By David Gindler & Jasper L. Tran
Has the worldwide distribution of COVID-19 vaccines been impacted by patent rights? David Gindler, head of IP at Milbank LA, and Jasper L. Tran, senior associate at Milbank LA, argue that the story is much more complicated — making vaccines involves much more than waiving patents, they explain.
The following article, which is adapted from the authors’ conversation with Vanderbilt Law Review podcast editor Jacob Goodman on Hot Topics in Intellectual Property Law, provides an overview of the complicated intellectual property landscape associated with COVID-19 vaccines and therapeutics.
What is a patent?
David: Generally, when a company develops a process that is highly effective in the manufacturing world, it more likely than not patents the process. You disclose to the public your invention, that’s what a patent does. Everybody can read it. But for 20 years you get the right to exclude. On balance, when most companies have something that is a significant breakthrough, whether for a new product or a new method of manufacturing, you are going to see a patent on it.
What is a patent waiver, and what effects does it have?
Jasper: Waiving patents — that right to exclude — doesn’t affect the manufacturing process. We still have the know-how problem and the raw materials problem. There are only limited raw materials worldwide [for] making vaccines. There’s a limited number of manufacturing plants that are capable of making these vaccines. And there’s a limited number of skilled scientists that know how to make the mRNA vaccines. Those issues are not captured by the patent-waiver debate, which seems politicized and blown out of proportion. It assumes that once you waive all the COVID patents, everyone all of the sudden starts getting vaccinated quicker and safer, but that’s just not the case.
What other IP protections do COVID vaccine manufacturers use?
Jasper: COVID vaccine [Pfizer and Moderna] was one of the very first times that people have used a combination of the mRNA and nano particle — tiny container — technologies. That’s what makes it so difficult for others to replicate that manufacturing process, because it’s still very secretive from the aspect of IP. I think companies are using trade secret, which has no time limit, to protect those manufacturing process and know-how, than using patent protection, which expires in 20 years.
David: Nobody is enforcing patents to shut down others from doing anything. COVID vaccines are not easy to manufacture. COVID vaccines are what we call a “biologic”; mRNA is biological material. It has to be presented in a certain way, encapsulated in a nano container. The process of making mRNA vaccine in a tiny little container to deliver to your cells is really hard to do. This is not the same technology that you use to make, for example, Lipitor. Making vaccine is much more complicated and it requires specialized and technical know-how.
What is mRNA?
David: mRNA is a sequence of nucleotides. We’ve all heard of DNA, which codes for proteins. Every protein in your body is made by a genetic code in your DNA. For a DNA to make a protein, it first has to get translated in a step called “translation” into mRNA. It’s mRNA that is read by cells to make a protein.
How do COVID vaccines work?
David: The scientists remarkably figured out the genetic sequence of the virus that causes COVID. The coronavirus has a unique structure with all sorts of crown, with little spikes at the top. The scientists looked at the genetic sequence of the spike that is at the outer part of the virus and were able to sequence it. The mRNA is the sequence to produce part of the spike protein.
They then put that into a tiny little container, which is really small and a completely different technology than mRNA. There are companies that do nano particles, which is almost like science fiction to me. These nano containers that contain mRNA get injected into your bloodstream and delivered to your cells.
Once your cells see the mRNA, they say, “We know what to do with mRNA; we make the protein.” The spike protein gets expressed in your bloodstream, your body’s immune system says, “What’s that? You don’t belong here.” And your body makes antibodies to the spike protein, which also happen to work remarkably well when the actual virus enters your system that has the same spike protein. The antibodies know: “We remember you. You’re that spike protein we don’t like.” And the antibodies go after and attack and destroy the coronavirus. That’s basically how it works.
But sequencing of the coronavirus was the easy work and publicly available. You can Google this now to get the sequence of the coronavirus, the sequence of the spike protein, the sequence of the mRNA in both of the mRNA vaccines, all of which are publicly available. What’s not publicly available, is all the know-how that goes into making a vaccine.
It’s been quite a remarkable journey from March 2020 when everything shut down. We were in clinical trials by summer. We had emergency authorization by the end of the year. It’s quite miraculous and what fueled all this was all the work that happened before 2020, which allowed us to get to a place where we were able to produce a vaccine in record time.
What role do patents play in terms of COVID-19 therapeutics?
David: We’re now starting to see COVID-specific pills. This is a huge breakthrough, not just because it was developed in record time, but because it’s a pill, not a biologic. A pill is made of chemicals, which can be easily made everywhere. If we could widely distribute a highly effective pill that actually treats COVID, that would also be as much of a game changer as the vaccine itself. What was once a disease that could go very wrong has become something which is not only preventable but also treatable. A pill can be widely manufactured in any place that manufactures generic drugs and does not have ultra-low temperature storage requirement. This is, in my view, a long-term solution to COVID.
Jasper: For patent waiver, we’re discussing a different kind of issue when talking about the pills than when talking about vaccines because pills don’t use the mRNA or nano particle — tiny container — technologies. While it is irrelevant to discuss patent waiver for vaccines, it is certainly relevant to discuss the patent waiver for pills because the manufacturing process for pills is much easier in terms of the know-how, raw materials, manufacturing plants, and skilled scientists. To focus the patent waiver discussion on pills would make more sense in the long term.
David Gindler is head of IP and Jasper L. Tran is senior associate at Milbank LA. The usual disclaimers apply, including views as their own and not necessarily reflective of Milbank or its clients.
