The Push for an IP Waiver
Vaccinating the world is a monumental task. The key leaders, Pfizer/BioNTech, Moderna, and AstraZeneca have made tremendous progress in developing and scaling up vaccines in a record time. It was not possible to produce billions of doses in a matter of months, so when the COVID-19 vaccine shortage became apparent, certain interest groups blamed patents as impeding full use of global vaccine manufacturing and supply chains. To ostensibly broaden manufacturing capacity and access to vaccines and other COVID-19-related technologies, India and South Africa submitted a proposal1 to the World Trade Organization in October 2020 to waive certain rights and enforcement provisions of the TRIPS agreement.
The original proposal was not limited to vaccines. It was broadly worded to waive protection for all subject matter related to fighting the pandemic and left open the question of how long such a waiver would last. This included waiving protection for copyrights, industrial designs, patents, and trade secrets. The negotiation process stalled, and by the December 31, 2020 deadline the TRIPS Council had only decided “to continue considerations of the proposal”.
On May 5, 2021, the United States announced2 their support for TRIPS waiver negotiations and their participation in the WTO’s talks. This marked a major policy change that breathed new life into the project. A broader coalition then submitted3 a second proposal in May 2021. The revised waiver was limited to 3 years and only to copyrights, designs, patents, and trade secrets related to “health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19”.
The 90-day deadline for the TRIPS Council to decide whether to accept the revised waiver is August 23, 2021.
An Alternative to a Waiver - Compulsory Licensing
During the discussion period, the European Union attempted to move focus away from a waiver toward a more conservative approach. The EU submitted a paper4 proposing to “reaffirm” the existing compulsory licensing processes within TRIPS under articles 31 and 31bis and recognizing the pandemic as an emergency that triggers their immediate application. A compulsory licence creates legally-mandated, limited permission to use IP when certain conditions are met. A waiver is broader than a compulsory licence because it outright waives the IP rights. Under the current compulsory licensing articles, in an emergency, a WTO member state may manufacture a patented product for domestic, non-commercial use without the patent owner’s consent. The agreement only requires notice to the patent owner and fair compensation determined by a competent authority. Pharmaceutical products, including vaccines, enjoy a further exception wherein they may be exported to eligible developing and least-developed countries.
The EU’s position may have thrown another wrench in the negotiations. When the TRIPS Council met on July 20, these fundamental disagreements yielded another decision “to continue consideration of the proposal”5. The TRIPS Council meets again in October and progress is uncertain.
Waivers and Vaccine Supply
Waiving patent rights may not solve the vaccine supply problem. Worldwide patents are the unicorns of intellectual property: many anti-patent interest groups speak of them, but they do not exist. Patents must be filed on a country-by-country basis. We reviewed the Moderna patent portfolio, as one example, and determined that there are already many countries where Moderna owns no patent rights.
Moderna’s patent portfolio, for example, includes most of the largest pharmaceutical markets such as the US, the EU, and China, and some smaller markets such as Canada, Colombia, the Philippines, and Tunisia6. This is not worldwide protection, because Moderna has no rights to enforce in over a hundred states. Hypothetically, its vaccine could potentially be produced, exported, and distributed among such states with no recourse by Moderna, where it has no patent rights7. Freedom to operate is only meaningful in such countries if there is also raw material to make vaccines, manufacturing capacity, and expertise to make a safe and effective product.
Lack of existing local capacity appears to provide the major bottleneck to widespread local vaccine production in countries where there are no patent rights. We do not have expertise in assessing manufacturing capacity, but as an indicator, we note that only 24 vaccine-producing countries’ regulators are recognized by the WHO as meeting its highest standards8. Three of them (Cuba, Iran, and Russia) are subject to some form of sanctions that may impair production and distribution. Beyond the WHO’s designated countries, the Developing Countries Vaccine Manufacturers Network has member producers in Argentina, Bangladesh, Pakistan, Saudi Arabia, South Africa, Taiwan, Thailand, and Vietnam9. In Africa, manufacturing capacity is concentrated in Egypt, South Africa, and Senegall0. It is beyond the scope of this article to assess what efforts are being made in these countries to develop COVID-19 vaccines.
Even if a waiver or compulsory licence is granted, it does not necessarily enable large-scale manufacture. Efficient scale-up still requires technology transfer from the rights holder to the new manufacturer. We wrote about this in a prior article. This rings especially true where manufacturing mRNA vaccines on a large scale is concerned. Patent and regulatory disclosures may provide a roadmap to manufacturing these vaccines, but critical recent know-how can avoid unnecessary experimentation or setbacks. In a pandemic context, this efficiency is even more critical.
None of the waivers, compulsory licences, or the lack of a national patent, require the rights holder to undertake a technology transfer. Consulting the COVID-19 innovator companies and getting their buy-in on any process to increase access to use IP is therefore vital since efficient and successful technology transfer depends on their voluntary cooperation. This may be easier to achieve when using a limited, existing tool without changing the international patent bargain, that innovators were aware of when they filed. Well-intentioned sudden and sweeping changes should only be considered where innovative companies are supportive and will not have their IP and their long-term viability permanently undermined.