Since the pandemic seems to lose its impact and life is going back to normal, it may be a good time to look into the lessons learned so far from Covid 19 pandemic and make necessary preparations against a possible new one.
The pandemic brought many discussions on IP rights from day one. As we all know, compulsory licensing was the first solution mechanism depended on by the governments as it was thought that the existing patent rights were the only obstacle to reaching a cure against Covid-19. The reality was, on the other hand, quite different. However, there was no proper medicine or vaccine that cures Covid 19 or blocked by a patent right when the pandemic was first outbroken.
Together, we experienced a journey where innovators and researchers are expected to develop an innovative cure in the shadow of the compulsory licensing threat. Meanwhile, many innovator pharma companies joined patent tools, opened their IP and know-how and shared what they have for humanity’s sake.
Eventually, BioNTech came up with the first Covid-19 vaccine, and the innovation saved the whole world. No one can deny that the most significant innovation incentive is IP rights. Therefore, one may expect governments to start investing in plans and actions to improve and support research and development and innovation against a possible new pandemic, which seems not to be the case.
On the other hand, as there is now a cure for Covid-19, the main problem to be solved is access to the vaccine. However, there is a severe gap in the vaccinated populations between the developed countries and the rest of the world, and as we all agree, no one is safe until everyone is safe. That is why governments should work together and, most importantly, work sincerely on accurate plans and solutions to fill this gap. However, it is sad to see that no true lesson could be learned from the pandemic, as the main discussion was compulsory licensing at the time when there was no cure at all and today, after the vaccine, IP Waiver is at the centre of discussions on how we can extend access to the vaccine.
Just as compulsory licensing was not the solution to developing a cure for Covid-19, waiving intellectual property rights is far from a solution for vaccine access.
It was first brought by India and South Africa in October 2020 via a proposal to WTO to temporarily waive intellectual property (IP) protection on coronavirus vaccines. The proposal rightly underlined the importance of global sharing of technology and know-how to enable all countries to access vaccines.
However, the proposal does not explain how the elimination of intellectual property rights disclosing the treatment of covid-19 will suddenly enable states to produce vaccines and vaccinate their populations in the lack of capacity, know-how, manufacturing sites, raw materials, and especially if the people are not informed and persuaded about the vaccination.
We should remember that Moderna had said in October 2020 that it would not enforce its patent rights against any company manufacturing vaccines, but still, no one could come up with vaccine manufacturing for a long time, which again proves that IP is not the real obstacle.
However, as the Government of India stated in the affidavit submitted to the Supreme Court of India concerning discussions on using the compulsory licensing mechanism to increase the production of Covid-19 vaccines and drugs; the actual barrier to access to the vaccine is the availability of raw materials and manufacturing capacity and not the IP.
“Prg 44 of the Affidavit: In the current scenario, the main constraint is the availability of raw materials and essential inputs. Therefore, any additional permissions and licenses may not increase production immediately.”
Moreover, one cannot help but think, if the IP is the only obstacle to access the vaccine, why not these countries in need operate their compulsory license provisions and eliminate intellectual property rights. In particular, India, as a co-leader for the IP Waiver proposal, has a special provision under Section 66 of its Patents Act, entitling the Central Government to revoke a patent in the public interest, which means that it has a direct tool to eliminate all patents allegedly hindering its access to vaccine via one single decision of the government.
While running a compulsory licensing mechanism may be burdensome for the other countries which have no such revocation tool, as there may be many intellectual property rights over the vaccine, and running the compulsory licensing procedure for each of them will lead to lengthy procedures, it is still more accessible than a process that requires all 164 members of WTO to consent on an IP waiver. Even today, there is no such consensus as the EU opposed to the waiver, whereas the US agrees to waive IP protection only for vaccines, not therapeutics and diagnostics and refuses to include China within the IP Waiver.
One of the fundamental reasons that compulsory licensing mechanisms or IP waivers do not help manufacture a vaccine is the limited information provided in the patent documents, especially in vaccine-related inventions. The patent document does not have to or need to disclose, for example, how to access the raw materials without which it may not be possible to put a vaccine together. It is important to remember that compulsory licenses or IP waivers do not create and cannot create legal mechanisms forcing patent owners to transfer their know-how or trade secrets. This emphasizes the importance of voluntary solutions and finding ways to have patent owners willingly collaborate.
Additionally, compulsory licenses or IP waivers cannot provide or create manufacturing facilities and equipment and raw materials in vaccine manufacturing. In the lack of those, even the patent owner is hopeless.
We should keep in our minds that the vaccine that saved the whole world could be found thanks to the research and development that were started to conduct years before the pandemic to treat cancer. If there were no previous research, test or data, it would be impossible to find and develop a vaccine within one year.
Therefore, if we really want to be prepared against a possible new pandemic and extend access to the vaccine, we need to encourage the research and development and invention activities today. The most powerful tool we have to do this is adequate intellectual property protection, which is not meaninglessly threatened in every possible crisis. In addition to genuinely supporting the R&D, we must find creative and efficient ways to incentivize the transfer of technology and know-how when needed, and we must think about the structures in which innovators/IP holders will be willing to cooperate and establish them from today. This is the only proper solution if the sincere aim is finding a cure or access to the vaccine or fighting against a pandemic.
First published by ManagingIP in Aug 15, 2022.