Wednesday January 19, 2022

Covid-19 and patents

July 01, 2020

During these unprecedented times, one area of law seems more relevant than ever – intellectual property rights. The big pharma companies are racing against time to beat the clock in the bid to make a curative drug for Covid-19.

For now, it appears that US-based company Gilead has been lucky. Gilead developed Remdesivir in 2009 to cure Ebola, and is now coming up as the front-runner to treat Covid-19.

Out of the several licences given to pharmaceutical companies in developing countries by Gilead, one has been given to Ferozsons Laboratories in Pakistan. Under the licensing agreement, the company has the right to receive a technology transfer of Gilead’s manufacturing process for Remdesivir to enable it to scale up their production. From the publicly available information, it appears that the licence will be royalty-free which means Gilead does not profit from this licensing. This may also mean that Gilead will try to recover its profits from sales of the drug in richer countries, where governments can purchase the drug in bulk, or where most people are insured.

The benefit to Ferozsons aside, the licensing arrangement is likely to be beneficial for Pakistan because of the spillovers that it promises. First, if Remdesivir proves to be successful, Pakistan will most likely not need to rely on the import of this drug from other countries for the treatment of the virus which would naturally make it more affordable for the population affected by the virus. Second, since it involves a technology transfer, there will not be a need to incur any cost for R&D, which Pakistan already struggles to bear. Third, a consequence of this licence can also be a shift to research into new molecular discovery and addition of more value to the relevant drug or some other drug for some other disease.

Theoretically speaking, it can always be argued if Pakistan or any Pakistani company ever needed the licence in the first place to produce the drug. This is because Gilead never applied for a patent in Pakistan. Patents by their very nature are regional rights – they only apply in the territory over which they have been granted and must, therefore, only be respected in that territory and since Gilead has a patent in the US, any challenge against unlicensed use can only be made in the US (or any other country in which it has a valid license).

This means that because of the regional nature of the patent, any person is free to produce Remdesivir for its sale in Pakistan (or other countries where there is no patent over Remdesivir) and the same will not constitute an infringement of intellectual property rights.

This also means that despite the licence to Ferozsons, there is no guaranteed exclusivity since any company can reverse engineer the drug and sell it – and since it is already a patented drug in the US, it should not be hard for the relevant experts in the field to reverse engineer the drug by just reading the patent document, which is available to the public.

What also needs to be kept in mind for the drug, the patent on it and the territorial nature of patents is the scope of the patent itself. While even though Gilead does not have a patent in Pakistan, it might have a patent or would have applied for a patent in other countries to which it is planning on selling its drug after Ferozsons has manufactured it but what is important is that Gilead’s patent on Remedisivr was originally filed and granted as a treatment for Ebola and not Covid-19. Therefore, the scope of the patent on the use of the drug is limited to a single disease, which restricts its scope to only that disease and precludes it from using an already existing patent for curing another disease and attempting to get a patent for that new use.

But the same can always be attempted. By way of an example, China’s state-owned Institute of Virology has applied for a patent in China for Remdesivir at the beginning of 2020. At first, this might look like an infringement on Gilead’s patent but it is not since China filed a patent for Remdesivir to treat coronavirus specifically and not Ebola. Whether the patent will be granted in China or not is a separate issue that is to be decided by assessing if specific use of the drug is new and non-obvious to experts in the field, but for now, it is useful to see how a patent granted for one disease can be manipulated to extend the monopoly over Remdesivir in these times.

From Pakistan’s perspective, this is important since Gilead does not have the patent for Remdesivir in Pakistan right now and will not be able to get it for the process and drug in the same form as its US patent because any US patent holder only has, by virtue of the Patent Ordinance, twelve months from the date of the US patent application to apply in Pakistan which has expired for Gilead.

But Gilead may still try to apply for a fresh patent for treating Covid-19 as opposed to Ebola in an attempt to extend its exclusive rights in Pakistan. However, while new uses of existing products do not get patents in Pakistan, it will be interesting to see if Gilead tries to work around this impediment in the law to get intellectual property protection in Pakistan in order to be able to control the sale of generic or counterfeit Remdesivirs in the Pakistani market.

For now, the only protection that this deal provides Gilead is its control over the technology used in the production but once someone tries to replicate the drug using different technology, without a patent, Gilead is likely to lose more than it can gain.

The writer is a lawyer.