arm of the U.S. Congress. The Office’s budget and leadership are determined by the Library, which is able to make important decisions independent of any outside review or accountability. It’s a curious arrangement, different from most other federal agencies whose leadership is subject to the checks and balances of an executive nomination and Congressional confirmation process.

As former Registers of Copyrights Ralph Oman and Marybeth Peters point out in a recent letter to Congress, the Copyright Office’s residence in the Library of Congress is a largely the result of a historical accident from the late 19th century. In 1870, Librarian of Congress Ainsworth Rand Spofford convinced Congress that copies of works submitted for copyright registration should be deposited to the Library to help build its collection, and thus the Copyright Office came under the authority of the Library. But nearly 150 years later, the Library of Congress—due to its own unique mission and approach to copyright law—is not best positioned to oversee the operation of an agency in need of reform.

There’s no dispute that the Copyright Office is in need of a facelift. For years, the Office has been underfunded, understaffed, and undervalued, making growth and development with the digital age all but impossible. Before her unexpected ouster, Register Maria Pallante provided Congress with a Register’s Perspective on Copyright Review that included a detailed list of deficiencies within the Office in need of improvement. While Pallante is no longer leading the Copyright Office, her concerns were echoed by stakeholders during the review hearings and listening tour, and Congress has recognized the need to begin an extensive modernization effort.

The copyright system is vitally important to the U.S. economy. According to a 2016 report by the International Intellectual Property Alliance, core copyright industries contributed over $1.2 trillion to the U.S. GDP and employed more than 5.5 million U.S. workers. Despite unfounded claims that its role is “mundane” and leader inconsequential, the Copyright Office plays a central role in the copyright system by providing expert reports and advice to Congress on a variety of copyright-related issues. Section 701(b) of the Copyright Act charges the Register of Copyrights with a number of meaningful duties, and Congress regularly looks to the Register and the Office for input on the development of copyright law.

Making the Register a presidential appointee with the advice and consent of the Senate is necessary to ensure that all stakeholder concerns are addressed prior to confirmation and that the Register remains accountable to Congress. Since the unprecedented removal of Register Pallante in October, there is no permanent Register of Copyrights in place, and the current Librarian of Congress is taking a highly unusual internet survey-based approach to determine the qualities of the next Register. The direct line of communication to the USCO that Congress enjoyed in the past has been disrupted, and consequential decisions are being made with little accountability or regard for Congress’s important role in the process.

These troubling developments are evidence that the system needs to change, and it’s imperative the next Register be subject to the same processes used to select the leaders of equally important government agencies. Only when the value of the Copyright Office is recognized and its infrastructure and operations updated can the system begin to modernize and keep up with the creative culture it serves.

Categories
Copyright

Another Huge Setback in CloudFlare’s Quixotic Campaign to Protect Pirate Sites

the word "copyright" typed on a computerLast August, I wrote about CloudFlare’s “desperate new strategy” to protect MP3Skull, a notorious pirate site that was sued by various recording companies for copyright infringement. CloudFlare offers content delivery networking, web optimization, and other performance services for websites. The plaintiffs easily obtained a permanent injunction against MP3Skull when it didn’t even bother to respond to the suit. However, that didn’t stop MP3Skull from opening up shop under several new top-level domains using CloudFlare’s services. When the plaintiffs sent a copy of the injunction to CloudFlare and asked it stop servicing the sites, CloudFlare put up a fight.

CloudFlare has a history of supporting pirate sites. After Grooveshark was found liable for willful copyright infringement and shut down, CloudFlare was there to lend a helping hand to the copycat sites that later sprung up. The plaintiffs obtained a restraining order against the new sites, and they asked CloudFlare to not provide them with services. CloudFlare balked at the suggestion, arguing in the district court that it was not in cahoots with the enjoined defendants. The district court held that, under Rule 65, CloudFlare was indeed bound by the injunction against the copycat sites. By providing the copycats with numerous services, CloudFlare was in “active concert or participation” with the defendants.

Just as CloudFlare took the low-road with Grooveshark, it again decided to stand up for adjudicated pirates with MP3Skull. Once confronted with the injunction against MP3Skull, CloudFlare tried a new strategy. Instead of arguing that it wasn’t acting in concert with the enjoined defendants, it argued that it couldn’t be enjoined because of the DMCA. In particular, CloudFlare contended that since Section 512(j) controls injunctions against internet service providers, and since that standard was not applied here, it was not bound by the injunction. As I mentioned in my last post, this argument is ridiculous for one simple reason: CloudFlare is not being enjoined.

