Posts Tagged: "compulsory licensing"

When it comes to how to best increase access to medicines in l0w and middle-income countries (LMICs), compulsory licensing gets most of the attention. Academic articles, non-governmental organization (NGO) campaigns, conferences and United Nations (UN)-endorsed technical symposia assert it is the best approach. Certain World Trade Organization (WTO) members are pushing for COVID-19 treatments and diagnostics to be included in the waiver of intellectual property rights under the Agreement on Trade-Related Aspects of IP Rights (TRIPs waiver), which revolves around compulsory licensing. Brazil has recently amended its IP laws to make compulsory licensing easier. Despite its high political profile, compulsory licensing has rarely been used (mainly by a handful African countries in the mid 2000s to address the HIV pandemic). Even then, IP-respecting treatments available from global procurement bodies have proven cheaper. No country has yet seen the need for a compulsory license for a COVID vaccine.

Health and Human Services (HHS) Secretary Xavier Becerra may consider himself a lucky man (which would probably sound ironic to him at the moment). He just received three letters which aptly summarize the fork in the road he faces in deciding which way to turn in a critical policy decision. On June 23, Senator Elizabeth Warren (D-MA) and Rep. Lloyd Doggett (D-TX), joined by 98 of their Democratic Congressional colleagues, sent him the latest in their series of letters urging him to use alleged existing authorities so that copycats can make expensive drugs to lower health care costs. That triggered an immediate rebuttal from six associations representing research universities and hospitals (including the Bayh-Dole Coalition, which I lead) and another from the Licensing Executives Society, USA & Canada, Inc. (LES), representing the licensing profession. It seems appropriate to let the letters speak for themselves, so let’s start with the Congressional letter, urging the Secretary to use tools they allege he already has to cut the Gordian Knot to lower drug costs.

Publishers scored a win yesterday in the U.S. District Court for the District of Maryland when the court granted their request for a preliminary injunction enjoining enforcement of the Maryland Act, which essentially calls for compulsory licensing of electronic literary works to libraries on “reasonable terms”. The law went into effect on January 1, 2022. The lawsuit was brought by the Association of American Publishers (AAP) against the state of Maryland and charged that the Maryland Act was preempted by the U.S. Copyright Act. The Maryland Act requires publishers to 1) offer to license copyrighted electronic literary products, such as eBooks and digital audiobooks, to public libraries, and (2) to ensure the terms of such licenses are fair. The goal was to avoid up-charging and stringent licensing restrictions on libraries.

A webinar hosted on Tuesday, January 12, by The Federalist Society’s Regulatory Transparency Project featured former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu and David Kappos, as well as Duke University Professor of Law and former USPTO Administrator of the Office of External Affairs Arti Rai, discussing the proposal to the World Trade Organization (WTO) to waive IP rights under the Trade-Related aspects of Intellectual Property Rights (TRIPS) Agreement for certain COVID-19 technologies. While all three panelists agreed that the IP waiver discussion has become a distraction that will not solve the fundamental problems, Iancu and Kappos were especially passionate that the precedent set by the U.S. government’s decision to back the proposal could do very real harm, rather than good.

On Monday of IPWatchdog LIVE in Dallas, a panel on “The TRIPS IP Waiver: Separating Fact & Fiction” was moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, and featured IP leaders Andrei Iancu, Patrick Kilbride, and Chris Israel. The Trade Related Aspects of Intellectual Property (TRIPS) agreement is an international agreement among members of the World Trade Organization (WTO), which sets minimum standards in the international rules governing intellectual property. In 2020, India and South Africa proposed a TRIPS Agreement waiver proposal that would temporarily waive intellectual property rights protections for technologies needed to prevent, contain, or treat COVID-19, including vaccines and vaccine-related products. The proposal has been hotly contested globally, but the Biden Administration said in May of this year that the United States would back it.

In the early days of the vaccination efforts, Americans were anxiously online trying to register for a COVID-19 vaccination appointment. Reports of success at 1:30 am and 2:30 am made the rounds as new appointments dropped onto websites. Also common were stories of vaccine elitism and discussions of which vaccine is “the best.”  News reports continue to show a steady uptick in the percentage of vaccinated Americans. Elsewhere in the world though, the story is very different, and a darker picture is emerging. In Africa, many countries have vaccinated less than 2% of their population. While vaccine distribution is difficult in many regions of the developing world, this is a hurdle that medical assistance groups, such as Doctors Without Borders, are accustomed to handling. The challenges are known. What is most difficult in combating COVID-19 is obtaining the vaccines in the first place. Some argue that IP rights are the key problem and should be waived, while others claim they are the only solution and that waiver would be catastrophic. This article suggests a third option, somewhere between voluntary vaccine donation and a full waiver of IP rights, that may offer a way forward.

