Professor Cynthia Ho is the Director of the Intellectual Property Program at Loyola University Chicago School of Law. She teaches courses in Intellectual Property as well as Civil Procedure. She has made particular contributions in the area of international intellectual property, as well as patent issues involving biotechnology or health policy.
I had the pleasure of taking Professor Ho’s Civil Procedure class in my first semester and her Global Access to Medicine: A Patent Perspective class (based on a book she wrote) in my second semester. This semester, I’m excited to be in her Intellectual Property Law class and learning more about the world of IP.
In her Global Access to Medicine class, Professor Ho introduced the topic of patents on medicines as they relate to TRIPS, which is a legal framework regarding intellectual property rights followed by member nations of the World Trade Organization (WTO). As we are witnessing with the pandemic, patents protections as required by TRIPS are playing a central role in the conversation regarding the COVID 19 vaccine and its global distribution. In a surprising move, the Biden Administration came out in favor of a “patent waiver” for the COVID vaccine and other COVID related technologies this past May.
I sat down with Professor Ho to learn a little bit more about what that means:
The Patent Waiver Misnomer
Louay: We’re hearing a lot about this idea of a COVID patent waiver in the news. From what we’ve learned in your Global Access to Medicine class, the TRIPS agreement already contains provisions for circumventing patent protections in cases of emergency. How does the proposed patent waiver differ from what’s already outlined within TRIPS?
Professor Ho: I think that there’s a lot of misconception right now because a lot of discussions about a patent waiver and the proposal by India and South Africa is to waive COVID-related IP rights that include, but are not limited to patents. It also includes trade secrets, which are really crucial to making vaccines for COVID. There are actually no TRIPS exceptions for trade secrets in general, whereas there are two different TRIPS exceptions to the usual patent rights. There is one article permitting “limited exceptions” to patent rights, but it has a whole bunch of criteria according to a prior WTO decision, which could make it hard to satisfy. There’s another article commonly referred to as permitting compulsory licensing, where a country could give someone other than the patent owner authority to make, use, and sell the patented invention for a government-imposed fee. This is the provision that the EU has come out in favor of using instead of a waiver.
Could Compulsory Licenses be the Answer?
Louay: You mentioned the idea of a compulsory license. The EU is proposing these compulsory licenses as an alternative to the waiver. Can you talk a little bit about compulsory licenses and how they’ve been used in the past?
Professor Ho: Compulsory licenses are an exception in international laws for patents. But that’s not enough to make it work. A country can’t actually issue a compulsory license unless it actually has a domestic law permitting it to do that. Although a lot of countries have compulsory license laws on the books, they are rarely used. Even when certain countries do use them, they tend to get a lot of pressure and pushback from other countries and also companies. For example, when Thailand issued a bunch of compulsory licenses for the HIV Antiretroviral, Kaletra, the pharmaceutical company Abbott stopped selling drugs there as a form of punishment. I think eventually they ended up selling in Thailand again, but countries definitely do not use compulsory licenses as much as public health policymakers think they should, and the case in Thailand shows why.
Louay: Do these countries need to seek permission to use compulsory licenses?
Professor Ho: A country doesn’t need to seek permission internationally. TRIPS says that each nation can issue a compulsory license so long as they follow the rules. The rules say that each country gets to decide the proper justification for compulsory licenses. While a national emergency is not a requirement to issue a compulsory license, if a country has one, it can skip the usual step of trying to negotiate with the patent owner. So, it saves a little time, although there are still a lot of time-consuming hurdles to overcome.
Louay: Does that mean that any country, including India and South Africa, could theoretically issue a compulsory license right now without negotiating with the patent holders?
Professor Ho: They could, but a compulsory license is done for one patent at a time. For each patent for which you issue a compulsory license, the patent owner has two different opportunities to object – one to the issuance of the compulsory license, and separately to the amount of money they get. So that could cause a delay. Plus, the normal rules are that the compulsory license has to be primarily for domestic use. While that could work for a country like India, because it has a lot of manufacturing capacity, many of the smaller countries don’t have the infrastructure to make their own vaccines. There was a very complicated setup created under TRIPS to allow a nation to issue a compulsory license for export. But it is so cumbersome, it’s only been used once in 20 years.
The Reality Behind Compulsory Licenses
Louay: It seems that, given the urgency of the COVID pandemic, it might not be practical to be issuing these compulsory licenses in the way that TRIPS has set forth. Would that be accurate to say?
