Pharma and biotech IP rights have come under the spotlight during the current pandemic, with some commentators expressing concerns that innovators’ exclusivities could impede public access to the medicines needed to counter the coronavirus emergency, and several governments readying compulsory licensing provisions to circumvent potential IP roadblocks.
Many rights holders are working to develop vaccines and drugs to treat covid-19. But, while some have already committed to granting non-exclusive licences to their inventions, several questions remain about how biopharma businesses will – or should – handle IP issues concerning coronavirus innovations. It is not clear, for example, to what extent companies will commit their IP to the Unitaid’s Medicines Patent Pool for Covid-19, or whether any large pharma innovators will sign up to the Open COVID Pledge.
To get an inside perspective on the novel coronavirus and its implications for pharma IP strategies, IAM spoke to Corey Salsberg, Head of IP Affairs at Novartis, which is in the process of testing to see if the existing medicines hydroxychloroquine and Jakafi can be used to treat covid-19 patients.
Novartis has already committed to license or waive any rights pertaining to a repurposed hydroxychloroquine, and Salsberg believes that legal exclusivities are unlikely to be a barrier to tackling the crisis, arguing that IP is crucial to finding breakthrough medicines. Expectations that all IP rights relating to covid-19 be set aside are misguided, he contends. Instead, he advocates a case-by-case approach.
IP no barrier to covid-19 innovation
“It is important to look at facts when assessing the situation,” Salsberg says. “Some are saying that the first thing we should do in this crisis is throw our IP system out of the window. From my perspective, this does not make a lot of sense.”
“The first thing to remember is that we are only in the position to tackle the pandemic, because of where the IP system has brought us so far,” he comments, arguing that IP has been the driving force behind most historical drug development. “That applies to all of the potential treatments that we have been reading about, whether novel compounds under investigation or existing drugs like hydroxychloroquine and Gilead’s remdesivir.”
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 states: “I am not aware of any situation where IP has been shown to be a barrier to collaboration regarding the coronavirus.” He gives as examples Novartis’s and others’ participation in the Gates Foundation’s Covid-19 Therapeutics Accelerator and the Innovative Medicines Initiative Covid-19 partnership.
Less obvious, but equally important, he suggests, is that IP actually help companies to collaborate on innovation. “For example, IP helps us to identify which other companies are working on particular compounds or vaccines,” Salsberg explains. “IP allows companies to understand and delineate the scope of a potential collaboration,” he adds. It gives businesses comfort that their proprietary information, for example, 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, Salsberg acknowledges, 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?
“What we do know so far is that several companies have voluntarily committed to make IP available,” Salsberg responds. 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, Salsberg adds, 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 licences, appropriate waivers or similar mechanisms.”
No one-size-fits-all approach
However, Salsberg pushes back against the idea that all IP rights relating to approved covid-19 vaccines or drugs should be waived by innovators. “There is not a one-size-fits-all solution where we can say that all IP should be relinquished for all time,” he insists. “We need to think about the circumstances of each medicine, and the long-term picture.”
For example, he explains, 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, he continues: “It is important to think about the role IP might play in driving future inventions. If you are developing whole new compounds for covid-19, it may be that those new medicines have potential applications well beyond coronavirus.”
Salsberg points out that IP also has further uses: “We have seen an unprecedented rise in counterfeiting during the pandemic. As a general matter, 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, Salsberg suspects. “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, he continues, 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, how can those small biotechs survive? Who will invest in those companies after the pandemic?”
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, he states, involves IP owners pooling their rights together with each other in order to advance innovation. “In a sense the collaborations we have already seen and joined are like that; companies are already sharing and collaborating,” Salsberg explains. “At the moment there is not a lot of evidence that a traditional patent pool is necessary, but we are not opposed to the idea.”
The other type of patent pool is one like the Medicines Patent Pool and is a clearing house that facilitates the granting of voluntary patent licences to manufacturers under a blanket agreement. These create a one-stop shop for lots of generic companies to get licences.
“We support that model in the right circumstances and it is possible that it could play a role here,” Salsberg confirms, before qualifying: “But we first need to have the medicines to work out whether and to what extent IP needs to be shared in that way. I don’t think anyone yet knows how much of a role that model will play.”
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.