How far are we from low-cost drugs?
The outbreak of the newly discovered Covid-19 -- an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) -- has now spread to over 200 countries, with more than 1.4 million reported cases of transmissions worldwide. This deadly virus has caused over 80,000 deaths globally till date. The World Health Organization (WHO) has already declared the coronavirus outbreak a pandemic. The entire world is now locked down in an effort to flatten the curve of spreading the disease within their respective communities. They are in a desperate look-out for ways to fight the fatal contagious disease, which is foreseen to claim many more lives.
Unquestionably, “innovation” could be the saviour that can come to rescue the world and her dwellers. Medical and technological innovations can therefore play a colossal role to mitigate the coronavirus threat to billions of lives. While the urgency for a vaccine or drug that may effectively treat Covid-19 is imperative, the need for accessibility to other technological innovations, such as health-tech, artificial intelligence, and data analytics, are equally important to equip us better to contain the rapid spread of the novel coronavirus and handle public health emergencies.
Countries are deploying modern technology to identify and trace the infected persons and the people they have come in physical contact with to limit the spread of the disease.
Bangladesh is not far behind in following this trend. Leading telecom operator Robi in association with ICT division and a2i is offering location-based technology solutions to spot out individuals, households, and locations affected by Covid-19.
Treatment for Covid-19 is yet to be developed. A vaccine or a drug that can effectively treat coronavirus is therefore the dire need of the moment. Big pharmaceuticals and biotech companies are in a rush to develop and produce a drug that can effectively treat the infectious disease.
In mid-January, researchers from China published the genetic sequence of the virus, which would help to develop the diagnostic method of the disease.
Specific diagnostic tests for the detection of Covid-19 have been designed, and locally produced low-cost diagnostic kits have been approved in various countries, including Bangladesh and India.
A number of leading drug and biotech companies including Johnson & Johnson and Gilead Sciences are rushing to produce a vaccine. Gilead has already developed a drug called “remdesivir,” which is showing promise against the extensive family of coronaviruses. It may be noted that Gilead owns several patents for treatments of diseases caused by the viruses that belong to the coronavirus family which includes Covid-19.
For remdesivir, Gilead has filed a patent application in China. On the contrary, a team of Chinese scientists at the Wuhan Institute of Virology (WIV) have claimed that they have improved the use of the drug (remdesivir), and thus have applied for a patent too. The Chinese scientists claim that their drug is designed with a different approach that specifically targets the Covid-19, not the entire family of coronaviruses.
However, according to Gilead, remdesivir has been applied on animals infected with viruses that are structurally similar to the Covid-19, and was found to inhibit the virus, and hence remdesivir offers hope. Gilead subsequently donated remdesivir to Chinese doctors for conducting clinical trials to test its safety and effectiveness.
Gilead’s patent is likely to be granted in China. Consequently, anyone wishing to use remdesivir will need a license from Gilead. The question now arises that what if the patent application filed by WIV scientists is granted in China? However, if both patents are granted, Gilead and WIV will be required to cross license their patents to each other, and any third party wishing to use either Gilead’s (remdesivir) or WIV’s drug will be required to obtain licenses from both parties.
As a matter of fact, medical innovation is complex, expensive, risky, and challenging. This is why intellectual property protection is critical in medical innovations. Intellectual property plays a critical role throughout the development process of a drug. Patent protection is an exclusive right allowed to the patent owner.
The protection incentivizes the patent owner, creates economic benefit, and encourages the undertaking of further innovation and engages in research and development of the same, which ultimately benefits the society and the people at large. This is why newly patented drugs come at a costly price that people in low-income countries often struggle to afford.
Considering the emergency caused by the Covid-19 pandemic throughout the world, it is expected that the patent owners will not resist licensing their drugs to others to serve the greater purpose of public interest.
WIV has already declared that they had applied for the patent (modified version of remdesivir) on the ground of “protecting national interest,” and thus it may be presumed that WIV would be open to license the drug.
Nonetheless, Gilead, being a commercial entity, may not agree to license their patented drug to WIV or any other entity. In such case, WIV would be able to request the government of China to issue a compulsory license to allow it to use Gilead’s patent without Gilead’s consent, through invoking Article 31 of the WTO’s Trade-Related Aspect of Intellectual Property Rights (TRIPS) Agreement.
