Data Exclusivity Patent

Patent Politics in the Time of Corona


3D medical depiction of coronavirus

Image from here

The new coronavirus threat/scare seems to be increasing with every passing day. At the time of writing this, it is reported that there are 138,941 cases (of which 80,815 are in China), of which 70,727 have recovered, 57,317 in mild condition, 5,786 are serious, and 5,111 have died. India has 81 cases of which 4 have recovered and 1 person has died. The new Coronavirus, or COVID 19 as it is technically known is, is now the 7th known coronavirus (other well known ones include SARS and MERS), and is suddenly in daily conversation everywhere. In case you were wondering – the “technical” name COVID 2019 is simply a value-neutral short form of Corona Virus Disease 2019. Countries are imposing travel bans (and some are not), economies are being affected, and at the same time, at least some experts are pointing out that it appears that the risk, while present, is causing too much panic (see here and here for eg). Nonetheless, there does seem to be a rough consensus now, that things will get worse before they get better now. (On a separate note: those face masks that are going out of stock everywhere are apparently not very likely to protect you – but given the various other threats as well as the seeming lack of India’s ability/inclination to do anything about pollution – it’s probably not a bad idea to keep using them anyway.)

Pharma patent (f)laws and policy

Anyhow – coming to the subject matter focus of this blog – where pharma issues go, IP issues are bound to follow. With no known vaccine or treatment, and the great panic it’s raised, COVID 19 has inadvertently brought to the forefront, the public-health, private-profits tension. This is a tension well known to developing countries, but now that this is a global pandemic with no known cure, it is being re-emphasised in the developed world as well. More importantly, it’s no longer relegated to health activists, as the public-health / private profits issue is suddenly ripe for the public sphere’s plucking. Going back to the basics of Copyright/Patent – these monopolistic privileges are granted by the state so that private players are incentivised to innovate more/faster than they would in the absence of such privileges. The underlying assumption here, is that innovation leads to the progress of society. Just how much progress … well, historically, let’s just say that it has been underwhelming, especially for the developing world. Due to the severe inadequacies of the pharma patent system, there have been many calls for delinking R&D costs from drug prices, as well as generally looking for new pharmaceutical innovation models but they’ve had unfortunately little impact.

Aside from pharma patents – there is also a much needed renewed emphasis on public health systems – a reminder that India with its ‘always-stuck-at-minuscule-levels’ public health budget, could do well to heed to. After all – even if by some miracle we manage to convince half of our 1.3 billion people to wash their hands multiple times a day, let’s think about what will happen when our sad truth is that we are already losing almost 700,000 people a year to unsafe water, dangerous sanitation and lack of handwashing facilities. (data from here – play around with the filters). Will they get saved from COVID 19 only to die of cholera? In the case of a quarantine – most of those who can (ie, money-ed, white collar jobs) will work from home, stay self-quarantined – but what do you do if you need to earn your next meal, pick up your rations, or when your job requires you to keep showing up or risk being fired? Additionally, its worth keeping in mind that if we do impose stringent measures, we don’t really have welfare measures in place which would ‘take care of the carers’, so to speak. Prof Amy Kapcyznski written an interesting piece in the same vein, on the ‘Corona Virus and the Politics of Care’, here.

There are issues I’d like to have gone into but won’t, here – such as why other diseases like Tuberculosis, Diarrheal diseases, Malaria, etc which have killed hundreds of 1000s every year for the last few decades, have not been getting the same ‘public health’ attention, but its likely that global attention is simply most given when the non-poor are threatened – and with COVID 19’s high infection rate and lack of vaccine, they now are. It’s high time to take public health seriously and not just assume a few quarantines + waiting for the vaccine is sufficient action. COVID 19 is neither the first public health emergency we’ve faced, nor will it be the last. But hopefully this will be the clarion call that finally gets heeded.

Looking at COVID 19 – as it’s grown, there have been bigger calls for open-access / open sharing of information and data related to COVID 19, since scientists and researchers seem to grasp the importance of collaboration in dealing with an urgent, important need (See WHO’s response here). More specifically – keeping this important information behind a copyrighted paywall, would mean slower progress and more deaths. At the same time, Big Pharma has shown that they are consistent with their demands, come rain or shine. In US, they’ve ensured that an $8.3 billion emergency spending bill (for COVID 19) has removed language that might threaten the intellectual property of vaccines or treatments that the government considers unfairly priced. Of this huge amount, $3.1 billion is earmarked for drug development. Clearly, this is more than the $2.87 billion that is supposedly the cost of new drug development (which is a claim others have said is grossly exaggerated to start with, not to mention that it includes more than $1billion as opportunity cost). The Global Preparedness Monitoring Board currently estimates that drug development costs will be about $2 billion (PDF here). Yet, the Pharma lobby is insisting on removal of the IP-price related clause because it will apparently cost them more than the $3.1 billion grant, to make it. (See here for source). Apparently, being granted more than the average cost of making a drug, as well as a being provided a guaranteed buyer, is not sufficient for Big Pharma!

