(Bio)ethics & Patent law: Uprise of the Global Pandemic Requisition the Extent of Control Among Pate
A Global Pandemic declared on 12th March 2020, revisits the stark reality of the longstanding debate on the marginalization of (bio)ethics within patent law. Obtaining preferential access to medicines and vaccines amidst the pandemic, while obstructing their equitable distribution across borders not only jeopardizes supplies of life-saving treatments but also imposes significant implications on public healthcare with such private governance extending to patent holders. This was specifically observed when in June 2020, the pharmaceutical- Gilead had produced doses of Remdesivir, which were then viewed as a potentially promising treatment for a faster recovery of patients infected with Covid-19. Gilead had agreed to provide USA with 500,000 doses of this antiviral drug, which was then predicted to be 90% of its full production capacity until September. Although the issuance of a patent provides an incentive to such large pharmaceutical companies, it withholds the power of private governance with them, to the extent of determining who would be the first one to obtain the treatment and at what price.
Issuance of Patents- Setback & Consequences
Patents are Intellectual Property Rights (IPRs), issuance of which allows the rightsholders to be the sole operator of that invention for the duration of the patent assigned (usually varying from 15-20 years). Such methods incentivize technological developments by assigning a monopolistic power to the patent holder to either refuse any third party the usage of the innovation, or only allow access with highly restrictive conditions in lieu of heavy monetary returns. The World Trade Organization (WTO), with 164 contracting states, have clarified that patents without any discrimination are available for all field of technology, provided, they met the standard substantive criteria for patentability- namely, novelty, inventive step and industrial application. Henceforth, this concludes the inclusion of innovations of healthcare technologies producing various medicines, medical equipment and vaccines. For instance- the underlying technologies behind COVID-19 vaccines are patented, such as - patented “novel adenoviral vectors derived from a chimpanzee adenovirus” produces AstraZeneca’s COVID-19 vaccine, patented lipid nanoparticle (NP) technology produces Pfizer-BioNTech’s BNT 162 Vaccine, etc., leading to an indirect issuance of patent protection to the vaccine or the medicine itself. Moreover, for the issuance of this private governance function to the patent holder, the licensing of such patents also impediment the ongoing inventions of other technologies involving the use of such patented technologies as an essential to operate. While this might be considered as a knock-on effect for other commercial technologies, it has significant implications on the healthcare technology industry that cannot be overlooked.
With COVID-19 acting as a significant catalyst, the bioethical community urges to reconsider the extent of control with the patent holder along the lines of equitable access to public healthcare. In fact, when remdesivir was believed to be a promising treatment, it was conceded that Gilead had agreed on providing voluntary licences to countries with low or middle incomes, with manufacturers in Egypt, Pakistan and India. Such a licence would have then alleviated the crisis in these nations, however, leaving aloof the nations with higher incomes. Certainly, it indicates the discretionary power held among such large pharmaceuticals despite the existence of a life-threatening virus. Fortunately, in the aforementioned case, the higher income countries were held at discretion, who had the resources to provide the patent holders with such monetary returns. But what if economically weaker nations are subjected to such an extent of maximising the patent holder’s profits while they are amidst a financial deficit, to even provide basic amenities to their citizens. Indeed, the USA appeared as one such nation which had demanded approx. $3200 per 6-day treatment course of remdesivir. On further research, it was discovered that its cost of production was less than $6 for a 6-day treatment. This huge profit margin was justified as a ‘recoup development cost’ and that of the past experiments. Even if such an issue is considered, with such opaqueness, there lies no guarantee about the amount spent on such experiments. Moreover, such issues are not limited among cross-border nations but also uprise within domestic patentholders. For example- Labrador Diagnostics, a large pharmaceutical had allegedly claimed an infringement of its patents provided on diagnostic testing for COVID-19, on BioFire Diagnostics. Had it not been abandoned because of the public’s backlash, it could have brought the healthcare sector under the aegis of such patent holders.
IPRs Beyond Patents
However, there lies a broader picture than mere issuance of patents’ wavier from such health technologies. Other types of intellectual property rights are also involved within each step of developing and manufacturing a medicine or a vaccine. A patent might only protect the conceptual idea behind the essential ingredients along with the triggering immunity-building process ,whereas the expertise to its production or the data obtained from various medical experiments might be secured under the issuance of a trade secret or copyright, respectively. In fact, when WHO took the initiative of proposing the COVID-19 Technology Access Pool (C-TAP) to encourage the publicising of such IPRs, several countries had eventually, although hesitantly, agreed-upon revealing only “sufficient” information.
