Month: August 2017

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Innovate4Health Innovation

Innovate4Health: New Oxygen Machine Technology Confronts Blackouts in Emerging Nations

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

Innovate4HealthBy Andrew B. Levey

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

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

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

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

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

Figure 2 from the patent application

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

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

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

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Copyright

Mayweather v. McGregor Warrants Preemptive Anti-Piracy Efforts

hand holding remote pointed towards a TV screen showing a sports gameThis Saturday, the world will be treated to one of the most hyped events in the history of sports when “The Notorious” Conor McGregor and Floyd “Money” Mayweather Jr. meet in Las Vegas to become (even more) rich while ostensibly also participating in a boxing match. The bout marks the first foray into boxing by a champion mixed martial artist—McGregor—at the height of his career, and is made even more compelling by the fact that he’ll be facing one of the greatest boxers of all time in Mayweather Jr.—albeit somewhat past his prime. The seemingly endless prefight activities have included an over-the-top press tour full of provocative trash talk, celebrity-attended training sessions, and a preventative effort by Showtime—the network airing the fight—to quash the inevitable flood of unauthorized streams that will pop up during what is predicted to be the most pirated event ever.

Last week, in response to concerns over lost revenue resulting from illegal feeds of a fight that is expected to take in close to a billion dollars, Showtime brought a preliminary injunction against over 40 websites affiliated with LiveStreamHDQ—a recurrent bad actor in unauthorized streaming—poised to broadcast illicit streams. In its complaint, the premium network targeted sites with blatant domain names such as mayweathervmcgregor.livestreamhdq.com and floydmayweathervconormcgregorfight.us, which Showtime alleges are engaged in “keyword stuffing” in an attempt to appear at the top of search engine results and draw as much traffic as possible to unauthorized streams. After review, District Judge Andre Birotte Jr. approved the injunction, prohibiting the websites from offering infringing content, and since then, it appears that at least some of the sites have backed away from their shameless promotion of free streams.

Preemptive strikes against anticipated copyright infringement are somewhat of a rarity, but they can be imperative when dealing with a short-lived yet furious demand for a marquee, live sporting event—especially one with a pay-per-view (PPV) price tag of nearly $100. In 2015, Showtime and HBO launched a “pre-piracy” offensive against two websites that had announced plans to stream the much-anticipated Mayweather v. Pacquiao boxing match. And while the threat of a lawsuit was successful in deterring the targeted websites, the fight was still subject to massive piracy through mobile live video streaming apps such as Periscope and Meerkat.

Despite their limited success, these proactive attempts to curb expected infringement have led some critics to accuse networks of censoring and site-blocking any website they choose for a theoretical crime that hasn’t yet occurred. But, as many of the same critics acknowledge, a clear provision in US copyright law allows for an infringement action before fixation takes place “[i]n the case of a work consisting of sounds, images, or both, the first fixation of which is made simultaneously with its transmission.” It’s an important distinction that represents lawmakers’ understanding of the unique concerns surrounding a live broadcast that loses most of its value immediately after its initial airing.

Section 411(c) of the Copyright Act provides that a copyright owner may bring an infringement action related to an unregistered work, and recover statutory damages for an unauthorized use, when the work is part of a live broadcast. Known as the “live broadcast exemption,” the Committee on the Judiciary explained that it “is intended to deal with the special situation presented by works that are being transmitted ‘live’ at the same time they are being fixed in tangible form for the first time,” such as “sporting events, concerts, theatrical presentations and news and public affairs programs.” The section goes on to list two requirements for obtaining statutory damages, including service of an “Advance Notice of Potential Infringement” at least 48 hours before the work is transmitted, and registration of the work within three months after its first transmission.

While it’s encouraging that Showtime’s injunction has already resulted in some of the targeted websites shutting down or offering links to legal viewing options, it’s likely that live-streaming apps will once again draw thousands of would-be paying customers towards unauthorized streams. Unfortunately, because of the massive paydays coming to McGregor and Mayweather, many who seek out illicit streams will justify the infringement by figuring it won’t hurt to take a few dollars out of their deep pockets. But as a recent article on MMA and boxing-related piracy points out, illegal feeds take money away from far less affluent athletes and from the organizations that make their careers possible.

