As the world is now grappling amidst the Global Pandemic, it is vital that efficient means are invented to curb this virus and by no means existing intellectual property laws should hinder the distribution or the use of any particular vaccine that has been invented. Law should act as a means to facilitate a conducive environment towards human beings and it should not be an obstacle or a hindrance. Hence it is important that one discusses the applicability of Patent regulations and the waivers permitted by law and the mechanisms that should be adopted by governments across the world to ensure efficient distribution of Covid Vaccines.
For many years, every pharmaceutical patents and their impact on prices have been at the center of the international debate over insufficient access to lifesaving HIV/AIDS medicines in developing countries and now the same argument will be extended to COVID-19 vaccines. The conflict has largely revolved around the implementation of an intellectual property system in the developing world, subsequent to the adaptation of the TRIPS Agreement, which has made a 20 year pharmaceutical patent protection mandatory for these countries and consequently contributed to exorbitant drug prices for patented medicines as well as limited the use of generic drugs.
We know at present vaccinations such as Pfizer-BioNTech, Moderna, and Oxford/AstraZeneca have been developed and it is a matter of time until the whole world has access to them.
The TRIPS Agreement imposes an obligation on Member States to make patent protection available for “any interventions, whether products or processes, in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application”, and this inevitably includes pharmaceuticals. However, exclusivity rights granted to a patent holder under the TRIPS Agreement are not absolute and can be subject to exceptions. Member States are permitted to adopt certain measures in order to facilitate access to medicines circumventing the monopoly granted to the patent holders. Whether those measures are effective in the face of a pandemic is a pertinent question.
The organizations such as Moderna responsible for the creation of Covid-19 vaccines have also announced that they will not enforce its Covid-19 related patent rights against other organizations that work towards making the vaccine.
Will countries be penalized for manufacturing therapeutic drugs, testing reagents, without license?
At no cost should Intellectual Property Rights prevent, prohibit or curtail the production of Covid-19 vaccines or drugs. In such an event it will remain out of reach for most of low and middle income countries.
This pandemic should not be a means or a business.
At present a proposal has been submitted to the WTO by India and South Africa supported by another 375 civil society organizations, temporarily waiving intellectual property rules pertaining to the vaccine. The proposal goes beyond Patents, ensures timely access to vaccines where transferring of the proprietary technology to manufacture vaccines in locally low and middle income countries.
Intellectual Property Laws pose a global challenge in ensuring global equitable rights and access to the effective tools needed in response to COVID-19 vaccines. More than 100 patents have been filed for the mRNA technology which Moderna has used to develop the vaccine. Although Moderna recently announced that it would not enforce its patents during the pandemic, the only vaccine corporation to do this thus far, the company did so after losing an important patent dispute and failing to disclose the US federal funding it received in the patent applications for its mRNA vaccine. In addition to following through on its previous commitment to not enforce its patents, Morderna must disclose all IP including the necessary technology, data and know how, so that other manufacturers can scale up production of these potentially lifesaving vaccines
Many COVID-19 vaccine developers, including Pfizer / BioNTech have taken no steps towards licensing or transferring IP-protected technologies to enable increased global manufacturing capacity and supply.
The importance of an IP waiver is that it offers and expedites, open and automatic global solution allowing for uninterrupted collaboration in development and scale up of production and supply that can collectively address the global challenge faced by all countries.
The current mechanism relating to the issuance of compulsory licenses stipulated in Article 31 and Article 31 bis of the TRIPS Agreement imposes certain territorial and procedural restrictions which in turn makes the practice of issuing product by product compulsory licenses a complex process hindering collaboration between countries. Countries that manufacture lifesaving medicine are unable to export them to other countries in need due to the limitation imposed in Article 31 which restricts the issuance of the compulsory license to cater to the supply in the domestic market.