It will be interesting to see if the US govt gets bullied by Big Pharma here. While US has been happy to support Big Pharma when they take such actions in other countries, it took barely any time for US to issue an executive ordinance threatening compulsory licence type action against Bayer, when the Anthrax scare (5 deaths in total) took place in 2001. Whether it gets bullied into it or not, it is worth noting that clearly when the US Govt feels threatened, it does not think the Pharma Patent system will deliver it from its crisis. One wonders if they’ll remember this, when they start telling other countries not to use Compulsory Licenses, etc, in the future, as I have no doubt they will continue to do.

Meanwhile, another set of Foundations (Wellcome Trust, Gates, and Mastercard) have also contributed and set up a $125 million Covid-19 Therapeutics Accelerator, for developing a treatment for the disease, with a call to other charity organisations to contribute as well. The Accelerator will work with the World Health Organisation as well as with private entities. It would surprise no one if other country governments, and foundations are also contributing money towards this cause – afterall, no one really expects the pharma patent system to actually incentivise a much needed emergency drug, without outside help.

On a partially tangential note –  given how much attention ‘hand-washing’ has received as a method of containing COVID 19, it might be a good time to really pay attention to the limits of the incentives of the patent system – for example see the ‘humble checklist’ example, in the introduction of this paper. The short version is that in the face of nearly 30,000 people dying from infection in US every year, several proposals were put forward to deal with the issue, most estimating costs of billions of dollars. Then, in one hospital, they realised that by giving nurses the authority to enforce a checklist of hospital procedural requirements against doctors, (such as handwashing and use of antiseptics), the rate of infection dropped by two-thirds!

COVID 19 related patents – who will get them? 

On February 24, 2020, at a WHO Press Conference, it was announced that WHO thinks a drug called Remdesivir has a good chance at showing efficacy against COVID 19. A paper published in the Cell Research journal in early February also identified Remdesivir, along with Chloroquine as potential treatments for COVID 19. Chloroquine, as readers may know, is used to treat Malaria, and was first discovered almost 90 years ago. So, while certain drugs containing chloroquine along with other compounds may be patented, chloroquine itself is in the public domain. Remdesivir on the other hand, was made by Gilead along with the US govt, sometime between 2010-2015, as an effort to treat the deadly Ebola virus (for which mortality rates average at 50% and have reached up to 90%!) , which was devastating West Africa at the time and where it continues to be active, incidentally. However, after Phase 3 testing, Remdesivir turned out to be less effective for Ebola than first thought. It has recently started garnering more attention due to the previously mentioned paper, as well as that a COVID 19 infected man in Washington who was granted Remdesivir under Gilead’s compassionate use program, recovered soon. It’s not clear whether the antiviral cured him, as he was apparently starting to recover anyway – full story here – But Gilead is now providing access to the drug to more patients in US, Europe and Japan under this ‘Expanded Access’ program, which allows access to a drug that has not yet received marketing approval, in emergency situations.

This is where the ‘patent’ situation gets a bit more interesting. That Cell Research paper that identified the use of Remdesivir as a potential treatment for COVID 19 was not by Gilead, but rather by 7 scientists from Wuhan Institute of Virology and 3 scientists from Beijing Institute of Pharmacology and Toxicology. In their paper, published on 4th February 2020, they had assessed 7 potential treatments and determined that 2 of them (remdesivir and chloroquin) were likely to be effective against COVID 19. The same day, the Wuhan Institute wrote on their webpage that they had also applied for a patent on this new use of the existing drug (“second medical use”), as per usual practice, on January 21st. Notably, they also mentioned “If relevant foreign companies intend to contribute to China’s epidemic prevention and control, we both agree that if the state needs it, we will not require the implementation of the rights claimed by the patent for the time being force.” The news that the Wuhan Institute was applying for a patent on this use of Remdesivir seems to have caused quite a ruckus, as our friends at IPKat have pointed out (for eg, see posts like this , this and this which seem to imply that China is doing something shady by applying for this patent). This is strange for many reasons, but amongst other reasons – one would think that if someone is going to criticise the Wuhan Institute for trying to claim a patent over a drug for COVID 19 made by Gilead, then that person would also criticise Gilead for having patented Remdesivir, seeing how it was a public-funded drug (for even more details on that, click here), and was meant to be a treatment for the devastating Ebola disease!! Much to no one’s surprise, this is being conveniently overlooked. This is also a good time to point readers back up to the 5th paragraph above – the bit where the Pharma lobby has complained that $3.1 billion is not sufficient to develop a new treatment.