Identifying and shutting down live streams that will inevitably appear (and reappear) via the likes of Periscope and Facebook Live is an uphill battle. Whereas Showtime’s injunction can address known infringing-enabling services and the websites they facilitate in the days and weeks leading up to the event, when the fight bell rings, it becomes impossible for the network and its affiliates to effectively play whack-a-mole with the surge of unauthorized streams.

As Ultimate Fighting Championship (UFC) CEO Lorenzo J. Fertitta explained in his testimony before the House Judiciary Committee nearly a decade ago, the content offered during PPV events is not only extremely valuable, but extremely perishable. Section 411(c) exists because once a popular event is over, the value is gone, and rights owners must have a way to combat potentially devastating infringement.

But Section 411 was enacted at a time when the current landscape of live-streaming app piracy (and the internet for that matter), could not have been anticipated. It’s a problem that requires attention not only from the rights holders and networks airing the events, but from the social media platforms that host the applications. Perhaps a Content ID system that would recognize and kill unauthorized streams of big ticket/PPV events is in order. But don’t expect the platforms to jump at the opportunity to implement such anti-piracy mechanisms, as they and their supporters are quick to label them ineffective and unconstitutional. Unfortunately, until a better system is put in place to supplement Section 411, every preeminent PPV fight will be predicted to be the most pirated event ever.

Categories
Copyright

Court Confirms the Obvious: Aiding and Abetting Criminal Copyright Infringement Is a Crime

Cross-posted from the Law Theories blog.

closeup of a circuit boardIn July of 2016, a criminal complaint was filed in the Northern District of Illinois alleging that Artem Vaulin of the Ukraine was the mastermind behind the popular torrent site, Kickass Torrents (KAT). At the time, KAT was one of the largest pirate sites in the world, with an estimated 50 million unique visitors each month. The complaint charged Vaulin with several crimes, including criminal copyright infringement. The district court issued an arrest warrant for Vaulin and a seizure warrant for the various KAT domain names. Less than two weeks later, Vaulin was arrested in Poland and the KAT website was under the government’s control.

The government then secured an indictment charging Vaulin with sixteen counts, including eleven counts of aiding and abetting criminal copyright infringement for distributing pre-release movies, including The Butler, Deadpool, and X-Men: Apocalypse.[1] There was also one aiding and abetting criminal copyright infringement count for reproducing and distributing “at least ten copies . . . of one or more copyrighted works which had a total retail value of more than $2,500” during “the 180 days leading up to and including July 8, 2016[.]”[2] Two months after the indictment was handed down, Vaulin filed a memorandum in support of his motion to dismiss that made a rather extraordinary claim: Aiding and abetting criminal copyright infringement is not a crime.

The twelve aiding and abetting criminal copyright infringement counts in the indictment all point to Section 2 of Title 18, the federal aiding and abetting statute. Section 2(a) provides: “Whoever commits an offense against the United States or aids, abets, counsels, commands, induces or procures its commission, is punishable as a principal.” The idea behind Section 2(a) is simple: Those who help or encourage another to commit a federal crime, with the intent to aid in its commission, are guilty just as if they had committed the crime themselves. The statute does not create a separate crime; it instead permits someone to be convicted of a crime even if that person did not commit all of the acts constituting the elements of the crime. The indictment charged Vaulin with aiding and abetting because his KAT website merely provided torrent files that helped others to directly commit criminal copyright infringement.

