Month: December 2017

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Innovate4Health

Innovate4Health: Embrace Infant Warmers Help Save Lives of Preterm Babies in Developing Countries

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

Innovate4HealthBy Gleb Savich

Preterm birth is the leading cause of death for children under five years old. An estimated 15 million babies are born before 37 weeks gestation each year, and nearly 1 million children under five die due to complications associated with such births. Nearly three quarters of them could be saved with current interventions. The disparity in survival rates of preterm babies based on a country’s wealth is startling. In high-income countries, almost all of the babies born after 32 weeks survive, but in low-income countries, only half survive.

Hypothermia is a significant factor contributing to the death of preterm babies. Preterm newborns are particularly vulnerable to hypothermia because they cannot generate enough heat to warm themselves on their own. They also have less stored fat to insulate themselves against heat loss. Infant incubators are commonly used in neonatal care units to help preterm infants maintain safe body temperature. Such equipment costs thousands of dollars and requires a stable source of electricity to operate.

Healthcare interventions in the developing world often prove ineffective. Expensive equipment donated to hospitals in the developing countries is often useless because a stable electricity supply and replacement parts are unavailable. Despite long-term efforts of well-intentioned people, innovative solutions have been needed to meet these local challenges rather than more donations of existing technology.

diagram of an infant in an infant warmerSpecifically, there has been a need to design infant incubators that address the unique challenges of the developing world. Embrace infant warmers, which were developed through a project class at Stanford University called Design for Extreme Affordability, were designed to meet these challenges. Embrace infant warmers have won several awards, including the Economist Innovation Award and TED Fellows award.

Projects start with developing-world challenges in mind, and students create innovative solutions that address problems with using existing technology. An integral part of the course are need-finding trips, during which the students learn about the needs of the target community while on location. This enables the students to formulate an appropriate design process while also establishing deep connections with the members of the community.

The challenge leading to Embrace was to create a cheap infant incubator. They started by visiting hospitals in Nepal, and they quickly realized that most births occur in villages far away from hospitals with stable sources of electricity. Donated infant incubators were available, but they were left in storage because the birth facility lacked the infrastructure to use the machines.

The team designed a portable device capable of maintaining the infant at approximately body temperature without having to be continuously connected to an electricity source. It is able to do so by utilizing specialized temperature-regulating materials that keep a near-constant temperature despite gaining or losing heat energy.

diagram of an open infant warmerThese materials are called “phase change materials” because they melt or solidify (in other words, they change phases) near body temperature. People normally think about the transfer of heat energy as making one thing warmer or another thing colder, but this is not true during a phase change. For example, during solidification, the material releases heat energy, which can be used to keep the infant warm, but it maintains its own temperature because the heat comes from the process of solidification rather than a loss of temperature.

Embrace infant warmers look like a swaddle or a tiny sleeping bag that cradles an infant. A temperature-regulating element is placed between the inner and outer fabric layers of the infant warmer. This element contains the phase change material, chosen so that it melts or solidifies around normal human body temperature.

The temperature-regulating element can be heated or cooled to the desired temperature utilizing a recharging unit plugged into an electrical outlet or by placing the element into warm or cool water. Thus, no electricity is required to use the device. But even intermittent power sources can be beneficial because the unit can be charged when it is not in use. Once at the desired temperature, the temperature-changing element is inserted between the fabric layers of the infant warmer. One current version of the infant warmer maintains the desired temperature for at least 4 hours.

diagram of a baby in an unrolled baby warmerTo further advance their invention, the team founded the Embrace Innovations company and have begun developing a strong patent portfolio. Secure and effective patent rights allow the enterprise to grow and adapt in furtherance of their mission. This includes adopting strategies such as providing products through for-profit and nonprofit mechanisms and contracting with third-party manufacturers to produce the devices. Income derived from the initial innovations can then be used for additional projects that will further benefit the developing world.

Today, Embrace infant warmers are manufactured by Phoenix Medical Systems in India and are available for a small fraction of the cost of standard incubators. The nonprofit arm of the company, Embrace Global, is a part of Thrive Networks, an international NGO that utilizes evidence-based innovations to improve the lives of underserved populations in Southeast Asia.

The Embrace team has also gone on to develop other products: sleeping bags and swaddles for infants under the brand, Little Lotus. Like Embrace infant warmers, these products utilize phase change materials to ensure optimal sleeping temperature for babies. A portion of proceeds from every purchase of a Little Lotus product goes to providing access to Embrace infant warmers, showing how parallel projects can be used to benefit vulnerable populations in the developing world.

With the help of Embrace Global and its partners, Embrace infant warmers have been used to care for over 200,000 low birth weight and premature infants across 20 countries in the developing world. This is the result of both the important innovation and the forward-thinking development that can only occur when inventors have control over the ideas they create.