Anyhow, to be clear – Chinese patent law does allow “second medical use’ patents, as do several developed countries. (See China’s Patent Examination Guidelines Chapter 10, Section 4.5.2 here – large PDF). Incidentally, India has come under severe criticism by Big Pharma for its Section 3(d), which does not allow second medical use patents – so one would assume that IP maximalists should be happy that China does allow it, and further that they are applying for patents under it.

In any case, clinical trials are now being done by both China as well as Gilead. I can’t help but wonder what the usual IP maximalists who cry hoarse about the importance of data exclusivity, will have to say on this, prior to knowing who may end up owning this data. Gilead, for its part, seems to not be focusing on the patent issue, and is also apparently supplying the drugs at no cost to China for their clinical trials. There’s more in this report on a press statement issued by Gilead (you may need to use your browser’s translating feature to read it, as it is in Chinese). The statement also does not speculate on the Wuhan Institute’s application, given that it is unpublished, but it does confirm that it holds existing patents on Remdesivir in US, China and other countries as well. According to IAM-Media, there is at least one potentially problematic piece of prior-art – a Gilead application for using remdesivir against SARS, MERS and other coronaviruses. Prima facie, it would appear that even if the Wuhan institute receives the patent they’ve filed for, it’s working may be dependent on Gilead’s earlier patents – and they have at least 3 relevant patents in China already, with 5 further applications still being reviewed (see here). In the above statement, Gilead possibly refers to this, when they say that it is too early to discuss compulsory or other licensing questions for now.

For readers who may be interested – China does have what seems to be fairly standard Compulsory Licensing provisions, which you can see in the Chinese Patent Act here (PDF). Relevant portions are Articles 48 to 58, with Article 49 and 50 dealing specifically with national emergency, public interest and public health.

Aside from all of this, it is also reported that a patient in Japan has recovered after being treated with Sanofi’s Plaquenil (hydroxychloroquine sulfate), which had earlier been used to treat SARS. Similarly, there are reports of Teijin Pharma’s Alvesco (ciclesonide) showing some promise.

Never waste a good disaster

Pic of Corona Beer with caption "Corona Beer offers $15 million to Scientists to change Virus name to BudLightVirus", followed by "Certified Fake News"

Meme news here

Meanwhile, closer home, authorities have busted a fake hand sanitiser manufacturing company, in Gurugram, Haryana, which had been using the name “Viro-rub”. However, over in China, BrightGene, a Chinese biotech company, has stepped it up a notch. It announced on Feb 12th that it had mass manufactured Remdesivir, leading to its stock price shooting up immediately. However, it soon came to light that they had neither had the licence from Gilead to be manufacturing Remdesivir, nor had it even managed to make it at commercial scale, but rather only in small quantities for clinical research, leading to an apparent reprimand and censuring from the Shanghai Stock Exchange.

One hopes that the type of ingenuity that goes into making a quick buck, is also at work amongst those looking to bring us a treatment quickly!

Please click here to view other COVID-19 related posts on SpicyIP and leave a comment.

2 comments.

  1. AvatarDr K Chaudhry

    Malaria had been eradicated from India for a decade and staged a comeback during year 1971. Since 1971, several avtars of fever afflicted India. Viral fever, Dengue fever, Chikungunya – all began as killers. With time we learnt how to coexist with those diseases. Corona Virus showed up during recent months. That engulfed the entire World. The world would soon learn how to coexist with Corona Virus.
    Since year 1971, Chloroquine has been my default drug in fever cases. Viral fever, Dengue fever, Chikungunya – all political entities responded to Chloroquine. By simple mathemathics, there can be two possibilities :-
    1. New avtars of fever during consecutive years were new variants of malaria.
    2. Chloroquine known as antimalarial, may be nonspecific fever drug, effective also against Viral fever, Dengue fever, Chikungunya, and now Corona Virus.
    Chloroquine is a harmless drug with single dose required in endemic population and 5 tablet (double strength) course required elsewhere.
    Immunity boosters in routine and Chloroquine at first fever sign may be a magic mantra to make the World Corona free. Atovaquone-proguanil should also be tried in place of Chloroquine.
    Dr K Chaudhry [url edited out]
    FIRST Author of Jaypee Brothers

    Reply

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