It is pertinent to mention that “compulsory license” is a provision prescribed through Article 31 of the TRIPS Agreement, wherein a generic copy of a drug can be produced by a Member State or by an entity in a Member State, without the authorization of the patent holder, during “national emergencies” or “other circumstances of extreme urgency” or for “public non-commercial use” or “government use,” subject to certain conditions which ensures that the patent owner is paid an adequate value determined by the government -- the drug is produced for domestic use only, for a limited period of time, and not interfering with the patent owner’s right to continue producing the drug.
Therefore, countries that are affected by Covid-19 and are willing to avail the patented drugs for the treatment of the novel coronavirus at a lower cost, may declare a state of emergency within their respective territory, and invoke the provision of “compulsory license” under their respective patent acts, in order to allow the local pharmaceutical companies or the government itself to produce the drug for their own citizens. This approach could therefore play a key role to save billions of lives across the world.
WHO has expressed its commitment for exploring ways to ensure equitable access to drugs and medical equipment for people to fight against the Covid-19 pandemic. WHO resonated with the proposal made by the government of Costa Rica for pharmaceutical companies to volunteer for an intellectual property pool and contribute their respective intellectual properties, ie drug patents, treatments, vaccines, diagnostics, and data, which would enable governments or generic drug makers to manufacture and sell the products at a lower price.
In the past, pharmaceutical companies joined intellectual property pools, which allowed low-income countries to access health care at an affordable price to combat various life-threatening diseases, such as HIV, tuberculosis, Hepatitis C.
Creation of the proposed intellectual property pool for Covid-19 can therefore produce faster and more equitable outcome for all countries.
Moreover, numerous countries seem to have taken new measures to ensure access to drugs that can cure the novel coronavirus disease. To this extent, in March 2020, the Israel government issued a special compulsory license to allow the import of generic version of “Kaletra” to treat novel coronavirus.
Kaletra is a patented drug owned by Abbvie -- a bio-pharmaceutical company based in the US. In response, Abbvie declared to not to enforce its patent rights throughout the word. This is the first compulsory license issued in Israel over the last 20 years. Governments in Chile and Ecuador have taken similar steps.
Governments in Germany and the UK are considering using their respective statutory provisions to suspend patent protection in order to make the necessary drugs available to battle the novel coronavirus pandemic.
So how would Bangladesh respond to ensure availability of low-cost drugs that can be used for the treatment of the novel coronavirus?
The Patents and Designs Act, 1911 of Bangladesh contains the provision of compulsory license which would allow an entity or person to make an application to the government (Ministry of Industry) for granting a compulsory license, on the ground that the demand of a patented drug in Bangladesh is not adequately met and on reasonable terms.
The government will consider the application, but if the patent holder and applicant fail to reach an arrangement between themselves, the government may dispose of the application at its discretion or refer the same to the High Court Division for a decision.
In 2018, Bangladesh fulfilled the eligibility criteria for the graduation out of the Least Developed Countries (LDC). Bangladesh still enjoys the exemption accorded to LDC countries under Article 66 of TRIPS Agreement, pursuant to which Bangladesh can delay protecting pharmaceutical patents.
As a result, pharmaceutical patents granted elsewhere do not enjoy patent protection in Bangladesh. Local pharmaceutical companies are therefore allowed to copy the formula or molecule of patented drugs and manufacture them for domestic use or export to other LDC countries.
Consequently, if a potential vaccine or drug, for the treatment of novel coronavirus, is granted patent elsewhere in the world, the same vaccine or drug will not be granted a patent in Bangladesh, and therefore the government of Bangladesh does not need to invoke the provision of the compulsory license for manufacturing the drug.
The local pharmaceutical companies would rather be able to manufacture the drug under the exemption accorded to LDC countries. Drug manufacturers that enjoy the benefits of TRIPS exemption do not need to obtain a license for the patented drug, hence they can produce the drug at a low cost. Thus, Bangladesh can ensure access to drugs at a very low cost for the treatment of novel coronavirus for over 160 million people, as well as for many other LDC countries in the world.
The novel coronavirus pandemic has exposed the world to a crisis she has never experienced before. This moment of crisis calls for people to stand united, to co-operate and take care of each other, to extend support to ensure equitable access to treatment, and to see the world defeat the Covid-19 pandemic together, yet maintaining the social distance.
Barrister ABM Hamidul Mishbah is an intellectual property practitioner practising at the Bangladesh Supreme Court, Managing Partner, Old Bailey Chambers, and Founder, Bangladesh IP Forum.