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

Categories
Innovation Patent Law

CPIP Scholars File Amicus Brief Urging Supreme Court to Fix Section 101

dictionary entry for the word "innovate"On December 4, 2017, CPIP Founder Adam Mossoff and CPIP John F. Witherspoon Legal Fellow David Lund filed an amicus brief urging the Supreme Court to grant certiorari in RecogniCorp. v. Nintendo. The amicus brief was joined by several law professors, including Richard Epstein and Michael Risch, as well as CPIP Senior Scholars Chris Holman, Kristen Osenga, Mark Schultz, and Ted Sichelman. Bob Sachs of Robert R. Sachs P.C. served as counsel of record.

The technology at issue involves a method of encoding and decoding composite facial images on a computer. The invention solved the problem of decreased image quality when such images are transmitted digitally. RecogniCorp sued Nintendo for patent infringement, and Nintendo challenged the eligibility of the patent under Section 101. Applying the Mayo-Alice framework, the district court held that invention was ineligible subject matter because it was directed to an abstract idea and lacked an inventive concept. Agreeing with that analysis, the Federal Circuit affirmed.

The amici argue that the Supreme Court should grant certiorari in this case in order to correct the continued misapplication of the Mayo-Alice test by the Federal Circuit, the district courts, and the Patent & Trademark Office. By breaking down claims into individual elements and then generalizing them in broad terms, the lower courts and the PTO are failing to properly consider the claimed invention as a whole.

The Summary of Argument is copied below:

SUMMARY OF ARGUMENT

This Court has repeatedly reminded the Court of Appeals for the Federal Circuit, district courts, and the United States Patent & Trademark Office (“PTO”) that § 101 of the Patent Act is a key requirement in assessing the validity of both patent applications and issued patents. In doing so, this Court set forth a two-part test for assessing whether an invention is patentable subject matter (the “Mayo-Alice test”). See Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014); Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). These cases build upon prior cases such as Diamond v. Diehr, 450 U.S. 175 (1981), which held that a software-based method for operating a rubber mold is patent eligible under § 101.

Unfortunately, the lower courts and the PTO have misunderstood how to apply the Mayo-Alice test. Specifically, the lower courts and the PTO have adopted an indeterminate and overly restrictive approach, invalidating legitimate patented innovation under § 101 with little predictability for inventors or patent attorneys. This frustrates the constitutional function of the patent system in promoting the “Progress of . . . useful Arts.” U.S. Const. art. 1, § 8, cl. 8.

This case exemplifies both of these fundamental problems—indeterminacy and over-restrictiveness—because the lower courts held that a claim is patent ineligible as an “abstract idea” merely because the process was implemented through the use of computer software. These problems undermine inventors’ ability to use the patent system to protect computer-mediated processes that are exactly the kind of innovation that the patent system is designed to promote.

Petitioner details the substantial confusion in the application of the Mayo-Alice test in this case, as well as at the PTO and in the lower courts. Amici here identify a further key insight: when lower courts and the PTO apply the Mayo-Alice test to only individualized elements of a claim, generalizing these elements into a broad, categorical description and not evaluating the claimed invention as a whole, they are using a methodological approach that conflicts with this Court’s existing precedents on determining patent eligibility under § 101.

In this case, the Federal Circuit held that a software-based method of producing images of faces on a computer screen is an “abstract idea.” RecogniCorp, LLC v Nintendo Co., 855 F.3d 1322, 1327 (Fed. Cir. 2017). It reached this conclusion by dissecting the claim into its separate elements and ignoring other key elements, ultimately finding the claimed invention is ineligible under § 101. By reducing the claim to “encoding and decoding data,” the court ignored the invention as a whole that improves the way computers generate digital representations of faces for display.

This Court can easily remedy this problem by (1) recognizing the role of the patent system in protecting computer-implemented innovation, a key driver of modern technological progress, and (2) providing further instructions to lower courts and to the PTO that they should apply the Mayo-Alice test only to the claimed invention as a whole. This is a predicate legal requirement in assessing novelty under § 102 and in assessing nonobviousness under § 103 of the Patent Act. It is also a fundamental legal requirement for asserting patents for both literal and equivalents infringement under § 271. In all of these other patent doctrines, this Court has maintained the basic requirement of assessing patentability or limiting assertion of patents to the claimed invention as a whole, as this avoids the same policy problems of indeterminacy and over-restrictiveness (or over-inclusiveness, depending on the perspective) in these other patent doctrines. Thus, this Court should grant the petition for certiorari, reverse the Federal Circuit, and provide further instructions for applying the Mayo-Alice test only to the “claimed invention as a whole.”

To read the amicus brief, please click here.