Vaulin argued that “[s]econdary liability in civil copyright law is a common-law creation of judges, but it is not a federal crime enacted by Congress.” Incredibly, Vaulin never once mentioned Section 2(a)—the very statute that makes it a crime to aid and abet the commission of a federal crime and that he was charged with violating a dozen times over—in arguing that aiding and abetting criminal copyright infringement is not a crime. Vaulin also made no mention of binding Seventh Circuit precedent erasing any doubt that Section 2(a) applies to all federal crimes. In the late 1980s, a defendant challenged his aiding and abetting conviction on the ground that Section 2(a) did not apply. The Seventh Circuit, sitting en banc, rejected the argument: “The question is not whether section 2(a) is applicable—it always is.”[3]

The government’s brief in response to Vaulin’s motion to dismiss pointed out this obvious flaw: “And make no mistake, § 2 applies to all violations of the criminal code.” It noted that no court had ever held that aiding and abetting criminal copyright infringement is not a crime, even though “scores of defendants” had been charged and found guilty of that very crime. The government then rebutted the only plausible argument that aiding and abetting criminal copyright infringement is not a crime—despite the fact that Vaulin had not bothered to make it. Under the Copyright Act of 1909, Congress expressly included language criminalizing aiding and abetting criminal copyright infringement.[4] That language was removed in the Copyright Act of 1976, and the argument is that Congress thus decriminalized the act of aiding and abetting criminal copyright infringement.

At first blush, this argument makes some sense. Indeed, one district court suggested in dicta over two decades ago that “Congress revamped the Copyright Act by eliminating the crime of aiding and abetting copyright infringement.”[5] And one scholar recently posited that “the Copyright Act of 1976 eliminated the provisions for aiding and abetting introduced in 1909[.]”[6] Notably, neither the district court nor the scholar mentioned the federal aiding and abetting statute—Section 2(a)—and explained why it would not apply to criminal copyright infringement. Nor did they explain why nothing in the legislative history indicates that Congress intended to make criminal copyright infringement the one-and-only federal crime that people can aid and abet with impunity.

In context, the argument makes no sense. Why would Congress want to decriminalize aiding and abetting criminal copyright infringement, thus making it different from every other federal crime? And why would it make such a drastic change, reversing almost seven decades of precedent, yet say nothing in the legislative history? The trend since copyright infringement was first criminalized one century ago has been to expand both the conduct that constitutes criminal infringement and its sanctions. In the four decades since the 1976 Act was enacted, Congress has systematically enlarged the law of criminal copyright infringement.[7] Why would Congress work so diligently to broaden criminal copyright infringement while at the same time make it the only crime in the entire U.S. Code that one can aid and abet without liability?

As the government noted in its brief, numerous scholars—as well as the venerable Nimmer on Copyright treatise—have concluded that aiding and abetting does apply to criminal copyright infringement.[8] Congress removed the aiding and abetting language with the 1976 Act because it was redundant with Section 2(a). Congress did not make an enormous change to criminal copyright law and then neglect to mention it in the legislative history; Congress removed surplusage and then said nothing because the redundancy was self-evident and unremarkable. Indeed, as Deputy Assistant Attorney General Irwin Goldbloom reported to Congress in 1975: “The provision . . . for aiders and abettors has been removed, but these individuals will be liable to prosecution under 18 U.S.C. 2.”

In his brief replying to the government’s brief, Vaulin finally made the argument—in all-bolded text, no less—that the government had already rebutted: “But aiding and abetting was removed from the Copyright Act by Congress in 1976 thereby eliminating the crime.” Overemphasis notwithstanding, Vaulin’s brief yet again failed to mention Section 2(a), the very aiding and abetting statute he again insisted does not exist. Instead, Vaulin engaged in hand-waving about “inventing new crimes” and the “rule of lenity,” apparently in the hope that the district court would not notice the glaring omission. Curiously, Vaulin even cited the DOJ’s Prosecuting Intellectual Property Crimes manual, despite its hot tip to federal prosecutors that they “may, for strategic reasons, wish to bring accessory charges, such as aiding-and-abetting or inducement, 18 U.S.C. § 2[.]”

Needless to say, District Judge John Z. Lee spent little time rejecting Vaulin’s argument that the crime he had been charged with twelve times over does not exist. In fact, Judge Lee did not need to reach the issue at all since he had already found that Vaulin’s motion could be dismissed under the fugitive disentitlement doctrine. To Vaulin’s claim that secondary liability for copyright infringement only exists in the civil law context, Judge Lee noted that “the indictment does not charge Vaulin with common law secondary liability” and pointed to Section 2(a). To Vaulin’s claim that Congress intended to decriminalize aiding and abetting, Judge Lee stated that Section 2(a) “applies to every criminal offense” and that “there was no need to include language in the Copyright Act itself” criminalizing “aiding and abetting criminal infringement” since it “would have been redundant.”

