As life returns to a new normal, scientists from academia and industry around the world continue in their quest to find a solution to COVID-19. The race is on to find a vaccine that will provide long term protection against the virus as well as for biologicals and small molecule solutions for effective treatments for the disease.
In the usual course of drug development, patent protection would play an important role in ensuring time-limited protection for intellectual assets thus allowing for commercialisation of pharmaceutical products to generate income for further research and development. But these are unusual times, so what role should patent protection play in a pandemic, particularly when governments are actively part funding pharmaceutical company research as demonstrated by the recent US government payment of $2.1 billion to Sanofi and GlaxoSmithKline?.
Drug development repurposing
Drug development is often a long and expensive process with each phase of development and regulatory approval taking many years. The repurposing of existing pharmaceutical products may provide a shortcut to this, allowing treatments for COVID-19 to reach patients as quickly and as safely as possible. There are more than 150 different drugs being investigated around the world with the UK running one of the largest clinical trials (12,000 patients), called ‘Recovery’, aimed at providing a definitive view on what works and what doesn’t. Many pharmaceutical companies are also running trials of their own drugs. However, it is likely that many of these existing drugs will carry with them intellectual property rights that are designed to protect their innovators from non-sanctioned exploitation.
IP pooling is one option that is being considered to ensure that IP does not hinder access to COVID-19 treatments. The World Health Organization (WHO) has already launched an initiative called C-TAP (Covid-19 Technology Access Pool) with Costa Rica aimed at reducing production costs and increasing access to diagnostics, therapeutics and vaccines. This voluntary scheme would involve participants sharing information including trial data and patent rights, however, it has been met with mixed reactions. Several countries including Norway, the Netherlands and India (who has a very significant generics market) have signed up but, understandably, many innovative pharmaceutical companies such as AstraZeneca, GlaxoSmithKline, Pfizer and Johnson & Johnson have expressed concerns. Patents provide a government granted monopoly that is the reward for innovation, thus providing the motivation to innovate often at great financial risk. IP pooling risks undermining the IP system and could consequently remove the motivation to innovate.
Licensing may provide a more acceptable alternative that results in equitable access whilst ensuring innovators maintain control of their IP. One group of US and UK-based scientists, lawyers, entrepreneurs and individuals, for example, have developed a time- limited formal licence that encourages rights holders to allow others to use their intellectual property, for free, in the fight against Covid-19. In addition, some pharmaceutical companies and medical technology companies have already publicly announced that they will waive or will not enforce patent rights and allow research access to their IP. For example, Gilead has requested that the US Food and Drug Administration (FDA) rescinds the 'orphan drug' designation that was granted for the investigational antiviral Remdesivir for the treatment of Covid-19 and announced that it is "waiving all benefits that accompany the designation". It has also been reported that Abbvie has said that it will not enforce its patent rights in Kaletra, a drug commonly used to treat HIV, in a move that will enable researchers to study its potential efficacy in treating Covid-19.
In any event, many governments have powers to override patent protections in emergency situations.
In addition to voluntary licensing efforts, some countries have the ability to allow compulsory licenses. Under section 48 of the UK Patents Act 1977, applications can be made for a compulsory license if the monopoly conferred by the patent in question is operating against the public interest.
Crown use provisions are also available to the UK government to provide exemptions from infringement to enable manufacturers to help in the fight against COVID-19. Under section 55(1)(a), the UK Patents Act 1977 provides that "any government department and any person authorised in writing by a government department may, for the services of the Crown" do various acts including making, using, importing and keeping, "without the consent of the proprietor of the patent…". The acts also extend to selling or offering to sell for the production or supply of specified drugs and medicines. Products of a patented process and the use of the process itself are also covered. The authorisation can be given retrospectively and compensation for loss of profit is available to the patent proprietor under section 57A through negotiation with the government after the event.
If compulsory licenses or Crown use provisions are used, it would be a serious step indeed, and hopefully such enforced measures will not be necessary in light of the huge collaborative efforts to find a solution. It cannot be in the interest of any country, company or person to hinder the global efforts against COVID-19.