said he would never use his patents related to the Covid-19 vaccine to prevent others from making his vaccine in more than 90 low- and middle-income countries, but signaled he was ready to start enforcing patents in richer countries.
The drugmaker said on Monday it now expects anyone in high-income countries wanting to use its patented technologies to respect the company’s intellectual property. He also said he was willing to license his patents to others in those countries on “commercially reasonable terms.”
These terms generally involve royalties on sales of products using the licensed technology.
The new position opens up the possibility for Moderna to file patent infringement lawsuits against companies in rich countries that fail to reach agreements on the use of Moderna’s technology, although it did not specify when. it could start looking to enforce its patents.
“If people have used or are using our technology to make a vaccine, I don’t understand why, once we’re in an endemic setting when there are plenty of vaccines and there’s no problem for provide vaccines, why we shouldn’t be rewarded for the things we invented,” Moderna chief executive Stephane Bancel said in an interview.
Moderna, of Cambridge, Mass., has several patents in the United States and other countries covering various aspects of its Covid-19 vaccine, named Spikevax.
Some of the company’s patents claim the invention of aspects of the underlying technology, known as messenger RNA, while others cover the use of an mRNA vaccine against coronaviruses.
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In 2020, Moderna pledged not to enforce patents covering its Covid-19 vaccine for the duration of the pandemic. Under this commitment, Moderna has not brought any patent infringement litigation against other companies or sought court injunctions to block the availability of vaccines.
As part of its amended undertaking, Moderna said it would never enforce its Covid-19 vaccine patents in 92 countries that are part of an international program, called Covax, which supplies Covid-19 vaccines.
These countries include India, Indonesia, Afghanistan, Haiti, Rwanda, Algeria, Egypt and Vietnam. Moderna said its new commitment applies to Covid-19 vaccines that are manufactured only for use in those 92 countries.
Moderna also said it would not enforce South Africa’s Covid-19 vaccine patents against efforts by Afrigen Biologics and Vaccines, in conjunction with the World Health Organization, to copy Moderna’s vaccine.
In low-income countries, “we don’t want people wasting time worrying about investing in Covid-19 vaccines using our technology,” Bancel said.
But the situation is different in high-income countries, Mr. Bancel said, because the supply of vaccines in these countries is no longer limited.
Bancel declined to say if and when Moderna might start enforcing its patents in high-income countries.
Pfizer’s Covid-19 vaccine Inc.
and BioNTech SE also uses mRNA technology. Pfizer said it does not expect intellectual property to be a barrier to its Covid-19 vaccine. The company has stated that it expects all third-party patent licenses to be available to it on reasonable terms.
However, disputes over patents surrounding Covid-19 vaccines have already erupted, with pharmaceutical companies pitting themselves against each other and government and academic scientists over who invented what.
Some poorer countries, including India and South Africa, have asked the World Trade Organization to waive certain patent obligations so that countries can more easily manufacture Covid-19 vaccines without breaching patent rights held by pharmaceutical companies. Last year, the Biden administration said it supported the move, while vaccine makers opposed it. It has not been implemented and is unlikely to occur.
Moderna faces patent infringement lawsuits. Last week, two small biotechnology companies, Arbutus Biopharma Corp.
and Genevant Sciences Inc., filed a lawsuit in federal court in Delaware, alleging that Moderna’s Covid-19 vaccine infringes six of their patents.
The companies said they were seeking compensation for what they claim was Moderna’s use of lipid nanoparticles – the tiny shells enveloping mRNA in vaccines – covered by their patents.
Moderna had previously attempted to invalidate some of the patents in a proceeding with the US patent office, but lost an appeal in federal court in December. Moderna has denied the allegations and said it plans to defend itself in the lawsuit. Moderna said its vaccine uses its own proprietary lipid nanoparticle technology.
Moderna has also had a dispute with the National Institutes of Health over who can be listed as co-inventors in a US patent application covering the Covid-19 vaccine mRNA sequence.
NIH researchers collaborated with Moderna on the design and testing of the vaccine, and opposed Moderna’s original plan not to list government scientists as inventors. Moderna has since dropped the patent application.
Moderna said the new patent promise is part of its efforts to promote global health. The company also said Monday that it plans to begin or advance vaccine testing against 15 pathogens identified as among the greatest public health risks, such as Zika and tuberculosis.
On Monday, Moderna announced plans to build an mRNA vaccine manufacturing facility in Kenya, with the goal of eventually producing up to 500 million doses of the vaccine per year for use in Africa.
Write to Peter Loftus at [email protected]
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