Vaulin’s self-serving—and ultimately losing—argument that the crime of aiding and abetting criminal copyright infringement disappeared four decades ago despite nobody noticing until now aside, this case raises some interesting questions. The simple fact is that there is very little case law applying criminal copyright law in the internet context, much less cases turning on an aiding and abetting theory. However, what is uninteresting is the fact that aiding and abetting criminal copyright infringement is a crime. It is absurd to think that criminal copyright infringement is the one crime that Congress wants people to be free to aid and abet.

[1] The indictment specified that each count is “[i]n violation of Title 17, United States Code, Section 506(a)(1)(C) and Title 18, United States Code, Sections 2319(d)(1) and 2.” Section 506(a)(1)(C) makes criminal “willfully” infringing a copyright if committed “by the distribution of a work being prepared for commercial distribution, by making it available on a computer network accessible to members of the public, if such person knew or should have known that the work was intended for commercial distribution.” Section 2319(d)(1) establishes the crime as a felony, punishable by up to three years imprisonment and a fine.

[2] The indictment specified that this count is “[i]n violation of Title 17, United States Code, Section 506(a)(1)(A) and Title 18, United States Code, Sections 2319(b)(1) and 2.” Section 506(a)(1)(A) makes criminal “willfully” infringing a copyright if committed “for purposes of commercial advantage or private financial gain[.]” Section 2319(b)(1) establishes the crime as a felony, punishable by up to five years imprisonment and a fine.

[3] United States v. Pino-Perez, 870 F.2d 1230, 1233 (7th Cir. 1989).

[4] Section 28 provided: “[A]ny person who willfully and for profit shall infringe any copyright secured by this Act, or who shall knowingly and willfully aid or abet such infringement, shall be deemed guilty of a misdemeanor[.]”

[5] United States v. LaMacchia, 871 F. Supp. 535, 539 (D. Mass. 1994).

[6] Irina D. Manta, The Puzzle of Criminal Sanctions for Intellectual Property Infringement, 24 Harv. J.L. & Tech. 469, 481 (2011); see also Mary Jane Saunders, Criminal Copyright Infringement and the Copyright Felony Act, 71 Denv. U. L. Rev. 671, 674 (1994) (“The 1976 general revision to the Copyright Act continued the offense of criminal copyright infringement, but eliminated the crime of aiding and abetting infringement.”).

[7] See, e.g., Piracy and Counterfeiting Amendments Act of 1982, Pub. L. No. 97-180, 96 Stat. 91 (1982); Sentencing Reform Act of 1984, Pub. L. No. 98-473, 98 Stat. 1987 (1984); Copyright Felony Act of 1992, Pub. L. No. 102-561, 106 Stat. 4233 (1992); Anticounterfeiting Consumer Protection Act of 1996, Pub. L. No. 104-153, 110 Stat. 1386 (1996); No Electronic Theft (NET) Act of 1997, Pub. L. No. 105-147, 111 Stat. 2678 (1997); Digital Theft Deterrence and Copyright Damages Improvement Act of 1999, Pub. L. No. 106-160, 113 Stat. 1774 (1999); Artists’ Rights and Theft Prevention (ART) Act of 2005, Pub. L. No. 109-9, 119 Stat. 218 (2005); Prioritizing Resources and Organization for Intellectual Property (PRO IP) Act of 2008, Pub. L. No 110-403, 122 Stat. 4256 (2008).