This past Thursday, District Judge Marcia G. Cooke of the Southern District of Florida easily shredded CloudFlare’s silly and self-serving argument: “CloudFlare contends that Section 512 of the Copyright Act (‘Section 512’) guides how the Permanent Injunction applies to it, not Rule 65(d) of the Federal Rules of Civil Procedure. I disagree.”

Judge Cooke agreed with CloudFlare that “Section 512 outlines rules for copyright infringement-related injunctions involving online service providers[.]” But she disagreed that Section 512(j) has anything to do with whether CloudFlare was bound by the injunction against MP3Skull under Rule 65. She noted that Section 512 “does not blunt a court’s power to enforce a permanent injunction involving non-parties such as CloudFlare that may be ‘in active concert or participation’ with Defendants.” Indeed, Judge Cooke stated that “[e]very injunction . . . automatically forbids non-parties” from aiding and abetting enjoined defendants.

This is clearly the correct result. The standards that apply when enjoining a service provider under Sections 512 have no applicability to the general rule that it’s contemptuous to aid and abet a defendant that has already been enjoined. Again, CloudFlare was not the party enjoined—only MP3Skull was enjoined. And even though Section 512(j) would apply if CloudFlare were being enjoined, that’s irrelevant to the issue of whether CloudFlare, or any other non-party, is bound by the injunction against MP3Skull.

Despite this huge loss for CloudFlare, Judge Cooke left open the possibility that it could continue its mission to protect the MP3Skull defendants. Since the parties did not brief the issue of whether CloudFlare is in “active concert or participation” with the defendants, Judge Cooke found that due process requires her to give CloudFlare a chance to argue that it is not. Given its past conduct, it seems likely that CloudFlare will vigorously argue that the services it provides don’t actually help its customers to do anything. Of course, given the Grooveshark defeat on this same issue, I don’t think Judge Cooke will waste too many pages rejecting CloudFlare’s next desperate attempt to protect pirate sites.

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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.

Categories
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.

Categories
Copyright

Kodi Software Enabling Widespread Copyright Infringement

hand holding remote pointing at television showing a sports gameAwards season always seems to arrive with new stories about how piracy is affecting the film industry and the way we watch movies. Whether it’s a promotional screener that was stolen and uploaded to a torrent site, or the latest software that allows users to download or stream pirated content, the tales are reminders of the enduring problem of online copyright infringement.

This year, when talking to people (outside of the copyright law world) about whether they’d seen certain Oscar-nominated films, the same name kept coming up: Kodi. Specifically, users described downloading the Kodi app to an internet connected device, then adding “plug-ins” or “add-ons” that deliver an extensive library of streaming TV shows and movies, including Moonlight, La La Land, and other Best Picture nominees. Though Kodi’s controversial popularity in the UK has been well-chronicled of late, the software is now becoming the preferred way to stream pirated content in the US, and it’s particularly discouraging because while Kodi is not in itself an illegal service, it is blurring the lines of accountability and contributing to massive IP theft.

Billing its product as “open source home theater software,” Kodi is a free media player application that allows users to view streaming media, such as videos, music, podcasts, and videos from the internet on a variety of platforms. Its open source, cross-platform nature enables interaction with third-party devices designed to facilitate infringement by including add-ons that deliver pirated content. Sales of pre-programmed “Kodi boxes” have become widespread in the UK, mostly because of their incorporation of the illicit add-ons. Kodi box popularity is catching the attention of rights holders and broadcasters such as the BBC, Sky, and the Premier League, and the UK’s Intellectual Property Office (IPO) just announced an investigation into the boxes.

The group behind Kodi recently acknowledged its connection to piracy, and pledged a renewed effort to distance itself from copyright infringement by going after unauthorized uses of its “Kodi” trademark. Unfortunately, they made the same promise in 2014, and Kodi-related piracy has grown exponentially. It’s also interesting that Kodi is threatening to enforce its own IP rights in an attempt to get people to stop “dragging our name through the muck,” while they simultaneously disregard the rights of the countless creators and copyright owners whose works their software helps pirate. In the same announcement warning of the plan to curb unauthorized use of its trademark, Kodi Product Manager Nathan Betzen displays a lack of concern for other victims of infringement.

“Team Kodi maintains an officially neutral stance on what users do with their own software. Kodi is open source software, and as long as the GPL [General Public License] is followed, you are welcome to do with it as you like.”

