IP is crucial to finding breakthrough COVID-19 medicines

 

How will bio-pharma businesses handle IP issues concerning COVID-19 innovations?

Many rights holders are working to develop vaccines and drugs to treat COVID-19. While some have already committed to granting non-exclusive licenses to their inventions, several questions remain.

In an interview of IAM with Corey Salsberg, Head of IP Affairs at Novartis, shared an inside perspective on the novel coronavirus and its implications for pharma IP strategies, especially with the process of testing to see if the existing medicines hydroxychloroquine and Jakafi 
can be used to treat COVID-19 patients.

Novartis committed to license or waive any rights pertaining to a repurposed hydroxychloroquine. Salsberg believes that legal exclusivities are unlikely to be a barrier to tackling the crisis as IP is crucial to finding breakthrough medicines. Therefore, the expectations that all IP rights relating to COVID-19 be set aside are misguided.

IP has been the driving force behind most historical drug development

The existing IP framework has created several candidate drugs and vaccines for COVID-19. This, along with the large number of partnerships already entered into by innovators during the crisis, suggests that this system is working.

Salsberg also suggests that less obvious, but equally important, is that IP actually helps companies to collaborate on innovation. It helps one to identify which other companies are working on particular compounds or vaccines. It also allows companies to understand and delineate the scope of potential collaboration. IP assures businesses that their proprietary information is only being shared for a certain purpose and “frees up companies which otherwise would be inhibited by prior arrangements”.

Making IP available

Another set of concerns relates to what will happen when COVID-19 vaccines or drugs are approved. Will IP rights prove a barrier to the access or affordability of these medicines?

According to Salsberg, several companies have voluntarily committed to make IP available. Regarding Novartis’s hydroxychloroquine pledge, he explains: “There is no longer any compound patent for the drug, but when you invest in new clinical studies for a new indication, you may produce data that would ordinarily qualify for regulatory exclusivity in countries like the US.”

A company may also produce patentable innovations by discovering the appropriate dosage if it is novel and non-obvious, or a new way of administration.

“Because this is an extraordinary situation, Novartis has committed to using any IP for this drug in ways that differ from normal circumstances, making relevant IP available through non-exclusive voluntary licenses, appropriate waivers, or similar mechanisms.”

No one-size-fits-all approach

IP rights relating to approved COVID-19 vaccines or drugs should not be waived by innovators. There is no one-size-fits-all solution but we have to take the circumstances and the long-term pictures into account.

A lot of drugs being tested for use against COVID-19 remain on-patent for treating other illnesses. “Innovators need to be able to ensure that those drugs are only being used in a limited way, for uses related to the treatment of COVID-19.”

Similarly, it is important to think about the role IP might play in driving future inventions. Whole new compounds for COVID-19 may also have potential applications well beyond coronavirus. Furthermore, there has been an unprecedented rise in counterfeiting during the pandemic. IP plays an important role in limiting partners to those who are going to create quality products.

Difficulties for small biotechs

Small and medium-sized innovators may have the most reservations about open-ended or blanket IP commitments.

“Novartis and its peers (large pharmaceutical companies) are in the fortunate position that we have a way of working that has allowed us to bring many medicines to market and keep investing in expensive R&D. So, when a major pandemic happens, we are able to make IP more widely available than usual.”

But many biotech innovators are small, have no products on the market yet, and rely on venture capital funding. If their only product turns out to relate to a pandemic, and there is a blanket rule that no profits can be made from COVID-19, it would be tremendously difficult for them to survive.

What does all this mean for participation in patent pools?

“We have not yet made a decision about whether we will or will not join any particular patent pooling mechanism,” comments Salsberg. “There may be a place for patent pools in responding to COVID-19, but a distinction needs to be made between two concepts of a patent pool.”

A traditional one involves IP owners pooling their rights together with each other in order to advance innovation. The other type of patent pool is one like the Medicines Patent Pool and is a clearinghouse that facilitates the granting of voluntary patent licenses to manufacturers under a blanket agreement. These create a one-stop-shop for lots of generic companies to get licenses.

In any case, Salsberg explains, that kind of approach is consistent with the voluntary licensing-type commitments that Novartis has already made with hydroxychloroquine and other companies have made with respect to some of their products.

Summarized from: IAM