The role of IP in strategies for repurposing medicines

However, researchers must give thought to how intellectual property (IP) rights might impact their repurposing projects.

Repurposing and its benefits

The repurposing of medicines can take a variety of guises. In many cases, repurposing entails exploring new therapeutic indications for an already authorised treatment. This approach can be fruitful because it involves the use of de-risked medicines that are already available to patients, and so can deliver advantages such as lower overall development costs and shorter development timelines, as well as economic and societal benefits for more sustainable healthcare systems in the long term. 

Repurposing can also mean finding new rules around the administering of medicines, such as making improvements to formulations, dosage or means of delivery. Repurposing can also entail new combinations of medicines previously used as separate products, or combining drugs with a medical device for the first time.

In some cases, researchers will also seek to repurpose failed assets or research initiatives that previously stalled. In this regard, a number of major pharmaceutical manufacturers have put some of their abandoned candidates in publicly available libraries.

Coronavirus and examples of repurposed medicines

In recent months, work exploring the repurposing of medicines has taken on additional significance as medical research has focused on not only finding a vaccine for Covid-19 but on determining whether existing treatments can help address at least the virus's severest effects.

In this context, antimalarial drug hydroxychloroquine made the headlines when former US president Donald Trump appeared to endorse its use in the treatment of Covid-19, though studies have subsequently cast doubt as to its utility in the Covid-19 context. However, other trials have been more successful.

In September last year, the European Medicines Agency endorsed the use of dexamethasone in Covid-19 patients on oxygen or mechanical ventilation, while recent reports concerning tocilizumab, an anti-rheumatic drug, found that use of the product can curb the number of deaths experienced by patients hospitalised with Covid-19.

There are many further examples of existing treatments having been repurposed successfully that pre-date the pandemic.

Prominent examples include the use of aspirin, which was initially developed as a pain killer, to prevent cardiovascular disease and cancer, particularly pancreatic cancer, while Viagra – perhaps best known for treating erectile dysfunction – was initially developed to treat hypertension.

Other examples include finasteride, which was found to not only treat prostrate enlargement but male baldness too, and thalidomide, which became a treatment for leprosy and then a blockbuster drug for the treatment of myeloma after its initial purpose for treating morning sickness in pregnancy ended in medical disaster.

The role of an IP strategy

A bespoke approach to IP is needed when repurposing medicines. This should form part of a broader strategy which organisations will need to adopt and implement in order to overcome the complex mix of other challenges they will face in successfully developing and launching repurposed medicines – including funding constraints and regulatory hurdles.

Some medicines that researchers may want to repurpose will be protected by patents or supplementary protection certificates, or otherwise benefit from another form of market exclusivity – such as those that apply to designated 'orphan' medicines for treating rare diseases. These patents could cover the existing product, its underlying chemical or biological make-up, as well as new indications, dosage regimes or mechanisms of delivery.

Short of challenging the validity of existing IP rights, those behind repurposing initiatives can look at the opportunity to negotiate a licence or enter a form of collaboration arrangement with rights holders to partner in bringing their medicine to market. An IP strategy will help researchers navigate existing protections and understand what licensing opportunities there might be.

If there are no third party patents then researchers' will have freedom to operate. An additional consideration then is the likely presence of generic competition in the market – this is particularly the case where products have been successful under patent and there remains a market for them after the patent protection runs out. This prospect of established competitors in the market can diminish the business case for investment in repurposing projects.  Researchers developing repurposed medicines should not rule out, therefore, the possibility to obtain patent protection themselves. Patents can be valuable assets – attracting investors, fostering cross-licensing opportunities and can offer some protection against any competitors entering the market for the repurposed product.

An effective IP strategy is only part of the puzzle when repurposing medicines but it is an essential tool in identifying risks and opportunities when setting out on new projects.

Pinsent Masons, in partnership with LifeArc, is hosting an online event on 9 March at which the importance of IP issues – as well as of regulation, commercial positioning and patient involvement – to any strategy for repurposing medicines will be discussed.