Professor Ho: Yes, I would agree, and especially because while we might think that one patent covers one drug, in reality it could be 50 or 100 patents to each drug. If a country couldn’t even make the drug domestically in the first place, that causes a problem. That’s without factoring in the public pressure that country could receive from issuing the compulsory license. For example, in 2020 – even though COVID already hit – the US issued its regular special 301-report, which lists countries we think are “naughty” in terms of not having strong enough IP rights. It specifically noted countries that had considered issuing compulsory licenses. This is even during the pandemic. So political pressure is not gone, even though we have COVID.
Louay: You mentioned logistical hurdles, such as manufacturing infrastructure, that would hobble the ability of a compulsory license to increase access to any COVID vaccine. Would the proposed waiver ameliorate such issues? Or do you envision those countries that lack the proper manufacturing infrastructure facing the same hurdles under the proposed waiver?
Professor Ho: I will admit that the waiver is not some magic thing, that all of a sudden everyone gets vaccines, because the countries without infrastructure aren’t magically going to get factories. But a country that does have infrastructure, whether it’s the US, Canada or India, could much more easily make the vaccine and export them, because they would be able to avoid all those complicated procedures with compulsory licenses. Also, whereas a compulsory license is only for patents, the waiver includes a waiver of trade secret rights. However, a company looking to replicate the vaccine would still need to find out what the trade secrets behind the vaccine are.
Trade Secrets are the Key
Louay: What exactly are trade secrets and what would a trade secret look like in the context of the COVID vaccine?
Professor Ho: The basic definition of a trade secret is that it’s information that’s valuable from being kept reasonably secret. So that’s very broad. A lot of things that wouldn’t be patentable, could be a trade secret. A classic example of a trade secret is the Coke formula. Keeping the formula a trade secret is really helpful for Coke, because trade secret protections can last forever as long as it stays secret. Patents, however, are only protected for a limited time. Most drugs are protected by patents, because drugs could possibly be reverse engineered. In the context of the vaccine, the trade secrets are mostly about the manufacturing process.
Louay: So, to circle back, the difference between the compulsory license and the waiver is the waiving of the trade secret protections?
Professor Ho: What’s waived is the international obligation that you have trade secret protection. The waiver however doesn’t automatically apply in each country. For example, we know Germany has been opposing the waiver. Even if the WTO adopts it, Germany never has to change its trade secret laws. It could still allow companies to sue others for violating their trade secrets. But a pro-waiver country like India could suspend all their trade secret laws. Then somebody who would normally be considered misappropriating (i.e. violating or stealing) a trade secret would not be liable. In essence, we’re saying that somebody could maybe be a whistleblower without legal consequences. Whereas right now, even if they wanted to do the right thing, they could have a serious penalty. I guess the assumption is if the waiver went forward, you would at least have a lot more pressure on the companies to share, even though they wouldn’t be legally obligated to do so.
Louay: So essentially the process of making the vaccine itself is a trade secret?
Professor Ho: And there are probably different trade secrets for each vaccine. The mRNA vaccines are probably going to be made quite differently than the Johnson & Johnson vaccine. Even between the two mRNA vaccines, each company may have different techniques to maximize different outcomes.
The Bottom Line
Louay: Let’s say that the waiver in question was adopted and that Pfizer or Moderna did not divulge their trade secrets on the manufacturing process. Any would-be generic manufacturer would essentially still have to reverse engineer the vaccine manufacturing process. So ultimately there would still be a delay until the vaccine could get made and distributed, right?
Professor Ho: Or you could pressure the company to do the right thing. Earlier on in the pandemic when we didn’t have enough supplies, such as ventilators, some of the Detroit automotive manufacturers helped with the shortage by retrofitting their equipment to make more ventilators. The companies who made ventilators shared their knowledge. Nobody forced them to share their technology and trade secrets. They were just all trying to do the right thing. So, it can happen, but I think the companies are just not used to sharing. Also, some have argued that the US could force some companies, such as Moderna to share, but that hasn’t happened yet. Given the usual US stance in favor of IP owners and especially pharmaceutical companies, that is not entirely surprising. But, since the US surprised the world by indicating support for waiver of TRIPS vaccines, perhaps the US might surprise us again?
Co-Technical Editor for the Loyola Intellectual Property Law Blog “IP Bytes”
Director of Programming for the Intellectual Property Law Society
Associate Editor for the International Law Review.
Loyola University Chicago School of Law, JD 2023