Furthermore, the previous year, on 2nd October, India and South Africa had approached the World Trade Organization (WTO) with the proposal of seeking a temporary waiver on intellectual property rights on certain innovations allied to the global pandemic, with the assistance of the TRIPS Agreement. Under Article 27 (2) of the TRIPS agreement, members of WTO can exclude the patentability of inventions that are in need to protect public health. Additionally, “TRIPS flexibilities” can also be granted under Article 30 by placing limited exceptions on one’s patent’s rights. Even though some developed economies such as the US and Europe have considered this proposal, others like Japan and the UK, have expressed considerable opposition. Moreover, even if such a consensual agreement is reached upon accepting the proposal, the issue would still lie with the time-period of such a temporary waiver. Due to such numerous barriers on the pathway, countries have started looking towards other avenues to limit the extent of the power withheld with these patent holders.
Compulsory Licensing- Limits Control of Patent Holders (?)
A compulsory license allows a third party to produce the patented technology without the permission of the patent holder. The issuance of compulsory licences was introduced under Article 31 of the TRIPS Agreement through the 2001 Doha Declaration, amidst the worldwide HIV/AIDS crisis. The declaration had affirmed that the rights granted under the TRIPS Agreement were not subjected to public healthcare’s stake. Although to issue the license certain criteria were laid out; firstly, a blanket compulsory license could not be granted as all cases were to be considered on their individual basis; secondly, prior attempts should be evidently made with the patent holders, although this could be waived off during ‘national emergencies’ or ‘in cases of public non-commercial use’; thirdly, the licence is authorised for a limited purpose only; fourthly, this does not exclude the patent holder from entering into other licensing agreements; fifthly, predominantly the grant of the license is issued for the domestic market governed by the state; and lastly, the patent holder must be paid ‘adequate remuneration’.
However, patents are national rights, and henceforth, also governed by national laws with varied legal avenues in each country. Section 92 of The Indian Patent Act of 1970, assigns the government the power to allow the issuance of a compulsory license in the circumstance of a national emergency or extreme urgency. Often, the procedure for obtaining such licences is either added with further requirements with their national laws or are heavily bureaucratic and unclear. For instance, Ireland does not permit the issuance of a compulsory license on any grounds unless 3 years are completed after the patent grant. Additionally, many nations impose regulatory obstacles on medicines and health technologies, which directly affects the grant to a compulsory license. As observed under the European Union Law, generic medicines could only be marketed after the completion of 10 years of the authorised original medicine. Even though these are regulations issued to safeguard the public welfare of their citizens, it did deter Romania from using a compulsory licence for sofosbuvir to treat hepatitis C in 2016.
Apart from this, the open-ended interpretation attached to the clause “adequate remuneration” to be paid to the patent holder also acts as a deterrent. This is highly dependent on the bilateral relations between the two nations. This lack of clarity failing to define an appropriate remuneration could also subject states to various litigation challenges. Even if somehow all such obstructions are reconciled through executing all the aforementioned stipulations, it is highly unlikely to expect that the issuance of a compulsory license alone can assist towards a time-efficient approach towards any life-threatening crisis.
Voluntary Licensing- A Step Towards Global Equitable Access (?)
A negotiation for the issuance of a voluntary license with the patent holder is considered as a prior attempt to that of issuing a compulsory one. This often acts as a perceived threat of a compulsory license, leading them to agree for issuing a voluntary one on much more reasonable terms. But this does not disregard those patent holders, who grant such a licence out of their ethical responsibilities or reputational concerns. However, relatedly, the Achilles’ heel of these licensing arrangements also depends solely on the patent holder’s buy-in. As COVID-19 poses a fundamental challenge to global health, initiatives of issuing voluntary licences were observed, especially under- the Open Covid Pledge and the World Health Organisation's (WHO) Covid Technology Access Pool (C-TAP). Initially, the latter was opposed by larger economic countries like the USA and the UK. But soon with more than 40 countries endorsing the C-TAP, it led to stronger pressurization and reputational concerns over the patentholders, which eventually acted as a triggering tool to their accent.
Ultimately, the patent holders uphold an unfettered discretionary power within the patent law. Despite the significant health and ethical implications, it is subject to the whilst of the rightsholders to exercise their patent responsibly or not. Clearly, the issuance of IPRs need to be reconsidered alongside the role of bioethics and unfortunately, COVID-19 has reflected the long overdue need of this reformation.