The “waiver” of patent rights on Covid-19 vaccines has become the intellectual property debate of the pandemic.
Earlier this year, Oxfam started an advocacy campaign calling for “patent-free development of a Covid-19 vaccine” and “open licensing” for poor countries. Nobel Prize-winning economist Joseph Stiglitz has argued eloquently that worldwide IP barriers to vaccines are “morally wrong and foolish.”
On Oct. 16, 2020, India and South Africa presented to the World Trade Organization a proposal for members to waive the TRIPS agreement of 1995. The agreement (Trade-Related Aspects of Intellectual Property Rights) gives members the right to compel licenses of patented medicines, and to ask for a waiver of prior negotiations, in cases of a national emergency. The same month, Moderna announced that, during the pandemic, they would not assert their patent rights against vaccine manufacturers.
Since then, most of the public discussions have been about whether, broadly, all developed countries should “waive” the patent rights of their pharmaceutical companies, and allow developing countries to manufacture vaccines free of constraints. There is, however, a problem with the debate.
Absence of Patent Rights on Specific Vaccines
In October 2020, when the request to the WTO was made, there were no patent rights on specific vaccines, and there still aren’t any. A recent search of several international databases showed that no patents on the specific mRNA vaccines by Pfizer, BioNTech, or Moderna had yet issued. Not a single unexamined patent application on their mRNA vaccines had even published.
The inventions of specific Covid-19 vaccines probably were not made until early to mid-2020. Since publication of the companies’ pending applications happens 18 months after their first filing, we would not expect that anything will publish until after August 2021.
We don’t even know if anything is pending. What’s more, absent some expedited handling, nothing specific will likely issue as a patent anywhere until 2022, if not later.
Most vaccine details are still confidential, published neither in patent applications nor in FDA approvals. All the FDA has done so far is issue an “Emergency Use Authorization” for the vaccines, which contains only minimal information. A definitive FDA approval would result in more complete descriptions than available now: formulae, composition, manufacture, and dosages.
Aware of the lack of detailed information, the 2020 request to the WTO was not about waiving existing or future patents on mRNA vaccines. The waiver request was about transferring confidential technology.
Patents vs. Trade Secrets and Know-How
If the pharmaceutical generic companies of the world want to quickly copy the existing mRNA vaccines, they need to get access to trade secrets and know-how, forms of IP that are more zealously protected than patents. That is indeed what they asked for.
The 2020 request asked for a waiver of all IP rights, not just patent rights. Mustaqeem De Gama, the leader of the South African Permanent Mission to the WTO, explained that the request was “for the transfer of technology.”
Thus, what’s at play are secrets. Opening the negotiation by requesting that pharmaceutical companies share their trade secrets became, quite predictably, a non–starter. Yet even a well-orchestrated confidential transfer of industrial secrets will not work in the short run. Coming up to speed will take a while.
Biologics and Biosimilars vs. Synthetics and Generics
Covid-19 vaccines are more complex than drugs, such as anti-retrovirals, for which compulsory patent licenses have issued in the past under TRIPS.
Such past drugs are what researchers call “synthetics,” copies of which are known as “generics.” But mRNA vaccines are not synthetics. They are made from a nucleic acid, and are known as “biologics.” Their copies are known as “biosimilars.”
Manufacturing a biosimilar from descriptions of the innovators’ procedures is not as straightforward as reproducing the methods of manufacturing synthetics to make generics. Since the efficacy of biosimilars depends on their methods of manufacturing, they are rarely if ever identical to the original biologic. And, whether they are “similar enough” to be approved by a health authority is a complex legal proposition.
The biological production line to make an mRNA vaccine is a complicated exercise in biotech manufacturing. It’s not quick, and things don’t always go as planned.
"[If] you want to establish a biological production line,” said John-Arne Røttingen, Norway’s Global Health Ambassador, “you need a lot of additional information, expertise, processes, and biological samples, cell lines, or bacteria.”
Exporting Vaccines Is Easier and Faster
Since time is of the essence, the fastest way to get jabs into muscles is to continue making the vaccines in the U.S. or Europe, have the governments buy them, and ship them, ready to go, to those in need. In June, President Biden announced that the U.S., together with other G-7 member countries, would do just that.
Accompanying these transfers, the innovators should at least share their know-how on transport and storage. Expertise related to cold storage is not likely to be as heavily guarded as that involved in manufacturing. In the short run then, vaccines should be available.
While that is being implemented, India and South Africa might be able to negotiate tech transfer agreements with the innovators and become self-sufficient. A license under TRIPS of future patents (with or without a waiver of negotiations) may then be needed to reassure the receiving governments that they will not be blocked from using patented vaccines.
If developing countries produce vaccines by themselves, access to vaccine patents under the guidelines of TRIPS will allow them to continue doing so.
The balancing of short-term needs, long-term self-sufficiency, and protection of trade secrets is a worthwhile policy for all involved.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Jorge Goldstein, Ph.D., is a co-founder of Sterne Kessler Goldstein & Fox PLLC, an intellectual property law firm. The opinions expressed are solely Dr. Goldstein’s and are not expressed by or on behalf of the law firm or its clients.