Moderna says it won't enforce coronavirus vaccine patents during pandemic.
Moderna will not enforce patent rights related to its experimental coronavirus vaccine during the pandemic, announcing Thursday that its leadership feels "a special obligation under the current circumstances" to address the global health crisis. The committment earned praise from an intellectual property activist who said Moderna's pledge "should be matched by every manufacturer."
Moderna said it will allow open access to the patents for the "pandemic period," and is willing to out-license the same intellectual property once the pandemic is over. In doing so, the biotech joins Gilead in making its patent-protected discoveries available in the name of fighting COVID-19, although Gilead has restricted its Veklury licensing activity only to low- and middle-income countries.
Moderna's vaccine candidate is one of six RNA-based coronavirus vaccines in human testing, one other of which could become available within the next couple months. A Moderna spokesperson did not immediately respond to questions about whether the company is aware of any vaccines that infringe on its intellectual property.
In normal times, drugmakers rely on patents to ensure their products are protected from competition and are willing to fight tooth and nail to keep those defenses intact. However, with a pandemic still raging and potentially billions of people seeking effective treatments, some developers have appeared to take a more flexible approach.
Gilead has bowed to public pressure in the past and granted low-cost licenses to its drugs for HIV and hepatitis C. In the early months of the pandemic, the company initially struggled to manufacture enough doses of Veklury — one of few medicines shown to benefit COVID-19 patients — to meet global demand. Partly as a result, Gilead licensed Veklury intellectual property to five generic manufacturers to help cover supply for 27 low- and middle-income countries.
Moderna now appears to be taking a similar path with its experimental coronavirus shot.
The biotech's announcement was commended by James Love, head of the activist group Knowledge Ecology International and a frequent critic of drugmaker's patent practices.
"Every manufacturer of a vaccine, drug or diagnostic should follow suit and publish the patents relevant to the technology, waive or license rights in those patents, and also also provide constructive transfer of manufacturing know-how and access to cell lines and data when necessary," Love said in an emailed statement.
Moderna listed seven patents related to its vaccine, mRNA-1273, on its website, including one for the shot itself, one related to the production of messenger RNA and one tied to how the vaccine is delivered.
Recently, some of Moderna's patents have been in dispute. The company has lost a court battle over ownership of some of the intellectual property surrounding the delivery technology it uses — microscopic fat bubbles called lipid nanoparticles — to Arbutus Biopharma. And federal scientists appear to own rights to some of the technology used to create mRNA-1273.
Moderna did not respond to questions about whether the seven patents it specified are the only ones it is clearing other companies to use.
The technology behind mRNA vaccines was recognized early on in the pandemic as ideally suited to quickly deliver experimental candidates and to scale up manufacturing. Those hopes have largely played out, as the two leading candidates expected to deliver the first efficacy data from large placebo-controlled trials are mRNA-based vaccines from Moderna and German group BioNTech, which has partnered with Pfizer.
A third company, CureVac, has advanced an mRNA-based vaccine into a Phase 2 trial.
Author:Jon Gardner
Published: https://www.biopharmadive.com/news/moderna-coronavirus-vaccine-patents/586678/