In order to tackle the efficient availability of drugs, developing countries, where patents are already in place, have sought to reduce high drug prices by making use of compulsory licensing, a practice that allows the production or importation of a generic medicine without the consent of the patent holder. The TRIPS Agreement does not provide an explicit definition for Compulsory licenses. They fall under a provision entitled “Other Use Without Authorisation of the Right Holder.” This establishes a mechanism for the granting of licences where Member States are permitted to make “use of the subject matter of a patent without the authorisation of the right holder, including use by the government or third parties authorised by the government”. In practical terms, this means that a third party may be permitted to use, manufacture or commercialise an invention, which is de facto protected by a patent without infringing the rights of the patent holder. In this respect, the public interest goal of achieving broader access to the patented invention is given more prominence than the private interest of the right holder in fully exploiting his exclusive rights. What this means in the context of public health necessities is that compulsory licensing helps countries produce generic drugs that are more affordable than patented medicines. However, since this amounts to an exception to the exclusive rights of the patent holder, the TRIPS Agreement imposes specific conditions on Member States to allow compulsory licenses.
Compulsory Licenses are not directly permitted under the TRIPS Agreement, but disagreements about the conditions, under which compulsory licenses are available for ‘essential medicines’, have restricted their use. Until 2003, there was no definition of the extent to which compulsory licensees can export generic drugs, medical supplies to developing countries who are unable to manufacture their own .On 30 August 2003, the WTO announced that it had resolved this problem by lifting the TRIPS Agreement’s restrictions on exports and permitting exports of drugs produced under a compulsory license as an exception to a patent right.
Benefits of compulsory licensing
It can increase the affordability and accessibility of essential medicines and advance technological capabilities by letting licensees reengineer the innovations of the right holders at a low cost. On the other, in order to make use of the safeguard, compulsory licensees must foresee a sufficiently profitable market to justify the costs of production. Therefore, a cost of compulsory licensing may be advantageous solely for commercially workable medicines.
The argument that can be generated by these companies developing the COVID-19 vaccine is that the cost to discover and develop is far more costly than to copy it. In the absence of protection, imitators could easily enter the market and erode the profit available to the actual inventor.
This can discourage potential inventors and investors in investing in R&D matters altogether. The fixed period of monopoly (usually 20 years) that is granted by a patent to the inventor allows patent holders to mark higher prices within that temporary exclusivity period which in turn permit them to reap the benefits of the time and money they invested in the first place.
However, compulsory licenses can deprive them of this opportunity make profits during that limited period and thereby disincentivize investors from engaging in R&D related to life saving medicine..
Once a patent is granted, the content of the patent is disclosed to the public. The disclosure requirements looks upon a patent as a contract between two parties, society and the inventor and focuses mainly on making the information publicly available. Even if the Covid -19 vaccines developed is considered as public information, not every pharmaceutical producer will be able to make use of it given that since using the information and developing the same vaccine can lead to patent infringement. Knowing how to successfully navigate the early stages of intellectual property protection can greatly increase the likelihood that discoveries and knowledge will become available for the greater good of the public.
It can be stated that, it is a fine act of balance to ensure access to medicine and protect the rights of patent holders. The current law as set out in the TRIPS agreement can be a hindrance to ensure that every country will benefit from a COVID 19 vaccine. Despite TRIPS measures related to Compulsory licensing of potentially lifesaving medicine, limiting such licenses only to the domestic market means developing countries that lack the required expertise and capacity to make such medicine will be barred from benefiting from a lifesaving COVID 19 vaccine. This can lead to widespread inequality between the countries and can potentially jeopardize the wellbeing of citizens in underdeveloped countries. On the other hand, compulsory licensing can also disincentivize potential inventors from engaging in discovering a lifesaving medicine since they can be deprived of possible profits from the invention due to compulsory licensing. Even though, measure related to compulsory licensing can be largely be confined to the domestic market, for inventors in bigger pharmaceutical markets such as United States, this can be a demotivating factor. Therefore, it can be concluded that existing intellectual property laws can play a crucial role in hindering access to medicine and medical facilities reasonably affordable to all and also disincentivize inventions of new products to deal with pandemics such as COVID19.
Varuni Weerasinghe, LL.B (London)