[8] See, e.g., 5 Nimmer on Copyright § 15.01[A][2] (2017) (“Persons who knowingly and willfully aid or abet copyright infringement are subject to the same criminal penalties as apply to the principal.”); Benton Martin & Jeremiah Newhall, Criminal Copyright Enforcement Against Filesharing Services, 15 N.C. J. L. & Tech. 101, 108 (2013) (“Aiding and abetting criminal copyright remains a crime under § 2(a).”); James Lincoln Young, Criminal Copyright Infringement and a Step Beyond: 17 U .S.C. § 506 (1976), 60 Neb. L. Rev. 114, 124 (1981) (“The continued inclusion of such a provision in the new section 506(a) would have been merely superfluous[.]”); Note, The Criminalization of Copyright Infringement in the Digital Era, 112 Harv. L. Rev. 1705, 1722 n.39 (1999) (“The new Act removed references to aider and abettor liability. However, because such liability was still possible under the general provision treating aiders and abettors of any federal criminal offense as principals, this change appears to be simply a removal of surplusage.”).

Categories
Administrative Agency Innovation Patent Law

The PTAB’s Regulatory Overreach and How it Cripples the Innovation Economy

files labeled as "patents"On August 14, 2017, the Regulatory Transparency Project of the Federalist Society published a new white paper, Crippling the Innovation Economy: Regulatory Overreach at the Patent Office. This white paper examines how an administrative tribunal created in 2011—the Patent Trial and Appeal Board (PTAB)—has become “a prime example regulatory overreach.” Several CPIP scholars are members of the Intellectual Property Working Group in the Regulatory Transparency Project that produced the white paper, including Professors Adam Mossoff, Kristen Osenga, Erika Lietzan, and Mark Schultz, and several are listed as co-authors.

Among the sweeping changes to the U.S. patent system included in the America Invents Act (AIA) was the creation of the PTAB, a new administrative body within the U.S. Patent and Trademark Office (USPTO). The PTAB hears petitions challenging already-issued patents as defective. Anyone can file a petition to have a patent declared invalid. The original idea was that this would help to weed out “bad patents,” i.e., patents that should not have been issued in the first place.

In the past five years, however, it has become clear that the PTAB has become an example of an administrative tribunal that has gone too far. Lacking the proper procedural and substantive restraints that constrain courts and even other agencies in respecting the rights of citizens brought before them, the PTAB is now “killing large numbers of patents and casting a pall of uncertainty for inventors and investors.”

In just a few years, the laudable goal of the PTAB in providing a cheaper, faster way to invalidate “bad patents” has led to a situation in which all patents now have a shroud of doubt around them, undermining the stable and effective property rights that serve as the engine of the innovation economy. The former chief judge of the court that hears all patent appeals recently said that the PTAB is a “patent death squad,” and confirming that this is not extreme rhetoric, the first chief judge of the PTAB responded to this criticism by embracing it: “If we weren’t, in part, doing some ‘death squadding,’ we would not be doing what the [AIA] statute calls on us to do.”

The white paper briefly discusses the history and purpose of the U.S. patent system and describes the PTAB and how it operates. The substance of the white paper details extensively the procedural and substantive problems in how the PTAB has failed to respect both the basic requirements of the rule of law and the rights of patent owners. The concern is that this undermines the stable and effective platform that patent rights provide as the engine of the innovation economy.

To read the white paper, please click here.

Categories
Patent Law

CPIP Affiliate Scholar Erika Lietzan Testifies at HJC Hearing on FDA Approval Process

U.S. Capitol buildingOn July 27, 2017, CPIP Affiliate Scholar and Associate Professor of Law at the University of Missouri–Columbia Erika Lietzan testified before the House Judiciary Committee’s Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a hearing on Antitrust Concerns and the FDA Approval Process. The hearing was an attempt by lawmakers to better understand the sometimes complex pharmaceutical development and approval process and to consider legislative tactics that could help curb regulatory abuses in the drug marketplace. Professor Lietzan’s testimony provides her perspective and recommendations on three aspects of the regulatory paradigm of particular interest to the Committee: citizen petitions, use and distribution restrictions, and FDA’s unapproved drugs initiative.

