Practical, legal and moral implications where research involves patent-protected drugs
One of the big talking points at present is how we can get back to living our lives in a way that resembles what was normal just a few months ago. It seems that in the longer term (but hopefully not too long) this may be achieved by finding a vaccine for COVID-19, but of course seeking treatments for COVID-19 is also at the forefront of efforts by the pharmaceutical industry. Suitable treatments would ideally lower mortality rates, but alleviating symptoms is also highly desirable.
As anyone in the pharmaceutical industry knows, it takes years and massive expenditure to get a completely new drug approved and onto the market. Also, the risk of failure along the development path is high. In relation to COVID-19, time scales are crucial and treatments are needed as soon as possible to save lives worldwide. In view of this, it is not surprising that the pharmaceutical industry is looking at drugs that are already approved and used to treat other conditions as potential treatments for COVID-19. In other words, can a drug that is already known to treat one disease be used as a treatment for COVID-19?
The concept of using a known (and approved) drug for treating one disease to treat another is known as “drug repurposing”. This concept is not new. If a drug has made it to market to treat one disease, then there are clear benefits (to both patients and pharmaceutical companies) if that drug can be used to treat other diseases too. Drug repurposing allows for new treatments to be studied more rapidly, at lower costs and with reduced risk of failure as the safety profile of the drug is typically already well-established.
As COVID-19 is caused by a virus (SARS-CoV-2), and different viruses may replicate and colonise in similar ways, then a sensible starting point is to look at known anti-viral drugs to treat COVID-19. Thus, starting points of interest in the search for COVID-19 treatments have been drugs that are approved and used for the treatment of other viruses such as influenza, HIV and hepatitis. Additionally, steroids are being considered due to their anti-inflammatory effects.
Several large International trials are currently investigating potential treatments for COVID-19. The World Health Organization (WHO) is leading the SOLIDARITY trial, which has been joined by more than 100 countries. Drugs being investigated as COVID-19 treatments in this trial include Hydroxychloroquine (currently used to treat malaria, rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda) and Remdesivir (currently used to treat ebola and marburg virus infections).
Another large trial is the RECOVERY trial, which is being run in the UK by the National Institute for Health Research (NIHR). This trail has had tremendous success in finding that the known drug Dexamethasone reduced mortality in COVID-19 patients who were ventilated or receiving oxygen. There was no benefit in patients who did not need respiratory intervention. Dexamethasone is a commonly used steroid that has been used to treat patients with a range of diseases since the 1960’s. The patents that protected the compound per se will have expired years ago, but, as would be the case with any longstanding successful drug, numerous patents exist to different uses and formulations of Dexamethasone.
Other drugs being investigated include Lopinavir-ritonavir (a HIV protease inhibitor) and Favilavir (an antiviral agent).
Known drugs identified as effective COVID-19 treatments will most likely be protected by patents per se, unless the patents have expired. Even if the compound patents have expired, it is possible at the European Patent Office, and at most Patent Offices worldwide, to obtain a patent for a new medical use of a known drug (known as a second medical use patent). For example, it is possible to obtain a patent that protects the use of the known drug to treat a new disease (such as COVID-19). It is also possible to obtain a patent that protects the use of a known drug in terms of a different treatment regime (including a combination treatment), dosage form or route of administration, or that protects a particular salt or polymorph. At this time, it is not known whether a patent directed to the use of Dexamethasone to treat COVID-19 has been applied for, or whether there are patents in existence that cover particular commercial forms or formulations of Dexamethasone.
Questions are often asked about whether it is morally acceptable for pharmaceutical companies to seek patents for such second medical uses, formulations etc and if they do whether these patents should be enforced. Such questions seem particularly relevant in light of the current pandemic. One point of view is that pharmaceutical companies are, of course, commercial entities that must make a profit to enable re-investment in future research and development whilst delivering to shareholders. Obtaining and enforcing valid patents helps this to happen. Another point of view is that pharmaceutical companies should not profit from the COVID-19 pandemic and should simply work to treat patients and save lives. Any pharmaceutical companies seen to be enforcing patents around COVID-19 inventions could suffer from bad publicity at least in the short term.
Even if pharmaceutical companies do obtain patents directed to COVID-19 treatments, governments can act to prevent enforcement by the patent owner. In the UK, the government could step in and allow acts that would otherwise constitute patent infringement without the consent of the patent owner, known as the “Crown use” provision. However, this provision is rarely used, and it would be for the government to decide whether to apply it. Perhaps if a treatment or vaccine for COVID-19 is identified as suitable for widespread use then there will be lobbying for Crown use provisions to be enacted. In this case, the government would have to provide reasonable compensation to patent owners for any loss in profit, which loss could be massive and add to the already escalating costs of COVID-19.
Another option is the grant of a compulsory licence, but this is only possible more than 3 years after grant of a relevant patent. In the UK, the government can intervene and apply for a compulsory licence on behalf of a third party, provided that the third party has tried to obtain a licence from the patent holder within a reasonable period of time and on reasonable terms. These requirements may mean that Crown use provisions could be more useful in the current situation. However, in Israel, the government has issued a compulsory licence that enables the use of Lopinavir-ritonavir to treat COVID-19 without the consent of the patent holder and other countries may follow.
Quite how the search for treatments for COVID-19 will progress remains to be seen, but there is certainly a great deal of effort being made, including by collaboration between different countries and parties. The hope is that effective treatments will be found quickly and that the patent system will not hinder their route to patients in need of them. Additionally, it should be remembered that COVID-19 is not the first pandemic in recent years, with SARS and MERS also causing outbreaks of respiratory disease. The successful search for effective treatments, as well as any changes to how the patent system is applied to accommodate the pandemic, may be vital in determining an effective response to future pandemics.