Categories
Uncategorized

A New NAFTA Must Protect the Rights of Copyright Owners and Creators

Cross-posted from the Mister Copyright blog.

chrome 3D copyright symbolLast week, the fifth round of the North American Free Trade Agreement (NAFTA) negotiations closed in Mexico City with tensions high and little progress made towards a modernized trade deal. While the most recent talks saw the U.S., Mexico, and Canada discussing (and disagreeing over) ways to resolve trade disputes and rules governing automobile tariffs, earlier meetings have focused on ways to update international intellectual property standards for the 21st century. And though it remains unclear how potential updates will take shape, it’s essential they give creators and copyright owners a fair shot at protecting their works, rather than reinforce an outdated system that promotes immunity for those who continually facilitate infringement.

Held in Ottawa in late September, the third round of NAFTA negotiations concentrated on intellectual property and used text from the Trans-Pacific Partnership (TPP) as a template for chapters on IP and digital trade—formerly called e-commerce. Following the talks, strong criticisms arose from the tech sector and their affiliate trade organizations, bemoaning what they considered a retreat from language confirming limitations on liability and exceptions to copyright that have allowed digital platforms and other internet intermediaries to avoid infringement accountability for years.

In a letter to United States Trade Representative (USTR) Robert Lighthizer, associations representing tech giants such as Google, Facebook, and Amazon, repeatedly call for NAFTA negotiators to commit to language from the twenty-year-old Digital Millennium Copyright Act (DMCA), which—according to the letter—would carry on the “balance” upon which their industry relies. Unfortunately, the letter fails to reveal that with every year that passes since the DMCA’s enactment, the scales tip further in favor of content users and intermediaries, leaving creators and copyright owners increasingly unable to control their works.

Critics of the recent NAFTA copyright discussions have accused the USTR of trying to advance proposals influenced by the “content industry,” which would make internet service providers (ISP) more responsible for removing infringing content and holding repeat infringers accountable. They’ve implied that the Trump administration has sided with Hollywood to promote a film industry agenda that’s tough on piracy, and they’ve claimed that it’s a policy that will come at the expense of free speech. But it’s a strange allegation to claim the current administration is somehow in cahoots with an industry it routinely derides, and it’s also one that has little to no corroborating evidence.

Reports have also surfaced that Canada, because it was not involved in early drafts of the sections on IP, is resisting using the TPP as a framework for the NAFTA updates. According to an article on the third round of negotiations, Canada prefers to use the original NAFTA IP language as a starting point for negotiations, augmenting it only with features of other agreements it has already signed onto. And while it may seem unreasonable to cling to an agreement written before an iPod existed, perhaps it shouldn’t be surprising that Canada would resist injecting more accountability into copyright law, as it has been notoriously weak on piracy and was recently recommended to be included in a USTR’s watch list of countries failing to implement international standards.

Before the IP talks in September, over twenty music industry organizations sent their own letter to the USTR regarding the NAFTA negotiations. In it, they stress that just as many tech companies have transformed from small startups to global titans over the past twenty years, the digital marketplace has changed drastically since earlier trade agreements. Respect for the contributions of the creative industries that was once the foundation of earlier IP policies has been replaced by the narrow agenda of a few powerful companies and interest groups that would prefer to keep the U.S. and its trade partners locked into antiquated guidelines. Instead of looking backward, the letter insists that NAFTA negotiators must look ahead to advance “an inclusive digital trade policy that capitalizes on the contributions of our creators to jobs, growth, and the U.S. competitive advantage in trade.”

To be sure, stakeholders in any sector involved in international trade want to see a NAFTA agreement that will benefit their individual companies and industry as a whole. But for those representing the interests of internet intermediaries who wish to shackle North America to regulations that have been become severely outdated in the age of lightning-fast technological advancement, the questions becomes: What will be the cost of unbalanced, continual benefits to these entities? Because for all the talk of maintaining balance between content creators and those whose business model relies upon the unfettered access and distribution of content, it’s clear that grasping at the obviously obsolete standards of the DMCA leaves creators and copyright owners in the lurch.

As renowned filmmaker Ron Maxwell recently described in an op-ed about the current NAFTA negotiations, now that the once intoxicating allure of Silicon Valley has started to wear off, it’s time to stop watering down our copyright policies so that a few can profit off the creations of many. Maxwell explains:

Silicon Valley is laser-focused on diluting the copyright language in the treaty and is arguing for broad and unchecked “safe harbors” — from copyright infringement as well as all other illegal activity perpetrated on their platforms. Why in the world do they deserve immunity from the same responsibilities everyone else must shoulder?

The reality is that the companies arguing for exceptions are no longer exceptional, and they should be subject to the same rules as any other entity that wishes to access, reproduce, or distribute copyrighted content. To allow otherwise would mean turning our back on the American cultural exports that have truly changed the world.