Citizen Petitions

Addressing the first topic, Lietzan praises the development of the citizen petition process, which was initiated in the late 1970s in order to allow any person to request that the FDA issue, amend, or revoke a regulation or order. Though citizen petitions were meant to move the administrative agency towards an “open government” philosophy and embrace transparency, access, and accountability, critics argue that they’ve enabled some innovative drug makers to intentionally delay the approval of generics through frivolous petitions. But as Lietzan points out, many critics’ concerns over meritless innovator petitions are based on inferences and not factual findings.

Professor Erika LietzanLietzan explains that there is scant factual evidence of delay in the approval of generic drugs due to petitions, noting that of 175 petitions related to pending applications over a recent eight-year period, only five resulted in delays not necessary to protect the public health. Additionally, while two of the most relied upon studies track denied petitions, neither of them evaluate the strength or contents of the petitions. As Lietzan notes, “[t]he claim that petitions are frequently frivolous appears based on the timing of petitions and denial rate, not the substance, of the petitions.”

In her recommendations to the Committee, Professor Lietzan suggests enhancing existing empirical work with a robust examination of the agency’s disposition of the issues presented in the petitions, rather than a cursory look at the requests stated in the petitions. In order to help conduct this research, Lietzan recommends providing the agency with additional resources and incentivizing petitioners to include more comprehensive data as part of their submissions.

Use and Distribution Restrictions

Of particular focus during the hearing was the proposed Creating and Restoring Equal Access to Equivalent Samples Act of 2017 (CREATES Act), which aims to prevent drug innovators from using FDA-required risk evaluation and mitigation strategies (REMS)—required for potentially high-risk drugs—to obstruct generic competition. Again, Lietzan points out that the studies relied upon to promote the CREATES Act often involve unclear methodology and weak empirical support.

When dealing with new drugs that may pose great risk to the public, innovators have legitimate concerns about the sale of their products to another company, regardless of a competitive relationship. As Lietzan explains, these innovators have a special responsibility to the public, and the CREATES Act lacks meaningful protections in the event their products lead to toxicity or other harm to patients.

Lietzan then challenges the CREATES Act as “flatly inconsistent with fundamental patent law.” She explains that by requiring a company to practice its patent for the benefit of a competitor, the Act contradicts a central principle of patent law which guarantees that a patent owner has no duty to practice their invention. After she warns that “[e]nacting this provision will inherently devalue patents” and “harm incentives to innovate,” Lietzan asserts that the FDA simply lacks the authority to require a company to practice their patent or sell their product to a competitor.

In lieu of enacting the flawed CREATES Act, Lietzan recommends that robust liability protections be implemented for innovative companies providing products to third parties, and that the agency examine ways to incentivize innovators to manufacture and sell patented drugs, as well as agree to shared access systems.

Unapproved Drugs Initiative

Addressing concerns over recent sharp increases in the price of drugs that have long been available at a low cost, Professor Lietzan explains that—despite public outrage—these  price hikes are a direct result of the FDA’s “unapproved drugs initiative” and represent a system working directly as designed. The reality is that there are several thousands of unapproved drugs marketed in the US, which Lietzan explains are the result of piecemeal evolution of drug approval mechanisms throughout the 20th century.

The FDA has adopted a risk-based approach to combating unapproved drugs, prioritizing those that pose the biggest threats to public health while also providing a grace period for some companies to try to bring their products into compliance. But Professor Lietzan notes that in order for many established medicines to obtain approval, companies must generate substantial data and perform research that will inevitably cost a significant amount of money. And while there may not be a way to bring these drugs into compliance without price disruptions, Lietzan recommends the creation of programs in which companies involved with specific ingredients pool resources and collaborate on research, allowing the FDA to save time and money by approving a group of applications at the same time.

Conclusion

Professor Lietzan’s testimony and recommendations reflect the core values of public health and open government embodied in the FDA’s mission of ensuring that pharmaceuticals are safe and effective. In addition, her testimony stresses the importance of maintaining effective patent property rights and promoting evidence-based policymaking—two fundamental principles that are unfortunately often overlooked.

Video of the full hearing can be found here.

Categories
Innovate4Health Innovation Patents

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

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

Innovate4HealthBy Gabrielle Eriquez

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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