Though it is not over, it seems that the end of the Covid-19 pandemic may be in sight. A select group of countries has managed to bring vaccines to the market in record time. Take the United States, for example. At the time of this writing, three U.S. companies have managed to produce vaccines that received approval from the U.S. Food and Drug Administration (FDA). The intellectual property that underlies these products quite literally has life-saving potential. This achievement no doubt represents a significant feat in human ingenuity, but it also presents a ripe issue in the intellectual property space — namely, compulsory licensing and intellectual property (IP) waivers. Some feel that the cost of sharing this information represents a bold degradation of the intellectual property system. In developing countries, however, the lack of vaccine availability is proving particularly difficult to manage.

Intellectual property protection has played an important role in this pandemic. As some have pointed out, without legal protection for innovative ideas, there may not have been such a rapid response to the pandemic – both in terms of testing/ treatment and, most recently, vaccines. Companies like Moderna, in conjunction with research and funding from the National Institutes of Health (NIH), have spent a decade developing key technology that enabled quicker vaccine development than ever before. Without some intellectual property protections in place that provide strong financial incentives to invest in new ideas, innovation like this may never have come to light. Nevertheless, India and South Africa initiated a proposal in October that is gaining traction among like-minded World Trade Organization (WTO) members. This proposal would temporarily suspend certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement) for products related to COVID-19, including vaccines. What began with a handful of nations has now reached a majority, with 57 national sponsors of the proposal, and over 60 WTO members who are in support.

India and South Africa recently urged the World Trade Organization to suspend intellectual property protections for COVID-19 vaccines and treatments. The claim is that this would allow developing countries to manufacture “cheap” COVID-19 therapeutics and vaccines, hastening the end to the pandemic—at least, that’s what proponents claim. They’re wrong. Dangerously wrong. Gutting IP protections won’t make COVID-19 medications more readily available but it will set a terrible precedent that will chill future medical innovation.

While coronavirus spent the majority of 2020 wreaking havoc on earth, pharmaceutical companies have been busy at work trying to invent a vaccine to combat it. Several companies, such as Pfizer, Moderna and AstraZeneca, have competed neck and neck to be the first to deliver a cure to the world. Renowned pharmaceutical companies have been successful in developing the vaccine, which will be protected under the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS).

By now, everyone in the IP arena has heard about the demands of more than 30 state and territorial attorneys general (AGs) regarding the promising COVID treatment remdesivir. These AGs seem to disrespect the exclusive rights of limited duration that patents afford. California Attorney General Xavier Becerra (D) and Louisiana Attorney General Jeff Landry (R) led a bipartisan effort getting colleagues to write the U.S. Department of Health and Human Services and call for what’s tantamount to eminent domain on intellectual property. To a conservative who works on IP matters, this demand in and of itself is troubling. Bedrock conservative principles include property rights, free enterprise and the rule of law. The AGs advocate government’s abrogation of all three of these foundational principles.

In the wake of COVID-19, government officials around the world face unprecedented decisions about when and to what extent they should reopen their respective societies before effective anti-viral medications or vaccines have been developed, necessary regulatory approvals obtained, and those solutions are manufactured for public use. Fundamentally, such decisions will require a delicate balance between protecting public health and facilitating economic growth, which, as we have all been reminded this year, are deeply intertwined.

As governments around the globe fight the COVID-19 outbreak, pharmaceutical companies race to develop a vaccine and potentially secure a patent for it. To speed the process, much of that effort builds on known drugs for other diseases. The World Economic Forum reports that 70 potential vaccines are currently in development around the world. According to a BBC report, research is in progress on more than 150 additional drugs globally, with many pre-existing drugs being trialed for potential usefulness in combatting COVID-19. Those which can are giving it their best shot—for people as well as profit. In the wake of this COVID-19 vaccine and patent sprint, questions arise concerning affordable and universal access: will governments, especially poorer ones, be able to secure affordable access to a vaccine if and when one becomes available? Can a patent owner actually be forced to license a COVID-19 vaccine for the benefit of the greater good? The answers are likely yes to both, depending where you are.

Whenever a national emergency sweeps through, the question of patents is tangentially swiped at in the context of whether any patents will have to be “broken”, or compulsory government licensing regime initiated, to eliminate any roadblocks to a national or global solution. And, just for good measure, another rock or two is hurled at “patents” using the common epithets: monopolistic, greed of patent holders, profiteers, etc. None of it is true; but that doesn’t stop those who are anti-patent from trying.