In the United Kingdom, a concerted effort was just announced to go after the source and target the servers feeding the illicit streams to the Kodi add-ons. Initially obtained by the English Premier League—the top-tier football (or soccer) organization in the UK—a High Court injunction will allow the League to compel the largest ISPs in the country to block the actual source of pirated streams, rather than engage in website whack-a-mole. The strategy involves going “up the content tree” to attack the servers where the streams originate, and for the moment, it seems that the ISPs are willing to cooperate.

In the US, in lieu of acquiring pre-programmed Kodi boxes, users are downloading the Kodi software directly to laptop computers, Amazon Fire Sticks, or smart TVs, and adding the illicit add-ons themselves. It makes going after Kodi for infringement difficult because its product is essentially a media player and is not actually distributing or making copies of the movies and TV shows it streams. Like the VCR thirty years before it, Kodi is capable of non-infringing uses and is likely to claim that it has no control over the bad actors using their product to infringe.

But liability for copyright infringement can extend to those who facilitate theft under the theory of secondary liability, which includes both vicarious and contributory liability. Just last year, in BMG v. Cox, a federal judge upheld a $25 million penalty against ISP giant Cox Communications for contributory and willful copyright infringement. Despite arguing that its Internet service is just like the VCR in Sony v. Universal, and therefore should not be liable for infringing acts of its customers, Cox was found to have made a material contribution to the infringement simply by providing the means—also referred to as the “site and facilities”—for a user to infringe, and to have had knowledge of repeated instances of infringement. This combination of material contribution and knowledge satisfies the test for contributory infringement, and the District Court’s finding represents a clear assignment of accountability to those that turn a blind eye to piracy.

While Cox’s failure to act in the face of blatant, repeated infringement may represent a more egregious example of contributory infringement, one could argue that Kodi is similarly exposing itself to secondary liability. By providing software that facilitates extensive piracy, Kodi surely makes a material contribution to infringement, and the Kodi group is well aware that its product “has grown to become one of the most-used pieces of software through which people can stream, download and otherwise obtain copyright infringing content.”

Though Kodi is different than Cox’s Internet service in that once the software is downloaded, its decentralized architecture means Kodi has no ability to monitor or control what it’s used for, the Supreme Court has made clear in MGM v. Grokster that the decentralized nature of software is not enough to escape contributory liability. If Kodi’s primary use can be shown to be streaming infringing content, it could face the same fate as some other illicit streaming services such as Popcorn Time. Those behind Kodi know that contributory liability for open-source software is somewhat of a gray area of copyright law that allows their product to exist, but as the Kodi name becomes more and more synonymous with piracy, it may become harder to avoid accountability.

Categories
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 Patent Litigation

CPIP Scholars Ask Supreme Court to Resist Call to Restrict Venue Choices for Patent Owners

U.S. Supreme Court buildingOn March 8, 2017, CPIP Scholars Adam Mossoff, Devlin Hartline, Chris Holman, Sean O’Connor, Kristen Osenga, & Mark Schultz joined an amicus brief in TC Heartland v. Kraft Foods. CPIP Scholars worked with USD Law’s Ted Sichelman to organize, write, and file the brief. The case focuses on whether patent owners may sue corporate defendants in any judicial district where the court has personal jurisdiction over the defendant, which is the default rule in federal cases.

Concerned about the allegedly abusive behavior of certain firms suing in the Eastern District of Texas, some would like to severely restrict where all patent owners may sue. The amici note that, even if the Supreme Court restricts venue choices as these people would like, patent lawsuits would not be equitably distributed as a result. A recent study showed that 60% of all patent cases would still be concentrated in 5 of the 94 judicial districts. Furthermore, instead of concentrating in one district—the Eastern District of Texas—cases would primarily concentrate in two districts—the Northern District of California and the District of Delaware.

As the amici argue: “No plausible argument can be made—and Petitioner and its amici have not offered an argument—that shifting cases from one district to two districts would result in a meaningful distribution of patent cases among the ninety-four federal district courts.” The amici note that concerns about “forum shopping” are overblown since patentees are just doing what all federal plaintiffs do—choosing “the forum that gives it the best opportunity for success.” Since “corporate defendants are generally subject in any civil complaint to venue in any district in which personal jurisdiction lies,” the amici suggest that the same rule should apply in patent cases.

The amici conclude: “Innovators and their investors have long been vital to a flourishing innovation economy in the United States. Startups, venture capitalists, individual inventors, universities, and established companies often rely heavily on patents to recoup their extensive investments in both research & development and commercialization. By restricting the districts in which a patent owner can bring suit, the value of the patent itself is lessened, diminishing the economic incentives the patent system provides to spur innovation.”

To read the amicus brief, please click here.