In an unprecedented move, the United States of America (US), under the Biden-Harris Administration, has endorsed a proposal to waive patent registrability on Covid-19 vaccines.
The move has riled pharmaceutical companies and sparked widespread debate on the potential effects and feasibility of the waiver on the production of vaccines.
In a statement, US Trade Representative, Katherine Tai, said, “This is a global health crisis and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures.”
Henceforth, “The US supports the waiver of IP protections on Covid-19 vaccines to help end the pandemic and we’ll actively participate in negotiations (with the World Trade Organization) to make that happen.”
She further said “the administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible.”
What is a patent?
According to the World Intellectual Property Office, a patent is the, “exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem.”
The invention must be new (novelty), inventive (i.e. not obvious to a person skilled in the art), and industrially applicable.
Full Disclosure forms the basis of the social contract for patent inventions. The inventor discloses his invention, how it is to be performed, and any relevant drawings (so that others can learn from it and improve), in exchange for exclusivity and protection.
Exclusive right refers to the patent owner’s ability to prevent or stop others from making and or commercially exploiting the patented invention and the right to redress.
This means that If patent protection is granted, the invention (vaccine/medicine) cannot be commercially made, used, distributed, imported, or sold by others without the patent owner’s consent unless rights are sold, assigned, or licensed by the patent owner.
The Patents Act [Chapter 26:03] provides for registration and protection of patents in Zimbabwe.
Advocating For A Waiver
The disparity in the global share of vaccines is high with the Frontline Economist postulating that developed countries secured, “over 3.7 billion doses, many through advanced-purchase orders agreed with vaccine manufacturers (at the outset of) the pandemic.”
This impasse is emblematic of how wealthy countries, where many major pharmaceutical companies are based are primed from the start to monopolize vaccine supplies.
India and South Africa who have been backing the waiver proposal since October, with India surpassing 22 million Covid-19 cases, assert that, “a suspension will make vaccines more accessible to poorer nations (by helping them manufacture and sell cheap vaccine copies.)”
The proposed waiver is also said to, “speed up the end of the pandemic, which if allowed to rage could see the emergence of vaccine-resistant Covid variants.”
Arguments Against A Waiver.
The waiver proposal has been vehemently opposed by wealthy nations including Britain and the European Union, who postulate that, “a ban would stifle innovation at pharmaceutical companies by robbing them of the incentive to make huge investments in research and development.”
The Information Technology and Innovation Foundation, a U.S. public policy think tank that focuses on public policies and technology innovation has stated that, “endorsing the waiver petition succumbs to the fallacy that IP rights represent a significant barrier to access and manufacturing of the medicines needed to overcome this crisis.”
Opponents also argue that the waiver will not address global shortages of vaccines in poorer countries as they may not have appropriate resources, facilities and raw materials to manufacture high quality “replica” vaccines.
Thus, the cumulative effect of the waiver has been argued as contradicting intentions of boosting vaccine production as waiving IP rights will dissuade pharmaceutical companies from producing rapid vaccines in the future.
Intellectual Property is the lifeblood of innovation, especially in the pharmaceutical and Bio-Tech fields.
Incorporating licensing agreements or compulsory licensing where the generic copy of the vaccine is produced mainly for domestic markets and not for export, with the patent owner still having rights over the patent, including a right to be paid compensation for copies of the products made under the compulsory license may be a better solution in striking the balance between incentivizing innovation and boosting vaccine production.
Waiving Patent protection will be counter-intuitive.
According to the Biotechnology Innovation Organization, “The technical and logistical complexities of the task before us will require vaccine manufacturers, suppliers, governments, multilateral organizations, and non-governmental organizations to work together in new and creative ways to find solutions to our shared challenges.