The COVID-19 pandemic has applied unprecedented pressure to supply chains across virtually every sector of the economy, as borders have been closed and entire industries shutdown.
However, as demand for specialist equipment such as ventilators has soared and supply chain bottlenecks for other products such as hand sanitiser has created market scarcity, many organisations have pivoted their productive capacity and reallocated their resources to where society needs them most.
Repurposing, though, presents challenges for organisations who want to contribute to tackling the pandemic while also protecting the commercial value of their intellectual property (IP). This blog will assess some of these challenges.
Repurposing in the pharmaceutical sector
The pandemic has led to a surge in research activity around the repurposing of existing pharmaceuticals to treat covid. For example, the anti-viral drug remdesivir was originally developed over 10 years ago to treat hepatitis C. It was shown to be ineffective for the treatment of hep C but was later repurposed (again, relatively unsuccessfully) during the Ebola outbreak, and has now been repurposed again to reduce recovery time for hospitalised covid patients. Similarly, the steroid dexamethasone, normally used to treat inflammatory and autoimmune conditions, has been shown to significantly improve survival rates for patients suffering life threatening cases of covid. Studies have also been conducted into the possibility of repurposing some antiretroviral and anti-malaria drugs.
It usually takes an average of around 10 years and $2.6 billion of investment to bring a new drug to market. Repurposing drastically reduces these timelines and costs because much of the original safety data gathered during clinical trials will still be useful for a new product use case, thereby accelerating an application for Emergency Use Authorisation or a conditional Marketing Authorisation. Repurposed drugs are therefore vital in providing efficient and cost-effective treatments in times of crisis.
However, repurposed pharmaceuticals also pose their own challenges in terms of IP protection. The 20-year period of patent protection for already-existing drugs may well have expired by the time their new purpose has been discovered and Supplementary Protection Certificates typically only extend a rights holder's monopoly for a further 5.5 years. It is possible to obtain a new patent from the European Patent Office for a second medical use of an existing drug, although such applications often fail due to lack of novelty of the invention and are open to challenge (by either examiners or competitors) if the original patent description covered "new" indications. For alternative use cases where strong patent protection may not be available, organisations may still be able to benefit from exclusivity of pre-clinical and clinical data conferred by Regulatory Data Protection, further incentivising organisations to develop robust data packages for repurposed drugs.
Repurposing is not unique to the pharmaceutical and life sciences industry. Businesses across a number of sectors have repurposed their production lines to satisfy the demand for covid-related products: several distilleries have started producing hand sanitiser; car manufacturers have started building hospital ventilators; textiles manufacturers are mass-producing face masks and other PPE.
In some instances, businesses can use their own resources and IP, whether registered (such as patents) or unregistered (such as know-how or standard operating procedures), to execute this commercial pivot, but it can also open the door to collaboration. Indeed, the pandemic has thrust together various stakeholders and organisations into new, makeshift working relationships - often between former commercial competitors. The effectiveness and productivity of these relationships is to a large extent dependent on robust, flexible IP agreements. Strong IP arrangements, such as licensing agreements or patent pooling, can protect the value of intangible assets while facilitating knowledge-sharing and allowing productive capacity to be scaled-up.
Where two or more parties are seeking to collaborate, having clearly protected rights makes determining the parameters of use and respective IP ownership easier. This prevents any confusion downstream as to whose IP is whose and how commercial risks or benefits are to be allocated. In times of crisis, this provides certainty, avoids unnecessary delays and allows resources to be mobilised effectively to where they are needed most.
Pivoting for success
Repurposed drugs and production lines have played a vital role in the response to COVID-19 by reallocating the productive capacity of the economy to crisis-critical areas. This pivoting of resources requires organisations to be shrewd and adaptable in how they harness and protect the value of their intangible assets. Robust IP arrangements can contribute to this adaptability by offering certainty in times of crisis.